| | | | | |
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|
| Dockets Entered
On November 28, 2003
Table of Contents
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|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1981N-0033P
|
| Antiplaque & Antiplaque-Related Claims
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
| 1998D-0173
|
| PMA/510(K)Expedited Review Guidance for Industry
|
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| 1999N-2637
|
| Public Information Regulations
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| 2001P-0298
|
| Permit Use of Symbols on In-Vitro Diagnostic Labeling
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| 2002E-0099
|
| Patent Term Extension Application for XIGRIS No. 4,775,624
|
|
|
| 2002E-0184
|
| Patent Extension Application for XIGRIS, No. 5,681,932
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| 2003D-0229
|
| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
| 2003D-0383
|
| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
|
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols b
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| 2003D-0504
|
| Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
|
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
|
|
| 2003E-0255
|
| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| 2003N-0472
|
| Statement of Work for the Evaluation of First Cycle Review Performance; Availability
|
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
|
|
| 2003N-0513
|
| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
|
|
|
| 2003P-0166
|
| Revoke Approval for Marketing of Menstrual Cups
|
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
|
|
| 2003P-0276
|
| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
|
|
| | | | | | | | |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
|
|
| 2003P-0511
|
| refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
|
|
|
| 2003P-0530
|
| Silicone Gel-filled Breast Implants
|
|
|
| 2003V-0541
|
| Laser Light Show
|
|
|
| 1981N-0033P
|
| Antiplaque & Antiplaque-Related Claims
|
|
|
| C 13
|
| WhiteHill Oral Technologies, Inc.
|
| Vol #:
|
| 78
|
|
|
| C 14
|
| Procter & Gamble Company
|
| Vol #:
|
| 81
|
|
|
| C 15
|
| Colgate-Palmolive Company (Colgate-Palmolive)
|
| Vol #:
|
| 82
|
|
|
| C
16
Attachment
|
| Colgate-Palmolive Company (Colgate-Palmolive)
|
| Vol #:
|
| 84
|
|
|
| C
17
Appendix
1, 2,
3
|
| Consumer Healthcare Products Assn (CHPA)
|
| Vol #:
|
| 85
|
|
|
| C
18
|
| Access Business Group (ABG)
|
| Vol #:
|
| 86
|
|
|
| C
19
Summary,
Attachment
1, 2,
3
|
| Johnson & Johnson
|
| Vol #:
|
| 86
|
|
|
| C
20
|
| Pfizer, Inc.
|
| Vol #:
|
| 86
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| EMC 945
|
| Steve Truett
|
| Vol #:
|
| 375
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
| EMC 258
|
| No signature
|
| Vol #:
|
| 41
|
|
|
| 1998D-0173
|
| PMA/510(K)Expedited Review Guidance for Industry
|
|
|
| GDL
2
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
|
|
| EMC 702
|
| Kathleen Eastman
|
| Vol #:
|
| 62
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
