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FDA Simultaneous Marketing ANPRM
Comments Numbers Sorted By Issue

Issues 3 – 9 (Responses to ANPRM Questions) 

May 19, 2006

Final
Prepared by
ICF Consulting

Contents

3 - Should FDA initiate a rulemaking regarding its interpretation of section 503(b)? [ANPRM Q 1.A.]
4 - Is there significant confusion regarding interpretation of section 503(b) of the act? [ANPRM Q 1.B.]
5 - Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.]
6 - If FDA limited sale of OTC product to sub-population, would FDA be able to enforce limitation as a matter of law? [ANPRM Q 2.A.]
7 - Would FDA be able to enforce limitation to sub-population as practical matter? [ANPRM Q 2.B.]
8 - Assuming legal to market both, may the prescription (Rx) and OTC products be legally sold in the same package? [ANPRM Q 3.A.]
9 - If they can be legally sold in same package, under what circumstances would it be inappropriate to do so? [ANPRM Q 3.B.]

3 - Should FDA initiate a rulemaking regarding its interpretation of section 503(b)? [ANPRM Q 1.A.]

Comment Number Received Date Organization Commenter(s)

3.1 - Yes

Comment Number

Received Date

Organization

Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC1030

2005-10-27

Ms. Maureen Gombas

Gombas, Maureen,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC1037

2005-10-27

Ms. Noel Wharton

Wharton, Noel,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC111

2005-09-20

Dr. Jerrold Black

Black, Jerrold,

2005N-0345-EC11209

2005-11-03

Dr. Keith Brill

Brill, Keith,

2005N-0345-EC11436

2005-11-03

Mr. Russell Ault

Ault, Russell,

2005N-0345-EC11799

2005-11-03

Mrs. Maggie Kettlewood

Kettlewood, Maggie,

2005N-0345-EC118

2005-09-20

Ms. Jackie Krugler

Krugler, Jackie,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC124

2005-09-20

Mrs. Rhonda Koenig

Koenig, Rhonda,

2005N-0345-EC12528

2005-11-03

Feminist Student Alliance

Shillingford, Tiffany,

2005N-0345-EC126

2005-09-20

Ms. Anne Dougherty

Dougherty, Anne,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC14889

2005-11-03

Miss. Anne Mason

Mason, Anne,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC15892

2005-11-03

Mr. Ann Durbin

Durbin, Ann,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC15971

2005-11-03

CNMI Department of Public Health

Lochabay, Latisha,

2005N-0345-EC16

2005-09-01

Ms. Stephanie Smart

Smart, Stephanie,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC164

2005-09-20

Ms. alisa arthur

arthur, alisa,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16704

2005-11-03

Ms. JoHannah Whitsett

Whitsett, JoHannah,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC16777

2005-11-03

Santa Clara Valley Medical Center

Fainstat, Theodore,

2005N-0345-EC1792

2005-10-31

Mrs. Anastasia Brien

Brien, Anastasia,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC1856

2005-10-31

United Church of Christ

Snborn, Hugh,

2005N-0345-EC186

2005-09-20

Ms. Rhianna Wilson

Wilson, Rhianna,

2005N-0345-EC1927

2005-10-31

Mrs. Kristin Moon

Moon, Kristin,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC2186

2005-10-31

Miss. Linda Drucker

Drucker, Linda,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC2248

2005-11-03

Kostis Kosmos Inc.

Kostis, Steven,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC229

2005-09-20

Mrs. Jennifer Swanson

Swanson, Jennifer,

2005N-0345-EC2359

2005-11-03

Dr. Carolyn Givens

Givens, Carolyn,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC2362

2005-11-03

Miss. Reagan Moseley

Moseley, Reagan,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC247

2005-09-20

Ms. Teresa Dennison

Dennison, Teresa,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC252

2005-09-20

Falk Pharmacy

Hrinya, Margaret,

2005N-0345-EC255

2005-09-20

Mr. Bennett Korach

Korach, Bennett,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC265

2005-09-20

Ms. Nancy Mangini

Mangini, Nancy,

2005N-0345-EC280

2005-09-20

Mr. Marc Shapiro

Shapiro, Marc,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC324

2005-09-20

Mrs. Kim Stanley

Stanley, Kim,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC341

2005-09-20

Ms. Loy Schroeder

Schroeder, Loy,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC367

2005-09-20

Utah Valley State College

Stratton, Jacquie,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC37

2005-09-01

Dr. Martha Hayes

Hayes, Martha,

2005N-0345-EC373

2005-09-20

Dr. Sandra Haak

Haak, Sandra,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC387

2005-09-20

Ms. Alice Reed

Reed, Alice,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC405

2005-09-20

Amoli Organics Pvt. Limited, INDIA

Kulshrestha, Vikram V,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC445

2005-09-26

Mr. Stephen Ross

Ross, Stephen,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC454

2005-09-26

Miss. Rachel Crow

Crow, Rachel,

2005N-0345-EC457

2005-09-26

Dr. Daniel Wujek

Wujek, Daniel,

2005N-0345-EC461

2005-09-26

Ms. Jenna Leskela

Leskela, Jenna,

2005N-0345-EC463

2005-09-26

Ms. Karen Quicker

Quicker, Karen,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC467

2005-09-26

Ms. susan shull

shull, susan,

2005N-0345-EC472

2005-09-27

Mr. Roger Lands

Lands, Roger,

2005N-0345-EC4726

2005-11-03

Ms. Nancy Gray

Gray, Nancy,

2005N-0345-EC475

2005-09-27

None

Tschirhart, Marceline,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC527

2005-09-29

Mr. Robert Ramirez

Ramirez, Robert,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC550

2005-10-03

Mrs. Christine Disibio

Disibio, Christine,

2005N-0345-EC59

2005-09-01

Ms. Ruth Tehila Leonard

Leonard, Ruth Tehila,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC624

2005-10-12

Mrs. Natalie Frey

Frey, Natalie,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC634

2005-10-12

Ms. Beth Hill

Hill, Beth,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC650

2005-10-12

Concerned Women for America

White, Virginia,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC697

2005-10-12

High School Teacher

Madrigal, Isela,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC724

2005-10-12

Mrs. Mary Roybal

Roybal, Mary,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC741

2005-10-13

none

Pinque, Tracey,

2005N-0345-EC75

2005-09-01

Ms. Peggy Andreas

Andreas, Peggy,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC763

2005-10-13

Mrs. Rosemary Zatkulak

Zatkulak, Rosemary,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC769

2005-10-13

Ms. C Davis

Davis, C,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC781

2005-10-13

Mrs. Theresa Otto

Otto, Theresa,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC793

2005-10-13

private practice

Kuskey, Garvan,

2005N-0345-EC811

2005-10-13

Mrs. Kiera Camron

Camron, Kiera,

2005N-0345-EC813

2005-10-13

Ms. Patricia Wagner

Wagner, Patricia,

2005N-0345-EC818

2005-10-13

Mr. Jim Rudnicki

Rudnicki, Jim,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC8423

2005-11-03

CTA/NEA-Retired

Hollowell, Roberta,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC861

2005-10-17

Internal Medicine and Women's Health

Larkin, Lisa,

2005N-0345-EC862

2005-10-17

Mrs. Joann Lander

Lander, Joann,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC886

2005-10-17

Dr. Paul Burstein

Burstein, Paul,

2005N-0345-EC895

2005-10-17

UCSF

Holden, Karen,

2005N-0345-EC899

2005-10-17

Mr. David Paul Xavier Burch

Burch, David Paul Xavier,

2005N-0345-EC912

2005-10-18

Mr. William Moses

Moses, William,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC9440

2005-11-03

Mr. John Leonard

Leonard, John,

2005N-0345-EC95

2005-09-20

HVMA

Trubow, Marshall,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC369

2005-10-30

M. Clark

Marshell Clark,

2005N-0345-EMC371

2005-10-30

A. Fusco

Anthony Fusco,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC377

2005-10-30

A. Roman

Andrei Roman,

2005N-0345-EMC383

2005-10-31

A. Babalola

Abimbola Babalola,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

3.10 - Examples of FDA actions disallowing simultaneous marketing

Comment Number Received Date Organization Commenter(s)

2005N-0345-C453

2005-11-04

Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.

Signature:,

2005N-0345-EC793

2005-10-13

private practice

Kuskey, Garvan,

2005N-0345-EC8588

2005-11-03

NOW

schwab, brittney,

3.11 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC13026

2005-11-03

Ms. Tiffany Thomas

Thomas, Tiffany,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC402

2005-09-20

University of Utah

Murphy, Patricia,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

3.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C116

2005-10-21

The Alan Guttmacher Institute

Sharon Camp,

2005N-0345-C19

2005-09-26

E Wright

Emily Wright,

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C31

2005-09-29

Form Letter Count 23

Form Letter Count 23,

2005N-0345-C320

2005-10-31

University of California, San Francisco (UCSF)

Claire Brindis, DrPH, MPH et al,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-C60

2005-10-11

Planned Parenthood of Metropolitan New Jersey Inc

,

2005N-0345-C61

2005-10-11

Family Planning Advocates of New York State

JoAnn M Smith,

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC106

2005-09-20

Mrs. Kathleen Shaffer

Shaffer, Kathleen,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC110

2005-09-20

Hunter College

Roye, Carol,

2005N-0345-EC11094

2005-11-03

Ms. Erika Brown

Brown, Erika,

2005N-0345-EC1147

2005-10-27

Mr. Mark Hey

Hey, Mark,

2005N-0345-EC11729

2005-11-03

USAFR

,

2005N-0345-EC119

2005-09-20

Mrs. Carol Smith

Smith, Carol,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC13660

2005-11-03

Ms. Julie Anne Watko

Watko, Julie Anne,

2005N-0345-EC13778

2005-11-03

Mrs. Carol Svenson

Svenson, Carol,

2005N-0345-EC13819

2005-11-03

Ms. Colleen Brady

Brady, Colleen,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC13970

2005-11-03

Mr. R. Bonne

Bonne, R.,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC14078

2005-11-03

Mrs. Lori Kaiping

Kaiping, Lori,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC14123

2005-11-03

Mrs. Julia Smith

Smith, Julia,

2005N-0345-EC14143

2005-11-03

Mr. Douglas Levy

Levy, Douglas,

2005N-0345-EC14195

2005-11-03

Ms. Melissa Brown

Brown, Melissa,

2005N-0345-EC142

2005-09-20

Mr. Donald J. Dupier

Dupier, Donald J.,

2005N-0345-EC14207

2005-11-03

Ms. Rachel Hayward

Hayward, Rachel,

2005N-0345-EC14215

2005-11-03

Ms. Shira Fagan

Fagan, Shira,

2005N-0345-EC14264

2005-11-03

Ms. Linda Cozze

Cozze, Linda,

2005N-0345-EC14340

2005-11-03

Mrs. Barbara Jansen

Jansen, Barbara,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC14401

2005-11-03

National Organization for Women

Hutton, Jessica,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC156

2005-09-20

Ms. Anita Fream

Fream, Anita,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC16371

2005-11-03

Mrs. Rebecca Wiegand

Wiegand, Rebecca,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16657

2005-11-03

Ms. J. Rowat Kraiss

Rowat Kraiss, J.,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC1720

2005-10-31

Dr. Bonnie Anderson

Anderson, Bonnie,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1941

2005-10-31

Dr. Michael Brent

Brent, Michael,

2005N-0345-EC1946

2005-10-31

Mrs. Ventura Quijas

Quijas, Ventura,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC1970

2005-10-31

Pittsburgh

Crousey, Joshua,

2005N-0345-EC1979

2005-10-31

Mrs. Shannon Farrand-Bernardin

Farrand-Bernardin, Shannon,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC200

2005-09-20

Ms. carol holden

holden, carol,

2005N-0345-EC2022

2005-10-31

Mrs. Margaret Munro

Munro, Margaret,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC21

2005-09-01

NYC DOE

RICHMAN, BOBBI,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC2177

2005-10-31

Ms. Donna Bailer

Bailer, Donna,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC2269

2005-11-03

Mrs. Laurel Hansen

Hansen, Laurel,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC2308

2005-11-03

NOW

Naugle, Kay,

2005N-0345-EC2309

2005-11-03

Ms. Eva Wilkins

Wilkins, Eva,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC2317

2005-11-03

Ms. Kimberly Eaton

Eaton, Kimberly,

2005N-0345-EC2323

2005-11-03

Dr. Cynthia Mesh

Mesh, Cynthia,

2005N-0345-EC2325

2005-11-03

Ms. Katherine Mowen

Mowen, Katherine,

2005N-0345-EC2334

2005-11-03

Ms. Martha Johnson

Johnson, Martha,

2005N-0345-EC241

2005-09-20

Mrs. fern bindelglass

bindelglass, fern,

2005N-0345-EC250

2005-09-20

Ms. Lyn Jackson

Jackson, Lyn,

2005N-0345-EC262

2005-09-20

Mrs. Bethany Winder

Winder, Bethany,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC267

2005-09-20

Mrs. Leslie Dilley

Dilley, Leslie,

2005N-0345-EC270

2005-09-20

University of British Columbia

Shoveller, Jean,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC29

2005-09-01

Mrs. melissa sansing

sansing, melissa,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC319

2005-09-20

UALR-student

Myers, Micah,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC473

2005-09-27

Mr. Richard Duguay

Duguay, Richard,

2005N-0345-EC4803

2005-11-03

Miss. Jennifer Charney

Charney, Jennifer,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC51

2005-09-01

Dr. Stephine Heitkemper

Heitkemper, Stephine,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC563

2005-10-12

Mrs. Rosemary Woerner

Woerner, Rosemary,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC567

2005-10-12

Mr. Dominic Colvert

Colvert, Dominic,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC57

2005-09-01

United States of Ameica Citizen

Letter, Alice,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC594

2005-10-12

Mrs. Vicki Charocopos

Charocopos, Vicki,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC620

2005-10-12

Ms. Marie Fordtner

Fordtner, Marie,

2005N-0345-EC627

2005-10-12

Mr. Dale Olsen

Olsen, Dale,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC641

2005-10-12

Miss. Nellie Christian

Christian, Nellie,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC657

2005-10-12

Mr. James Thompson

Thompson, James,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC681

2005-10-12

Mrs. Kathryn Anthony

Anthony, Kathryn,

2005N-0345-EC689

2005-10-12

Mrs. Pamela Al-Bawab

Al-Bawab, Pamela,

2005N-0345-EC709

2005-10-12

Mrs. Regina Defauw

Defauw, Regina,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC725

2005-10-12

Mrs. Feleiteau Epley

Epley, Feleiteau,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC737

2005-10-13

Mr. Stan Young

Young, Stan,

2005N-0345-EC745

2005-10-13

Texas House of Representatives

Meyer, Dina,

2005N-0345-EC747

2005-10-13

Ms. Sandra Jordan

Jordan, Sandra,

2005N-0345-EC752

2005-10-13

Alpha Pregnancy Services

Humber, Prudence,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC7626

2005-11-03

Ms. Sonya Shelton

Shelton, Sonya,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC777

2005-10-13

Mr. John Long

Long, John,

2005N-0345-EC778

2005-10-13

Mrs. Lucia Rossi

Rossi, Lucia,

2005N-0345-EC784

2005-10-13

food supplements distributor

komm, phrana,

2005N-0345-EC785

2005-10-13

Mrs. Kathryn St Pierre

St Pierre, Kathryn,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC789

2005-10-13

Ms. Trista Delamere

Delamere, Trista,

2005N-0345-EC792

2005-10-13

Ms. Adele E. Zimmermann

Zimmermann, Adele E.,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC804

2005-10-13

Mrs. Denise Morningstar

Morningstar, Denise,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC815

2005-10-13

Mr. Joseph DeRitis

DeRitis, Joseph,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC851

2005-10-13

Ms. Lynne Garcia

Garcia, Lynne,

2005N-0345-EC854

2005-10-13

Ms. Johanna Roberts

Roberts, Johanna,

2005N-0345-EC865

2005-10-17

Mr. Steven Jago

Jago, Steven,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC888

2005-10-17

Mrs. Barbara Rine

Rine, Barbara,

2005N-0345-EC889

2005-10-17

ABC Pregnancy Help Center

Egging, Patrice,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC905

2005-10-18

Reproductive Endocriniologists

Gambrell, Jr., R. Don,

2005N-0345-EC908

2005-10-18

Mrs. Heather Thomas

Thomas, Heather,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

2005N-0345-EC925

2005-10-27

Dr. Stefanie Falz

Falz, Stefanie,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC952

2005-10-27

Central Alabama OB/GYN Associates, PA

Duggar, Christopher,

2005N-0345-EMC166

2005-09-16

M Dalton

Mike Dalton,

2005N-0345-EMC186

2005-10-11

Planned Parenthood of the Inland Northwest

Jet Tilley,

2005N-0345-EMC190

2005-10-12

Planned Parenthood of Central Pennsylvania

,

2005N-0345-EMC191

2005-10-12

Northern Adirondack Planned Parenthood

Martha Stahl,

2005N-0345-EMC204

2005-10-20

Planned Parenthood of New York City

Joan Malin,

2005N-0345-EMC446

2005-11-01

American Civil Liberties Union (ACLU)

Caroline Fredrickson and Greg No,

3.3 - FD&C Act and Amendments

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC21

2005-09-01

NYC DOE

RICHMAN, BOBBI,

3.3.1 - FD&C Act requires rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

3.3.2 - FD&C Act is clear regarding when a drug should be prescription only

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC106

2005-09-20

Mrs. Kathleen Shaffer

Shaffer, Kathleen,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC527

2005-09-29

Mr. Robert Ramirez

Ramirez, Robert,

2005N-0345-EC547

2005-10-03

Mr. Ralph Arnsparger

Arnsparger, Ralph,

2005N-0345-EC59

2005-09-01

Ms. Ruth Tehila Leonard

Leonard, Ruth Tehila,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

3.3.3 - Other arguments related to FD&C Act

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C407

2005-11-01

Pfizer, Inc.

Bert W. Rein,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC14598

2005-11-03

Ms. Nicole Garden

Garden, Nicole,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC16

2005-09-01

Ms. Stephanie Smart

Smart, Stephanie,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC447

2005-09-26

Mr. kurt anspach

anspach, kurt,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

3.4 - Administrative Procedure Act (APA) arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

3.5 - Supplemental New Drug Application (SNDA) and New Drug Application (NDA) regulations

Comment Number Received Date Organization Commenter(s)

3.5.1 - SNDA/NDA regulatory arguments supporting rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

3.5.2 - SNDA/NDA regulatory arguments opposing rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C61

2005-10-11

Family Planning Advocates of New York State

JoAnn M Smith,

2005N-0345-EMC446

2005-11-01

American Civil Liberties Union (ACLU)

Caroline Fredrickson and Greg No,

3.6 - Court opinion legal arguments

Comment Number Received Date Organization Commenter(s)

3.6.1 - Court case arguments supporting a rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

3.6.2 - Court case arguments opposing a rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

3.7 - Other legal arguments

Comment Number Received Date Organization Commenter(s)

3.7.1 - Other legal arguments supporting rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

3.7.2 - Other legal arguments opposing rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1117

2005-10-27

Dr. Stephanie Ahmed

Ahmed, Stephanie,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC23

2005-09-01

Ms. C. Parks

Parks, C.,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

3.8 - Policy arguments

Comment Number Received Date Organization Commenter(s)

3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC1037

2005-10-27

Ms. Noel Wharton

Wharton, Noel,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC383

2005-10-31

A. Babalola

Abimbola Babalola,

3.8.2 - Two-class system (OTC and Rx) not sufficient/behind-the-counter approach

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-C489

2005-11-16

Women's Bar Association of the State of New York (WBASNY)

,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC14421

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC38

2005-09-01

Dr. Sarah Scarpace

Scarpace, Sarah,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

3.8.3 - Other policy arguments for initiating a rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC13643

2005-11-03

Mr. Eugene Kwak

Kwak, Eugene,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC1927

2005-10-31

Mrs. Kristin Moon

Moon, Kristin,

2005N-0345-EC193

2005-09-20

Ms. Carol Witherwax

Witherwax, Carol,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC527

2005-09-29

Mr. Robert Ramirez

Ramirez, Robert,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC811

2005-10-13

Mrs. Kiera Camron

Camron, Kiera,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC895

2005-10-17

UCSF

Holden, Karen,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC383

2005-10-31

A. Babalola

Abimbola Babalola,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

3.8.4 - Interpretation is clear in present form

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC13026

2005-11-03

Ms. Tiffany Thomas

Thomas, Tiffany,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

3.8.5 - Circumstances for OTC safety are case-specific

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC461

2005-09-26

Ms. Jenna Leskela

Leskela, Jenna,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

3.8.6 - Develop/update guidance as alternative for rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C453

2005-11-04

Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.

