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| Dockets
Entered On January 29, 2004
Table of Contents
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|
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|
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| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
| |
|
|
| 1977P-0353
|
| HAIR DYE PROD CONTAINING 4-DIAMINOANISOLE OR 4-DIAMIN-SUL
|
| |
|
|
| 1978N-0021A
|
| Skin Protectant Drug Prod to OTC, Astringent Drug Products
|
| |
|
|
| 1978N-0036L
|
| OTC Laxative
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| 1997N-0484R
|
| Human Cellular and Tissue-Based Products
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2002P-0520
|
| Reclassification of Beta-Tricalcium Phosphate,
|
| |
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
| |
|
|
| 2003E-0245
|
| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
|
| |
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
| |
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| 2003N-0425
|
| Agency Information Collection Activities: Proposed Collection; Comment Request
|
| |
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
| |
|
|
| 2003N-0506
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
|
|
|
|
|
|
|
|
|
| 2003N-0507
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
|
| |
|
|
| 2003N-0575
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients
|
| |
|
|
| 2003P-0119
|
| ANDA for Methadone Hydrochloride Tablets USP,15mg,20mg,30mg
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| 2004D-0014
|
| Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
|
| |
|
|
| 2004N-0026
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Form FDA 3356
|
|
|
|
|
|
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
| |
|
|
| 2004P-0044
|
| de nova Classification of Factor V Leiden Kit
|
| |
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
| |
|
|
| LET
146
|
| Bayer HealthCare, Consumer Care Division
|
| Vol #:
|
| 235
|
|
| | | | | | | | |
| |
|
|
| 1977P-0353
|
| HAIR DYE PROD CONTAINING 4-DIAMINOANISOLE OR 4-DIAMIN-SUL
|
| |
|
|
| ANS 1
|
| The Cosmetic, Toiletry and Franrance Assn.
|
| Vol #:
|
| 5
|
| |
|
|
| ANS 2
|
| Answer
|
| Vol #:
|
| 5
|
| |
|
|
| ANS 3
|
| Answer
|
| Vol #:
|
| 5
|
| |
|
|
| ANS 4
|
| Answer
|
| Vol #:
|
| 5
|
| |
|
|
| ANS 5
|
| Answer
|
| Vol #:
|
| 5
|
| |
|
|
| 1978N-0021A
|
| Skin Protectant Drug Prod to OTC, Astringent Drug Products
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 3
|
| |
|
|
| 1978N-0036L
|
| OTC Laxative
|
| |
|
|
| C
213
Tab
A, B,
C, D
|
| Boehringer Ingelheim Pharmaceuticals (BI)
|
| Vol #:
|
| 134
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| C 5
|
| M. Weil, MD, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| R. White, MD
|
| Vol #:
|
| 1
|
| |
|
|
| C 7
|
| D. Persse, MD,FACEP
|
| Vol #:
|
| 1
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| RPT
15
Attachments
|
| Northfield Laboratories, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| 1997N-0484R
|
| Human Cellular and Tissue-Based Products
|
| |
|
|
| NFR
2
|
| FDA
|
| Vol #:
|
| 7
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12370
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12371
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12372
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12373
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12374
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12375
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12376
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12377
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12378
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12379
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12380
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12381
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12382
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12383
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
|
| | | | | | | | |
| |
|
|
| LET
12384
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12385
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12386
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12387
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12388
|
| NBTY Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12389
|
| Natural Organics Inc.
