Dockets Entered On September 5, 2003

Table of Contents

Docket #

Title

1988N-0258. 1           Prescription Drug Marketing Act of 1987; Guideline. 1

1989N-0106. 1           Shellac and Shellac Wax 1

1992N-0297. 1           Prescription Drug Marketing Act of 1987, Drug Amds of 1992. 1

1995N-0304. 1           Ephedrine Alkaloids: Reports of Adverse Events; Availability. 1

1995N-0309. 1           CGMPs for the Production of Infant Formula. 1

1996N-0417. 1           CGMP in Mfg. Packing or Holding Dietary Supplements. 1

1997S-0162. 1           30-Day Structure Function Claim Notification Letters Dietary. 1

1998N-0359. 2           Program priorities/Center for Food Safety & Applied Nutrition. 2

2002N-0204. 2           Bar Code Label Requirements for human drug products. 2

2002N-0278. 2           Bioterrorism; Prior Notice of Imported Food Shipments. 2

2002P-0029. 2           Mylan estradiol transdermal system as generic substitute. 2

2002P-0219. 2           Amend the "Orange Book" for Fluocinide Emulsified Base. 2

2003D-0165. 2           Current Good Manufacturing Practices for Medical Gases. 2

2003D-0317. 2           Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products  2

2003N-0084. 2           Electronic Records; Electronic Signatures; Agency Information. 2

2003N-0168. 2           July 31, 2003 Public Meeting on Consumer Medication Information. 2

2003N-0191. 2           Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices  2

2003N-0233. 2           Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients  2

2003N-0338. 2           Secretary's Roundtable on Obesity/Nutrition. 2

2003P-0159. 2           Venlafaxine Hydrochloride Extended-Release Tablets. 2

2003P-0162. 2           Import Canadian food products that do not meet labeling regs. 2

2003P-0409. 2           Reclassification for Moblie Bearing Knees from Class III and Class II 2

1988N-0258

Prescription Drug Marketing Act of 1987; Guideline

M 1

Kleinfeld, Kaplan and Becker, LLP

Vol #:

6

1989N-0106

Shellac and Shellac Wax

LET 3

HFS-255 to McKenna, Long, & Aldridge, LLP

Vol #:

1

1992N-0297

Prescription Drug Marketing Act of 1987, Drug Amds of 1992

M 1

Kelinfield, Kaplan and Becker, LLP

Vol #:

8

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 4047

Boston University School of Public Health

Vol #:

374

RPT 9           Continued 1, 2, 3

Lopez, Hodes, restaino, Milman & Skikos

Vol #:

376

1995N-0309

CGMPs for the Production of Infant Formula

C 21

Mead Johnson & Company

Vol #:

9

C 22

Solus Products, LLC

Vol #:

9

C 23

Nestle USA

Vol #:

9

C 24

American Academy of Pediatrics

Vol #:

9

C 25

International Formula Council

Vol #:

11

CR 1

International Formula Council (IFC)

Vol #:

9

EMC 3

Nestle USA

Vol #:

10

EMC 4

Solus Products, LLC

Vol #:

10

EMC 5

Abbott Laboratories

Vol #:

10

EMC 6

International Formula Council

Vol #:

10

EMC 7

International Formula Council

Vol #:

10

EMC 8           Attachment 1, 2, 3, 4, 5

Wyeth Nutrition

Vol #:

10

EMC 9

International Formula Council (IFC)

Vol #:

10

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 244

Utah Natural Products Alliance

Vol #:

41

1997P-0329

Require Quantitative Labeling of Caffeine Content

EMC 71

Amy Hartsough

Vol #:

7

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10701

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10702

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10703

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10704

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10705

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10706

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10707

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10708

Dee Cee Laboratories. Inc.

Vol #:

81

LET 10709

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10710

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10711

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10712

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10713

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10714

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10715

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10716

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10717

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10718

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10719

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10720

Dee Cee Laboratories, Inc.

Vol #:

81

LET 10721

Tabak's Health Products

Vol #:

81

LET 10722

Source Naturals

Vol #:

81

LET 10723

Source Naturals

Vol #:

81

LET 10724

Planetary Formulas

Vol #:

81

LET 10725

NBTY Inc.

Vol #:

81

LET 10726

NBTY, Inc.

Vol #:

81

LET 10727

NBTY Inc.

Vol #:

81

LET 10728

NBTY Inc.

Vol #:

81

LET 10729

NBTY Inc.

Vol #:

81

LET 10730

NBTY, Inc.

Vol #:

81

LET 10731

NBTY, Inc.

Vol #:

81

LET 10732

NBTY, Inc.

Vol #:

81

LET 10733

NBTY, Inc.

Vol #:

81

LET 10734

NBTY, Inc.

Vol #:

81

LET 10735

NBTY, Inc.

Vol #:

81

LET 10736

NBTY, Inc.

Vol #:

81

LET 10737

NBTY, Inc.

Vol #:

81

LET 10738

NBTY, Inc.

Vol #:

81

LET 10739

NBTY, Inc.

Vol #:

81

LET 10740

NBTY, Inc.

Vol #:

81

LET 10741

NBTY, Inc.

Vol #:

81

LET 10742

NBTY, Inc.

Vol #:

81

LET 10743

NBTY, Inc.

Vol #:

81

LET 10744

NBTY, Inc.

Vol #:

81

LET 10745

NBTY, Inc.

Vol #:

81

LET 10746

NBTY, Inc.

Vol #:

81

LET 10747

NBTY, Inc.

