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 30, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement *
91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
99D-2335 Guidance for Medical Gloves A workshop Manual *
99P-4613 Revoke the Regulation That Approved Posilac *
99V-5156 Variance from requirements for Purchasing & Servicing Info *
99V-5157 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, etc *
85N-0322 CARDIAC PACEMAKER REGISTRY

NFR 2 HFZ-342 Vol#: 1

91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

C 119 Dr. Julian Whitaker et al Vol#: 23

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

C 175 Dr. Julian Whitaker et al Vol#: 41

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

C 115 Dr. Julian Whitaker et al Vol#: 44

C 116 Massachusetts General Hospital Vol#: 29

C 117 Enreco, Inc. Vol#: 29

C 118 CHPA, CRN & NFI Vol#: 45

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

C 100 Dr. Julian Whitaker et al Vol#: 12

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

LET 4176 NBTY Inc Vol#: 29

LET 4177 NBTY Inc Vol#: 29

LET 4178 NBTY Inc Vol#: 29

LET 4179 NBTY Inc Vol#: 29

LET 4180 Weeks and Leo Co Inc Vol#: 29

LET 4181 Taste Fully Done Vol#: 29

LET 4182 Palmi Food Co Ltd Vol#: 29

LET 4183 MedLand RX Vol#: 29

LET 4184 Shaklee Corporation Vol#: 29

LET 4185 Shaklee Corporation Vol#: 29

LET 4186 Shaklee Corporation Vol#: 29

LET 4187 Shaklee Corporation Vol#: 29

LET 4188 Shaklee Corporation Vol#: 29

LET 4189 Shaklee Corporation Vol#: 29

LET 4190 Shaklee Corporation Vol#: 29

LET 4191 Shaklee Corporation Vol#: 29

LET 4192 Shaklee Corporation Vol#: 29

LET 4193 Shaklee Corporation Vol#: 29

LET 4194 Shaklee Corporation Vol#: 29

LET 4195 Naturalife Corporation Vol#: 29

LET 4196 Earthrise Company Vol#: 29

LET 4197 Earthrise Company Vol#: 29

LET 4198 Earthrise Company Vol#: 29

LET 4199 Earthrise Company Vol#: 29

LET 4200 Earthrise Company Vol#: 29

LET 4201 Earthrise Company Vol#: 29

LET 4202 Warner Lambert Consumer Healthcare Vol#: 29

LET 4203 Kaire Nutraceuticals Inc Vol#: 29

LET 4204 DCV Inc Vol#: 29

LET 4205 DCV Inc Vol#: 29

LET 4206 The Winning Combination Vol#: 29

LET 4207 The Winning Combination Vol#: 29

LET 4208 The Vitamin Shoppe Vol#: 29

LET 4209 Shaman Pharmaceuticals Inc Vol#: 29

LET 4210 Kaire Pharmaceuticals Inc Vol#: 29

LET 4211 Kaire Pharmaceuticals Inc Vol#: 29

LET 4212 Kaire Pharmaceuticals Inc Vol#: 29

LET 4213 Kaire Pharmaceuticals Inc Vol#: 29

LET 4214 Kaire Pharmaceuticals Inc Vol#: 29

LET 4215 Kaire Pharmaceuticals Inc Vol#: 29

LET 4216 Kaire Pharmaceuticals Inc Vol#: 29

LET 4217 Weider Nutrition International Inc Vol#: 29

LET 4218 Weider Nutrition International Inc Vol#: 29

LET 4219 Weider Nutrition International Inc Vol#: 29

LET 4220 Weider Nutrition International Inc Vol#: 29

LET 4221 Weider Nutrition International Inc Vol#: 29

LET 4222 Weider Nutrition International Inc Vol#: 29

LET 4223 Weider Nutrition International Inc Vol#: 29

LET 4224 Weider Nutrition International Inc Vol#: 29

LET 4225 Weider Nutrition International Inc Vol#: 29

LET 4226 Weider Nutrition International Inc Vol#: 29

LET 4227 Weider Nutrition International Inc Vol#: 29

LET 4228 Weider Nutrition International Inc Vol#: 29

LET 4229 Weider Nutrition International Inc Vol#: 29

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

