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| Dockets Entered
On August 30, 2004
Table of Contents
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| Docket
#
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| Title
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| 1991P-0434
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| Implement a series
of changes in the regulatory process for
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| 1992P-0409
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| Permit Vets. to Dispense
& Compound Legally Available Drugs
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| 1995S-0158
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| Community Disclosure
of Institutional Review Boards
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| 1997N-0484R
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| Human Cellular and
Tissue-Based Products
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 2002P-0317
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| Recall Aspartame as
a Neurotoxic Drug
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| 2003P-0029
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| Remove metered-dose
inhalers (MDI) containing moiety albuter
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| 2003P-0064
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| Withhold Approval
of Generic Lovenox (enoxaparin sodium inje
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| 2004D-0193
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| Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)
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| 2004D-0198
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| Guidance for Industry:
Acceptable Full-Length Donor History Questionnaire and Accompanying
Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004N-0115
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| Prescription Drug
Importation Study
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0184
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| Requirements Pertaining
to Sampling and Private Laboratories Used in Connection With Importing
Food
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| 2004N-0194
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| DEFINITION OF PRIMARY
MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0264
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| Federal Measures to
Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0330
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| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
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| 2004P-0105
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| Nutrient Content Claim:
Total Carbohydrate Content of Foods
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| 1991P-0434
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| Implement a series
of changes in the regulatory process for
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| PDN
1
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| HFC-1 to Animal Health
Institute
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| Vol #:
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| 1
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| 1992P-0409
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| Permit Vets. to
Dispense & Compound Legally Available Drugs
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| LET
2
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| HFC-1 to Hyman, Phelps
& McNamara, P.C.
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| Vol #:
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| 2
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| 1995S-0158
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| Community Disclosure
of Institutional Review Boards
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| SUP
28
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| Northfield Laboratories
Inc BB IND 10719
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| Vol #:
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| 28
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| 1997N-0484R
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| Human Cellular
and Tissue-Based Products
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| C
34
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| Xytex Corporation
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| Vol #:
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| 7
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| 1998P-0151
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| Introduction Of
Downed Cattle Into The Food Supply
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| C 7449
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| Illegible
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| Vol #:
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| 307
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| 2002P-0317
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| Recall Aspartame
as a Neurotoxic Drug
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| SUP
6
Attachment
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| Calorie Control Council
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| Vol #:
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| 3
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| 2003P-0029
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| Remove metered-dose
inhalers (MDI) containing moiety albuter
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| C
32
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| 3M Company
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| Vol #:
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| 6
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| CR
1
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 6
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| | | | | | | | |
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
4
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| Teva Pharmaceuticals, USA
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| Vol #:
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| 3
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| C
13
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| Fairfax Cryobank
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| Vol #:
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| 1
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| C
14
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| Northwest Tissue Center
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| Vol #:
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| 1
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| C
15
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| Seattle Cancer Care Alliance and the Fred Hutchinson Cancer Research Center
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| Vol #:
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| 1
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| C
16
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| Rainbow Flag Health Services
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| Vol #:
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| 1
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| C
17
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| Lambda Legal Defense and Education Fund et al.
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| Vol #:
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| 1
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| C 6
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| B. Siegfried, MD
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| CR 1
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| R. Smythe
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| Vol #:
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| 19
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| 2004N-0181
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| Critical Path Initiative
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| C
60
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| ECR Pharmaceuticals
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| Vol #:
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| 3
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| C
8
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| Anresco, Inc.
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| Vol #:
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| 2
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| C
9
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| National Coalition of Food Importing Associations (NCFIA or the Coalition)
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| Vol #:
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| 2
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| C
10
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| American Council of Independent Laboratories (ACIL)
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| Vol #:
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| 2
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| C
11
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| American Academy of Orthopaedic Surgeons (AAOS/Academy)
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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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| EMC 1386
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| L. Kurzhals
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| Vol #:
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| 10
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| EMC 1387
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| M. Stieren
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| Vol #:
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| 10
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| EMC 1388
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| C. Engler
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| Vol #:
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| 10
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| EMC 1389
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| D. Wright
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| Vol #:
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| 10
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| EMC 1390
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| J. Affonso
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| Vol #:
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| 10
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| EMC 1391
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| M. Miles
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| Vol #:
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| 10
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| EMC 1392
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| E. Swaya
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| Vol #:
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| 10
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| EMC 1393
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| R. Dean
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| Vol #:
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| 10
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| EMC 1394
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| M. Jansen
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| Vol #:
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| 10
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| EMC 1395
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| V. Brown
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| Vol #:
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| 10
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| EMC 1396
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| S. Collins
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| Vol #:
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| 10
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| |
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| EMC 1397
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| M. Alford
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| Vol #:
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| 10
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| EMC 1398
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| S. Piffath
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| Vol #:
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| 10
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| EMC
1399
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| Center for Food Safety (CFS)
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| Vol #:
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| 10
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| EMC 1400
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| P. Meissner
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| Vol #:
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| 10
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| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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|
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| EC 3
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| Mr. Clifford Harbin
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| Vol #:
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| 1
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| EC 4
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| Mrs. Mathy Milling Downing
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| Vol #:
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| 1
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| EC
5
Attachment 1, 2,
3
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| National Alliance for the Mentally Ill (NAMI)
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| Vol #:
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| 1
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| EC 6
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| National Latino Behavioral Health Association
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| Vol #:
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| 1
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| EC 7
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| Dr. Jeffry Klugman
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| Vol #:
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| 1
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| EC 8
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| Mrs. T McClain
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| Vol #:
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| 1
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| EC 9
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| Ms. Catherine Fountain
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| Vol #:
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| 1
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| EC 10
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| Dr. Peter Breggin
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| Vol #:
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| 1
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| EC 11
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| American College of Neuropsychopharmacology
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| Vol #:
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| 1
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| EC
12
Attachment
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| American College of Neuropsychopharmacology
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| Vol #:
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| 1
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| EC 13
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| Mrs. Karen Eagle
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| Vol #:
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| 1
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| EC 14
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| Mrs. DeeAnn Davis
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| Vol #:
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| 1
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| EC 15
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| Mr. Barry Bratt
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| Vol #:
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| 1
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| EC 16
|
| Hillcrest X-Ray Physicians
|
| Vol #:
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| 1
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| EC 17
|
| Mr. Kiran Mull
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| Vol #:
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| 1
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| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
|
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| LET
3
|
| Kraft Foods
|
| Vol #:
|
| 1
|
|