Signature:,

3.8.7 - Cost-benefit concerns regarding rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C407

2005-11-01

Pfizer, Inc.

Bert W. Rein,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

3.8.8 - Other policy arguments opposing a rulemaking

Comment Number Received Date Organization Commenter(s)

2005N-0345-C320

2005-10-31

University of California, San Francisco (UCSF)

Claire Brindis, DrPH, MPH et al,

2005N-0345-C71

2005-10-12

D Ruckdeschel

Diana Ruckdeschel,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC157

2005-09-20

Mrs. Jennifer Smith

Smith, Jennifer,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC1946

2005-10-31

Mrs. Ventura Quijas

Quijas, Ventura,

2005N-0345-EC200

2005-09-20

Ms. carol holden

holden, carol,

2005N-0345-EC319

2005-09-20

UALR-student

Myers, Micah,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC710

2005-10-12

Mrs. Naomi Devine

Devine, Naomi,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC882

2005-10-17

Mr. Peter Vander Bleek

Vander Bleek, Peter,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EMC166

2005-09-16

M Dalton

Mike Dalton,

3.9 - Examples of previous FDA actions in allowing simultaneous marketing of Rx and OTC products

Comment Number Received Date Organization Commenter(s)

3.9.1 - Drug approval examples

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C5

2005-09-12

Micro ICU Project

Eurica Califorrniaa,

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC13

2005-09-01

Mr. Alexander Clague

Clague, Alexander,

2005N-0345-EC13643

2005-11-03

Mr. Eugene Kwak

Kwak, Eugene,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC148

2005-09-20

Ms. CINDY SCOTT

SCOTT, CINDY,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC15127

2005-11-03

Feminist Majority Foundation

Jordan, Beth,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC16427

2005-11-03

Mr. Christian Marcelli

Marcelli, Christian,

2005N-0345-EC16546

2005-11-03

Ms. Elle Saling

Saling, Elle,

2005N-0345-EC186

2005-09-20

Ms. Rhianna Wilson

Wilson, Rhianna,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC2056

2005-10-31

Ms. Pat Malcolm

Malcolm, Pat,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC2090

2005-10-31

Mrs. Jackie Bodden

Bodden, Jackie,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC228

2005-09-20

Mr. Clay Evans

Evans, Clay,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC335

2005-09-20

Dr. Jill Devenport

Devenport, Jill,

2005N-0345-EC373

2005-09-20

Dr. Sandra Haak

Haak, Sandra,

2005N-0345-EC382

2005-09-20

Ms. Elizabeth Graham

Graham, Elizabeth,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC925

2005-10-27

Dr. Stefanie Falz

Falz, Stefanie,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

2005N-0345-EC95

2005-09-20

HVMA

Trubow, Marshall,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

3.9.2 - FDA guidance/other docs (e.g., 1999 Manual of Policy and Procedures)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

3.9.3 - Veterinary drug policy

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

3.9.4 - Other examples

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC280

2005-09-20

Mr. Marc Shapiro

Shapiro, Marc,

4 - Is there significant confusion regarding interpretation of section 503(b) of the act? [ANPRM Q 1.B.]

Comment Number Received Date Organization Commenter(s)

4.1 - Yes

Comment Number Received Date Organization Commenter(s)

2005N-0345-C453

2005-11-04

Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.

Signature:,

2005N-0345-EC1030

2005-10-27

Ms. Maureen Gombas

Gombas, Maureen,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC106

2005-09-20

Mrs. Kathleen Shaffer

Shaffer, Kathleen,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC1114

2005-10-27

Ms. Kelly Lash

Lash, Kelly,

2005N-0345-EC11642

2005-11-03

Dr. Mallary Tytel

Tytel, Mallary,

2005N-0345-EC126

2005-09-20

Ms. Anne Dougherty

Dougherty, Anne,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC14143

2005-11-03

Mr. Douglas Levy

Levy, Douglas,

2005N-0345-EC14185

2005-11-03

Dr. Richard Kaslow

Kaslow, Richard,

2005N-0345-EC14207

2005-11-03

Ms. Rachel Hayward

Hayward, Rachel,

2005N-0345-EC14217

2005-11-03

Ms. Jennifer Doleac

Doleac, Jennifer,

2005N-0345-EC14340

2005-11-03

Mrs. Barbara Jansen

Jansen, Barbara,

2005N-0345-EC14401

2005-11-03

National Organization for Women

Hutton, Jessica,

2005N-0345-EC14462

2005-11-03

Ms. Diane Boudreau

Boudreau, Diane,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC1485

2005-10-28

Ms. Maggie Daly

Daly, Maggie,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC164

2005-09-20

Ms. alisa arthur

arthur, alisa,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16777

2005-11-03

Santa Clara Valley Medical Center

Fainstat, Theodore,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC16921

2005-11-03

Ms. Heather Nesemeier

Nesemeier, Heather,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC1856

2005-10-31

United Church of Christ

Snborn, Hugh,

2005N-0345-EC1863

2005-10-31

Women's Political Caucus

Ralston, Virginia,

2005N-0345-EC1927

2005-10-31

Mrs. Kristin Moon

Moon, Kristin,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2129

2005-10-31

Ms. Sandra Stevenson

Stevenson, Sandra,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC2186

2005-10-31

Miss. Linda Drucker

Drucker, Linda,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC2248

2005-11-03

Kostis Kosmos Inc.

Kostis, Steven,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC2292

2005-11-03

Institute of Shamanic Wisdom, Inc.

Carbon, Liana,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC247

2005-09-20

Ms. Teresa Dennison

Dennison, Teresa,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC265

2005-09-20

Ms. Nancy Mangini

Mangini, Nancy,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC278

2005-09-20

N/A

endris, kelle,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC282

2005-09-20

Ms. Darci Kolb, MSN, FNP

Kolb, MSN, FNP, Darci,

2005N-0345-EC284

2005-09-20

Mrs. Linda Shroyer

Shroyer, Linda,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC304

2005-09-20

Ms. Kathryn Scharplaz

Scharplaz, Kathryn,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC373

2005-09-20

Dr. Sandra Haak

Haak, Sandra,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC415

2005-09-20

Dr. Barbara Bittner

Bittner, Barbara,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC428

2005-09-20

INOVA Fairfax Hospital

Rizzo, Anne,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC445

2005-09-26

Mr. Stephen Ross

Ross, Stephen,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC461

2005-09-26

Ms. Jenna Leskela

Leskela, Jenna,

2005N-0345-EC463

2005-09-26

Ms. Karen Quicker

Quicker, Karen,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC472

2005-09-27

Mr. Roger Lands

Lands, Roger,

2005N-0345-EC475

2005-09-27

None

Tschirhart, Marceline,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC615

2005-10-12

Ms. Mary Gillman

Gillman, Mary,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC631

2005-10-12

Mrs. B Lang

Lang, B,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC643

2005-10-12

None

Conner, Dixie,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

2005N-0345-EC650

2005-10-12

Concerned Women for America

White, Virginia,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC652

2005-10-12

Mrs. Cynthia Choo

Choo, Cynthia,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC657

2005-10-12

Mr. James Thompson

Thompson, James,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC661

2005-10-12

none

Gill, Barbara,

2005N-0345-EC681

2005-10-12

Mrs. Kathryn Anthony

Anthony, Kathryn,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC697

2005-10-12

High School Teacher

Madrigal, Isela,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC699

2005-10-12

Mrs. Christine Lund-Molfese

Lund-Molfese, Christine,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC710

2005-10-12

Mrs. Naomi Devine

Devine, Naomi,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC717

2005-10-12

Mr. Joseph Gorini

Gorini, Joseph,

2005N-0345-EC724

2005-10-12

Mrs. Mary Roybal

Roybal, Mary,

2005N-0345-EC725

2005-10-12

Mrs. Feleiteau Epley

Epley, Feleiteau,

2005N-0345-EC729

2005-10-13

Mrs. M. Brown

Brown, M.,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC741

2005-10-13

none

Pinque, Tracey,

2005N-0345-EC750

2005-10-13

Mrs. stella milam

milam, stella,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC781

2005-10-13

Mrs. Theresa Otto

Otto, Theresa,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC785

2005-10-13

Mrs. Kathryn St Pierre

St Pierre, Kathryn,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC793

2005-10-13

private practice

Kuskey, Garvan,

2005N-0345-EC815

2005-10-13

Mr. Joseph DeRitis

DeRitis, Joseph,

2005N-0345-EC821

2005-10-13

Ms. Lenore Satterfield

Satterfield, Lenore,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC851

2005-10-13

Ms. Lynne Garcia

Garcia, Lynne,

2005N-0345-EC854

2005-10-13

Ms. Johanna Roberts

Roberts, Johanna,

2005N-0345-EC859

2005-10-17

Ms. Anne Koerber

Koerber, Anne,

2005N-0345-EC861

2005-10-17

Internal Medicine and Women's Health

Larkin, Lisa,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC909

2005-10-18

Mrs. Judith Bayba

Bayba, Judith,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

2005N-0345-EC95

2005-09-20

HVMA

Trubow, Marshall,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC371

2005-10-30

A. Fusco

Anthony Fusco,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

4.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C61

2005-10-11

Family Planning Advocates of New York State

JoAnn M Smith,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC111

2005-09-20

Dr. Jerrold Black

Black, Jerrold,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC1147

2005-10-27

Mr. Mark Hey

Hey, Mark,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC124

2005-09-20

Mrs. Rhonda Koenig

Koenig, Rhonda,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC139

2005-09-20

N/A

Alldrin, Lynn,

2005N-0345-EC142

2005-09-20

Mr. Donald J. Dupier

Dupier, Donald J.,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC156

2005-09-20

Ms. Anita Fream

Fream, Anita,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC16

2005-09-01

Ms. Stephanie Smart

Smart, Stephanie,

2005N-0345-EC163

2005-09-20

Mr. Leo Smith

Smith, Leo,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC1728

2005-10-31

Ms. Kristie Gantt-Bean

Gantt-Bean, Kristie,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC1792

2005-10-31

Mrs. Anastasia Brien

Brien, Anastasia,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC200

2005-09-20

Ms. carol holden

holden, carol,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC2177

2005-10-31

Ms. Donna Bailer

Bailer, Donna,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC250

2005-09-20

Ms. Lyn Jackson

Jackson, Lyn,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC267

2005-09-20

Mrs. Leslie Dilley

Dilley, Leslie,

2005N-0345-EC270

2005-09-20

University of British Columbia

Shoveller, Jean,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC298

2005-09-20

Mrs. Jennifer Hoyle-Franklin

Hoyle-Franklin, Jennifer,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC334

2005-09-20

Ms. Lori Wilbois

Wilbois, Lori,

2005N-0345-EC341

2005-09-20

Ms. Loy Schroeder

Schroeder, Loy,

2005N-0345-EC387

2005-09-20

Ms. Alice Reed

Reed, Alice,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC392

2005-09-20

Dr. LeClair Bissell

Bissell, LeClair,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC473

2005-09-27

Mr. Richard Duguay

Duguay, Richard,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC563

2005-10-12

Mrs. Rosemary Woerner

Woerner, Rosemary,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC594

2005-10-12

Mrs. Vicki Charocopos

Charocopos, Vicki,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC614

2005-10-12

Mr. Kevin Doran

Doran, Kevin,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC620

2005-10-12

Ms. Marie Fordtner

Fordtner, Marie,

2005N-0345-EC624

2005-10-12

Mrs. Natalie Frey

Frey, Natalie,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC670

2005-10-12

Miss. Alisa Craddock

Craddock, Alisa,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC695

2005-10-12

Franciscan Univ. Steubenville OH, Austrian Campus

,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC719

2005-10-12

Rachel Ministry

Peterson, Eileen,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC747

2005-10-13

Ms. Sandra Jordan

Jordan, Sandra,

2005N-0345-EC752

2005-10-13

Alpha Pregnancy Services

Humber, Prudence,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC789

2005-10-13

Ms. Trista Delamere

Delamere, Trista,

2005N-0345-EC792

2005-10-13

Ms. Adele E. Zimmermann

Zimmermann, Adele E.,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC804

2005-10-13

Mrs. Denise Morningstar

Morningstar, Denise,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC862

2005-10-17

Mrs. Joann Lander

Lander, Joann,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC889

2005-10-17

ABC Pregnancy Help Center

Egging, Patrice,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC905

2005-10-18

Reproductive Endocriniologists

Gambrell, Jr., R. Don,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

2005N-0345-EC925

2005-10-27

Dr. Stefanie Falz

Falz, Stefanie,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

2005N-0345-EMC204

2005-10-20

Planned Parenthood of New York City

Joan Malin,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

4.3 - Arguments supporting significant confusion regarding FDA’s interpretation

Comment Number Received Date Organization Commenter(s)

4.3.1 - FDA’s interpretation of FD&C Act 505(b)(2) conflicts with interpretation of 503(b)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C453

2005-11-04

Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.

Signature:,

4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA’s authority

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC57

2005-09-01

United States of Ameica Citizen

Letter, Alice,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC912

2005-10-18

Mr. William Moses

Moses, William,

4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA’s interpretation

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC14261

2005-11-03

Mr. B Owens

Owens, B,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

4.3.4 - Other policy arguments/statements supporting confusion re: FDA’s interpretation

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC21

2005-09-01

NYC DOE

RICHMAN, BOBBI,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC59

2005-09-01

Ms. Ruth Tehila Leonard

Leonard, Ruth Tehila,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC631

2005-10-12

Mrs. B Lang

Lang, B,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC710

2005-10-12

Mrs. Naomi Devine

Devine, Naomi,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC895

2005-10-17

UCSF

Holden, Karen,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

4.4 - Arguments indicating that little or no confusion exists

Comment Number Received Date Organization Commenter(s)

4.4.1 - Legal arguments that little or no confusion exists

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

4.4.2 - Policy arguments that little or no confusion exists

Comment Number Received Date Organization Commenter(s)

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC200

2005-09-20

Ms. carol holden

holden, carol,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

4.5 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC447

2005-09-26

Mr. kurt anspach

anspach, kurt,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC90

2005-09-20

Mrs. Elisha Townsend

Townsend, Elisha,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

5 - Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.]

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC631

2005-10-12

Mrs. B Lang

Lang, B,

2005N-0345-EC643

2005-10-12

None

Conner, Dixie,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

5.1 - Yes

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC1030

2005-10-27

Ms. Maureen Gombas

Gombas, Maureen,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC1114

2005-10-27

Ms. Kelly Lash

Lash, Kelly,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC163

2005-09-20

Mr. Leo Smith

Smith, Leo,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16777

2005-11-03

Santa Clara Valley Medical Center

Fainstat, Theodore,

2005N-0345-EC16921

2005-11-03

Ms. Heather Nesemeier

Nesemeier, Heather,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC1856

2005-10-31

United Church of Christ

Snborn, Hugh,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2186

2005-10-31

Miss. Linda Drucker

Drucker, Linda,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC2248

2005-11-03

Kostis Kosmos Inc.

Kostis, Steven,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC247

2005-09-20

Ms. Teresa Dennison

Dennison, Teresa,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC265

2005-09-20

Ms. Nancy Mangini

Mangini, Nancy,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC34

2005-09-01

Mr. Ralph Hudson

Hudson, Ralph,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC37

2005-09-01

Dr. Martha Hayes

Hayes, Martha,

2005N-0345-EC373

2005-09-20

Dr. Sandra Haak

Haak, Sandra,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC428

2005-09-20

INOVA Fairfax Hospital

Rizzo, Anne,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC445

2005-09-26

Mr. Stephen Ross

Ross, Stephen,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC463

2005-09-26

Ms. Karen Quicker

Quicker, Karen,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC472

2005-09-27

Mr. Roger Lands

Lands, Roger,

2005N-0345-EC475

2005-09-27

None

Tschirhart, Marceline,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC650

2005-10-12

Concerned Women for America

White, Virginia,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC661

2005-10-12

none

Gill, Barbara,

2005N-0345-EC68

2005-09-01

Ms. Lynn Max

Max, Lynn,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC724

2005-10-12

Mrs. Mary Roybal

Roybal, Mary,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC741

2005-10-13

none

Pinque, Tracey,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC821

2005-10-13

Ms. Lenore Satterfield

Satterfield, Lenore,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC836

2005-10-13

Friends

Winfield-Kutza, Mary,

2005N-0345-EC840

2005-10-13

Home Health Care

Rew, Barbara,

2005N-0345-EC861

2005-10-17

Internal Medicine and Women's Health

Larkin, Lisa,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC912

2005-10-18

Mr. William Moses

Moses, William,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC371

2005-10-30

A. Fusco

Anthony Fusco,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

5.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C61

2005-10-11

Family Planning Advocates of New York State

JoAnn M Smith,

2005N-0345-EC106

2005-09-20

Mrs. Kathleen Shaffer

Shaffer, Kathleen,

2005N-0345-EC112

2005-09-20

Infectious Diseases Assoc. of Fort Lauderdale

Combs, RN, Michelle,

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC1147

2005-10-27

Mr. Mark Hey

Hey, Mark,

2005N-0345-EC11642

2005-11-03

Dr. Mallary Tytel

Tytel, Mallary,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC1398

2005-10-28

Mr. David Stuart

Stuart, David,

2005N-0345-EC142

2005-09-20

Mr. Donald J. Dupier

Dupier, Donald J.,

2005N-0345-EC1427

2005-10-28

Mrs. Christine Danner

Danner, Christine,

2005N-0345-EC1440

2005-10-28

Mrs. Kimberly Scott

Scott, Kimberly,

2005N-0345-EC14462

2005-11-03

Ms. Diane Boudreau

Boudreau, Diane,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC1483

2005-10-28

Ms. Megan Santiestevan

Santiestevan, Megan,

2005N-0345-EC1485

2005-10-28

Ms. Maggie Daly

Daly, Maggie,

2005N-0345-EC1509

2005-10-31

Ms. Jennifer M Weishaar

Weishaar, Jennifer M,

2005N-0345-EC1548

2005-10-31

Dr. Carol Flinn

Flinn, Carol,

2005N-0345-EC1623

2005-10-31

Mrs. Deborah Gallagher

Gallagher, Deborah,

2005N-0345-EC164

2005-09-20

Ms. alisa arthur

arthur, alisa,

2005N-0345-EC1644

2005-10-31

Miss. karlee rockey

rockey, karlee,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC1673

2005-10-31

Dr. Nora Fahlberg

Fahlberg, Nora,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC1700

2005-10-31

NOW

Bledsoe, Betty,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC1720

2005-10-31

Dr. Bonnie Anderson

Anderson, Bonnie,

2005N-0345-EC1723

2005-10-31

Ms. Sarah Wallace

Wallace, Sarah,

2005N-0345-EC1754

2005-10-31

Ms. Caryn Bernstein

Bernstein, Caryn,

2005N-0345-EC1762

2005-10-31

Ms. Elizabeth Fisher

Fisher, Elizabeth,

2005N-0345-EC1787

2005-10-31

Pharmacist

Pinkerton, James,

2005N-0345-EC1792

2005-10-31

Mrs. Anastasia Brien

Brien, Anastasia,

2005N-0345-EC1808

2005-10-31

Ms. Deidre Purcell

Purcell, Deidre,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1849

2005-10-31

Ms. Dominique Gagnon

Gagnon, Dominique,

2005N-0345-EC1859

2005-10-31

Mrs. Steph Gerber

Gerber, Steph,

2005N-0345-EC1871

2005-10-31

Ms. Andrea Cedusky

Cedusky, Andrea,

2005N-0345-EC1884

2005-10-31

Ms. Jessica Goforth

Goforth, Jessica,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC1986

2005-10-31

Ms. Jamie Hart

Hart, Jamie,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC2008

2005-10-31

Dr. David Lehnherr

Lehnherr, David,

2005N-0345-EC2012

2005-10-31

Ms. Seana Blake

Blake, Seana,

2005N-0345-EC2036

2005-10-31

Ms. Jennifer Chapin Harris

Chapin Harris, Jennifer,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC2077

2005-10-31

Miss. kristin kearns

kearns, kristin,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC2138

2005-10-31

Mr. Nathan Brothers

Brothers, Nathan,

2005N-0345-EC2144

2005-10-31

National Organization for Women

Vives, Olga,

2005N-0345-EC2177

2005-10-31

Ms. Donna Bailer

Bailer, Donna,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC2206

2005-11-03

Ms. Marion Nichols

Nichols, Marion,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC2287

2005-11-03

Mrs. Nancy Ellingham

Ellingham, Nancy,

2005N-0345-EC2292

2005-11-03

Institute of Shamanic Wisdom, Inc.

