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DOCKETS ENTERED on 12/23/02

TABLE OF CONTENTS

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94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95S-0158 Community Disclosure of Institutional Review Boards *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
01P-0150 Salad Dressing Deviating *
02D-0266 Guidance preventive measures to reduce risk of (CJD) *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0428 Information for the use of Human Blood & Blood Components *
02N-0417 Applications for FDA Approval to Market a New Drug *
02N-0471 Cox-2 Inhibitors: Vioxx and Celebrex *
02P-0009 Amend 21 CFR 120.24 concentrated and shelf-stable juice *
02P-0292 Health Claims: Walnuts & Cornary Disease *
02P-0462 Use of Implied Nutrient Content Claim - "Carbolite" *

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2288 Virginia Tech Vol#: 67

C 2289 DuPont Agriculture & Nutrition Vol#: 67

C 2290 National Cotton Council (NCC) Vol#: 67

C 2291 Dale Merritt Vol#: 67

C 2292 Biscuit & Cracker Manufacturers Assn Vol#: 67

C 2293 Institute of Shortening & Edible Oils Vol#: 67

C 2294 Chocolate Manufacturers Assn Vol#: 67

C 2295 National Pork Producers Council (NPPC) Vol#: 67

C 2296 CSPI Vol#: 67

95S-0158 Community Disclosure of Institutional Review Boards

SUP 24 Concentric Medical, Inc. Vol#: 5

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 85 North Carolina Pork Council Vol#: 18

98N-0778 Bioavailability and Bioequivalence Requirements

NFR 1 Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 413 Pamela Caillouet Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 317 Pamela Caillouet Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 315 Pamela Caillouet Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 318 Pamela Caillouet Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3833 B. McClintock Vol#: 512

EMC 3834 Vicki Johnson Vol#: 512

EMC 3835 Roger Adkins Vol#: 512

EMC 3836 Angela Ross Vol#: 512

EMC 3837 Aric Villarreal Vol#: 512

EMC 3838 Jnana Hand Vol#: 512

EMC 3839 Chip Angell Vol#: 512

EMC 3840 Lorraine Schuchart Vol#: 512

EMC 3841 Carol Sulanke Vol#: 512

EMC 3842 Gregg Mau Vol#: 512

EMC 3843 Julie & Charles Frank Vol#: 512

EMC 3844 Julie Rodgers Vol#: 512

EMC 3845 Anthony J. Menard Vol#: 512

EMC 3846 Pamela Caillouet Vol#: 512

EMC 3847 Libby Rains Vol#: 512

EMC 3848 Karen Kinsman Vol#: 512

EMC 3849 Nicole Patteson Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3599 Kelly Doherty Vol#: 217

