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DOCKETS ENTERED on 1/24/03

Docket Number - Title

80N-0280 Vaginal Contraceptive Drug Products for OTC Use *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
00P-1378 Cosmetic Products Containing Alpha Hydroxy Acids *
01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin *
02D-0073 Validation of Procedures for Processing of Human Tissues *
02D-0266 Guidance preventive measures to reduce risk of (CJD) *
02D-0324 Bioengineered Plants for Use in Humans and Animals *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0362 Quarantine/Retrieval of Blood Prod.in Recipients of Smallpox *
02D-0371 Human Dura Mater; Class II Special Controls Guidance *
02D-0468 Manufacture and Labeling of Raw Meat Foods *
02N-0273 Animal Proteins Prohibited in Ruminant Feed *
02N-0370 Neurological Devices; Classification of Human Dura Mater *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02P-0067 All estrogen-containing products intended for oral use *
02P-0435 Effective Approval of Alphanate Antihemophilic Factor *
02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2% *

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 1 LA City College Vol#: 14

EC 2 Personal Vol#: 14

EC 3 Ms. Dee Troll Vol#: 14

EC 4 Mrs. Tiffany Berry Vol#: 14

EC 5 Miss Nichole Johnson Vol#: 14

EC 6 Mrs. Tamika Woodley Vol#: 14

EC 7 Mr. Eric Chan Vol#: 14

EC 8 Mr. Chris Fairfield Vol#: 14

EC 9 VNIIFK Vol#: 14

EC 10 Ms. Denise Williams Vol#: 14

EC 11 Mr. J Waller Vol#: 14

EC 12 Mrs. Nicole Yee Vol#: 14

EC 13 Miss Lynn Anderson Vol#: 14

EC 14 cchmc Vol#: 14

EC 15 Mrs. Suzanne Faber Vol#: 14

EC 16 Ms. Kimberly Teart Vol#: 14

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

C 2298 Marian Garrett Vol#: 68

SUP 3 ConAgra Foods Vol#: 68

00E-1238 Patent Extension Temodar (temozolomide), #5,260,291

LET 3 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

00E-1239 Patent Extension Rapamune (sirolimus), #5,100,899

LET 2 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

00E-1249 Patent Extension Avandia #5,002,953

LET 2 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

00N-1531 Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari

EXT 1 Bruce I Diamond PhD Vol#: 1

00P-1378 Cosmetic Products Containing Alpha Hydroxy Acids

C 2 Bristol-Myers Squibb Company Vol#: 1

01E-0225 Patent Term Extension Application, CANCIDAS No. 5,514,650

LET 3 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

01E-0367 Patent Term Extension Application, STARLIX No. 34,878

LET 4 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

01E-0403 Patent Term Extension Application; Valcyte No. 6,083,953

LET 3 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin

LET 4 HFS-24 to Ruth Armstrong Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1299 Ms. Irene B. Hull Vol#: 226

