| | | | | |
|
|
| Dockets Entered
On February 10, 2004
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| 1995P-0099
|
| Permit term Polyols in Lieu of Sugar Alcohols on Food Label
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
| 1996P-0143
|
| Amend food labeling regs to permit removal of ingredients of
|
|
|
| 1997P-0056
|
| Caloric value not more than two per gram for soluble fiber
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| 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-0338
|
| Obesity
|
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
|
|
| 2003N-0482
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10
|
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
|
| | | | | | | | |
|
|
| EMC 1211
|
| G. Case
|
| Vol #:
|
| 377
|
|
|
| EMC 1212
|
| G. Case
|
| Vol #:
|
| 377
|
|
|
| EMC 1213
|
| B. Davis
|
| Vol #:
|
| 377
|
|
|
| EMC 1214
|
| M. Tice
|
| Vol #:
|
| 377
|
|
|
| EMC 1215
|
| C. Murray
|
| Vol #:
|
| 377
|
|
|
| EMC 1216
|
| R. Polanowski
|
| Vol #:
|
| 377
|
|
|
| 1995P-0099
|
| Permit term Polyols in Lieu of Sugar Alcohols on Food Label
|
|
|
| EMC
1
|
| Calorie Control Council
|
| Vol #:
|
| 1
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
| EMC
261
Attachment
|
| American Herbal Products Assn, Council for Responsible Nutrition and National Nutritional Foods Ass
|
| Vol #:
|
| 41
|
|
|
| 1996P-0143
|
| Amend food labeling regs to permit removal of ingredients of
|
|
|
| EMC
1
|
| Calorie Control Council
|
| Vol #:
|
| 1
|
|
|
| 1997P-0056
|
| Caloric value not more than two per gram for soluble fiber
|
|
|
| EMC
1
|
| Calorie Control Council
|
| Vol #:
|
| 2
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
12633
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12634
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12635
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12636
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12637
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12638
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 103
|
|
|
| LET
12639
|
| MuscleTech Research and Development, Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12640
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12641
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12642
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12643
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12644
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12645
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12646
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12647
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12648
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| LET
12649
|
| NBTY Inc.
|
| Vol #:
|
| 103
|
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
|
| | | | | | | | |
|
|
| EMC
29
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
|
| 2
|
|
|
| EMC
30
|
| Dairy & Food Culture Technologies
|
| Vol #:
|
| 2
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| EMC 5769
|
| Mike Lenkowski
|
| Vol #:
|
| 789
|
|
|
| EMC 5770
|
| Benjamin Carl
|
| Vol #:
|
| 789
|
|
|
| EMC 5771
|
| Benjamin Carl
|
| Vol #:
|
| 789
|
|
|
| EMC 5772
|
| Tigre Lusardi
|
| Vol #:
|
| 789
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
| EMC 467
|
| R. Thurstin
|
| Vol #:
|
| 8
|
|
|
| EMC 468
|
| D. Lozier
|
| Vol #:
|
| 8
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EMC 2946
|
| J. Schmitt
|
| Vol #:
|
| 130
|
|
|
| EMC 2947
|
| D. Myers
|
| Vol #:
|
| 130
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| EMC 3155
|
| H. Stucky
|
| Vol #:
|
| 252
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| EMC 1217
|
| L. Kelly
|
| Vol #:
|
| 5
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| EMC 146
|
| A. Adams
|
| Vol #:
|
| 3
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 309
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 129
|
| D. Tanner
|
| Vol #:
|
| 3
|
|
|
| EMC 130
|
| C. Rye
|
| Vol #:
|
| 3
|
|
|
| EMC 131
|
| No signature
|
| Vol #:
|
| 3
|
|
|
| EMC 132
|
| K. Grube
|
| Vol #:
|
| 3
|
|
|
| EMC 133
|
| M. Vanderville
|
| Vol #:
|
| 3
|
|
|
| EMC 134
|
| I. Walker, MD
|
| Vol #:
|
| 3
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| EMC
51
|
| Calorie Control Council
|
| Vol #:
|
| 10
|
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
|
| | | | | | | | |
|
|
| EMC
2
|
| Hogan & Hartson, LLP
|
| Vol #:
|
| 1
|
|
|
| 2003N-0482
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
| EMC 6
|
| M. Weeks
|
| Vol #:
|
| 6
|
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
| EMC 38
|
| P. McMahon
|
| Vol #:
|
| 4
|
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
|
|
| EMC 84
|
| A. Thornburg
|
| Vol #:
|
| 3
|
|
|
| EMC 85
|
| J. Lynch
|
| Vol #:
|
| 3
|
|
|
| EMC 86
|
| No signature
|
| Vol #:
|
| 3
|
|
|
| EMC 87
|
| No signature
|
| Vol #:
|
| 3
|
|
|
| EMC 88
|
| C. Wheldon
|
| Vol #:
|
| 3
|
|
|
| EMC 89
|
| B. Drury
|
| Vol #:
|
| 3
|
|
|
| EMC 90
|
| D. Motley
|
| Vol #:
|
| 3
|
|
|
| EMC 91
|
| D. Kopel
|
| Vol #:
|
| 3
|
|
|
| EMC
92
|
| Hepatitis Education Project
|
| Vol #:
|
| 3
|
|
|
| EMC 93
|
| S. Turner
|
| Vol #:
|
| 3
|
|
|
| EMC 94
|
| S. Griffin
|
| Vol #:
|
| 3
|
|
|
| EMC 95
|
| F. Leenknecht
|
| Vol #:
|
| 3
|
|
|
| EMC 96
|
| F. Leenknecht
|
| Vol #:
|
| 3
|
|
|
| EMC 97
|
| O. Shachar, MD
|
| Vol #:
|
| 3
|
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
|
|
| EMC
38
|
| Audiology Foundation of America
|
| Vol #:
|
| 2
|
|
|
| EMC
39
|
| Hearing Centers Network
|
| Vol #:
|
| 2
|
|
|
| EMC
40
|
| International Hearing Society (IHS)
|
| Vol #:
|
| 2
|
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
|
|
| EMC
15
|
| Audiology Foundation of America (AFA)
|
| Vol #:
|
| 1
|
|
|
| EMC
16
|
| Hearing Centers Network
|
| Vol #:
|
| 1
|
|
|
| EMC
17
|
| International Hearing Society (IHS)
|
| Vol #:
|
| 1
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
| EMC
6
|
| American Thyroid Assn
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10
|
|
|
| EMC 1
|
| R. Thomsen, MD
|
| Vol #:
|
| 1
|
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
|
|
| EMC 38
|
| D. Nelson
|
| Vol #:
|
| 1
|
|
|
| 2004D-0027
|
| Guidance for Industry on Time and Extent Applications
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| BKG
2
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| GDL
2
|
| guidance
|
| Vol #:
|
| 1
|
|
|
| GDL
3
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
| SUP
2
|
| Purdue Pharma L P
|
| Vol #:
|
| 1
|
|
|
| 2004P-0061
|
| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
|
|
|
| ACK 1
|
| HFA-305 to Reed Smith, LLP
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Jerome Stevens Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|