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| Dockets Entered
On July 21, 2004
Table of Contents
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| Docket #
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2002D-0371
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| Human Dura Mater; Class II Special
Controls Guidance
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| 2003D-0379
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| Draft Guidance for Industry
on Preparing a Claim of Categorical Exclusion or an Environmental Assessment
for Submission to the Center for Food Safety and Applied Nutrition;
Availability
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| 2004M-0310
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| P020030 - Stelid II
steroid eluting pacing leads, Approved 6/17/04
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| 2004M-0312
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| P970043/S015- LADARVision
4000 Excimer Laser System, Approved 6/29/04
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| 2004M-0313
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| P030054 - St. Jude Medical
Epic HF System, Approved 6/30/04
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| 2004N-0062
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Color Additive Certification
Requests and Recordkeeping
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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-0093
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| Agency Information Collection
Activities: Registration of Producers of Drugs and Listing of Drugs
in Commercial Distribution , 21 CFR Part 207.
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0242
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| Institutional Review Boards; Registration
Requirements
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| 2004N-0254
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| Possible Barriers to the Availability
of Medical Devices Intended to Treat or Diagnose Diseases and Conditions
that Affect Children
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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-0258
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| Produce Safety from
Production to Consumption: An Action Plan to Minimize Foodborne Illness
Associated with Fresh Produce
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| 2004N-0264
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| Federal Measures to
Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0326
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| ANDA for Adenosine Injection,
USP 3 mg/mL with 6 mL and 10 mL fill volumes
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| 2004V-0272
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| Projector for a Laser
Light Show
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| 2004V-0273
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| Laser Light Show
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| 2004V-0274
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| Projector for a Laser
Light Show
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| 2000N-1571
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| Enrofloxacin for
Poultry: Opportunity for Hearing
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| C 261
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| Becky J. Tilley, DVM,
ACPV
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| Vol #:
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| 99
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| C
262
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| The University of Georgia,
College of Veterinary Medicine
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| Vol #:
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| 99
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| C
263
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| Wayne Farms LLC
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| Vol #:
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| 99
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| 2002D-0371
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| Human Dura Mater;
Class II Special Controls Guidance
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| EC
6
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| Cryonic Life Insurance
Company
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| Vol #:
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| 1
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| 2003D-0282
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| Medical
Device User Fee and Modernization Act of 2002, Validation Data in Premarket
Notification Submissions [510(k)s] for Reprocessed Single-Use Medical
Devices; Guidance for Industry and FDA; Availa
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| EC 2
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| Mrs. cherie moffatt
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| Vol #:
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| 1
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| 2003D-0379
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| Draft
Guidance for Industry on Preparing a Claim of Categorical Exclusion
or an Environmental Assessment for Submission to the Center for Food
Safety and Applied Nutrition; Availability
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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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| EC 7
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| Ms. Ellen Greever
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| Vol #:
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| 2
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| EC 8
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| Mrs. Jana Boone
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| Vol #:
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| 2
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| 2004M-0310
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| P020030 - Stelid
II steroid eluting pacing leads, Approved 6/17/04
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| AAV
1
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| ELA Medical, Inc.
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| Vol #:
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| 1
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| | | | | | | | |
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| |
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| 2004M-0312
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| P970043/S015- LADARVision 4000 Excimer Laser System, Approved 6/29/04
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| AAV
1
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| Alcon Laboratories, Inc.
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| Vol #:
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| 1
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| 2004M-0313
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| P030054 - St. Jude Medical Epic HF System, Approved 6/30/04
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| AAV
1
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| St. Jude Medical, Inc.
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| Vol #:
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| 1
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| 2004N-0062
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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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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| 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
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0093
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| Agency Information Collection Activities: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution , 21 CFR Part 207.
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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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| 2004N-0181
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| Critical Path Initiative
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| EC 4
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| Tripos, Inc.
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| Vol #:
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| 1
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| EC 5
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| Mrs. P. Mullen
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| Vol #:
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| 1
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| EC 6
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| Ms. Candi Clark
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| Vol #:
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| 1
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| EC 2
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| Cryonic Life Insurance Company
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| Vol #:
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| 1
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| EC 2
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| Gammell Applied Technologies
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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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| REF
1
Tab A, B,
C
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| OMB Review for July 14, 2004
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| Vol #:
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| 3
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| 2004N-0258
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| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
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| C
1
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| United Fresh Fruit and Vegetable Assn (United)
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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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| EC 1
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| Mrs. Florence Jones
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| Vol #:
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| 1
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| EXT
1
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| Griffin Industries, Inc.
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| Vol #:
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| 1
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| EXT
2
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| Baker Commodities, Inc.
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| Vol #:
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| 1
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| 2004P-0326
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| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
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|
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| ACK 1
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| HFA-305 to the Apotex Corp.
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| Vol #:
|
| 1
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| CP
1
Appendix A, B
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| Apotex Corp.
|
| Vol #:
|
| 1
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| 2004V-0272
|
| Projector for a Laser Light Show
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