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 9, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
86V-0194 Rainbow Hene Serial #3050*
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97N-0511 Procedures the safe and sanitary processing/importing juice *
98N-0313 Sugeons's and Patient Examination Gloves Reclassification *
98N-1038 Irradiation in the production, processing, &handling of food98N-1215 Foreign Establishment Registration and Listing *
98N-1265 Distribution of Compounded Drug Products *
99D-1454 Nasal spray, inhalation solution, suspension&spray drug 99D-1541 Establishing Pregnancy Registries Draft Guidance Industry *
99D-2335 Guidance for Medical Gloves A workshop Manual *
99N-1309 Proposed Classification of Female Condoms *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate 99V-4002 Laser Light Show*

86V-0194 Rainbow Hene Serial #3050

AMD 4 Lasertainment Productions International Vol#: 1

91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

N 1 Vol#: 20

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

N 1 Vol#: 40

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

N 1 Vol#: 29

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

N 1 Vol#: 11

94F-0334 Safe use of Methyltin-2-mercaptoethyloleate Sulfide Mixtures

NFL 2 Morton International, Inc. 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 185 Lenora Stevens Vol#: 8

C 186 Ronney A. Berinstein Vol#: 8

C 187 Dale & Sheryl Murphy Vol#: 8

C 188 Gail Spies Vol#: 8

C 189 Diane Graves Vol#: 8

C 190 Marsha Bassett Vol#: 8

C 191 Amrit Hansmeyer Vol#: 8

C 192 Carmela Turi Vol#: 8

C 193 Margie & Vince Mortimer Vol#: 8

C 194 Patricia K. Danser & M. Edward Nesselroa Vol#: 8

C 195 Muriel Geach Vol#: 8

C 196 Stephen J. Appel Vol#: 8

C 197 Commonwealth of Pennsylvania Dept of Agr Vol#: 8

EC 2 Kathryn Caldwell Vol#: 8

97D-0433 In Vivo Bioequivalence Studies Based on Population

GDL 2 Guideline Vol#: 2

NAD 2 Vol#: 2

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

BKG 1 HFD-7 Vol#: 198

NPR 2 Vol#: 198

97N-0074 President's National Food Safety Initiative

C 84 Grocery Manufacturers of America Vol#: 10

C 85 Molecular Circuitry, Inc Vol#: 10

C 86 Senior Citizens for Humane Legislation Vol#: 10

C 87 Farm Animal Reform Movement Vol#: 10

97N-0511 Procedures the safe and sanitary processing/importing juice

MM 1 HFS-024 Vol#: 13

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

C 186 Lenora Stevens Vol#: 7

C 187 Ronney A. Berinstein Vol#: 7

C 188 Dale & Sheryl Murphy Vol#: 7

C 189 Gail Spies Vol#: 7

C 190 Diane Graves Vol#: 7

C 191 Marsha Bassett Vol#: 7

C 192 Amrit Hansmeyer Vol#: 7

C 193 Carmela Turi Vol#: 7

C 194 Margie & Vince Mortimer Vol#: 7

C 195 Patricia K. Danser & M. Edward Nesselroa Vol#: 7

C 196 Muriel Geach Vol#: 7

C 197 Stephen J. Appel Vol#: 7

C 198 Commonwealth of Pennsylvania Dept of Agr Vol#: 7

EC 2 Kathryn Caldwell Vol#: 7

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

C 1 Top Glove SDN. BHD. Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

ANS 3 HFD-560 to Consumer HealthCare Prod Assn Vol#: 3

ANS 4 HFD-560 to Cosmetic Toiletry & Frag Assn Vol#: 3

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

N 1 Vol#: 1

98N-0721 Premarket Approval of Medical Devices; Agency Inforomation

N 3 Vol#: 1

SS 1 Supporting Statement Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 4719 Caleb Crawford Vol#: 135

