| | | | | |
|
|
|
|
| Dockets Entered
On August 3, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| 1994P-0036
|
| Req labeling of trans fatty acid & prohibit deceptive claims
|
|
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
|
|
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutritin
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| 2000P-1439
|
| Iceberg Water Deviating From Identity Standard
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2002P-0285
|
| Combination oxycodone hydrochloride/acetaminophen tablet
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| 2003P-0188
|
| ANDA Suitability for Glyburide & Metformin HCl Tablets
|
|
|
|
|
| 2003P-0218
|
| ANDA for Glipizide and Metformin HCI Tablets for Oral Solution
|
|
|
|
|
| 2003P-0534
|
| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
|
|
|
|
|
| 2003V-0374
|
| Laser Light Show
|
|
|
|
|
| 2004D-0065
|
| Guidance for Industry: Prior Notice of Imported Food Questions and Answers
|
|
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
|
|
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
|
|
|
|
| 2004N-0289
|
| Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
|
|
|
|
|
| 2004P-0068
|
| Establish specific bioequivalence requirements for oral products contanining desmopressin
|
|
|
|
|
| 2004P-0206
|
| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| 2004P-0320
|
| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
|
|
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
|
|
| 2004V-0278
|
| Laser Light Show
|
|
| | | | | | | | |
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| LET
116
|
| HFN-810 to Nonprescription Drug Manufactures Assn.
|
| Vol #:
|
| 95
|
|
|
|
|
| 1994P-0036
|
| Req labeling of trans fatty acid & prohibit deceptive claims
|
|
|
|
|
| C 2611
|
| K. Cooper, MD, MPH
|
| Vol #:
|
| 84
|
|
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
|
|
|
|
| SUP
4
Attachment
|
| Federal Trade Commission (FTC)
|
| Vol #:
|
| 7
|
|
|
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
|
|
|
| SUP
4
|
| Federal Trade Commission (FTC)
|
| Vol #:
|
| 9
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
14140
|
| Enzymatic Therapy
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14141
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14142
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14143
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14144
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14145
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14146
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14147
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14148
|
| New Chapter, Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14149
|
| Awareness Corporation
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14150
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14151
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14152
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14153
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 122
|
|
|
|
|
| LET
14154
|
| Nature's Answer
|
| Vol #:
|
| 122
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutritin
|
|
|
|
|
| C 105
|
| J. Salmon
|
| Vol #:
|
| 8
|
|
|
|
|
| C 106
|
| J. Wood
|
| Vol #:
|
| 8
|
|
|
|
|
| C 107
|
| L. Lockwood
|
| Vol #:
|
| 8
|
|
|
|
|
| C 108
|
| J. Burk
|
| Vol #:
|
| 8
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7444
|
| L. Taylor
|
| Vol #:
|
| 307
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
| | | | | | | | |
|
|
|
|
| C 50
|
| A. Blackwelder
|
| Vol #:
|
| 2
|
|
|
|
|
| C 51
|
| S. Sabbeth, RD
|
| Vol #:
|
| 2
|
|
|
|
|
| C 52
|
| L. Garvey
|
| Vol #:
|
| 2
|
|
|
|
|
| C 53
|
| G Harris
|
| Vol #:
|
| 2
|
|
| |
|
| C 54
|
| No signature
|
| Vol #:
|
| 2
|
|
|
|
|
| C 55
|
| P. Tyler
|
| Vol #:
|
| 2
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| C
266
|
| Association of Poultry Primary Breeder Veterinarians
|
| Vol #:
|
| 99
|
|
|
|
|
| C
267
|
| Carroll's Turkeys LLC
|
| Vol #:
|
| 99
|
|
|
|
|
| EXB 444
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 426
|
|
|
|
|
| EXB 445
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 426
|
|
|
|
|
| EXB 446
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 426
|
|
|
|
|
| EXB 447
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 426
|
|
|
|
|
| EXB 448
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 426
|
|
|
|
|
| 2000P-1439
|
| Iceberg Water Deviating From Identity Standard
|
|
|
|
|
| M
1
|
| HFS-822
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| EMC 9961
|
| K. Cottier
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9962
|
| I. Sun
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9963
|
| T. Carl
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9964
|
| M. McMahon
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9965
|
| J. L. Goldstein
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9966
|
| E. Kitzerow
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9967
|
| V. Boubelik
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9968
|
| M. M. Churchman
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9969
|
| A. Bloomenthal
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9970
|
| L. Y. Emms
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9971
|
| K. McGlashan
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9972
|
| C. Guerrero
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9973
|
| S. Harrison
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9974
|
| E. A. Fisher
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9975
|
| V. Graham
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9976
|
| N. Hill
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9977
|
| J. Grace
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 9978
|
| C. Little
|
| Vol #:
|
| 287
|
|
| | | | | | | | |
|
|
|
|
| EMC 10201
|
| K. Young