C 6 USCLA School of Medicine Vol#: 1

98H-1179 Civil Money Penalties; Ruth Gillis,d/b/a Gillis General Merc

EXB 1 GCF-1 Vol#: 1

98N-1109 Mercury Compounds in Drugs and Food

GDL 1 Background Vol#: 2

NAD 1 Vol#: 2

99D-2335 Guidance for Medical Gloves A workshop Manual

C 13 Association of Malaysian Medical Industr Vol#: 2

EMC 1 Canadian Medical Devices Agency Vol#: 2

99D-4718 In Vivo Drug Metabolism/Drug Interaction Studies-Design-Data

GDL 1 Guidancee Vol#: 1

NAD 1 HFD-210 Vol#: 1

99D-4808 Industry on Drug Master Files for Bulk Antibiotic Drug Subst

GDL 1 HFD-643 Vol#: 1

NAD 1 Vol#: 1

99F-1170 Stabilizer for Repeat Use of Rubber Articles

NFR 1 HFS-215 Vol#: 1

99H-0542 Civil Money Penalties;Holmes Oil Co Inc,d/b/a Starpoint Phil

LET 2 Office of Tobacco Programs Vol#: 1

99H-1281 Civil Money Penalty;Sam R Palazzolo d/b/a Palazzolos Grocery

LET 2 Office of Tobacco Programs Vol#: 1

99H-1579 Civil Money Penalty; Casey's Marketing Co dba Casey's Genera

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

MO 1 GCF-1 Vol#: 1

99H-2035 Civil Money Penalty;James Fisher,dba Economart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2251 Civil Money Penalty;Francisco Espindola,dba La Flor

LET 3 Office of Tobacco Programs Vol#: 1

99H-2257 Civil Money Penalty;James Hudson,dba Hudco Superette

LET 2 Office of Tobacco Programs Vol#: 1

99H-2466 Civil Money Penalty;DC & LC Inc,dba Hilltop Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2806 Civil Money Civil Penalty;David Adams,dba David's Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-2859 Civil Money Penalty;Energy Mart Stores Inc,dba Energy Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2918 Civil Money Penalty;Tom Brecklin,dba Brecklin's Amoco

LET 2 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4366 Civil Money Penalty;John Micalizzi,dba Washington St Getty

ANS 1 Washington St. Getty Vol#: 1

99H-4458 Civil Money Penalty;Multicorp Mgt Group Inc,dba Citgo Food M

ANS 1 Citgo Food Mart Vol#: 1

99H-4482 Civil Money Penalty;Charles L Webb,dba Webb Truck Stop

ANS 1 Webb Truck Stop Vol#: 1

LET 2 Hon. Max Cleland (CI) Vol#: 1

99H-4542 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #830

MO 1 Wawa Inc. Vol#: 1

99H-4574 Civil Money Penalty;Mustafa Uwainat,dba B-52 Market #2

ANS 1 Mustafa Uwainat,dba B-52 Market #2 Vol#: 1

99H-4687 Civil Money Penalty;Joseph A Piexoto,dba Oakland Variety

ANS 1 Joseph A Piexoto,dba Oakland Variety Vol#: 1

99H-4764 Civil Money Penalty;Bourbon Street Casino & Hotel Limited

ANS 1 Bourbon Street Casino Vol#: 1

99H-4849 Civil Money Penalty;Asour Inc,dba University Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4850 Civil Money Penalty;Mary Cuezze,dba Town & Country Fruit Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4851 Civil Money Penalty;Giant Food Stores Inc,dba Martins Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4852 Civilo Money Penalty;Honey Farms inc,dba Honey Farms #80

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4853 Civil Money Penalty;K-mart Corp,dba Big Kmart Store #7706

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4854 Civil Money Penalty;Sung Kim,dba Sunoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4855 Civil Money Penalty;Mack A. Reece,dba Craigtown Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

