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 5, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
95S-0117 Human Drugs Patent Term Extension & New Patents *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97D-0381 Guidance on Archiving Submissions in Electronic Format *
97P-0350 Reclassify Home Uterine Activity Monitors from III to II *
98D-0317 Electronic Submissions of CRF's, CRT's & Data to CBER *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-2212 Quality Systems Regulation Information for Various Premarket *
99D-2729 Industry on BA/BE studies orally administered drug products *
99M-4692 PMA PepGen P-15, P990033 *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
95S-0117 Human Drugs Patent Term Extension & New Patents

LST 48 List as of October 8, 1999 Vol#: 3

96N-0417 CGMP in Packing or Holding Dietary Supplements

TR 3 Transcript of October 21, 1999 meeting Vol#: 6

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

C 218 Sherie Grotzinger Vol#: 6

97D-0381 Guidance on Archiving Submissions in Electronic Format

EMC 1 Genentech, PROsys LLC Vol#: 1

97P-0350 Reclassify Home Uterine Activity Monitors from III to II

C 1 National Women's Health Network Vol#: 5

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

EMC 1 Genentech, PROsys LLC Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 163 Edelson Center for Environmental & Preve Vol#: 20

C 164 Edelson Center for Environmental & Preve Vol#: 20

C 165 Edelson Center for Environmental & Preve Vol#: 20

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 694 Hon Phil Gramm (CI) Vol#: 23

LET 5 Hon Jim Saxton Vol#: 23

99D-2212 Quality Systems Regulation Information for Various Premarket

C 3 Orthopedic Surgical Manufacturers Associ Vol#: 1

C 4 Medical Device Manufacturers Association Vol#: 1

99D-2729 Industry on BA/BE studies orally administered drug products

C 3 AstraZeneca LP Vol#: 1

C 4 Procter & Gamble Company Vol#: 1

C 5 Bristoly-Myers Squibb Pharmaceutical Mfg Vol#: 1

C 6 DuPont Pharmaceuticals Company Vol#: 1

C 7 Merck & Co Inc Vol#: 1

C 8 Washington Hospital Center Vol#: 1

C 9 Knoll Pharmaceutical Company Vol#: 1

C 10 Generic Pharamceutical Industry Associat Vol#: 1

C 11 International Generic Pharmaceutical All Vol#: 1

C 12 National Pharamceutical Alliance Vol#: 1

99H-4120 Civil Money Penalty;Joseph R Miller III,dba Potomac Liquor

ANS 1 Office of Tobacco Programs Vol#: 1

99H-4469 Civil Money Penalty;Prestige Stations Inc,dba Arco AM/PM

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4470 Civil Money Penalty;Prestige Stations Inc,dba ARCO AM/PM

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4471 Civil Money Penalty;Sheikhan Shahram,dba ARCO AM/PM

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4472 Civil Money Penalty;Moyle Petroleum Co,dba Common Cents #152

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4473 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-4474 Civil Money Penalty;Jung Lee,dba E Z Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4475 Civil Money Penalty;Frank Morello Inc,dba Getty Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4476 Civil Money Penalty;Knight's Inc,dba Knight's Super Food Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4477 Civil Money Penalty;Neighborhood Liquor & Variety Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4478 Civil Money Penalty;Scott Petroleum Corp,dba Scott Petroleum

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4479 Civil Money Penalty;Prakesh Patel,dba TJ's Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4480 Civil Money Penalty;Corr-Williams Wholesale Co of Meridian,

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4481 Civil Money Penalty;Don L Resweber Inc,dba Tuffy's Diamond

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4483 Civil Money Penalty;George Pechin,dba Williamsville Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-4692 PMA PepGen P-15, P990033

AAV 1 CeraMed Corp Vol#: 1

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

C 3 Athena M Herrmann Vol#: 1

EMC 23 Nancy E Trageser Vol#: 1

EMC 24 Russell Turbill Vol#: 1

EMC 25 Mha Atma S Khalsa Vol#: 1

EMC 26 Stephen Glanville Vol#: 1

EMC 27 Gerard W Houser Vol#: 1

EMC 28 Jessica L Bekman Vol#: 1

EMC 29 Luke D Arno Vol#: 1

EMC 30 David E Standridge Vol#: 1

EMC 31 Barbara R Dreisbach-Towle Vol#: 1

EMC 32 Brent G Harding Vol#: 1

EMC 33 Judith S Parsons Vol#: 1

EMC 34 Maia Rose Vol#: 1

EMC 35 Abhi Sachdev Vol#: 1

EMC 36 John Arns Vol#: 1

EMC 37 Michele L Ballein Vol#: 1

EMC 38 Robert B Jarrett Vol#: 1

EMC 39 Linda L Tinsley Vol#: 1

EMC 40 Chris Anifantakis Vol#: 1

EMC 41 S M Keenum Vol#: 1

EMC 42 Eugenia Anderson-Ellis Vol#: 1

EMC 43 Sharon Lieberman Vol#: 1

EMC 44 Linda J Fels Vol#: 1

EMC 45 Bob Gilstein Vol#: 1

EMC 46 Michael Casaday Vol#: 1

EMC 47 Kathryn Darrow Vol#: 1

EMC 48 Marion Barnes-Schwartz Vol#: 1

EMC 49 Rosa A Barragan Vol#: 1

EMC 50 Susan Myers Vol#: 1

EMC 51 Plant Rights & 6 others Vol#: 1

EMC 52 Kathleen J Wilk Vol#: 1

EMC 53 Gregg Randell Vol#: 1

EMC 54 Lori B Woosley Vol#: 1

EMC 55 Michael T Hoh Vol#: 1

EMC 56 Tan N Trinh Vol#: 1

EMC 57 Gwendolyn R Taylor Vol#: 1

EMC 58 Chris Dixon Vol#: 1

EMC 59 Virginia L Colclough Vol#: 1

EMC 60 David Kostiner Vol#: 1

EMC 61 Joshua D Berkowitz Vol#: 1

EMC 62 Emily A Phillips Vol#: 1

EMC 63 Dan M Cooper Vol#: 1

EMC 64 Maja C Gray Vol#: 1

EMC 65 Meagan R Miller Vol#: 1

EMC 66 Joan E Summers Vol#: 1

EMC 67 Dee Winters Vol#: 1

EMC 68 Carol Bryson Vol#: 1

EMC 69 Nancy B Spears Vol#: 1

EMC 70 Cara L Richards Vol#: 1

EMC 71 Gregg K Witkins Vol#: 1

EMC 72 Heather M Dowding Vol#: 1

EMC 73 Gian Andrea Morresi Vol#: 1

EMC 74 Suzanne Fisher Vol#: 1

EMC 75 Katie E Easley Vol#: 1

EMC 76 Neal H Crandall Vol#: 1

EMC 77 Louise A Curnow Vol#: 1

EMC 78 Marian Rose Butler Vol#: 1

EMC 79 Leslee Lorraine Freeman Vol#: 1

EMC 80 Jessica Williams Vol#: 1

EMC 81 Sylvia Kaye Viars Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

ANS 5 Honorable Charles E Grassley (CI) Vol#: 163

C 1775 Form letter count 9 Vol#: 167

C 1776 Mike Wenzetl Vol#: 163

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

C 78 Form letters count 47 Vol#: 5