Carbon, Liana,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC2305

2005-11-03

Ms. Dana Reinisch

Reinisch, Dana,

2005N-0345-EC2307

2005-11-03

Ms. eva grove

grove, eva,

2005N-0345-EC250

2005-09-20

Ms. Lyn Jackson

Jackson, Lyn,

2005N-0345-EC267

2005-09-20

Mrs. Leslie Dilley

Dilley, Leslie,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC447

2005-09-26

Mr. kurt anspach

anspach, kurt,

2005N-0345-EC454

2005-09-26

Miss. Rachel Crow

Crow, Rachel,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC615

2005-10-12

Ms. Mary Gillman

Gillman, Mary,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC620

2005-10-12

Ms. Marie Fordtner

Fordtner, Marie,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC624

2005-10-12

Mrs. Natalie Frey

Frey, Natalie,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC639

2005-10-12

Mrs. Bonnie Sager

Sager, Bonnie,

2005N-0345-EC641

2005-10-12

Miss. Nellie Christian

Christian, Nellie,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC652

2005-10-12

Mrs. Cynthia Choo

Choo, Cynthia,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC657

2005-10-12

Mr. James Thompson

Thompson, James,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC681

2005-10-12

Mrs. Kathryn Anthony

Anthony, Kathryn,

2005N-0345-EC699

2005-10-12

Mrs. Christine Lund-Molfese

Lund-Molfese, Christine,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC717

2005-10-12

Mr. Joseph Gorini

Gorini, Joseph,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC725

2005-10-12

Mrs. Feleiteau Epley

Epley, Feleiteau,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC752

2005-10-13

Alpha Pregnancy Services

Humber, Prudence,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC777

2005-10-13

Mr. John Long

Long, John,

2005N-0345-EC785

2005-10-13

Mrs. Kathryn St Pierre

St Pierre, Kathryn,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC792

2005-10-13

Ms. Adele E. Zimmermann

Zimmermann, Adele E.,

2005N-0345-EC815

2005-10-13

Mr. Joseph DeRitis

DeRitis, Joseph,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC879

2005-10-17

Mrs. Linda McLaughlin

McLaughlin, Linda,

2005N-0345-EC909

2005-10-18

Mrs. Judith Bayba

Bayba, Judith,

2005N-0345-EC95

2005-09-20

HVMA

Trubow, Marshall,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

2005N-0345-EMC204

2005-10-20

Planned Parenthood of New York City

Joan Malin,

5.3 - Arguments that support concept that a rulemaking would provide clarification

Comment Number Received Date Organization Commenter(s)

5.3.1 - Legal arguments supporting rulemaking to dispel confusion

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

5.3.2 - Policy arguments supporting rulemaking to dispel confusion

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC126

2005-09-20

Ms. Anne Dougherty

Dougherty, Anne,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

5.4 - Arguments that a rulemaking would not provide clarification

Comment Number Received Date Organization Commenter(s)

5.4.1 - Legal arguments that rulemaking would not clarify

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

5.4.2 - Policy arguments that rulemaking would not clarify

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

5.4.2.1 - Guidance instead of rulemaking

Comment Number Received Date Organization Commenter(s)

5.4.2.2 - Other policy arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC21

2005-09-01

NYC DOE

RICHMAN, BOBBI,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC447

2005-09-26

Mr. kurt anspach

anspach, kurt,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

5.4.3 - There is no confusion, therefore rulemaking unnecessary

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

5.5 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC895

2005-10-17

UCSF

Holden, Karen,

2005N-0345-EC90

2005-09-20

Mrs. Elisha Townsend

Townsend, Elisha,

6 - If FDA limited sale of OTC product to sub-population, would FDA be able to enforce limitation as a matter of law? [ANPRM Q 2.A.]

Comment Number Received Date Organization Commenter(s)

6.1 - Yes

Comment Number Received Date Organization Commenter(s)

2005N-0345-C29

2005-09-29

M A Morris

Mary Ann Morris,

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C321

2005-10-31

S. Ashe

Susan Ashe,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC1076

2005-10-27

Mr. Robert Quinlan

Quinlan, Robert,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC1108

2005-10-27

Mr. Darrell Tangman

Tangman, Darrell,

2005N-0345-EC120

2005-09-20

Mr. Brad Thomson

Thomson, Brad,

2005N-0345-EC122

2005-09-20

Ms. Tamara Waters

Waters, Tamara,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC137

2005-09-20

Mr. Craig Pennington

Pennington, Craig,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC14202

2005-11-03

Ms. Leslie McCollom

McCollom, Leslie,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC174

2005-09-20

Ms. d pearlman

pearlman, d,

2005N-0345-EC175

2005-09-20

Ms. K Johnson

Johnson, K,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC217

2005-09-20

Mr. Ken Dietz

Dietz, Ken,

2005N-0345-EC219

2005-09-20

Ms. m solomon

solomon, m,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC2248

2005-11-03

Kostis Kosmos Inc.

Kostis, Steven,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC227

2005-09-20

Ms. Heather May

May, Heather,

2005N-0345-EC2272

2005-11-03

Ms. Elizabeth Ellcessor

Ellcessor, Elizabeth,

2005N-0345-EC228

2005-09-20

Mr. Clay Evans

Evans, Clay,

2005N-0345-EC2308

2005-11-03

NOW

Naugle, Kay,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC233

2005-09-20

Ms. Margaret Martin

Martin, Margaret,

2005N-0345-EC235

2005-09-20

Ms. Pauline Yu

Yu, Pauline,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC271

2005-09-20

Mrs. Michelle McGaw

McGaw, Michelle,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC278

2005-09-20

N/A

endris, kelle,

2005N-0345-EC280

2005-09-20

Mr. Marc Shapiro

Shapiro, Marc,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC298

2005-09-20

Mrs. Jennifer Hoyle-Franklin

Hoyle-Franklin, Jennifer,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC334

2005-09-20

Ms. Lori Wilbois

Wilbois, Lori,

2005N-0345-EC345

2005-09-20

Mrs. Marla Kundey

Kundey, Marla,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC367

2005-09-20

Utah Valley State College

Stratton, Jacquie,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC392

2005-09-20

Dr. LeClair Bissell

Bissell, LeClair,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC428

2005-09-20

INOVA Fairfax Hospital

Rizzo, Anne,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC432

2005-09-20

Ms. shaniya jarrett

jarrett, shaniya,

2005N-0345-EC445

2005-09-26

Mr. Stephen Ross

Ross, Stephen,

2005N-0345-EC446

2005-09-26

Mrs. Loretta Rech

Rech, Loretta,

2005N-0345-EC45

2005-09-01

Planned Parenthood

Lohman, Theresa,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC472

2005-09-27

Mr. Roger Lands

Lands, Roger,

2005N-0345-EC475

2005-09-27

None

Tschirhart, Marceline,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC51

2005-09-01

Dr. Stephine Heitkemper

Heitkemper, Stephine,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC612

2005-10-12

Michian State Medical Society

Connaughton, Peter,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC624

2005-10-12

Mrs. Natalie Frey

Frey, Natalie,

2005N-0345-EC633

2005-10-12

Consumer

Joyce, Allison,

2005N-0345-EC650

2005-10-12

Concerned Women for America

White, Virginia,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC681

2005-10-12

Mrs. Kathryn Anthony

Anthony, Kathryn,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC742

2005-10-13

Ms. Katherine Dalesandre

Dalesandre, Katherine,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC769

2005-10-13

Ms. C Davis

Davis, C,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC776

2005-10-13

Ms. Corene Kendrick

Kendrick, Corene,

2005N-0345-EC78

2005-09-20

Ms. Martha Kneib

Kneib, Martha,

2005N-0345-EC784

2005-10-13

food supplements distributor

komm, phrana,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

2005N-0345-EC840

2005-10-13

Home Health Care

Rew, Barbara,

2005N-0345-EC844

2005-10-13

Private Individual

Rousu, Dwight,

2005N-0345-EC848

2005-10-13

Dr. Harnath Holmes

Holmes, Harnath,

2005N-0345-EC851

2005-10-13

Ms. Lynne Garcia

Garcia, Lynne,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC862

2005-10-17

Mrs. Joann Lander

Lander, Joann,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC87

2005-09-20

Mrs. Patricia Brown

Brown, Patricia,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC90

2005-09-20

Mrs. Elisha Townsend

Townsend, Elisha,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC413

2005-10-31

Honorable Louise M. Slaughter et al.

Honorable Louise M. Slaughter et,

6.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C19

2005-09-26

E Wright

Emily Wright,

2005N-0345-C346

2005-10-31

S. Hauss

Stephen Hauss,

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC1037

2005-10-27

Ms. Noel Wharton

Wharton, Noel,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC111

2005-09-20

Dr. Jerrold Black

Black, Jerrold,

2005N-0345-EC1114

2005-10-27

Ms. Kelly Lash

Lash, Kelly,

2005N-0345-EC112

2005-09-20

Infectious Diseases Assoc. of Fort Lauderdale

Combs, RN, Michelle,

2005N-0345-EC11436

2005-11-03

Mr. Russell Ault

Ault, Russell,

2005N-0345-EC1147

2005-10-27

Mr. Mark Hey

Hey, Mark,

2005N-0345-EC11642

2005-11-03

Dr. Mallary Tytel

Tytel, Mallary,

2005N-0345-EC119

2005-09-20

Mrs. Carol Smith

Smith, Carol,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC124

2005-09-20

Mrs. Rhonda Koenig

Koenig, Rhonda,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC14688

2005-11-03

Miss. Luella Williams

Williams, Luella,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC1485

2005-10-28

Ms. Maggie Daly

Daly, Maggie,

2005N-0345-EC14884

2005-11-03

Dr. David Hutchison

Hutchison, David,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1602

2005-10-31

Miss. Katherine Kirkland

Kirkland, Katherine,

2005N-0345-EC163

2005-09-20

Mr. Leo Smith

Smith, Leo,

2005N-0345-EC164

2005-09-20

Ms. alisa arthur

arthur, alisa,

2005N-0345-EC16529

2005-11-03

SCVMC

M, J,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC16704

2005-11-03

Ms. JoHannah Whitsett

Whitsett, JoHannah,

2005N-0345-EC16777

2005-11-03

Santa Clara Valley Medical Center

Fainstat, Theodore,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC186

2005-09-20

Ms. Rhianna Wilson

Wilson, Rhianna,

2005N-0345-EC1863

2005-10-31

Women's Political Caucus

Ralston, Virginia,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1970

2005-10-31

Pittsburgh

Crousey, Joshua,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2129

2005-10-31

Ms. Sandra Stevenson

Stevenson, Sandra,

2005N-0345-EC2177

2005-10-31

Ms. Donna Bailer

Bailer, Donna,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC2182

2005-10-31

Dr. michele curtis

curtis, michele,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC2304

2005-11-03

Mrs. Laura Los

Los, Laura,

2005N-0345-EC2333

2005-11-03

Ms. Loreen Bowen

Bowen, Loreen,

2005N-0345-EC2334

2005-11-03

Ms. Martha Johnson

Johnson, Martha,

2005N-0345-EC2362

2005-11-03

Miss. Reagan Moseley

Moseley, Reagan,

2005N-0345-EC2372

2005-11-03

Dr. C. Hummel

Hummel, C.,

2005N-0345-EC2391

2005-11-03

Ms. Katrina Molnar

Molnar, Katrina,

2005N-0345-EC250

2005-09-20

Ms. Lyn Jackson

Jackson, Lyn,

2005N-0345-EC252

2005-09-20

Falk Pharmacy

Hrinya, Margaret,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC265

2005-09-20

Ms. Nancy Mangini

Mangini, Nancy,

2005N-0345-EC267

2005-09-20

Mrs. Leslie Dilley

Dilley, Leslie,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC284

2005-09-20

Mrs. Linda Shroyer

Shroyer, Linda,

2005N-0345-EC296

2005-09-20

Ms. Suzanne Marks

Marks, Suzanne,

2005N-0345-EC304

2005-09-20

Ms. Kathryn Scharplaz

Scharplaz, Kathryn,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC316

2005-09-20

Dr. Patrick Herrick

Herrick, Patrick,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC363

2005-09-20

Mrs. Marsha Kelley

Kelley, Marsha,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC402

2005-09-20

University of Utah

Murphy, Patricia,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC413

2005-09-20

Ms. Jennifer Springsteen

Springsteen, Jennifer,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC457

2005-09-26

Dr. Daniel Wujek

Wujek, Daniel,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC473

2005-09-27

Mr. Richard Duguay

Duguay, Richard,

2005N-0345-EC49

2005-09-01

Mr. Christopher Landauer

Landauer, Christopher,

2005N-0345-EC50

2005-09-01

Mrs. Christine Valli

Valli, Christine,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC526

2005-09-29

Mt. Carmel St. Ann's Hospital

Thompson, Sharon,

2005N-0345-EC527

2005-09-29

Mr. Robert Ramirez

Ramirez, Robert,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC547

2005-10-03

Mr. Ralph Arnsparger

Arnsparger, Ralph,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC563

2005-10-12

Mrs. Rosemary Woerner

Woerner, Rosemary,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC584

2005-10-12

Ms. Margaret Victor

Victor, Margaret,

2005N-0345-EC586

2005-10-12

Mr. Gregory Doran

Doran, Gregory,

2005N-0345-EC594

2005-10-12

Mrs. Vicki Charocopos

Charocopos, Vicki,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC598

2005-10-12

Mr. Christopher Horrocks

Horrocks, Christopher,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC603

2005-10-12

Ms. Estelle padawer

padawer, Estelle,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC614

2005-10-12

Mr. Kevin Doran

Doran, Kevin,

2005N-0345-EC615

2005-10-12

Ms. Mary Gillman

Gillman, Mary,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC625

2005-10-12

Mrs. Janet Crook

Crook, Janet,

2005N-0345-EC627

2005-10-12

Mr. Dale Olsen

Olsen, Dale,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC636

2005-10-12

Ms. Maura Mudd

Mudd, Maura,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC639

2005-10-12

Mrs. Bonnie Sager

Sager, Bonnie,

2005N-0345-EC641

2005-10-12

Miss. Nellie Christian

Christian, Nellie,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC659

2005-10-12

Self-Employed

Langford, Willis,

2005N-0345-EC661

2005-10-12

none

Gill, Barbara,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC667

2005-10-12

Mrs. Cynthia Raschke

Raschke, Cynthia,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC67

2005-09-01

Mr. Douglas Lucas

Lucas, Douglas,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC689

2005-10-12

Mrs. Pamela Al-Bawab

Al-Bawab, Pamela,

2005N-0345-EC690

2005-10-12

n/a

Abdullah, Cheryl,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC695

2005-10-12

Franciscan Univ. Steubenville OH, Austrian Campus

,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC699

2005-10-12

Mrs. Christine Lund-Molfese

Lund-Molfese, Christine,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC724

2005-10-12

Mrs. Mary Roybal

Roybal, Mary,

2005N-0345-EC725

2005-10-12

Mrs. Feleiteau Epley

Epley, Feleiteau,

2005N-0345-EC729

2005-10-13

Mrs. M. Brown

Brown, M.,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC734

2005-10-13

Mr. gerald hackert

hackert, gerald,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC745

2005-10-13

Texas House of Representatives

Meyer, Dina,

2005N-0345-EC752

2005-10-13

Alpha Pregnancy Services

Humber, Prudence,

2005N-0345-EC757

2005-10-13

Salt & Light

Nixon-Escochea, Sharon,

2005N-0345-EC758

2005-10-13

Ms. Anna Schmidt, RN

Schmidt, RN, Anna,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC777

2005-10-13

Mr. John Long

Long, John,

2005N-0345-EC778

2005-10-13

Mrs. Lucia Rossi

Rossi, Lucia,

2005N-0345-EC781

2005-10-13

Mrs. Theresa Otto

Otto, Theresa,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC785

2005-10-13

Mrs. Kathryn St Pierre

St Pierre, Kathryn,

2005N-0345-EC786

2005-10-13

Ms. Kathleen Pokorny

Pokorny, Kathleen,

2005N-0345-EC790

2005-10-13

Ms. Deborah Walsh

Walsh, Deborah,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC804

2005-10-13

Mrs. Denise Morningstar

Morningstar, Denise,

2005N-0345-EC808

2005-10-13

Mr. Steven Goranson

Goranson, Steven,

2005N-0345-EC809

2005-10-13

Mrs. Elizabeth McGrane Tran

McGrane Tran, Elizabeth,

2005N-0345-EC815

2005-10-13

Mr. Joseph DeRitis

DeRitis, Joseph,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC833

2005-10-13

Mrs. Lori Hogg

Hogg, Lori,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC849

2005-10-13

Mr. Michael Swarner

Swarner, Michael,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC854

2005-10-13

Ms. Johanna Roberts

Roberts, Johanna,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC879

2005-10-17

Mrs. Linda McLaughlin

McLaughlin, Linda,

2005N-0345-EC889

2005-10-17

ABC Pregnancy Help Center

Egging, Patrice,

2005N-0345-EC905

2005-10-18

Reproductive Endocriniologists

Gambrell, Jr., R. Don,

2005N-0345-EC909

2005-10-18

Mrs. Judith Bayba

Bayba, Judith,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

6.3 - Legal/policy arguments that support/detail FDA’s authority to enforce limitation on availability of OTC products by sub-population

Comment Number Received Date Organization Commenter(s)

6.3.1 - FD&C Act

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C407

2005-11-01

Pfizer, Inc.

Bert W. Rein,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

6.3.2 - No laws prevent the policy

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

6.3.3 - Court cases

Comment Number Received Date Organization Commenter(s)

6.3.4 - Age limitations are in line with other meaningful differences

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC111

2005-09-20

Dr. Jerrold Black

Black, Jerrold,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

6.3.5 - Other legal/policy arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

6.4 - Examples/precedents that support/detail FDA’s authority to enforce limitation by sub-population

Comment Number Received Date Organization Commenter(s)

6.4.1 - Nicotine replacement therapy (e.g., Nicorette)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC14078

2005-11-03

Mrs. Lori Kaiping

Kaiping, Lori,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC153

2005-09-20

Ms. Joan Bokermann

Bokermann, Joan,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC1573

2005-10-31

Ms. Sarah Mauet

Mauet, Sarah,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC1618

2005-10-31

Mr. Gregory Schulte

Schulte, Gregory,

2005N-0345-EC16371

2005-11-03

Mrs. Rebecca Wiegand

Wiegand, Rebecca,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC1979

2005-10-31

Mrs. Shannon Farrand-Bernardin

Farrand-Bernardin, Shannon,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC228

2005-09-20

Mr. Clay Evans

Evans, Clay,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC235

2005-09-20

Ms. Pauline Yu

Yu, Pauline,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

6.4.2 - Other examples

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

6.5 - Legal/policy arguments FDA does not have authority to enforce the limitation

Comment Number Received Date Organization Commenter(s)

6.5.1 - FDA’s authority limited to drug safety, effectiveness/efficacy, and labeling

Comment Number Received Date Organization Commenter(s)

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-C407

2005-11-01

Pfizer, Inc.

