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 16, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
97N-0314 Prescription Drug Products; Levothyroxine Sodium *
97N-484S Human Cellular and Tissue-Based Products *
98D-0388 Dermatological Drug Product NDA's and ANDA's *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-0419 Omega-3 Fatty Acids/Risk in Adults Cardiovascular Disease *
98N-0581 Requirements for Testing Human Blood Donors *
98N-0607 General Requirements for Blood,Blood Components and Derivati *
98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma 
98N-1265 Distribution of Compounded Drug Products *
99D-2211 Electro-optical sensors/vivo detection of cervical cancer *
99D-2212 Quality Systems Regulation Information for Various Premarket *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99P-2630 Establish a Daily Value for "added sugars" *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-4958 Doxcycline Monohydrate Tablets, 50 mg & 100 mg *
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 68 National Pharmaceutical Alliance Vol#: 26
 
 

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

C 14 East Texas Eye Associates Vol#: 1

C 15 Coastal Bend Eye Center Vol#: 1

C 16 Shannon Clinic Vol#: 1

C 17 Internat'l Plasma Products Industry Assn Vol#: 1
 
 

97N-0314 Prescription Drug Products; Levothyroxine Sodium

SUP 3 Knoll Pharmaceutical Company Vol#: 1
 
 

97N-484S Human Cellular and Tissue-Based Products

C 6 Pacific Coast Tissue Bank Vol#: 6

EC 34 San Francisco Board of Supervisors Vol#: 6

EC 35 Ms Nancy Hugman Vol#: 6

98D-0316 Electronic Submissions of a BLA or PLA/ELA to CBER

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1

98D-0317 Electronic Submissions of CRF's, CRT's & Data to CBER

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1
 
 

98D-0388 Dermatological Drug Product NDA's and ANDA's

ACK 1 HFA-305 Vol#: 1

CP 1 Bristol-Myers Squibb Company Vol#: 1

98D-0928 Semiannual Guidance Agenda (Good Guidance Practices)

N 2 Vol#: 1

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

EMC 1 J Tapiero Vol#: 2
 
 

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

SUP 2 KAO Corporation Vol#: 8
 
 

98N-0419 Omega-3 Fatty Acids/Risk in Adults Cardiovascular Disease

THIS LINKED COMMENT DUPLICATES THOSE FOR 98N-0421, -2, TO -4, AND -6

TO -8, ALSO BELOW

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0421 Zinc/Body's Ability to Fight Infection/Heal Wounds in Adults

ANS 3 HFS-450 Vol#: 1

98N-0422 Garlic, Reduction of Serum Cholesterol

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0423 Calcium Consumption/Adolescents/Adults/Bone Density/Fracture

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0424 Chromium/Risk in Adults of Hyperglycemia/Glucose Intolerance

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0426 Antioxidant Vitamins C & E/Atherosclerosis/Coronary Heart Di

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0427 B-Complex Vitamins/Lowered Homocysteine Levels

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1

98N-0428 Antioxidant Vitamin A/Beta-Carotene

ANS 3 HFS-450 to Emord & Associates, P.C. Vol#: 1
 
 

98N-0581 Requirements for Testing Human Blood Donors

C 6 Mayo Clinic Vol#: 5
 
 

98N-0607 General Requirements for Blood,Blood Components and Derivati

C 5 Mayo Clinic Vol#: 2

98N-0617 Treatment of Narcotic Dependence

C 29 A Henri Moyal MD Vol#: 8

C 30 Essex Substance Abuse Treatment Center I Vol#: 8

C 31 Robert R Hosford Vol#: 8

C 32 Somerset Treatment Services Vol#: 8

C 33 Richard Lunden Vol#: 8

C 34 CA Organization of Methadone Providers Vol#: 8

C 35 American Methadone Treatment Association Vol#: 8

EMC 9 Sue Vol#: 8
 
 

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

C 3 Mayo Clinic Vol#: 1
 
 

98N-1265 Distribution of Compounded Drug Products

LET 4 Intl Academy of Compounding Pharmacists Vol#: 171
 
 

99D-2211 Electro-optical sensors/vivo detection of cervical cancer

C 1 Polar Technics Vol#: 1
 
 

99D-2212 Quality Systems Regulation Information for Various Premarket

C 5 Beckman Coulter Inc Vol#: 1

C 6 Allergan Surgical Produts Vol#: 1
 
 

99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis

C 27 Abbott Laboratories Vol#: 2

C 28 Catalytica Pharmaceuticals Inc Vol#: 2

99D-4575 New Use of a Food Contact Substance Notification System

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-4576 New Use of a Food Contact Substance Notification Systems

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

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

CS 3 HFA-305 Vol#: 1

OR 3 HF-3 Vol#: 1

99H-4543 Civil Money Penalty;Max Perez and Marysol Perez,dba La Bodeg

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4544 Civil Money Penalty;Paula Cooper,dba Sunny Cigar Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4545 Civil Money Penalty;Gray's Foods Inc,dba Gray's IGA Food Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4546 Civil Money Penalty;The Vons Companies Inc,dba Vons #191

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4547 Civil Money Penalty;Ron Hannusch,dba Southpaw Bar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4548 Civil Money Penalty;Sam Lim and Tieng Lim,dba Sunrise Donuts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4549 Civil Money Penalty;Ralph Macklin,dba Concord Rotary Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4550 Civil Money Penalty;OD-OD Inc,dba Patriot's Corner Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4551 Civil Money Penalty;Sloan Tap of Iowa Company,dba Sloan Tap

