| | | | | | | | | | |
|
|
| Dockets Entered
On December 7, 2004
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| 2003D-0007
|
| Estrogen Progestin Drug Prod.to Treat Vasomotor Symptoms &
|
|
|
| 2004D-0431
|
| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
|
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
|
|
| 2004D-0453
|
| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
|
|
|
| 2004D-0499
|
| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
|
|
|
| 2004N-0114
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
|
|
| 2004N-0482
|
| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
|
|
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
| 2004P-0489
|
| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
|
|
|
| 2004P-0519
|
| Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing
|
|
|
| 2004P-0523
|
| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
|
|
|
| 2004P-0540
|
| Don't approve any new or pending ANDA for generic fentanyl transdermal product
|
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
| LET
793
|
| HFS-800 to Tianshi Health Products, Inc
|
| Vol #:
|
| 24
|
|
|
| LET
794
|
| HFS-800 to EuroPharma, Inc
|
| Vol #:
|
| 24
|
|
|
| LET
795
|
| HFS-800 to Leiner Health Products
|
| Vol #:
|
| 24
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| ANS
9
|
| HF-40 to The University of Georgia
|
| Vol #:
|
| 464
|
|
|
| ANS
10
|
| HF-40 to Aviagen North America
|
| Vol #:
|
| 464
|
|
|
| ANS
11
|
| HF-40 to Sietsema Farms
|
| Vol #:
|
| 464
|
|
|
| ANS
12
|
| HF-40 to Carroll's Turkeys LLC
|
| Vol #:
|
| 464
|
|
|
| ANS
13
|
| HF-40 to National Turkey Federation
|
| Vol #:
|
| 464
|
|
|
| ANS
14
|
| HF-40 to Fieldale Farms Corporation
|
| Vol #:
|
| 464
|
|
|
| ANS
15
|
| HF-40 to College of Veterinary Medicine, Cornell University
|
| Vol #:
|
| 464
|
|
|
| ANS
16
|
| HF-40 to Consumers Union
|
| Vol #:
|
| 464
|
|
|
| ANS
17
|
| HF-40 to Consumers Union
|
| Vol #:
|
| 464
|
|
|
| ANS
18
|
| HF-40 to Jennie-O Turkey Store
|
| Vol #:
|
| 464
|
|
|
| ANS
19
|
| HF-40 to Jennie-O Turkey Store
|
| Vol #:
|
| 464
|
|
|
| ANS
20
|
| HF-40 to American Association of Avian Pathologists
|
| Vol #:
|
| 464
|
|
|
| ANS
21
|
| HF-40 to Hector Cervantes, DVM, MS, Dipl, ACPV
|
| Vol #:
|
| 464
|
|
| | | | | | | |
|
|
| ANS
22
|
| HF-40 to Association of Veterinarians in Turkey Production
|
| Vol #:
|
| 464
|
|
|
| ANS
23
|
| HF-40 to Carroll's Turkeys LLC
|
| Vol #:
|
| 464
|
|
|
| ANS
24
|
| HF-40 to American College of Poultry Veterinarians
|
| Vol #:
|
| 464
|
|
|
| ANS
25
|
| HF-40 to Goldsboro Milling Company
|
| Vol #:
|
| 464
|
|
|
| ANS
26
|
| HF-40 to Sanderson Farms, Inc.
|
| Vol #:
|
| 464
|
|
|
| ANS
27
|
| HFW-1 to The Honorable Charles W. "Chip Pickering, Jr.
|
| Vol #:
|
| 464
|
|
|
| ANS
28
|
| HFW-1 to The Honorable Marion Berry
|
| Vol #:
|
| 464
|
|
|
| ANS
29
|
| HFW-1 to The Honorable Charlie Norwood
|
| Vol #:
|
| 464
|
|
|
| ANS
30
|
| HFW-1 to The Honorable Jerry Moran
|
| Vol #:
|
| 464
|
|
|
| ANS
31
|
| HFW-1 to The Honorable Mike McIntyre
|
| Vol #:
|
| 464
|
|
|
| ANS
32
|
| HFW-1 to The Honorable Jim Marshall
|
| Vol #:
|
| 464
|
|
|
| ANS
33
|
| HFW-1 to The Honorable Sanford D. Bishop, Jr.
