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| Dockets Entered
On August 8, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0231
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| PENICILLIN IN ANIMAL FEEDS
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| 2005A-0014
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| Regarding hip joint metal constrained
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| 2005N-0031
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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| 2005N-0045
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| 1977N-0231
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| PENICILLIN IN ANIMAL FEEDS
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| ANS
587
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| HFV-1 to A. T. Blades
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| Vol #:
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| 23
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| 2005A-0014
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| Regarding hip joint metal constrained
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| LET
1
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| HFZ-001 to Bill G. Pierson #907177
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| Vol #:
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| 1
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| C
7
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| C
8
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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| C
9
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| National Council on Patient Information and Education (NCPIE)
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| Vol #:
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| 1
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| C
10
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 1
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| C
11
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| Genentech
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| Vol #:
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| 1
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| C
12
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| American Society of Clinical Oncology (ASCO)
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| Vol #:
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| 1
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| EC
5
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| American Medical Association
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| Vol #:
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| 1
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| EC
6
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| Hoffmann-La Roche, Inc.
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
16
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| C 8
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| J. Halperin
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| Vol #:
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| 2
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| C
2
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| Bristol-Myers Squibb (BMS)
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| Vol #:
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| 1
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| C
3
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| Health Industry Group Purchasing Association (HIGPA)
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| Vol #:
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| 1
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| C
8
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| Grunenthal USA, Inc.
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| Vol #:
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| 1
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| C
9
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| C
10
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| EC
9
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| Japan Pharmaceutical Manufacturers Association
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| Vol #:
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| 1
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| EC
10
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| Bristol-Myers Squibb
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| Vol #:
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| 1
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| EC
11
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| Organon
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| Vol #:
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| 1
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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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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| 2005N-0031
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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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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| 2005N-0045
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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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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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| C
1
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| International Wheat Gluten Association (IWGA) and European Cereal Starch Industry Association (AA
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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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| EC
18
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| Miss. Amanda Kennedy
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| Vol #:
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| 1
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| EC
19
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| Mr. Doug Buntley
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| Vol #:
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| 1
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| EC
20
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| Mrs. Roxanna Perry
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| Vol #:
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| 1
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| EC
21
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| Mrs. lorrie kelley
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| Vol #:
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| 1
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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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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