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10202
|
| C. Scottie Hardy
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10203
|
| J. Howell
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10204
|
| L. Rogalski
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10205
|
| P. Starliper
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10206
|
| M. & M. Ferriter
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10207
|
| J. P. K. Dawes
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10208
|
| V. S. Jackson
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10209
|
| J. Howell
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10210
|
| L. Rogalski
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10211
|
| P. Starliper
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10212
|
| M. & M. Ferriter
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10213
|
| J. P. K. Daews
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10214
|
| V. S. Jackson
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10215
|
| S. Wilson
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10216
|
| J. Ruby
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10217
|
| S. Nicholson
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10218
|
| C. M. Lander
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10219
|
| M. Panasenko
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10220
|
| D. Houtberg
|
| Vol #:
|
| 287
|
|
|
|
|
| EMC 10221
|
| E. Hayes
|
| Vol #:
|
| 287
|
|
|
|
|
| 2002P-0285
|
| Combination oxycodone hydrochloride/acetaminophen tablet
|
|
|
|
|
| PDN
2
|
| HF-22 to King & Spalding LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| C
20
|
| Pennington Biomedical Research Center
|
| Vol #:
|
| 12
|
|
|
|
|
| 2003P-0188
|
| ANDA Suitability for Glyburide & Metformin HCl Tablets
|
|
|
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0218
|
| ANDA for Glipizide and Metformin HCI Tablets for Oral Solution
|
|
|
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0534
|
| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003V-0374
|
| Laser Light Show
|
|
|
|
|
| AMD
1
|
| Beaming Man
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| 2004D-0065
|
| Guidance for Industry: Prior Notice of Imported Food Questions and Answers
|
|
|
|
|
| C
1
|
| Acadian Seaplants Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
|
|
| C
12
|
| University of California SanFrancisco (UCSF) Center for Consumer Self Care
|
| Vol #:
|
| 2
|
|
|
|
|
| C
13
|
| Pfizer, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
|
|
| C
12
|
| Pfizer, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| C
13
|
| University of California SanFrancisco (UCSF) Center for Consumer Self Care
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
|
|
| C
11
|
| Pfizer, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| C
12
|
| University of California SanFrancisco (UCSF) Center for Consumer Self Care
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| C
3
|
| Mayo Clinic
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| C
2
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
3
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
4
|
| American Red Cross (Red Cross)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| C
36
|
| The Epilepsy Project
|
| Vol #:
|
| 2
|
|
|
|
|
| C
37
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
38
|
| Genentech, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| C 39
|
| M. Loeffel
|
| Vol #:
|
| 2
|
|
|
|
|
| C
40
|
| Citizens United for Research in Epilepsy (CURE)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
41
|
| Cystic Fibrosis Foundation
|
| Vol #:
|
| 2
|
|
|
|
|
| C
42
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
43
|
| BIOCOM
|
| Vol #:
|
| 2
|
|
|
|
|
| C 44
|
| Illegible
|
| Vol #:
|
| 2
|
|
|
|
|
| C
45
|
| University of Pennsylvania Medical Center
|
| Vol #:
|
| 2
|
|
|
|
|
| C 46
|
| J and D Bohn
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
|
| C
47
|
| AstraZeneca, LP
|
| Vol #:
|
| 2
|
|
|
|
|
| C
48
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 2
|
|
|
|
|
| C
49
|
| Cato Research (CATO)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
|
|
|
|
| C
4
|
| The Cleveland Clinic Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
|
|
| C
11
|
| Ohio Vegetable and Potato Growers Assn (OVPGA) and Ohio Fruit Growers Society (OFGS)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| C 7
|
| E. Desipris
|
| Vol #:
|
| 7
|
|
|
|
|
| C 8
|
| S. Snyder
|
| Vol #:
|
| 7
|
|
|
|
|
| C 9
|
| D. Kozminski
|
| Vol #:
|
| 7
|
|
|
|
|
| C
10
|
| Fred D. Bisplinghoff and Associates
|
| Vol #:
|
| 7
|
|
|
|
|
| C 11
|
| Form Letters
|
| Vol #:
|
| 8
|
|
|
|
|
| C 12
|
| Form Letters
|
| Vol #:
|
| 9
|
|
|
|
|
| EXT
15
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 7
|
|
|
|
|
| EXT
16
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 7
|
|
|
|
|
| EXT
17
|
| Sun Land Beef Company
|
| Vol #:
|
| 7
|
|
|
|
|
| EXT
18
|
| US Poultry & Egg Assn
|
| Vol #:
|
| 7
|
|
|
|
|
| EXT
19
|
| Poultry Protein & Fat Council
|
| Vol #:
|
| 7
|
|
|
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
|
|
|
|
| C
1
|
| Pharmaco-Diagnostics (Rx-Dx) Partnerships Program
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0289
|
| Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0068
|
| Establish specific bioequivalence requirements for oral products contanining desmopressin
|
|
|
|
|
| LET
1
|
| HFD-005 to Buchanan Ingersoll, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0206
|
| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
|
|
|
|
|
| C
2
|
| Frommer Lawrence & Haug, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| C
1
|
| Frommer Lawrence & Haug, LLP
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0320
|
| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
|
|
|
|
|
| LET
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
