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 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]

 
78N-0038 Sunscreen Drug Products*
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
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 *
97P-0197 Require that warning labels about risks of salmonella enteri *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
99D-2335 Guidance for Medical Gloves A workshop Manual *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99D-2638 Use of Medicated Feeds for Minor Species *
99D-2726 Labeling for laboratory tests*
99D-2873 Evidence models for the least burdensome means to market *
99D-4488 Reducing microbial food safety hazards for sprouted seeds *
99D-4489 Sampling & microbial testing of spent irrigation water *
99N-2151 New Animal Drug Applications; Sheep as a Minor Species *
99P-1231 Revise Labeling on Tamoxifen (Nolvadex)*
99P-2630 Establish a Daily Value for "added sugars" *
99P-4848 Carbinoxamine Maleate 4 mg/5 cc Elixir *
78N-0038 Sunscreen Drug Products

LET 169 HFD-560 to Procter & Gamble Co. Vol#: 131

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

C 55 Teva Pharmaceuticals USA Vol#: 25

C 56 Purepac Pharmaceutical Co Vol#: 25

C 57 Perrigo Company Vol#: 25

C 58 Bristol-Myers Squibb Company Vol#: 25

C 59 Federal Trade Commission Vol#: 25

C 60 Agvar Chemicals Inc Vol#: 25

C 61 Eli Lilly and Company Vol#: 25

C 62 GPIA, Generic Pharmaceutical Industry As Vol#: 25

C 63 MOVA Pharmaceutical Corp Vol#: 25

C 64 PhRMA Vol#: 26

C 65 Barr Laboratories Inc Vol#: 26

C 66 Private Label Manufacturers Association Vol#: 26

C 67 Hyamn Phelps & McNamara Vol#: 26

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8558 Kendrick G Vol#: 116

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 93 Leiner Health Products Vol#: 3

C 94 Jarrow Formulas Inc 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 782 Linda Mosca Vol#: 31

C 783 Judi Henrie Vol#: 31

C 784 Linda & Jim Yester Vol#: 31

EMC 1 Bob Framks (CI) Vol#: 31

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

C 13 Inova Blood Donor Services Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9605 Park Nicollett Clinic, HealthSystem MN Vol#: 197

97N-0074 President's National Food Safety Initiative

C 154 Carol Frith Vol#: 11

C 155 Edward J. Russo Vol#: 11

C 156 Ms. Rosalind Dobkin Vol#: 11

C 157 Ruth Connery Vol#: 11

C 158 Animal Care & Welfare Inc.,S.P.C.A. Vol#: 11

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

C 783 Linda Mosca Vol#: 30

C 784 Judi Henrie Vol#: 30

C 785 Linda & Jim Yester Vol#: 30

EMC 1 Bob Framks (CI) Vol#: 30

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 6 AABP Committee on Pharmaceutical & Biolo Vol#: 3

LET 2 Veterinary Medical Research Institute Vol#: 3

LET 3 Elanco Animal Health Vol#: 3

LET 4 Federaltion of Animal Science Societies Vol#: 3

98H-0154 Civil Money Penalties;Gateway Marketing Inc,d/b/a Tobacco St

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0351 Civil Money Penalties; Scheitler Ent.d/b/a Silver Liquors

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0367 Civil Money Penalty;DB Marketing Co Inc,dba Dairy Mart #2408

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0444 Civil Money Penalties; Kelly Square Liquors Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0598 Civil Money Penalties;Gulshan Enterprises,d/b/a Texaco Handi

LET 4 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0600 Civil Money Penalties;Murphy's Liquors,d/ba/ Regal Beagle Li

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0640 Civil Money Penalties;Tina Eddy,d/b/a Buster's General Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0737 Civil Money Penalty;Major Properties Inc,dba Texaco Food Mar

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0762 Civil Money Penalties;Do Phoi, d/b/a Zip N go Food Store

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0764 Civil Money Penalty;Fourway Marts Inc,dba Courtesy Mart-Anto

