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| Dockets Entered
On October 2, 2003
Table of Contents
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| Docket #
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| Title
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| 1993P-0174
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| Amend Regs for Liquid Medicated Animal Feed
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1997D-0302
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| Consumer-Directed Broadcast Advertisements
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-1146
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| Microbial effects of antimicrobial new animal drugs/human sa
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| 1998V-0703
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| Laser Light Show
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999V-0125
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| Laser Light Show Laserium CSMX250
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0063
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| Consumer Surveys on Food & Dietary Supplement Labeling
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| 2002N-0204
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| Bar Code Label Requirements for human drug products
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0186
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| Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
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| 2003D-0226
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| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
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| 2003D-0236
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| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003N-0338
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| Obesity
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| | | | | | | | |
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| 2003N-0424
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0279
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| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| 2003V-0052
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| Laser Light Show
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| C
120
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| US Dermatologics, Inc. (US Derm)
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| Vol #:
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| 102
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| 1993P-0174
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| Amend Regs for Liquid Medicated Animal Feed
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| EMC
1
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| National Grain and Feed Assn (NGFA)
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| Vol #:
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| 1
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
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| EMC 902
|
| Charles Rodholm
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| Vol #:
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| 375
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| EMC 903
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| Sue Parker
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| Vol #:
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| 375
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| EMC 904
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| Tood, April & Joshua Cooper
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| Vol #:
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| 375
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| EMC 905
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| Tood, April & Joshua Cooper
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| Vol #:
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| 375
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| EMC 906
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| No signature
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| Vol #:
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| 375
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| EMC 907
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| Marjorie S. Kemp
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| Vol #:
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| 375
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| EMC 908
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| Marjorie S. Kemp
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| Vol #:
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| 375
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| EMC 909
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| Pam Mitchell
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| Vol #:
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| 375
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| EMC 910
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| Jessica Lopretta
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| Vol #:
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| 375
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| EMC 911
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| No signature
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| Vol #:
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| 375
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| EMC 912
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| Susan Wagganer, RN
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| Vol #:
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| 375
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| EMC 913
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| No signature
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| Vol #:
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| 375
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| EMC 914
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| Maryellen Baker
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| Vol #:
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| 375
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| EMC 915
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| Beau G. Barendt,MCSE,CCA
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| Vol #:
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| 375
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| EMC 916
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| Pam Carnline
|
| Vol #:
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| 375
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| EMC 917
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| Betty Martini
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| Vol #:
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| 375
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| EMC 918
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| Don Unhock
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| Vol #:
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| 375
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| LET
11
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| HFS-800 to Colorado Biolabs, Inc.
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| Vol #:
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| 116
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
|
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| EMC 257
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| Lucinda
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| Vol #:
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| 41
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| 1997D-0302
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| Consumer-Directed Broadcast Advertisements
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| | | | | | | | |
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| EMC 539
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| Deb Fett
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| Vol #:
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| 32
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| EMC 540
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| Bonita Aures
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| Vol #:
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| 32
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| EMC 541
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| David Quintana
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| Vol #:
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| 32
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| EMC 542
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| Martha Gene Landry-Murphy
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| Vol #:
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| 32
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| EMC 543
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| Lauren Murphy
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| Vol #:
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| 32
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| EMC 544
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| Julie Ta
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| Vol #:
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| 32
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| EMC 545
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| Marlene Lesson
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| Vol #:
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| 32
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| EMC 546
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| Amy Ard
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| Vol #:
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| 32
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| EMC 547
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| Jennifer Ingersoll
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| Vol #:
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| 32
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| EMC 548
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| Jill Mittelhauser Geiger
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| Vol #:
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| 32
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| EMC 549
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| Emily Bates
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| Vol #:
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| 32
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| EMC 550
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| J. Fordyce
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| Vol #:
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| 32
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| EMC 551
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| Annie Christopher
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| Vol #:
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| 32
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| EMC 552
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| Christine Dobberpuhl
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| Vol #:
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| 32
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| EMC 553
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| Judy Murnan
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| Vol #:
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| 32
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| 1999V-0125
|
| Laser Light Show Laserium CSMX250
|
|
|
|
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| VRA
3
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| HFZ-300 to Universal Orlando
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| Vol #:
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| 1
|
|
|
|
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| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
|
|
|
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| EMC
10
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| European Federation of Pharmaceutical Industries and Associations (EFPIA)
|
| Vol #:
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| 3
|
|
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| EMC
11
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| PPD Medical Communications
|
| Vol #:
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| 3
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|
|
|
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| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
|
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| EMC
24
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| Pascual Dairy, Inc.
