Food and Drug Administration

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 4, 1999

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

78N-036L OTC Laxative *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0197 Require that warning labels about risks of salmonella enteri *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98P-0683 Soy Protein Containing Products*
98P-1191 ANDA referencing Naprelan*
99D-2167 Facilities Inspections *
99D-2212 Quality Systems Regulation Information for Various Premarket *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99D-2729 Industry on BA/BE studies orally administered drug products *
99N-2079 Assessment of Preclinical Reproductive Toxicity Data *
99N-2151 New Animal Drug Applications; Sheep as a Minor Species *
99N-3089 Draft Affirmative Agenda for International Activities *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *

78N-036L OTC Laxative

RPT 14 Boehringer Ingelheim Vol#: 116

84F-0050 SAFE USE OF POLYSORBATE AS AN EMULSIFIER

BKG 1 Background Vol#: 2

91F-0431 Resinous and Polymeric Coatings

BKG 1 Background Vol#: 1

NFR 1 Vol#: 1

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

Following linked comments duplicate those in 97p-0197 and 98n-1230 below

C 780 Jackie Raven Vol#: 31

C 781 Marsha Peters Vol#: 31

97N-0074 President's National Food Safety Initiative

C 146 Mrs. Rita Flygar Vol#: 11

C 147 Edward Castellano Vol#: 11

C 148 Committee For Children Vol#: 11

C 149 Rod & Janice Guehn Vol#: 11

C 150 Michael & Ingrid Alexander Vol#: 11

C 151 Patricia Purwin Vol#: 11

C 152 Mr. & Mrs. J. L. Denison Vol#: 11

C 153 Amrit & Chris Hansmeyer Vol#: 11

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

C 781 Jackie Raven Vol#: 30

C 782 Marsha Peters Vol#: 30

98N-0617 Treatment of Narcotic Dependence

APE 1 Center for Addictive Problems Vol#: 7

APE 2 Center for Addictive Problems Vol#: 7

APE 3 Boehringer Ingelheim Roxane Laboratories Vol#: 7

APE 4 American Osteopathic Association Vol#: 7

APE 5 Fairfax-falls Church Community Services Vol#: 7

C 17 Gary Vancleave Vol#: 7

C 18 American Methadone Treatment Association Vol#: 7

C 19 New Horizons Health Services Inc Vol#: 7

C 20 Texas Department of Health Vol#: 7

C 21 Texas National Alliance of Methadone Vol#: 7

C 22 Robin Robinette Vol#: 7

EMC 1 Timothy Tiedemann Vol#: 7

EMC 2 Stanford University School of Medicine Vol#: 7

EMC 3 NIDA - IRP, Clinical Trials Section Vol#: 7

EMC 4 Suzanne Gandolfi-Lapham Vol#: 7

LET 1 Research Triangle Institute Vol#: 7

LST 1 Agenda of meeting Vol#: 7

LST 2 Sign-In List Vol#: 7

TS 1 SAMSHA Vol#: 7

TS 2 Joint Commission on Accreditation of Hea Vol#: 7

TS 3 American Methadone Treatment Association Vol#: 7

TS 4 College on Problems of Drug Dependence I Vol#: 7

TS 5 Nat Assn of State Alcohol & Drug Abuse D Vol#: 7

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

C 780 Jackie Raven Vol#: 32

C 781 Marsha Peters Vol#: 32

98P-0683 Soy Protein Containing Products

OB 1 Richard F James Vol#: 21

98P-1191 ANDA referencing Naprelan

PDN 1 HFC-1 to Elan Pharmaceuticals Vol#: 2

99D-2167 Facilities Inspections

C 1 HIMA Vol#: 1

99D-2212 Quality Systems Regulation Information for Various Premarket

C 1 The Innovation factory Vol#: 1

C 2 HIMA Vol#: 1

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

C 23 Novartis Pharamceuticals Corporation Vol#: 2

C 24 Geneva Pharmaceuticals Inc Vol#: 2

C 25 McNeil Consumer Healthcare Vol#: 2

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

C 2 SmithKline Beecham Vol#: 1

99F-0345 Components of Coatings on Cellophane

BKG 1 Background Vol#: 2

99F-4373 Safe use of Solid Solution

NFL 1 Engelhard Corp. Vol#: 1

99H-0943 Civil Money Penalties;Outdoor Sportman Inc,dba Buffalo Conoc

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-1064 Civil Money Penalties;Stephen W Hunt,d/b/a Texaco Food Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1103 Civil Money Penalties;Wanda Wilkerson,a/k/a Wanda Hailey

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1854 Civil Money Penalty;Samuel Shoup & Nina Shoup dba Ashland Ch

LET 2 Office of Tobacco Programs Vol#: 1

99H-1891 Civil Money Penalty;Pine's Edge Grocery Inc,dba Pine's Edge

LET 2 Office of Tobacco Programs Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

LET 2 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2855 Civil Money Penalty;Coloradopongas Inc,dba Coloradopongas

LET 2 Office of Tobacco Programs Vol#: 1

99H-4029 Civil Money Penalty;Balafas Enterprises Inc,dba Campus Liquo

LET 2 Office of Tobacco Programs Vol#: 1

99H-4083 Civil Money Penalty;Jim Ignatius and Scott Ignatius,dba Gold

LET 2 Office of Tobacco Programs Vol#: 1

99H-4238 Civil Money Penalty;CRM Ent Inc,dba Longmeadow Liquors

LET 2 Office of Tobacco Programs Vol#: 1

99H-4455 Civil Money Penalty;CVS Revco D S Inc,dba Pharmacy #6355