Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail] 

DOCKETS ENTERED on November 3, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
97N-484S Human Cellular and Tissue-Based Products *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols *
99D-2096 Interpreting Sameness of Monoclonal Antibody Products *
99D-2335 Guidance for Medical Gloves A workshop Manual *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99D-4201 Dioxin Anti-caking Agents in Animal Feed/Feed ingredients *
99M-4763 PMA, CardioSEAL Septal Occlusion System, H990005 *
99P-4775 ANDA for naltrexone hydrochloride tablets for 25 100, &150mg *
99V-4774 Laser Light Show (Laser Electro Oplic Technology) *
77N-0145 X-Otag Plus Tablets

ND 2 Vol#:

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 53 National Association of Pharmaceutical M Vol#: 24

C 54 Schein Pharmaceutical Inc Vol#: 24

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6198 Julia Gorczyca Vol#: 159

C 6199 S Buckley Vol#: 159

C 6200 Nation Building Forum Vol#: 159

C 6201 Jessica Joseph Vol#: 159

C 6202 Timothy Frank Vol#: 159

C 6203 Paula Mayer & Dorothy Groteluschen Vol#: 159

C 6204 Food Co-op Vol#: 159

C 6205 Joan Gray Vol#: 159

C 6206 Erika Vorozhenkine Vol#: 159

C 6207 Mary Ann Squeo Vol#: 159

C 6208 Andrea Heggen Vol#: 159

C 6209 Dorothy Olinger Vol#: 159

C 6210 Virginia Snyder Vol#: 159

C 6211 Marian Jane Porter Vol#: 159

C 6212 Jennifer Selig Vol#: 159

C 6213 Sandra Squire Fluck Vol#: 159

C 6214 Honorable Herb Kohl (CI) Vol#: 159

C 6215 Gene Diefenbach Vol#: 159

C 6216 Christina Davenport Vol#: 159

C 6217 Patricia S Rose Vol#: 159

C 6218 Drew & Roseanna Pontz Vol#: 159

C 6219 Drew Arterburn Vol#: 159

C 6220 Anita Whiterede Vol#: 159

C 6221 Bill Strubbe Vol#: 159

C 6222 Eric Moore Vol#: 159

C 6223 Charlene Sherman-Ragatz Vol#: 159

C 6224 Unsigned Vol#: 159

C 6225 A Feldman Vol#: 159

C 6226 Ruth Bardach Vol#: 159

C 6227 Mary Ann Robinson Vol#: 159

C 6228 Martin Bloom Vol#: 159

C 6229 Barb Olijnek Vol#: 159

C 6230 Mike Olijnek Vol#: 159

C 6231 Elizabeth Scott Vol#: 159

C 6232 Jon Garner Vol#: 159

C 6233 Andrea Berstein Vol#: 159

C 6234 Kathleen E Trenholm & 11 signatures Vol#: 159

C 6235 Diane M Hardy Vol#: 159

C 6236 Betty Jo Miller Vol#: 159

C 6237 Stacey L Klaman Vol#: 159

C 6238 Neva Anderson Vol#: 159

C 6239 Crystal C Wooldridge Vol#: 159

C 6240 Sue Welburn Vol#: 159

C 6241 Susanne C Jessen Vol#: 159

C 6242 Alison Johnson Vol#: 159

C 6243 Robert L Manning Vol#: 159

C 6244 Hugh McGuire Vol#: 159

C 6245 Robert Petersen Vol#: 159

C 6246 Marian Jane Porter Vol#: 159

C 6247 Frank Bonneville Vol#: 159

C 6248 Karen Golosman Vol#: 159

93N-0260 Medical Device Recall Authority

N 1 HFA-250 Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9604 University of California, Los Angeles Vol#: 197

