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DOCKETS ENTERED on 4/17/03

Docket Number - Title

79N-0113 Parenteral Multivitamin Products *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use *
95G-0208 pullulanase enzyme derived from Bacillus licheniformis GRAS *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
00N-1484 Safety Report Requirements Human Drug/Biological Products *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0495 Determine Ultram's safety or effectiveness reasons *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0475 Financial Relationships & Interest in Research Involving Hum *
02P-0163 Expedite Over-the-Counter Approval for Desloratidine *
02P-0168 Request better product labeling of sports & energy beverages *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *
02P-0252 Seek immediate final approval of generic tramadol hydrochlor *
03D-0044 Reporting Results for Studies Evaluating Diagnostic Tests *
03D-0092 Food and Cosmetic Security Guidances *
03N-0017 Risk Management Programs on the Practice of Pharmacy *
03N-0024 Prohibiting extralabel use phenylbutazone animal/human drugs *
03P-0132 Part 135 FDA regulations standard of identity frozen dessert *
03P-0162 Import Canadian food products that do not meet labeling regs *

76N-052G OTC general comments & combinations

NCR 2 Vol#: 35

79N-0113 Parenteral Multivitamin Products

WDL 3 AAP, American Pharmaceutical Partners,In Vol#: 5

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 135 Ms. Donna Malayeri Vol#: 14

EC 136 Medicines & Healthcare products Regulato Vol#: 14

EC 137 Arizona College of Osteopathic Med. Vol#: 14

95G-0208 pullulanase enzyme derived from Bacillus licheniformis GRAS

CP 1 Vol#: 2

98P-0151 Introduction Of Downed Cattle Into The Food Supply

EMC 3160 Gayle Rollers Vol#: 265

EMC 3161 Lorie Buford Vol#: 265

EMC 3162 Janet Hutson Vol#: 265

EMC 3163 Tammy Durante Vol#: 265

EMC 3164 Robin Budry Vol#: 265

EMC 3165 Cindy Truan Vol#: 265

EMC 3166 Vivian Neiger Vol#: 265

EMC 3167 Deborah A. Resnick Vol#: 265

EMC 3168 Art Zernis Vol#: 265

EMC 3169 Leigh Platte Vol#: 265

EMC 3170 Lisa Klein Vol#: 265

EMC 3171 M. Crisan Vol#: 265

EMC 3172 Tony Bellano Vol#: 265

EMC 3173 Honey Jackson Vol#: 265

EMC 3174 Patricia Moore Vol#: 265

EMC 3175 Janice Raucci Vol#: 265

EMC 3176 Alison Franklin-Stetler Vol#: 265

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C 47 CFA, Consumer Federation of America Vol#: 5

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3642 Richard Stanley Vol#: 217

C 3643 Tom McCormick Vol#: 217

99P-1340 Declared Eternity eau de Parfum Misbranded

C 754 Dorothy Anderson Vol#: 21

EMC 436 Dwight Shackelford Vol#: 21

EMC 437 Trixie Nett Vol#: 21

EMC 438 Mary Kozlowski Vol#: 21

EMC 439 Barbara Wilkie Vol#: 21

EMC 440 Bart Worley Vol#: 21

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9409 Form Letter (12) Vol#: 410

