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 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]
 
95S-0158 Community Disclosure of Institutional Review Boards
96P-0328 Modify 640.3(d) after 'Therapeutic Bleedings'
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
98N-0313 Sugeons's and Patient Examination Gloves Reclassification
98N-1215 Foreign Establishment Registration and Listing
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99D-0239 Resolving scientific disputes concerning regulation Medical
99D-1269 Draft Guidance on Quality Systems Inspections Technique
99D-1878 Good Manufacturing Practice for Blood and Blood Components:
99D-2249 Technical Requirements for VICH
99M-2748 PMA Bayer Immuno 1 PSA Assay, P950021/S1
99N-0193 Supplements and Other Changes to an Approved Application
99N-0386 Talking with Stakeholders About FDA Modernization
99P-1041 Temporary Marketing Permit Salad Dressing
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast
99P-2630 Establish a Daily Value for "added sugars"
99P-3083 Determine if Neurontin (Gabapentin) tablets 600mg & 800 have
95S-0158 Community Disclosure of Institutional Review Boards

SUP 19 Icos Corporation BB IND-7371 Vol#: 5

96P-0328 Modify 640.3(d) after 'Therapeutic Bleedings'

C 67 Iron Overload Diseases Vol#: 1

C 68 John R. Erisman Vol#: 1

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 148 Carleen Peitzmeyer Vol#: 6

C 149 Elaine Smagacz Vol#: 6

C 150 Jane Harnett Vol#: 6

C 151 Nancy L. Robinson, M.S.Ed Vol#: 6

C 152 Mrs. Jill Cresko Vol#: 6

C 153 Linda Dionne Vol#: 6

C 154 Ms. Jannelle C. Jones Vol#: 6

C 155 Helene L. Dwyer, Ph.D. Vol#: 6

C 156 Eleanor L. Jones Vol#: 7

C 157 Anne E. Clary Vol#: 7

C 158 Maryanne Appel Vol#: 7

C 159 Jessica Fomalont Vol#: 7

C 160 Bonnie A. Engelman Vol#: 7

C 161 Mary Mutolese Vol#: 7

C 162 Nina J. Thomsen Vol#: 7

C 163 Leigh J. Benton Vol#: 7

C 164 Mia Lancaster Vol#: 7

Docket Title

Number

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

C 149 Carleen Peitzmeyer Vol#: 5

C 150 Elaine Smagacz Vol#: 5

C 151 Jane Harnett Vol#: 5

C 152 Nancy L. Robinson, M.S.Ed Vol#: 5

C 153 Mrs. Jill Cresko Vol#: 5

C 154 Linda Dionne Vol#: 5

C 155 Ms. Jannelle C. Jones Vol#: 5

C 156 Helene L. Dwyer, Ph.D. Vol#: 5

C 157 Eleanor L. Jones Vol#: 6

C 158 Anne E. Clary Vol#: 6

C 159 Maryanne Appel Vol#: 6

C 160 Jessica Fomalont Vol#: 6

C 161 Bonnie A. Engelman Vol#: 6

C 162 Mary Mutolese Vol#: 6

C 163 Nina J. Thomsen Vol#: 6

C 164 Leigh J. Benton Vol#: 6

C 165 Mia Lancaster Vol#: 6

98H-1158 Civil Money Penalties; Mae Brown, d/b/a P & m Food Center

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

98H-1256 Civil Money Penalties;Jim Iceman, d/b/a H & R Food Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 to Entrepreneur Inc Vol#: 1

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

EC 1 Phira T. Suwan Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 17 Cangene Corporation Vol#: 1

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

C 148 Carleen Peitzmeyer Vol#: 9

C 149 Elaine Smagacz Vol#: 9

C 150 Jane Harnett Vol#: 9

C 151 Nancy L. Robinson, M.S.Ed Vol#: 9

C 152 Mrs. Jill Cresko Vol#: 9

C 153 Linda Dionne Vol#: 9

C 154 Ms. Jannelle C. Jones Vol#: 9

C 155 Helene L. Dwyer, Ph.D. Vol#: 9

C 156 Eleanor L. Jones Vol#: 10

C 157 Anne E. Clary Vol#: 10

C 158 Maryanne Appel Vol#: 10

C 159 Jessica Fomalont Vol#: 10

C 160 Bonnie A. Engelman Vol#: 10

C 161 Mary Mutolese Vol#: 10

C 162 Nina J. Thomsen Vol#: 10

C 163 Leigh J. Benton Vol#: 10

C 164 Mia Lancaster Vol#: 10

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

C 2235 Josephine H. Parker Vol#: 64

C 2236 Karen Sylvester Vol#: 64

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 266 The Maryland Watermen's Assn, Inc. Vol#: 18