C 3600 T. Dorf Vol#: 217

C 3601 Walter F. Trucks Vol#: 217

C 3602 Jessica McCaig Vol#: 217

C 3603 Amanda Moore Vol#: 217

C 3604 Emily Eacho Vol#: 217

C 3605 Lindsay Greene Vol#: 217

C 3606 Abbi MacFarlane Vol#: 217

C 3607 Mrs. Norman Berg Vol#: 217

C 3608 Nancy L. Cook Vol#: 217

C 3609 J. Salty Honcharik Vol#: 217

C 3610 Emilia Trafton Vol#: 217

C 3611 Loretta J. Forrest Vol#: 217

C 3612 Maia H. Whalen Vol#: 217

C 3613 Sophie & Victor Greenblatt Vol#: 217

C 3614 Keith Stott Vol#: 217

C 3615 Janice Stixrud, RD, CDE Vol#: 217

C 3616 Lesley Kash Vol#: 217

C 3617 Stanley J. Jerome Vol#: 217

C 3618 Linda Nowicki Vol#: 217

C 3619 Ernest Mac Neill Vol#: 217

C 3620 Roald Cann Vol#: 217

C 3621 Aubree Gresham Vol#: 217

C 3622 Robert Capella Vol#: 217

C 3623 Sonya & Noman Noor Vol#: 217

C 3624 Veronica Mayer Vol#: 217

C 3625 Margaret S. Anderson Vol#: 217

C 3626 J. V. B. Prescott Vol#: 217

C 3627 Mary Wilson Vol#: 217

C 3628 Gretchen Dunn Vol#: 217

C 3629 Harold E. Blake Vol#: 217

C 3630 Vivian G. Taylor Vol#: 217

C 3631 Marjorie J. Madden Vol#: 217

C 3632 Martin Rowe & Mia MacDonald Vol#: 217

C 3633 Mrs. Joan F. McEvoy Vol#: 217

C 3634 S. M. Martone Vol#: 217

C 3635 Maxine M. Bellamy Vol#: 217

C 3636 Assn. of Veterinarians in Broiler Produc Vol#: 217

C 3637 Bordentown Family Dental, P.C. Vol#: 217

C 3638 Polly Thurston Vol#: 217

C 3639 Hobart & William Smith Colleges Vol#: 217

C 3640 Ned & Sandy Kice Vol#: 217

EMC 894 Steve Barney Vol#: 217

99P-1340 Declared Eternity eau de Parfum Misbranded

C 751 Form Letter Count 15 Vol#: 23

EMC 422 L. Rothman Vol#: 21

EMC 423 Elaine Dalton Vol#: 21

99P-5589 Reclassification of Absorbable Polydioxanone Surgical Suture

NFR 1 Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

LST 11 Gen. References for Guidance 12/13/02 Vol#: 8

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

LST 11 Gen. References for Guidance 12/13/02 Vol#: 8

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

LST 11 Gen. References for Guidance 12/13/02 Vol#: 6

00D-1541 Electronic Signatures: Audit Trails

LST 11 Gen. References for Guidance 12/13/02 Vol#: 6

00D-1542 Electronic Signatures: Time Stamps

LST 11 Gen. References for Guidance 12/13/02 Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

LST 11 Gen. References for Guidance 12/13/02 Vol#: 7

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11879 Trent Massey Vol#: 426

EMC 11880 Jony Flores Vol#: 426

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 415 Pamela Caillouet Vol#: 6

01P-0150 Salad Dressing Deviating

LET 1 HFS-800 to Kraft Foods, Inc. Vol#: 1

NTP 2 Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1155 Diana Dickson Vol#: 5

EMC 1156 Michelle & David schultz Vol#: 5

02D-0266 Guidance preventive measures to reduce risk of (CJD)

C 8 National Marrow Donor Program (NMDP) Vol#: 1

C 9 University of Texas Vol#: 1

C 10 University of Texas Vol#: 1

EMC 10 Cairo American College Vol#: 1

EMC 11 Doug Prellwitz Vol#: 1

EMC 12 Puget Blood Center et al. Vol#: 1

EMC 13 No signature Vol#: 1

EMC 14 Anita Washburn Vol#: 1

EMC 15 Claudia French Vol#: 1

02D-0289 Surgical Sutures

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 138 Christa J. Ernst Vol#: 2

