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 21, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]
 
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-1273 Medical Devices: Draft Guidance for FDA Staff on Civil Money *
99D-1541 Establishing Pregnancy Registries Draft Guidance Industry *
99D-2213 Invalidation of test results when using licensed & 510(k) *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-2339 Make ANDA 74-984 Immediately Effective, Diltizazem HCl *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-4132 Exempt for Performance Std for Electrode Lead Wires & Patien *
99V-4133 Mobolazer ML 10-200,ML10-300,ML10-300W,ML10-1000 
96P-0215 Withdrawal Norplant's approval for sale in the United States

C 212 Joseph & Michelle Butlig Vol#: 5

97N-0074 President's National Food Safety Initiative

C 88 Ms. Katherine C. Brown Vol#: 10

C 89 Jo Ann Arcarese Vol#: 10

C 90 Marianne Annibali Vol#: 10

C 91 Kenneth & Cherie Mason Vol#: 10

C 92 Jackie Pomies Vol#: 10

C 93 Louise Perata Vol#: 10

C 94 Alma Blackwelder Vol#: 10

C 95 Laurelee Blanchard Vol#: 10

C 96 Stacy Swartz Vol#: 10

C 97 Valerie Bliss Vol#: 10

C 98 Lauren Relchert Vol#: 10

C 99 Susan Francis Vol#: 10

C 100 Evelyn Gray Vol#: 10

C 101 United Egg Producers Vol#: 10

C 102 Janet J. Reekers Vol#: 10

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 3901 HealthWatchers System Inc Vol#: 26

