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| Dockets Entered
On November 7, 2005
Table of Contents
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| Docket #
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| Title
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2002E-0020
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| Patent Term Application for Zometa No. 4,939,130
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005G-0367
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| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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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-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0422
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System
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| 2005N-0447
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| Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 2005P-0449
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| Amend existing regulations authorizing health claims relating beta-glucan soluble fiber from specific whole oat sources to reduced risk of coronary heart disease, to permit foods which exceed the nutr
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| ANS 4
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| HFC-150 to B. Smith
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| Vol #:
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| 116
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| C 8584
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| B. Smith
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| Vol #:
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| 116
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| LET 13
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| HFV-12 to B. Smith
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| Vol #:
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| 116
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16798
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| Health From The Sun
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| Vol #:
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| 151
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| LET
16799
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| Health From The Sun
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| Vol #:
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| 151
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| LET
16800
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| American Longevity Healthcare, Inc.
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| Vol #:
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| 151
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| LET
16801
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| Gulf Biomedical Corporation
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| Vol #:
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| 151
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| LET
16802
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| Metagenics, Inc.
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| Vol #:
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| 151
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7508
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| C. McGeorge
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| Vol #:
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| 319
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| C 7509
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| S. Ontiveros
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| Vol #:
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| 319
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| C 7510
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| Eligible
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| Vol #:
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| 319
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| C 7511
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| C. Hutman
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| Vol #:
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| 319
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| 2002E-0020
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| Patent Term Application for Zometa No. 4,939,130
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C
209
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| Texas Association of Business
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| Vol #:
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| 23
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| C
6
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| C
1
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| United States Senate
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| Vol #:
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| 1
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| 2005G-0367
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| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 455
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| M. Thompson
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| Vol #:
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| 165
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| C 456
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| M. Hospador
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| Vol #:
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| 165
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| C 457
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| B. Muto
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| Vol #:
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| 165
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| C 458
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| R. DeMichiel
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| Vol #:
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| 165
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| C 459
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| P. Gunderson
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| Vol #:
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| 165
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| C 460
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| M. O'Connor
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| Vol #:
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| 165
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| C 461
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| J. Williamson
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| Vol #:
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| 165
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| C 462
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| M. Lee
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| Vol #:
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| 165
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| C 463
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| A and J Clapper
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| Vol #:
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| 165
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| C 464
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| C. Capria
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| Vol #:
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| 165
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| C 465
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| Rev F. Bartos
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| Vol #:
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| 165
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| C 466
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| T. Rowan
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| Vol #:
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| 165
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| C 467
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| T. Fox
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| Vol #:
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| 165
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| C 468
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| E. Quinn
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| Vol #:
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| 165
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| C 469
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| R. Hoffman
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| Vol #:
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| 165
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| C 470
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| W. Vanommeren
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| Vol #:
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| 165
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| C 471
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| A. Cavrao
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| Vol #:
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| 165
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| C 472
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| C. Cavrao
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| Vol #:
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| 165
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| C 473
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| A. Cavrao
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| Vol #:
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| 165
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| C 474
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| A. McNichol
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| Vol #:
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| 165
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| C 475
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| A and H Bakow
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| Vol #:
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| 165
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| C 476
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| J. Lohmueller
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| Vol #:
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| 165
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| C 477
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| M. Denny
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| Vol #:
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| 165
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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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| TS
1
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| Hearing Industries Association (HIA)
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| Vol #:
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| 2
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| APE 8
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| National Council on Patient Information and Education
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| Vol #:
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| 1
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| APE 9
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| Inflammatory Skin Disease Institute
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| Vol #:
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| 1
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| EAPE 28
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| cranston, joseph