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| Vol #:
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| 1
|
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| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
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| EMC 448
|
| Ruth Solomon
|
| Vol #:
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| 8
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|
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| EMC 449
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| Barbara Thrasher
|
| Vol #:
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| 8
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| EMC 450
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| Deborah Syme
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| Vol #:
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| 8
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|
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| EMC 451
|
| Jody Moren
|
| Vol #:
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| 8
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|
|
|
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| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| EMC 454
|
| Jessica M. Sell
|
| Vol #:
|
| 39
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| EMC 3094
|
| Jody Moren
|
| Vol #:
|
| 252
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
| | | | | | | | |
|
|
|
|
| EMC 1197
|
| Lindsay Star
|
| Vol #:
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| 5
|
|
|
|
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| EMC 1198
|
| Cindy Motz
|
| Vol #:
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| 5
|
|
|
|
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| EMC 1199
|
| Judy Fairbanks
|
| Vol #:
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| 5
|
|
|
|
|
| EMC 1200
|
| Jessica
|
| Vol #:
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| 5
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 130
|
| Mary Logerfo
|
| Vol #:
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| 3
|
|
|
|
|
| 2002N-0063
|
| Consumer Surveys on Food & Dietary Supplement Labeling
|
|
|
|
|
| EMC
11
|
| Honorable Ron Paul
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0204
|
| Bar Code Label Requirements for human drug products
|
|
|
|
|
| EMC
205
|
| CDO Technologies, Inc.
|
| Vol #:
|
| 16
|
|
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
|
|
| EMC
7
|
| Association of Medical Device Reprocessors (AMDR)
|
| Vol #:
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| 2
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 273
|
| Betty Martini
|
| Vol #:
|
| 5
|
|
|
|
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| EMC 274
|
| Betty Martini
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 275
|
| Betty Martini
|
| Vol #:
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| 5
|
|
|
|
|
| EMC 276
|
| Betty Martini
|
| Vol #:
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| 5
|
|
|
|
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| EMC 277
|
| Betty Martini
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 278
|
| Betty Martini
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 279
|
| Betty Martini
|
| Vol #:
|
| 5
|
|
|
|
|
| 2003D-0186
|
| Guidance for Industry: Use of Material From Deer and Elk In Animal Feed
|
|
|
|
|
| EMC 7
|
| Terry S. Singeltary Sr.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0226
|
| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
|
|
|
|
|
| EMC
1
|
| Association of Medical Device Reprocessors (AMDR)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| McKesson Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0236
|
| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
|
|
|
|
|
| EMC
1
|
| American Association of Blood Banks (AABB)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
Attachment
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0263
|
| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
|
|
|
|
|
|
|
|
|
| EMC
1
|
| U.S. Apple Association (USApple)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| The Implementation Working Group (IWG)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| EMC
3
|
| Minor Crop Farmers Alliance (MCFA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| The Implementation Working Group (IWG)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
5
|
| U.S. Apple Association (USApple)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
6
|
| Perishable Proiducts and Flowers National Dept of Agriculture, South Africa
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
7
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
|
|
| EMC
1
|
| Bovis Lend Lease
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Agalloco & Associates
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| C
3
|
| American Dietetic Asscociation (ADA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
|
|
| APE 22
|
| FFF Enterprises, Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| APE 23
|
| National Agency of Vigilancia Sanitaria (ANVISA), Brasil
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 24
|
| Massachusetts Institute of Technology
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 25
|
| Tracer Detection Technology Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 26
|
| Pharmaceutical Printed Literature Association (PPLA)
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 27
|
| Flex Products, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 28
|
| Owens-Illinois, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 29
|
| Pharmaceutical Research and Manufacturers of American (PhRMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 30
|
| Chromatic Technologies, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 31
|
| AMCO
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 32
|
| INKODE Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 33
|
| Industrial Fingerprinting (Pharmaceutical
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 34
|
| Enercon Industries
|
| Vol #:
|
| 1
|
|
|
|
|
| APE 35
|
| ANGSTROM TECHNOLOGIES
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
1
|
| Congruence LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0424
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 29
|
| Jonathan Camp
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
|
|
| EMC
3
Attachment
|
| National Breat Cancer Coalition
(NBCC)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| Patient Representative/Consultant,Breast Cancer
|
| Vol #:
|
| 1
|
|
