|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered
On October 26, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0064
|
| OTC Antiperspirant
|
|
|
|
|
| 1987F-0179
|
| Sucrose polyester as
replacement for fats & oil in food
|
|
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing
Health Claims & Nutrient Claims
|
|
|
|
|
| 1995P-0241
|
| Implied Nutrient Content
Claim 'Healthy' & Health Claims
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of
Natural Flavorings
|
|
|
|
|
| 2001N-0463
|
| Workshop on Preclinical
Testing for Endovascular Grafts
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0291
|
| Proposal to Debar Baldev
Raj Bhutani;Notice of Opportunity
|
|
|
|
|
| 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
|
|
|
|
|
| 2003P-0176
|
| Follow-Up Approval of
Therapeutic Protein Products
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading
Labeling
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional
Guidance to Reduce Entrapment
|
|
|
| 2004D-0440
|
| Guidance for Industry on Computerized
Systems Used in Clinical Trials
|
|
|
| 2004D-0476
|
| Draft guidance customs
devices, for filing pursuant to 21 CFR 10.20
|
|
|
|
|
| 2004N-0049
|
| Agency Information Collection
Activities; Proposed Collection; Comment Request; Control of Communicable
Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain
Other Animals
|
|
|
|
|
| 2004N-0355
|
| Scientific Considerations
Related to Developing Follow-on Protein Products
|
|
|
|
|
| 2004N-0408
|
| Regulatory Site Visit
Training Program
|
|
|
|
|
| 2004N-0441
|
| Agency Information Collection
Activities; Proposed Collection; Comment Request; Application For FDA
Approval to Market a New Drug
|
|
|
|
|
| 2004N-0454
|
| Dietary Supplements;
Premarket Notification for New Dietary Ingredient Notifications; Public
Meeting
|
|
|
|
|
| 2004P-0171
|
| Standards for 'Similarity'
or 'Sameness' of Biotechnology-Derived Products
|
|
|
|
|
| 2004P-0276
|
| Initiate proceedings
to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the
administrative record in connection with CTI's premarket approval application
in P010035
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing
added Mercury
|
|
|
|
|
| 2004P-0429
|
| Revoke 21 C.F.R. Part
11 in its entirety, and purse implementation of electronic record and
signature
|
|
|
|
|
| 2004P-0464
|
| Vitamin D and Calcium
and Reduced Risk of Osteoporosis
|
|
|
|
|
| 2004P-0472
|
| refuse final approval
to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current
proposed labeling
|
|
|
|
|
| 2004P-0473
|
| Labeling Claims Using
Net Effective Carbohydrates and Similar Terms
|
|
|
|
|
| 2004Q-0072
|
| QHC Eggs w/Enhanced
omega-3 fatty acid content and reduced risk of heart disease and sudden
fatal heart attack
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim
(QHC): soy protein and cancer
|
|
|
|
|
| 2004S-0212
|
| Pandemic Influenza Preparedness
and Response Plan
|
|
|
| 2004V-0475
|
| Laser Light Show
|
|
|
|
|
| 1978N-0064
|
| OTC Antiperspirant
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 53
|
|
|
|
|
| 1987F-0179
|
| Sucrose polyester
as replacement for fats & oil in food
|
|
|
|
|
| RPT
6
|
| Center for Science in
the Public Interest (CSPI)
|
| Vol #:
|
| 42
|
|
|
|
|
| 1994P-0390
|
| Adopt Amendments
Governing Health Claims & Nutrient Claims
|
|
| | | | | | | | |
|
|
|
|
| C
67
Tab A
|
| Carbolite Foods, Inc. (Carbolite)
|
| Vol #:
|
| 7
|
|
|
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
|
|
|
| C
84
Tab A
|
| Carbolite Foods, Inc. (Carbolite)
|
| Vol #:
|
| 9
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| EMC 4287
|
| P. Reed
|
| Vol #:
|
| 320
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 209
|
| Y. Baker
|
| Vol #:
|
| 3
|
|
|
|
|
| 2001N-0463
|
| Workshop on Preclinical Testing for Endovascular Grafts
|
|
|
|
|
| TR
3
part 2, part
3, part 4
|
| Transcript of the July 28, 2004 Workshop
|
| Vol #:
|
| 3
|
|
|
|
|
| TR
4
Part 2, part
3
|
| Transcript of the July 29, 2004 Workshop
|
| Vol #:
|
| 4
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 2039
|
| J. Mueller, MD
|
| Vol #:
|
| 295
|
|
|
|
|
| EC 820
|
| Mrs. MELINDA BOWLING
|
| Vol #:
|
| 163
|
|
|
|
|
| EMC 10887
|
| J. Manders
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10888
|
| A. Witt
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10889
|
| E. Todd
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10890
|
| A. Miller
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10891
|
| A. Bachan
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10892
|
| K. Brown
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10893
|
| K. Mendez
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10894
|
| M. Chisum
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10895
|
| J. Nichols
