DOCKETS ENTERED

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 December 3, 1999

(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 *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
98D-0449 Inspection of Medical Device Manufacturers *
98N-0581 Requirements for Testing Human Blood Donors *
98N-1170 Sunlamp Products Performance Standard *
99D-2445 Using plasma HIV RNA measurements/approval of Antiretroviral *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99D-2638 Use of Medicated Feeds for Minor Species *
99D-2729 Industry on BA/BE studies orally administered drug products *
99D-4003 Preclinical and Clinical Data and Labeling Breast Prostheses *
99N-4491 Reuse of Single Use Devices proposal *
99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml *
99P-5198 Request amendment of the definition of milk *
99P-5215 Provisions of Title 21 of the Code of Federal Regulations *
99V-5196 Laser Light Show*
99V-5197 *

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

C 69 Upsher-Smith Labs., Inc. Vol#: 26

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

C 6276 Samuel S Weiss Vol#: 160

C 6277 Unsigned Vol#: 160

C 6278 Melissa Russo Vol#: 160

C 6279 Shantara & Michael Polizzi Vol#: 160

C 6280 Donna Lipschutz Vol#: 160

C 6281 Paul Campbell Vol#: 160

C 6282 Helen Nora Montague Vol#: 160

C 6283 E Fesenko-Kowalskyj Vol#: 160

C 6284 Laxmi Narain Modi Vol#: 160

C 6285 David L Price Vol#: 160

C 6286 Maja Ramirez Vol#: 160

C 6287 Steve Graham Vol#: 160

C 6288 Naomi Rennekamp Vol#: 160

C 6289 Kent Paul Vol#: 160

C 6290 Alex Stephens Vol#: 160

C 6291 Ellen Halloran Vol#: 160

C 6292 Unsigned Vol#: 160

C 6293 Andrea Singmaster-Gladfelter Vol#: 160

C 6294 William Calia Vol#: 160

C 6295 Michael & Janet Costello Vol#: 160

C 6296 Mary K Libby Vol#: 160

C 6297 Pricilla Kline Vol#: 160

C 6298 Judy L Meyer Vol#: 160

C 6299 Nicole A Hart Vol#: 160

C 6300 Susan Gajewski Vol#: 160

C 6301 Corabe Miller Vol#: 160

C 6302 Brian Sander Vol#: 160

C 6303 Byron Efird Vol#: 160

C 6304 John Levitt Vol#: 160

95F-0150 Safe use of polymeric 2,2,4,4-tetramethyl

BKG 1 Background Vol#: 1

NFR 1 Vol#: 1

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 95 K&K Laboratories, Inc. Vol#: 3

C 96 Herb Pharm Vol#: 3

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 787 Maureen Edwards Vol#: 31

C 788 Frank Pallone, Jr. (CI) Vol#: 31

C 789 Richard J. Durbin (CI) Vol#: 31

C 790 John Edward Porter (CI) Vol#: 31

C 791 Donald A. Manzullo (CI) Vol#: 31

C 792 no signature Vol#: 31

C 793 Mary Ellen Tang Vol#: 31

C 794 Vera Kramer Vol#: 31

MM 1 HFW-12 & Pennsylvania Egg Industry et al Vol#: 31

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 18 Bascom Palmer Eye Institute Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9607 AARC, American Assn. for Respiratory Vol#: 197

C 9608 Thomas R. Farese Vol#: 197

97P-0197 Require that warning labels about risks of salmonella enteri

C 788 Maureen Edwards Vol#: 30

C 789 Frank Pallone, Jr. (CI) Vol#: 30

C 790 Richard J. Durbin (CI) Vol#: 30

C 791 John Edward Porter (CI) Vol#: 30

C 792 Donald A. Manzullo (CI) Vol#: 30

C 793 no signature Vol#: 30

C 794 Mary Ellen Tang Vol#: 30

C 795 Vera Kramer Vol#: 30

MM 1 HFW-12 & Pennsylvania Egg Industry et al Vol#: 30

98D-0449 Inspection of Medical Device Manufacturers

C 5 Beckman Coulter Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 166 David Spero, RN Vol#: 20

C 167 25 signatures Vol#: 20

98N-0581 Requirements for Testing Human Blood Donors

C 8 Beth Israel Deaconess Med Ctr & Harvard Vol#: 5

98N-1170 Sunlamp Products Performance Standard

C 28 Douglas L. Harding Vol#: 3

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 787 Maureen Edwards Vol#: 32

C 788 Frank Pallone, Jr. (CI) Vol#: 32

C 789 Richard J. Durbin (CI) Vol#: 32

C 790 John Edward Porter (CI) Vol#: 32

C 791 Donald A. Manzullo (CI) Vol#: 32

C 792 no signature Vol#: 32

C 793 Mary Ellen Tang Vol#: 32

C 794 Vera Kramer Vol#: 32

MM 1 HFW-12 & Pennsylvania Egg Industry et al Vol#: 32

99D-2445 Using plasma HIV RNA measurements/approval of Antiretroviral

C 1 Glaxo Wellcome Inc. Vol#: 1

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

C 29 Perrigo Co. Vol#: 2

C 30 NAPM, National Assn of Pharmaceutical Mf Vol#: 2

99D-2638 Use of Medicated Feeds for Minor Species

C 5 State of Wisconsin Dept of Natural Resou Vol#: 1

C 6 Mac Farlane Pheasant Farm, Inc. Vol#: 1

C 7 University of Florida Vol#: 1

C 8 St. of Washington Dept of Fish & Wildlif Vol#: 1

99D-2729 Industry on BA/BE studies orally administered drug products

C 13 Generic Pharamceutical Industry Assn. Vol#: 1

C 14 NAPM, National Assn. of Pharmaceutical M Vol#: 1

99D-4003 Preclinical and Clinical Data and Labeling Breast Prostheses

C 1 Chemically Associated Neurological Disor Vol#: 1

99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99F-5012 use of oxidized bis(hydrogenated tallow alkyl) amines

NFL 1 Ciba Specialty Chemicals Corp. Vol#: 1

99F-5111 Rubber Articles Intended for Use In Contact With Food

NFL 1 Goodyear Tire & Rubber Co. Vol#: 1

99H-4811 Civil Money Penalty;Kayo Oil Co,dba Conoco Cono Mart