C 1300 Michael Yankeus Vol#: 226

C 1301 Tom Clark Vol#: 226

EMC 2660 Maureen Langberg Vol#: 228

EMC 2661 Stuart L. Cohn, M.D. & Carola V. Cohn Vol#: 228

02D-0073 Validation of Procedures for Processing of Human Tissues

EC 4 CJD WATCH Vol#: 1

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

C 17 King & Spalding, LLP Vol#: 1

C 18 American Society for Microbiology (ASM) Vol#: 1

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

C 545 Sylvia Fine, MD Vol#: 12

C 546 No signature Vol#: 12

C 547 Ruth F. Hooke Vol#: 12

C 548 Gwendolyn R. Robinson Vol#: 12

C 549 W.E. Longshaw Vol#: 12

C 550 Athum A. Malley Vol#: 12

C 551 John M. Ely, Jr. Vol#: 12

C 552 Kathleen Isbell Vol#: 12

C 553 Rebecca J. Peak Vol#: 12

C 554 Jeffrey S. Bowers Vol#: 12

C 555 Jill Hunter Vol#: 12

C 556 Helen P. Thomas Vol#: 12

C 557 George L. Taylor Vol#: 12

C 558 Christel Jorgenson Vol#: 12

C 559 Governemnt of Iowa Vol#: 12

C 560 Kevin Riley Vol#: 12

C 561 Shirley Sabbeth, RD Vol#: 12

C 562 Martin Marietta Aggregates Vol#: 12

C 563 Keith Sexton Vol#: 12

C 564 Emalu C. Nix Vol#: 12

C 565 Sara Bhakti, PhD Vol#: 12

C 566 Iowa Quality Producers Alliance, LLC Vol#: 12

C 567 Greenpeace Vol#: 12

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

C 38 American Chemistry Council Vol#: 3

02D-0362 Quarantine/Retrieval of Blood Prod.in Recipients of Smallpox

C 1 Mayo Clinic Vol#: 1

02D-0371 Human Dura Mater; Class II Special Controls Guidance

EC 1 CJD WATCH Vol#: 1

02D-0402 Field offices on "Regulatory procedures Manual, Chapter 9

EC 2 Number Not Used Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

EC 8 U of Florida Vol#: 1

EC 9 Ms. Jill Zavis Vol#: 1

02E-0020 Patent Term Application for Zometa No. 4,939,130

LET 3 HFD-005 to US Patent & Trademark Ooffice Vol#: 1

02N-0273 Animal Proteins Prohibited in Ruminant Feed

C 4 Jimmy L. Sine Vol#: 2

C 5 Robert L. Harper Vol#: 2

C 6 Mississippi Farm Bureau Federation (MFBF Vol#: 2

C 7 American Farm Bureau Federation et al. Vol#: 2

C 8 Form Letter 41 Vol#: 2

EC 10 CJD WATCH Vol#: 2

EC 11 CJD WATCH Vol#: 2

EC 12 Number Not Used Vol#: 2

02N-0370 Neurological Devices; Classification of Human Dura Mater

EC 1 CJD WATCH Vol#: 1

02N-0445 FDA Regulation of Combination Products; Public Hearing

C 4 Medical Imaging Agent Contrast Assn Vol#: 4

C 5 Becton, Dickinson and Company Vol#: 4

C 6 AdvaMed Vol#: 4

EC 10 Optimal Women's Wellness Vol#: 4

EC 11 Pharmacia Vol#: 4

02N-0486 Prescription Drug Marketing Act of 1987

EC 6 Mrs. Marsha Raczniak Vol#: 1

EC 7 Mrs. Marsha Raczniak Vol#: 1

02N-0534 Medical Device User Fee and Modernization Act of 2002

EC 1 Number Not Used Vol#: 1

02P-0067 All estrogen-containing products intended for oral use

LET 2 Physicians Committe for Responsible Med Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

C 3 William Lee Bowersock Vol#: 3

EMC 222 William Bowersock Vol#: 5

EMC 223 Robert & Susanna Austin Vol#: 5

EMC 224 Jane M. Griechen Vol#: 5

EMC 225 Judy Evans Vol#: 5

EMC 226 Doris Ranson Vol#: 5

EMC 227 Doug468dart Vol#: 5

EMC 228 Violet Hosler Vol#: 5

EMC 229 James & Betty Hendrix Vol#: 5

EMC 230 D. Schneid Vol#: 5

EMC 231 Betty Martini Vol#: 5

02P-0435 Effective Approval of Alphanate Antihemophilic Factor

C 1 Alpha Therapeutic Corp. Vol#: 2

C 2 Alpha Therapeutic Corporation Vol#: 1

02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%

RC 1 Allergan, Inc. Vol#: 1

03M-0010 PMA SIR-Spheres, P990065

AAV 1 Sirtex Medical, Inc. Vol#: 1

03M-0011 PMA Karl Storz Autofluorescence System, p020008

AAV 1 Karl Storz Endoscopy-America Vol#: 1