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| Dockets Entered
On October 12, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive
yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as
a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
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| 2003N-0575
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; 2004 National Tracking
Survey of Prescription Drug Information Provided to Patients
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| 2004D-0283
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| Waivers of In Vivo Demonstration
of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles
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| 2004D-0343
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| Hospital Bed System Dimensional
Guidance to Reduce Entrapment
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| 2004D-0438
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| Guidance for Industry:
Use of Material from BSE-Positive Cattle in Animal Feed
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| 2004N-0034
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Medical Devices; Current
Good Manufacturing Practice Quality System Regulation
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| 2004N-0079
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| Specific Requirements
on Content and Format of Labeling for Human Prescription Drugs; Addition
of Geriatric Use Subsection in the Labeling
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| 2004N-0081
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| BSE Risk Materials in
Foods and Cosmetics
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| 2004N-0101
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| Agency Information
Collection Activities: Proposed Collection; Comment Request; Requirements
for Testing Human Blood Donors for Evidence of Infection Due to Communicable
Disease Agents; and Requiremen
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| 2004N-0103
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Guidance for Industry
on Special Protocol Assessment
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| 2004N-0132
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| Agency Information Collection
Activities: Proposed Collection; Comment Request: Premarket Approval
of Medical Devices
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| 2004N-0161
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Information from U.S.
Processors that Export to the European Community
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| 2004N-0166
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Infant Feeding Practices
Study II
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| 2004N-0214
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| Public Information Regulations
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| 2004N-0242
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| Institutional Review Boards; Registration
Requirements
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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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| 2004N-0408
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| Regulatory Site Visit Training
Program
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| 2004N-0442
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Recall Regulations
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| 2004S-0212
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| Pandemic Influenza Preparedness
and Response Plan
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| 1978N-0036L
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| OTC Laxative
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| PAV
4
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| HFC-1 to Sonnenschein,
Nath & Rosenthal LLP
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| Vol #:
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| 138
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14656
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| Tabak's Health Products
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| Vol #:
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| 128
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| LET
14657
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| Biotech Corporation
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| Vol #:
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| 128
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| LET
14658
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| Enzymatic Therapy
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| Vol #:
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| 128
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| LET
14659
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| Mead Johnson & Company
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| Vol #:
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| 128
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| 2000N-0504
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| Egg Safety Action
Plan
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| EC
2
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| TNO Nutrition and Food
Reserach
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| Vol #:
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| 17
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| 2000N-1571
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| Enrofloxacin for
Poultry: Opportunity for Hearing
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| EXB 617
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| Center for Veterinary
Medicine
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| Vol #:
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| 437
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| EXB 618
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| Center for Veterinary
Medicine
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| Vol #:
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| 437
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| EXB 619
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 620
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 621
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 622
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 623
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 624
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 625
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 626
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 627
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| Center for Veterinary Medicine
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| Vol #:
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| 437
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| EXB 628
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| Center for Veterinary Medicine
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| Vol #:
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| 438
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| EXB 629
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| Center for Veterinary Medicine
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| Vol #:
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| 438
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| EXB 630
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| Center for Veterinary Medicine
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| Vol #:
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| 438
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| EXB 631
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| Center for Veterinary Medicine
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| Vol #:
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| 438
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| EXB 632
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| Center for Veterinary Medicine
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| Vol #:
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| 438
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| EXB 633
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 634
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 635
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 636
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 637
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 638
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 639
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 640
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 641
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 10511
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| A. Williams
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| Vol #:
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| 294
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| EMC 10512
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| A. Stupi
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| Vol #:
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| 294
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| EMC 10513
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| K. Schweighofer
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| Vol #:
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| 294
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| EMC 10514
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| L. Kestel
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| Vol #:
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| 294
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| EMC 10515
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| C. Reece
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| Vol #:
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| 294
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| EMC 10516
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| H. Wilkinson
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| Vol #:
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| 294
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| EMC 10517
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| L. Clayton
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| Vol #:
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| 294
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| EMC 10518
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| E. Lester
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| Vol #:
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| 294
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| EMC 10519
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| K. Fahy
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| Vol #:
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| 294
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| EMC 10520
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| N. Struthers M.D.
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| Vol #:
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| 294
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| EMC 10521
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| D. Luquias
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| Vol #:
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| 294
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| EMC 10522
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| D. McPhetridge
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| Vol #:
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| 294
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| EMC 1014
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| K. Kirchdoerfer and D. Basechle
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| Vol #:
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| 11
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| EMC 1015
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| D. Walker
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| Vol #:
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| 11
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| EMC 1016
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| H. Schiemann
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| Vol #:
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| 11
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| EMC 1017
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| M. Rickson
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| Vol #:
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| 11
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| EMC 1018
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| L. Preisser
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| Vol #:
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| 11
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| EMC 1019
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| M. Bahleda
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| Vol #:
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| 11
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| EMC 1020
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| G. Towle
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| Vol #:
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| 11
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| EMC 1021
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| K and C Haley
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| Vol #:
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| 11
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| EMC 1022
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| M and B Dubman
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| Vol #:
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| 11
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| EMC 1023
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| North American Natural Casing Assn (NANCA)
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| Vol #:
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| 11
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| EMC 1024
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| A. Ballon
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| Vol #:
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| 11
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| 2004N-0101
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; and Requiremen
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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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| 2004N-0103
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
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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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| 2004N-0132
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
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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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| 2004N-0161
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Information from U.S. Processors that Export to the European Community
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| NAD
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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| 2004N-0166
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
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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-0214
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| Public Information Regulations
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| EC
1
Attachment
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| FAME Systems
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| Vol #:
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| 1
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| EMC
2
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| Facility Automation Management Engineering (FAME) Systems
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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 3
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| University of California Office of the President
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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 1428
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| J. Guzy
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| Vol #:
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| 19
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| EC 48
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| State University of New York at Stony Brook
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| Vol #:
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| 2
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| EC 49
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| MPH
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| Vol #:
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| 2
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| EC 50
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| Yale University
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| Vol #:
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| 2
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| EC 51
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| Dr. Steven Dickstein
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| Vol #:
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| 2
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| EMC
6
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| American Academy of Child and Adolescent Psychiatry (AACAP)
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| Vol #:
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| 2
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| EC 4
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| Gulf Coast Regional Blood Center
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| Vol #:
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| 1
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| EC 5
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| University of Washington
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| Vol #:
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| 1
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| EC 6
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| The Institute for Transfusion Medicine
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| Vol #:
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| 1
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| 2004N-0442
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations
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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-0349
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| Action on Products containing added Mercury
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| EC 19
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| N/A
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| Vol #:
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| 1
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| 2004S-0212
|
| Pandemic Influenza Preparedness and Response Plan
|
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| EC 5
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| Mr. Wolfgang Rech
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| Vol #:
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| 1
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| EC 6
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| Minnesota Department of Health
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| Vol #:
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| 1
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