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| Dockets Entered On
December 7, 2005
Table of Contents
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| Docket #
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| Title
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2001V-0378
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| Laser Light Show
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0343
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| Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0355
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| Revocation of Status of Specific Products; Group A Streptococcus
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0443
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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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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| 2005P-0487
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| Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14.
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| VRA
5
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| HFZ-200 to Insight Technology Incorporated
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| Vol #:
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| 1
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C
45
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| American clinical Laboratory Association (ACLA)
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| Vol #:
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| 3
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| C
46
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| Abbott Laboratories, Medical Products Group
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| Vol #:
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| 3
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| C
47
Attachment
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| American College of Pathologists (CAP)
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| Vol #:
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| 3
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| C
48
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| HemoCue Inc
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| Vol #:
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| 5
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| EC
5
Attachment
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| College of American Pathologists
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| Vol #:
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| 5
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| EC
6
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| CDC
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| Vol #:
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| 5
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| EC
7
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| CDC on behalf of CLIAC
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| Vol #:
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| 5
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| EC
8
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| Trinity Biotech Plc
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| Vol #:
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| 5
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| EC
9
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| Cholestech
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| Vol #:
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| 5
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| EC
10
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| American Association of Bioanalysts
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| Vol #:
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| 5
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| EC
11
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| Advanced Medical Technology Association
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| Vol #:
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| 5
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| EC
12
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| Roche Diagnostics
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| Vol #:
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| 5
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| EC
13
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| Genzyme Diagnostics
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| Vol #:
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| 5
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| EC
14
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| San Francisco Department of Public Health
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| Vol #:
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| 5
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| EC
15
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| California Office of AIDS
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| Vol #:
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| 5
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| EC
16
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| Los Angeles County,Office of AIDS Programs
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| Vol #:
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| 5
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| 2001V-0378
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| Laser Light Show
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| EXP 1
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| Dymax Laser Technologies
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
347
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| Vale Wood Farms
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| Vol #:
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| 31
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| C 348
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| L. Newtown
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| Vol #:
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| 31
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| C 349
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| R. King
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| Vol #:
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| 31
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| C 350
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| D. Guerin
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| Vol #:
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| 31
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| C 351
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| H. LeBreton, Sr.
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| Vol #:
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| 31
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| C 352
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| A. Rowe
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| Vol #:
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| 31
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| C 353
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| L. Friend
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| Vol #:
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| 31
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| C 354
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| G. Congleton
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| Vol #:
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| 31
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| C 355
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| Eligible
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| Vol #:
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| 31
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| C 356
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| J. Rojas
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| Vol #:
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| 31
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| C 357
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| H. Hoover
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| Vol #:
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| 31
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| C 358
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| M. Booz
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| Vol #:
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| 31
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| C 359
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| K. Siegfried
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| Vol #:
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| 31
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| C 360
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| D. Trash
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| Vol #:
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| 31
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| C 361
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| D. Blalock
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| Vol #:
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| 31
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| C 362
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| E. Crosby, Jr.
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| Vol #:
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| 31
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| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
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| EMC 1
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| B Sachau
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| Vol #:
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| 4
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EMC 352
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| M. Yetman
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| Vol #:
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| 9
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| PDN
1
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| HFS-800 to Emord & Associates PC
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| Vol #:
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| 21
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C
9
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| Indiana University, School of Dentistry
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| Vol #:
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| 1
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| EMC
4
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| Targeted Genetics Coporation (TGC)
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| Vol #:
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| 1
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| FLN
1
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| F & A Dairy of California Inc
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EMC
299
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| Cream Hill Estates Ltd.