Bert W. Rein,

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC14078

2005-11-03

Mrs. Lori Kaiping

Kaiping, Lori,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC1573

2005-10-31

Ms. Sarah Mauet

Mauet, Sarah,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC1618

2005-10-31

Mr. Gregory Schulte

Schulte, Gregory,

2005N-0345-EC16371

2005-11-03

Mrs. Rebecca Wiegand

Wiegand, Rebecca,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC16546

2005-11-03

Ms. Elle Saling

Saling, Elle,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC16704

2005-11-03

Ms. JoHannah Whitsett

Whitsett, JoHannah,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC169

2005-09-20

Ms. Lauren Gre

Gre, Lauren,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC175

2005-09-20

Ms. K Johnson

Johnson, K,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC1979

2005-10-31

Mrs. Shannon Farrand-Bernardin

Farrand-Bernardin, Shannon,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC2022

2005-10-31

Mrs. Margaret Munro

Munro, Margaret,

2005N-0345-EC204

2005-09-20

Centre Shops Family Practice and Urgent Care

Letts, Pamela,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC49

2005-09-01

Mr. Christopher Landauer

Landauer, Christopher,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC74

2005-09-01

n/a

Willis, Evelyn,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

2005N-0345-EC912

2005-10-18

Mr. William Moses

Moses, William,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EMC112

2005-08-30

E Honey

Ellen Honey,

2005N-0345-EMC86

2005-08-30

E S Honey

Ellen S Honey,

6.5.2 - Other FD&C Act arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC14261

2005-11-03

Mr. B Owens

Owens, B,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

6.5.3 - Court cases

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

6.5.4 - Other arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-C71

2005-10-12

D Ruckdeschel

Diana Ruckdeschel,

2005N-0345-EC106

2005-09-20

Mrs. Kathleen Shaffer

Shaffer, Kathleen,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1595

2005-10-31

Mrs. Stephanie Schulte

Schulte, Stephanie,

2005N-0345-EC16

2005-09-01

Ms. Stephanie Smart

Smart, Stephanie,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC186

2005-09-20

Ms. Rhianna Wilson

Wilson, Rhianna,

2005N-0345-EC1970

2005-10-31

Pittsburgh

Crousey, Joshua,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC34

2005-09-01

Mr. Ralph Hudson

Hudson, Ralph,

2005N-0345-EC38

2005-09-01

Dr. Sarah Scarpace

Scarpace, Sarah,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC82

2005-09-20

Ms. Katharine Fogelgren

Fogelgren, Katharine,

2005N-0345-EC9

2005-08-29

Dr. TRACI CORDER

CORDER, TRACI,

2005N-0345-EC921

2005-10-27

Ms. Jennifer Aengst

Aengst, Jennifer,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

6.6 - Authority of other entities to enforce the limitation

Comment Number Received Date Organization Commenter(s)

6.6.1 - State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C3

2005-08-29

P. Neal

Patricia Neal,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C5

2005-09-12

Micro ICU Project

Eurica Califorrniaa,

2005N-0345-EC1021

2005-10-27

Miss. Kathleen Salmon

Salmon, Kathleen,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC1108

2005-10-27

Mr. Darrell Tangman

Tangman, Darrell,

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC122

2005-09-20

Ms. Tamara Waters

Waters, Tamara,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC137

2005-09-20

Mr. Craig Pennington

Pennington, Craig,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC149

2005-09-20

Ms. Page Schindler

Schindler, Page,

2005N-0345-EC153

2005-09-20

Ms. Joan Bokermann

Bokermann, Joan,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC205

2005-09-20

Miss. Cory Walker

Walker, Cory,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC51

2005-09-01

Dr. Stephine Heitkemper

Heitkemper, Stephine,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EMC141

2005-09-02

C Sprouse

Cynthia Sprouse,

2005N-0345-EMC450

2005-11-02

M. Murdoch

Meagan Murdoch,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

6.6.2 - Congress

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC2022

2005-10-31

Mrs. Margaret Munro

Munro, Margaret,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

6.6.3 - Alcohol and tobacco enforcement

Comment Number Received Date Organization Commenter(s)

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-C346

2005-10-31

S. Hauss

Stephen Hauss,

2005N-0345-EC101

2005-09-20

Mrs. Irene Warshauer

Warshauer, Irene,

2005N-0345-EC1021

2005-10-27

Miss. Kathleen Salmon

Salmon, Kathleen,

2005N-0345-EC105

2005-09-20

Mrs. carol small

small, carol,

2005N-0345-EC1057

2005-10-27

Dr. Janet Novak

Novak, Janet,

2005N-0345-EC108

2005-09-20

Mrs. Glenda Cass

Cass, Glenda,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC118

2005-09-20

Ms. Jackie Krugler

Krugler, Jackie,

2005N-0345-EC120

2005-09-20

Mr. Brad Thomson

Thomson, Brad,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC126

2005-09-20

Ms. Anne Dougherty

Dougherty, Anne,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC133

2005-09-20

University of Minnesota

Korell, Allison,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC137

2005-09-20

Mr. Craig Pennington

Pennington, Craig,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC140

2005-09-20

Ms. Laila Shahrokhi

Shahrokhi, Laila,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC14078

2005-11-03

Mrs. Lori Kaiping

Kaiping, Lori,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC14202

2005-11-03

Ms. Leslie McCollom

McCollom, Leslie,

2005N-0345-EC14217

2005-11-03

Ms. Jennifer Doleac

Doleac, Jennifer,

2005N-0345-EC14359

2005-11-03

Ms. L McCarty

McCarty, L,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC149

2005-09-20

Ms. Page Schindler

Schindler, Page,

2005N-0345-EC152

2005-09-20

Mrs. Heather Heimbuch

Heimbuch, Heather,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC153

2005-09-20

Ms. Joan Bokermann

Bokermann, Joan,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC1542

2005-10-31

my home

Pellegrino, Margo,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC156

2005-09-20

Ms. Anita Fream

Fream, Anita,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC1573

2005-10-31

Ms. Sarah Mauet

Mauet, Sarah,

2005N-0345-EC15892

2005-11-03

Mr. Ann Durbin

Durbin, Ann,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC161

2005-09-20

Mr. Garland Allen

Allen, Garland,

2005N-0345-EC1618

2005-10-31

Mr. Gregory Schulte

Schulte, Gregory,

2005N-0345-EC16371

2005-11-03

Mrs. Rebecca Wiegand

Wiegand, Rebecca,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC169

2005-09-20

Ms. Lauren Gre

Gre, Lauren,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC17

2005-09-01

Mr. Rick LaChance

LaChance, Rick,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC174

2005-09-20

Ms. d pearlman

pearlman, d,

2005N-0345-EC175

2005-09-20

Ms. K Johnson

Johnson, K,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC18

2005-09-01

Ms. Susan Nowak

Nowak, Susan,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1865

2005-10-31

Ms. Nancy Groceman

Groceman, Nancy,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC1979

2005-10-31

Mrs. Shannon Farrand-Bernardin

Farrand-Bernardin, Shannon,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC2

2005-08-29

Mrs. Joan Casadonte

Casadonte, Joan,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC217

2005-09-20

Mr. Ken Dietz

Dietz, Ken,

2005N-0345-EC219

2005-09-20

Ms. m solomon

solomon, m,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC227

2005-09-20

Ms. Heather May

May, Heather,

2005N-0345-EC2272

2005-11-03

Ms. Elizabeth Ellcessor

Ellcessor, Elizabeth,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC3

2005-08-29

Mrs. Mary Ann Pollock

Pollock, Mary Ann,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC31

2005-09-01

Mrs. Karen Zeiger

Zeiger, Karen,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC345

2005-09-20

Mrs. Marla Kundey

Kundey, Marla,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC366

2005-09-20

Mrs. Laura Sare

Sare, Laura,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC3764

2005-11-03

Mr. John Getty

Getty, John,

2005N-0345-EC38

2005-09-01

Dr. Sarah Scarpace

Scarpace, Sarah,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC421

2005-09-20

Temple University Physicians

Brown, Michael,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC510

2005-09-27

Advanced Women's Care

Davidson, J Michael,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC695

2005-10-12

Franciscan Univ. Steubenville OH, Austrian Campus

,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC78

2005-09-20

Ms. Martha Kneib

Kneib, Martha,

2005N-0345-EC813

2005-10-13

Ms. Patricia Wagner

Wagner, Patricia,

2005N-0345-EC86

2005-09-20

None

Lebman, Sanford,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

2005N-0345-EC87

2005-09-20

Mrs. Patricia Brown

Brown, Patricia,

2005N-0345-EC918

2005-10-27

Mrs. susan lyon

lyon, susan,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EC964

2005-10-27

Mr. Jason Halbert

Halbert, Jason,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC160

2005-09-08

A Bee

Amanda Bee,

2005N-0345-EMC166

2005-09-16

M Dalton

Mike Dalton,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

2005N-0345-EMC450

2005-11-02

M. Murdoch

Meagan Murdoch,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

2005N-0345-EREG21

2005-09-29

Maggie Ciskanik

Ciskanik, Maggie,

6.6.4 - Other entities

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC217

2005-09-20

Mr. Ken Dietz

Dietz, Ken,

6.7 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC95

2005-09-20

HVMA

Trubow, Marshall,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

7 - Would FDA be able to enforce limitation to sub-population as practical matter? [ANPRM Q 2.B.]

Comment Number Received Date Organization Commenter(s)

7.1 - Yes

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C321

2005-10-31

S. Ashe

Susan Ashe,

2005N-0345-EC100

2005-09-20

Lahey Clinic

Neels MPH, RD, Cindy,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC105

2005-09-20

Mrs. carol small

small, carol,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC108

2005-09-20

Mrs. Glenda Cass

Cass, Glenda,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC118

2005-09-20

Ms. Jackie Krugler

Krugler, Jackie,

2005N-0345-EC120

2005-09-20

Mr. Brad Thomson

Thomson, Brad,

2005N-0345-EC122

2005-09-20

Ms. Tamara Waters

Waters, Tamara,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC14202

2005-11-03

Ms. Leslie McCollom

McCollom, Leslie,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC149

2005-09-20

Ms. Page Schindler

Schindler, Page,

2005N-0345-EC14939

2005-11-03

Ms. Cassandra Brulotte

Brulotte, Cassandra,

2005N-0345-EC153

2005-09-20

Ms. Joan Bokermann

Bokermann, Joan,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC156

2005-09-20

Ms. Anita Fream

Fream, Anita,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC161

2005-09-20

Mr. Garland Allen

Allen, Garland,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC175

2005-09-20

Ms. K Johnson

Johnson, K,

2005N-0345-EC18

2005-09-01

Ms. Susan Nowak

Nowak, Susan,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC1974

2005-10-31

Mrs. Meryl Motika

Motika, Meryl,

2005N-0345-EC198

2005-09-20

Mr. Holt Gollatz

Gollatz, Holt,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC205

2005-09-20

Miss. Cory Walker

Walker, Cory,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC219

2005-09-20

Ms. m solomon

solomon, m,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC227

2005-09-20

Ms. Heather May

May, Heather,

2005N-0345-EC228

2005-09-20

Mr. Clay Evans

Evans, Clay,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC233

2005-09-20

Ms. Margaret Martin

Martin, Margaret,

2005N-0345-EC235

2005-09-20

Ms. Pauline Yu

Yu, Pauline,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC255

2005-09-20

Mr. Bennett Korach

Korach, Bennett,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC271

2005-09-20

Mrs. Michelle McGaw

McGaw, Michelle,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC280

2005-09-20

Mr. Marc Shapiro

Shapiro, Marc,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC298

2005-09-20

Mrs. Jennifer Hoyle-Franklin

Hoyle-Franklin, Jennifer,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC324

2005-09-20

Mrs. Kim Stanley

Stanley, Kim,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC334

2005-09-20

Ms. Lori Wilbois

Wilbois, Lori,

2005N-0345-EC34

2005-09-01

Mr. Ralph Hudson

Hudson, Ralph,

2005N-0345-EC345

2005-09-20

Mrs. Marla Kundey

Kundey, Marla,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC366

2005-09-20

Mrs. Laura Sare

Sare, Laura,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC421

2005-09-20

Temple University Physicians

Brown, Michael,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC446

2005-09-26

Mrs. Loretta Rech

Rech, Loretta,

2005N-0345-EC45

2005-09-01

Planned Parenthood

Lohman, Theresa,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC51

2005-09-01

Dr. Stephine Heitkemper

Heitkemper, Stephine,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC650

2005-10-12

Concerned Women for America

White, Virginia,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC742

2005-10-13

Ms. Katherine Dalesandre

Dalesandre, Katherine,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC78

2005-09-20

Ms. Martha Kneib

Kneib, Martha,

2005N-0345-EC787

2005-10-13

Ms. Christina Zarrella

Zarrella, Christina,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC840

2005-10-13

Home Health Care

Rew, Barbara,

2005N-0345-EC848

2005-10-13

Dr. Harnath Holmes

Holmes, Harnath,

2005N-0345-EC851

2005-10-13

Ms. Lynne Garcia

Garcia, Lynne,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC862

2005-10-17

Mrs. Joann Lander

Lander, Joann,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC87

2005-09-20

Mrs. Patricia Brown

Brown, Patricia,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC908

2005-10-18

Mrs. Heather Thomas

Thomas, Heather,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EMC141

2005-09-02

C Sprouse

Cynthia Sprouse,

2005N-0345-EMC160

2005-09-08

A Bee

Amanda Bee,

2005N-0345-EMC177

2005-09-28

M Dressler

Monika Dressler,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC4

2005-08-26

A. Biehl

Allison Biehl,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

7.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C19

2005-09-26

E Wright

Emily Wright,

2005N-0345-C292

2005-10-27

T. Murray

Thomas J. Murray,

2005N-0345-C346

2005-10-31

S. Hauss

Stephen Hauss,

2005N-0345-C487

2005-11-15

K. Raviele, M.D., F.A.C.O.G.

Kathleeen M. Raviele, M.D., F.A.,

2005N-0345-C493

2005-12-14

M. Sadowski

Mary Sadowski,

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC1037

2005-10-27

Ms. Noel Wharton

Wharton, Noel,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC1076

2005-10-27

Mr. Robert Quinlan

Quinlan, Robert,

2005N-0345-EC1108

2005-10-27

Mr. Darrell Tangman

Tangman, Darrell,

2005N-0345-EC112

2005-09-20

Infectious Diseases Assoc. of Fort Lauderdale

Combs, RN, Michelle,

2005N-0345-EC14215

2005-11-03

Ms. Shira Fagan

Fagan, Shira,

2005N-0345-EC1485

2005-10-28

Ms. Maggie Daly

Daly, Maggie,

2005N-0345-EC14884

2005-11-03

Dr. David Hutchison

Hutchison, David,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC158

2005-09-20

Mrs. Wanda Ricketson

Ricketson, Wanda,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1602

2005-10-31

Miss. Katherine Kirkland

Kirkland, Katherine,

2005N-0345-EC16036

2005-11-03

Ms. Lynn Lillis

Lillis, Lynn,

2005N-0345-EC16529

2005-11-03

SCVMC

M, J,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC16736

2005-11-03

Dr. Walter Harry

Harry, Walter,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC1863

2005-10-31

Women's Political Caucus

Ralston, Virginia,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC210

2005-09-20

Ms. Amy Felty

Felty, Amy,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2129

2005-10-31

Ms. Sandra Stevenson

Stevenson, Sandra,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC2182

2005-10-31

Dr. michele curtis

curtis, michele,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC2285

2005-11-03

Mr. Ron Slonneger

Slonneger, Ron,

2005N-0345-EC2289

2005-11-03

Ms. Jen Halbert

Halbert, Jen,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC2304

2005-11-03

Mrs. Laura Los

Los, Laura,

2005N-0345-EC2334

2005-11-03

Ms. Martha Johnson

Johnson, Martha,

2005N-0345-EC2372

2005-11-03

Dr. C. Hummel

Hummel, C.,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC265

2005-09-20

Ms. Nancy Mangini

Mangini, Nancy,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC284

2005-09-20

Mrs. Linda Shroyer

Shroyer, Linda,

2005N-0345-EC304

2005-09-20

Ms. Kathryn Scharplaz

Scharplaz, Kathryn,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC316

2005-09-20

Dr. Patrick Herrick

Herrick, Patrick,

2005N-0345-EC319

2005-09-20

UALR-student

Myers, Micah,

2005N-0345-EC332

2005-09-20

Ms. Mary K Maxwell

Maxwell, Mary K,

2005N-0345-EC343

2005-09-20

Mrs. Julie Fisher

Fisher, Julie,

2005N-0345-EC359

2005-09-20

Ms. Rhea Williams

Williams, Rhea,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC402

2005-09-20

University of Utah

Murphy, Patricia,

2005N-0345-EC405

2005-09-20

Amoli Organics Pvt. Limited, INDIA

Kulshrestha, Vikram V,

2005N-0345-EC407

2005-09-20

Ms. Jeanette Carr

Carr, Jeanette,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC437

2005-09-21

Families for Life

Mawn, Marie,

2005N-0345-EC457

2005-09-26

Dr. Daniel Wujek

Wujek, Daniel,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC49

2005-09-01

Mr. Christopher Landauer

Landauer, Christopher,

2005N-0345-EC50

2005-09-01

Mrs. Christine Valli

Valli, Christine,

2005N-0345-EC503

2005-09-27

Mr. John Sullivan

Sullivan, John,

2005N-0345-EC510

2005-09-27

Advanced Women's Care

Davidson, J Michael,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC567

2005-10-12

Mr. Dominic Colvert

Colvert, Dominic,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC572

2005-10-12

Mr. John Naughton

Naughton, John,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC585

2005-10-12

WOMEN'S HEALTH ISSUES

Harper, Jan,

2005N-0345-EC59

2005-09-01

Ms. Ruth Tehila Leonard

Leonard, Ruth Tehila,

2005N-0345-EC594

2005-10-12

Mrs. Vicki Charocopos

Charocopos, Vicki,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC598

2005-10-12

Mr. Christopher Horrocks

Horrocks, Christopher,

2005N-0345-EC603

2005-10-12

Ms. Estelle padawer

padawer, Estelle,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC614

2005-10-12

Mr. Kevin Doran

Doran, Kevin,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC625

2005-10-12

Mrs. Janet Crook

Crook, Janet,

2005N-0345-EC627

2005-10-12

Mr. Dale Olsen

Olsen, Dale,

2005N-0345-EC628

2005-10-12

Mr. Ted Rowell

Rowell, Ted,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC633

2005-10-12

Consumer

Joyce, Allison,

2005N-0345-EC635

2005-10-12

Mr. Leo Paquette, RPh

Paquette, RPh, Leo,

2005N-0345-EC636

2005-10-12

Ms. Maura Mudd

Mudd, Maura,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC659

2005-10-12

Self-Employed

Langford, Willis,

2005N-0345-EC661

2005-10-12

none

Gill, Barbara,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC67

2005-09-01

Mr. Douglas Lucas

Lucas, Douglas,

2005N-0345-EC670

2005-10-12

Miss. Alisa Craddock

Craddock, Alisa,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC683

2005-10-12

Mr. Richard Cochran

Cochran, Richard,

2005N-0345-EC689

2005-10-12

Mrs. Pamela Al-Bawab

Al-Bawab, Pamela,

2005N-0345-EC690

2005-10-12

n/a

Abdullah, Cheryl,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC695

2005-10-12

Franciscan Univ. Steubenville OH, Austrian Campus

,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC699

2005-10-12

Mrs. Christine Lund-Molfese

Lund-Molfese, Christine,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC706