Vol #:

81

LET 10748

NBTY, Inc.

Vol #:

81

LET 10749

NBTY, Inc.

Vol #:

81

1998D-1146

Microbial effects of antimicrobial new animal drugs/human sa

EMC 692

Timothy Kraft

Vol #:

19

1998N-0359

Program priorities/Center for Food Safety & Applied Nutrition

C 101

Center for Science in the Public Interest (CSPI)

Vol #:

7

1999F-4372

National Fisheries Institute and the Louisiana Dep of Agricu

EMC 436

Rick Hoffman

Vol #:

8

1999F-5321

Food Safety & Inspection service safe use of ionizing radiai

EMC 339

Rick Hoffman

Vol #:

8

1999F-5322

Ionizing Radiation for the Treatment of Food

EMC 338

Rick Hoffman

Vol #:

6

1999F-5522

Ionizing radiation /control of Food-borne pathogens safe use

EMC 341

Rick Hoffman

Vol #:

6

1999N-4282

Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 4027

Rich Yurman

Vol #:

514

EMC 4028

Rick Hoffman

Vol #:

514

EMC 4029

Bob DeBolt

Vol #:

514

EMC 4030

Martha Gene Landry-Murphy

Vol #:

514

EMC 4031

Tammy Schwendeman

Vol #:

514

EMC 4032

Tammy Schwendeman

Vol #:

514

1999P-1340

Declared Eternity eau de Parfum Misbranded

EMC 457

Connie Jo Gandy

Vol #:

21

EMC 458

Joan M. Ripple

Vol #:

21

EMC 459

Daniel Whittaker

Vol #:

21

EMC 460

Wanda Nicholas

Vol #:

21

EMC 461

Vivian Bain

Vol #:

21

1999P-2630

Establish a Daily Value for "added sugars"

EMC 484

James Carey

Vol #:

32

1999P-4613

Revoke the Regulation That Approved Posilac

EMC 2422

Bobbi Collyer

Vol #:

46

2000P-0685

Revise of Yogurt Standards

C 6

A.C. Olmstead

Vol #:

1

EMC 23

Don Kicklighter

Vol #:

1

2001P-0075

Switch Status of Emergency Contraceptives from Rx to OTC

C 292

Form Letter 23,600

Vol #:

40

2001P-0345

Listing the color additive yellow #5 for use in food/Drug

EMC 1188

No signature

Vol #:

5

EMC 1189

Connie S. Welsh

Vol #:

5

2002N-0204

Bar Code Label Requirements for human drug products

C 117

Lincare Inc. (Lincare)

Vol #:

15

2002N-0278

Bioterrorism; Prior Notice of Imported Food Shipments

C 229

Processed Apples Institute

Vol #:

15

C 230

Vinegar Institute

Vol #:

15

C 231

Association for Dressings & Sauces

Vol #:

15

2002P-0029

Mylan estradiol transdermal system as generic substitute

SUP 3       Appendices

Berlex Laboratories, Inc. (Berlex) and 3M Drug Delivery Systems

Vol #:

1

2002P-0219

Amend the "Orange Book" for Fluocinide Emulsified Base

PAV 1         Enclosed

HFD-1 to Altana Inc.

Vol #:

3

2003D-0165

Current Good Manufacturing Practices for Medical Gases

C 8

International Assn of Fire Chiefs

Vol #:

1

C 9

Respond Industries, Inc.

Vol #:

1

2003D-0317

Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products

C 2

Biotechnology Industry Organization (BIO)

Vol #:

1

2003E-0418

Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147

APP 1

Merck & Co. Inc.

Vol #:

1

LET 1

United States Patent and Trademark Office

Vol #:

1

2003E-0419

Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177

APP 1

Novartis Corporation and UCP Gen-Pharma AG

Vol #:

1

LET 1

United States Patent and Trademark Office

Vol #:

1

2003N-0084

Electronic Records; Electronic Signatures; Agency Information

C 1

Aventis Pharmaceuticals, Inc.

Vol #:

1

2003N-0168

July 31, 2003 Public Meeting on Consumer Medication Information

C 6

Pharmaceutical Printed Literature Assn (PPLA)

Vol #:

3

EMC 1

Merck Research Laboratories

Vol #:

3

EMC 2

Advanced of Managed Care Pharmacy (AMCP)

Vol #:

3

EMC 3

Pfizer Inc

Vol #:

3

EMC 4

Pharmaceutical Care Management Association (PCMA)

Vol #:

3

EMC 5

National Association of Chain Drug Stores

Vol #:

3

2003N-0191

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices

SS 1

Background Material

Vol #:

1

2003N-0233

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

RPT 1

Ego Pharmaceuticals, Ltd

Vol #:

1

2003N-0338

Secretary's Roundtable on Obesity/Nutrition

C 1            Attachment

American Society for Clinical Nutrition, Inc.

Vol #:

1

2003N-0344

Consumer-Directed Promotion; Public Meeting

APE 27

VA Medical Center

Vol #:

1

APE 28

American Pharmacists Association

Vol #:

1

2003P-0159

Venlafaxine Hydrochloride Extended-Release Tablets

C 1

Wyeth Pharmaceuticals (Wyeth)

Vol #:

1

2003P-0162

Import Canadian food products that do not meet labeling regs

WDL 1

J.M. Investments, Inc. D.B.A. Lucky

Vol #:

1

2003P-0409

Reclassification for Moblie Bearing Knees from Class III and Class II

ACK 1

HFA-305 to Orthopedic Surgical Manufacturers Assn.

Vol #:

1