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 October 7, 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*
80N-0042 Anticaries Drug Products for OTC Human Use *
81N-0033 Oral Health Care Drug Products for OTC Human Use *
90P-0201 Optimum size & Style of print to be used to label OTC Drugs *
95N-0259 Over the Counter Drug Labeling; Public Hearing *
96N-0420 OTC Human Drugs; Proposed Labeling Requirements *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0197 Require that warning labels about risks of salmonella enteri *
99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy *
99N-3089 Draft Affirmative Agenda for International Activities *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99V-4362 Laser Light Show*

78N-0038 Sunscreen Drug Products

MM 17 GCF-1 with CTFA (9/2/99) Vol#: 131

MM 18 GCF-1 with CTFA (9/8/99) Vol#: 131

MM 19 GCF-1 with CTFA (9/17/99) Vol#: 131

PAV 2 HFC-1 to CTFA Vol#: 131

80N-0042 Anticaries Drug Products for OTC Human Use

LET 47 HFD-560 to Hyman Phelps & McNamara Vol#: 31

PR 2 Warner Lambert Company Vol#: 32

81N-0033 Oral Health Care Drug Products for OTC Human Use

PR 6 Warner Lambert Company Vol#: 60

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

PAV 2 HFC-1 to CTFA Vol#: 7

95N-0259 Over the Counter Drug Labeling; Public Hearing

PAV 1 HFC-1 to CTFA Vol#: 12

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

PAV 1 HFC-1 to CTFA Vol#: 24

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

Following duplicates linked comments in 97P-0197 below

C 509 UEP, United Egg Producers Vol#: 19

C 510 National Restaurant Assn. Vol#: 19

C 511 Michael Smith Vol#: 19

C 512 John W. Arnold Vol#: 19

C 513 Karen Allen Vol#: 19

C 514 Susan Rothman Vol#: 19

C 515 Susan Rothman Vol#: 19

C 516 Bernadine Sutliff Vol#: 19

C 517 Delia K. Uherec Vol#: 19

C 518 Susan Gensinger Vol#: 19

C 519 Tim Campbell Vol#: 19

C 520 T. J. Boriths Vol#: 19

C 521 Virginia Grossman Vol#: 19

C 522 Christina Costello Vol#: 19

C 523 Will Tuttle, Ph.D. Vol#: 19

C 524 Carol Muckleroy Vol#: 19

C 525 Doris Wurst Vol#: 19

C 526 H. Kett Vol#: 19

C 527 Thomas R. Durocher Vol#: 19

C 528 Bette Kent Vol#: 19

C 529 Vanessa Gaglione Vol#: 19

C 530 Princessland Academy of Music, Inc. Vol#: 19

C 531 NERO, National Egg Regulatory Officials Vol#: 19

C 532 FACT, Food Animal Concerns Trust Vol#: 19

C 533 J. D. Foster Vol#: 20

C 534 Beth Henke Vol#: 20

C 535 Emily Amarnick Vol#: 20

C 536 Lisa Schueck Vol#: 20

C 537 Emily E. Teodorski Vol#: 20

C 538 Kerry Veber Vol#: 20

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

C 510 UEP, United Egg Producers Vol#: 18

C 511 National Restaurant Assn. Vol#: 18

C 512 Michael Smith Vol#: 18

C 513 John W. Arnold Vol#: 18

C 514 Karen Allen Vol#: 18

C 515 Susan Rothman Vol#: 18

C 516 Susan Rothman Vol#: 18

C 517 Bernadine Sutliff Vol#: 18

C 518 Delia K. Uherec Vol#: 18

C 519 Susan Gensinger Vol#: 18

C 520 Tim Campbell Vol#: 18

C 521 T. J. Boriths Vol#: 18

C 522 Virginia Grossman Vol#: 18

C 523 Christina Costello Vol#: 18

C 524 Will Tuttle, Ph.D. Vol#: 18

C 525 Carol Muckleroy Vol#: 18

C 526 Doris Wurst Vol#: 18

C 527 H. Kett Vol#: 18

C 528 Thomas R. Durocher Vol#: 18

C 529 Bette Kent Vol#: 18

C 530 Vanessa Gaglione Vol#: 18

C 531 Princessland Academy of Music, Inc. Vol#: 18

C 532 NERO, National Egg Regulatory Officials Vol#: 18

C 533 FACT, Food Animal Concerns Trust Vol#: 18

C 534 J. D. Foster Vol#: 19

C 535 Beth Henke Vol#: 19

C 536 Emily Amarnick Vol#: 19

C 537 Lisa Schueck Vol#: 19

C 538 Emily E. Teodorski Vol#: 19

C 539 Kerry Veber Vol#: 19

98D-0362 Stability Testing of Drug Substances and Drug Products

