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 Us]

DOCKETS ENTERED on December 5, 2000

TABLE OF CONTENTS

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

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]
 

 
76N-052N OTC Nasal Decongestants *
81N-0022 OTC Weight Control Drug Products for Human Use *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc *
00N-1534 National Surveys Prescriptions Drug Info provide to patients *
00P-0788 Totally Implanted Spinal Cord Stimulator *
00P-1263 Initiation of Procedure to Determine Whether DHEA is exclude *
00P-1499 Remove alosetron (Lotronex) from the market *

76N-052N OTC Nasal Decongestants

EMC 70 G Carpenter Vol#: 76

EMC 71 M Moffit Vol#: 76

EMC 72 D Golden Vol#: 76

EMC 73 J Estock Vol#: 76

EMC 74 C Schmidt Vol#: 76


81N-0022 OTC Weight Control Drug Products for Human Use

EMC 15 E Sisson Vol#: 95

EMC 16 G Carpenter Vol#: 95

EMC 17 A Helm Vol#: 95

EMC 18 D Beth Vol#: 95

EMC 19 unsigned Vol#: 95

EMC 20 C Martinsson Vol#: 95

EMC 21 J Hall Vol#: 95

EMC 22 M Carroll Vol#: 95

EMC 23 N Raddie Vol#: 95

EMC 24 Javs Vol#: 95

EMC 25 P Majia Vol#: 95

EMC 26 C Billingsley Vol#: 95

EMC 27 D R Santillo Vol#: 95

EMC 28 Dylan Vol#: 95

EMC 29 J Kaplan Vol#: 95

EMC 30 F Nagy Vol#: 95

EMC 31 N Shriver Vol#: 95

EMC 32 M Arnold Vol#: 95

EMC 33 R Wakefield Vol#: 95

EMC 34 P Marcotti Vol#: 95

EMC 35 J Gillen Vol#: 95

EMC 36 D Pratt Vol#: 95

EMC 37 E Cameron Vol#: 95

EMC 38 J Lynch Vol#: 95

EMC 39 K Crox Vol#: 95

EMC 40 ta Vol#: 95

EMC 41 S Johnson Vol#: 95

EMC 42 t Doogie Vol#: 95

EMC 43 J Estock Vol#: 95

EMC 44 D Golden Vol#: 95

EMC 45 B Porter Vol#: 95

EMC 46 D Clark Vol#: 95

EMC 47 J Stephens Vol#: 95

EMC 48 L Scullion Vol#: 95

EMC 49 R Wedderburn Vol#: 95

EMC 50 S Cooper Vol#: 95

EMC 51 C Francis Vol#: 95

EMC 52 S Ferich Vol#: 95

82F-0349 COPOLYMERS OF DIALLYLDIMETHYLAMMONIUM CHLORIDE

NWL 1 Vol#: 1

90F-0188 Polyethylene phthalate polymers

NWL 1 Vol#: 1

91F-0169 Resinous and Polymeric Coatings

NWL 1 Vol#: 1

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

REF 2 Reference 1-129 Vol#: 63

93F-0157 SHELL OIL CO.; FILING OF FOOD ADDITIVE PETITION

NWL 1 Vol#: 1

93F-0199 Safe use of maleic anhydride modified hydrogenated styrene

NWL 1 Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

NEC 2 Vol#: 64

95F-0011 Safe use of styrene block copolymer

NWL 1 Vol#: 1

95N-0220 Substances Appoved use in Preparation Meat/Poultry Products

N 1 Vol#: 1

96F-0032 silver-zinc zeolite an agent control growth of microorganism

NWL 1 Vol#: 1

96F-0223 Sodium salt as an emulsifier in production of acrylic & viny

NWL 1 Vol#: 1

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

NFR 1 Vol#: 31

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

NFR 1 Vol#: 30

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

LET 6205 Country Life Vol#: 49

LET 6206 Country Life Vol#: 49

LET 6207 Twin Laboratories, Inc. Vol#: 49

LET 6208 Twin Laboratories, Inc. Vol#: 49

LET 6209 Golden Temple of Oregon, Inc. Vol#: 49

LET 6210 Country Life Vol#: 49

LET 6211 Country Life Vol#: 49

LET 6212 Pharmavite Corporation Vol#: 49