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12390
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12391
|
| Quality of Life Labs
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12392
|
| Quality of Life labs
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12393
|
| Quality of Life Labs
|
| Vol #:
|
| 100
|
| |
|
|
| LET
12394
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 100
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7363
|
| P. Glynn
|
| Vol #:
|
| 307
|
| |
|
|
| C 7364
|
| J. Faulkner
|
| Vol #:
|
| 307
|
| |
|
|
| C 7365
|
| G. Brion
|
| Vol #:
|
| 307
|
| |
|
|
| C 7366
|
| J. McKenzie
|
| Vol #:
|
| 307
|
| |
|
|
| C 7367
|
| M. Secara
|
| Vol #:
|
| 307
|
| |
|
|
| C 7368
|
| S. Fontanarose
|
| Vol #:
|
| 307
|
| |
|
|
| C 7369
|
| C. Yanchak
|
| Vol #:
|
| 307
|
| |
|
|
| C 7370
|
| E. Katz
|
| Vol #:
|
| 307
|
| |
|
|
| C 7371
|
| A. Dubman
|
| Vol #:
|
| 307
|
| |
|
|
| C 7372
|
| T. Maderak
|
| Vol #:
|
| 307
|
| |
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
| |
|
|
| C
14
|
| Kraft Foods North America, Inc. (Kraft)
|
| Vol #:
|
| 1
|
| |
|
|
| C
15
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
|
| 2
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 350
|
| N. Rossbach
|
| Vol #:
|
| 125
|
| |
|
|
| C 351
|
| D. Davis
|
| Vol #:
|
| 125
|
| |
|
|
| C
352
|
| American Public Health Assn (APHA)
|
| Vol #:
|
| 125
|
| |
|
|
| LET
6
|
| HFD-240 to American Public Health Assn
|
| Vol #:
|
| 125
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| REF
3
|
| OMB review for Publication Date February 3, 2003
|
| Vol #:
|
| 21
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
292
|
| Crystal International
|
| Vol #:
|
| 22
|
|
| | | | | | | | |
| |
|
|
| 2002P-0520
|
| Reclassification of Beta-Tricalcium Phosphate,
|
| |
|
|
| LET
1
|
| Bicon, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
| |
|
|
| EC 1
|
| Yang, Song
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| unsigned
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0245
|
| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
| |
|
|
| EC 91
|
| Murphy, William
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
17
Attachment
1, 2, 3
|
| Grocery Manufacturers of America
|
| Vol #:
|
| 5
|
|
| |
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| C
3
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Vyas, Sharad
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Goldhammer, Alan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0425
|
| Agency Information Collection Activities: Proposed Collection; Comment Request
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
| |
|
|
| C
4
|
| Almond Board of California (ABC)
|
| Vol #:
|
| 6
|
| |
|
|
| C
5
|
| American Feed Industry Association
|
| Vol #:
|
| 6
|
| |
|
|
| C
6
|
| Nutritional Nutritoinal Foods Association
|
| Vol #:
|
| 6
|
| |
|
|
| C
7
|
| Carnegie Mellon University
|
| Vol #:
|
| 6
|
| |
|
|
| C
8
|
| American Heart Association
|
| Vol #:
|
| 6
|
| |
|
|
| EC 3
|
| Of Goverment, Afraid
|
| Vol #:
|
| 6
|
| |
|
|
| EC 5
|
| Plummer, James
|
| Vol #:
|
| 6
|
| |
|
|
| EC 6
|
| Plummer, James
|
| Vol #:
|
| 6
|
| |
|
|
| EC 7
|
| Plummer, James
|
| Vol #:
|
| 6
|
| |
|
|
| EC 8
|
| Plummer, James
|
| Vol #:
|
| 6
|
| |
|
|
| EC 9
|
| Plummer, James
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
| |
|
|
| EC 10
|
| Rader, Roger
|
| Vol #:
|
| 6
|
| |
|
|
| EC 11
|
| Soller, R. William
|
| Vol #:
|
| 6
|
| |
|
|
| NPR
2
|
| FDA
|
| Vol #:
|
| 6
|
|
| |
|
| 2003N-0506
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
|
|
|
|
|
|
|
| |
|
|
| C
2
|
| Trans Fat Industry Coalition
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0507
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
|
|
|
| C
1
|
| Trans Fat Industry Coatition
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0575
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0119
|
| ANDA for Methadone Hydrochloride Tablets USP,15mg,20mg,30mg
|
| |
|
|
| AMD
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| C
11
|
| American Academy of Audiology
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| C
2
|
| American Academy of Audiology
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0014
|
| Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2004N-0026
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Form FDA 3356
|
|
|
|
|
|
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
| |
|
|
| M 1
|
| HFM-300 to Docket
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0044
|
| de nova Classification of Factor V Leiden Kit
|
| |
|
|
| ACK
1
|
| HFZ-440 to Roche Diagnostics Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Roche Diagnostics Corporation
|
| Vol #:
|
| 1
|
|
|
|