| C 7286
|
| Evelyn Marks
|
| Vol #:
|
| 305
|
|
|
| C 7287
|
| Kym Barnes
|
| Vol #:
|
| 305
|
|
|
| C 7288
|
| Eva J. Crowe
|
| Vol #:
|
| 305
|
|
|
| C 7289
|
| Susan Dressen
|
| Vol #:
|
| 305
|
|
|
| C 7290
|
| Eligible
|
| Vol #:
|
| 305
|
|
|
| C 7291
|
| Jenny S. Ercolino
|
| Vol #:
|
| 305
|
|
|
| C 7292
|
| Bob Hartwig
|
| Vol #:
|
| 305
|
|
|
| C 7293
|
| Joan M. Raymond
|
| Vol #:
|
| 305
|
|
|
| C 7294
|
| Marita Treat
|
| Vol #:
|
| 305
|
|
| | | | | | | | |
|
|
| C 7295
|
| Donna Grulke
|
| Vol #:
|
| 305
|
|
|
| C 7296
|
| Barbara Jones
|
| Vol #:
|
| 305
|
|
|
| C 7297
|
| Joline Bettendorf
|
| Vol #:
|
| 305
|
|
|
| C 7298
|
| AK Morro Masonis
|
| Vol #:
|
| 305
|
|
|
| 1999N-2637
|
| Public Information Regulations
|
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18223
|
| Virginia Williams
|
| Vol #:
|
| 514
|
|
|
| EMC 4082
|
| Richard Phillips
|
| Vol #:
|
| 514
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| EMC 490
|
| Nancy Doing
|
| Vol #:
|
| 21
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| EMC 704
|
| Katherine Larrabee
|
| Vol #:
|
| 32
|
|
|
| EMC 705
|
| Matthew Tom
|
| Vol #:
|
| 32
|
|
|
| EMC 706
|
| L. Sieffert
|
| Vol #:
|
| 32
|
|
|
| EMC 707
|
| Cynthia Cavallaro
|
| Vol #:
|
| 32
|
|
|
| EMC 708
|
| Jennifer Mitchell
|
| Vol #:
|
| 32
|
|
|
| EMC 709
|
| Tandy Boynton
|
| Vol #:
|
| 32
|
|
|
| EMC 710
|
| William D. Bartlett
|
| Vol #:
|
| 32
|
|
|
| EMC 711
|
| William Fisher
|
| Vol #:
|
| 32
|
|
|
| EMC 712
|
| Anna Jacus
|
| Vol #:
|
| 32
|
|
|
| EMC 713
|
| Kathy Bowden
|
| Vol #:
|
| 32
|
|
|
| EMC 714
|
| Jennifer Leister
|
| Vol #:
|
| 32
|
|
|
| EMC 715
|
| Alison Brantley
|
| Vol #:
|
| 32
|
|
|
| EMC 716
|
| John P. Stoltenberg, PE
|
| Vol #:
|
| 32
|
|
|
| EMC 717
|
| J. Richard Maritt
|
| Vol #:
|
| 32
|
|
|
| EMC 718
|
| Peter C. Reilly and Maureen A. Flannery
|
| Vol #:
|
| 32
|
|
|
| EMC 719
|
| Christina Gleason
|
| Vol #:
|
| 32
|
|
|
| EMC 720
|
| Karen Janda
|
| Vol #:
|
| 32
|
|
|
| EMC 721
|
| Deborah Smith
|
| Vol #:
|
| 32
|
|
|
| EMC 722
|
| Julio Contreras
|
| Vol #:
|
| 32
|
|
|
| EMC 723
|
| Laureen Berdofe
|
| Vol #:
|
| 32
|
|
|
| EMC 724
|
| Marta Simmons
|
| Vol #:
|
| 32
|
|
|
| EMC 725
|
| Veneita Mullins
|
| Vol #:
|
| 32
|
|
| | | | | | | | |
|
|
| EMC 726
|
| Victoria Cole
|
| Vol #:
|
| 32
|
|
|
| EMC 727
|
| Duy Nguyen
|
| Vol #:
|
| 32
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 39
|
|
|
| 2001P-0298
|
| Permit Use of Symbols on In-Vitro Diagnostic Labeling
|
|
|
| PAV
1
|
| HFZ-1 to Bio-Rad Laboratories
|
| Vol #:
|
| 1
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| EMC 1209
|
| Penny Edler
|
| Vol #:
|
| 5
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| EMC 136
|
| J. Walters
|
| Vol #:
|
| 3
|
|
|
| 2002E-0099
|
| Patent Term Extension Application for XIGRIS No. 4,775,624
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2002E-0184
|
| Patent Extension Application for XIGRIS, No. 5,681,932
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
| C
167
|
| Uniform Code Council, Inc. (UCC)
|
| Vol #:
|
| 15
|
|
|
| C 168
|
| ATOFINA Chemicals, Inc.