LET 6213 Country Life Vol#: 49

LET 6214 Country Life Vol#: 49

LET 6215 Young Living Essential Oils Vol#: 49

LET 6216 Country Life Vol#: 49

LET 6217 Country Life Vol#: 49

LET 6218 Country Life Vol#: 49

LET 6219 Country Life Vol#: 49

LET 6220 Country Life Vol#: 49

LET 6221 Sonrich Corporation Vol#: 49

LET 6222 Pharmavite Corporation Vol#: 49

LET 6223 Traditional Medicinals, Inc. Vol#: 49

LET 6224 Weider Nutrition International, Inc. Vol#: 49

LET 6225 Weider Nutrition International, Inc. Vol#: 49

LET 6226 Weider Nutrition International, Inc. Vol#: 49

LET 6227 Weider Nutrition International, Inc. Vol#: 49

LET 6228 Weider Nutrition International, Inc. Vol#: 49

LET 6229 Weider Nutrition International, Inc. Vol#: 49

LET 6230 Weider Nutrition International, Inc. Vol#: 49

LET 6231 Weider Nutrition International, Inc. Vol#: 49

LET 6232 Weider Nutrition International, Inc. Vol#: 49

LET 6233 Weider Nutrition International, Inc. Vol#: 49

LET 6234 Weider Nutrition International, Inc. Vol#: 49

LET 6235 Weider Nutrition International, Inc. Vol#: 49

LET 6236 Weider Nutrition International, Inc. Vol#: 49

LET 6237 Weider Nutrition International, Inc. Vol#: 49

LET 6238 Weider Nutrition International, Inc. Vol#: 49

LET 6239 Weider Nutrition International, Inc. Vol#: 49

LET 6240 Weider Nutrition International, Inc. Vol#: 49

LET 6241 Weider Nutrition International, Inc. Vol#: 49

LET 6242 Weider Nutrition International, Inc. Vol#: 49

LET 6243 Country Life Vol#: 49

LET 6244 Country Life Vol#: 49

LET 6245 Country Life Vol#: 49

LET 6246 Natrol, Inc. Vol#: 49

LET 6247 Country Life Vol#: 49

LET 6248 Country Life Vol#: 49

LET 6249 Country Life Vol#: 49

LET 6250 E'ola International Vol#: 49

LET 6251 Country Life Vol#: 49

98F-0226 Safe Use of Disodium or Dipotassium Fluorescein

NWL 1 Vol#: 1

98F-0288 Food regulations in Olefin Polymers

NWL 1 Vol#: 1

98F-0289 Safe Use of Nylon 6/12 copolymer resins

NWL 1 Vol#: 1

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

NFR 1 Vol#: 32

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

C 3141 T Pritchard Vol#: 94

C 3142 D. DuVal Vol#: 94

C 3143 A Lamberti Vol#: 94

C 3144 J Boehm Vol#: 94

C 3145 I. Steinberg, Ph.D. Vol#: 94

C 3146 S Yi Vol#: 94

C 3147 C Mandina Vol#: 94

C 3148 G. Calhoun Vol#: 94

C 3149 S Taffet Vol#: 94

EMC 447 A Kuesel Vol#: 94

EMC 448 R. Smith & Family Vol#: 94

EMC 449 P Stevens Vol#: 94

EMC 450 N Kriegler Vol#: 94

EMC 451 J D'Angelo Vol#: 94

EMC 452 S Carmody Vol#: 94

EMC 453 A Stuck Vol#: 94

EMC 454 S Thurman Vol#: 94

EMC 455 W Smith Vol#: 94

EMC 456 D Towbin Vol#: 94

99F-0052 Ion-exchange resins

NWL 1 Vol#: 1

99F-0460 Production of Olefin Polymers

NWL 1 Vol#: 1

99F-1074 Safe use of Quaternary Amine Cellulose Ion Exchange Resins

NWL 1 Vol#: 1

99F-1719 4-(Diiodomethylsulfonyl) toluene as slimicide food contact

NFL 2 Vol#: 1

99F-2244 Safe use of terpolymer of styrene as an ion-exchange resin

NWL 1 Vol#: 1

99F-2245 Safe use of polymers intended for contact with food

NWL 1 Vol#: 1

99F-5012 Antioxidants and/or Stabilizers for Polymers

NWL 1 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16642 R Kahn Vol#: 483

