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| Dockets Entered
On June 28, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001D-0262
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| Automated Testing Instruments used in Blood Establishments
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0456
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| 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
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005P-0267
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| remove from labeling for propofol(Diprivan) the warning that propofol should be administered only by persons trained
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| 2005P-0269
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| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
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| 2005V-0266
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| Laser Light Show
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|
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| 2005V-0268
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| Projector for a Laser Light Show
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
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|
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| LET
16348
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| Enzymatic Therapy
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| Vol #:
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| 145
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| |
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| 2001D-0262
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| Automated Testing Instruments used in Blood Establishments
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| RPT
2
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| Break-out Group Reports - April 5, 2005 meeting
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| Vol #:
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| 6
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| RPT
3
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| Attendance Report - April 5, 2005 meeting
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| Vol #:
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| 6
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| TR
3
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| Transcript of the April 5-6, 2005 public meeting
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| Vol #:
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| 5
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| TS
8
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| Introduction to April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
9
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| Welcome to April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
10
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| Framework to April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
11
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| Comprehensive April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
12
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| Risk Based Definition - April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
13
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| Safe Feed Ingredients - April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
14
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| Limits for Animal Feed Contaminants - April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
15
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| Process Control for the Production of Feed- April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
16
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| Regulatory Oversight - April 5, 2005 meeting
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| Vol #:
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| 6
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| TS
17
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| Break-out Group Instructions - April 5, 2005 meeting
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| Vol #:
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| 6
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS
8
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| HFA-305
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| Vol #:
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| 2
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| OR
8
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| HF-3 to Ecumed Health Group
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| Vol #:
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| 2
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| |
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| 2004N-0456
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| 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
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| EMC 773
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| M. Berman
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| Vol #:
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| 4
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| EMC 774
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| J. E. Flood
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| Vol #:
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| 4
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| EMC 775
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| A. Bodor
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| Vol #:
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| 4
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| EMC 776
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| J. Filion
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| Vol #:
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| 4
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| EMC 777
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| D. Border
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| Vol #:
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| 4
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| EMC 778
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| L. Brugler
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| Vol #:
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| 4
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| EMC 779
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| S. Marcouiller
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| Vol #:
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| 7
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| EMC 780
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| D. M. Davis
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| Vol #:
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| 4
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| EMC 781
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| B. Earl
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| Vol #:
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| 4
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| EMC 782
|
| A. Kuzmicka
|
| Vol #:
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| 4
|
|
| |
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| 2005D-0240
|
| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0267
|
| remove from labeling for propofol(Diprivan) the warning that propofol should be administered only by persons trained
|
|
|
|
|
| ACK
1
|
| HFA-305 to William & Connolly LLP
|
| Vol #:
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| 1
|
|
|
|
|
| CP
1
|
| American College of Gastroenterology
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0269
|
| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
|
|
|
|
|
|
|
|
|
| ACK
1
|
| HFA-305 to Bell, Boyd & Lloyd LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Claxton Bakery et al.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005V-0266
|
| Laser Light Show
|
|
|
|
|
| ACK
1
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| HFA-305 to Stone Mountain Media LLC
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| Vol #:
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| 1
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| VAR
1
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| Stone Mountain Media LLC
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| Vol #:
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| 1
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| 2005V-0268
|
| Projector for a Laser Light Show
|
|
|
|
|
| ACK
1
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| HFA-305 to Alchemy Concert Systems, LLC
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| Vol #:
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| 1
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| VAR
1
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| Alchemy Concert Systems, LLC
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| Vol #:
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| 1
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| | | | | | | | | | |
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| Dockets Entered On 06/28/2005
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2001D-0262
|
| Automated Testing Instruments used in Blood Establishments
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| 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
|
|
|
|
|
|
|
|
|
| 2005D-0240
|
| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
|
|
|
|
|
| 2005P-0267
|
| remove from labeling for propofol(Diprivan) the warning that propofol should be administered only by persons trained
|
|
|
|
|
| 2005P-0269
|
| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
|
|
|
|
|
|
| 2005V-0266
|
| Laser Light Show
|
|
|
|
|
| 2005V-0268
|
| Projector for a Laser Light Show
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 16348
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
|
|
|
|
| 2001D-0262
|
| Automated Testing Instruments used in Blood Establishments
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| RPT 2
|
| Break-out Group Reports - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| RPT 3
|
| Attendance Report - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TR 3
|
| Transcript of the April 5-6, 2005 public meeting
|
| Vol #:
|
| 5
|
|
|
|
|
| TS 8
|
| Introduction to April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 9
|
| Welcome to April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 10
|
| Framework to April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 11
|
| Comprehensive April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 12
|
| Risk Based Definition - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 13
|
| Safe Feed Ingredients - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 14
|
| Limits for Animal Feed Contaminants - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 15
|
| Process Control for the Production of Feed- April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 16
|
| Regulatory Oversight - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| TS 17
|
| Break-out Group Instructions - April 5, 2005 meeting
|
| Vol #:
|
| 6
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| CS 8
|
| HFA-305
|
| Vol #:
|
| 2
|
|
|
|
|
| OR 8
|
| HF-3 to Ecumed Health Group
|
| Vol #:
|
| 2
|
|
|
|
|
| 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 773
|
| M. Berman
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 774
|
| J. E. Flood
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 775
|
| A. Bodor
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 776
|
| J. Filion
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 777
|
| D. Border
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 778
|
| L. Brugler
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 779
|
| S. Marcouiller
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 780
|
| D. M. Davis
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 781
|
| B. Earl
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 782
|
| A. Kuzmicka
|
| Vol #:
|
| 4
|
|
|
|
|
| 2005D-0240
|
| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0267
|
| remove from labeling for propofol(Diprivan) the warning that propofol should be administered only by persons trained
|
|
|
|
|
| ACK 1
|
| HFA-305 to William & Connolly LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| American College of Gastroenterology
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0269
|
| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
|
|
|
|
|
|
|
|
|
| ACK 1
|
| HFA-305 to Bell, Boyd & Lloyd LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Claxton Bakery et al.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005V-0266
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Stone Mountain Media LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Stone Mountain Media LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005V-0268
|
| Projector for a Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Alchemy Concert Systems, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Alchemy Concert Systems, LLC
|
| Vol #:
|
| 1
|
|
