FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On November 12, 2003
Table of Contents
Docket # Title
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
1981N-0033P Antiplaque & Antiplaque-Related Claims
1983V-0151 LASER LIGHT SHOW
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-1658 Codify Existing Practice to determine Active Ingredients
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2000P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d
2000P-1276 Health Claim: Plant stanol esters and heart disease
2001P-0573 Petition for Regulation of S & F Nicotine Water
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
2002N-0276 Bioterrorism Preparedness; Registration of Food Facilities
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2002P-0067 All estrogen-containing products intended for oral use
2002P-0431 Delcobese Tablets and Capsules
2002P-0506 Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
2003D-0382 Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
2003D-0383 Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2003D-0498 Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
2003E-0153 Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
2003E-0246 Patent Extension for Deramaxx (deracoxib), 5,521,207,
2003E-0250 Patent Extension for Invanz (ertapenem sodium), 5,478,820
2003E-0253 Patent Extension for Lexapro (escitalopram oxalate), 34,712
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
2003N-0211 Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
2003N-0361 Anti-Counterfeit Drug Initiative
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003N-0506 Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
2003N-0507 Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
2003P-0021 Withdrawal of Wydase, Hyaluronidase Injection
2003P-0078 Public Health Security & Bioterrorism Preparedness & Respons
2003P-0270 Prohibit False and Misleading Labeling
2003P-0274 In re Tier 1 initial Approval Program
2003P-0461 Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
2003P-0523 ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
2003V-0131 Laser Light Show
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
M 10 HFD-560 Annoucement of 11/19/2003 Meeting w/Bayer Healthcare LLC Vol #: 235
1981N-0033P Antiplaque & Antiplaque-Related Claims
SUP 2 Janet M. Wehrli, RDH Vol #: 1
1983V-0151 LASER LIGHT SHOW
VRA 10 HFZ-300 to Precision Projection Systems, Inc. Vol #: 1
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
REF 1
Part A1, A2, A3, A4, A5, A6, B1, B2, C
OMB Review held on March 13, 2003 Vol #: 42
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7245 Jeane M. Palmer Vol #: 303
C 7246 J.P. Aarnow Vol #: 303
C 7247 Michele R. Waddill Vol #: 303
C 7248 Karon Mariani Vol #: 303
C 7249 Mary Fox Vol #: 303
C 7250 T. Kelly Mason Vol #: 303
C 7251 Mary Pinto Vol #: 303
C 7252 Stephanie M. Williams Vol #: 303
C 7253 Gabriele Timmusman Vol #: 303
C 7254 Patricia K. Luxford Vol #: 303
C 7255 Sally & Dick Blinke Vol #: 303
C 7256 Linda WIlliams Vol #: 303
C 7257 Eligible Vol #: 303
C 7258 Nancy S. Kilgore Vol #: 303
C 7259 Christa Viola Vol #: 303
C 7260 Jo Noble Vol #: 303
C 7261 Nicole Brunt Vol #: 303
C 7262 Jean Palmer Vol #: 303
C 7263 Michele Madaski Vol #: 303
EMC 3950 Andrea Knepper Vol #: 304
EMC 3951 Crystal Ringkvist-Helsel Vol #: 304
EMC 3952 Tanja Froehlich Vol #: 304
EMC 3953 Beverly Siegel Vol #: 304
EMC 3954 Ellen Tchartorisky Vol #: 304
EMC 3955 Kimberly A. Hutchins Vol #: 304
EMC 3956 Amos El-Roy Vol #: 304
EMC 3957 Jayne Cotten Vol #: 304
EMC 3958 Jennifer Marione Vol #: 304
EMC 3959 Meredith Johnston Vol #: 304
EMC 3960 Tiffiney Sparhawk Vol #: 304
EMC 3961 Brian Smith Vol #: 304
EMC 3962 Pinky Jain Pan Vol #: 304
EMC 3963 Karen-Jean Grant Vol #: 304
EMC 3964 Dale Masters Vol #: 304
EMC 3965 Jennifer Browning Vol #: 304
EMC 3966 Dia Redman Vol #: 304
EMC 3967 Amy Liberatore Vol #: 304
EMC 3968 Brian Kestner Vol #: 304
EMC 3969 Donna Hammett Vol #: 304
1999P-1658 Codify Existing Practice to determine Active Ingredients
WDL 1 Generic Pharmaceutical Assn (GPhA) Vol #: 1
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
M 4 GCF-1 Vol #: 389
2000P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d
MM 2 Meeting on Smart Balance and Coronary Heart Disease Vol #: 22
2000P-1276 Health Claim: Plant stanol esters and heart disease
MM 6 Meeting on Smart Balance and Coronary Heart Disease Vol #: 22
2001P-0573 Petition for Regulation of S & F Nicotine Water
C 3
Tab A-G
GlaxoSmithKline Consumer Healthcare, LP (GSK) Vol #: 1
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
LET 2 HFD-005 to US Patent and Trademark Office Vol #: 1
2002N-0276 Bioterrorism Preparedness; Registration of Food Facilities
C 165 Government of the Honh Kong Special Administrative Region Vol #: 15