C 139 Maria Moniz Vol#: 2

C 140 Ann C. Tate Vol#: 2

C 141 David M. Jackson Vol#: 2

C 142 Ernest Stern Vol#: 2

C 143 Joan A. Lahmon Vol#: 2

C 144 Marion P. Goodale Vol#: 2

C 145 Judith G. Stetson Vol#: 2

C 146 Susan DeSilver Vol#: 2

C 147 Adolph Fuerst Vol#: 2

C 148 Dealy Eyes Maddux Vol#: 2

C 149 Sherry Redd Vol#: 2

C 150 Rene Mae Gagon Vol#: 2

C 151 Clark Vogel Vol#: 2

C 152 Mrs. Enid A. Hodes Vol#: 2

C 153 Joan Lind Vol#: 2

C 154 Portia W. Weiskel Vol#: 2

C 155 Elizabeth Ketcham Vol#: 2

C 156 Caitlin McMurtry Vol#: 2

C 157 Anna H. Endreny, Ed.D Vol#: 2

C 158 Norman Wettberg Vol#: 2

C 159 S. Kistler Vol#: 2

C 160 Fred Nussbaum Vol#: 2

C 161 Eleanor Spagnoletti Vol#: 2

C 162 Patrick R. Carey Vol#: 2

C 163 J.E. Fox Vol#: 2

C 164 Florence Schneider Vol#: 2

C 165 Maryanna Foskett Vol#: 2

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

EMC 51 Emily Hughes Vol#: 3

EMC 52 Environmental Community Action, Inc. Vol#: 3

EMC 53 Robert Gaskins Vol#: 3

EMC 54 Laurine Brown Vol#: 3

02D-0385 Approval of Labeling for Foods Treated by Irradiation

C 3 Laurel Browne Vol#: 1

02D-0389 Nonclinical Studies for Development of Pharmaceutical Excipi

C 2 Alexander Apostolou DVM, PhD, CRA Vol#: 1

02D-0428 Information for the use of Human Blood & Blood Components

EMC 1 American Blood Centers Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

BKG 1 Background Material Refs 1-10 Vol#: 2

EMC 1 Leslie Carlson-Elliott Vol#: 1

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02N-0281 General Administrative Procedures Petition reconsideration

N 2 Vol#: 1

02N-0288 Special Control for Eight Surgical Suture

NPR 1 Vol#: 1

02N-0417 Applications for FDA Approval to Market a New Drug

C 4 Greenblum & Bernstein, P.L.C. Vol#: 1

C 5 Pfizer, Inc. Vol#: 1

C 6 Johnson & Johnson Vol#: 1

C 7 American Assn of health Plans (AAHP) Vol#: 1

C 8 American Society of Consultant Pharmacis Vol#: 1

C 9 Generic Pharmaceutical Assn (GPhA) Vol#: 1

C 10 Food Marketing Institute (FMI) Vol#: 1

C 11 Families USA Vol#: 1

C 12 Barr Laboratories, Inc. Vol#: 1

C 13 Caterpillar, Inc. et al. Vol#: 1

C 14 Michigan for Affordable Pharm (MAP) Vol#: 1

C 15 GlaxoSmithKline (GSK) Vol#: 1

C 16 Blue Cross Blue Shield of Michigan Vol#: 1

C 17 AARP Vol#: 1

C 18 Blue Cross and Blue Shield Assn (BCBSA) Vol#: 1

C 19 Business for Affordable Medicine (BAM) Vol#: 1

C 20 Academy of Managed Care Pharmacy (AMCP) Vol#: 1

C 21 Mylan Pharmaceuticals, Inc. Vol#: 1

EMC 1 Federal Trade Commission Vol#: 1

EMC 2 Mylan Pharmaceuticals, Inc. Vol#: 1

EMC 3 Families USA Vol#: 1

EMC 4 Teva Pharmaceuticals, Inc. Vol#: 1

02N-0471 Cox-2 Inhibitors: Vioxx and Celebrex

C 1 Pharmacia Corporation Vol#: 1

02N-0496 Large & Small Volume Parenterals Used in Total Parenteral Nu

N 1 Vol#: 1

02P-0009 Amend 21 CFR 120.24 concentrated and shelf-stable juice

C 1 Florida Dep of Agriculture and Consumer Vol#: 1

02P-0127 Determine if Phenergan has been withdrawn or withheld from s

N 1 Vol#: 1

02P-0292 Health Claims: Walnuts & Cornary Disease

EXT 1 California Walnut Commission Vol#: 6

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 88 Sheila Swift Vol#: 1

EMC 89 Joy Metcalf Vol#: 1

EMC 90 Joyce Fleming Vol#: 1

02P-0462 Use of Implied Nutrient Content Claim - "Carbolite"

C 1 Universal Nutrition Vol#: 1