|
| Vol #:
|
| 464
|
|
|
| ANS
34
|
| HFW-1 to The Honorable Roy Blunt
|
| Vol #:
|
| 464
|
|
|
| ANS
35
|
| HFW-1 to The Honorable Thomas E. Petri
|
| Vol #:
|
| 464
|
|
|
| ANS
36
|
| HFW-1 to The Honorable Sam Graves
|
| Vol #:
|
| 464
|
|
|
| ANS
37
|
| HFW-1 to The Honorable Mike Ross
|
| Vol #:
|
| 464
|
|
|
| ANS
38
|
| HFW-1 to The Honorable Roger F. Wicker
|
| Vol #:
|
| 464
|
|
|
| ANS
39
|
| HFW-1 to The Honorable Devin Nunes
|
| Vol #:
|
| 464
|
|
|
| ANS
40
|
| HFW-1 to The Honorable Baron P. Hill
|
| Vol #:
|
| 464
|
|
|
| ANS
41
|
| HFW-1 to The Honorable Mark Kennedy
|
| Vol #:
|
| 464
|
|
|
| ANS
42
|
| HFW-1 to The Honorable Steve King
|
| Vol #:
|
| 464
|
|
|
| ANS
43
|
| HFW-1 to The Honorable Jack Kingston
|
| Vol #:
|
| 464
|
|
|
| ANS
44
|
| HFW-1 to The Honorable John P. Kline
|
| Vol #:
|
| 464
|
|
|
| ANS
45
|
| HFW-1 to The Honorable John A. Boehner
|
| Vol #:
|
| 464
|
|
|
| ANS
46
|
| HFW-1 to The Honorable Max Burns
|
| Vol #:
|
| 464
|
|
|
| ANS
47
|
| HFW-1 to The Honorable Eric I. Cantor
|
| Vol #:
|
| 464
|
|
|
| ANS
48
|
| HFW-1 to The Honorable Nathan Deal
|
| Vol #:
|
| 464
|
|
|
| ANS
49
|
| HFW-1 to The Honorable Bob Etheridge
|
| Vol #:
|
| 464
|
|
|
| ANS
50
|
| HFW-1 to The Honorable Albert R. Wynn
|
| Vol #:
|
| 464
|
|
|
| ANS
51
|
| HFW-1 to The Honorable Mike Pence
|
| Vol #:
|
| 464
|
|
|
| ANS
52
|
| HFW-1 to The Honorable Chris Chocola
|
| Vol #:
|
| 454
|
|
|
| C
282
|
| The University of Georgia
|
| Vol #:
|
| 464
|
|
|
| C
283
|
| Aviagen North America
|
| Vol #:
|
| 464
|
|
|
| C
284
|
| Sietsema Farms
|
| Vol #:
|
| 464
|
|
|
| C
285
|
| Carroll's Turkeys LLC
|
| Vol #:
|
| 464
|
|
|
| C
286
|
| National Turkey Federation
|
| Vol #:
|
| 464
|
|
|
| C
287
|
| Fieldale Farms Corporation
|
| Vol #:
|
| 464
|
|
| | | | | | | | |
|
|
| C
288
|
| College of Veterinary Medicine, Cornell University
|
| Vol #:
|
| 464
|
|
|
| C
289
Attachment
|
| Consumers Union
|
| Vol #:
|
| 464
|
|
|
| C
290
|
| Jennie-O Turkey Store
|
| Vol #:
|
| 464
|
|
|
| C
291
|
| American Association of Avian Pathologists
|
| Vol #:
|
| 464
|
|
|
| C
292
|
| Hector Cervantes, DVM, MS, Dipl, ACPV
|
| Vol #:
|
| 464
|
|
|
| C
293
|
| Association of Veterinarians in Turkey Production
|
| Vol #:
|
| 464
|
|
|
| C
294
|
| Carroll's Turkeys LLC
|
| Vol #:
|
| 464
|
|
|
| C
295
|
| American College of Poultry Veterinarians
|
| Vol #:
|
| 464
|
|
|
| C
296
|
| Goldsboro Milling Company
|
| Vol #:
|
| 464
|
|
|
| C
297
|
| Sanderson Farms, Inc.
|
| Vol #:
|
| 464
|
|
|
| C
298
|
| Congress of the United States
|
| Vol #:
|
| 464
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| C 12742
|
| Virginia Williams
|
| Vol #:
|
| 789
|
|
|
| C 12743
|
| V M O'Brien
|
| Vol #:
|
| 789
|
|
|
| C 12744
|
| Julie Holelman
|
| Vol #:
|
| 789
|
|
|
| 2003D-0007
|
| Estrogen Progestin Drug Prod.to Treat Vasomotor Symptoms &
|
|
|
| C
7
|
| Berlex, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004D-0431
|
| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
|
|
|
| C
2
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
|
| C
3
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| C
4
|
| Alkermes, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
5
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
7
|
| Medtronic Neurological
|
| Vol #:
|
| 1
|
|
|
| C
8
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 1
|
|
|
| C
9
|
| Genentech
|
| Vol #:
|
| 1
|
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
|
|
| C
7
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| C
8
|
| Genentech
|
| Vol #:
|
| 1
|
|
|
| C
9
|
| American Red Cross
|
| Vol #:
|
| 1
|
|
|
| C
10
|
| QualityHub, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
11
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
| C
12
|
| American Assn for Homecare (AAHomecare)
|
| Vol #:
|
| 1
|
|
|
| C
13
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2004D-0453
|
| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
|
|
|
| C
1
|
| Upstate Farms Cooperative, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
2
|
| Nestle USA, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004D-0499
|
| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
|
|
|
| C
2
|
| Savi Tecnology, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004N-0114
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2004N-0482
|
| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
|
|
|
|
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
| ANS
1
|
| HF-1 to National Consumers League
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| National Consumers League
|
| Vol #:
|
| 1
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
| C
3
|
| Mylan Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0489
|
| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
|
|
|
| C
2
|
| Intervet, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0519
|
| Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing
|
|
|
| LET
1
Attachment
|
| HFS-800 to Wells' Dairy, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0523
|
| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
|
|
| SUP
1
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
| 2004P-0540
|
| Don't approve any new or pending ANDA for generic fentanyl transdermal product
|
|
|
| ACK
1
|
| London and Mead
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| London and Mead
|
| Vol #:
|
| 1
|
|