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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 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
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
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
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
02D-0371 Human Dura Mater; Class II Special Controls Guidance
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 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 12 Number Not Used Vol#: 2
02N-0370 Neurological Devices; Classification of Human Dura Mater
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
EC 10 Optimal Women's Wellness 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%
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