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0767 Civil Money Penalties; Kerr Drug Inc,dba Kerr Drug Store

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0770 Civil Money Penalties;R Gail Reagel Muri,dba Main Event

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0773 Civil Money Penalty;Springer-Eubank Oil Co Inc,dba S-E Food

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0832 Civil Money Penalty;Walgreen Co,dba Walgreens #02003

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0883 Civil Money Penalty; CVS Corp d/b/a CVS Pharmacy

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0885 Civil Money Penalty; Friendly Shopping Inc d/b/a Scott's Gal

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0888 Civil Money Penalty;Doris Marion,dba Marion's Corner Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0889 Civil Money Penalty;Yeyha Elkhatib,dba Little Peach

CR 1 GCF-1 Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

C 22401 Rose Marie Williams Vol#: 876

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

C 782 Linda Mosca Vol#: 32

C 783 Judi Henrie Vol#: 32

C 784 Linda & Jim Yester Vol#: 32

EMC 1 Bob Framks (CI) Vol#: 32

98P-0944 Remove Designation Accorded to Cleocin 3 as a Ref.listed in

WDL 1 Washington Information Resources Inc Vol#: 1

99D-2335 Guidance for Medical Gloves A workshop Manual

C 12 Massachusetts Nurses Association Vol#: 2

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

C 26 GPIA, Generic Pharmaceutical Industry A Vol#: 2

99D-2638 Use of Medicated Feeds for Minor Species

C 4 National Aquaculture Association Vol#: 1

99D-2726 Labeling for laboratory tests

C 2 Genzyme Regulatory Affairs Vol#: 1

C 3 Gen Bio Vol#: 1

99D-2873 Evidence models for the least burdensome means to market

C 1 Genzyme Regulatory Affairs Vol#: 1

99D-4488 Reducing microbial food safety hazards for sprouted seeds

THESE LINKED COMMENTS DUPLICATE THOSE FOR 99d-4489, ALSO BELOW

C 1 Electron Processing Systems Inc Vol#: 1

C 2 John Morguarnd Vol#: 1

C 3 Wendy B Everhane Vol#: 1

99D-4489 Sampling & microbial testing of spent irrigation water

C 1 Electron Processing Systems Inc Vol#: 1

C 2 John Morguarnd Vol#: 1

C 3 Wendy B Everhane Vol#: 1

99H-0170 Civil Money Penalties; WTSU Inc,d/b/a Wades Texaco Serv Sta

LET 2 Office of Tobacco Programs Vol#: 1

99H-0491 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Fred'

CR 1 GCF-1 Vol#: 1

99H-0880 Civil Money Penalties;MFA Oil Co,d/b/a Break Time

HER 1 MFA Petroleum Co Vol#: 1

MO 1 MFA Petroleum Co Vol#: 1

99H-1298 Civil Money Penalties;MFA Petroleum Co,d/b/a Break Time

HER 1 MFA Petroleum Co Vol#: 1

99H-1468 Civil Money Penalties;MFA Petroleum Co,d/b/a Break Timem

HER 1 MFA Petroleum Co Vol#: 1

99H-1479 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Fred'

CR 1 GCF-1 Vol#: 1

99H-1509

CR 1 GCF-1 Vol#: 1

99H-1510

CR 1 GCF-1 Vol#: 1

99H-1896 Civil Money Penalty;Petroleum World Inc,dba Maggie Valley

CR 1 GCF-1 Vol#: 1

99H-1966 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Fred'

CR 1 GCF-1 Vol#: 1

99H-2404 Civil Money Penalty;The McArdle Co Inc,dba Hancock Tobacco

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2589 Civil Money Penalty;MFA Petroleum Company.dba Marston Fuel

