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 17, 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-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
98D-0834 Non-Contraceptive Estrogen Class Labeling *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
99P-1149 Label of Mintezol be Amended*
99P-2148 Label or Labeling of food ingredients and regulation *
99P-2630 Establish a Daily Value for "added sugars" *
99P-4053 Sympathominetic Amine Phentermine*
87N-0262 Pentaerythritol Tatranitrate (PETN)

WDL 3 Watson Laboratories Vol#: 136
 
 

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

C 106 Omega-3 Research Institute, Inc. (O3RI) Vol#: 29

C 107 Alaska Seafood Marketing Institute Vol#: 29

CR 2 Omega-3 Research Institute, Inc. (O3RI) Vol#: 29

92C-0348 Safe Use of FD&C Blue No. 2-Aluminum Lake

NCD 1 Notice comfirmation of effective date Vol#: 1
 
 

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6264 Frank R & Joyce Neal Vol#: 160

C 6265 Vania Winardi Vol#: 160

C 6266 Jonathan Jensen Vol#: 160

C 6267 Nancy Wygant Vol#: 160

C 6268 Lisa Heldke Vol#: 160

C 6269 Consumers Union Vol#: 160

C 6270 Elizabeth Raintree PhD Vol#: 160

C 6271 Rieh Yurman Vol#: 160

C 6272 Elizabeth S Lowell Vol#: 160

C 6273 David Klein Vol#: 160

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

BKG 1 Background material Vol#: 26

NPR 1 Vol#: 26

97N-0074 President's National Food Safety Initiative

C 166 Dorothy C. Ramsaier Vol#: 11

C 167 Andrea B. White Vol#: 11

C 168 Susan & Hubert van Wyck Vol#: 11

C 169 Kay Bushnell Vol#: 11

C 170 Melinda Rosin-Seltzer Vol#: 11
 
 

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 10 University of California San Francisco Vol#: 1

98F-0492 Amend Regs. in 178.3130 Antistatic and/or Antifogging Agents

BKG 1 Background material Vol#: 2

NFR 1 HFS-215 Vol#: 2
 
 

98N-1038 Irradiation in the production, processing, &handling of food

C 4780 no signature Vol#: 138

C 4781 Jean Callaghan Vol#: 138
 
 

98N-1265 Distribution of Compounded Drug Products

C 6142 Margaret Wheeler Vol#: 171

C 6143 Patricia Lynn Boone Vol#: 171

99D-4487 Conducting Stability Testing to Support an Expiration Date

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99H-0663 Civil Money Penalty; Spaceway Oil Co Inc d/b/a Spaceway Oil

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0666 Civil Money Penalty; Tomick Inc d/b/a/ Tomick Shell

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0750 Civil Money Penalties;Kathy Khong,d/b/a Victoria Mart

CS 2 HFA-305 Vol#: 1

99H-1218 Civil Money Penalty; James Morgan d/b/a Morgan's Bestway

LET 2 Office oF Tobacco Programs Vol#: 1

99H-1330 Civil Money Penalties;Caldwell's Inc,d/b/a Caldwell's Coasta

MO 1 GCF-1 Vol#: 1

99H-1485 Civil Money Penalties;R R Morrison & Son Inc,d/b/a Fast Lane

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park

LET 3 Office oF Tobacco Programs Vol#: 1

99H-2354 Civil Money Penalty;Dave Jaros,dba Country Cupboard

LET 2 Office oF Tobacco Programs Vol#: 1

99H-2584 Civil Money;Broadway Petroleum Inc,db Teele Square Auto

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

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

ANS 1 David's Market Vol#: 1

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

LET 2 Office oF Tobacco Programs Vol#: 1

99H-2911 Civil Money Penalty;Sunny Trading Inc,dba, Martin Bluff Groc

LET 2 Office oF Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2982 Civil Money Penalty;Ewing Oil Co inc,dba Williamsport Shell

