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| Dockets Entered
On January 12, 2005
Table of Contents
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| Docket #
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| Title
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| 1989P-0314
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| Exemption from Preemption on Hearing Aids
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| 1994P-0453
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| Amend Food Labeling Regs re: Quantity Of Fat Content Claims
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| 1995N-0203
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| Beverages: Bottled Water
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| 1995N-0298
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| PMA Of Partially Fabricated Denture Kits
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| 1995P-0250
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| Revoke Std of Identity - Various Lower-fat Milk & Cream Prod
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| 1996N-0149
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| Reinvention of regulations needing revision; food standards
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| 1996N-0177
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| Reinvention of certain food additive regulations
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| 1996N-0244
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| Food Labeling; Declaration of Free Glutamate in Food
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| 1996N-0364
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| Regulations of Medical Foods
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| 1996N-0421
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| Nutrient Claims pertaining available fat content of Food
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| 1996P-0023
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| Amend 101.12(b) Table 2 on Hard Candies
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| 1996P-0179
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| Establishes RACCs for various types of food products candies
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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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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003F-0128
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| Permitted Use Concentration and to Expand pH Range for acidi
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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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| 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-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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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-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| 2004N-0545
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| Nonclinical and Clinical Datasets; Notice of Pilot Project
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| 2004P-0540
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| Don't approve any new or pending ANDA for generic fentanyl transdermal product
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| 1989P-0314
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| | | | | | | | |
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| Exemption from Preemption on Hearing Aids
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| NWL
1
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| FDA
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| Vol #:
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| 10
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| 1994P-0453
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| Amend Food Labeling Regs re: Quantity Of Fat Content Claims
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1995N-0203
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| Beverages: Bottled Water
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1995N-0298
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| PMA Of Partially Fabricated Denture Kits
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1995P-0250
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| Revoke Std of Identity - Various Lower-fat Milk & Cream Prod
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1996N-0149
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| Reinvention of regulations needing revision; food standards
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| NWL
1
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| FDA
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| Vol #:
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| 6
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| 1996N-0177
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| Reinvention of certain food additive regulations
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1996N-0244
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| Food Labeling; Declaration of Free Glutamate in Food
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| NWL
2
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| FDA
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| Vol #:
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| 1
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| 1996N-0364
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| Regulations of Medical Foods
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1996N-0421
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| Nutrient Claims pertaining available fat content of Food
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| NWL
1
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| FDA
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| Vol #:
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| 5
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| 1996P-0023
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| Amend 101.12(b) Table 2 on Hard Candies
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| NWL
1
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| FDA
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| Vol #:
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| 3
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| 1996P-0179
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| Establishes RACCs for various types of food products candies
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| NWL
1
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| FDA
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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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| EXB 884
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| Bayer Corporation
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| Vol #:
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| 473
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| EXB 885
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| Bayer Corporation
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| Vol #:
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| 473
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| EXB 886
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| Bayer Corporation
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| Vol #:
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| 473
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| EXB 887
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| Bayer Corporation
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| Vol #:
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| 473
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| EMC 165
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| B. Sachau
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| Vol #:
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| 16
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
412
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| Mission Possible International
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| Vol #:
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| 7
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| EMC
413
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| Mission Possible International
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| Vol #:
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| 7
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| EMC
414
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| Mission Possible International
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| Vol #:
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| 7
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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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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| 2003F-0128
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| Permitted Use Concentration and to Expand pH Range for acidi
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| EMC 1
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| B. Sachau
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| Vol #:
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| 2
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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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| EMC 491
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| No signature
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| Vol #:
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| 9
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| EMC 492
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| T. Rondy
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| Vol #:
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| 9
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| EMC 493
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| B. Williams
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| Vol #:
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| 9
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| EMC 494
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| B. Williams
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| Vol #:
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| 9
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| EMC 495
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| P. Smith
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| Vol #:
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| 9
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| EMC 496
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| L. Lazer
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| Vol #:
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| 9
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| EMC 497
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| S. Bash
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| Vol #:
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| 9
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| EMC 498
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| K. Banister
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| Vol #:
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| 9
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| EMC 499
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| No signature
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| Vol #:
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| 9
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| EMC 500
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| K. Meyer
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| Vol #:
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| 9
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| EMC 501
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| G. Roberts
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| Vol #:
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| 9
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| EMC 502
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| G. Cruz
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| Vol #:
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| 9
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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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| EMC
294
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| National Embryo Donation Center
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| Vol #:
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| 5
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| EMC
11
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| Samritan Lebanon Community Hospital
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| Vol #:
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| 3
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| EMC
12
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| Bloomington Hospital and Healthcare System
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| Vol #:
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| 3
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| EMC
13
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| Memorial Medical Center of West Michigan
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| Vol #:
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| 3
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| EMC
14
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| Health Canada
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| Vol #:
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| 3
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| EMC
5
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| International Assn for Pharmaceutical science and Technology (PDA)
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| Vol #:
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| 1
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| | | | | | | | |
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| EMC
4
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| Triangle PEERS
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| Vol #:
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| 1
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| EMC
5
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| Phase Forward
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| Vol #:
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| 1
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| EMC
6
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| EMC
7
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| Society of Quality Assurance (SQA)
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| Vol #:
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| 1
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| EMC
1
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| Miami Research Associates
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| Vol #:
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| 1
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| EMC
1
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| Taylor Shellfish Farms
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| Vol #:
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| 1
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| EMC
2
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| North American ImEX, Inc.
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| EMC 1138
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| N and G Shinn et al.
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| Vol #:
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| 15
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| EMC 1139
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| N and G Shinn et al.
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| Vol #:
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| 15
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| EMC 1140
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| N and G Shinn et al.
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| Vol #:
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| 15
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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 1430
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| L. Pastor
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| Vol #:
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| 19
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| EMC
6
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 4
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| EMC
2
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| Accium BioSciences
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| Vol #:
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| 1
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| EMC 3
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| T. Trefts
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| Vol #:
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| 1
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| EMC
4
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| SSG Silver-Blue
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| EMC 7
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| A. Micka
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| Vol #:
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| 4
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| EMC 8
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| L. Wilson
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| Vol #:
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| 4
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| EMC 9
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| R. Rogers
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| Vol #:
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| 4
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| EMC 10
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| J. Sellens
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| Vol #:
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| 4
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| EMC 11
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| N. Ollis
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| Vol #:
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| 4
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| EMC 12
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| C. Damian
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| Vol #:
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| 4
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| EMC 13
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| W. Strobel
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| Vol #:
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| 4
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| EMC 14
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| E. Robbins
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| Vol #:
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| 4
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| EMC 15
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| E. Robbins
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| Vol #:
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| 4
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| EMC 16
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| D. Kepanis
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| Vol #:
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| 4
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