|
| Vol #:
|
| 15
|
|
|
| LST
2
|
| Satellite Teleconference Attendees
|
| Vol #:
|
| 15
|
|
|
| LST
3
|
| 10/28/2003 List of Attendees
|
| Vol #:
|
| 15
|
|
|
| LST
4
|
| Participant List for the Houston BT Downlink
|
| Vol #:
|
| 15
|
|
|
| LST
5
|
| BT Downlink Registration
|
| Vol #:
|
| 15
|
|
|
| LST
6
|
| 10/28 Satellite Conference Participants
|
| Vol #:
|
| 15
|
|
|
| LST
7
|
| Memphis, TN BT Downsite 10/28/2003
|
| Vol #:
|
| 15
|
|
|
| LST
8
|
| Denver site of the 10/28 downlink
|
| Vol #:
|
| 15
|
|
|
| LST
9
|
| List for the Minneapolis Formal Downlink on 10/28
|
| Vol #:
|
| 15
|
|
|
| LST
10
|
| List of Wisconsin Dowlink
|
| Vol #:
|
| 15
|
|
|
| LST
11
|
| List of attendees for 10/28th Conference in Portland, Oregon
|
| Vol #:
|
| 15
|
|
|
| LST
12
|
| BT downlink list of attendees in Baton Rouge, LA
|
| Vol #:
|
| 15
|
|
|
| LST
13
|
| List regarding BT Downlink
|
| Vol #:
|
| 15
|
|
|
| LST
14
|
| List that attended the 10/28/03 Satellite Downlink in Cincinnati District
|
| Vol #:
|
| 15
|
|
|
| LST
15
|
| New York District registration list from 10/28 Downlink
|
| Vol #:
|
| 15
|
|
|
| LST
16
|
| List for BT Downlink held in Washington
|
| Vol #:
|
| 15
|
|
| | | | | | | | |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| LST
2
|
| Satellite Teleconference Attendees
|
| Vol #:
|
| 17
|
|
|
| LST
3
|
| 10/28/2003 List of Attendees
|
| Vol #:
|
| 17
|
|
|
| LST
4
|
| Participant List for the Houston BT Downlink
|
| Vol #:
|
| 17
|
|
|
| LST
5
|
| BT Downlink Registration
|
| Vol #:
|
| 17
|
|
|
| LST
6
|
| 10/28 Satellite Conference Participants
|
| Vol #:
|
| 17
|
|
|
| LST
7
|
| Memphis, TN BT Downsite 10/28/2003
|
| Vol #:
|
| 17
|
|
|
| LST
8
|
| Denver site of the 10/28 downlink
|
| Vol #:
|
| 17
|
|
|
| LST
9
|
| List for the Minneapolis Formal Downlink on 10/28
|
| Vol #:
|
| 17
|
|
|
| LST
10
|
| List of Wisconsin Dowlink
|
| Vol #:
|
| 17
|
|
|
| LST
11
|
| List of attendees for 10/28th Conference in Portland, Oregon
|
| Vol #:
|
| 17
|
|
|
| LST
12
|
| BT downlink list of attendees in Baton Rouge, LA
|
| Vol #:
|
| 17
|
|
|
| LST
13
|
| List regarding BT Downlink
|
| Vol #:
|
| 17
|
|
|
| LST
14
|
| List that attended the 10/28/03 Satellite Downlink in Cincinnati District
|
| Vol #:
|
| 17
|
|
|
| LST
15
|
| New York District registration list from 10/28 Downlink
|
| Vol #:
|
| 17
|
|
|
| LST
16
|
| List for BT Downlink held in Washington
|
| Vol #:
|
| 17
|
|
|
| 2003D-0229
|
| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| NCR 1
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
| LET
1
|
| Organon, Inc.
|
| Vol #:
|
| 3
|
|
|
| 2003D-0383
|
| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
|
|
|
| C
2
|
| Dade Behring, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
3
|
| Invitrogen, Corporation
|
| Vol #:
|
| 1
|
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols b
|
|
|
| EMC
1
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| C
2
|
| Thomas Layloff, PhD et al.
|
| Vol #:
|
| 1
|
|
|
| 2003D-0504
|
| Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
|
| | | | | | | | |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003E-0255
|
| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
| SUP
10
|
| American Dental Assn (ADA)
|
| Vol #:
|
| 4
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| C
9
|
| Atkins Nutritionals, Inc.