97N-484S Human Cellular and Tissue-Based Products

ANS 1 HF-40 to Doni Gewirtzman Vol#: 6

C 1 Lambda Legal Defense & Education Fund In Vol#: 6

EC 24 Kerry Macintosh Vol#: 6

EC 25 Greggor Mattson Vol#: 6

EC 26 Joseph M Mendoza Vol#: 6

EC 27 Rabbi Harry A Manhoff Vol#: 6

EC 28 Corey Datz-Greenberg Vol#: 6

EC 29 Paul Park Vol#: 6

EC 30 Fred Harvey Vol#: 6

EC 31 Mike Horgan Vol#: 6

EC 32 Brian M Kochera Vol#: 6

EC 33 Mariah Randolph Vol#: 6

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 25 Reichhold Inc Vol#: 7

C 26 Kuala Lumpur, Malaysia Vol#: 7

C 27 Safeskin Corporation Vol#: 7

C 28 American Society of Anesthesiologists Vol#: 7

C 29 Jean M Carazza-Mahoney BS RN Vol#: 7

C 30 Kao Corporation Vol#: 8

C 31 Lembaga Getah Malaysia Vol#: 8

C 32 Grain Processing Corporation Vol#: 8

C 33 Ultravena Industries USA Ltd Vol#: 8

C 34 Assn of periOperative Registered Nurses Vol#: 8

C 35 Sumitomo Rubber Industries Vol#: 8

C 36 Potomac Latex Allergy Association Vol#: 8

C 37 American Nurses Association Vol#: 8

C 38 Malaysian Rubber Glove Mfg Assn Vol#: 8

98N-1038 Irradiation in the production, processing, &handling of food

C 4773 Unsigned Vol#: 138

C 4774 Karen Golosman Vol#: 138

C 4775 A. Acchione Vol#: 138

C 4776 E.P. & G.J. Shelley Vol#: 138

C 4777 Lora Byxbe Vol#: 138

C 4778 Betsy Rothstein Vol#: 138

98N-1265 Distribution of Compounded Drug Products

C 6137 Rose Broun Vol#: 171

C 6138 Nancy Dagenhart, MA, MFCC Vol#: 171

C 6139 Audrey Toll Vol#: 171

C 6140 Joyce Soule Vol#: 171

C 6141 M. Epstein, M.D. Vol#: 171

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 15 SmithKline beecham Pharmaceuticals Vol#: 1

99D-2096 Interpreting Sameness of Monoclonal Antibody Products

C 5 Lilly Research Laboratories Vol#: 1

C 6 Hyman Phelps & McNamara PC Vol#: 1

99D-2335 Guidance for Medical Gloves A workshop Manual

C 7 Health Canada Vol#: 2

C 8 RI State Nurses Association Vol#: 2

C 9 Elastic Inc Vol#: 2

C 10 Safeskin Corporation Vol#: 2

C 11 American Nurses Association Vol#: 2

99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis

C 22 Procter & Gamble Vol#: 2

99D-4114 Testing for Replication Competent Retrovirus in Retroviral

GDL 1 Guideline Vol#: 1

NAD 1 HFM-017 Vol#: 1

99D-4201 Dioxin Anti-caking Agents in Animal Feed/Feed ingredients

C 1 Bentonite Performance Minerals Vol#: 1

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

NFL 1 National Fisheries Institute Vol#: 1

99H-1101 Civil Money Penalties;Fraga Inc,d/b/a Italian Village Restau

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1107 Civil Money Penalties;Dairy Mart Convenience Stores,d/b/a

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99M-4763 PMA, CardioSEAL Septal Occlusion System, H990005

AAV 1 Nitinol Medical Technologies Inc Vol#: 1

99N-2250 Blood and Blood Components at Increased Risk for Transmittin

NFR 1 HFZ-460 Vol#: 1

NPR 1 HFZ-460 Vol#: 1

99N-2550 Technical data in hearing aid labeling

NFR 1 HFZ-460 Vol#: 1

NPR 1 HFZ-460 Vol#: 1

99N-4491 Reuse of Single Use Devices proposal

BKG 1 Background material Vol#: 1

NAD 1 HFZ-220 Vol#: 1

99N-4614 Changes to an Approved NDA or ANDA

N 1 HFA-250 Vol#: 1

99P-0895 Reclassify Fiber Optic Light Sources

ND 1 HFZ-470 Vol#: 1

99P-4775 ANDA for naltrexone hydrochloride tablets for 25 100, &150mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

99V-4774 Laser Light Show (Laser Electro Oplic Technology)

ACK 1 HFA-305 Vol#: 1

VAR 1 Texas State Technical College Vol#: 1