2005-10-12

Mr. Abraham Weaver

Weaver, Abraham,

2005N-0345-EC710

2005-10-12

Mrs. Naomi Devine

Devine, Naomi,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC717

2005-10-12

Mr. Joseph Gorini

Gorini, Joseph,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC724

2005-10-12

Mrs. Mary Roybal

Roybal, Mary,

2005N-0345-EC725

2005-10-12

Mrs. Feleiteau Epley

Epley, Feleiteau,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC734

2005-10-13

Mr. gerald hackert

hackert, gerald,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC737

2005-10-13

Mr. Stan Young

Young, Stan,

2005N-0345-EC738

2005-10-13

Mr. Brian Caulfield

Caulfield, Brian,

2005N-0345-EC745

2005-10-13

Texas House of Representatives

Meyer, Dina,

2005N-0345-EC75

2005-09-01

Ms. Peggy Andreas

Andreas, Peggy,

2005N-0345-EC750

2005-10-13

Mrs. stella milam

milam, stella,

2005N-0345-EC752

2005-10-13

Alpha Pregnancy Services

Humber, Prudence,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC777

2005-10-13

Mr. John Long

Long, John,

2005N-0345-EC778

2005-10-13

Mrs. Lucia Rossi

Rossi, Lucia,

2005N-0345-EC781

2005-10-13

Mrs. Theresa Otto

Otto, Theresa,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC786

2005-10-13

Ms. Kathleen Pokorny

Pokorny, Kathleen,

2005N-0345-EC789

2005-10-13

Ms. Trista Delamere

Delamere, Trista,

2005N-0345-EC790

2005-10-13

Ms. Deborah Walsh

Walsh, Deborah,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC803

2005-10-13

Mr. Timothy Laws

Laws, Timothy,

2005N-0345-EC805

2005-10-13

Mrs. Violet Corey

Corey, Violet,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC818

2005-10-13

Mr. Jim Rudnicki

Rudnicki, Jim,

2005N-0345-EC822

2005-10-13

Mr. james McGill

McGill, james,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

2005N-0345-EC833

2005-10-13

Mrs. Lori Hogg

Hogg, Lori,

2005N-0345-EC845

2005-10-13

Mrs. Dorothy Perron

Perron, Dorothy,

2005N-0345-EC854

2005-10-13

Ms. Johanna Roberts

Roberts, Johanna,

2005N-0345-EC859

2005-10-17

Ms. Anne Koerber

Koerber, Anne,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC877

2005-10-17

Ms. Ravenna Oakes

Oakes, Ravenna,

2005N-0345-EC879

2005-10-17

Mrs. Linda McLaughlin

McLaughlin, Linda,

2005N-0345-EC905

2005-10-18

Reproductive Endocriniologists

Gambrell, Jr., R. Don,

2005N-0345-EC909

2005-10-18

Mrs. Judith Bayba

Bayba, Judith,

2005N-0345-EC912

2005-10-18

Mr. William Moses

Moses, William,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC945

2005-10-27

Mr. Zachary Galiyas

Galiyas, Zachary,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC988

2005-10-27

Mrs. Karen OLoughlin

OLoughlin, Karen,

2005N-0345-EMC10

2005-08-27

R. Coryell

Ryan Coryell,

2005N-0345-EMC11

2005-08-27

C. Hardin

Christa Hardin,

2005N-0345-EMC126

2005-08-31

S Sears

Steve Sears,

2005N-0345-EMC15

2005-08-29

L. Armstrong

Lisa Armstrong,

2005N-0345-EMC18

2005-08-29

T. van Loan

Torie van Loan,

2005N-0345-EMC188

2005-10-11

F Alterton RN

Faith Alterton RN,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

2005N-0345-EREG2

2005-09-20

Cindy Diggs

Diggs, Cindy,

7.3 - Actions FDA could take in order to enforce limitation of an OTC product to a sub-population

Comment Number Received Date Organization Commenter(s)

7.3.1 - Regulate product sponsor

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC38

2005-09-01

Dr. Sarah Scarpace

Scarpace, Sarah,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC428

2005-09-20

INOVA Fairfax Hospital

Rizzo, Anne,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

7.3.1.2 - Require retailer, pharmacist, and consumer education programs

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

7.3.1.3 - Require risk management program

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

7.3.1.4 - Other product approval conditions

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

7.3.2 - Other FDA enforcement practices that it has the legal authority to put in place

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC34

2005-09-01

Mr. Ralph Hudson

Hudson, Ralph,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

7.4 - Other point-of-sale enforcement suggestions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

7.4.1 - Implement “behind-the-counter” system (pharmacist distributed)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-C489

2005-11-16

Women's Bar Association of the State of New York (WBASNY)

,

2005N-0345-EC100

2005-09-20

Lahey Clinic

Neels MPH, RD, Cindy,

2005N-0345-EC1021

2005-10-27

Miss. Kathleen Salmon

Salmon, Kathleen,

2005N-0345-EC1044

2005-10-27

Ms. Trisha Pruis

Pruis, Trisha,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC122

2005-09-20

Ms. Tamara Waters

Waters, Tamara,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC133

2005-09-20

University of Minnesota

Korell, Allison,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC140

2005-09-20

Ms. Laila Shahrokhi

Shahrokhi, Laila,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC149

2005-09-20

Ms. Page Schindler

Schindler, Page,

2005N-0345-EC153

2005-09-20

Ms. Joan Bokermann

Bokermann, Joan,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC15892

2005-11-03

Mr. Ann Durbin

Durbin, Ann,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC18

2005-09-01

Ms. Susan Nowak

Nowak, Susan,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC1974

2005-10-31

Mrs. Meryl Motika

Motika, Meryl,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC205

2005-09-20

Miss. Cory Walker

Walker, Cory,

2005N-0345-EC2051

2005-10-31

US Citizen and voter

Castro, Linda,

2005N-0345-EC2056

2005-10-31

Ms. Pat Malcolm

Malcolm, Pat,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC219

2005-09-20

Ms. m solomon

solomon, m,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC2272

2005-11-03

Ms. Elizabeth Ellcessor

Ellcessor, Elizabeth,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC248

2005-09-20

Ms. Erica Goss

Goss, Erica,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC252

2005-09-20

Falk Pharmacy

Hrinya, Margaret,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC345

2005-09-20

Mrs. Marla Kundey

Kundey, Marla,

2005N-0345-EC35

2005-09-01

Mrs. Michelle Thornton-Taylor

Thornton-Taylor, Michelle,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC45

2005-09-01

Planned Parenthood

Lohman, Theresa,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC51

2005-09-01

Dr. Stephine Heitkemper

Heitkemper, Stephine,

2005N-0345-EC526

2005-09-29

Mt. Carmel St. Ann's Hospital

Thompson, Sharon,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC787

2005-10-13

Ms. Christina Zarrella

Zarrella, Christina,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC848

2005-10-13

Dr. Harnath Holmes

Holmes, Harnath,

2005N-0345-EC851

2005-10-13

Ms. Lynne Garcia

Garcia, Lynne,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC141

2005-09-02

C Sprouse

Cynthia Sprouse,

2005N-0345-EMC160

2005-09-08

A Bee

Amanda Bee,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

7.4.2 - Involve other authorities (e.g., states, state boards of pharmacies)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C350

2005-10-31

American Society for Reproductive Medicine

Joseph S. Sanfilippo, M.D. and R,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC278

2005-09-20

N/A

endris, kelle,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

7.4.3 - Monitor compliance and enforcement / conduct random inspections

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC136

2005-09-20

Mr. James Beaudin

Beaudin, James,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

7.4.4 - Require identification for age

Comment Number Received Date Organization Commenter(s)

2005N-0345-C3

2005-08-29

P. Neal

Patricia Neal,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-C443

2005-11-02

National Association of Boards of Pharmacy (NABP)

,

2005N-0345-C489

2005-11-16

Women's Bar Association of the State of New York (WBASNY)

,

2005N-0345-EC100

2005-09-20

Lahey Clinic

Neels MPH, RD, Cindy,

2005N-0345-EC101

2005-09-20

Mrs. Irene Warshauer

Warshauer, Irene,

2005N-0345-EC1021

2005-10-27

Miss. Kathleen Salmon

Salmon, Kathleen,

2005N-0345-EC1044

2005-10-27

Ms. Trisha Pruis

Pruis, Trisha,

2005N-0345-EC105

2005-09-20

Mrs. carol small

small, carol,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC108

2005-09-20

Mrs. Glenda Cass

Cass, Glenda,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC120

2005-09-20

Mr. Brad Thomson

Thomson, Brad,

2005N-0345-EC122

2005-09-20

Ms. Tamara Waters

Waters, Tamara,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC13

2005-09-01

Mr. Alexander Clague

Clague, Alexander,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC133

2005-09-20

University of Minnesota

Korell, Allison,

2005N-0345-EC134

2005-09-20

Ms. Ilene Goldberg

Goldberg, Ilene,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC140

2005-09-20

Ms. Laila Shahrokhi

Shahrokhi, Laila,

2005N-0345-EC14055

2005-11-03

Mr. Matthew Bork

Bork, Matthew,

2005N-0345-EC14359

2005-11-03

Ms. L McCarty

McCarty, L,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC149

2005-09-20

Ms. Page Schindler

Schindler, Page,

2005N-0345-EC14939

2005-11-03

Ms. Cassandra Brulotte

Brulotte, Cassandra,

2005N-0345-EC152

2005-09-20

Mrs. Heather Heimbuch

Heimbuch, Heather,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC161

2005-09-20

Mr. Garland Allen

Allen, Garland,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC169

2005-09-20

Ms. Lauren Gre

Gre, Lauren,

2005N-0345-EC170

2005-09-20

Mrs. Beverly Babb

Babb, Beverly,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC174

2005-09-20

Ms. d pearlman

pearlman, d,

2005N-0345-EC18

2005-09-01

Ms. Susan Nowak

Nowak, Susan,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC193

2005-09-20

Ms. Carol Witherwax

Witherwax, Carol,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC1974

2005-10-31

Mrs. Meryl Motika

Motika, Meryl,

2005N-0345-EC198

2005-09-20

Mr. Holt Gollatz

Gollatz, Holt,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC205

2005-09-20

Miss. Cory Walker

Walker, Cory,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC219

2005-09-20

Ms. m solomon

solomon, m,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC227

2005-09-20

Ms. Heather May

May, Heather,

2005N-0345-EC2272

2005-11-03

Ms. Elizabeth Ellcessor

Ellcessor, Elizabeth,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC233

2005-09-20

Ms. Margaret Martin

Martin, Margaret,

2005N-0345-EC235

2005-09-20

Ms. Pauline Yu

Yu, Pauline,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC255

2005-09-20

Mr. Bennett Korach

Korach, Bennett,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC271

2005-09-20

Mrs. Michelle McGaw

McGaw, Michelle,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC280

2005-09-20

Mr. Marc Shapiro

Shapiro, Marc,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC341

2005-09-20

Ms. Loy Schroeder

Schroeder, Loy,

2005N-0345-EC35

2005-09-01

Mrs. Michelle Thornton-Taylor

Thornton-Taylor, Michelle,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC366

2005-09-20

Mrs. Laura Sare

Sare, Laura,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC383

2005-09-20

Dr. Cheri Corley

Corley, Cheri,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC432

2005-09-20

Ms. shaniya jarrett

jarrett, shaniya,

2005N-0345-EC45

2005-09-01

Planned Parenthood

Lohman, Theresa,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC464

2005-09-26

Mr. Fred W. Bergmann

Bergmann, Fred W.,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC495

2005-09-27

Mr. Christopher Stier

Stier, Christopher,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC742

2005-10-13

Ms. Katherine Dalesandre

Dalesandre, Katherine,

2005N-0345-EC759

2005-10-13

Dr. Susan Yoshihara

Yoshihara, Susan,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC78

2005-09-20

Ms. Martha Kneib

Kneib, Martha,

2005N-0345-EC787

2005-10-13

Ms. Christina Zarrella

Zarrella, Christina,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC87

2005-09-20

Mrs. Patricia Brown

Brown, Patricia,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC918

2005-10-27

Mrs. susan lyon

lyon, susan,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC160

2005-09-08

A Bee

Amanda Bee,

2005N-0345-EMC23

2005-08-29

B. Papish

Barbara Papish,

2005N-0345-EMC32

2005-08-29

Speaking for Many People in Texas

Speaking for Many People in Texa,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

2005N-0345-EMC4

2005-08-26

A. Biehl

Allison Biehl,

2005N-0345-EMC450

2005-11-02

M. Murdoch

Meagan Murdoch,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

7.4.5 - Pursue criminal actions against violators

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC298

2005-09-20

Mrs. Jennifer Hoyle-Franklin

Hoyle-Franklin, Jennifer,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC503

2005-09-27

Mr. John Sullivan

Sullivan, John,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC78

2005-09-20

Ms. Martha Kneib

Kneib, Martha,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

2005N-0345-EMC4

2005-08-26

A. Biehl

Allison Biehl,

7.4.6 - Other actions

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC161

2005-09-20

Mr. Garland Allen

Allen, Garland,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC170

2005-09-20

Mrs. Beverly Babb

Babb, Beverly,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC35

2005-09-01

Mrs. Michelle Thornton-Taylor

Thornton-Taylor, Michelle,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC526

2005-09-29

Mt. Carmel St. Ann's Hospital

Thompson, Sharon,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC373

2005-10-30

P. Tadeo

Peter Tadeo,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

7.5 - FDA will be unable or it will be difficult to enforce as a practical matter

Comment Number Received Date Organization Commenter(s)

7.5.1 - FDA does not have authority to enforce limitation, therefore it cannot enforce as a practical matter

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC36

2005-09-01

Mrs. Anita vanHeeswyk

vanHeeswyk, Anita,

2005N-0345-EC49

2005-09-01

Mr. Christopher Landauer

Landauer, Christopher,

2005N-0345-EC922

2005-10-27

Dr. Michele Gray

Gray, Michele,

7.5.2 - Infrastructure for FDA enforcement (e.g., resources, personnel, training, monitoring, third-party regulations) not in place

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC210

2005-09-20

Ms. Amy Felty

Felty, Amy,

2005N-0345-EC343

2005-09-20

Mrs. Julie Fisher

Fisher, Julie,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC437

2005-09-21

Families for Life

Mawn, Marie,

2005N-0345-EC49

2005-09-01

Mr. Christopher Landauer

Landauer, Christopher,

2005N-0345-EC50

2005-09-01

Mrs. Christine Valli

Valli, Christine,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve

Comment Number Received Date Organization Commenter(s)

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-C346

2005-10-31

S. Hauss

Stephen Hauss,

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-C457

2005-11-07

B. Muto

Bernadette E. Muto,

2005N-0345-C487

2005-11-15

K. Raviele, M.D., F.A.C.O.G.

Kathleeen M. Raviele, M.D., F.A.,

2005N-0345-C54

2005-10-07

R L LaChance

Robin L LaChance,

2005N-0345-C71

2005-10-12

D Ruckdeschel

Diana Ruckdeschel,

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1009

2005-10-27

University of California

Rose, Demian,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1044

2005-10-27

Ms. Trisha Pruis

Pruis, Trisha,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC110

2005-09-20

Hunter College

Roye, Carol,

2005N-0345-EC112

2005-09-20

Infectious Diseases Assoc. of Fort Lauderdale

Combs, RN, Michelle,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC13026

2005-11-03

Ms. Tiffany Thomas

Thomas, Tiffany,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC13778

2005-11-03

Mrs. Carol Svenson

Svenson, Carol,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13845

2005-11-03

Mr. Michael Rahl

Rahl, Michael,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC14078

2005-11-03

Mrs. Lori Kaiping

Kaiping, Lori,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC14884

2005-11-03

Dr. David Hutchison

Hutchison, David,

2005N-0345-EC15

2005-09-01

Ms. Laura Marshall

Marshall, Laura,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC15690

2005-11-03

Association of American Physicians & Surgeons

Schlafly, Andrew,

2005N-0345-EC1573

2005-10-31

Ms. Sarah Mauet

Mauet, Sarah,

2005N-0345-EC158

2005-09-20

Mrs. Wanda Ricketson

Ricketson, Wanda,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC1595

2005-10-31

Mrs. Stephanie Schulte

Schulte, Stephanie,

2005N-0345-EC1602

2005-10-31

Miss. Katherine Kirkland

Kirkland, Katherine,

2005N-0345-EC1618

2005-10-31

Mr. Gregory Schulte

Schulte, Gregory,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC1720

2005-10-31

Dr. Bonnie Anderson

Anderson, Bonnie,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1927

2005-10-31

Mrs. Kristin Moon

Moon, Kristin,

2005N-0345-EC193

2005-09-20

Ms. Carol Witherwax

Witherwax, Carol,

2005N-0345-EC1970

2005-10-31

Pittsburgh

Crousey, Joshua,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC21

2005-09-01

NYC DOE

RICHMAN, BOBBI,

2005N-0345-EC210

2005-09-20

Ms. Amy Felty

Felty, Amy,

2005N-0345-EC211

2005-09-20

Mr. Stan Young

Young, Stan,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC319

2005-09-20

UALR-student

Myers, Micah,

2005N-0345-EC343

2005-09-20

Mrs. Julie Fisher

Fisher, Julie,

2005N-0345-EC38

2005-09-01

Dr. Sarah Scarpace

Scarpace, Sarah,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC405

2005-09-20

Amoli Organics Pvt. Limited, INDIA

Kulshrestha, Vikram V,

2005N-0345-EC412

2005-09-20

Mr. Phillipe Wernette

Wernette, Phillipe,

2005N-0345-EC415

2005-09-20

Dr. Barbara Bittner

Bittner, Barbara,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC437

2005-09-21

Families for Life

Mawn, Marie,

2005N-0345-EC447

2005-09-26

Mr. kurt anspach

anspach, kurt,

2005N-0345-EC454

2005-09-26

Miss. Rachel Crow

Crow, Rachel,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC50

2005-09-01

Mrs. Christine Valli

Valli, Christine,

2005N-0345-EC503

2005-09-27

Mr. John Sullivan

Sullivan, John,

2005N-0345-EC510

2005-09-27

Advanced Women's Care

Davidson, J Michael,

2005N-0345-EC526

2005-09-29

Mt. Carmel St. Ann's Hospital

Thompson, Sharon,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC531

2005-09-29

Mrs. Clare Kosmalski

Kosmalski, Clare,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC547

2005-10-03

Mr. Ralph Arnsparger

Arnsparger, Ralph,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC56

2005-09-01

Mrs. Rebecca Porter

Porter, Rebecca,

2005N-0345-EC569

2005-10-12

Miss. Kathleen Tansley

Tansley, Kathleen,

2005N-0345-EC572

2005-10-12

Mr. John Naughton

Naughton, John,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC586

2005-10-12

Mr. Gregory Doran

Doran, Gregory,

2005N-0345-EC59

2005-09-01

Ms. Ruth Tehila Leonard

Leonard, Ruth Tehila,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC628

2005-10-12

Mr. Ted Rowell

Rowell, Ted,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC661

2005-10-12

none

Gill, Barbara,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC668

2005-10-12

Mrs. Anna Vrankar

Vrankar, Anna,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC710

2005-10-12

Mrs. Naomi Devine

Devine, Naomi,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC75

2005-09-01

Ms. Peggy Andreas

Andreas, Peggy,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC813

2005-10-13

Ms. Patricia Wagner

Wagner, Patricia,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

2005N-0345-EC896

2005-10-17

Mrs. Katie Guy

Guy, Katie,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

2005N-0345-EC922

2005-10-27

Dr. Michele Gray

Gray, Michele,

2005N-0345-EMC10

2005-08-27

R. Coryell

Ryan Coryell,

2005N-0345-EMC11

2005-08-27

C. Hardin

Christa Hardin,

2005N-0345-EMC126

2005-08-31

S Sears

Steve Sears,

2005N-0345-EMC15

2005-08-29

L. Armstrong

Lisa Armstrong,

2005N-0345-EMC18

2005-08-29

T. van Loan

Torie van Loan,

7.5.4 - Other arguments

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC135

2005-09-20

Mr. Peter Severance

Severance, Peter,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC713

2005-10-12

Mrs. Betty Feldman

Feldman, Betty,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EMC18

2005-08-29

T. van Loan

Torie van Loan,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

7.6 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC13026

2005-11-03

Ms. Tiffany Thomas

Thomas, Tiffany,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC313

2005-09-20

Dr. Lisa Neidert

Neidert, Lisa,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC402

2005-09-20

University of Utah

Murphy, Patricia,

2005N-0345-EC510

2005-09-27

Advanced Women's Care

Davidson, J Michael,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

8 - Assuming legal to market both, may the prescription (Rx) and OTC products be legally sold in the same package? [ANPRM Q 3.A.]

