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| Dockets Entered
On March 5, 2004
Table of Contents
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| Docket #
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| Title
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999P-2778
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| Adopt a policy of publicizing on the internet certain info
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| 2000P-1556
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| Policy regarding ANDA holder confidentiality
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0333
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| Juice HACCP Hazards and Controls
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| 2003D-0391
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| 2003E-0406
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| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| 2003E-0458
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| Patent Extension, Velcade, bortezomib, #5,780,454
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| 2003N-0397
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles
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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-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003N-0508
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
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| 2003P-0494
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| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2003V-0510
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| Spectra Scan Laser Systems Cat's Meow Projector
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| 2003V-0540
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| Laser Light Show
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| 2004C-0078
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| Petition proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products (CAP 4C0276)
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| 2004D-0027
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| Guidance for Industry on Time and Extent Applications
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| 2004N-0063
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| 2004P-0058
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| market phenylbutazone powder that is the same formulation as the approved NADA Butatron(phenylbutazone) tablets
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| 2004P-0092
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| ANDA Suitability Petition for Potassium Iodide Oral Solution 65 mg per mL
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2004V-0112
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| Laser Light Show
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| REF
3
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| OMB Review of NFR 07/11/2003
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| Vol #:
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| 85
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13009
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| EMC 3529
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| A. St John
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| Vol #:
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| 166
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| EMC 3530
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| R. R. P. Goldstein
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| Vol #:
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| 166
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| EMC 3531
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| K. Cheung
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| Vol #:
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| 166
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| EMC 3532
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| J. Roecker
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| Vol #:
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| 166
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| EMC 3533
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| A. Melichar
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| Vol #:
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| 166
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| EMC 3534
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| E. S. Ruymaker
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| Vol #:
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| 166
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| EMC 3535
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| E. Gallup
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| Vol #:
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| 166
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| EMC 3536
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| J. Lenoir
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| Vol #:
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| 166
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| EMC 3537
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| M. Hammond
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| Vol #:
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| 166
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| 2002D-0333
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| Juice HACCP Hazards and Controls
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003D-0391
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys
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| C
1
Attachment
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| Nickel Institute (Ni-I)
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| GDL
2
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| GUIDANCE
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| Vol #:
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| 5
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| NAD
2
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| FDA
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| Vol #:
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| 5
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| C
5
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| Dade Behring, Inc.
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| Vol #:
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| 1
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| C
6
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| Varian, Inc.
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| Vol #:
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| 1
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| C
7
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| American Assn for Clinical Chemistry (AACC) & National Academy of Clinical Biochemistry(NACB)
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| Vol #:
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| 1
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| 2003E-0406
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| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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| LET
4
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| LET
4
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| LET
4
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0458
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| Patent Extension, Velcade, bortezomib, #5,780,454
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| LET
4
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| C
2
Attachment
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| Nickel Institute (Ni-I)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2003N-0397
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles
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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-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| C 81
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| J. Korsmo
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| Vol #:
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| 9
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| C 82
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| J.W. Vanderpool
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| Vol #:
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| 9
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| C
83
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| Ratkateers Rodentry
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| Vol #:
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| 9
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| C 84
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| R. Weiner
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| Vol #:
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| 9
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| C
24
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| Kellogg Company (Kellogg)
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| Vol #:
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| 7
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| C
25
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| California Walnut Commission/Walnut Marketing Board (CWC)
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| Vol #:
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| 7
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| C
26
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| American Dietetic Assn (ADA)
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| Vol #:
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| 7
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| C
27
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| Consumers Union
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| Vol #:
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| 7
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| C
28
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| Mercatus Center at George Mason University
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| Vol #:
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| 7
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| C
29
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| Betafoods Corporation
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| Vol #:
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| 7
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| C
30
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| General Mills
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| Vol #:
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| 7
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| C
31
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| Burdock Group
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| Vol #:
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| 7
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| CR
1
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 7
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| 2003N-0508
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
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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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| 2003P-0494
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| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
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| C
1
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| Gregory A. Paiva & Associates
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| Vol #:
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| 2
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 26
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| K. Wilson
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| Vol #:
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| 2
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| C 27
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| C. Douthit
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| Vol #:
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| 2
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| C
28
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| Gray Panthers
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| Vol #:
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| 2
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| C 29
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| B. Long
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| Vol #:
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| 2
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| C 30
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| M. Harmer
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| Vol #:
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| 2
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| 2003V-0510
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| Spectra Scan Laser Systems Cat's Meow Projector
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| VRA
1
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| HFZ-300 to InterVision
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| Vol #:
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| 1
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| 2003V-0540
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Colossal Mobile Sound
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| Vol #:
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| 1
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| 2004C-0078
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| Petition proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products (CAP 4C0276)
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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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| 2004D-0027
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| Guidance for Industry on Time and Extent Applications
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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-0063
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
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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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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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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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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| SUP
3
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| Purdue Pharm LP
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| Vol #:
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| 2
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| 2004P-0058
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| market phenylbutazone powder that is the same formulation as the approved NADA Butatron(phenylbutazone) tablets
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| WDL
1
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| Bimeda Inc
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| Vol #:
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| 1
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| 2004P-0092
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| ANDA Suitability Petition for Potassium Iodide Oral Solution 65 mg per mL
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| PAV
1
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| HFD-600 to RRD International LLC
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| Vol #:
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| 1
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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|
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| ACK
1
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| HFA-305 to Public Citizen
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| CP
1
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| Public Citizen
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| Vol #:
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| 1
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| 2004V-0112
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| Laser Light Show
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| ACK 1
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| HFA-305 to Intelligent Dance Factory
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| Vol #:
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| 1
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| VAR
1
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| Intelligent Dance Factory
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| Vol #:
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| 1
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