TR 2 transcript of 9/22/99 meeting Vol#: 10

98N-0222 Dissemination of Information on Unapproved/New Uses

NAL 2 Vol#: 4

S 2 Statement Vol#:

98N-0337 Over the counter human drugs labeling requirements

PAV 1 HFC-1 to CTFA Vol#: 3

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

C 740 Luater Potate Vol#: 30

C 741 Katrelya Angus Vol#: 30

C 742 Tenneco Packaging, Inc. Vol#: 30

99H-2584 Civil Money;Broadway Petroleum Inc,db Teele Square Auto

ANS 1 Teele Square Auto Vol#: 1

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

ANS 1 Mounds Park Quick Stop Vol#: 1

99H-2911 Civil Money Penalty;Sunny Trading Inc,dba, Martin Bluff Groc

LET 1 Office oF Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#:

99H-3026 Civil Money Penalty;Sandra L Ross & Con Ross,dba Mom & Pop's

ANS 1 Mom & Pops Little Store Vol#: 1

99H-4008 Civil Money Penalty;Young Hee Choi,dba I Like Deli & Sundrie

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4009 Civil Money Penalty;Demoulas Super Markets Inc,dba Market Ba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4010 Civil Money Penalty;Hazaa El Fakih,dba Route 3A Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4011 Civil Money Penalty;Fred's Inc,dba Fred's of Holly Springs

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4013 Civil Money Penalty;Richard Kefauver,dba Fountaindale Conven

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4014 Civil Money Penalty;Shahzad Khan,dba 7-Eleven #11510A

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4015 Civil Money Penalty;Kmart Corp,dba Big Kmart Store #3288

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4036 Civil Money Penalty;Albertson's Inc,dba Albertson's #778

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4037 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #7685

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4038 Civil Money Penalty;CVS Revco DS Inc,dba CVS Pharmacy #6364

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4039 Civil Money Penalty;David's Food Center Inc,dba David's Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4040 Civil Money Penalty;Hy-Vee Inc,dba Hy-Hee Store #1065

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4041 Civil Money Penalty;Johnnie C. Williams,dba Williams Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4042 Civil Money Penalty;Kindra Malone,dba 7-Eleven Food Store #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4043 Civil Money Penalty;Kmart Corporation,dba Kmart Store #7154

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4044 Civil Money Penalty;Kmart Corporation, dba Kmart Store #4160

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4045 Civil Money Penalty;Larry Lilley,dba Lilley's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4046 Civil Money Penalty;Merit Oil of Maryland Inc,dba Merit Reis

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4047 Civil Money Penalty;Saddika Mawla,dba 7-Eleven Food Store #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4048 Civil Money Penalty;Safeway Inc,dba Safeway Store #1559

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4049 Civil Money Penalty;Walgreen Co,dba Walgreens

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4050 Civil Money Penalty;Walgreen Co,dba Walgreens #1285

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4051 Civil Money Penalty;Walgreen Co,dba Walgreens #3330

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4066 Civil Money Penalty;Bobd Drug Company of Illinois,dba Walgre

LET 1 Offcie of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4067 Civil Money Penalty;Speedway SuperAmerica LLC,dba Speedway

