|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered
On April 19, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic,
Antipyretic & Antirheumatic Products
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the
Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value
for "added sugars"
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive
yellow #5 for use in food/Drug
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using
Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration
of Food Facilities
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of
Imported Food Shipments
|
|
|
| 2002P-0317
|
| Recall Aspartame as
a Neurotoxic Drug
|
|
|
|
|
| 2003D-0493
|
| Guidance on Powder Blends
and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling
and Assessmen
|
|
|
|
|
| 2003D-0545
|
| Questions and Answers Regarding
Registration of Food Facilities
|
|
|
| 2003D-0570
|
| Draft on the Clinical
Evaluation of Weight-Control Drugs
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty,
Korangy Radiology Associates, PA
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety
System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture
and Distribution of Animal Feeds
|
|
|
| 2003N-0400
|
| Control of Communicable
Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain
Other Animals
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving
(ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading
Labeling
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner
of Food and Drug take action described methodology for oral levothyroxine
sodium drug products
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
|
|
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug
Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation
Study
|
|
|
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear
Applicant Letter Regarding Metaxalone Labeling
|
|
|
| 2004S-0170
|
| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic,
Antipyretic & Antirheumatic Products
|
|
|
|
|
| SUP
50
|
| Brigham and Women's
Hospital
|
| Vol #:
|
| 235
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
13648
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13649
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13650
|
| Enzymatic Therapy Naural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13651
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13652
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13653
|
| PhytoPharmica Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13654
|
| PhytoPharmica Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13655
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13656
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13657
|
| Enzymatic Therapy Natural
Medicines
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13658
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13659
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
| | | | | | | | |
|
|
|
|
| LET
13660
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13661
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13662
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13663
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13664
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13665
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| LET
13666
|
| Neways, Inc.
|
| Vol #:
|
| 115
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7432
|
| J. Klein
|
| Vol #:
|
| 307
|
|
|
|
|
| EMC 4219
|
| T. Hutchings
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4220
|
| J. Burns
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4221
|
| C. Brennan
|
| Vol #:
|
| 304
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| EMC 4196
|
| E. Kempf
|
| Vol #:
|
| 515
|
|
|
|
|
| EMC 4197
|
| E. Kempf
|
| Vol #:
|
| 515
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 780
|
| J. Hodges
|
| Vol #:
|
| 33
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| EC 716
|
| Mrs. Maureen Quackenbush
|
| Vol #:
|
| 163
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1229
|
| A. Cox
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 161
|
| D. Wahlberg
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 162
|
| S. Kramer, MPH
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 163
|
| I. Mason
|
| Vol #:
|
| 3
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| EC 349
|
| Porter Marketing Group, Inc.
|
| Vol #:
|
| 20
|
|
|
|
|
| EC 350
|
| Poplar Valley Organic Farms inc.
|
| Vol #:
|
| 20
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| EC 392
|
| Quik X Transportation
|
| Vol #:
|
| 22
|
|
|
|
|
| EC 393
|
| Affiliated Customs Brokers
|
| Vol #:
|
| 22
|
|
|
|
|
| EC 394
|
| WebWright Enterprises
|
| Vol #:
|
| 22
|
|
| | | | | | | | |
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 329
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 330
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003D-0493
|
| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
|
|
|
|
| EMC
9
|
| Johnson and Johnson Pharmaceutical Research and Development, LLC
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003D-0545
|
| Questions and Answers Regarding Registration of Food Facilities
|
|
|
|
|
| EC 5
|
| Seko Worldwide
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Hasbro, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Seawind Trading International
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Seawind Trading International
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0570
|
| Draft on the Clinical Evaluation of Weight-Control Drugs
|
|
|
|
|
| C
2
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
Attachment
|
| Pennington Biomedical Research Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
| CS
4
|
| HFA-305
|
| Vol #:
|
| 2
|
|
|
|
|
| OR
4
|
| HF-3
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| C
19
|
| United Coconut Associations of the Philippines (UCAP)
|
| Vol #:
|
| 7
|
|
|
|
|
| C
20
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 7
|
|
|
|
|
| C
21
|
| Independent Bakers Assn (IBA)
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 16
|
| Loders Croklaan
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 17
|
| Ms. Lila Shelton
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
18
Attachment
|
| The American Dietetic Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 19
|
| Sonoma State University
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
20
Attachment
|
| American Heart Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 21
|
| Institute of Shortening and Edible Oils
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
22
Attachment
|
| BanTransFats.com, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
23
Attachment
|
| BanTransFats.com, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
24
Attachment
|
| Federal Trade Commission
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 25
|
| Miss. Jennifer Willis
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 163
|
| I. Mason
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 164
|
| V. Dynak
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 165
|
| V. Dynak
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 166
|
| S. Muia
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
|
|
|
| EMC
167
|
| BantransFats.com
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
168
|
| The Institute of Shortening and Edible Oils (ISEO)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 169
|
| No signature
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
170
Attachment
|
| Federal Trade Commission (FTC)
|
| Vol #:
|
| 3
|
|
|
|
|
| NEC
2
|
| FDA
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| EC 4
|
| Victims of Pedigree Pet Food Mycotoxin Poisoning
|
| Vol #:
|
| 4
|
|
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
| C 99
|
| Illegible
|
| Vol #:
|
| 37
|
|
|
|
|
| C 100
|
| D. Hogue
|
| Vol #:
|
| 99
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| SUP
5
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 69
|
| A and B Powers
|
| Vol #:
|
| 6
|
|
|
|
|
| C 70
|
| A. Medeiros
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| SUP
6
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
|
|
| C 5
|
| E. Abraham
|
| Vol #:
|
| 2
|
|
|
|
|
| C 6
|
| D. Carwile
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 18
|
| Committee for Truth in Psychiatry
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0050
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
|
|
|
|
| EXT
1
|
| Clariant GmbH
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| APE 11
|
| National Alliance for the Mentally Ill (NAMI)
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 12
|
| London School of Economics and Political Science
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 13
|
| Canadian Treatment Action Council
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 14
|
| Consumer Advocare Network (Canada)
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 15
|
| Lewis T Kontnik
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 16
|
| Coalition for Manitoba Pharmacy
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 17
|
| RetireSafe.org
|
| Vol #:
|
| 3
|
|
|
|
|
| APE 18
|
| Giuliani Partners/Giuliani-Kerik
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
|
|
|
| EC
26
|
| Mr. Kurt Hoehne
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
27
|
| Ms. Bonnie Hall
|
| Vol #:
|
| 3
|
|
|
|
|
| EC
28
|
| Ms. Barb Ditzenberger
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
14
|
| State of Illinois
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
15
|
| London School of Economics and Political Science
|
| Vol #:
|
| 4
|
|
|
|
|
| TS
16
|
| American Society of Health-System Pharmacist's
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
17
|
| Canadian Treatment Action Council
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
18
|
| National Alliance for the Mentally Ill (NAMI)
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
19
|
| Consumer Advocare Network (Canada)
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
20
|
| Jeffrey Axelrad
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
21
|
| Flex Products
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
22
|
| Lewis Kontnik
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
23
|
| Coalition for Manitoba Pharmacy
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
|
|
|
|
| SUP
1
Exhibits
|
| King Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| EC 2
|
| Mr. John Perun
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
|
|
| EC
1
Attachment
|
| Washington University
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| West Virginia Medical Institute
|
| Vol #:
|
| 1
|
|
