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| Dockets
Entered On January 22, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1992N-0139
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| Statement Policy: Foods Derived from New Plant Varieties
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0209
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| Governing First Amendment Case Law
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003E-0245
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| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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| 2003N-0069
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| FDA Task Force on Consumer Health Info for Better Nutrition
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| 2003N-0267
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Studies for Licensed Biological Products; Status Reports
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| 2003N-0295
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| Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0425
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| Agency Information Collection Activities: Proposed Collection; Comment Request
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004P-0036
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| Office of Mental Health be deemed pharmacies of other health care entities language of 503(d)(3)(A)(ii), and be allwed to inventory and dispense drug samples to its patients
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| 2004P-0037
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| 513(f) Reclassification Petition for TV-TIP Sound Amplifier
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| 1978N-0036L
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| OTC Laxative
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| C
209
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| Purdue Frederick Company (Purdue)
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| Vol #:
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| 134
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| C
210
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| Procter & Gamble Company (Procter & Gamble)
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| Vol #:
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| 134
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| C
211
Tab
1, 2, 3, 4
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| Madaus AG
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| Vol #:
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| 134
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| C
212
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| C.B. Fleet Company, Inc.
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| Vol #:
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| 135
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| 1992N-0139
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| Statement Policy: Foods Derived from New Plant Varieties
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| C 6496
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| J. & S. Cody
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| Vol #:
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| 164
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| LET
18
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| HF-40
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| Vol #:
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| 164
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| RPT
14
Attachment
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| Northfield Laboratories
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| Vol #:
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| 22
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7359
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| I. Szurgot
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| Vol #:
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| 305
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| C 7360
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| C. Pappa
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| Vol #:
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| 305
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| C 7361
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| Eligible
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| Vol #:
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| 305
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| C 7362
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| P. Boeh
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| Vol #:
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| 305
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| SUP 1
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| B. Bridges, RN
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| Vol #:
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| 21
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10008
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| B.U. Fanur
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| Vol #:
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| 580
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 340
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| B. Schulte
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| Vol #:
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| 125
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| C 341
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| Eligible
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| Vol #:
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| 125
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| C 342
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| Eligible
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| Vol #:
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| 125
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| C 343
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| J. Kelly
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| Vol #:
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| 125
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| C 344
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| P. Maas
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| Vol #:
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| 125
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| C 345
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| Eligible
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| Vol #:
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| 125
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| C 346
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| Eligible
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| Vol #:
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| 125
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| C 347
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| L. Lees
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| Vol #:
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| 125
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| C 348
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| K. Petersen
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| Vol #:
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| 125
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| C 349
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| Eligible
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| Vol #:
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| 125
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| 2002N-0209
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| Governing First Amendment Case Law
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| C
114
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| Florida Gift Fruit Shippers Assn (FGFSA)
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| Vol #:
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| 26
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| EMC
1
Attachment
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| Johnson & Johnson Pharmaceutical Research (Johnson & Johnson)
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| Vol #:
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| 1
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| 2003E-0245
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| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003N-0069
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| FDA Task Force on Consumer Health Info for Better Nutrition
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| C
6
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| Grocery Manufacturers of America et al.
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| Vol #:
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| 1
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| 2003N-0267
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Studies for Licensed Biological Products; Status Reports
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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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| 2003N-0295
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| Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile
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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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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| EMC 17
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| D. James
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| Vol #:
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| 5
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| EMC 18
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| B. Malott
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| Vol #:
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| 5
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| EMC 19
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| L.A. MEans
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| Vol #:
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| 5
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| EMC 20
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| K. Gee
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| Vol #:
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| 5
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| EMC 21
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| C. Disbro
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| Vol #:
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| 5
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| EMC 22
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| K. Muzechuk
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| Vol #:
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| 5
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| EMC 23
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| C. Cattellion
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| Vol #:
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| 5
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| EMC 24
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| R. Houston
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| Vol #:
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| 5
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| EMC 25
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| No signature
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| Vol #:
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| 5
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| EMC 26
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| C. Cattellion
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| Vol #:
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| 5
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| EMC 27
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| D. Hogue
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| Vol #:
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| 5
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| EMC 28
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| No signature
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| Vol #:
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| 5
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| EMC 29
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| R. Blair
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| Vol #:
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| 5
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| EMC 30
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| D. Derwin
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| Vol #:
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| 5
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| EMC
31
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| Animal Protection Institute (API)
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| Vol #:
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| 5
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| EMC 32
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| No signature
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| Vol #:
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| 5
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| EMC 33
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| S. Bechtholt
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| Vol #:
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| 5
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| EMC
34
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| Animal Protection Institute (API)
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| Vol #:
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| 5
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| EMC 35
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| L. & J. Bender
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| Vol #:
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| 5
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| EMC 36
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| K. Sanchez
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| Vol #:
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| 5
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| 2003N-0425
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| Agency Information Collection Activities: Proposed Collection; Comment Request
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| N
2
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| FDA (mislabelled as 2002N-0273)
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| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 22
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| L.S. Remensnyder, AuD
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| Vol #:
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| 1
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| EMC
23
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| American Academy of Otolaryngology
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| Vol #:
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| 1
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| EMC 24
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| W.M. Gatti, MD
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| Vol #:
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| 1
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC 9
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| W.M. Gatti, MD
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| Vol #:
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| 1
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| EMC 33
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| J. Shwner
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| Vol #:
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| 1
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| EMC 34
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| B. Schwener
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| Vol #:
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| 1
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| EMC 35
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| No signature
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| Vol #:
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| 1
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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