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 September 8, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
76N-052N OTC Nasal Decongestants*
92N-0416 Debarment of David Brancato - Opportuni of hearing *
96P-0418 Reduce Precense Salmonella Enteritidis in Shell Eggs *
96P-0460 Add Clotrimazole 1.0% - Treat of Athlete's Foot etc. *
97D-0318 Revised Precautionary Measure Reduce Trans  CJD *
97P-0354 Reclassify Shoulder Joint Prostheses*
98D-1266 Therapeutic Equivalence Code Prescrip Drug Labels *
99D-1269 Draft Guidance on Quality Systems Inspections Technique *
99D-1454 Nasal spray, inhalation solution, suspen&spray drug prod *
99D-1878 Good Manufacturing Practice for Blood and Blood Comp: *
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices *
99N-0193 Supplements and Other Changes to an Approved Application *
99N-0438 Contamination ready-to-eat foods associated food prepartion *
99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat *
76N-052N OTC Nasal Decongestants

ACK 2 HFA-305 Vol#: 73

PSA 2 The Proctor & Gamble Company Vol#: 73

92C-0348 Safe Use of FD&C Blue No. 2-Aluminum Lake

EA 1 Vol#: 1

FONS2 Vol#: 1

NFR 1 Vol#: 1

92N-0416 Debarment of David Brancato - Notice Opportunity of Hearing

LET 4 David Brancato Vol#: 1

96N-0417 CGMP in Packing or Holding Dietary Supplements

NM 2 Vol#: 3

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

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

C 165 Joanna Seere Vol#: 7

C 166 Miriam Cohen Vol#: 7

C 167 Barbara Bonsignore Vol#: 7

C 168 Rachel Thompson Vol#: 7

C 169 Action Volunteers For Animals Vol#: 7

C 170 Isabell Spindler Vol#: 7

C 171 Lillian & Woodrow Mac Bain Vol#: 7

C 172 Dr. Jack B. Kinder Vol#: 7

C 173 Dorothy C. Ramsaier Vol#: 7

C 174 Ivan Holster Vol#: 7

C 175 Lea-Marie Karney Vol#: 7

C 176 Kristin Reiter Grove Vol#: 7

C 177 Committee For Children Vol#: 7

C 178 Gloria Mack Vol#: 7

C 179 Linda Phillips Tarte Vol#: 7

C 180 Ruth Platt Vol#: 7

C 181 R. Soto Vol#: 7

C 182 Barbara Trudell Vol#: 7

C 183 David & Eva-Maria Frank Vol#: 8

C 184 Federico Gonzalez Vol#: 8

96P-0460 Add Clotrimazole 1.0% for Treatment of Athlete's Foot etc.

