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| Dockets Entered
On December 9, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2001D-0281
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| Proposed Globally Harmonized Alternative for PMA Procedures
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2005D-0312
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| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0389
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0426
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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| 2005P-0293
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| Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 1976N-0052G
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| OTC general comments & combinations
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| ACK
2
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| HFA-305 to Foley & Lardner LLP
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| Vol #:
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| 35
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| PSA
1
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| American Council on Regulatory Compliance
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| Vol #:
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| 35
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| EC
2
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| P.E.T.Net Pharmaceuticals, Inc.
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| Vol #:
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| 15
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| EC
3
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| Cardinal Health
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| Vol #:
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| 15
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| EC
2
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| Mr. Robin Hills
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| Vol #:
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| 1
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| EC
3
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| Mr. Alan Moore
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| Vol #:
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| 1
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| EC
17
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| American Soc for Clinical Laboratory Science
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| Vol #:
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| 5
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| EC
18
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| DSTDP, Centers for Disease Control and Prevention
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| Vol #:
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| 5
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| EC
19
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| NASTAD
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| Vol #:
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| 5
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| EC
1
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| MediSISS
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| EC
8
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| Mrs. Kathleen Cahill
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| Vol #:
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| 1
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| EC
9
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| Fluoroquinolone Toxicity Research Foundation
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| Vol #:
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| 1
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| EC
10
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| Mr. Bernhard Raez
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| Vol #:
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| 1
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| 2005N-0426
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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| EC
1
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| Dolle Communications
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| Vol #:
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| 1
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| 2005P-0293
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| Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
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| LET
1
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| HFS-800 to David Getoff, CCN, FAAIM
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| Vol #:
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| 1
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| EC
3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
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| EC
1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EC
2
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| National Partnership for Women
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| Vol #:
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| 1
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| EC
3
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| Association of Reproductive Health Professionals
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| Vol #:
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| 1
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| EC
4
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| National Partnership for Women
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| Vol #:
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| 1
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