C 9410 Mary A. Currier Vol#: 408

C 9411 Rena Cassidy Vol#: 408

C 9412 Karen L. Pedler Vol#: 408

C 9413 Bobbe Besold Vol#: 408

C 9414 Tami Augustyn Vol#: 408

C 9415 Erbin Crowell Vol#: 408

C 9416 Hazel H. Landa Vol#: 408

C 9417 Charles D. Stauffacher Vol#: 408

C 9418 Angelina M. Hart Vol#: 408

C 9419 Alice M. Carron Vol#: 408

C 9420 Lovel Pratt Vol#: 408

C 9421 Phyllis Swackhamer Vol#: 408

C 9422 Kimberly Sims Vol#: 408

C 9423 Nancy Wong Vol#: 408

C 9424 Stan Ayers Vol#: 408

C 9425 Individual Consumer Vol#: 408

C 9426 Liisa Wale Vol#: 408

C 9427 T. Maksimovich Vol#: 408

C 9428 April Reed + 12 signatures Vol#: 408

C 9429 A Mom in San Francisco Vol#: 408

C 9430 Unreadable Vol#: 408

C 9431 Alisha Rett Vol#: 408

C 9432 Virginia A. Nixon Vol#: 408

C 9433 Norman J. Birthmark Vol#: 408

C 9434 Dominick Genna Vol#: 408

C 9435 Will Harlan Vol#: 408

C 9436 Kimberly S. Kelton Vol#: 408

C 9437 Carolyn Bobola Vol#: 408

C 9438 Susan Coryell Vol#: 408

C 9439 J. M. Lambert Vol#: 408

C 9440 James & Sharon Hoffman Vol#: 408

C 9441 Janet Hitt Vol#: 408

C 9442 awyn@sover.net Vol#: 408

C 9443 Ron Marsh Vol#: 408

C 9444 Donna Staggs Vol#: 408

C 9445 Susan E. Wagner Vol#: 408

C 9446 Mr. Kris Kallmeyer Vol#: 408

C 9447 Tim Stone Vol#: 408

C 9448 Tammie Cramey + 9 signatures Vol#: 408

C 9449 Andrew C. Schoeneman Vol#: 408

C 9450 Ashley Quales + 6 signatures Vol#: 408

00N-1484 Safety Reporting Requirements Human Drug/Biological Products

EC 10 Aventiss Pharmaceueticals Vol#: 3

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5595 Beth Treweek Vol#: 788

EMC 5596 Tala Deaton Vol#: 788

EMC 5597 Stephanie Ellington Vol#: 788

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 241 CFA, Consumer Federation of America Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2713 Doris Loud Vol#: 228

EMC 2714 Tracey Ahring Vol#: 228

EMC 2715 Bonnie Lau Vol#: 228

01P-0495 Determine Ultram's safety or effectiveness reasons

PAV 2 HF-22 to Johnson & Johnson Vol#: 2

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

C 633 Edwin Price Vol#: 13

C 634 Pamela Johnson Vol#: 13

C 635 Virginia Horvath Vol#: 13

C 636 Virginia Ernst Vol#: 13

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

EC 14 Mrs. Cheri Riley Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

C 31 Colorcon Vol#: 13

C 32 Eva Mendoza Vol#: 13

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 256 LHL Enterprises Inc. Vol#: 11

EC 257 International Foodservice Distributors A Vol#: 11

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

EC 306 Mr. Maha sardessai Vol#: 14

02N-0475 Financial Relationships & Interest in Research Involving Hum

C 2 Nat. Organization for Rare Disorders, In Vol#: 1

02P-0163 Expedite Over-the-Counter Approval for Desloratidine

C 4 CFA, Consumer Federation of America Vol#: 1

02P-0168 Request better product labeling of sports & energy beverages

LET 1 HFD-240 to Citzen Outreach Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

PAV 2 HF-22 to Johnson & Johnson Vol#: 1

02P-0252 Seek immediate final approval of generic tramadol hydrochlor

PAV 2 HF-22 to Johnson & Johnson Vol#: 1

03D-0044 Reporting Results for Studies Evaluating Diagnostic Tests

EC 2 Diagnostic Products Corporation Vol#: 1

03D-0060 Part11, Electronic records, electronic signatures scope

EC 10 Ms. Janis Halvorsen Vol#: 1

EC 11 PharmaSys, Inc. Vol#: 1

03D-0092 Food and Cosmetic Security Guidances

EC 2 Instituto Especializado de Analisis Vol#: 1

03N-0017 Risk Management Programs on the Practice of Pharmacy

EC 2 American Society of Health-Sysetm Pharma Vol#: 1

03N-0024 Prohibiting extralabel use phenylbutazone animal/human drugs

EC 2 Southern Methodist University Student Vol#: 1

03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey

EC 8 Miss Kathleen Sweeney Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 23 Technovation Systems, Inc. Vol#: 1

EC 24 Technovation Systems, Inc. Vol#: 1

EC 25 Dishman pharmaceuticals&chemicals Ltd Vol#: 1

EC 26 SST Corporation Vol#: 1

03N-0068 Beverages: Bottled Water

EC 8 Miss Madeleine Asplundh Vol#: 1

03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition

EC 43 Mrs. Bernadette Moore Vol#: 1

EC 44 Mrs. Carolyn Roetering Vol#: 1

EC 45 Number Not Used Vol#: 1

EC 46 Number Not Used Vol#: 1

03N-0134 Team Biologics Program Effectiveness; Public Meeting

APE 1 Clearant, Inc. Vol#: 1

APE 2 FDC Reports Vol#: 1

APE 3 Thompson Publishing Group Vol#: 1

APE 4 Cambrex Bio Science Walkersville, Inc. Vol#: 1

APE 5 HFC-210 Vol#: 1

APE 6 HFM-610 Vol#: 1

APE 7 FDA/ORA/OE/DCMO Vol#: 1

APE 8 Human Genome Sciences, Inc. Vol#: 1

APE 9 BDDCB/DCM/OCBQ Vol#: 1

APE 10 FDA Vol#: 1

NM 1 Vol#: 1

03P-0132 Part 135 FDA regulations standard of identity frozen dessert

C 1 National Milk Producers Federation Vol#: 1

03P-0162 Import Canadian food products that do not meet labeling regs

ACK 1 HFA-305 Vol#: 1

CP 1 J.M. Investments, Inc. D.B.A. Lucky"7" F Vol#: 1