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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products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