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4098 Civil Money Penalty;Allen Breaux & Darlene Breaux,dba Tobacc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4099 Civil Money Penalty;Cleveland Circle Gulf Inc,dba Cleveland

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4100 Civil Money Penalty;Crook's Inc,dba Crook's Sav-Mor Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4102 Civil Money Penalty;Manroy Corporation,dba Dandea's Superett

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4103 Civil Money Penalty;Mississippi Discount Drugs Inc,dba Missi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4104 Civil Money Penalty;Fred Safi,dba Flash Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4105 Civil Money Penalty;Southern Iowa Petroleum Co LC,dba Lucas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4106 Civil Money Penalty;Sunoco Inc,dba Great Road Sunoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4109 Civil Money Penalty;Steven D Allen,dba Prairie Street Pub

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4110 Civil Money Penalty;Dan Davidson & Cindy Davidson,dba Palmer

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4111 Civil Money Penalty;Dale Meyer,dba Corner Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4112 Civil Money Penalty;Stephen Wilmer Rasmus,dba Hurribak Club

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4113 Civil Money Penalty;Roberta Wilson,dba Russell Mall Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4115 Civil Money Penalty;Casey's Marketing Co,dba Casey's General

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4116

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4117 Civil Money Penalty;Dick Armstrong,dba Mom's Minit Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4118 Civil Money Penalty;Frank E Marconi,dba Locust Point Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4119 Civil Money Penalty;Jalen Beverage LLC,dba Jerry's Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4120 Civil Money Penalty;Joseph R Miller III,dba Potomac Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4121 Civil Money Penalty;K & G Stores Inc,dba K & G Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4122 Civil Money Penalty;Kath Fuel Oil Service Co,dba Kath Fuel

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4123 Civil Money Penalty;L.S. Inc, dba Brunswick Citgo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4124 Civil Money Penalty;Minhaj Ahmed, dba Broadway Citgo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4125 Civil Money Penalty;Quick Change Inc,dba Quick Change

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4126 Civil Money Penalty;Richard D Ingram & Sons Inc,dba Ingrams'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4127 Civil Money Penalty;Rite Aid Corp,dba Rite Aid #6122

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4128 Civil Money Penalty;Stevenson's Hi-Pointe Standard Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4129 Civil Money Penalty;Tim Thompson,dba R & B Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4177 Civil Money Penalty:Interstate Foods Inc dba the Curb Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-1010 Investigational New Drug Regulations; Information Collection

NAL 1 Vol#: 1

S 1 Statement Vol#: 1
 
 

99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy

C 3 Tenneco Packaging Vol#: 1
 
 

99N-3089 Draft Affirmative Agenda for International Activities

HER 1 Center for Science in the Public Interes Vol#: 1
 
 

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1683 Jason Culp Vol#: 162

C 1684 George Pelton Vol#: 162

C 1685 Linda Bronstein Vol#: 162

C 1686 Ms Lark Hammond Vol#: 162

C 1687 Gisela S Ray Vol#: 162

C 1688 Elaine Dale Vol#: 162

C 1689 Malcolm Goldstein Vol#: 162

C 1690 Philip J Church Vol#: 162

C 1691 Thomas & Joyce Soule Vol#: 162

C 1692 Gloria Banach Vol#: 162

C 1693 Sarah Jewett Vol#: 162

C 1694 Zita Stein Vol#: 162

C 1695 Annette Messina Vol#: 162

C 1696 Mary W Howes Vol#: 162

C 1697 Tiffany & Chris Abells Vol#: 162

C 1698 Vivienne Blanquie Vol#: 162

C 1699 Andrew Jones Vol#: 162

C 1700 Mary T Hess Vol#: 162

C 1701 Barbara Austin Vol#: 162

C 1702 Scott Graham Vol#: 162

C 1703 Ken & Julie Maloney Vol#: 162
 
99V-4362 Laser Light Show

VAR 1 Jake Esparza Vol#: 1