LET 3902 Pure Encapsulations Inc Vol#: 26

LET 3903 Quest Nutrition Vol#: 26

LET 3904 Leiner Health Products Vol#: 26

LET 3905 Natrol Inc Vol#: 26

LET 3906 Intelligent Nutrients Vol#: 26

LET 3907 Intelligent Nutrients Vol#: 26

LET 3908 Intelligent Nutrients Vol#: 26

LET 3909 Intelligent Nutrients Vol#: 26

LET 3910 Intelligent Nutrients Vol#: 26

LET 3911 Naturade Inc Vol#: 26

LET 3912 Naturade Inc Vol#: 26

LET 3913 Doctor's Best Inc Vol#: 26

LET 3914 Doctor's Best Inc Vol#: 26

LET 3915 Doctor's Best Inc Vol#: 26

LET 3916 Doctor's Best Inc Vol#: 26

LET 3917 Doctor's Best Inc Vol#: 26

LET 3918 Doctor's Best Inc Vol#: 26

LET 3919 E'OLA International Inc Vol#: 26

LET 3920 E'OLA International Inc Vol#: 26

LET 3921 E'OLA International Inc Vol#: 26

LET 3922 E'OLA International Inc Vol#: 26

LET 3923 E'OLA International Inc Vol#: 26

LET 3924 E'OLA International Inc Vol#: 26

LET 3925 E'OLA International Inc Vol#: 26

LET 3926 E'OLA International Inc Vol#: 26

LET 3927 Natrol Inc Vol#: 26

LET 3928 Standard Process Inc Vol#: 26

LET 3929 Standard Process Inc Vol#: 26

LET 3930 Standard Process Inc Vol#: 26

LET 3931 Standard Process Inc Vol#: 26

LET 3932 Standard Process Inc Vol#: 26

LET 3933 Standard Process Inc Vol#: 26

LET 3934 Standard Process Inc Vol#: 26

LET 3935 Standard Process Inc Vol#: 26

LET 3936 Standard Process Inc Vol#: 26

LET 3937 Standard Process Inc Vol#: 26

LET 3938 Standard Process Inc Vol#: 26

LET 3939 Standard Process Inc Vol#: 26

LET 3940 Vitamer Div of Anabolic Laboratories Inc Vol#: 26

LET 3941 Vitamer Div of Anabolic Laboratories Inc Vol#: 26

LET 3942 Vitamer Div of Anabolic Laboratories Inc Vol#: 26

LET 3943 Vitamer Div of Anabolic Laboratories Inc Vol#: 26

LET 3944 Vitamer Div of Anabolic Laboratories Inc Vol#: 26

LET 3945 Warner Lambert Cmopany Vol#: 26

LET 3946 En Garde Health Products Vol#: 26

LET 3947 En Garde Health Products Vol#: 26

LET 3948 En Garde Health Products Vol#: 26

LET 3949 En Garde Health Products Vol#: 26

LET 3950 En Garde Health Products Vol#: 26

LET 3951 En Garde Health Products Vol#: 26

LET 3952 En Garde Health Products Vol#: 26

98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt

C 9 University School of Medicine Vol#: 1

C 10 Procter & Gamble Pharmaceuticals Vol#: 1

C 11 Parke-Davis Pharmaceutical Research Vol#: 1

C 12 Bristol-Myers Squibb Pharma Res Inst Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 60 Elizabeth Cook Vol#: 2

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

C 22397 Advanced Care Products Vol#: 876

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 15 Andrx Corp. Vol#: 4

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

C 2239 Susan M. Reigner Vol#: 64

99D-1273 Medical Devices: Draft Guidance for FDA Staff on Civil Money

C 2 Abbott Laboratories Vol#: 1

99D-1541 Establishing Pregnancy Registries Draft Guidance Industry

C 9 MERCK & Co, Inc Vol#: 1

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

EC 1 Dan Vol#: 1

99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor

BRF 1 GCF-1 Vol#: 1

CR 1 Hamrick's Inc. Vol#: 1

99H-0787 Civil Money Penalty; Dennie Anderson d/b/a General Store

ANS 1 The Genberal Store Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

HER 1 Lazy Lee's One Stop Inc Vol#: 1

99H-1806 Civil Money Penalty;Kroger Corporation,dba King Soopers

ANS 3 Kroger Corp, dba King Soopers Vol#: 1

99H-2136 Civil Money Penalty;Kroger Ltd Partnership I,dba Kroger L332

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-2508 Civil Money Penalty;Larry Bellamy,dba Iron Gates Service

ANS 1 Larry Bellamy Vol#: 1

99H-2581 Civil Money Penalty;Phil Troutwine,dba Buhl Short Stop

ANS 1 C & B Warehouse Distributing Inc. Vol#: 1

99H-2596 Civil Money Penalty;Clinkoco Inc,dba Clinkoco #5

ANS 1 Clinkoco Inc Vol#: 1

99H-2597 Civil Money Penalty;Clinkoco Inc,dba Clinkoco #6

ANS 1 Clinkoco Inc Vol#: 1

99H-2693 Civil Money Penalty;Frankie Wayne Jordan,dba Lucern Country

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2706 Civil Money Penalty;Chester Cadieux dba Quik Trip

ANS 1 Chester Cadieux d/b/a QuikTrip Vol#: 1

99H-2708 Civil Money Penalty;Fuhr Enterprises Inc dba Sunray Amoco

ANS 1 Fuhr Ent Inc,dba Sunray Amoco Vol#: 1

99H-2713 Civil Money Penalty;Perohn, Inc dba Pronto Market

ANS 1 Perohn, Inc,dba Pronto Market Vol#: 1

99H-2732 Civil Money Penalty;Talat M. Khan,dba Lil Short Stop #4

ANS 1 Talat M Khan,dba Lil Short Stop #4 Vol#: 1

99H-2743 Civil Money Penalty;Service Energy LLC,dba Milford Mobile

EXT 1 Service Energy LLC,dba Milford Mobil Vol#: 1

99H-2780 Civil Money Penalty;Coastal Energy Co of Mississippi Inc

ANS 1 Coastal Energy Co of MS, Inc. Vol#: 1

99H-2786 Civil Money Penalty;Ilderton OIl Co,dba Iloco Mart No.7

ANS 1 Ilderton Oil Co Inc Vol#: 1

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

ANS 1 J-K Investments Inc,dba Casey's General Vol#: 1

99H-2863 Civil Money Penalty;Petro-Plus inc,dba petro Plus #103

ANS 1 Adium Marketing Inc,dba Petro Plus #103 Vol#: 1

99H-2876 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2877

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2878 Civil Money Penalty;7-Eleven Inc,dba 7-eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2879

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2880 Civil Money Penalty;Country Club Liquors Inc,dba Country Clu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2881 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #1437

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2882 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #7778

