Table of Contents

WDL 1 Leiner Health Products Vol#: 73

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 645 HFD-611 Vol#: 4

95F-0129 Safe use of Poly(oxy-1,2-ethanediyloxyearcarbonyl-2,6-naphth

EA 1 Shell Chemical Company Vol#: 1

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 52 GloboAsia LLC Vol#: 29

RPT 53 General Nutrition Corporation Vol#: 30

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

LINKED COMMENTS BELOW DUPLICATE THOS FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 362 Joan W. Jenrich Vol#: 13

C 363 Laura Salter Vol#: 13

C 364 Don & Terry Hein Vol#: 13

C 365 Susan Cava Vol#: 13

C 366 Lynne Rohde Vol#: 14

C 367 Linda K. Anderson Vol#: 14

C 368 Sandra Lynn Vol#: 14

C 369 Diana Ward Vol#: 14

C 370 Marc Cassius Vol#: 14

C 371 API, Animal Protection Institute Vol#: 14

C 372 Amber Herman Vol#: 14

C 373 Riley Canuel Vol#: 14

C 374 Jaime Teahen Vol#: 14

C 375 M. N. O'Sullivan Vol#: 14

C 376 Valerie Christie BA, M.Ed., MS Vol#: 14

C 377 Erin K. Branham Vol#: 14

C 378 Yvonne E. Aguia Vol#: 14

C 379 Dr. William A. Wright Vol#: 14

C 380 Jane Bigler Vol#: 14

C 381 Mac Mannes, Inc. Vol#: 14

C 382 Marie T. Gordon Vol#: 14

C 383 Kathi Bigler Vol#: 14

C 384 Frances Rosato Vol#: 14

EC 3 William McMullin Vol#: 14

96P-0444 Change in Man. Labeling & Warnings of CNS Delta, SCD & ASD

SUP 1 Stephen M. Dolle Vol#: 1

97N-0074 President's National Food Safety Initiative

C 103 Emilio & Mary Rios Vol#: 10

C 104 David A. Brunetti Vol#: 10

C 105 Kelley Updike Vol#: 10

C 106 Marian A. Kelner Vol#: 10

C 107 Center for Science in the Public Interes Vol#: 10

C 108 Sallie Carlson Vol#: 10

97P-0197 Require that warning labels about risks of salmonella enteri

C 363 Joan W. Jenrich Vol#: 12

C 364 Laura Salter Vol#: 12

C 365 Don & Terry Hein Vol#: 12

C 366 Susan Cava Vol#: 12

C 367 Lynne Rohde Vol#: 13

C 368 Linda K. Anderson Vol#: 13

C 369 Sandra Lynn Vol#: 13

C 370 Diana Ward Vol#: 13

C 371 Marc Cassius Vol#: 13

C 372 API, Animal Protection Institute Vol#: 13

C 373 Amber Herman Vol#: 13

C 374 Riley Canuel Vol#: 13

C 375 Jaime Teahen Vol#: 13

C 376 M. N. O'Sullivan Vol#: 13

C 377 Valerie Christie BA, M.Ed., MS Vol#: 13

C 378 Erin K. Branham Vol#: 13

C 379 Yvonne E. Aguia Vol#: 13

C 380 Dr. William A. Wright Vol#: 13

C 381 Jane Bigler Vol#: 13

C 382 Mac Mannes, Inc. Vol#: 13

C 383 Marie T. Gordon Vol#: 13

C 384 Kathi Bigler Vol#: 13

C 385 Frances Rosato Vol#: 13

EC 3 William McMullin Vol#: 13

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

LST 2 Agenda etc for 9/28/99 meeting Vol#: 1

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

CS 4 HFA-305 Vol#: 1

OR 4 HF-3 Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 156 Sinclair Photography Vol#: 19

EC 2 No Signature Vol#: 19

EC 3 Margaret Ruark Vol#: 19

EC 4 Anita Boone Vol#: 19

EC 5 Katherine Matthews Vol#: 19

EC 6 Pam Allwardt Vol#: 19

EC 7 Joseph Birmingham Vol#: 19

EC 8 Nancy Anderson Vol#: 19

98N-0562 Civil Money Penalties; Rajaram K Matkari

LET 2 GCF-1 Vol#: 1

MO 2 GCF-1 Vol#: 1

98N-0581 Requirements for Testing Human Blood Donors

C 3 Blood Bank of San Bernadino Vol#: 5

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 362 Joan W. Jenrich Vol#: 16