Comment Number Received Date Organization Commenter(s)

8.1 - Yes

Comment Number Received Date Organization Commenter(s)

2005N-0345-C9

2005-09-16

J Nichols

Joseph Nicols,

2005N-0345-EC100

2005-09-20

Lahey Clinic

Neels MPH, RD, Cindy,

2005N-0345-EC101

2005-09-20

Mrs. Irene Warshauer

Warshauer, Irene,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC1069

2005-10-27

Mrs. Ruth Voluck

Voluck, Ruth,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC108

2005-09-20

Mrs. Glenda Cass

Cass, Glenda,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC12728

2005-11-03

Miss. H.A. Stratford

Stratford, H.A.,

2005N-0345-EC12749

2005-11-03

Ms. Jessica Arons

Arons, Jessica,

2005N-0345-EC12817

2005-11-03

Mrs. Elizabeth Dahan

Dahan, Elizabeth,

2005N-0345-EC12827

2005-11-03

Ms. Sarah Warren

Warren, Sarah,

2005N-0345-EC13301

2005-11-03

Ms. Karen Hughes

Hughes, Karen,

2005N-0345-EC137

2005-09-20

Mr. Craig Pennington

Pennington, Craig,

2005N-0345-EC14261

2005-11-03

Mr. B Owens

Owens, B,

2005N-0345-EC144

2005-09-20

Mr. Alan McAllister

McAllister, Alan,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC148

2005-09-20

Ms. CINDY SCOTT

SCOTT, CINDY,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC156

2005-09-20

Ms. Anita Fream

Fream, Anita,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC159

2005-09-20

Mrs. Elizabeth Wilke

Wilke, Elizabeth,

2005N-0345-EC1602

2005-10-31

Miss. Katherine Kirkland

Kirkland, Katherine,

2005N-0345-EC162

2005-09-20

Dr. Paul Hutson

Hutson, Paul,

2005N-0345-EC163

2005-09-20

Mr. Leo Smith

Smith, Leo,

2005N-0345-EC164

2005-09-20

Ms. alisa arthur

arthur, alisa,

2005N-0345-EC16529

2005-11-03

SCVMC

M, J,

2005N-0345-EC16543

2005-11-03

Ms. Kim Jones

Jones, Kim,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC16777

2005-11-03

Santa Clara Valley Medical Center

Fainstat, Theodore,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC1708

2005-10-31

Ms. Amy Miller

Miller, Amy,

2005N-0345-EC175

2005-09-20

Ms. K Johnson

Johnson, K,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC1856

2005-10-31

United Church of Christ

Snborn, Hugh,

2005N-0345-EC186

2005-09-20

Ms. Rhianna Wilson

Wilson, Rhianna,

2005N-0345-EC1863

2005-10-31

Women's Political Caucus

Ralston, Virginia,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC190

2005-09-20

privat

Maaser, H,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC196

2005-09-20

Ms. Rachel Hibberd

Hibberd, Rachel,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC200

2005-09-20

Ms. carol holden

holden, carol,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2129

2005-10-31

Ms. Sandra Stevenson

Stevenson, Sandra,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC2218

2005-11-03

Mrs. JOY LEWIS

LEWIS, JOY,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC226

2005-09-20

Ms. Baudi Cepeda

Cepeda, Baudi,

2005N-0345-EC228

2005-09-20

Mr. Clay Evans

Evans, Clay,

2005N-0345-EC2285

2005-11-03

Mr. Ron Slonneger

Slonneger, Ron,

2005N-0345-EC2287

2005-11-03

Mrs. Nancy Ellingham

Ellingham, Nancy,

2005N-0345-EC2288

2005-11-03

Ms. Jacqui Barnett

Barnett, Jacqui,

2005N-0345-EC2289

2005-11-03

Ms. Jen Halbert

Halbert, Jen,

2005N-0345-EC2290

2005-11-03

Ms. Jeniffer Woo

Woo, Jeniffer,

2005N-0345-EC2293

2005-11-03

James Madison University

Santiago, Anna,

2005N-0345-EC2298

2005-11-03

Mrs. Susan Lynch

Lynch, Susan,

2005N-0345-EC2304

2005-11-03

Mrs. Laura Los

Los, Laura,

2005N-0345-EC2305

2005-11-03

Ms. Dana Reinisch

Reinisch, Dana,

2005N-0345-EC2307

2005-11-03

Ms. eva grove

grove, eva,

2005N-0345-EC2308

2005-11-03

NOW

Naugle, Kay,

2005N-0345-EC2309

2005-11-03

Ms. Eva Wilkins

Wilkins, Eva,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC2317

2005-11-03

Ms. Kimberly Eaton

Eaton, Kimberly,

2005N-0345-EC2323

2005-11-03

Dr. Cynthia Mesh

Mesh, Cynthia,

2005N-0345-EC2325

2005-11-03

Ms. Katherine Mowen

Mowen, Katherine,

2005N-0345-EC233

2005-09-20

Ms. Margaret Martin

Martin, Margaret,

2005N-0345-EC2333

2005-11-03

Ms. Loreen Bowen

Bowen, Loreen,

2005N-0345-EC235

2005-09-20

Ms. Pauline Yu

Yu, Pauline,

2005N-0345-EC2377

2005-11-03

Dr. Lauri Costello

Costello, Lauri,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC25

2005-09-01

Ms. Colleen Meegan

Meegan, Colleen,

2005N-0345-EC252

2005-09-20

Falk Pharmacy

Hrinya, Margaret,

2005N-0345-EC260

2005-09-20

University of Utah

Roller, Laura,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC267

2005-09-20

Mrs. Leslie Dilley

Dilley, Leslie,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC276

2005-09-20

Ms. Elizabeth Lower-Basch

Lower-Basch, Elizabeth,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC282

2005-09-20

Ms. Darci Kolb, MSN, FNP

Kolb, MSN, FNP, Darci,

2005N-0345-EC284

2005-09-20

Mrs. Linda Shroyer

Shroyer, Linda,

2005N-0345-EC297

2005-09-20

Dr. R. Saul Levinson

Levinson, R. Saul,

2005N-0345-EC298

2005-09-20

Mrs. Jennifer Hoyle-Franklin

Hoyle-Franklin, Jennifer,

2005N-0345-EC300

2005-09-20

Mr. Ryan Franklin

Franklin, Ryan,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC325

2005-09-20

Ms. Heather Llewellyn

Llewellyn, Heather,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC334

2005-09-20

Ms. Lori Wilbois

Wilbois, Lori,

2005N-0345-EC341

2005-09-20

Ms. Loy Schroeder

Schroeder, Loy,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC369

2005-09-20

University of Utah College of Nursing

Cole, Beth,

2005N-0345-EC388

2005-09-20

Mrs. Wai Chin Lachell

Lachell, Wai Chin,

2005N-0345-EC392

2005-09-20

Dr. LeClair Bissell

Bissell, LeClair,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC413

2005-09-20

Ms. Jennifer Springsteen

Springsteen, Jennifer,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC421

2005-09-20

Temple University Physicians

Brown, Michael,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC454

2005-09-26

Miss. Rachel Crow

Crow, Rachel,

2005N-0345-EC457

2005-09-26

Dr. Daniel Wujek

Wujek, Daniel,

2005N-0345-EC458

2005-09-26

Ms. Cheryl Betz

Betz, Cheryl,

2005N-0345-EC467

2005-09-26

Ms. susan shull

shull, susan,

2005N-0345-EC496

2005-09-27

Mr. David Hill

Hill, David,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC505

2005-09-27

Mr. Phillip Padden

Padden, Phillip,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC543

2005-10-03

Ms. Monica Mattice

Mattice, Monica,

2005N-0345-EC57

2005-09-01

United States of Ameica Citizen

Letter, Alice,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC614

2005-10-12

Mr. Kevin Doran

Doran, Kevin,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC657

2005-10-12

Mr. James Thompson

Thompson, James,

2005N-0345-EC68

2005-09-01

Ms. Lynn Max

Max, Lynn,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC747

2005-10-13

Ms. Sandra Jordan

Jordan, Sandra,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC769

2005-10-13

Ms. C Davis

Davis, C,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC789

2005-10-13

Ms. Trista Delamere

Delamere, Trista,

2005N-0345-EC808

2005-10-13

Mr. Steven Goranson

Goranson, Steven,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC844

2005-10-13

Private Individual

Rousu, Dwight,

2005N-0345-EC848

2005-10-13

Dr. Harnath Holmes

Holmes, Harnath,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC862

2005-10-17

Mrs. Joann Lander

Lander, Joann,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC87

2005-09-20

Mrs. Patricia Brown

Brown, Patricia,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC877

2005-10-17

Ms. Ravenna Oakes

Oakes, Ravenna,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC925

2005-10-27

Dr. Stefanie Falz

Falz, Stefanie,

2005N-0345-EC926

2005-10-27

University of Illinois College of Pharmacy

Freeman, Joseph,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

8.2 - No

Comment Number Received Date Organization Commenter(s)

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1028

2005-10-27

Miss. Kelsey McManis

McManis, Kelsey,

2005N-0345-EC1035

2005-10-27

University of Alaska Anchorage

Landis, Karen,

2005N-0345-EC105

2005-09-20

Mrs. carol small

small, carol,

2005N-0345-EC11436

2005-11-03

Mr. Russell Ault

Ault, Russell,

2005N-0345-EC1147

2005-10-27

Mr. Mark Hey

Hey, Mark,

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC124

2005-09-20

Mrs. Rhonda Koenig

Koenig, Rhonda,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC130

2005-09-20

Miss. Stephanie Lee

Lee, Stephanie,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC16770

2005-11-03

Subcommittee on Criminal Justice, Drug Policy, Hum

,

2005N-0345-EC18

2005-09-01

Ms. Susan Nowak

Nowak, Susan,

2005N-0345-EC193

2005-09-20

Ms. Carol Witherwax

Witherwax, Carol,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC2177

2005-10-31

Ms. Donna Bailer

Bailer, Donna,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC2255

2005-11-03

Ms. carolyn king

king, carolyn,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC247

2005-09-20

Ms. Teresa Dennison

Dennison, Teresa,

2005N-0345-EC262

2005-09-20

Mrs. Bethany Winder

Winder, Bethany,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC278

2005-09-20

N/A

endris, kelle,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC291

2005-09-20

Ms. Penny Svetlik

Svetlik, Penny,

2005N-0345-EC304

2005-09-20

Ms. Kathryn Scharplaz

Scharplaz, Kathryn,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC327

2005-09-20

Mr. Scott Drummond

Drummond, Scott,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC34

2005-09-01

Mr. Ralph Hudson

Hudson, Ralph,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC40

2005-09-01

Mr. robert falcone

falcone, robert,

2005N-0345-EC405

2005-09-20

Amoli Organics Pvt. Limited, INDIA

Kulshrestha, Vikram V,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC428

2005-09-20

INOVA Fairfax Hospital

Rizzo, Anne,

2005N-0345-EC43

2005-09-01

Mr. Richard J. Lamermayer

Lamermayer, Richard J.,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC446

2005-09-26

Mrs. Loretta Rech

Rech, Loretta,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC46

2005-09-01

Mrs. Clara Gondreau

Gondreau, Clara,

2005N-0345-EC472

2005-09-27

Mr. Roger Lands

Lands, Roger,

2005N-0345-EC473

2005-09-27

Mr. Richard Duguay

Duguay, Richard,

2005N-0345-EC475

2005-09-27

None

Tschirhart, Marceline,

2005N-0345-EC50

2005-09-01

Mrs. Christine Valli

Valli, Christine,

2005N-0345-EC510

2005-09-27

Advanced Women's Care

Davidson, J Michael,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC533

2005-09-29

Mrs. Mary Shelton

Shelton, Mary,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC558

2005-10-05

Univ of Ala Birmingham

Combs, Bart,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC563

2005-10-12

Mrs. Rosemary Woerner

Woerner, Rosemary,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC584

2005-10-12

Ms. Margaret Victor

Victor, Margaret,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC598

2005-10-12

Mr. Christopher Horrocks

Horrocks, Christopher,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC609

2005-10-12

Mr. Daniel Billingsley

Billingsley, Daniel,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC612

2005-10-12

Michian State Medical Society

Connaughton, Peter,

2005N-0345-EC615

2005-10-12

Ms. Mary Gillman

Gillman, Mary,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC624

2005-10-12

Mrs. Natalie Frey

Frey, Natalie,

2005N-0345-EC627

2005-10-12

Mr. Dale Olsen

Olsen, Dale,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC634

2005-10-12

Ms. Beth Hill

Hill, Beth,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC638

2005-10-12

Mr. Gary Allen

Allen, Gary,

2005N-0345-EC641

2005-10-12

Miss. Nellie Christian

Christian, Nellie,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC647

2005-10-12

Mother, wife, and someone who miscarried a child

,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC663

2005-10-12

Mr. Anthony Hunter

Hunter, Anthony,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC689

2005-10-12

Mrs. Pamela Al-Bawab

Al-Bawab, Pamela,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC697

2005-10-12

High School Teacher

Madrigal, Isela,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC699

2005-10-12

Mrs. Christine Lund-Molfese

Lund-Molfese, Christine,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC709

2005-10-12

Mrs. Regina Defauw

Defauw, Regina,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC729

2005-10-13

Mrs. M. Brown

Brown, M.,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC741

2005-10-13

none

Pinque, Tracey,

2005N-0345-EC745

2005-10-13

Texas House of Representatives

Meyer, Dina,

2005N-0345-EC750

2005-10-13

Mrs. stella milam

milam, stella,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC786

2005-10-13

Ms. Kathleen Pokorny

Pokorny, Kathleen,

2005N-0345-EC798

2005-10-13

Mrs. Gloria Kindon

Kindon, Gloria,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC804

2005-10-13

Mrs. Denise Morningstar

Morningstar, Denise,

2005N-0345-EC809

2005-10-13

Mrs. Elizabeth McGrane Tran

McGrane Tran, Elizabeth,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC83

2005-09-20

Dr. Rodney Smith

Smith, Rodney,

2005N-0345-EC839

2005-10-13

CVS Pharmacy

Jago, Laura,

2005N-0345-EC849

2005-10-13

Mr. Michael Swarner

Swarner, Michael,

2005N-0345-EC873

2005-10-17

Mrs. Mary Barrett

Barrett, Mary,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EC879

2005-10-17

Mrs. Linda McLaughlin

McLaughlin, Linda,

2005N-0345-EC889

2005-10-17

ABC Pregnancy Help Center

Egging, Patrice,

2005N-0345-EC90

2005-09-20

Mrs. Elisha Townsend

Townsend, Elisha,

2005N-0345-EC905

2005-10-18

Reproductive Endocriniologists

Gambrell, Jr., R. Don,

2005N-0345-EC909

2005-10-18

Mrs. Judith Bayba

Bayba, Judith,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

2005N-0345-EMC188

2005-10-11

F Alterton RN

Faith Alterton RN,

2005N-0345-EMC231

2005-10-27

S. Sakoutis

Stephanie Sakoutis,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

8.3 - Legal arguments supporting one package label for Rx and OTC sales

Comment Number Received Date Organization Commenter(s)

8.3.1 - FD&C Act arguments (e.g., single label could be created that satisfies both sets of statutory requirements)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC13

2005-09-01

Mr. Alexander Clague

Clague, Alexander,

2005N-0345-EC14491

2005-11-03

Miss. Chauncey Corlette

Corlette, Chauncey,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC77

2005-09-01

Mr. Brent Carlson

Carlson, Brent,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC98

2005-09-20

pharmacist

Keys, Lori,

8.3.2 - Do not need separate National Drug Code (NDC) numbers

Comment Number Received Date Organization Commenter(s)

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

8.3.3 - Court cases

Comment Number Received Date Organization Commenter(s)

8.3.4 - Other legal arguments supporting one package label

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC13851

2005-11-03

Miss. Marie Nguyen

Nguyen, Marie,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC779

2005-10-13

Miss. Megan Macdonell

Macdonell, Megan,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

8.4 - Policy arguments supporting one package label for Rx and OTC sales

Comment Number Received Date Organization Commenter(s)

8.4.1 - Other policy arguments supporting one package label

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC126

2005-09-20

Ms. Anne Dougherty

Dougherty, Anne,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC14261

2005-11-03

Mr. B Owens

Owens, B,

2005N-0345-EC1565

2005-10-31

Dr. Yvonne Yao

Yao, Yvonne,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC281

2005-09-20

Mrs. Catherine TomHon

TomHon, Catherine,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

8.5 - Legal arguments opposing one package for Rx and OTC sales

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC111

2005-09-20

Dr. Jerrold Black

Black, Jerrold,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC171

2005-09-20

Humanity

Pinkerton, Mike,

2005N-0345-EC813

2005-10-13

Ms. Patricia Wagner

Wagner, Patricia,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

8.5.1 - FD&C Act - Legal differences between statutory requirements for Rx and OTC

Comment Number Received Date Organization Commenter(s)

2005N-0345-C407

2005-11-01

Pfizer, Inc.

Bert W. Rein,

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC1108

2005-10-27

Mr. Darrell Tangman

Tangman, Darrell,

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC649

2005-10-12

Mrs. Jodi Wagner

Wagner, Jodi,

8.5.2 - Court cases arguments opposing one package

Comment Number Received Date Organization Commenter(s)

8.5.3 - Need separate National Drug Code (NDC) numbers for billing

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC15687

2005-11-03

Academy of Managed Care Pharmacy

Cahill, Judith,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

8.5.4 - Other legal arguments opposing one package

Comment Number Received Date Organization Commenter(s)

2005N-0345-C414

2005-11-01

Kirkpatrick & Lockhart Nicholson Graham (K&LNG)

,

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC405

2005-09-20

Amoli Organics Pvt. Limited, INDIA

Kulshrestha, Vikram V,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC896

2005-10-17

Mrs. Katie Guy

Guy, Katie,

8.6 - Policy arguments opposing one package for Rx and OTC sales

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

8.6.1 - Single package contrary to meaningful difference standard

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

8.6.2 - Risk of medication errors or threats to patient safety

Comment Number Received Date Organization Commenter(s)

2005N-0345-C29

2005-09-29

M A Morris

Mary Ann Morris,

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-C71

2005-10-12

D Ruckdeschel

Diana Ruckdeschel,

2005N-0345-C83

2005-10-13

F Alterton, RN

Faith Alterton, RN,

2005N-0345-EC1108

2005-10-27

Mr. Darrell Tangman

Tangman, Darrell,

2005N-0345-EC112

2005-09-20

Infectious Diseases Assoc. of Fort Lauderdale

Combs, RN, Michelle,

2005N-0345-EC11436

2005-11-03

Mr. Russell Ault

Ault, Russell,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC147

2005-09-20

n/a

Loomis, Shirley,

2005N-0345-EC154

2005-09-20

Dr. Karen Geller

Geller, Karen,

2005N-0345-EC165

2005-09-20

Mrs. Elizabeth Reusch

Reusch, Elizabeth,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC221

2005-09-20

Mr. William Blatnik

Blatnik, William,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC427

2005-09-20

Mr. Hugh Wygmans

Wygmans, Hugh,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC65

2005-09-01

Ms. Amy Ray

Ray, Amy,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC742

2005-10-13

Ms. Katherine Dalesandre

Dalesandre, Katherine,

2005N-0345-EC813

2005-10-13

Ms. Patricia Wagner

Wagner, Patricia,

2005N-0345-EC929

2005-10-27

Mrs. Heather Ipema

Ipema, Heather,

2005N-0345-EC93

2005-09-20

Mr. ben burns

burns, ben,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

8.6.3 - Same packaging permits/encourages trading/swapping

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1080

2005-10-27

Miss. Gwendolyn Rucker

Rucker, Gwendolyn,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC90

2005-09-20

Mrs. Elisha Townsend

Townsend, Elisha,

2005N-0345-EC97

2005-09-20

Ms. Anita Brakman

Brakman, Anita,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

8.6.4 - Other arguments opposing one package

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1121

2005-10-27

University of Wisconsin

White, V. Alan,

2005N-0345-EC132

2005-09-20

Ms. Jeanette Peters

Peters, Jeanette,

2005N-0345-EC14388

2005-11-03

Ms. Lauren Soriano

Soriano, Lauren,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC1927

2005-10-31

Mrs. Kristin Moon

Moon, Kristin,

2005N-0345-EC2107

2005-10-31

N/A

Oyen, Duane,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC301

2005-09-20

Ms. Amanda Jensen

Jensen, Amanda,

2005N-0345-EC307

2005-09-20

Ms. Jackie Wu

Wu, Jackie,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC54

2005-09-01

Mr. Scott Rommel

Rommel, Scott,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC566

2005-10-12

Mrs. Annette Burgess

Burgess, Annette,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC63

2005-09-01

Ms. Karen Andreas

Andreas, Karen,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC827

2005-10-13

Mr. James O'Hagan

O'Hagan, James,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

8.7 - Examples of Rx and OTC labeling that is similar but with one or two differences – e.g., dosage/age distinction

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC118

2005-09-20

Ms. Jackie Krugler

Krugler, Jackie,

2005N-0345-EC13

2005-09-01

Mr. Alexander Clague

Clague, Alexander,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC507

2005-09-27

Mr. Roger McCrady

McCrady, Roger,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EMC391

2005-10-31

T. Bell

Tanya Bell,

2005N-0345-EMC459

2005-11-14

D. Hamilton

Debbie Hamilton,

8.8 - Examples of similar labeling of Rx and OTC products that are the same drug and dose, in the market place or previously marketed

Comment Number Received Date Organization Commenter(s)

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-EC148

2005-09-20

Ms. CINDY SCOTT

SCOTT, CINDY,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1954

2005-10-31

Mrs. Diane Steele

Steele, Diane,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC207

2005-09-20

Ms. Cathryn Lawson

Lawson, Cathryn,

2005N-0345-EC216

2005-09-20

Gainesville Area National Organization for Women

Signature:,

2005N-0345-EC73

2005-09-01

Mr. Stephen Ricci

Ricci, Stephen,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

8.9 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-C403

2005-10-31

Arnall Golden Gregory. LLP

Alan G. Minsk,

2005N-0345-EC1032

2005-10-27

Ms. Judy Ladd

Ladd, Judy,

2005N-0345-EC1044

2005-10-27

Ms. Trisha Pruis

Pruis, Trisha,

2005N-0345-EC13197

2005-11-03

Mr. Ziad Chihane

Chihane, Ziad,

2005N-0345-EC16

2005-09-01

Ms. Stephanie Smart

Smart, Stephanie,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC323

2005-09-20

Mr. Charles Rupp

Rupp, Charles,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC677

2005-10-12

Miss. Jennifer Gordon

Gordon, Jennifer,

2005N-0345-EC680

2005-10-12

Christian Leadership Alliance in Memphis

Schulz, Stan,

2005N-0345-EC716

2005-10-12

Citizen

Hager, Joseph R,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC85

2005-09-20

Ms. Sandra Oyola

Oyola, Sandra,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC91

2005-09-20

Ms. Susan Hawkins

Hawkins, Susan,

2005N-0345-EMC368

2005-10-30

M. Syed

Misbah Syed,

9 - If they can be legally sold in same package, under what circumstances would it be inappropriate to do so? [ANPRM Q 3.B.]