|
| Vol #:
|
| 6
|
|
|
| C
10
|
| Donald K. Layman, PhD
|
| Vol #:
|
| 6
|
|
|
| C
11
|
| Mount Sinai Medical Center
|
| Vol #:
|
| 6
|
|
|
| EMC
24
|
| Capitol Policy Institute
|
| Vol #:
|
| 6
|
|
|
| EMC
25
|
| Girl Scouts of the USA
|
| Vol #:
|
| 6
|
|
|
| NM
2
|
| FDA
|
| Vol #:
|
| 6
|
|
|
| TS
17
|
| National Dairy Council (NDC)
|
| Vol #:
|
| 6
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
| C
2
|
| Kristin A. Altar, RN,BSN
|
| Vol #:
|
| 2
|
|
|
| SUP
2
|
| Catalina Health Resource (CHR)
|
| Vol #:
|
| 2
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| C
42
|
| Healthcare Distribution Management Assn (HDMA)
|
| Vol #:
|
| 5
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| C 18
|
| Lorraine Hanes
|
| Vol #:
|
| 3
|
|
|
| C 19
|
| Tracy Wills
|
| Vol #:
|
| 3
|
|
|
| C 20
|
| Tracy Wills
|
| Vol #:
|
| 3
|
|
|
| C 21
|
| 5 signatures
|
| Vol #:
|
| 3
|
|
|
| C 22
|
| 6 signatures
|
| Vol #:
|
| 3
|
|
|
| C 23
|
| 5 signatures
|
| Vol #:
|
| 3
|
|
|
| C 24
|
| W.B. "Bill" McCaslin
|
| Vol #:
|
| 3
|
|
|
| 2003N-0472
|
| Statement of Work for the Evaluation of First Cycle Review Performance; Availability
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| C
1
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| REF
1
Tab A,
B, C
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| OMB Review March 13, 2003
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| Vol #:
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| 1
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
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| | | | | | | | |
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0166
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| Revoke Approval for Marketing of Menstrual Cups
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|
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| ANS 1
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| HFZ-1 to Associated Pharmacologists & Toxicologis
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| Vol #:
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| 1
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|
|
| 2003P-0274
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| In re Tier 1 initial Approval Program
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|
|
| C
10
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| Colon Cancer Alliance
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| Vol #:
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| 1
|
|
|
| 2003P-0276
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| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
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|
|
| LET
1
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| HFS-300 to Center for Science in the Public Interest
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| Vol #:
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| 1
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|
|
| 2003P-0362
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| Over-the-counter Hearing Aids
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|
|
| C
3
|
| Rancho Bernardo Hearing Services, Inc.
|
| Vol #:
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| 1
|
|
|
| C
4
|
| Active Hearing and Balance CenterRichard Navarro, PhD
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| Vol #:
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| 1
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|
|
| EMC 6
|
| Susan Sykes, MS/CCC/SLP
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| Vol #:
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| 1
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|
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| EMC 7
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| Anthony Mercadante, MA,CCC-A
|
| Vol #:
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| 1
|
|
|
| 2003P-0511
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| refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
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|
|
| C
1
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| Inamed Corporation (Inamed)
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| Vol #:
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| 1
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|
|
| 2003P-0530
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| Silicone Gel-filled Breast Implants
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|
|
| EMC 1
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| Bridgitte V. Engler
|
| Vol #:
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| 1
|
|
|
| EMC 2
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| Lori Hackett
|
| Vol #:
|
| 1
|
|
|
| EMC 3
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| Margaret Rath
|
| Vol #:
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| 1
|
|
|
| EMC 4
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| April Lassetter
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| Vol #:
|
| 1
|
|
|
| EMC 5
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| George J. Gottwald
|
| Vol #:
|
| 1
|
|
|
| EMC 6
|
| Bernard M. Patten,MD,FACP,FRSM,FTNS
|
| Vol #:
|
| 1
|
|
|
| 2003V-0541
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| Laser Light Show
|
|
|
| ACK 1
|
| HFA-305 to Crobar
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| Vol #:
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| 1
|
|
Page created December 1, 2003 jb
Page updated December 24, 2003 jb
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