C 4720 Charles Comerford Vol#: 135

C 4721 Peter W. Gonzalez Vol#: 135

C 4722 L. R. Vann, M.Ed. Vol#: 135

C 4723 Elizabeth Sartain Vol#: 135

C 4724 Janice M. Rogers Vol#: 135

C 4725 Richard Kurtz Vol#: 135

C 4726 Scott Kravitz Vol#: 135

C 4727 Margaret Anna-Robertson Vol#: 135

C 4728 Carole Tashel Vol#: 135

C 4729 Sherry Bishop Vol#: 135


98N-1215 Foreign Establishment Registration and Listing

C 18 Alchymars Vol#: 1

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

C 185 Lenora Stevens Vol#: 11

C 186 Ronney A. Berinstein Vol#: 11

C 187 Dale & Sheryl Murphy Vol#: 11

C 188 Gail Spies Vol#: 11

C 189 Diane Graves Vol#: 11

C 190 Marsha Bassett Vol#: 11

C 191 Amrit Hansmeyer Vol#: 11

C 192 Carmela Turi Vol#: 11

C 193 Margie & Vince Mortimer Vol#: 11

C 194 Patricia K. Danser & M. Edward Nesselroa Vol#: 11

C 195 Muriel Geach Vol#: 11

C 196 Stephen J. Appel Vol#: 11

C 197 Commonwealth of Pennsylvania Dept of Agr Vol#: 11

EC 2 Kathryn Caldwell Vol#: 11

98N-1265 Distribution of Compounded Drug Products

C 6081 Alicja Hoppe Vol#: 171

C 6082 Rosamond March Vol#: 171

C 6083 A. Susan Murphy Vol#: 171

C 6084 Irene Lucille Johnson Vol#: 171

C 6085 Bruny Greaves Vol#: 171

C 6086 Joan C. Dine Vol#: 171

C 6087 Vivian T. Johnson Vol#: 171

C 6088 Maxwell Balabar Vol#: 171

C 6089 Shirley Hallberg Vol#: 171

C 6090 Elly D. Rovins Vol#: 171

C 6091 Lisa Gehlken Vol#: 171

C 6092 Rhea C. Rebmann Vol#: 171

C 6093 Mary G. Butler Vol#: 171

C 6094 Elvina Miller Vol#: 171

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

C 11 Glaxo Wellcome Inc Vol#: 1

C 12 Pfeiffer of America Vol#: 1

C 13 SmithKline Beecham Pharmaceuticals Vol#: 1

C 14 Kos Pharmaceuticals Inc Vol#: 1

C 15 Schering Corporation Vol#: 1

C 16 Novo Nordisk A/S Vol#: 1

C 17 Novartis Pharmaceuticals Corporation Vol#: 1

C 18 AstraZeneca Vol#: 1

99D-1540 Reviewers on Evaluation of Human Pregnancy Outcome Data

C 1 Pharma Research & Manuf of America Vol#: 1

C 2 Glaxo Wellcome Inc Vol#: 1

C 3 Bristol-Myers Squibb Pharm Res Institute Vol#: 1

99D-1541 Establishing Pregnancy Registries Draft Guidance Industry

THESE LINKED COMMENTS DUPLICATE THOSE FOR 99D-1540 ABOVE

C 2 Pharma Research & Manuf of America Vol#: 1

C 3 Glaxo Wellcome Inc Vol#: 1

C 4 Bristol-Myers Squibb Vol#: 1

C 5 Pharma Research Corporation Vol#: 1

C 6 Organization of Teratology Info Services Vol#: 1

C 7 Organization of Teratology Info Services Vol#: 1

C 8 Abbott Pharmaceutical Products Division Vol#: 1

99D-2213 Invalidation of test results when using licensed & 510(k)

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

99D-2335 Guidance for Medical Gloves A workshop Manual

EC 1 Randy Fugate Vol#: 1

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

GDL 1 Guidline Vol#: 1

NAD 1 Vol#: 1

99D-2726 Labeling for laboratory tests

GDL 1 Guideline Vol#: 2

NAD 1 Vol#: 2

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

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

99F-0994 Lubricants with Incidental Food Contact

NFR 1 Vol#: 1

99F-2908 Use of terpolymers use in can end cements/food contact

NFL 1 Goodyear Tire & Rubber Co Vol#: 1

99F-2998 Tridecanol phosphite butylidenebis[2-(1,-dimethylethy)-5-met

NFL 1 Asahi Denka Kogyo K.K Vol#: 1

99F-2999 Benzenepropanoic acid, 3-5-bis(1,1-dimethylethy)-4-hydroxy-

NFL 1 Ciba Specialty Chemicals Vol#: 1

99H-0245 Civil Money Penalties;Charles Eldridge,d/b/a Charlie's Citgo

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0264 Civil Money Penalties;Juan Munez,d/b/a R & J Friendly Market

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0407 Civil Money Penalties;Judd M Murray Sr,d/b/a Hilltop Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0415 Civil Money Penalties;Hattie Davis,d/b/a Buds Pick Up

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0502 Civil Money Penalties;Sara Rogers,d/b/a Olde' Tyme Country

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

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

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

C 58 American Academy of Anti-Aging Medicine Vol#: 6

99N-1309 Proposed Classification of Female Condoms

C 1 The Female Health Company Vol#: 1

99N-2695 Agency Emergency Processing Under OMB Review; Biomedical Equ

NAL 1 Vol#: 1

S 1 SPECIAL Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1571 Form letter count Vol#: 26

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

EC 1 Gary & Carol Levin Vol#: 3

EC 2 Joseph K. Long Vol#: 3

99V-4002 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 P.F. Entertainment, L.L.C. Vol#: 1