Comment Number Received Date Organization Commenter(s)

9.1 - Circumstances in which it is inappropriate to distribute products in a single package

Comment Number Received Date Organization Commenter(s)

9.1.1 - Specific circumstances

Comment Number Received Date Organization Commenter(s)

2005N-0345-C307

2005-10-31

GlaxoSmithKline (GSK)

Sue James,

2005N-0345-C412

2005-11-01

Consumer Healthcare Products Association (CHPA)

,

2005N-0345-C415

2005-11-01

Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (Duramed)

,

2005N-0345-EC100

2005-09-20

Lahey Clinic

Neels MPH, RD, Cindy,

2005N-0345-EC1030

2005-10-27

Ms. Maureen Gombas

Gombas, Maureen,

2005N-0345-EC1041

2005-10-27

Mr. Thomas Speight

Speight, Thomas,

2005N-0345-EC109

2005-09-20

Mr. Charles Burometto, Jr

Burometto, Jr, Charles,

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC12

2005-09-01

UCLA Medical Center, Dept of Pharm Serv

Reynolds, Charles,

2005N-0345-EC121

2005-09-20

Ms. april slee

slee, april,

2005N-0345-EC124

2005-09-20

Mrs. Rhonda Koenig

Koenig, Rhonda,

2005N-0345-EC146

2005-09-20

Mr. Robert Steele

Steele, Robert,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC1602

2005-10-31

Miss. Katherine Kirkland

Kirkland, Katherine,

2005N-0345-EC16675

2005-11-03

American Pharmacists Association

Gans, John,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC168

2005-09-20

Ms. Rachel Hein

Hein, Rachel,

2005N-0345-EC180

2005-09-20

Ms. Kimberly Magee

Magee, Kimberly,

2005N-0345-EC1997

2005-10-31

NYU School of Medicine

Lubit, Elana,

2005N-0345-EC2009

2005-10-31

Ms. Bridget Gibbons

Gibbons, Bridget,

2005N-0345-EC201

2005-09-20

Dr. Marla Tuchinsky

Tuchinsky, Marla,

2005N-0345-EC212

2005-09-20

Ms. Anne Kisly

Kisly, Anne,

2005N-0345-EC2294

2005-11-03

Ms. Amy Hashiguchi

Hashiguchi, Amy,

2005N-0345-EC252

2005-09-20

Falk Pharmacy

Hrinya, Margaret,

2005N-0345-EC255

2005-09-20

Mr. Bennett Korach

Korach, Bennett,

2005N-0345-EC283

2005-09-20

Redmond Family Care

Richey, Wayne,

2005N-0345-EC311

2005-09-20

Mr. W. Aaron Waychoff

Waychoff, W. Aaron,

2005N-0345-EC364

2005-09-20

Mr. Doug McLeod

McLeod, Doug,

2005N-0345-EC399

2005-09-20

Ms. Gillian Tufts

Tufts, Gillian,

2005N-0345-EC408

2005-09-20

Mr. Carl Labbe

Labbe, Carl,

2005N-0345-EC414

2005-09-20

Mrs. Constance Rice

Rice, Constance,

2005N-0345-EC416

2005-09-20

National Defense University

Thompson, Donald,

2005N-0345-EC426

2005-09-20

Mrs. Kathleen Duchon

Duchon, Kathleen,

2005N-0345-EC431

2005-09-20

Ms. Mary Scott

Scott, Mary,

2005N-0345-EC451

2005-09-26

Mr. Russell Engbrecht

Engbrecht, Russell,

2005N-0345-EC454

2005-09-26

Miss. Rachel Crow

Crow, Rachel,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC5

2005-08-29

Miss. LAURA CUNNINGHAM

CUNNINGHAM, LAURA,

2005N-0345-EC522

2005-09-28

Ms. Elizabeth Dolinski

Dolinski, Elizabeth,

2005N-0345-EC58

2005-09-01

Ventura Associates

Venturella, Vincent S.,

2005N-0345-EC6

2005-08-29

Mr. Evan Goodman

Goodman, Evan,

2005N-0345-EC605

2005-10-12

Mrs. Rebecca Harrington

Harrington, Rebecca,

2005N-0345-EC627

2005-10-12

Mr. Dale Olsen

Olsen, Dale,

2005N-0345-EC651

2005-10-12

Mrs. Mary Rapp

Rapp, Mary,

2005N-0345-EC659

2005-10-12

Self-Employed

Langford, Willis,

2005N-0345-EC66

2005-09-01

Ms. Debora Baird

Baird, Debora,

2005N-0345-EC678

2005-10-12

Ms. Kathleen Socha

Socha, Kathleen,

2005N-0345-EC691

2005-10-12

Mr. Thomas Carter

Carter, Thomas,

2005N-0345-EC7

2005-08-29

Ms. Jennifer Dawson

Dawson, Jennifer,

2005N-0345-EC711

2005-10-12

Mrs. Kathleen Steinmetz

Steinmetz, Kathleen,

2005N-0345-EC712

2005-10-12

Mrs. Kathleen J. den Breejen

den Breejen, Kathleen J.,

2005N-0345-EC777

2005-10-13

Mr. John Long

Long, John,

2005N-0345-EC782

2005-10-13

Dr. Dale Michels

Michels, Dale,

2005N-0345-EC786

2005-10-13

Ms. Kathleen Pokorny

Pokorny, Kathleen,

2005N-0345-EC81

2005-09-20

Ms. Ann Schmierer

Schmierer, Ann,

2005N-0345-EC815

2005-10-13

Mr. Joseph DeRitis

DeRitis, Joseph,

2005N-0345-EC860

2005-10-17

Ms. Sara Oberst

Oberst, Sara,

2005N-0345-EC880

2005-10-17

Ms. Elizabeth Brookbank

Brookbank, Elizabeth,

2005N-0345-EC896

2005-10-17

Mrs. Katie Guy

Guy, Katie,

2005N-0345-EC903

2005-10-18

Mrs. Margaret Kopp

Kopp, Margaret,

2005N-0345-EC94

2005-09-20

Dr. Richard Wurtz

Wurtz, Richard,

2005N-0345-EC946

2005-10-27

Mrs. Barbara Presnell

Presnell, Barbara,

2005N-0345-EC951

2005-10-27

Ms. Kathryn Brass

Brass, Kathryn,

2005N-0345-EMC374

2005-10-30

S. Thames

Samuel Thames,

2005N-0345-EMC397

2005-10-31

T. Vu

Tram Vu,

9.1.2 - All circumstances (i.e., it’s always inappropriate)

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC117

2005-09-20

Miss. Kellie Dorn

Dorn, Kellie,

2005N-0345-EC12630

2005-11-03

Ms. Naomi Kenenr

Kenenr, Naomi,

2005N-0345-EC128

2005-09-20

none

Ann Marie, Finley,

2005N-0345-EC160

2005-09-20

Ms. Emiliann Bachelor

Bachelor, Emiliann,

2005N-0345-EC218

2005-09-20

Mr. Graham Green

Green, Graham,

2005N-0345-EC236

2005-09-20

Virginia Commonwealth University

Jennings, Brandon T.,

2005N-0345-EC247

2005-09-20

Ms. Teresa Dennison

Dennison, Teresa,

2005N-0345-EC264

2005-09-20

Mr. Andrew Richardson

Richardson, Andrew,

2005N-0345-EC27

2005-09-01

Priority Healthcare

Pechacek, Deborah,

2005N-0345-EC278

2005-09-20

N/A

endris, kelle,

2005N-0345-EC304

2005-09-20

Ms. Kathryn Scharplaz

Scharplaz, Kathryn,

2005N-0345-EC309

2005-09-20

Mrs. Kris Birch

Birch, Kris,

2005N-0345-EC322

2005-09-20

Mrs. Keri Lee Stevens

Stevens, Keri Lee,

2005N-0345-EC33

2005-09-01

Dr. Mark Collum

Collum, Mark,

2005N-0345-EC411

2005-09-20

Mrs. Betty Ann Elliott CNM

Elliott CNM, Betty Ann,

2005N-0345-EC415

2005-09-20

Dr. Barbara Bittner

Bittner, Barbara,

2005N-0345-EC435

2005-09-20

Mr. richard parente

parente, richard,

2005N-0345-EC446

2005-09-26

Mrs. Loretta Rech

Rech, Loretta,

2005N-0345-EC509

2005-09-27

Ms. Pros Senke

Senke, Pros,

2005N-0345-EC518

2005-09-28

Ms. Brigid Kowalczyk

Kowalczyk, Brigid,

2005N-0345-EC52

2005-09-01

Mr. Steven Zahn

Zahn, Steven,

2005N-0345-EC562

2005-10-12

Mrs. Anna Daniel

Daniel, Anna,

2005N-0345-EC57

2005-09-01

United States of Ameica Citizen

Letter, Alice,

2005N-0345-EC597

2005-10-12

Mrs. Deborah Thieme

Thieme, Deborah,

2005N-0345-EC598

2005-10-12

Mr. Christopher Horrocks

Horrocks, Christopher,

2005N-0345-EC599

2005-10-12

Mr. Colin Donovan

Donovan, Colin,

2005N-0345-EC601

2005-10-12

Mr. Craig Modrzynski

Modrzynski, Craig,

2005N-0345-EC602

2005-10-12

Mrs. Carolyn Mulligan

Mulligan, Carolyn,

2005N-0345-EC604

2005-10-12

None

Bellinger, J. Barry,

2005N-0345-EC607

2005-10-12

n/a

Whalen, Ev,

2005N-0345-EC610

2005-10-12

Mrs. Frances Koch

Koch, Frances,

2005N-0345-EC611

2005-10-12

Mrs. Anne Risti

,

2005N-0345-EC612

2005-10-12

Michian State Medical Society

Connaughton, Peter,

2005N-0345-EC617

2005-10-12

Mr. Jackie Barnes

Barnes, Jackie,

2005N-0345-EC618

2005-10-12

Dr. Diane Poythress

Poythress, Diane,

2005N-0345-EC622

2005-10-12

Mrs. Margaret Tooley

Tooley, Margaret,

2005N-0345-EC629

2005-10-12

Miss. Cindy Morgan

Morgan, Cindy,

2005N-0345-EC633

2005-10-12

Consumer

Joyce, Allison,

2005N-0345-EC634

2005-10-12

Ms. Beth Hill

Hill, Beth,

2005N-0345-EC637

2005-10-12

Mrs. Natalie Rios

Rios, Natalie,

2005N-0345-EC641

2005-10-12

Miss. Nellie Christian

Christian, Nellie,

2005N-0345-EC643

2005-10-12

None

Conner, Dixie,

2005N-0345-EC644

2005-10-12

Mrs. Lucille Mattair

Mattair, Lucille,

2005N-0345-EC645

2005-10-12

Mr. Robert Fricke

Fricke, Robert,

2005N-0345-EC652

2005-10-12

Mrs. Cynthia Choo

Choo, Cynthia,

2005N-0345-EC653

2005-10-12

HOLY LOVE MINISTRIES

,

2005N-0345-EC655

2005-10-12

Mrs. Suzan Marcy

Marcy, Suzan,

2005N-0345-EC666

2005-10-12

Mr. Don Vasas

Vasas, Don,

2005N-0345-EC669

2005-10-12

Walgreens

Taylor, Larry,

2005N-0345-EC671

2005-10-12

Mrs. Mary Frances Friedl

Friedl, Mary Frances,

2005N-0345-EC675

2005-10-12

Dr. Catherine Shoemaker

Shoemaker, Catherine,

2005N-0345-EC681

2005-10-12

Mrs. Kathryn Anthony

Anthony, Kathryn,

2005N-0345-EC694

2005-10-12

Ms. J Conroy

Conroy, J,

2005N-0345-EC697

2005-10-12

High School Teacher

Madrigal, Isela,

2005N-0345-EC698

2005-10-12

Mrs. Kari Spencer

Spencer, Kari,

2005N-0345-EC705

2005-10-12

Ms. Nancy Cariglio

Cariglio, Nancy,

2005N-0345-EC709

2005-10-12

Mrs. Regina Defauw

Defauw, Regina,

2005N-0345-EC717

2005-10-12

Mr. Joseph Gorini

Gorini, Joseph,

2005N-0345-EC721

2005-10-12

Ms. Madeline Ashley

Ashley, Madeline,

2005N-0345-EC730

2005-10-13

Mrs. Arlene Hamm

Hamm, Arlene,

2005N-0345-EC736

2005-10-13

Mr. Wayne Hill

Hill, Wayne,

2005N-0345-EC741

2005-10-13

none

Pinque, Tracey,

2005N-0345-EC745

2005-10-13

Texas House of Representatives

Meyer, Dina,

2005N-0345-EC761

2005-10-13

Dr. Gary Fitsimmons

Fitsimmons, Gary,

2005N-0345-EC766

2005-10-13

none

Lukas, Ellen,

2005N-0345-EC775

2005-10-13

Providence Hospital

Pomeroy, Mark,

2005N-0345-EC781

2005-10-13

Mrs. Theresa Otto

Otto, Theresa,

2005N-0345-EC788

2005-10-13

Dr. Thomas Phlips

Phlips, Thomas,

2005N-0345-EC805

2005-10-13

Mrs. Violet Corey

Corey, Violet,

2005N-0345-EC817

2005-10-13

Mr. Charles Seay, III

Seay, III, Charles,

2005N-0345-EC854

2005-10-13

Ms. Johanna Roberts

Roberts, Johanna,

2005N-0345-EC940

2005-10-27

Pharmacy Student

Mock, Suzanne,

2005N-0345-EC99

2005-09-20

Miss. Melissa Stockton

Stockton, Melissa,

9.2 - Circumstance in which it is appropriate to distribute in single package

Comment Number Received Date Organization Commenter(s)

9.2.1 - Specific circumstances

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC12379

2005-11-03

Miss. Claire-Helene Mershon

Mershon, Claire-Helene,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC2314

2005-11-03

National Research Center for Women

Zuckerman, Diana,

2005N-0345-EC32

2005-09-01

Ms. Jane Hagan

Hagan, Jane,

2005N-0345-EC47

2005-09-01

New Mexico State University

Clason, Dennis,

2005N-0345-EC516

2005-09-28

Ms. Elise katrib

katrib, Elise,

2005N-0345-EC53

2005-09-01

Mr. Tim McGhee

McGhee, Tim,

2005N-0345-EC646

2005-10-12

Mr. Raymond Settle

Settle, Raymond,

2005N-0345-EC693

2005-10-12

Mr. Sidney Baker

Baker, Sidney,

2005N-0345-EC870

2005-10-17

Fitzgerald Pharmacy

Vander Bleek, RPh, Luke,

2005N-0345-EC875

2005-10-17

Women's Care Center

Moore, Glenn,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

9.2.2 - All circumstances (i.e., it’s always appropriate, there are no inappropriate circumstances)

Comment Number Received Date Organization Commenter(s)