HER 1 MFA Petroleum Co Vol#: 1

99H-2602 Civil Money Penalty;David James,dba James Grocery & Service

LET 2 Office of Tobacco Programs Vol#: 1

99H-2843 Civil Money Penalty;Underwood Convenience Stores Inc,dba Und

ANS 2 Underwood Convenience Stores Inc Vol#: 1

99H-2940 Civil Money Penalty;Azhar Shaikh,dba East Boston Shell

LET 2 Office of Tobacco Programs Vol#: 1

99H-4011 Civil Money Penalty;Fred's Store s of Tennessee Inc,dba Fred

CR 1 GCF-1 Vol#: 1

99H-4087 Civil Money Penalty;McLain Grocery Co Inc,dba Piggly Wiggly

ANS 1 Piggly Wiggly Vol#: 1

99H-4435 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Store #16656

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4436 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Store #19948

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4437 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Store #26789

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4438 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-4439 Civil Money Penalty;Eddie Rawis,dba Rawls Country Mall

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4440 Civil Money Penalty;Food Lion Inc,dba Food Lion #236

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4441 Civil Money Penalty;Flash Foods inc,dba Flash Foods #195

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4442 Civil Money Penalty;James D. Dalton,dba Dalton's Farm Supply

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4443 Civil Money Penalty;Kmart Corporation,dba Kmart Store #7281

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4444 Civil Money Penalty;Maydell Welty,dba 7-Eleven Store #13685

LET 1 Office of Tobacco programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4445 Civil Money Penalty;McDonald Oil Company,dba Money Back #47

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4446 Civil Money Penalty;Multicorp Management Group Inc,dba Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4447 Civil Money Penalty;Richard Davies & Linda Davies,dba 7-Elev

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4448 Civil Money Penalty;Rite Aid of Georgia Inc,dba Rite Aid #15

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4449 Civil Money Penalty;Steve Monzo,dba 7-Eleven Store #20084

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4450 Civil Money Penalty;Thomas Davis,dba 7-Eleven Store #29384

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4451 Civil Money Penalty;Vester Davis,dba Huckaby's Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4452 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal Mart Store #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4453 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4454 Civil Money Penalty;Winn-Dixie Stores Inc,dba Winn-Dixie Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

C 61 Hon Phil Gramm (CI) Vol#: 6

99N-2151 New Animal Drug Applications; Sheep as a Minor Species

C 7 Washington State Farm Bureau Vol#: 1

99P-1231 Revise Labeling on Tamoxifen (Nolvadex)

LET 1 HFD-1 to Public Citizen Health Research Vol#: 1

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

C 79 South End Community Health Center Vol#: 6

C 80 Carolyn J. Knutson Vol#: 6

C 81 Mario Manning Vol#: 6

C 82 Valerina Quintana Vol#: 6

C 83 Pamela Sotir Vol#: 6

C 84 Macky Bennett Vol#: 6

C 85 Cynthia Kerrigan Vol#: 6

C 86 Alan Oxley Vol#: 6

C 87 Martha Parry Vol#: 6

C 88 Suzie DuPuis, R.D. Vol#: 6

C 89 Dr. Shakuntala Chaube Vol#: 6

C 90 Mark Elbaum Vol#: 6

C 91 Cheryl Gresl, R.D., L.D. Vol#: 6

C 92 Robert J. L. Waugh, M.D. Vol#: 6

C 93 Janette Trofimik Vol#: 6

C 94 Emily W. Herbert, Ph.D. Vol#: 6

C 95 JoAnn Heron Vol#: 6

C 96 Mary Jane C. Willey Vol#: 6

C 97 Sue Roberts Health Concepts, Inc. Vol#: 6

C 98 Ann S. Murray Vol#: 6

C 99 Teresa Sheehan Vol#: 6

C 100 Roslyn Holtz, R.D. Vol#: 6

99P-4648 Grated Parmesan Cheese Deviating from Identity Standards

NTP 1 Sartori Foods Corp. Vol#: 1

99P-4848 Carbinoxamine Maleate 4 mg/5 cc Elixir

ACK 1 HFA-305 Vol#: 1

CP 1 Mikart Inc. Vol#: 1