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| Dockets Entered
On August 23, 2004
Table of Contents
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| Docket #
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| Title
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| 1982N-0166
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| OTC Drug Products for Overindulgence of Alcohol
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| 1986V-0315
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| Ion laser technology series ILT 5000 Demo unit
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1997D-0299
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| Ethnic Factors in the Acceptability of Foreign Clinical Data
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| 1997N-0484R
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| Human Cellular and Tissue-Based Products
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 1998N-0583
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| Exports: Notification and Recordkeeping requirements
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| 1999N-0193
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| Supplements and Other Changes to an Approved Application
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0558
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| Guidance Levels for Radionuclides in Domestic and Imported Foods
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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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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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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-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 1982N-0166
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| OTC Drug Products for Overindulgence of Alcohol
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| LET
4
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| Procter & Gamble Company (P&G)
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| Vol #:
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| 26
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| 1986V-0315
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| Ion laser technology series ILT 5000 Demo unit
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| VRA
9
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| HFZ-300 to California Technical Associates dba CTA Systems
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| Vol #:
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| 1
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C
251
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| Biotec Foods/Biomed Foods/Biovet International
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| Vol #:
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| 43
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| EMC
263
Attachment
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| Biotec Foods/Biomed Foods/Biovet International
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| Vol #:
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| 43
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| 1997D-0299
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| Ethnic Factors in the Acceptability of Foreign Clinical Data
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| C
5
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| 1997N-0484R
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| Human Cellular and Tissue-Based Products
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| C
31
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| California Cryobank, Inc.
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| Vol #:
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| 7
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| C
32
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| The Repository, Inc.
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| Vol #:
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| 7
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| C
33
Attachment 1,
2
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| Sperm & embryo Bank of New Jersey, Inc. (SEBNJ)
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| Vol #:
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| 7
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| C
497
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| Assn of Organ Procurement Organizations (AOPO)
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| Vol #:
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| 44
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| C
109
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 9
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| C
110
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 9
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| C
111
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| Assn for Dressings and Sauces (ADS)
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| Vol #:
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| 9
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| C
112
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| Cosmetic, Toiletry and Fragrance Assn (CTFA)
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| Vol #:
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| 9
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| C
113
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| International Food Additives Council (IFAC)
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| Vol #:
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| 9
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| C
114
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| Calorie Control Council (the Council)
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| Vol #:
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| 9
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| C
115
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 9
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| C
116
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| International Bottled Water Assn (IBWA)
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| Vol #:
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| 9
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| C
117
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| Food Allergy & Anaphylaxis Network
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| Vol #:
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| 9
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| EMC
18
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| Kraft Foods
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| Vol #:
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| 8
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| EMC
19
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 8
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| 1998N-0583
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| Exports: Notification and Recordkeeping requirements
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| C
19
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 4
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| C
20
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| Grocery Manufacturers of America (GMA) and the Cosmetic, Toiletry and Frangrance Assn (CTFA)
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| Vol #:
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| 4
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| C
21
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| Grocery Manufacturers of America (GMA) and the Cosmetic, Toiletry and Frangrance Assn (CTFA)
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| Vol #:
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| 4
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| EMC
2
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 4
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|
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| 1999N-0193
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| Supplements and Other Changes to an Approved Application
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|
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| C
33
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| International Phamaceutical Exipients Council of the Americas (IPEC-Americas)
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| Vol #:
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| 5
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|
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
|
|
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|
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| EMC 551
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| T. Oliver
|
| Vol #:
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| 24
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|
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| 1999P-5106
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| Identify Sources of Natural Flavorings
|
|
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|
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| EMC 200
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| L. B. Irish
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| Vol #:
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| 3
|
|
|
|
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
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| C
273
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| Jennie-O Turkey Store
|
| Vol #:
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| 99
|
|
| | | | | | | | |
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| EXB 471
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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| EXB 472
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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|
|
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| EXB 473
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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|
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| EXB 474
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| Center for Veterinary Medicine
|
| Vol #:
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| 431
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|
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| EXB 475