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4552 Civil Money Penalty;Nell Tolar,dba The Country Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4553 Civil Money Penalty;American Drug Stores Inc,dba Osco Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4554 Civil Money Penalty;C Mart Inc,dba C Mart IGA

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4555 Civil Money Penalty;CVS Revco DS Inc,dba CVS Pharmacy #5673

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4556 Civil Money Penalty;CVS Revco DS Inc,dba CVS Pharmacy #6353

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4557 Civil Money Penalty;Dillon Companies Inc,dba Loaf N'Jug #63

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4558 Civil Money Penalty;Double J Grocery & Produce Inc,dba Doubl

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4559 Civil Money Penalty;Fon Chhan Chhen,dba Rainbow Donuts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4560 Civil Money Penalty;Fredun Hojabri,dba Lomas Sante Fe Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4561 Civil Money Penalty;Herman Thrower & Charlene Thrower,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4562 Civil Money Penalty;Johnny Allen,dba Allen Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4563 Civil Money Penalty;Mary Lou Ford,dba Mary's One Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4564 Civil Money Penalty;Rexoco Stores Ltd,dba Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4565 Civil Money Penalty;RMW Ent Inc,dba RMW Cigarette Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4566 Civil Money Penalty;Safeway Inc,dba Safeway Store #1624

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4567 Civil Money Penalty;Sandbar Corp,dba Midget Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4568 Civil Money Penalty;Taylor's Supermarket Inc,dba Taylor's Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4569 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Diamo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4570 Civil Money Penalty;Victor Aguiar,dba Silver Dollar Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4571 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal Mart Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4572 Civil Money Penalty;Walter's Service Center Inc,dba Walter's

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 4 Dr Mha Atma Singh Khalsa Vol#: 3

EMC 229 Bari F Schlosser Vol#: 3

EMC 230 Carrie M McLaren Vol#: 3

EMC 231 Sunil V Somalwar PhD Vol#: 3

EMC 232 Louise T Johnson Vol#: 3

EMC 233 Kristine L Ramming Vol#: 3

EMC 234 Mary G Schneider Vol#: 3

EMC 235 Beate Nilsen Vol#: 3

EMC 236 Seneca S Bowers Vol#: 3

EMC 237 Diana Hardy Vol#: 3

EMC 238 Pam Gilmore Vol#: 3

EMC 239 Dana Fennell Vol#: 3

EMC 240 Kimberley March Vol#: 3

EMC 241 Diane Galli Vol#: 3

EMC 242 Stephanie Endsley Vol#: 3

EMC 243 Teresa Loiacono-Jones Vol#: 3

EMC 244 Frederick E Sawyer Vol#: 3

EMC 245 Lisa R McGary Vol#: 3

EMC 246 Mary Michelle Noon Vol#: 3

EMC 247 Dianah R Ybarra Vol#: 3

EMC 248 Jessica Burridge Vol#: 3

EMC 249 Tee Defacendis Vol#: 3

EMC 250 Charmaine Treherne Vol#: 3

EMC 251 Helen Cipher Vol#: 3

EMC 252 Eric Johnson Vol#: 3

EMC 253 Weldon E Miers Vol#: 3

EMC 254 Carla Geovanis Vol#: 3

EMC 255 Donna Hoaglin Vol#: 3

EMC 256 Steve Mace Vol#: 3

EMC 257 Susan M Korb Vol#: 3

EMC 258 Dr Andrew C Millard Vol#: 3

EMC 259 Joey T Green Vol#: 3

EMC 260 Chris Halaska Vol#: 3

EMC 261 Victoria L Cervens Vol#: 3

EMC 262 Greg Smestad PhD Vol#: 3

EMC 263 Jay R Mc Ginnis Jr Vol#: 3

EMC 264 Barbra C Skrak Vol#: 3

EMC 265 Michael Serpa Vol#: 3

EMC 266 Barbara & Debbie Vol#: 3

EMC 267 Jeffrey P Murray Vol#: 3

EMC 268 Anonymous Vol#: 3

EMC 269 Michael Idrogo Vol#: 3

EMC 270 William Cotten Vol#: 3

EMC 271 Madeline Hargrave Vol#: 3

EMC 272 Beth Cervantes Vol#: 3

EMC 273 Elaine Dalton Vol#: 3

EMC 274 Gretchen E Edmiston Vol#: 3

EMC 275 Karen Barlow Vol#: 3

EMC 276 Ruth F Myers Vol#: 3

EMC 277 Ann K Rick Vol#: 3

EMC 278 Audrey Lyle Vol#: 3

EMC 279 Roger Zimmerman Vol#: 3

EMC 280 Patrick McBride Vol#: 3

EMC 281 Flora H Kavitch Vol#: 3

EMC 282 Kurt D Schanaman Vol#: 3

EMC 283 Tony Kaperick Vol#: 3

EMC 284 Katherine Eviston Vol#: 3
 
 

99P-2630 Establish a Daily Value for "added sugars"

SUP 3 CSPI Vol#: 6
 
 

99P-4613 Revoke the Regulation That Approved Posilac

EMC 1 Matt Kaufman Vol#: 1
 
 

99P-4958 Doxcycline Monohydrate Tablets, 50 mg & 100 mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consulting Services, Inc. Vol#: 1