EMC 101 Peter Hodge Transport Vol #: 15
EMC 102 The Landfall Centre Vol #: 15
EMC 103 The Landfall Centre Vol #: 15
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 233 Government of the Honh Kong Special Administrative Region Vol #: 17
C 234 The Chicago Wine Company Vol #: 17
EMC 123 The Landfall Centre Vol #: 17
EMC 124 The Landfall Centre Vol #: 17
2002P-0067 All estrogen-containing products intended for oral use
PDN 1 HFD-001 to Physicians Committee for Responsible Medicine Vol #: 1
2002P-0431 Delcobese Tablets and Capsules
N 1 FDA Vol #: 1
2002P-0506 Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons
LET 2 HFD-007 to Lachman Consultant Services, Inc. Vol #: 1
2003D-0382 Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
C 30 Allergan, Inc. Vol #: 3
C 31 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 3
2003D-0383 Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
C 1 Promega, Corporation Vol #: 1
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
C 1 Hilda Horvat Vol #: 1
C 2 Rosalie Zwain Vol #: 1
2003D-0498 Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0153 Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0246 Patent Extension for Deramaxx (deracoxib), 5,521,207,
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0250 Patent Extension for Invanz (ertapenem sodium), 5,478,820
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0253 Patent Extension for Lexapro (escitalopram oxalate), 34,712
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
LET 2 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
LET 4 HFD-005 to US Patent and Trademark Office Vol #: 1
2003N-0211 Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
C 11 Canadian Blood Services (CBS) Vol #: 1
C 12 University of California, Davis Vol #: 1
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
C 5 National Grain and Feed Assn (NGFA) Vol #: 1
LST 1 List of Attendees at the Animal Feed Safety System Public Meeting held 9/23-24/2003 Vol #: 1
LST 2 Agenda for Animal Feed Safety System (AFFSS) public meeting held on 9/23-24/2003 Vol #: 1
LST 3 List of AFSS Team and Participates Vol #: 1
SUP 1 Breakout Group 1A Vol #: 1
SUP 2 Breakout Group 1B Vol #: 1
SUP 3 Breakout Group 2A Vol #: 1
SUP 4 Breakout Group 2B Vol #: 1
SUP 5 Breakout Group 3A Vol #: 1
SUP 6 Breakout Group 3B Vol #: 1
SUP 7 Breakout Group 4A Vol #: 1
SUP 8 Breakout Group 4B Vol #: 1
SUP 9 Breakout Group 5A Vol #: 1
SUP 10 Breakout Group 5B Vol #: 1
SUP 11 Breakout Group 6A Vol #: 1
SUP 12 Breakout Group 6B Vol #: 1
TR 1 Animal Feed Safety System Public Meeting held 9/23/2003 Vol #: 2
TR 2 Animal Feed Safety System Public Meeting held 9/24/2003 Vol #: 3
TS 1 Prince Agri Products, Inc. Vol #: 1
TS 2 Taylor Packing Co. Vol #: 1
TS 3 Wenger Feeds Vol #: 1
TS 4 Dcane Pet Food Vol #: 1
TS 5 California Department of Food & Agriculture Vol #: 1
TS 6 Herr Angus Farm Vol #: 1
TS 7 Food Animal Concerns Trust Vol #: 1
2003N-0361 Anti-Counterfeit Drug Initiative
C 37
Enclosure
Watson Label Products Vol #: 5
C 38 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 5
C 39 NorthAmerican-Pharmotherapeutic Consultants Assn (NorthAmerican - PCA) Vol #: 5
TR 1
Part 2, 3, 4
Anti-Counterfeit Drug Initiative Public Meeting held 10/15/2003 Vol #: 6
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 1 Maureen McDonald Vol #: 1
C 2 Matthew Kohut Vol #: 1
C 3 Allison J. Maffucci Vol #: 1
REF 1
Tab A, B, C
OMB Review for Control of Cummunicable Diseases;Restrictions on African Rodents, Prairie Dogs Vol #: 1
2003N-0506 Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
N 1 FDA Vol #: 1
2003N-0507 Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
N 1 FDA Vol #: 1
2003P-0021 Withdrawal of Wydase, Hyaluronidase Injection
LET 2 HFD-007 to Amphastar Pharmaceuticals, Inc. Vol #: 1
2003P-0078 Public Health Security & Bioterrorism Preparedness & Respons
LET 1 HF-22 to Olsson, Frank and Weeda, PC Vol #: 1
2003P-0270 Prohibit False and Misleading Labeling
C 37 Marian Orvis Vol #: 6
C 38 Dianne Bahr Vol #: 6
2003P-0274 In re Tier 1 initial Approval Program
C 2 Gene E. Krueger Vol #: 1
C 3 Patricia Harper Haas Vol #: 1
C 4 Susan M. Hurdle Vol #: 1
C 5 Michael Post Vol #: 1
C 6 Aids Treatment Activist Coalition (ATAC) Vol #: 1
C 7 Cindy Shaw Vol #: 1
C 8 Robert L. Stewart Vol #: 1
2003P-0461 Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI
C 1 McNeil Consumer & Speciality Phamaceuticals (McNeil) Vol #: 1
2003P-0523 ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
ACK 1 HFA-305 to Karen A. Sisson Vol #: 1
CP 1
Enclosure
Karen A. Sisson Vol #: 1
2003V-0131 Laser Light Show
VRA 2 HFZ-300 to Laser Design Productions, Inc. Vol #: 1

Page created on November 13, 2003
Page update on December 8, 2003 jb

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management