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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|
|
|
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| EXB 476
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| Center for Veterinary Medicine
|
| Vol #:
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| 431
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|
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| EXB 477
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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|
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| EXB 478
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| Center for Veterinary Medicine
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| Vol #:
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| 431
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|
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
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| EMC 10254
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| R. McCook
|
| Vol #:
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| 287
|
|
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| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
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|
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| EMC 359
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| Dr. B. Martini
|
| Vol #:
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| 6
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| EMC 360
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| R. Murray
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| Vol #:
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| 6
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|
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| EMC 361
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| R. Murray
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| Vol #:
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| 6
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| EMC 362
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| Dr. B. Martini
|
| Vol #:
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| 6
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|
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| EMC 363
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| Dr. B. Martini
|
| Vol #:
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| 6
|
|
|
|
|
| 2003D-0558
|
| Guidance Levels for Radionuclides in Domestic and Imported Foods
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
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| EMC 329
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| L. Cotter
|
| Vol #:
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| 8
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| EMC 330
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| L. Cotter
|
| Vol #:
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| 8
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|
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| EMC 331
|
| No signature
|
| Vol #:
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| 8
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|
|
|
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| EMC 332
|
| S. Webb
|
| Vol #:
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| 8
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|
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| EMC 333
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| K. Allen
|
| Vol #:
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| 8
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|
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| EMC 334
|
| J. Waters
|
| Vol #:
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| 8
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| EMC 335
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| J. Moore
|
| Vol #:
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| 8
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| EMC 336
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| J. Graham
|
| Vol #:
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| 8
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|
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| EMC 337
|
| S and C Moore
|
| Vol #:
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| 8
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|
|
|
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| EMC 338
|
| J. Peek
|
| Vol #:
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| 8
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|
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|
|
| EMC 339
|
| F. Marice
|
| Vol #:
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| 8
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|
|
|
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| EMC 340
|
| T. Lilly
|
| Vol #:
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| 8
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|
|
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| EMC 341
|
| M. Goodman
|
| Vol #:
|
| 8
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|
|
|
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| EMC 342
|
| L. Ball
|
| Vol #:
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| 8
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|
|
|
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| EMC 343
|
| E. Manaois
|
| Vol #:
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| 8
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|
| | | | | | | | |
|
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|
|
| EMC 344
|
| E. Davies
|
| Vol #:
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| 8
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|
|
|
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| EMC 345
|
| M. Jennings
|
| Vol #:
|
| 8
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|
|
|
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| EMC 346
|
| J. Jack
|
| Vol #:
|
| 8
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|
|
|
|
| EMC 347
|
| J. Halloran
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 348
|
| D. Christian
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
|
|
| EMC 8
|
| D. Weitz
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 9
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| A. Jonge
|
| Vol #:
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| 2
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|
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| EMC 10
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| L. McCullough
|
| Vol #:
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| 2
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| EMC 11
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| D. Oaks
|
| Vol #:
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| 2
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|
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|
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| EMC 12
|
| C. Smith
|
| Vol #:
|
| 2
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|
|
|
|
| EMC
13
|
| Protection & Advocacy, Inc. (PAI)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| EMC
5
|
| Seneca Foods Corporation
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
6
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
7
|
| Public Citizen
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| EMC
8
|
| Pfizer, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
9
|
| National Consumers League
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| EMC 242
|
| A. Penwarden
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 243
|
| K. Ross
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 244
|
| N and R Poole
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 245
|
| M. Surrette
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 246
|
| A. Brainerd
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 247
|
| H. Devos
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 248
|
| S. Burk
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 249
|
| T. Vertullo
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 250
|
| B. Reed
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 251
|
| J. Benzel
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 252
|
| J. Steck
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 253
|
| A. Lashley
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 254
|
| J. Barkdull
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 255
|
| L. Sinovoi
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
|
|
|
| EMC 256
|
| Dr. A. Colby
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 257
|
| No signature
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 258
|
| H. Merritt
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 259
|
| J. Mendlik
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 260
|
| C. Mendlik
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 261
|
| V. Katsikis
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 262
|
| C. Tagawa
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 263
|
| J and C Hague
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 264
|
| N. Cotton
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 265
|
| C. Williams
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 266
|
| A. Perez
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 267
|
| A. Perez
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| EMC
1
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Blood Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| EXT
1
|
| Ecumed Health Group, Amador Reyes
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
2
|
| Ecumed Health Group, Erlinda B. Enriquez
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| EMC
3
|
| Golden State Foods (GSF)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
Exhibit 1, 2
|
| Lafarge North America, Inc. (Lafarge)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
5
|
| Rohwer Technical Consulting, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
|
|
|
|
| EMC
2
|
| National electrical Manufacturers Assn (NEMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
|
|
| EMC
11
Attachment 1, 2
|
| American Meat Institute (AMI)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
12
|
| NOVA Chemicals, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
13
|
| Devro, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
14
|
| Nitta Casings, Inc. (NCI)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 15
|
| F. McDonald, III
|
| Vol #:
|
| 3
|
|