C 40 Evan Stajduhar Vol#: 12

C 41 Ignazia Angela Daidone Vol#: 12

C 42 Charles M Shea Vol#: 12

C 43 G E Forest & Sarah Rock Vol#: 12

C 44 Margaret M Childress Vol#: 12

C 45 Richard Pollens & Kristina Deimel Vol#: 12

C 46 Antonia Cotta Vol#: 12

C 47 Amy Concilio Vol#: 12

C 48 Sheldon & Hilde Rotenberg Vol#: 12

C 49 Sharon Jeanne Smith Vol#: 12

C 50 Bonny Meyer Vol#: 12

C 51 Jon Gilbert Heiken Vol#: 12

C 52 Jon Gilbert Heiken Vol#: 12

C 53 Annabelle Quince Vol#: 12

C 54 Wallace Sampson MD Vol#: 12

C 55 Page Prescott Vol#: 12

C 56 Susan Ann Schefter Vol#: 12

C 57 Paul Hwoschinsky Vol#: 12

C 58 K Mason Redding Vol#: 12

C 59 Alexander Hero Vol#: 12

C 60 Breana Wheeler Vol#: 12

C 61 Martha Bernard Vol#: 12

C 62 Susanne C Jessen Vol#: 12

C 63 Florence Katrosik Vol#: 12

C 64 Susan Jarrett Vol#: 12

C 65 Jessica Hewit Vol#: 12

C 66 Todd Anthony Junker Vol#: 12

C 67 Terri Middleton Vol#: 12

C 68 Sue Overmyer Vol#: 12

C 69 Joseph H Overmyer Vol#: 12

C 70 Public Citizen Vol#: 12

C 71 Suzanne M Wuerthele PhD Vol#: 12

C 72 Iran Abrams Vol#: 12

C 73 Len Tischler Vol#: 12

C 74 John C Baize Vol#: 12

C 75 Winifred A Pritrone Vol#: 12

C 76 Deanne Anderson Vol#: 12

C 77 Caroline Draves Vol#: 12

C 78 Jessie Myszka Vol#: 12

EMC 475 Andrew H Haase Vol#: 12

EMC 476 Montana Blue Vol#: 12

EMC 477 John S Webster Vol#: 12

EMC 478 Dana Davis Vol#: 12

EMC 479 Lionel Trepanier Vol#: 12

EMC 480 Jeffrey S Atkin Vol#: 12

EMC 481 Chris Matera Vol#: 12

EMC 482 Frank D Snyder Vol#: 12

EMC 483 Liana Forman Vol#: 12

EMC 484 Bret Huntman Vol#: 12

EMC 485 Henry J Senn Vol#: 12

EMC 486 Joshua J Delawarr MD Vol#: 12

EMC 487 Damon C Plackis Vol#: 12

EMC 488 Ann N Gleason Vol#: 12

EMC 489 Don Haberstroh Vol#: 12

EMC 490 David W Plum Vol#: 12

EMC 491 Barbara Ann Spencer Vol#: 12

EMC 492 Georgette Tholey Vol#: 12

EMC 493 Brad McClellan Vol#: 12

EMC 494 Karen Birkner Vol#: 12

EMC 495 Miguel A Altieri Vol#: 12

EMC 496 Paul & Alison Wiediger Vol#: 12

EMC 497 Ben Sharp Vol#: 12

EMC 498 Debra S Bruck Vol#: 12

EMC 499 Bryan Wilson Vol#: 12

EMC 500 Gordon Dutter Vol#: 12

EMC 501 Jennifer E Schaffer Vol#: 12

EMC 502 Leonard E Sienko Jr Vol#: 12

EMC 503 Debbie Ortman Vol#: 12

EMC 504 Matthew J Rezac Vol#: 12

EMC 505 D Haworth Vol#: 12

EMC 506 Jesse Kates Vol#: 12

EMC 507 Alicia Smith Hanta Vol#: 12

EMC 508 Dennis Randall Vol#: 12

EMC 509 Lad Riter Vol#: 12

EMC 510 Paul Messier Vol#: 12

EMC 511 Ralph Hamilton Vol#: 12

EMC 512 Paola Milano Vol#: 12

EMC 513 Jay A Lane Jr Vol#: 12

EMC 514 Margie A Hoyt Vol#: 12

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2 James E Murphy Vol#: 1

EMC 3 Ann Wiley Vol#: 1

EMC 4 Claire N Pacheco Vol#: 1

EMC 5 Dennis Randall Vol#: 1

EMC 6 Mike McCullough Vol#: 1

EMC 7 Annette E Gras Vol#: 1

EMC 8 Tom Schrade Vol#: 1

EMC 9 D Defranco Vol#: 1

EMC 10 Kevin B Brown Vol#: 1

EMC 11 Tim Truby Vol#: 1

EMC 12 InBalance Health Resource Vol#: 1

EMC 13 Chris Yourchik Vol#: 1

EMC 14 Philip A Gormley Vol#: 1

EMC 15 Alice A White Vol#: 1

EMC 16 Linda Pile Vol#: 1

EMC 17 Christian A. Ross Vol#: 1

99V-5156 Variance from requirements for Purchasing & Servicing Info

ACK 1 HFA-305 Vol#: 1

VAR 1 Therma-Wave Vol#: 1

99V-5157 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, etc

ACK 1 HFA-305 Vol#: 1

VAR 1 J's Homemade Jams Vol#: 1