C 363 Laura Salter Vol#: 16

C 364 Don & Terry Hein Vol#: 16

C 365 Susan Cava Vol#: 16

C 366 Lynne Rohde Vol#: 17

C 367 Linda K. Anderson Vol#: 17

C 368 Sandra Lynn Vol#: 17

C 369 Diana Ward Vol#: 17

C 370 Marc Cassius Vol#: 17

C 371 API, Animal Protection Institute Vol#: 17

C 372 Amber Herman Vol#: 17

C 373 Riley Canuel Vol#: 17

C 374 Jaime Teahen Vol#: 17

C 375 M. N. O'Sullivan Vol#: 17

C 376 Valerie Christie BA, M.Ed., MS Vol#: 17

C 377 Erin K. Branham Vol#: 17

C 378 Yvonne E. Aguia Vol#: 17

C 379 Dr. William A. Wright Vol#: 17

C 380 Jane Bigler Vol#: 17

C 381 Mac Mannes, Inc. Vol#: 17

C 382 Marie T. Gordon Vol#: 17

C 383 Kathi Bigler Vol#: 17

C 384 Frances Rosato Vol#: 17

EC 3 William McMullin Vol#: 17

98N-1265 Distribution of Compounded Drug Products

C 6120 Smiley Audrey Neakok Vol#: 171

98P-0683 Soy Protein Containing Products

C 139 American Bakers Association Vol#: 21

C 140 Protein Technologies International Vol#: 21

C 141 Grocery Manufacturers of America Vol#: 21

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 684 Rebecca R. Klimowicz Vol#: 18

C 685 Mary Kopet Vol#: 18

C 686 Larry Hampel Vol#: 18

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 38 PDA Vol#:

C 39 Verband forschender Arzneimittelherstell Vol#: 1

99D-2013 Cooperative Manufacturing Arrangements for Licensed

C 1 Central Illinois Community Blood Bank Vol#: 1

99H-0523 Civil Money Penalties;OB Liquors Inc,d/b/a OB Liquors

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0584 Civil Money Penalties;Kevin Cavan,d/b/a Jung's Oriental Food

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

CS 2 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

99H-1672 Civil Money Penalty;Mogg Retail LLC,dba Hy-Klas Foods

CR 1 GCF-1 Vol#: 1

99H-2525 Civil Money Penalty;Jim Nassif Ent Inc,dba Tatnuck Square

CR 1 GCF-1 Vol#: 1

99H-2863 Civil Money Penalty;Adium Marketing Inc,dba Petro Plus #103

CR 1 GCF-1 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1610 C Paglia Vol#: 25

C 1611 Ellen Brooks Vol#: 25

C 1612 Janet Lowery Vol#: 25

C 1613 Gayle Harris Birk Vol#: 25

C 1614 Kari Little Vol#: 25

C 1615 Jenifer "Jes" Hilton Hawkins Vol#: 25

C 1616 Harold W Payne Vol#: 137

C 1617 K Sloane Vol#: 137

C 1618 Karen Riener Vol#: 137

C 1619 Diane R Rose Vol#: 137

C 1620 Helen M Beverwyk Vol#: 137

C 1621 Barbara L Likosi Vol#: 137

C 1622 Victoria Mosse Vol#: 137

C 1623 Amy O'Connor Vol#: 137

C 1624 Timothy V White Vol#: 137

C 1625 Laurie Hope & 4 signatures Vol#: 137

C 1626 Dorothy Calvani Vol#: 137

C 1627 Mary Jo Napoli Vol#: 137

C 1628 Ms Leah Wolin Vol#: 137

C 1629 Mildred Howard Smith Vol#: 137

C 1630 Nancy Starr Vol#: 137

C 1631 Dava Weinstein Vol#: 137

C 1632 Gale Anderson Vol#: 137

C 1633 Kathy Castillo Vol#: 137

C 1634 Ward Stalnaker Vol#: 137

C 1635 Sharon Berman Vol#: 137

C 1636 Cynthia Vazqueg Vol#: 137

C 1637 Karen Golosman Vol#: 137

C 1638 Tom Felt Vol#: 137

C 1639 Wendi Raw Vol#: 137

C 1640 Maya Gonzalez Vol#: 137

C 1641 Gina Davis Wexler Vol#: 137

C 1642 Sara Schwartz Kendall Vol#: 137

C 1643 B S Golosman Vol#: 137

C 1644 Tim Krause Vol#:

