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

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99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4812 Civil Money Penalty;Anan W Kahala,dba El Amigo Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4813 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #2356

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4814 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #7150

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4815 Civil Money Penalty;Do Your Deal'N Inc,dba Connolly's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4816 Civil Money Penalty;Habbas Inc,dba Ranch Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4817 Civil Money Penalty;Howard Tommie,dba Strothers Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4818 Civil Money Penalty;Mildred Sykes,dba Bob's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4819 Civil Money Penalty;Nick Robinson & Anna Robinson,dba Brown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4820 Civil Money Penalty;Richard Smith,dba Sooner Country Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4821 Civil Money Penalty;Ruth Jones,dba Statesville Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4822 Civil Money Penalty;The Three E Corp,dba Family Pride IGA

ANS 1 Family Price IGA Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4823 Civil Money Penalty;Vas Arora,dba La Sierra Shell

ANS 1 La Sierra Shell Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4824 Civil Money Penalty;Viet Wah Trading Corp,dba Viet Wah Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4825 Civil Money Penalty;Watkins Mgt Services Inc,dba Liberty Amo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

NPH 2 HHS/CDER/FDA Vol#: 1

99H-4826 Civil Money Penalty;Wingate Ent Inc,dba The Little Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4827 Civil Money Penalty;Metro Petroleum Co Inc,dba Amoco Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4828 Civil Money Penalty;H & K Ashton Crown Inc,dba Ashton Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4829 Civil Money Penalty;K-Mart Corp,dba Big Kmart Store #7682

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4830 Civil Money Penalty; Valley Markets Inc & Warren Butler,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4831 Civil Money Penalty;W & R Inc,dba Cairo Wine & Liquor Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4832 Civil Money Penalty;Radd Inc,dba Exxon of Olney

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4833 Civil Money Penalty;KM Inc,dba Exxon Shop

ANS 1 KM Inc,dba Exxon Shop Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4834 Civil Money Penalty;High's of Baltimore Inc,High's of Baltim

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4835 Civil Money Penalty;Jeanette Bryant,dba J & J Bait & Tackle

ANS 1 J J Bait & Tackle Shop Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4836 Civil Money Penalty;Hsiu Hsieh,dba Lawai General Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4837 Civil Money Penalty;Oasis Inc,dba Oasis Gourmet Deli

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4838 Civil Money Penalty;Intercontinental Investments Inc,dba Oln

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4839 Civil Money Penalty;American Drug Store Inc,dba Osco Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4840 Civil Money Penalty;Paul Singh,dba Pitman Xtra

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4841 Civil Money Penalty;Jesus Rosa,dba Rossi Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4842 Civil Money Penalty;Cloverland Farms Dairy Inc,dba Royal Far

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4843 Civil Money Penalty;Sang Chil Hong,dba Shell Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4844 Civil Money Penalty;Tienda Izalco Inc,dba Tienda Izalco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4845 Civil Money Penalty;Tschiffely International Inc,dba Tschiff

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4846 Civil Money Penalty;Daniel Weston & Linda Weston,dba Weston'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4847 Civil Money Penalty;Kahn International Ent Inc,Mohammed Kahn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-2497 Actions That Can be Requested by Petition; Denials, Withdraw

NPR 1 Vol#: 1

99N-4397 Survey of Food Manufacturing Facilities/Year 2000 compliance

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1
 
 

99N-4491 Reuse of Single Use Devices proposal

C 1 Gordon R. Bond Vol#: 1

99N-4933 FDA Safety Alert Public Health Advisory Readership Survey

N 1 Vol#: 1
 
 

99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml

C 1 Faulding Pharmaceutical Co. Vol#: 1
 
 

99P-5198 Request amendment of the definition of milk

ACK 1 HFA-305 Vol#: 1

CP 1 American Dairy Products Institute Vol#: 1
 
 

99P-5215 Provisions of Title 21 of the Code of Federal Regulations

ACK 1 HFA-305 Vol#: 1

CP 1 Wiley, Rein & Felding Vol#: 1
 
 

99V-5196 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Science City At Union Station Vol#: 1
 
 

99V-5197

ACK 1 HFA-305 Vol#: 1

VAR 1 ARK of MIAMI Inc. Vol#: 1