| | | | | | | | | | |
|
| |
|
| Dockets Entered
On April 25, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
|
|
| 1977N-0094I
|
| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1998D-0514
|
| Industry on ANDA's: Impurities in Drug Substances
|
|
|
|
|
| 2000D-1383
|
| Surveillance & Detention w/o Physical Examination of Condoms
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
|
|
|
|
| 2004N-0242
|
| Institutional Review Boards; Registration Requirements
|
|
|
|
|
| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| 2004N-0539
|
| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
|
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
|
|
| 2005P-0013
|
| Cefixime for Oral Suspension, 200 mg/mL, as an Abbreviated New Drug Applicaton(ANDA)
|
|
|
|
|
| 2005P-0044
|
| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
|
|
|
|
|
| 2005P-0060
|
| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
|
|
|
|
|
| 2005P-0080
|
| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
|
|
|
|
|
| 2005P-0090
|
| Amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis, intended purpose and actual societal needs
|
|
|
|
|
| 2005P-0093
|
| Revoke part of 5 CFR 5501.104(b)(3) prohibits owership of financial interest in a publicly traded or publicly available inestment funds
|
|
| |
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
|
|
| MT
16
|
| HFD-560 and Consumer Healthcare Products Assn (CHPA)
|
| Vol #:
|
| 257
|
|
|
|
|
| 1977N-0094I
|
| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
|
|
|
|
|
| MT
1
|
| HFD-560 and Consumer Healthcare Products Assn (CHPA)
|
| Vol #:
|
| 10
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| CR 9
|
| Number not used
|
| Vol #:
|
| 150
|
|
| | | | | | | | |
|
|
|
| 1998D-0514
|
| Industry on ANDA's: Impurities in Drug Substances
|
|
|
|
|
| C
8
|
| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals (Sanofi Aventis)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000D-1383
|
| Surveillance & Detention w/o Physical Examination of Condoms
|
|
|
|
|
| C
2
|
| Ansell Healthcare (Ansell)
|
| Vol #:
|
| 1
|
|
| |
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 2086
|
| P. Harrington
|
| Vol #:
|
| 300
|
|
|
|
|
| C 2087
|
| B. McCall
|
| Vol #:
|
| 300
|
|
|
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
|
|
|
|
| TR
1
|
| 2/1/2005 Transcript on Domestic Outreach Grassroots Meeting held in Boston, Massachusetts
|
| Vol #:
|
| 21
|
|
|
|
|
| TR
2
|
| 2/1/2005 Transcript on Domestic Outreach Grassroots Meeting held in Philadelphia, Pennsylvania
|
| Vol #:
|
| 22
|
|
|
|
|
| TR
3
|
| 1/25/2005 Transcript on Domestic Outreach Grassroots Meeting held in Chicago, Illinois
|
| Vol #:
|
| 23
|
|
|
|
|
| TR
4
|
| 1/25/2005 Transcript on Domestic Outreach Grassroots Meeting held in Seattle, Washington
|
| Vol #:
|
| 24
|
|
|
|
|
| TR
5
|
| 1/27/2005 Transcript on Domestic Outreach Grassroots Meeting held in San Francisco, California
|
| Vol #:
|
| 25
|
|
|
|
|
| 2004N-0242
|
| Institutional Review Boards; Registration Requirements
|
|
|
| REF
1
|
| OMB Review of NPR1 published 07/06/2004
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
|
|
|
|
|
| C
2
|
| American Osteopathic Association
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C 23
|
| Mr. J. C. Groen
|
| Vol #:
|
| 1
|
|
|
|
|
| REF
1
Tab
A, Tab
B, Tab
C
|
| OMB review ANPR published 4-4-2005
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0539
|
| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
|
|
|
|
|
| C
1
|
| American Red Cross (Red Cross)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| LET
7
|
| Marine Bio Co. Ltd
|
| Vol #:
|
| 15
|
|
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
|
|
| LET
9
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 9
|
|
| |
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
|
|
| LET
7
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| LET
7
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
| |
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| LET
6
|
| Nutrition 21 Inc
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| C 99
|
| J. Acia
|
| Vol #:
|
| 9
|
|
|
|
|
| C 100
|
| L. Fulwider
|
| Vol #:
|
| 9
|
|
|
|
|
| EXT
1
|
| The Solae Company
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
|
|
| LET
5
|
| American Longevity Inc
|
| Vol #:
|
| 16
|
|
|
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
|
|
|
|
| C
6
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
|
|
| C 1
|
| B. Lenich
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
|
|
| C
5
|
| Cook Group, Inc. (Cook)
|
| Vol #:
|
| 3
|
|
|
|
|
| C
6
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 3
|
|
|
|
|
| C
7
|
| MedImmune, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| C
8
|
| AstraZeneca, LP
|
| Vol #:
|
| 3
|
|
|
|
|
| C
9
|
| Novartis Pharmaceuticals Corporation (Novartis)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
|
|
| C
2
|
| Assn of Food and Drug Officials (AFDO)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0013
|
| Cefixime for Oral Suspension, 200 mg/mL, as an Abbreviated New Drug Applicaton(ANDA)
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lupin Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0044
|
| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0060
|
| Hydrochlorothiazide Tablets 12.5 mg, is suitable for submission in an ANDA
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0080
|
| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0090
|
| Amend or revoke 5 CFR 5501.101(c)(2) based upon a review of the basis, intended purpose and actual societal needs
|
|
|
|
|
| C 1
|
| J. Bryce
|
| Vol #:
|
| 1
|
|