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2883 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2884 Civil Money Penalty;Hung Thanh Tran,dba Marigold Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2885 Civil Money Penalty;Magline Jacobs Barker,dba Leons Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2886 Civil Money Penalty;Phar-Mor Inc,dba Phar-Mor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2887 Civil Money Penalty;Pilot Corp,dba Pilot Travel Center

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2888 Civil Money Penalty;Rapid Roberts Inc,dba Rapid Roberts #109

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2889 Civil Money Penalty;Robert Lutz & Kathy Lutz,dba Shell Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2890 Civil Money Penalty;Steve Berning & Bob Raudensbush,dba Texa

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2891 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2892

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2893 Civil Money Penalty;Walgreen Co,dba Walgreens #2730

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2894 Civil Money Penalty;Walgreen Co,dba Walgreens #3175

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2895 Civil Money Penalty;Walgreen Co,dba Walgreens #3914

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2896 Civil Money Penalty;Woodrow Medler,dba March's Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2909 Civil Money Penalty;Clallam Bay Grocery Inc,dba Clallam Bay

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2910 Civil Money Penalty;Houchens Ind Inc,dba Save-A-Lot #105

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2953 Civil Money Penalty;Arthur Wallace III,dba Greenridge Variet

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2954 Civil Money Penalty;Day Square Getty Inc,dba Day Square Gett

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2955 Civil Money Penalty;Green River Ent Ltd Liability Co,dba Hil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2956 Civil Money Penalty;Mary Clipper Ship Inc,dba Mary Clippler

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2957 Civil Money Penalty;Samale's Package Store Inc,dba Samale's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-3090 Civil Money Penalty;Burns Oil Co Inc,dba MS Fuel Center #17

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3091 Civil Money Penalty;Vincenzo Capogreco,dba Bennington Food M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3092 Civil Money Penalty;Danville Village Market Enterprises of

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0670 Labeling Requirements for Color Additives and Petitions