LET 5 Schering-Plough HealthCare Products Vol#: 1

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

C 1 American Association of Blood Banks Vol#: 1

97N-0074 President's National Food Safety Initiative

C 83 Donna Matthews Vol#: 10

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

C 166 Joanna Seere Vol#: 6

C 167 Miriam Cohen Vol#: 6

C 168 Barbara Bonsignore Vol#: 6

C 169 Rachel Thompson Vol#: 6

C 170 Action Volunteers For Animals Vol#: 6

C 171 Isabell Spindler Vol#: 6

C 172 Lillian & Woodrow Mac Bain Vol#: 6

C 173 Dr. Jack B. Kinder Vol#: 6

C 174 Dorothy C. Ramsaier Vol#: 6

C 175 Ivan Holster Vol#: 6

C 176 Lea-Marie Karney Vol#: 6

C 177 Kristin Reiter Grove Vol#: 6

C 178 Committee For Children Vol#: 6

C 179 Gloria Mack Vol#: 6

C 180 Linda Phillips Tarte Vol#: 6

C 181 Ruth Platt Vol#: 6

C 182 R. Soto Vol#: 6

C 183 Barbara Trudell Vol#: 6

C 184 David & Eva-Maria Frank Vol#: 7

C 185 Federico Gonzalez Vol#: 7

97P-0354 Reclassify Shoulder Joint Prostheses

C 1 ASTM Vol#: 3

C 2 American Assn of Orthopaedic Surgeons Vol#: 3

98D-1266 Therapeutic Equivalence Code on Prescription Drug Labels

C 25 Pharma Res & Manufacturers of America Vol#: 1

98F-0893 Siloxanes and silicones itended for use in contact with food

NFR 1 Vol#: 1

98F-1122 Pigment Dispersants

NFR 1 Vol#: 1

98H-1094 Civil Money Penalties;Seamark Enterprises Inc,d/b/a Seamark

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 Office of Tobacco Programs Vol#: 1

98H-1100 Civil Money Penalties;Fakhoury Ent Inc.,d/b/a Flash Food Sto

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 Office of Tobacco Programs Vol#: 1

98H-1117 Civil Money Penalties;B.J.Ray,d/b/a Ray Produce

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 Office of Tobacco Programs Vol#: 1

98H-1119 Civil Money Penalties;Mustafa Uwainat,d/b/a B 52 Market #2

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1255 Civil Money Penalties;Gray's Food Inc,d/b/a Gray's Iga Food

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1257 Civil Money Penalties;Gant Oil Co,d/b/a Gant Oil Station #15

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1264 Civil Money Penalties;Sun Food Market Inc,d/b/a Sun Food Mar

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1273 Civil Money Penalties; Barbara Gee,d/b/a New J C Supermark

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1275 Civil Money Penalties; Holyoke News Co Inc,d/b/a Amherst

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1281 Civil Money Penalties;Pearl A Nevels,d/b/a Eagle Shore Gro

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

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

C 165 Joanna Seere Vol#: 10

C 166 Miriam Cohen Vol#: 10

C 167 Barbara Bonsignore Vol#: 10

C 168 Rachel Thompson Vol#: 10

C 169 Action Volunteers For Animals Vol#: 10

C 170 Isabell Spindler Vol#: 10

C 171 Lillian & Woodrow Mac Bain Vol#: 10

C 172 Dr. Jack B. Kinder Vol#: 10

C 173 Dorothy C. Ramsaier Vol#: 10

C 174 Ivan Holster Vol#: 10

C 175 Lea-Marie Karney Vol#: 10

C 176 Kristin Reiter Grove Vol#: 10

C 177 Committee For Children Vol#: 10

C 178 Gloria Mack Vol#: 10

C 179 Linda Phillips Tarte Vol#: 10

C 180 Ruth Platt Vol#: 10

C 181 R. Soto Vol#: 10

C 182 Barbara Trudell Vol#: 10

C 183 David & Eva-Maria Frank Vol#: 11

C 184 Federico Gonzalez Vol#: 11

99D-1269 Draft Guidance on Quality Systems Inspections Technique

C 2 American Red Cross Vol#: 1

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

some of these linked comments duplicate those for 99d-1738, also below

C 2 Apotex Corp Vol#: 1

C 3 ALPHARMA US Pharmaceuticals Division Vol#: 1

C 4 S. A. Valois Vol#: 1

C 5 S. A. Valois Vol#: 1

C 6 S. A. Valois Vol#: 1

C 7 S. A. Valois Vol#: 1

C 8 The Intl Pharm Aerosol Consort Vol#: 1

C 9 Boehringer Ingelheim Vol#: 1

C 10 Lilly Research Laboratories Vol#: 1

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 1 Apotex Corp Vol#: 1

C 2 ALPHARMA US Pharmaceuticals Division Vol#: 1

99D-1878 Good Manufacturing Practice for Blood and Blood Components:

