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| Dockets Entered
On August 18, 2004
Table of Contents
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| Docket
#
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| Title
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| 2000N-1399
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| Presubmission Conferences
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003N-0308
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| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004N-0046
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0287
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| Change of Names and Addresses; Technical Amendment
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| 2004P-0070
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| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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| 2004P-0368
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| Interchangeability of Medical Devices with One Another.
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| 2000N-1399
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| Presubmission Conferences
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 1983
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| Keith Benhan and 26 signatures
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| Vol #:
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| 289
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| C 1984
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| J. Dempsey
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| Vol #:
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| 289
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| C 1985
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| D. Bruce
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| Vol #:
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| 289
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| C 1986
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| K. Lund Shoffeitt
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| Vol #:
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| 289
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| C 1987
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| H. Shell
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| Vol #:
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| 289
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| C 1988
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| L. S. Ward
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| Vol #:
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| 289
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| C 1989
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| K. Maresca MacDougall
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| Vol #:
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| 289
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| C 1990
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| K. O'Loughlin
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| Vol #:
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| 289
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| C 1991
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| A. Radbil
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| Vol #:
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| 289
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| C 1992
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| M. McGuire
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| Vol #:
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| 289
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| C 1993
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| J. Latimer
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| Vol #:
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| 289
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| C 1994
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| P. J. Whetstone
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| Vol #:
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| 289
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| C 1995
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| T. K. Shannon
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| Vol #:
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| 289
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| C 1996
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| Erick Trevino & 63 Signatures
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| Vol #:
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| 289
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| C 1997
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| J. L. Sinsky
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| Vol #:
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| 289
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| C 1998
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| B. Gotbaum
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| Vol #:
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| 289
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| C 1999
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| L. Martin
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| Vol #:
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| 289
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| CR 1
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| Erick Trevino & 63 Signatures
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| Vol #:
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| 289
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| | | | | | | | |
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| NAL
2
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| FDA
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| Vol #:
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| 1
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| SS
2
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| Supporting Statement
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| Vol #:
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| 1
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| N
1
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| FDA
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| Vol #:
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| 2
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| 2003N-0308
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| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
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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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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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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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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
22
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| International Pharmaceutical Aerosol Consortium
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| Vol #:
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| 5
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| C
23
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| GlaxoSmithKline
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| Vol #:
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| 5
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| C
24
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| INEOS Fluor
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| Vol #:
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| 5
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| C
25
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| National Economic Research Associates,Inc. (NERA)
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| Vol #:
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| 5
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| EMC 25
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| R. Carlson
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| Vol #:
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| 5
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| EMC
26
Attachment 1, 2
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| American Academy of Allergy, Asthma, & Immunology
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| Vol #:
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| 5
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| EMC
27
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| INEOS Fluor
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| Vol #:
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| 5
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| EMC 28
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| S. Dotson
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| Vol #:
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| 5
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| EMC 29
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| P. Dotson
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| Vol #:
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| 5
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| EMC 30
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| M. Kinnard
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| Vol #:
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| 5
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| EMC
31
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| Asthma & Allergy Foundation of America
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| Vol #:
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| 5
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| EMC
32
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| National Association of Chain Drug Stores
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| Vol #:
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| 5
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| EMC
33
Attachment
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| US STAKEHOLDERS GROUP ON MDI TRANSITION
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| Vol #:
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| 5
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| EMC
34
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| Sciarra Laboratories, Inc.
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| Vol #:
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| 5
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| EMC
35
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| Sciarra Laboratories, Inc.
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| Vol #:
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| 5
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| EMC
36
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| Asthma Therapy Coalition
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| Vol #:
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| 5
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| EMC
37
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| Honeywell International, Inc.
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| Vol #:
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| 5
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| EMC
38
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| Honeywell International, Inc.
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| Vol #:
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| 5
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| 2004N-0046
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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|
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| NAL
1
|
| FDA
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| Vol #:
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| 1
|
|
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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