C 1645 Helen Golosman Vol#: 137

C 1646 Elizabeth Allemann MD Vol#: 137

C 1647 Janet St. Aubin Vol#: 137

C 1648 Christine B Moratto Vol#: 137

EC 162 Mark & Cheryle Wilcox Vol#: 25

EC 163 Kenneth Aikin & Laurel Kallenbach Vol#: 25

EC 164 Steven Ignots & Elizabeth Hiser Vol#: 25

EC 165 Seth Swoboda Vol#: 25

EC 166 Janine Turner Vol#: 25

EC 167 Sheryl Kaplan Vol#: 25

EC 168 Faith Patterson Betz & Family Vol#: 25

EC 169 Mikel Aradhana Thurman Vol#: 25

EC 170 David Eldridge Vol#: 25

EC 171 Margery Blonder Vol#: 25

EC 172 Don A Bristow Vol#: 25

EC 173 Norm & Shelly Cimon Vol#: 25

EC 174 Eleanor Hoffman Vol#: 137

EC 175 Jill Harmer Vol#: 137

EC 176 Holly M Hatch Vol#: 137

EC 177 Robert J Havrilla Vol#: 137

EC 178 Dr Kevin Kuehlwein Vol#: 137

EC 179 Dr Kevin Kuehlwein Vol#: 137

EC 180 Jennie Grace Vol#: 137

EC 181 Jacob Gatschet Vol#: 137

EC 182 Roger & Carol Stoughton Vol#: 137

EC 183 Diana Selig Vol#: 137

EC 184 Miriam Bloomfield Vol#: 137

99P-1340 Declared Eternity eau de Parfum Misbranded

C 331 Pauler Cenanri Vol#: 6

C 332 Cathleen Weitzner Vol#: 6

C 333 Mette Hansen Vol#: 6

EC 39 Dianne Courtney Vol#: 6

EC 40 B. W. Kolk Vol#: 6

EC 41 Elizabeth O'Nan Vol#: 6

EC 42 Pamela K. Dazey Vol#: 6

EC 43 Robert G. Briant Vol#: 6

99P-2630 Establish a Daily Value for "added sugars"

C 48 Robert & Caroline Lichtenstein Vol#: 1

C 49 Ms. H. Betty Gidlof Vol#: 1

C 50 Chris Keenan, M.D., M.P.H Vol#: 1

C 51 Harry Kemmerer Vol#: 1

C 52 Betty Taylor Vol#: 1

C 53 Laurie & Chet Figg Vol#: 1

C 54 Ruth W. Yanover Vol#: 1

C 55 Phillip H. Coe Vol#: 1

C 56 Susan Steffenhagen Vol#: 1

C 57 Nancy J. Weber Vol#: 1

C 58 LaVerne Fundling Vol#: 1

C 59 Virginia L. Courtney Vol#: 1

C 60 Vera Stillman Vol#: 1

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

LINKED COMMENTS BELOW DUPLICATE THOS FOR 99P-3030, ALSO BELOW

C 76 Francis R Gilmartin Vol#: 4

C 77 Pearl Dunn Vol#: 4

C 78 Glenn Towery Vol#: 4

C 79 Bernice R Beso Vol#: 4

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 76 Francis R Gilmartin Vol#: 3

C 77 Pearl Dunn Vol#: 3

C 78 Glenn Towery Vol#: 3

C 79 Bernice R Beso Vol#: 3

99P-4208 Action to Revise the Labeling Requirements for Foods Contain

CP 1 CSPI Vol#: 1

99P-4209 Hydrocodone Bitartrate & Acetaminophen Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Mallinckrodt Inc. Vol#: 1