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10896
|
| L. Peterson
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10897
|
| C. Jack
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10898
|
| K. Kimberling
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10899
|
| F. Zamora
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10900
|
| K. Seaber
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10901
|
| K. Fearnley
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10902
|
| E. Taylor
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10903
|
| M. Niles
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10904
|
| A. Belton
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10905
|
| A. Beach
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10906
|
| C. Elkasim
|
| Vol #:
|
| 294
|
|
|
|
|
| EMC 10907
|
| K. McLeran
|
| Vol #:
|
| 294
|
|
| | | | | | | | |
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 80
|
| J. Thompson
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
|
|
|
| EC 6
|
| Masonic Pathways
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
7
|
| Metropolitan Chicago Healthcare Council
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0440
|
| Guidance for Industry on Computerized Systems Used in Clinical Trials
|
|
|
|
|
| EC
1
Attachment
|
| CRF Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0476
|
| Draft guidance customs devices, for filing pursuant to 21 CFR 10.20
|
|
|
|
|
| GDL
1
|
| AGA Medical Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
|
|
|
|
| EC 52
|
| Mrs. Kristin Falco
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
|
|
|
|
| EC
9
Attachment
|
| Pharmaceutical Scientist Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| TR
1
|
| Transcripts
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
|
|
|
|
| EC 7
|
| St. Jude Childrens Research Hospital
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| SICOR, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| LifeCell Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Indiana Blood Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 11
|
| Mayo Clinic Rochester Transfusion Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| Neuronyx, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Xcyte Therapies
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
14
|
| Johns Hopkins Hospital and University
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 15
|
| University of Texas MD Anderson Cancer Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Panacea Biotec Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0441
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
|
| | | | | | | | |
|
|
|
|
| C 1
|
| T. Tiedt, PhD
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 1
|
| A. Green
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
|
|
|
| EMC
2
|
| University of California
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0276
|
| Initiate proceedings to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the administrative record in connection with CTI's premarket approval application in P010035
|
|
|
|
|
|
|
|
|
|
|
| PDN
1
|
| HF-22 to Sidley Austin Brown & Wood LLP
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| EC 20
|
| Ms. Christine Ewton
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 6
|
| J. Masuda
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0351
|
| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
|
|
|
|
|
| EC 5
|
| Mr. Steve Anderson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0429
|
| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
|
|
|
|
|
| C
2
|
| Society of Quality Assurance Computer Validation Initiative Committee (CVIC)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0464
|
| Vitamin D and Calcium and Reduced Risk of Osteoporosis
|
|
|
|
|
| LET
1
|
| HFS-800 to Johnson Nutrition Solutions LLC
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
|
|
| CP
1
Attached CV
|
| Dr. Daniel Brookoff and Dr. Eric A. Voth
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0473
|
| Labeling Claims Using Net Effective Carbohydrates and Similar Terms
|
|
|
|
|
| ACK
1
|
| HFA-305 to Carbolite Foods, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Carbolite Foods, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0072
|
| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
|
|
|
|
|
| LET
2
|
| AAC Consulting Group
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| LET
2
|
| The Solae, LLC
|
| Vol #:
|
| 5
|
|
|
|
|
| SUP
1
Attachments
|
| The Solae Company
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004S-0212
|
| Pandemic Influenza Preparedness and Response Plan
|
|
|
|
|
| EC 7
|
| Dr. Clarence Scott
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
8
|
| Rensselaer Polytechnic University
|
| Vol #:
|
| 1
|
|