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| Vol #:
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| 1
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| EAPE 29
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| Gilstrap, Darin
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| Vol #:
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| 1
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| EAPE 30
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| Jambhekar, Priya
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| Vol #:
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| 1
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| EAPE 31
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| Ehrich, Elliot
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| Vol #:
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| 1
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| EAPE 32
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| Silverman, Bernard
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| Vol #:
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| 1
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| EAPE 33
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| Kim, Paul
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| Vol #:
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| 1
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| EAPE 34
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| Liversidge, Ellen
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| Vol #:
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| 1
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| EAPE 35
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| Wolfe, Sidney
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| Vol #:
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| 1
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| EAPE 36
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| Johnson, Hardy
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| Vol #:
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| 1
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| EAPE 37
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| Tran, Huan
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| Vol #:
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| 1
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| EAPE 38
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| Monk, Kim
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| Vol #:
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| 1
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| EAPE 39
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| Kotkoskie, Lois
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| Vol #:
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| 1
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| EAPE 40
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| Cook, Judy
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| Vol #:
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| 1
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| EAPE 41
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| Zuckerman, Diana
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| Vol #:
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| 1
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| EAPE 42
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| Wade, Lindsey
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| Vol #:
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| 1
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| EAPE 43
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| Munn, Sally
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| Vol #:
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| 1
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| EAPE 44
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| Groman, Rachel
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| Vol #:
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| 1
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| EAPE 45
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| Evanich, MaryEllen
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| Vol #:
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| 1
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| EAPE 46
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| Trout, Gretchen
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| Vol #:
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| 1
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| EAPE 47
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| Konnerth, Nancy
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| Vol #:
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| 1
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| EAPE 48
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| Tirigotis, Kimberly
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| Vol #:
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| 1
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| EAPE 49
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| Aleknavage, Debra
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| Vol #:
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| 1
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| EAPE 50
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| Gallagher, Maryann
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| Vol #:
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| 1
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| EAPE 51
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| Esposito, Carlene
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| Vol #:
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| 1
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| EAPE 52
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| Khan, Sofia
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| Vol #:
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| 1
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| EAPE 53
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| Cavallini, Mario
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| Vol #:
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| 1
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| EAPE 54
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| Wight, Evelyn
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| Vol #:
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| 1
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| EAPE 55
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| Henteleff, Thomas
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| Vol #:
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| 1
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| EAPE 56
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| Bloom, Adam
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| Vol #:
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| 1
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| EAPE 57
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| Siegel, Marlene
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| Vol #:
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| 1
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| EAPE 58
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| Mayberry, Peter
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| Vol #:
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| 1
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| EAPE 59
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| Clark, Robert
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| Vol #:
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| 1
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| EAPE 60
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| Kamp, John
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| Vol #:
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| 1
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| EAPE 61
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| Sweeney, Harry
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| Vol #:
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| 1
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| EAPE 62
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| Dunsavage, Janice
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| Vol #:
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| 1
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| EAPE 63
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| benattia, cherif
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| Vol #:
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| 1
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| EAPE 64
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| Goldhammer, Alan
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| Vol #:
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| 1
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| EAPE 65
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| Liversidge, Ellen
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| Vol #:
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| 1
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| |
|
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| NCR
1
|
| FDA
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| Vol #:
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| 1
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| 2005N-0422
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System
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|
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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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| 2005N-0447
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| Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting
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| |
|
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| NM
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| |
|
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| EMC 10
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| Form Letter Count:
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| Vol #:
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| 3
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| C 1
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| S. Frazier, MD
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| Vol #:
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| 1
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| C 2
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| M. Ramirez, MS,CRC
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| Vol #:
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| 1
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| 2005P-0449
|
| Amend existing regulations authorizing health claims relating beta-glucan soluble fiber from specific whole oat sources to reduced risk of coronary heart disease, to permit foods which exceed the nutr
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|
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|
|
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| ACK
1
|
| HFA-305 to The Quaker Oats Company
|
| Vol #:
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| 1
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| CP
1
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| The Quaker Oats Company
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| Vol #:
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| 1
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