C 26 Texas Hospital Assn Vol#: 1

99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices

C 1 Animal Health Institute Vol#: 1

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

GDL 1 Vol#: 1

NAL 1 Vol#: 1

99F-1420 Amend to provide safe use of butylated reaction product

NFR 1 Vol#: 1

99F-2799 Irradiate animal feeds/feed ingredients for microbial contro

EA 1 Vol#: 1

M 1 Vol#: 1

NFL 1 Sterigenics International, Inc. Vol#: 1

99H-0070 Civil Money Penalties;Quick Stop LLC,d/b/a Quick Stop

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0084 Civil Money Penalties;Nick Nassar,d/b/a Nick Food Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0154 Civil Money Penalties;Bradley Petroleum Inc,d/b/a Bradley

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0256 Civil Money Penalties; Khurram Quraishi,d/b/a Isalys

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0306 Civil Money Penalties;Clifford Mason,d/b/a Mason's Amoco Ser

LET 2 Office of Tobacco Programs Vol#: 1

99H-0399 Civil Money Penalties;Ramon Guevara-Felix,d/b/a Columbia Rd

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0729 Civil Money Penalties;Family Co of America L C,d/b/a Ntl Mak

ANS 1 Family Co of America, L C Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0750 Civil Money Penalties;Kathy Khong,d/b/a Victoria Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0943 Civil Money Penalties;Mitch Rayl,d/b/a Buffalo Conoco

ANS 1 Buffalo Conoco Vol#: 1

99H-1239 Civil Money Penalties;Pacific Foods Inc

LET 2 Office of Tobacco Programs Vol#: 1

99H-1816 Civil Money Penalty;Jim Wagner,dba Wagner's One Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-1929 Civil Money Penalty;Ruth Taylor,dba R & W Variety

LET 2 Office of Tobacco Programs Vol#: 1

99H-1934 Civil Money Penalty;Waring Oil Co,dba Interstate Station

LET 2 Office of Tobacco Programs Vol#: 1

99H-2023 Civil Money Penalty;Town Zippy Mart Inc,dba Town Zippy Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-2157 Civil Money Penalty;Emergency Fuel Station Inc,dba Emergency

LET 2 Office of Tobacco Programs Vol#: 1

99H-2369 Civil Money Penalty;John Cucchi,dba Kingshighway Manchester

ANS 1 Kingshighway Manchester Amoco Vol#: 1

99H-2466 Civil Money Penalty;DC & LC Inc,dba Hilltop Food Mart

EXT 1 DC & LC Inc, dba Hilltop Food Mart Vol#: 1

99H-2540 Civil Money Penalty;Freeport Cooperative Creamery Associatio

ANS 2 Freeport Cooperative Creamery Assn Vol#: 1

99H-2543 Civil Money Penalty;McLean County Fuel Corporation Inc,dba

LET 2 Office of Tobacco Programs Vol#: 1

99H-2557 Civil Money Penalty;Mike Brawner,dba A J's Food Mart

ANS 1 Mike Brawner, dba Food Mart Vol#: 1

99H-2601 Civil Money Penalty;Leon Fleming,dba,Fleming Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2766 Civil Money Penalty;Peter Sybrandt,dba Mounds Park Quick Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2767 Civil Money Penalty;Tabo's Ent Inc,dba Tabo's Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2768 Civil Money Penalty;Joe Terzich,dba Terzich Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2769 Civil Money Penalty;Victor Thomas,dba Mattapan Square Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2770 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Diamo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2771 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Total

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2772 Civil Money Penalty;Richard Wenndt & Diane Wenndt,dba Killdu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2773 Civil Money Penalty;Angela Williams & Linda Deymonaz,dba Esm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 5 PDA Vol#: 1

C 6 PDA Vol#: 1

C 7 Zeneca Pharmaceuticals Vol#: 1

C 8 Apotex Corp Vol#: 1

C 9 Pharma Res & Manufacturers of America Vol#: 2

C 10 Lilly Research Laboratories Vol#: 2

C 11 Bristol-Myers Squibb Pharm Res Institute Vol#: 2

99N-0438 Contamination ready-to-eat foods associated food prepartion

C 14 Hy-Tech Consultancy Vol#: 5

99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat

EXT 2 Applied Research Ethics National Assn Vol#: 1

99N-2875 Blood Establishment Registration /Product Listing Form 2830

N 1 Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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