MO 1 GCF-1 Vol#: 1

99H-3061 Civil Money Penalty;Eads News Inc,dba Eads News & Smoke Shop

ANS 1 Eads News Inc Vol#: 1

99H-4008 Civil Money Penalty;Young Hee Choi,dba I Like Deli & Sundrie

LET 3 Office of Tobacco Programs Vol#: 1

99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market

LET 2 Office oF Tobacco Programs Vol#: 1

99H-4138 Civil Money Penalty;Archer's Mobil Inc,dba Archer's Mobil Ce

ANS 1 Archer's Mobil Inc Vol#: 1

99H-4216 Civil Money Penalty;Jamie W Howell Sr,dba Huckster's Mart

ANS 1 Huckster's Mart Vol#: 1

99H-4231 Civil Money Penalty;Thomson Trucking Inc,dba Amoco West

ANS 1 Thomson Trucking Inc Vol#: 1

99H-4266 Civil Money Penalty;Pramod Handa,dba Acton Sunoco

LET 2 Office oF Tobacco Programs Vol#: 1

99H-4345 Civil Money Penalty;Leach Enterprises Ltd,dba Your Country S

ANS 1 Leach Ent Ltd,dba Your Country Store Vol#: 1

99H-4364 Civil Money Penalty;Fred Coscia,dba Fred's Cigar Store

ANS 1 Fred's Coscia Cigar Store Vol#: 1

99H-4367 Civil Money Penalty;O T Ent LLC,dba Old Town Market & Deli

LET 2 Office of Tobacco Programs Vol#: 1

99H-4390 Civil Money Penalty;QCS Inc,dba Fastway Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-4457 Civil Money Penalty;Irvin F Lacoste,dba Waffles Plus Conoco

LET 2 Office oF Tobacco Programs Vol#: 1

99H-4464 Civil Money Penalty;Emilio's Grocery Inc,dba Emilio's Grocer

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4465 Civil Money Penalty;Charles Freedman,dba Las Vegas Experienc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4467 Civil Money Penalty;Kenjo Inc,dba Kenjo #10

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4468 Civil Money Penalty;R & L Enterprises Inc,dba Rob's Village

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4492 Civil Money Penalty;Bob and Eileen Inc,dba Bob & Eileen Supe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4493 Civil Money Penalty;James W. Bonner,dba Bonner's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4494 Civil Money Penalty;Brabham Petroleum Co,dba Lancer Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4495 Civil Money Penalty;Broome's Grocery & Market Inc,dba Broome

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4496 Civil Money Penalty;Bullock's Market Incorporated,dba Bulloc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4497 Civil Money Penalty;Cato, Incorporated,dba Felton Goosecreek

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4498 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #851

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4499 Civil Money Penalty;Davis Company Incorporated,dba Fillers 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4508 Civil Money Penalty;Krause Gentle Corporation,dba Kum & Go #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4509 Civil Money Penalty;Liberty Petroleum Inc,dba Liberty A Plus

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4510 Civil Money Penalty;Maxi Drug Inc,dba Brooks Pharmacy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4511 Civil Money Penalty;McLain Grocery Co Inc,dba Piggly Wiggly

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4512 Civil Money Penalty;Richard Mitchell,dba Mitchell Motore Exx

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4513 Civil Money Penalty;Park Place Entertainment Corporation,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4514 Civil Money Penalty;Donald J. Parker,dba Sports Corral

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4515 Civil Money Penalty;Jeffrey Ramos,dba J & L Convenience Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4516 Civil Money Penalty;Randy Raven,dba Raven's Food Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4517 Civil Money Penalty;Scott Petroleum Corporation,dba Scott Pe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4518 Civil Money Penalty;Sunoco Inc,dba A Plus Mini Market #7063

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4519 Civil Money Penalty;Triple J and L Inc,dba Noble Truck Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4520 Civil Money Penalty;Christopher Tucker,dba Tucker Boys

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4521 civil Money Penalty;Valentine Petroleum Services Inc,dba B &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4522 Civil Money Penalty;B S J Inc,dba Broadway Convience