C 267 Garret Spillane Vol#: 18

C 268 Ms. Joanne McCall Magness Vol#: 18

99D-0239 Resolving scientific disputes concerning regulation Medical

C 3 Abbott Laboratories Vol#: 1

99D-1269 Draft Guidance on Quality Systems Inspections Technique

C 1 Abbott Laboratories Vol#: 1

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

C 22 American Red Cross Vol#: 1

C 23 Baylor University Medical Center Vol#: 1

C 24 American Hospital Assn Vol#: 1

C 25 Baptist Medical Center Vol#: 1

99D-2249 Technical Requirements for VICH

C 2 Pharma Science, Inc Vol#: 1

99H-0055 Civil Money Penalties;Entrepreneur Inc,d/b/a Scotchman Store

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

ANS 1 Mason Amoco West Vol#: 1

99H-0365 Civil Money Penalty; WW & DR Inc d/b/a/ Hole in the Wall Gro

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park

ANS 3 Rocky Mountain Pharmacy of Estes Park Vol#: 1

99H-2257 Civil Money Penalty;James Hudson,dba Hudco Superette

EXT 1 Hudco Superette Vol#: 1

99H-2262 Civil Money Penalty;Brad Williams & Pam Williams,dba William

LET 2 Office of Tobacco Programs Vol#: 1

99H-2452 Civil Money Penalty;Robert Klepaida,dba Munich Hofbrau

ANS 1 Munich Hofbrau Vol#: 1

99H-2507 Civil Money Penalty;Kathy Nelson,dba Bonne Terre C-Mart

ANS 1 Bonne Terre C-Mart Vol#: 1

99H-2520 Civil Money Penalty;Endicott Pharmacy Inc,dba Endicott Pharm

ANS 1 Endicott Pharmacy Vol#: 1

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

ANS 1 Freeport Cooperative Creamery Associatio Vol#: 1

99H-2658 Civil Money Penalty;Thigpen Inc,dba Night Rider Mart

ANS 1 Thigpen Inc dba Nightrider Mart Vol#: 1

99H-2699 Civil Money Penalty;Toot 'N Totum food Stores Inc,dba Toot'N

ANS 1 Toot'n Totum Vol#: 1

99H-2737 Civil Money Penalty;Toot 'N Totum Food Stores Inc,dba Toot

ANS 1 Toot'n Totum Vol#: 1

99H-2738 Civil Money Penalty;Toot 'N Totum Food Stores Inc, dba Toot

ANS 1 Toot'n Totum Vol#: 1

99H-2739 Civil Money Penalty;Toot 'N Totum Food Stores Inc,dba Toot

ANS 1 Toot'n Totum Vol#: 1

99H-2800 Civil Money Penalty;April Davis,dba Davis Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2801 Civil Money Penalty;American Drug Stores Inc,dba Sav-On Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2802 Civil Money Penalty;Albertson's Inc,dba Albertson's Store #8

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2803 Civil Money Penalty;CVS Revco DS Inc,dba CVS Pharmacy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2804 Civil Money Penalty;Citizen's Fuel Co,dba Citizens Food Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2805 Civil Money Penalty;Casey's General Stores Inc,dba Casey's G

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2806 Civil Money Civil Penalty;David Adams,dba David's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2807 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drugs #253

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2808 Civil Money Penalty;Glen's Food Center Inc,dba Glen's Food C

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2809 Civil Money Penalty;Ingles Markets Incorporated,dba Ingles #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2810

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2811 Civil Money Penalty;J-K Investments Inc,dba Casey's General

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2812 Civil Money Penalty;Kmart Corporation,dba Kmart Store #7099

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2813 Civil Money Penalty;Kmart Corporation,dba Kmart Store #4872

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2814 Civil Money Penalty;Lowe's Food Stores Inc,dba Lowe's Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-2748 PMA Bayer Immuno 1 PSA Assay, P950021/S1

AAV 1 Bayer Corporation Vol#: 1

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

TS 1 United States Pharmacopeia Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

EC 26 Gail Lawley Vol#: 3

99P-1041 Temporary Marketing Permit Salad Dressing

LET 4 Kraft Foods, Inc. Vol#: 1

LET 5 Kraft Foods, Inc. Vol#: 1

LET 6 Kraft Foods, Inc. Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

C 1 Intravenous Nurses Society Vol#: 1

99P-2630 Establish a Daily Value for "added sugars"

LET 1 HFS-151 to CSPI Vol#: 1

99P-3083 Determine if Neurontin (Gabapentin) tablets 600mg & 800 have

ACK 1 HFA-305 Vol#: 1

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