C 16643 C Hawkins Vol#: 483

C 16644 J Detor Vol#: 483

C 16645 S Altom Vol#: 483

C 16646 G Paravati Vol#: 483

C 16647 A. Haase Vol#: 483

C 16648 L Berdnik Vol#: 483

C 16649 J Gipson Vol#: 483

C 16650 T MacDonald Vol#: 483

C 16651 D Hansen Vol#: 483

C 16652 L Wish-Anderson Vol#: 483

C 16653 A. Amaro Vol#: 483

C 16654 M Vahey Vol#: 483

C 16655 E O'Kane Vol#: 483

C 16656 C. Andrews Vol#: 483

C 16657 M Hudak Vol#: 483

C 16658 K. White Vol#: 483

C 16659 E Danko Vol#: 483

C 16660 P. Stefan Vol#: 483

C 16661 A. Johnson Vol#: 483

C 16662 R Matthews Vol#: 483

C 16663 B Anderson Vol#: 483

C 16664 D Cantel Vol#: 483

C 16665 L. Aronson Vol#: 483

C 16666 J. Johnson Vol#: 483

C 16667 T. Flessa Vol#: 483

C 16668 N Tharp Vol#: 483

C 16669 R Stevens Vol#: 483

C 16670 F Matt Vol#: 483

EMC 3304 P Donoghue Vol#: 483

EMC 3305 J Whitley Vol#: 483

EMC 3306 A Ditonno Vol#: 483

EMC 3307 D DiLallo Vol#: 483

EMC 3308 J Smith Vol#: 483

EMC 3309 M Breslin Vol#: 483

EMC 3310 B Berman Vol#: 483

EMC 3311 R Smith Vol#: 483

EMC 3312 J Stevens Vol#: 483

EMC 3313 M Cole Vol#: 483

EMC 3314 G Campbell Vol#: 483

EMC 3315 D. Cinquemani Vol#: 483

EMC 3316 H Shih Vol#: 483

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

LET 6 HFS-800 to Jonathan W. Emord Esq Vol#: 13

REF 1 Reference 1-97 Vol#: 14

00F-0089 Stabilizer in olefin polymers/safe use in food contact

NWL 1 Vol#: 1

00N-1283 Reporting & Recordkeeping Requirements/Electronic Products

NAL 1 Vol#: 1

00N-1440 User Fee Cover Sheet; Form FDA 3397

N 2 Vol#: 1

00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc

C 6 Bristol-Myers Squibb Pharm. res. Institu Vol#: 1

C 7 Pharmacia Corp. Vol#: 1

C 8 State of Michigan Dept. of Community Hlt Vol#: 1

C 9 Procter & Gamble Pharmaceuticals Vol#: 1

C 10 SmithKline Beecham Pharmaceuticals Vol#: 1

C 11 Bayer Pharmaceutical Div. Vol#: 1

C 12 APUA Vol#: 1

C 13 PhRMA Vol#: 1

C 14 Society Of Infectious Diseases Pharmacis Vol#: 1

C 15 Wythe-Ayerst Labs., a div. Am. Home Prod Vol#: 4

C 16 Abbott Labs. Vol#: 1

CR 1 APUA Vol#: 1


00N-1534 National Surveys Prescriptions Drug Info provide to patients

C 1 Merck & Co., Inc. Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

EMC 2 CSPI Vol#: 16

00N-1575 Nutrition Labeling; Declaration of Caloric Amounts and Servi

N 1 Vol#: 1

00N-1599 Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses

N 1 Vol#: 1

00N-1620 2001 National Antimicrobial Resistance Monitoring System

NM 1 Vol#: 1

00P-0788 Totally Implanted Spinal Cord Stimulator

C 30 Marshfield Clinic Vol#: 4

C 31 ANS, Advanced Neuromodulation Systems, I Vol#: 4

C 32 ANS, Advanced Neuromodulation Systems, I Vol#: 4


00P-1263 Initiation of Procedure to Determine Whether DHEA is exclude

SUP 2 Genelabs Technologies Inc Vol#: 3


00P-1499 Remove alosetron (Lotronex) from the market

EMC 49 B Bardin Vol#: 2

EMC 50 J Stover Vol#: 2

EMC 51 C White Vol#: 2

EMC 52 A Odhner Vol#: 2

EMC 53 R. Stewart, MD Vol#: 2

EMC 54 S. Drews Vol#: 2

EMC 55 M. Fennerty, MD Vol#: 2

EMC 56 L Crowe Vol#: 2

EMC 57 C Mackin Vol#: 2

EMC 58 L Henne Vol#: 2

EMC 59 Consumer Vol#: 2

EMC 60 S Alsted Vol#: 2

EMC 61 M Yard Vol#: 2

EMC 62 C Earl Vol#: 2

EMC 63 M Mosher Vol#: 2

EMC 64 G Berkhofer Vol#: 2

EMC 65 C Condron Vol#: 2

EMC 66 J. Gieske Vol#: 2

EMC 67 Corsentino Vol#: 2

EMC 68 C Patrick Vol#: 2

EMC 69 L Baddley Vol#: 2

EMC 70 Robin MS Vol#: 2

00V-1653 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Marathon Marketing, LLC Vol#: 1