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| Dockets Entered On
December 4, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005N-0494
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006E-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| 2006N-0472
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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| 2006N-0475
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0496
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| Determine whether the following drugs have been voluntarily withdrawn or withheld for safety or efficacy reasons
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| 2006V-0485
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| Projector for a Laser Light Show
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C
43
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| A Craig Cattell MD & Associates
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| Vol #:
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| 15
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| C
44
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| American Society for Dermatologic Surgery
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| Vol #:
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| 15
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| C
45
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| Long Island Skin Cancer & Dermatologic Surgeery
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| Vol #:
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| 15
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| C
46
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| Long Island Skin Cancer & Dermatologic Surgeery
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| Vol #:
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| 15
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| C
47
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| Long Island Skin Cancer & Dermatologic Surgeery
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| Vol #:
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| 15
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| PDN
1
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| FDA/CDER to Buchanan Ingersoll PC on behalf of Savient Pharmaceuticals Inc
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| Vol #:
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| 1
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C
9
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| HollisterStier Laboratories LLC
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| Vol #:
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| 3
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| 2005N-0494
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| PDN
1
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| FDA/CDER to Buchanan Ingersoll PC on behald of Savient Pharmaceuticals Inc
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| Vol #:
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| C
13
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| Public Responsibility in Medicine and Research (PRIMER)
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| Vol #:
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| 3
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious
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| EC 46
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| Dr. Stephen Warres
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| Vol #:
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| 1
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| EC 47
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| Feeling Blue Suicide Prevention Council
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| Vol #:
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| 1
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| EC 48
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| Dr. Laura Gaffney
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| Vol #:
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| 1
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| EC 49
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| American Foundation for Suicide Prevention
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| Vol #:
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| 1
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| EC 50
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| Pogust
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| Vol #:
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| 1
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| EC 51
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| Siani Hospital
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| Vol #:
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| 1
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| EC 52
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| Mental Health America
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| Vol #:
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| 1
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| EC 53
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| National Alliance on Mental Illness
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| Vol #:
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| 1
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| EC 54
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| Dr. Nada Stotland, MD, MPH
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| Vol #:
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| 1
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| EC 55
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| National Alliance on Mental Illness
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| Vol #:
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| 1
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| EC 56
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| Mr. Andy Vickery
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| Vol #:
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| 1
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| EC 57
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| Mr. Andy Vickery
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| Vol #:
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| 1
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| EC 58
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| National Alliance on Mental Illness
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| Vol #:
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| 1
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| EC 59
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC 60
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| National Alliance on Mental Illness (NAMI)
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| Vol #:
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| 1
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| EC 61
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| Washington State Psychiatric Association
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| Vol #:
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| 1
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| EC 62
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| Mrs. Laura Milanese-Husband
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| Vol #:
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| 1
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| EC 63
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| Dr. David Fassler
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| Vol #:
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| 1
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| EC 64
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| National Alliance on Mental Illness
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| Vol #:
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| 1
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| EC 65
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| American Academy of Child
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| Vol #:
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| 1
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| EC 66
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| Ms. Sherri Walton
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| Vol #:
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| 1
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| EC 67
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| Mr. Charles Graves
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| Vol #:
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| 1
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| EC 68
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| Mental Health America
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| Vol #:
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| 1
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| EC 69
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| Mrs. Kimberly Porto
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| Vol #:
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| 1
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| EC 70
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| EC 71
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| University of Colorado School of Pharmacy
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| Vol #:
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| 1
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| EC 72
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| Ms. Kim Witczak
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| Vol #:
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| 1
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| EC 73
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| American Psychiatric Association
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| Vol #:
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| 1
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| EC 74
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| SSRI Crusaders
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| Vol #:
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| 1
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| EC 75
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| Baum Hedlund
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| Vol #:
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| 1
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| 2006N-0472
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2006N-0475
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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| N
1
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| FDA
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| Vol #:
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| 1
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