| | | | | | | | | | |
|
|
| Dockets Entered
On December 20, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| 1999N-1075
|
| Vibrio Parahaemolyticus in molluscan shellfish public health
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2003N-0273
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
|
|
| 2004P-0297
|
| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
|
|
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| 2005N-0364
|
| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
| 2005N-0410
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
|
|
| 2005P-0495
|
| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
|
|
|
| 2005P-0496
|
| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
|
|
|
| 2005P-0498
|
| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| RPT
298
|
| Albion Laboratories Inc
|
| Vol #:
|
| 233
|
|
|
| RPT
299
|
| Natural ASA
|
| Vol #:
|
| 234
|
|
|
| RPT
300
|
| Access Business Group
|
| Vol #:
|
| 238
|
|
|
| RPT
301
|
| Biocodex Inc
|
| Vol #:
|
| 239
|
|
|
| RPT
302
|
| pH Sciences Inc
|
| Vol #:
|
| 230
|
|
|
| 1999N-1075
|
| Vibrio Parahaemolyticus in molluscan shellfish public health
|
|
|
| TR
4
|
| Transcript of the August 13, 2005 Meeting
|
| Vol #:
|
| 27
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
| EMC 3
|
| Diane
|
| Vol #:
|
| 1
|
|
|
| EMC 4
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| EMC 1300
|
| M. Dows
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
| C
428
|
| Australian Government
|
| Vol #:
|
| 36
|
|
|
| C 429
|
| M. Peppercorn, MD
|
| Vol #:
|
| 36
|
|
|
| C 430
|
| B. Robinson
|
| Vol #:
|
| 36
|
|
|
| C 431
|
| D. Rosenstein
|
| Vol #:
|
| 36
|
|
|
| C 432
|
| Illegible
|
| Vol #:
|
| 36
|
|
|
| C
433
|
| American Veterinary Medical Association (AVMA)
|
| Vol #:
|
| 36
|
|
|
| C
434
|
| Griffin Industries, Inc.
|
| Vol #:
|
| 36
|
|
|
| C
435
|
| Government of Japan
|
| Vol #:
|
| 36
|
|
|
| C
436
|
| Valley Proteins, Inc.
|
| Vol #:
|
| 36
|
|
|
| C 437
|
| Mr and Mrs R. Nelson
|
| Vol #:
|
| 36
|
|
|
| C 438
|
| M. Howard
|
| Vol #:
|
| 36
|
|
|
| C 439
|
| G. White
|
| Vol #:
|
| 36
|
|
|
| C
440
|
| Honorable Steve King
|
| Vol #:
|
| 36
|
|
|
| C 441
|
| S. Frantz, MD
|
| Vol #:
|
| 39
|
|
|
| C 442
|
| L. Lucas
|
| Vol #:
|
| 39
|
|
|
| C 443
|
| S. Craig
|
| Vol #:
|
| 39
|
|
|
| C 444
|
| C. Grace
|
| Vol #:
|
| 39
|
|
|
| C 445
|
| J. Buning
|
| Vol #:
|
| 39
|
|
|
| C 446
|
| M. Glowacki
|
| Vol #:
|
| 39
|
|
|
| C 447
|
| R. Vidinha
|
| Vol #:
|
| 39
|
|
|
| C 448
|
| J. Hale
|
| Vol #:
|
| 39
|
|
|
| C 449
|
| C. Tanaka
|
| Vol #:
|
| 39
|
|
|
| C 450
|
| J and C Bryan
|
| Vol #:
|
| 39
|
|
|
| C 451
|
| L. Colvin
|
| Vol #:
|
| 36
|
|
|
| C
452
|
| Mississippi Farm Bureau Federation (MFBF)
|
| Vol #:
|
| 39
|
|
|
| C
453
Attachment
|
| Virginia Department of Environmental Quality
|
| Vol #:
|
| 39
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 569
|
| Mission Possible International
|
| Vol #:
|
| 8
|
|
|
| EMC 570
|
| Mission Possible International
|
| Vol #:
|
| 8
|
|
|
| EMC 571
|
| Mission Possible International
|
| Vol #:
|
| 8
|
|
|
| EMC
572
|
| Calorie Control Council
|
| Vol #:
|
| 8
|
|
|
| EMC 573
|
| Mission Possible International
|
| Vol #:
|
| 8
|
|
|
| EMC 574
|
| Mission Possible International
|
| Vol #:
|
| 8
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
| | | | | | | | |
|
|
| EMC 1177
|
| D. Milligan
|
| Vol #:
|
| 12
|
|
|
| 2003N-0273
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
| EMC 3
|
| Diane
|
| Vol #:
|
| 1
|
|
|
| EMC 4
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
|
|
| EMC 78
|
| G. Norris
|
| Vol #:
|
| 2
|
|
|
| 2004P-0297
|
| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
|
|
|
| LET
4
|
| Center for Science In The Public Interest
|
| Vol #:
|
| 3
|
|
|
| 2005D-0340
|
| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
|
|
|
| EMC
1
Attachment
|
| Coria Laboratories, LTD
|
| Vol #:
|
| 1
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
|
| EMC
3
|
| Johnson & Johnson
|
| Vol #:
|
| 1
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| EMC
75
|
| Society for Women's Health Research
|
| Vol #:
|
| 4
|
|
|
| EMC 76
|
| W. Bradford, PhD
|
| Vol #:
|
| 4
|
|
|
| 2005N-0364
|
| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
|
|
|
| LST
1
|
| Agenda for November 17, 2005 Stakeholder Meeting
|
| Vol #:
|
| 1
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
| TS
21
|
| Pfizer
|
| Vol #:
|
| 2
|
|
|
| 2005N-0410
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
|
|
| EMC
1
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
| 2005P-0495
|
| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
|
|
|
| ACK
1
|
| Vigconic (International), Ltd.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Vigconic (International), Ltd.
|
| Vol #:
|
| 1
|
|
|
| 2005P-0496
|
| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
|
|
|
| ACK
1
|
| HFA-305 to Mayne Pharma (USA) Inc.
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Mayne Pharma (USA) Inc.
|
| Vol #:
|
| 1
|
|