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| Vol #:
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| 23
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| 2005N-0343
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| Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| EMC 1
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| B Sachau
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| EMC 463
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| T Cucchiari
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| Vol #:
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| 165
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| EMC 464
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| L Mooneu
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| Vol #:
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| 165
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| EMC 465
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| M Oliver
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| Vol #:
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| 165
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| EMC 466
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| J Biglin
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| Vol #:
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| 165
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| EMC 467
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| T Lee
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| Vol #:
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| 165
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| EMC 468
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| J Schwener
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| Vol #:
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| 165
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| EMC 469
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| J Krieger
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| Vol #:
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| 165
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EC
42
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| Holistic Action Group
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| Vol #:
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| 5
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| EC
43
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| XXX
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| Vol #:
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| 5
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| EC
44
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| Dr. Matthew Irwin
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| Vol #:
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| 5
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| EC
45
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| ISPS-US -Int Soc Psycholog rx Schizophrenia
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| Vol #:
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| 5
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| EC
46
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| Ms. Shirley Willett
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| Vol #:
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| 5
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| EC
47
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| MPower
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| Vol #:
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| 5
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| EC
48
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| Ms. Ann Menasche
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| Vol #:
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| 5
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| EC
49
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| University of Nebraska
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| Vol #:
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| 5
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| EC
50
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| Ms. Elizabeth Root
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| Vol #:
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| 5
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| EC
51
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| Ms. diana gonzalez
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| Vol #:
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| 5
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| EC
52
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| Mrs. Diane Bianchi
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| Vol #:
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| 5
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| EC
53
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| artmass
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| Vol #:
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| 5
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| EC
54
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| Associated Psychological Health Services
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| Vol #:
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| 5
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| EC
55
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| American Psychoanalytic Association
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| Vol #:
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| 5
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| EC
56
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| Ms. kristina kahl
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| Vol #:
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| 5
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| EC
57
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| Mrs. Dominique Beck
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| Vol #:
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| 5
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| EC
58
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| Mr. Fred Hall
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| Vol #:
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| 5
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| EC
59
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| Mr. Aleksey Tsalolikhin
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| Vol #:
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| 5
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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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| NPR
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| EC
4
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| Consumers Union
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| Vol #:
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| 1
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| EC
5
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| Mr. Robert Spiller
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| Vol #:
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| 1
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| LST
1
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| Agenda for November 14, 25005 FDA and Stateholders Public Meeting
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| Vol #:
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| 1
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| LST
2
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| Biographies for November 14, 2005 Meeting
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| Vol #:
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| 1
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| TS
1
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| Deputy Commissioner for Operations, FDA
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| Vol #:
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| 1
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| TS
2
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| Director, Center for Drug Evaluation and Research, FDA
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| Vol #:
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| 1
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| TS
3
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| Director, Center for Biologics Evaluation and Research, FDA
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| Vol #:
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| 1
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| TS
4
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| Tufts University, Tufts Center for the Study of Drug Development
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| Vol #:
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| 1
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| TS
5
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| Critical Path Institute
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| Vol #:
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| 1
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| TS
6
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| MIT Sloan School and National Bureau of Econimic Research
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| Vol #:
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| 1
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| TS
7
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| Centers for Education & Research on Therapeutics (CERTs)
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| Vol #:
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| 1
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| TS
8
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| Parkinson Pipeline Project
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| Vol #:
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| 1
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| TS
9
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| National Organization for Rare Disorder (NORD)
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| Vol #:
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| 1
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| TS
10
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| Deputy Commissioner for Policy, FDA
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| Vol #:
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| 1
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| TS
11
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| Consumers Union
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| Vol #:
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| 1
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| TS
12
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| TS
13
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| Blue Cross Blue Shield Association
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| Vol #:
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| 1
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| TS
14
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 1
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| TS
15
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| American Pharmacists Association
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| Vol #:
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| 1
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| TS
16
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| Institute for Safe Medication Practices
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| Vol #:
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| 1
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| TS
17
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| TS
18
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| Friends of Cancer Research
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| Vol #:
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| 1
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| TS
19
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| National Research Center fro Women & Families
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| Vol #:
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| 1
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| 2005N-0443
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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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|
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| EMC 1
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| B Sachau
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| Vol #:
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| 1
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|
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C
79
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| The Montgomery Surgical Center
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| Vol #:
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| 20
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|
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| EC
176
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| The Cleveland Clinic Foundation
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| Vol #:
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| 3
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|
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| EC
177
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| Mrs. Diane Blanchard
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| Vol #:
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| 3
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| EC
178
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| Ms. Valerie McKinley
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| Vol #:
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| 3
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| EC
179
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| Dr. Kenneth Stone
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| Vol #:
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| 3
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| EC
180
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| Davis County Hospital
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| Vol #:
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| 3
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