2005N-0345-C217

2005-10-25

Form Letter count 142

Form Letter count 142,

2005N-0345-EC101

2005-09-20

Mrs. Irene Warshauer

Warshauer, Irene,

2005N-0345-EC102

2005-09-20

Ms. Wendy Gantos

Gantos, Wendy,

2005N-0345-EC107

2005-09-20

Ms. Molly White

White, Molly,

2005N-0345-EC1086

2005-10-27

Ms. Michelle McCormick

McCormick, Michelle,

2005N-0345-EC11670

2005-11-03

Ms. Wanda Farren

Farren, Wanda,

2005N-0345-EC12406

2005-11-03

Ms. Tonya van Tol

van Tol, Tonya,

2005N-0345-EC12497

2005-11-03

Ms. Ginger Loggins

Loggins, Ginger,

2005N-0345-EC125

2005-09-20

Ms. Sharon Hartmann

Hartmann, Sharon,

2005N-0345-EC12506

2005-11-03

Ms. Kathy Denison

Denison, Kathy,

2005N-0345-EC12609

2005-11-03

Miss. Sarah Friedfeld

Friedfeld, Sarah,

2005N-0345-EC12681

2005-11-03

National Organization for Women

Savoy, Shae,

2005N-0345-EC12704

2005-11-03

Ms. Sarah Pike

Pike, Sarah,

2005N-0345-EC12749

2005-11-03

Ms. Jessica Arons

Arons, Jessica,

2005N-0345-EC12785

2005-11-03

Global Exchange

Cooke, Clare,

2005N-0345-EC12817

2005-11-03

Mrs. Elizabeth Dahan

Dahan, Elizabeth,

2005N-0345-EC12829

2005-11-03

N/A

Karpf, David,

2005N-0345-EC12932

2005-11-03

Mrs. Tracy Traut

Traut, Tracy,

2005N-0345-EC12980

2005-11-03

Ms. Susan Earl

Earl, Susan,

2005N-0345-EC13004

2005-11-03

Miss. Hajira Buser

Buser, Hajira,

2005N-0345-EC13138

2005-11-03

Mrs. Rosemary Wright

Wright, Rosemary,

2005N-0345-EC13158

2005-11-03

Miss. Josie Kusner

Kusner, Josie,

2005N-0345-EC13179

2005-11-03

Mrs. Mary Stanton

Stanton, Mary,

2005N-0345-EC13185

2005-11-03

Mr. Douglas Stanton

Stanton, Douglas,

2005N-0345-EC13194

2005-11-03

Ms. Shelley Watkins

Watkins, Shelley,

2005N-0345-EC13228

2005-11-03

Human Being

Fritz, Virgil,

2005N-0345-EC13256

2005-11-03

Ms. Maria Pacenza

Pacenza, Maria,

2005N-0345-EC13285

2005-11-03

Ms. Denese Deeds

Deeds, Denese,

2005N-0345-EC13392

2005-11-03

Mrs. Pauline Erickson

Erickson, Pauline,

2005N-0345-EC13447

2005-11-03

Ms. Tedi Elliott

Elliott, Tedi,

2005N-0345-EC13630

2005-11-03

Ms. Crystal Carmany

Carmany, Crystal,

2005N-0345-EC13825

2005-11-03

Miss. Elizabeth Alvy

Alvy, Elizabeth,

2005N-0345-EC13914

2005-11-03

Ms. Janice L. Myers

Myers, Janice L.,

2005N-0345-EC1397

2005-10-28

Ms. Anais Spitzer

Spitzer, Anais,

2005N-0345-EC1398

2005-10-28

Mr. David Stuart

Stuart, David,

2005N-0345-EC13992

2005-11-03

Ms. Cassalyn David

David, Cassalyn,

2005N-0345-EC14097

2005-11-03

Mrs. Susan Ware

Ware, Susan,

2005N-0345-EC1427

2005-10-28

Mrs. Christine Danner

Danner, Christine,

2005N-0345-EC1440

2005-10-28

Mrs. Kimberly Scott

Scott, Kimberly,

2005N-0345-EC1467

2005-10-28

Mrs. Kathleen jenkins

jenkins, Kathleen,

2005N-0345-EC148

2005-09-20

Ms. CINDY SCOTT

SCOTT, CINDY,

2005N-0345-EC1483

2005-10-28

Ms. Megan Santiestevan

Santiestevan, Megan,

2005N-0345-EC1509

2005-10-31

Ms. Jennifer M Weishaar

Weishaar, Jennifer M,

2005N-0345-EC1529

2005-10-31

Ms. Lynn Ziebell

Ziebell, Lynn,

2005N-0345-EC1540

2005-10-31

Ms. Kim Bullis-Byrd

Bullis-Byrd, Kim,

2005N-0345-EC15468

2005-11-03

Mr. Adam Wisnewski

Wisnewski, Adam,

2005N-0345-EC1548

2005-10-31

Dr. Carol Flinn

Flinn, Carol,

2005N-0345-EC155

2005-09-20

University of California Santa Cruz

Lamotte, Diane,

2005N-0345-EC1566

2005-10-31

Ms. Debra Oppenheimer

Oppenheimer, Debra,

2005N-0345-EC1573

2005-10-31

Ms. Sarah Mauet

Mauet, Sarah,

2005N-0345-EC15892

2005-11-03

Mr. Ann Durbin

Durbin, Ann,

2005N-0345-EC15931

2005-11-03

Ms. Melissa Walsh

Walsh, Melissa,

2005N-0345-EC1594

2005-10-31

Ms. Jeannie Barnes

Barnes, Jeannie,

2005N-0345-EC1595

2005-10-31

Mrs. Stephanie Schulte

Schulte, Stephanie,

2005N-0345-EC1618

2005-10-31

Mr. Gregory Schulte

Schulte, Gregory,

2005N-0345-EC1623

2005-10-31

Mrs. Deborah Gallagher

Gallagher, Deborah,

2005N-0345-EC163

2005-09-20

Mr. Leo Smith

Smith, Leo,

2005N-0345-EC1644

2005-10-31

Miss. karlee rockey

rockey, karlee,

2005N-0345-EC16499

2005-11-03

Mr. Eric Burtz

Burtz, Eric,

2005N-0345-EC16558

2005-11-03

Ms. Lara Owensby

Owensby, Lara,

2005N-0345-EC16594

2005-11-03

Ms. Michelle Lopez

Lopez, Michelle,

2005N-0345-EC16682

2005-11-03

Ms. Bonnie Margay Burke

Burke, Bonnie Margay,

2005N-0345-EC167

2005-09-20

Mr. John Blume

Blume, John,

2005N-0345-EC16701

2005-11-03

Mr. Brandon Perry

Perry, Brandon,

2005N-0345-EC1673

2005-10-31

Dr. Nora Fahlberg

Fahlberg, Nora,

2005N-0345-EC16792

2005-11-03

Miss. Constance Edwards

Edwards, Constance,

2005N-0345-EC16818

2005-11-03

Ms. Mary Griffith

Griffith, Mary,

2005N-0345-EC16861

2005-11-03

Ms. Melanie Ash

Ash, Melanie,

2005N-0345-EC16907

2005-11-03

Dr. Aaron Schutz

Schutz, Aaron,

2005N-0345-EC1700

2005-10-31

NOW

Bledsoe, Betty,

2005N-0345-EC172

2005-09-20

Ms. Angela Ross

Ross, Angela,

2005N-0345-EC1720

2005-10-31

Dr. Bonnie Anderson

Anderson, Bonnie,

2005N-0345-EC174

2005-09-20

Ms. d pearlman

pearlman, d,

2005N-0345-EC1754

2005-10-31

Ms. Caryn Bernstein

Bernstein, Caryn,

2005N-0345-EC176

2005-09-20

Ms. Cynthia Murphy

Murphy, Cynthia,

2005N-0345-EC1762

2005-10-31

Ms. Elizabeth Fisher

Fisher, Elizabeth,

2005N-0345-EC1787

2005-10-31

Pharmacist

Pinkerton, James,

2005N-0345-EC1808

2005-10-31

Ms. Deidre Purcell

Purcell, Deidre,

2005N-0345-EC181

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1811

2005-10-31

Ms. Bryn Poland

Poland, Bryn,

2005N-0345-EC1812

2005-10-31

self

Levicy, Tara,

2005N-0345-EC1813

2005-10-31

Miss. Melissa Lang

Lang, Melissa,

2005N-0345-EC1814

2005-10-31

Ms. Susan Stuckert

Stuckert, Susan,

2005N-0345-EC1815

2005-10-31

Ms. Allison White

White, Allison,

2005N-0345-EC1816

2005-10-31

Mrs. Melanie Weinraub

Weinraub, Melanie,

2005N-0345-EC1818

2005-10-31

Mr. Pedro Jimenez

Jimenez, Pedro,

2005N-0345-EC1820

2005-10-31

Ms. Karen Burrow

Burrow, Karen,

2005N-0345-EC1821

2005-10-31

Miss. Hope Arnold

Arnold, Hope,

2005N-0345-EC1822

2005-10-31

Mr. ROYCE YOUNG

YOUNG, ROYCE,

2005N-0345-EC1823

2005-10-31

Ms. Alicia Cox

Cox, Alicia,

2005N-0345-EC1824

2005-10-31

Ms. Cynthia Lee

Lee, Cynthia,

2005N-0345-EC1826

2005-10-31

Mrs. SUZETTE SPENCER

SPENCER, SUZETTE,

2005N-0345-EC1827

2005-10-31

Mrs. Michelle Tschannen

Tschannen, Michelle,

2005N-0345-EC1828

2005-10-31

Ms. Carey Butlien

Butlien, Carey,

2005N-0345-EC1829

2005-10-31

Ms. Leigh McKinney

McKinney, Leigh,

2005N-0345-EC183

2005-09-20

Mrs. Linda Steward

Steward, Linda,

2005N-0345-EC1830

2005-10-31

Ms. Cary Stanford

Stanford, Cary,

2005N-0345-EC1831

2005-10-31

Ms. Cathy Gage

Gage, Cathy,

2005N-0345-EC1832

2005-10-31

Ms. Patricia Parsley

Parsley, Patricia,

2005N-0345-EC1833

2005-10-31

Ms. Jessica Knapp

Knapp, Jessica,

2005N-0345-EC1834

2005-10-31

Mr. billy rainbow

rainbow, billy,

2005N-0345-EC1835

2005-10-31

Ms. Ann Merriman

Merriman, Ann,

2005N-0345-EC1836

2005-10-31

Mr. Richard Low

Low, Richard,

2005N-0345-EC1837

2005-10-31

Ms. Margaret Russell

Russell, Margaret,

2005N-0345-EC1838

2005-10-31

Ms. Bonnie Hurliman

Hurliman, Bonnie,

2005N-0345-EC1839

2005-10-31

Mrs. Dawn Merritt

Merritt, Dawn,

2005N-0345-EC1840

2005-10-31

NOW

Brown, Topanga,

2005N-0345-EC1841

2005-10-31

Mrs. Ilene Heller

Heller, Ilene,

2005N-0345-EC1842

2005-10-31

Mr. Aaron Method

Method, Aaron,

2005N-0345-EC1849

2005-10-31

Ms. Dominique Gagnon

Gagnon, Dominique,

2005N-0345-EC185

2005-09-20

Ms. Kathleen West

West, Kathleen,

2005N-0345-EC1855

2005-10-31

Ms. Cynthia Aspen

Aspen, Cynthia,

2005N-0345-EC1856

2005-10-31

United Church of Christ

Snborn, Hugh,

2005N-0345-EC1859

2005-10-31

Mrs. Steph Gerber

Gerber, Steph,

2005N-0345-EC1863

2005-10-31

Women's Political Caucus

Ralston, Virginia,

2005N-0345-EC1871

2005-10-31

Ms. Andrea Cedusky

Cedusky, Andrea,

2005N-0345-EC188

2005-09-20

Ms. Janet Jones

Jones, Janet,

2005N-0345-EC1884

2005-10-31

Ms. Jessica Goforth

Goforth, Jessica,

2005N-0345-EC1899

2005-10-31

Ms. Natalie Kashian

Kashian, Natalie,

2005N-0345-EC1922

2005-10-31

Miss. Kimberly Farnan

Farnan, Kimberly,

2005N-0345-EC1935

2005-10-31

Dr. Susan Dudley

Dudley, Susan,

2005N-0345-EC194

2005-09-20

Mrs. Julia Morrisroe

Morrisroe, Julia,

2005N-0345-EC195

2005-09-20

Dr. Duane Dowell

Dowell, Duane,

2005N-0345-EC1958

2005-10-31

Miss. Michelle Miller

Miller, Michelle,

2005N-0345-EC1979

2005-10-31

Mrs. Shannon Farrand-Bernardin

Farrand-Bernardin, Shannon,

2005N-0345-EC1986

2005-10-31

Ms. Jamie Hart

Hart, Jamie,

2005N-0345-EC199

2005-09-20

Ms. Sarah Gay

Gay, Sarah,

2005N-0345-EC2008

2005-10-31

Dr. David Lehnherr

Lehnherr, David,

2005N-0345-EC2012

2005-10-31

Ms. Seana Blake

Blake, Seana,

2005N-0345-EC203

2005-09-20

Miss. Lindsay Knoll

Knoll, Lindsay,

2005N-0345-EC2036

2005-10-31

Ms. Jennifer Chapin Harris

Chapin Harris, Jennifer,

2005N-0345-EC2044

2005-10-31

Ms. Colleen Bradley

Bradley, Colleen,

2005N-0345-EC206

2005-09-20

Ms. Gayle Levy

Levy, Gayle,

2005N-0345-EC2077

2005-10-31

Miss. kristin kearns

kearns, kristin,

2005N-0345-EC2111

2005-10-31

Ms. stewart rego

,

2005N-0345-EC2129

2005-10-31

Ms. Sandra Stevenson

Stevenson, Sandra,

2005N-0345-EC213

2005-09-20

Ms. Terresa Goggin

Goggin, Terresa,

2005N-0345-EC2138

2005-10-31

Mr. Nathan Brothers

Brothers, Nathan,

2005N-0345-EC214

2005-09-20

Ms. Debra Di Blasi

Di Blasi, Debra,

2005N-0345-EC2144

2005-10-31

National Organization for Women

Vives, Olga,

2005N-0345-EC2145

2005-10-31

Ms. Kristen Benson

Benson, Kristen,

2005N-0345-EC2169

2005-10-31

Dr. Deborah Thorp

Thorp, Deborah,

2005N-0345-EC2179

2005-10-31

Ms. amy margolin

margolin, amy,

2005N-0345-EC22

2005-09-01

Mr. A. A. Rankis

Rankis, A. A.,

2005N-0345-EC220

2005-09-20

Mrs. Helen Broman

Broman, Helen,

2005N-0345-EC2206

2005-11-03

Ms. Marion Nichols

Nichols, Marion,

2005N-0345-EC222

2005-09-20

Mr. Guy Haas

Haas, Guy,

2005N-0345-EC2221

2005-11-03

Miss. Heather Evans

Evans, Heather,

2005N-0345-EC224

2005-09-20

none

Roettcher, Phil,

2005N-0345-EC2278

2005-11-03

Mr. Willis Guess

,

2005N-0345-EC2285

2005-11-03

Mr. Ron Slonneger

Slonneger, Ron,

2005N-0345-EC2287

2005-11-03

Mrs. Nancy Ellingham

Ellingham, Nancy,

2005N-0345-EC2288

2005-11-03

Ms. Jacqui Barnett

Barnett, Jacqui,

2005N-0345-EC2289

2005-11-03

Ms. Jen Halbert

Halbert, Jen,

2005N-0345-EC2290

2005-11-03

Ms. Jeniffer Woo

Woo, Jeniffer,

2005N-0345-EC2293

2005-11-03

James Madison University

Santiago, Anna,

2005N-0345-EC2298

2005-11-03

Mrs. Susan Lynch

Lynch, Susan,

2005N-0345-EC2304

2005-11-03

Mrs. Laura Los

Los, Laura,

2005N-0345-EC2305

2005-11-03

Ms. Dana Reinisch

Reinisch, Dana,

2005N-0345-EC2307

2005-11-03

Ms. eva grove

grove, eva,

2005N-0345-EC2308

2005-11-03

NOW

Naugle, Kay,

2005N-0345-EC2309

2005-11-03

Ms. Eva Wilkins

Wilkins, Eva,

2005N-0345-EC231

2005-09-20

University of Florida

Livingston, Jessica,

2005N-0345-EC2317

2005-11-03

Ms. Kimberly Eaton

Eaton, Kimberly,

2005N-0345-EC2323

2005-11-03

Dr. Cynthia Mesh

Mesh, Cynthia,

2005N-0345-EC2325

2005-11-03

Ms. Katherine Mowen

Mowen, Katherine,

2005N-0345-EC233

2005-09-20

Ms. Margaret Martin

Martin, Margaret,

2005N-0345-EC2333

2005-11-03

Ms. Loreen Bowen

Bowen, Loreen,

2005N-0345-EC2341

2005-11-03

Ms. Laura Clary

Clary, Laura,

2005N-0345-EC2344

2005-11-03

Dr. Kelly Dennis

Dennis, Kelly,

2005N-0345-EC2354

2005-11-03

Ms. Cheryl Gillett

Gillett, Cheryl,

2005N-0345-EC2363

2005-11-03

Ms. Suzanne Sorrells

Sorrells, Suzanne,

2005N-0345-EC2366

2005-11-03

Mrs. Kavita Aggarwal

Aggarwal, Kavita,

2005N-0345-EC2377

2005-11-03

Dr. Lauri Costello

Costello, Lauri,

2005N-0345-EC2381

2005-11-03

Ms. Jessica Cresseveur

Cresseveur, Jessica,

2005N-0345-EC24

2005-09-01

Mr. Aaron Salvo

Salvo, Aaron,

2005N-0345-EC240

2005-09-20

Mr. Wayne Cunningham

Cunningham, Wayne,

2005N-0345-EC243

2005-09-20

University of Miami

Papeika, Rachel,

2005N-0345-EC261

2005-09-20

Dr. Peter Bridgman

Bridgman, Peter,

2005N-0345-EC269

2005-09-20

Emory University

Degoursac, Elizabeth,

2005N-0345-EC277

2005-09-20

Mr. Kevin Lewis

Lewis, Kevin,

2005N-0345-EC284

2005-09-20

Mrs. Linda Shroyer

Shroyer, Linda,

2005N-0345-EC318

2005-09-20

Dr. Joel Fein

Fein, Joel,

2005N-0345-EC331

2005-09-20

Ms. Michelle Durand

Durand, Michelle,

2005N-0345-EC334

2005-09-20

Ms. Lori Wilbois

Wilbois, Lori,

2005N-0345-EC341

2005-09-20

Ms. Loy Schroeder

Schroeder, Loy,

2005N-0345-EC365

2005-09-20

University of Utah

Deneris, Angela,

2005N-0345-EC37

2005-09-01

Dr. Martha Hayes

Hayes, Martha,

2005N-0345-EC39

2005-09-01

Mrs. Diane Green

Green, Diane,

2005N-0345-EC4

2005-08-29

Mr. Michael Bilz

Bilz, Michael,

2005N-0345-EC417

2005-09-20

Mrs. Sharon Van Dyke

Van Dyke, Sharon,

2005N-0345-EC418

2005-09-20

Dr. Marvin Schulman

Schulman, Marvin,

2005N-0345-EC421

2005-09-20

Temple University Physicians

Brown, Michael,

2005N-0345-EC423

2005-09-20

Ms. Elizabeth Stokes

Stokes, Elizabeth,

2005N-0345-EC430

2005-09-20

Dr. peter Bolton

Bolton, peter,

2005N-0345-EC500

2005-09-27

ACOG

Stone, Dana,

2005N-0345-EC532

2005-09-29

Mr. Albert Perkins

Perkins, Albert,

2005N-0345-EC555

2005-10-04

Pharmacist

Della Paolera, Mark,

2005N-0345-EC563

2005-10-12

Mrs. Rosemary Woerner

Woerner, Rosemary,

2005N-0345-EC574

2005-10-12

Retired

Vassar, John A.,

2005N-0345-EC60

2005-09-01

Ms. Donna Hoaglin

Hoaglin, Donna,

2005N-0345-EC614

2005-10-12

Mr. Kevin Doran

Doran, Kevin,

2005N-0345-EC62

2005-09-01

Ms. Trudie Gardner

Gardner, Trudie,

2005N-0345-EC626

2005-10-12

Gerald L. Peer, MD

Peer, Gerald,

2005N-0345-EC633

2005-10-12

Consumer

Joyce, Allison,

2005N-0345-EC64

2005-09-01

Mrs. Alice Cox

Cox, Alice,

2005N-0345-EC70

2005-09-01

Ms. helena champion

champion, helena,

2005N-0345-EC747

2005-10-13

Ms. Sandra Jordan

Jordan, Sandra,

2005N-0345-EC76

2005-09-01

Mrs. Lucia Rosati

Rosati, Lucia,

2005N-0345-EC762

2005-10-13

Ms. Laura Jean Long

Long, Laura Jean,

2005N-0345-EC789

2005-10-13

Ms. Trista Delamere

Delamere, Trista,

2005N-0345-EC80

2005-09-20

Dr. Clifton Cahoon

Cahoon, Clifton,

2005N-0345-EC802

2005-10-13

Mr. Jim Anthony

Anthony, Jim,

2005N-0345-EC823

2005-10-13

Ms. Kay Ropp

Ropp, Kay,

2005N-0345-EC828

2005-10-13

Mr. LLoyd Fojas

Fojas, LLoyd,

2005N-0345-EC844

2005-10-13

Private Individual

Rousu, Dwight,

2005N-0345-EC848

2005-10-13

Dr. Harnath Holmes

Holmes, Harnath,

2005N-0345-EC8663

2005-11-03

Ms. Dana Levin

Levin, Dana,

2005N-0345-EC869

2005-10-17

Miss. Jennifer Wilbois

Wilbois, Jennifer,

2005N-0345-EC874

2005-10-17

Ms. Mary Hartigan

Hartigan, Mary,

2005N-0345-EC877

2005-10-17

Ms. Ravenna Oakes

Oakes, Ravenna,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

9.3 - Miscellaneous arguments/discussions

Comment Number Received Date Organization Commenter(s)

2005N-0345-EC1129

2005-10-27

Ms. JoAnn Paslawsky

Paslawsky, JoAnn,

2005N-0345-EC13

2005-09-01

Mr. Alexander Clague

Clague, Alexander,

2005N-0345-EC141

2005-09-20

Dr. Meaghan Connors

Connors, Meaghan,

2005N-0345-EC166

2005-09-20

Dr. Timothy Fischer

Fischer, Timothy,

2005N-0345-EC326

2005-09-20

Miss. Rebecca Kolar

Kolar, Rebecca,

2005N-0345-EC535

2005-09-30

Mr. Theodore Rectenwald

Rectenwald, Theodore,

2005N-0345-EC61

2005-09-01

U. of South FL Public Health Student Association

Card, Alan,

2005N-0345-EC623

2005-10-12

Concerned Parents and Citizens of Fullerton

DeWitte, Conrad,

2005N-0345-EC654

2005-10-12

Mr. Peter Kortebein

Kortebein, Peter,

2005N-0345-EC72

2005-09-01

Ms. Cathy Bettoney

Bettoney, Cathy,

2005N-0345-EC96

2005-09-20

Ms. Eleanor Etter

Etter, Eleanor,

2005N-0345-EMC355

2005-10-30

J. Temple

Jennie Temple,

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