| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On May 3, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| 2004N-0436
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| 2004N-0437
|
| Agency Information Collection Activities: Proposed Collection; Medical Devices; Third Party Review under FDAMA Third-Party Premarket Submission Review, and Quality System Inspections Under U.S./E.U. M
|
|
|
|
|
|
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| 2004N-0564
|
| Agency Information Collection Activities; Proposed Collection;
|
|
|
|
|
| 2004N-0565
|
| Agency Information Collection Activities; Proposed Collection;
|
|
|
|
|
| 2004P-0520
|
| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
|
|
|
|
|
| 2005D-0004
|
| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| 2005F-0138
|
| provide for the safe use of a mixture of hydrogen peroxide, silver nitrate, phosphoric acid, tartaric acid, glutamic acid, and sodium tripolyphosphate as an antimicrobial agent in bottled drinking wat
|
|
|
|
|
| 2005N-0016
|
| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
|
|
|
|
|
| 2005N-0031
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
|
|
|
|
|
| 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
|
|
|
|
|
| 2005N-0120
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| 2005N-0124
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
|
|
|
|
|
|
|
|
|
| 2005N-0148
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Extralabel Drug Use in Animals
|
|
|
|
|
| 2005N-0153
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring
|
|
|
|
|
| 2005N-0157
|
| Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
|
|
|
|
|
| 2005P-0094
|
| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
15993
|
| Natures Benefit, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15994
|
| Natural Factors Nutritional Products Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15995
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15996
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15997
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15998
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
15999
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16000
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16001
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16002
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
| | | | | | | |
|
|
|
|
| LET
16003
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16004
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16005
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16006
|
| International Nature Nutraceutidcals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16007
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16008
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16009
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16010
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16011
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16012
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16013
|
| International Nature Nutraceuticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16014
|
| International Nature Nutraceu.ticals, Inc.
|
| Vol #:
|
| 141
|
|
|
|
|
| LET
16015
|
| TheralLife Inc.
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16016
|
| Proliant Health Ingredients
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16017
|
| Nutrition Now, Inc.
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16018
|
| Nutrition Now, Inc.
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16019
|
| Northwest Natural Products
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16020
|
| Source Naturals
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16021
|
| Bionorica LLC
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16022
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16023
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16024
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16025
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16026
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16027
|
| NOW Foods
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16028
|
| Pharmavite LLC
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16029
|
| Enzymatic Therapy
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16030
|
| FoodScience Corporation
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16031
|
| Herbalife International of America, Inc.
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16032
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16033
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16034
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16035
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16036
|
| Garden Of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16037
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16038
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16039
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
| | | | | | | | |
|
|
|
|
| LET
16040
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16041
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16042
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16043
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| LET
16044
|
| Garden of Life
|
| Vol #:
|
| 142
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
|
|
| ACK
3
|
| HFA-305 to Wyeth Pharmaceuticals
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| EMC 296
|
| J. Mumme
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| RMO 2
|
| GCF-1
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0436
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statment
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0437
|
| Agency Information Collection Activities: Proposed Collection; Medical Devices; Third Party Review under FDAMA Third-Party Premarket Submission Review, and Quality System Inspections Under U.S./E.U. M
|
|
|
|
|
|
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
|
|
| EMC 705
|
| M. & G. Gutierrez
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 706
|
| R. Ewing
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 707
|
| L. Hoffman
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 708
|
| A. Wiedel
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 709
|
| J. Seematter
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 710
|
| B. N. Sale
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 711
|
| B. N. Sale
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 712
|
| M. Pietzak
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 713
|
| E. R. Pearson
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 714
|
| B. Hicks
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 715
|
| S. Baker
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004N-0564
|
| Agency Information Collection Activities; Proposed Collection;
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| 2004N-0565
|
| Agency Information Collection Activities; Proposed Collection;
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0520
|
| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
|
|
|
|
|
| EMC
1
|
| Eon Labs, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0004
|
| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
|
|
|
|
|
| EMC
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Amgen
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005F-0138
|
| provide for the safe use of a mixture of hydrogen peroxide, silver nitrate, phosphoric acid, tartaric acid, glutamic acid, and sodium tripolyphosphate as an antimicrobial agent in bottled drinking wat
|
|
|
|
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0016
|
| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
|
|
|
|
|
|
|
|
|
| EMC
1
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0031
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
|
|
| EMC
6
|
| Johns Hopkins Bloomberg School of Public Health
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 7
|
| D. Wynes, PhD
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
8
|
| Cook Group, Inc. (Cook)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 9
|
| R. Reinhard
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
10
|
| Consortium of Independent Review Boards (CIRB)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
11
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
12
|
| Applied Research Ethnics National Assn (ARENA)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
13
|
| IRB-Sponsor Roundtable (the Roundtable)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
14
|
| Quorum Review, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
|
|
| EMC
1
|
| Assn of Food and Drug Officials (AFDO)
|
| Vol #:
|
| 1
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
