DOCKETS ENTERED on 04/26/99

FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 26, 1999

Updated as of 8:30 am, May 3, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

NOTE: Starting July 1, 1999, documents on public display, such as this listing and the Federal Register - Public Inspection Listing, will be available primarily in electronic format. There will be no physical (hard copy) display.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

96P-0023 Amend 101.12(b) Table 2 on Hard Candies
96P-0179 Establishes RACCs for various types of food products
98D-1146 Microbial effects of antimicrobial new animal drugs/human
98E-0488 Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957
98E-0614 AMERGE (naratriptan hydrochloride) Patent No. 4,997,841
98E-0846 Patent Extension, APLIGRAF, 4,485,096
98N-0044 Effect of dietary supplement on structure/function of body
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99D-0236 Skin Irriation/Sensitization testing of generic transdermal
99N-0386 Talking with Stakeholders About FDA Modernization
99P-0033 Combat the spread of transmissible spongiform
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

96P-0023 Amend 101.12(b) Table 2 on Hard Candies

ACK 1 HFA-305 Vol#: 3

96P-0179 Establishes RACCs for various types of food products

ACK 1 HFA-305 Vol#: 3

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

SUP 2 Supplements to Agenda 2/18/99 Vol#: 1

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

C 48 Treasure Valley Transplants,Inc Vol#: 2

98E-0488 Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957

LET 4 HFY-20 Vol#: 1

98E-0614 AMERGE (naratriptan hydrochloride) Patent No. 4,997,841

LET 3 HFY-20 Vol#: 1

98E-0846 Patent Extension, APLIGRAF, 4,485,096

LET 3 HFY-20 Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

C 22306 Mr. Thomas Mower Vol#: 771

98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA

ACK 1 HFA-305 Vol#: 3

CP 1 Pfizer, Inc. Vol#: 3

98N-1265 Distribution of Compounded Drug Products

C 1291 Garrett C. Caputo Vol#: 71

C 1292 Betty Bellman Vol#: 71

C 1293 T. Eufest Vol#: 71

C 1294 Donna Gates Andreasen Vol#: 71

C 1295 Al & Barb Tornquist Vol#: 71

C 1296 Deborah De Piano Vol#: 71

C 1297 Sharon Warren Vol#: 71

C 1298 Lorraine Dambro Vol#: 71

C 1299 Rita B. Hall Vol#: 71

C 1300 Rickie G. Giono Vol#: 71

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

C 2093 Elaine Douglas Vol#: 52

C 2094 Noam Mohr Vol#: 52

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 140 Blue Gulf Seafood, Inc. Vol#: 12

C 141 Adriatic, Inc. Vol#: 12

C 142 Mermaid Seafood, Inc. Vol#: 12

C 143 Dolphin J. Inc. Vol#: 12

C 144 T & J Oyster Co. Vol#: 12

C 145 Wine Island, Inc. Vol#: 12

C 146 Captain Salty's Seaford, Inc. Vol#: 12

C 147 Bayou Gourmet, Inc. Vol#: 12

C 148 Motivatit Seafoods, Inc. Vol#: 12

C 149 Louisiana Seafood Processors Council Vol#: 12

C 150 Marcia Barinaga, Ph.D. Vol#: 12

C 151 Cape Henlopen Shellfish, Inc. Vol#: 15

C 152 Coalition for Consumer Choice Vol#: 15

C 153 Ron Johansen Vol#: 15

C 154 William M. Bumgordner Vol#: 15

C 155 Rita Lynn Johansen Vol#: 15

C 156 Bagala's Quality Oysters, Inc. Vol#: 15

C 157 Becky's Bivalues Vol#: 15

C 158 Louisiana Oyster Dealers & Growers Assn. Vol#: 15

C 159 State of Washington Dept. of Health Vol#: 15

99D-0236 Skin Irriation/Sensitization testing of generic transdermal

C 3 Procter & Gamble Pharmceuticals Vol#: 1

C 4 3M Pharmceuticals Vol#: 1

99E-1114 Ziagen, Patent No. 5,034,394

APP 1 Glaxo Wellcome Inc. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

99E-1115 Lumbar I/F Cage, Patent No. 4,834,757

APP 1 DePuy AcroMed, Inc. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

C 8 Association of Food & Drug Officials Vol#: 1

99P-0033 Combat the spread of transmissible spongiform

ACK 2 HFA-305 Vol#: 1

C 42 Camille Jordan Vol#: 1

CP 2 Humane Farming Assn Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 75 Mr. & Mrs. John A. Sperry Vol#: 1

C 76 Mollie Leibowitz Vol#: 1

C 77 Sherlyn M. Kistner Vol#: 1

C 78 Liz Hardy & Sue Atols Vol#: 1

C 79 Agnes Priddy Vol#: 1

C 80 Carol Krawczyk Vol#: 1

C 81 Kevin M. Crupi Vol#: 1

C 82 Sheila Jacobs Vol#: 1

C 83 Agnes Annunziata Vol#: 1

C 84 Genevieve Jenkins Vol#: 1

C 85 Elaine Urabel Vol#: 1

C 86 Gloria Gray Vol#: 1

C 87 D. Smith Vol#: 1

C 88 Suzanne Weinstein Vol#: 1

C 89 Carol Logen Vol#: 1

C 90 Deborah Avalos Vol#: 1