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 22, 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 *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-4167 ANADA for Phenylbutazone Powder for Horses *
96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency

N 4 Vol#: 1

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 213 Jeanie E. Frazier Vol#: 5

C 214 Verlinda I. Bigby Vol#: 5

C 215 Marcy A. Soderberg Vol#: 5

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

C 3 Community Blood Bank Center Vol#: 1

C 4 Community Blood Bank Center Vol#: 1

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

LET 3953 En Garde Health Products Vol#: 26

LET 3954 En Garde Health Products Vol#: 26

LET 3955 En Garde Health Products Vol#: 26

LET 3956 En Garde Health Products Vol#: 26

LET 3957 En Garde Health Products Vol#: 26

LET 3958 En Garde Health Products Vol#: 26

LET 3959 En Garde Health Products Vol#: 26

LET 3960 En Garde Health Products Vol#: 26

LET 3961 En Garde Health Products Vol#: 26

LET 3962 En Garde Health Products Vol#: 26

LET 3963 En Garde Health Products Vol#: 26

LET 3964 En Garde Health Products Vol#: 26

LET 3965 En Garde Health Products Vol#: 26

LET 3966 En Garde Health Products Vol#: 26

LET 3967 En Garde Health Products Vol#: 26

LET 3968 En Garde Health Products Vol#: 26

LET 3969 En Garde Health Products Vol#: 26

LET 3970 En Garde Health Products Vol#: 26

LET 3971 Quest Nutrition Vol#: 26

LET 3972 American Institutional Products Inc Vol#: 26

LET 3973 Oregon's Wild Harvest Vol#: 26

LET 3974 Natrol Inc Vol#: 26

LET 3975 M K Health Food Distrubotors Inc dba Nat Vol#: 26

LET 3976 Yerba Prima Vol#: 26

LET 3977 Yerba Prima Vol#: 26

LET 3978 Weider Nutrition International Inc Vol#: 26

LET 3979 Weider Nutrition International Inc Vol#: 26

LET 3980 Weider Nutrition International Inc Vol#: 26

LET 3981 Weider Nutrition International Inc Vol#: 26

LET 3982 Weider Nutrition International Inc Vol#: 26

LET 3983 Weider Nutrition International Inc Vol#: 26

LET 3984 Weider Nutrition International Inc Vol#: 26

LET 3985 Weider Nutrition International Inc Vol#: 26

LET 3986 Weider Nutrition International Inc Vol#: 26

LET 3987 Weider Nutrition International Inc Vol#: 26

LET 3988 Weider Nutrition International Inc Vol#: 26

LET 3989 Weider Nutrition International Inc Vol#: 26

LET 3990 Leiner Health Products Vol#: 26

LET 3991 Lane Labs Vol#: 26

LET 3992 Natrol Inc Vol#: 26

LET 3993 Metagenics Inc Vol#: 26

LET 3994 Feeling Fine Compnay LLC Vol#: 26

LET 3995 Feeling Fine Compnay LLC Vol#: 26

LET 3996 Feeling Fine Compnay LLC Vol#: 26

LET 3997 Feeling Fine Compnay LLC Vol#: 26

LET 3998 Nature's Way Products Inc Vol#: 26

LET 3999 Nature's Way Products Inc Vol#: 26

LET 4000 Nature's Way Products Inc Vol#: 26

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

CS 3 HFA-305 Vol#: 1

OR 3 HF-3 Vol#: 1

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

C 22 Pennsylvania Inst For Community Studies Vol#: 1

C 23 Independent Cosmetic Manuf & Distrib,Inc Vol#: 1

EXT 1 Consumer Healthcare Products Association Vol#: 1

98P-0968 Guidance regarding Surimi Ingredient Labeling

NFR 1 Vol#: 1

99D-2975 EIA's for Veterinary Medicinal Products -Phase 1

GDL 1 Vol#:

NRD 1 Vol#: 1

99H-0515 Civil Money Penalties;Fulciniti Inc,d/b/a Fulciniti's Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-2506 Civil Money Penalty;James Wood & Joan Wood,dba Fox Quick Sto

LET 2 GCF-1 Vol#: 1

99H-2722 Civil Money Penalty;Lyndall Flowers,dba Wolflin Square Texac

ANS 1 Wolflin Square Texaco Vol#: 1

99H-2785 Civil Money Penalty;GMG Inc,dba Midlothia Citgo

ANS 1 GMG Inc Vol#: 1

99H-2796 Civil Money Penalty;Stanley Vaysman & Ilona Vaysman,dba J &

ANS 1 J & M Route 9 Amoco Vol#: 1

99H-2820 Civil Money Penalty;Assim Abuhejleh,dba Kormann's Supermarke

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2821 Civil Money Penalty;Ajay Roop Ent Inc,dba Samson's Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2822 Civil Money Penalty;Amani Ent Inc,dba Dash-N Convenience Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2823 Civil Money Penalty;BNB Corporation,dba Short Stop 150

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2824 Civil Money Penalty;Circle K Stores Inc,dba Circle K #8309

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2825 Civil Money Penalty;Virginia Clay,dba Hall's Drug Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2827 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #626