NAL 1 Vol#: 1

S 1 SPECIAL Vol#: 1

99N-2549 Cosmetic Product Voluntary Reporting Program

C 1 Steinberg & Associates, Inc Vol#: 1

99P-0033 Combat the spread of transmissible spongiform encephalopathy

ANS 1 International Center for Technology Asse Vol#: 8

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

C 3 Susan McMillan Vol#: 3

EC 7 Robert B. Stone, M.D. Vol#: 3

EC 8 George C. Jeffrey Vol#: 3

EC 9 Sandra Solomon Vol#: 3

EC 10 Aquene Freechild Vol#: 3

99P-2339 Make ANDA 74-984 Immediately Effective, Diltizazem HCl

C 1 Andrx Pharmaceuticals, Inc Vol#: 1

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

THESE LINKED COMMENTS DUPLICATE THOSE FOR 99P-3030, ALSO BELOW

C 1 Marianne A Crocker Vol#: 4

C 2 Ruth Elfstrom Riggles Vol#: 4

C 3 Jerry & Judy Hatton Family Vol#: 4

C 4 Mirian Corvalt Vol#: 4

C 5 Helen Trietsch Vol#: 4

C 6 Milton Smith Vol#: 4

C 7 F Miles Peterson Vol#: 4

C 8 Andrew Oddo Vol#: 4

C 9 Nick Baki Vol#: 4

C 10 Diane Hulme Vol#: 4

C 11 Priscilla Lawrence Vol#: 4

C 12 E Sue Laurie Vol#: 4

C 13 Joarine Phelps Vol#: 4

C 14 Pat Giardino Vol#: 4

C 15 Dorothy D Vanderbilt Vol#: 4

C 16 Lorraine J Morgan Vol#: 4

C 17 Yvonne A Hilden Vol#: 4

C 18 Marlys Rich Vol#: 4

C 19 Kermit L Sommer & Julian Whitaker MD Vol#: 4

C 20 Therese C Tanalski Vol#: 4

C 21 Audrey Espey Vol#: 4

C 22 Henry I Morton Vol#: 4

C 23 Margaret Feldkamp Vol#: 4

C 24 Richard Bulot Vol#: 4

C 25 Edwin & Eleanor Staub Vol#: 4

C 26 Dorothy O'Leary Vol#: 4

C 27 Land Dynamics Inc Vol#: 4

C 28 Kerry Wallace Vol#: 4

C 29 Samuel S Mohabir Vol#: 4

C 30 Paul D Young Vol#: 4

C 31 William L Danek Vol#: 4

C 32 TnK Natural Food Store Vol#: 4

C 33 James & Sherry Connolly Vol#: 4

C 34 Richard H Hadley Vol#: 4

C 35 E H Abbott Vol#: 4

C 36 Charlotte V Sherman Vol#: 4

C 37 SuzAnne Fullmer Vol#: 4

C 38 Francie Hutton Vol#: 4

C 39 Edward Hensley Vol#: 4

C 40 Martha Cross Vol#: 4

C 41 Lois Van Wyk Vol#: 4

C 42 Benjamin P Upham Vol#: 4

C 43 Joseph Kiraly Vol#: 4

C 44 Rita Kicherer Vol#: 4

C 45 Don & Kaylee Phillips Vol#: 4

C 46 Annette K Briesacher Vol#: 4

C 47 Elmer W Wood Vol#: 4

C 48 Barbara L Shales Vol#: 4

C 49 Frank Battiste Vol#: 4

C 50 Larry & Valere Althouse Vol#: 4

C 51 Dixie Clark Vol#: 4

C 52 John McKenzie Vol#: 4

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 1 Marianne A Crocker Vol#: 3

C 2 Ruth Elfstrom Riggles Vol#: 3

C 3 Jerry & Judy Hatton Family Vol#: 3

C 4 Mirian Corvalt Vol#: 3

C 5 Helen Trietsch Vol#: 3

C 6 Milton Smith Vol#: 3

C 7 F Miles Peterson Vol#: 3

C 8 Andrew Oddo Vol#: 3

C 9 Nick Baki Vol#: 3

C 10 Diane Hulme Vol#: 3

C 11 Priscilla Lawrence Vol#: 3

C 12 E Sue Laurie Vol#: 3

C 13 Joarine Phelps Vol#: 3

C 14 Pat Giardino Vol#: 3

C 15 Dorothy D Vanderbilt Vol#: 3

C 16 Lorraine J Morgan Vol#: 3

C 17 Yvonne A Hilden Vol#: 3

C 18 Marlys Rich Vol#: 3

C 19 Kermit L Sommer & Julian Whitaker MD Vol#: 3

C 20 Therese C Tanalski Vol#: 3

C 21 Audrey Espey Vol#: 3

C 22 Henry I Morton Vol#: 3

C 23 Margaret Feldkamp Vol#: 3

C 24 Richard Bulot Vol#: 3

C 25 Edwin & Eleanor Staub Vol#: 3

C 26 Dorothy O'Leary Vol#: 3

C 27 Land Dynamics Inc Vol#: 3

C 28 Kerry Wallace Vol#: 3

C 29 Samuel S Mohabir Vol#: 3

C 30 Paul D Young Vol#: 3

C 31 William L Danek Vol#: 3

C 32 TnK Natural Food Store Vol#: 3

C 33 James & Sherry Connolly Vol#: 3

C 34 Richard H Hadley Vol#: 3

C 35 E H Abbott Vol#: 3

C 36 Charlotte V Sherman Vol#: 3

C 37 SuzAnne Fullmer Vol#: 3

C 38 Francie Hutton Vol#: 3

C 39 Edward Hensley Vol#: 3

C 40 Martha Cross Vol#: 3

C 41 Lois Van Wyk Vol#: 3

C 42 Benjamin P Upham Vol#: 3

C 43 Joseph Kiraly Vol#: 3

C 44 Rita Kicherer Vol#: 3

C 45 Don & Kaylee Phillips Vol#: 3

C 46 Annette K Briesacher Vol#: 3

C 47 Elmer W Wood Vol#: 3

C 48 Barbara L Shales Vol#: 3

C 49 Frank Battiste Vol#: 3

C 50 Larry & Valere Althouse Vol#: 3

C 51 Dixie Clark Vol#: 3

C 52 John McKenzie Vol#: 3

99P-4132 Exempt for Performance Std for Electrode Lead Wires & Patien

ACK 1 HFA-305 Vol#: 1

CP 1 Mercy Wellness Center Vol#: 1

99V-4133 Mobolazer ML 10-200,ML10-300,ML10-300W,ML10-1000 ML10-1.G,

ACK 1 HFA-305 Vol#: 1

VAR 1 Matthews Studio Group Nevada Vol#: 1