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

ANS 1 Walter's Service Center Vol#: 1

99H-4649 Civil Money Penalty;Country Pump Inc,dba Country Pump

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4650 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4651 Civil Money Penalty;Dollar World Inc,dba Dollar World

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4652 Civil Money Penalty;Interstate Petroleum Ltd,dba Branson Wes

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4653 Civil Money Penalty;Morris Marketers Inc,dba Finish Line She

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4654 Civil Money Penalty;C K Smith & Co Inc,dba Holyoke United

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4655 Civil Money Penalty;Ronald Swindle,dba Swindles Food Town

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4656 Civil Money Penalty;Tony Tereso,dba Jenrose Wine & Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4657 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #1787

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4658 Civil Money Penalty;Winn-Dixie Raleigh, Inc,dba Winn-Dixie

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4682 Civil Money Penalty;Dalip Singh Bedi,dba N K Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4683 Civil Money Penalty;Morris Brown,dba Price Chopper

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4684 Civil Money Penalty;Buffalo Services Inc,dba BKwik #7

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4685 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4686 Civil Money Penalty;Dillow Foods Co,dba Dillow Super Valu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4688 Civil Money Penalty;Plymouth Country Store LLC,dba Plymouth

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4689 Civil Money Penalty;Valerie Podogrodzki,dba The Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4690 Civil Money Penalty;Vista Stores LLC,dba Vista Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4691 Civil Money Penalty;Daniel Walsh,dba Eagan's Package Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4692 Civil Money Penalty;Leon's Food Mart Inc,dba Leon's Food Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0188 Progestational Drug Products for Human Use

NFR 1 Vol#: 1

99N-0486 Physician Labeling and Patient Labeling for Progestational

N 2 Vol#: 1

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

C 5 Margaret Jones Vol#: 6

EMC 285 Mark M Giese Vol#: 6

EMC 286 Tony Smith Vol#: 6

EMC 287 Danuta Marciszek Vol#: 6

EMC 288 Sean Sheehan Vol#: 6

EMC 289 Carnet Williams Vol#: 6

EMC 290 Jennifer Mollett Vol#: 6

EMC 291 Janet Kriseman Vol#: 6

EMC 292 Kathy Smith Vol#: 6

EMC 293 Tony Kaperick Vol#: 6

EMC 294 Jenny Kosminskas Vol#: 6

EMC 295 Sharon Rhodes Vol#: 6

EMC 296 Rob Stuart Vol#: 6

EMC 297 Richard S Frank Vol#: 6

EMC 298 Bill Dorsey Vol#: 6

EMC 299 Katie Flynn-Jambeck Vol#: 6

EMC 300 Kenneth A Marianos Vol#: 6

EMC 301 Sara Meric Vol#: 6

EMC 302 Nora E Wikoff Vol#: 6

EMC 303 Barbara Funaiole Vol#: 6

EMC 304 Amy C Agigian PhD Vol#: 6

EMC 305 Bonnie L Hartley Vol#: 6

EMC 306 Gina M Roache Vol#: 6

EMC 307 Sharley S Edwards Vol#: 6

EMC 308 Mike Foley Vol#: 6

EMC 309 Margaret C Fernald PhD Vol#: 6

EMC 310 Susan C Kline Vol#: 6

EMC 311 Pamela Koslyn Vol#: 6

EMC 312 Gloria J Larkin Vol#: 6
 
 

99P-1149 Label of Mintezol be Amended

PDN 1 HFD-1 to Scott G. Beach Vol#: 1
 
 

99P-2148 Label or Labeling of food ingredients and regulation

C 5 Roberta Molony Vol#: 1
 
 

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

C 101 Robert D. Abeloff, D.D.S. Vol#: 6

C 102 Karen Knox Vol#: 6
 
 

99P-4053 Sympathominetic Amine Phentermine

SUP 1 Medeva Pharmaceuticals, Inc. Vol#: 3

99P-4064 Class II 510(K) Exemption Petition for Vascular Tunnelers

N 1 Vol#: 2