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2828 Civil Money Penalty;Davis Investments Ltd Pharnership,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2829 Civil Money Penalty;Mike Desmond,dba Desmond Deli

ANS 1 Desmond Deli Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2830 Civil Money Penalty;Dunaire Pharmacy Inc,dba Dunaire Pharmac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2831 Civil Money Penalty;East Main Grocery & Market Inc,dba East

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2832 Civil Money Penalty;Robert Henderson,dba Long Branch Saloon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2833 Civil Money Penalty;Jackie Horton,dba Horton's Supermarket

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2834 Civil Money Penalty;Hunt Ent Inc,dba Hilltop Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2835 Civil Money Penalty;Ronald Kennedy,dba Ye Olde Tobacco Barre

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2836 Civil Money Penalty;Wilfred Lachapelle,dba Paul's Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2837 Civil Money Penalty;M & M Distributing Co of Luverne, Inc,

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2838 Civil Money Penalty;Motorcade Inc,dba Grand Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2839 Civil Money Penalty;O'Neil's Markets Inc,dba Tru-Buy Warehou

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2840 Civil Money Penalty;Robert Osborn,dba R & J's Bar & Grill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2841 Civil Money Penalty;Earl Schoenheider,dba Savoy Inn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2842 Civil Money Penalty;Shop-A-Minit Jr Inc,dba Shop-A-Minit Jr

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2844 Civil Money Penalty;Wade's Super Markets Inc,dba Wade's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2845 Civil Money Penalty;Williams Express Inc,dba Williams Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2846

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2847 Civil Money Penalty;Williams Oil Co,A.T,dba Wilco #601

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2848 Civil Money Penalty;Winkels Petroleum Inc,dba Gas & Grub

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2849 Civil Money Penalty;Yoder Oil Co & Jerry Yoder,dba Westside

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2861 Civil Money Penalty;Hyder's Kountry Kubbard Inc,dba Kountry

ANS 1 Hyder's Kountry Kubbard Inc Vol#: 1

99H-2871 Civil Money Penalty;Michael S. Singley,dba Church Street Gro

ANS 1 Michael S Singley Vol#: 1

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

ANS 1 Shell Food Mart Vol#: 1

99H-3094 Civil Money Penalty;Gateway Country Store of NH Inc,dba Gate

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0407 Reclassification Petitions for Medical Devices

N 1 Vol#: 1

99N-2874 Stakeholders input under FDA Modernization Act of 1997

NM 1 Vol#: 1

99N-3089 Draft Affirmative Agenda for Interinational Activities

BKG 1 Vol#: 1

NAD 1 Vol#: 1

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

THESE LINKED COMMENTS DU[LICATE THOSE FOR 99P-3030, ALSO BELOW

C 53 John B Byrne Vol#: 4

C 54 William J Giessler Vol#: 4

C 55 Mary Sauer Vol#: 4

C 56 Tanya Chidester Vol#: 4

C 57 Gerald L Groff Vol#: 4

C 58 Orlando Angelo Vol#: 4

C 59 Mr & Mrs Joseph E White Vol#: 4

C 60 John Showalter Vol#: 4

C 61 Matt Ellis Vol#: 4

C 62 Mona Bower Vol#: 4

C 63 Dale E & Evelyn R Heath Vol#: 4

C 64 Ruth Adams Vol#: 4

C 65 Dorothy E Nelson Vol#: 4

C 66 Charles R Hendricks Vol#: 4

C 67 Joan Fontaine Vol#: 4

C 68 K E Gibson Vol#: 4

C 69 Ernie & Bev Sherne Vol#: 4

C 70 Clyde J Randall Vol#: 4

C 71 Joe & Betty Shearon Vol#: 4

C 72 E Steward Vol#: 4

C 73 S J Brazelton Vol#: 4

C 74 Roy Baylinson Vol#: 4

C 75 Joseph Gilmour Vol#: 4

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

C 53 John B Byrne Vol#: 3

C 54 William J Giessler Vol#: 3

C 55 Mary Sauer Vol#: 3

C 56 Tanya Chidester Vol#: 3

C 57 Gerald L Groff Vol#: 3

C 58 Orlando Angelo Vol#: 3

C 59 Mr & Mrs Joseph E White Vol#: 3

C 60 John Showalter Vol#: 3

C 61 Matt Ellis Vol#: 3

C 62 Mona Bower Vol#: 3

C 63 Dale E & Evelyn R Heath Vol#: 3

C 64 Ruth Adams Vol#: 3

C 65 Dorothy E Nelson Vol#: 3

C 66 Charles R Hendricks Vol#: 3

C 67 Joan Fontaine Vol#: 3

C 68 K E Gibson Vol#: 3

C 69 Ernie & Bev Sherne Vol#: 3

C 70 Clyde J Randall Vol#: 3

C 71 Joe & Betty Shearon Vol#: 3

C 72 E Steward Vol#: 3

C 73 S J Brazelton Vol#: 3

C 74 Roy Baylinson Vol#: 3

C 75 Joseph Gilmour Vol#: 3

99P-4167 ANADA for Phenylbutazone Powder for Horses

ACK 1 HFA-305 Vol#: 1

CP 1 A & G Pharmaceuticals, Inc. Vol#: 1