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| Dockets Entered
On August 31, 2004
Table of Contents
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| Docket
#
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| Title
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| 1977N-0409
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| FIBRINOGEN (HUMAN)
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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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| 2004D-0251
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| Requests for Inspection
by an Accredited Person under the Inspections by Accredited Persons
Program Authorized by Section 201 of the Medical Device User Fee and
Modernization Act of 2002
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| 2004N-0230
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| Food; Current Good
Manufacturing Practice Regulations; Public Meetings
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| 2004N-0279
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| Developing DIA/FDA
Workshop: Pharmacogenomic Combination Product Co-development; Public
Meeting
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| 2004N-0287
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| Change of Names and
Addresses; Technical Amendment
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| 2004N-0330
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| Suicidality in Clinical
Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0366
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| Working with Stakeholders
on Scientific Opportunities for Facilitating Development of Vaccines,
Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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| 2004P-0340
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| action on regulation
of generic transdermal fentanyl delivery system, and new product approvals
for transdermal fentanyl products
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| 2004P-0379
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| Determine whether
Penthrane inhalation has been voluntarily withdrawn from sale for
safety or efficacy reasons
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| 2004P-0383
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| ANADA for different
concentration of active in Ivermectin Pour-On for cattle
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| 2004P-0384
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| ANADA for a different
concentration,presentation(ready to use solution) of Levamisole Hydrochloride
for cattle and sheep
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| 2004P-0386
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| Reject New Drug Application
21-695
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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| 1977N-0409
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| FIBRINOGEN (HUMAN)
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| C
9
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| E.R.Squibb & Sons,
Inc.
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| Vol #:
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| 1
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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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| 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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| 2004D-0251
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| Requests
for Inspection by an Accredited Person under the Inspections by Accredited
Persons Program Authorized by Section 201 of the Medical Device User
Fee and Modernization Act of 2002
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| C
1
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| National Electrical
Manufacturers Assn (NEMA)
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| Vol #:
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| 1
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| 2004N-0230
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| Food; Current Good
Manufacturing Practice Regulations; Public Meetings
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| EXT
3
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| International Dairy
Foods Assn (IDFA)
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| Vol #:
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| 1
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| EXT
4
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| National Food Processors
Assn (NFPA)
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| Vol #:
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| 1
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| 2004N-0279
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| Developing DIA/FDA
Workshop: Pharmacogenomic Combination Product Co-development; Public
Meeting
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| C
2
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| Abbott Laboratories
(Abbott)
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| Vol #:
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| 1
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| 2004N-0287
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| Change of Names
and Addresses; Technical Amendment
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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-0330
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| Suicidality in
Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| TS
1
Attachment
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| National Alliance
for the Mentally Ill
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| Vol #:
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| 1
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| TS
2
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| Suicide Prevention
Action Network (SPAN USA)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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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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| 2004P-0340
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| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
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| C
1
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| Mylan Technologies, Inc. (Mylan)
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| Vol #:
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| 2
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| |
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| CR 1
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| HFA-305 to AAC Consulting Group
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| Vol #:
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| 1
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| 2004P-0383
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| ANADA for different concentration of active in Ivermectin Pour-On for cattle
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| ACK
1
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| Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| CP
1
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| Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| 2004P-0384
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| ANADA for a different concentration,presentation(ready to use solution) of Levamisole Hydrochloride for cattle and sheep
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| ACK
1
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| Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| CP
1
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| Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| 2004P-0386
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| Reject New Drug Application 21-695
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| ACK 1
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| HFA-305 to Arnold & Porter LLP
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| Vol #:
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| 1
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| CP
1
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| Abbott Laboratories & Laboratoires Fournier
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| Vol #:
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| 1
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| |
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| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
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| C
12
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 2
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| C
13
Executive Summary
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| Value Group
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| Vol #:
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| 2
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| C
14
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| Society for Women's Health Research
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| Vol #:
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| 2
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| C 15
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| H. Welch
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| Vol #:
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| 2
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| C
16
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 2
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