| | | | | | | | | | |
|
| |
|
| Dockets Entered
On June 15, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1981N-0033
|
| Oral Health Care Drug Products for OTC Human Use
|
|
|
|
|
| 2000D-1306
|
| Content & Format of the Adverse Reactions Section of Labeling
|
|
|
|
|
| 2001D-0269
|
| Clinical Studies Section for Prescription Drugs & Biologics
|
|
|
|
|
| 2003N-0355
|
| Medical Devices; Exception from General Requirements for Informed Consent
|
|
|
|
|
| 2005D-0199
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
|
|
|
|
|
|
|
|
|
| 2005D-0200
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
|
|
|
|
|
|
|
|
|
| 2005D-0483
|
| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
|
| 2006E-0250
|
| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
|
|
|
|
|
| 2006F-0225
|
| Filing of Food Additive Petition (FAP 6A4765) to amend the food additive regulations in 172.735 Glycerol ester of wood or gum rosin (21 CFR 172.735)
|
|
|
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
|
|
|
|
| 2006N-0109
|
| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
|
|
|
|
|
| 2006N-0181
|
| Product Stability Data: Notice of Pilot Project
|
|
|
|
|
| 2006P-0249
|
| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
|
|
|
|
|
| 2006V-0248
|
| Laser Light Show
|
|
|
|
|
| 1981N-0033
|
| Oral Health Care Drug Products for OTC Human Use
|
|
|
|
|
| EC 1
|
| Mrs. Sandra Swayze
|
| Vol #:
|
| 72
|
|
|
|
|
| EC 2
|
| Consumer Healthcare Products Association
|
| Vol #:
|
| 72
|
|
| |
|
| 2000D-1306
|
| Content & Format of the Adverse Reactions Section of Labeling
|
|
|
|
|
| EC 7
|
| Dr. Stephen Sack
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001D-0269
|
| Clinical Studies Section for Prescription Drugs & Biologics
|
|
|
|
|
| EC 1
|
| Dr. Stephen Sack
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0355
|
| Medical Devices; Exception from General Requirements for Informed Consent
|
|
|
|
|
| EC 1
|
| Ms. Amy Todisco
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Mrs. R Thomas
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Mr. Steven White DTR
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Mr. Shirley Isbill
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0199
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
|
|
|
|
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2005D-0200
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
|
|
|
|
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0483
|
| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
|
|
|
|
|
| EC 9
|
| Mr. Randal South
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| MO 12
|
| TMJ Implants, Inc., and Robert W. Christensen and Maureen K Mooney
|
| Vol #:
|
| 3
|
|
|
|
|
| RMO 4
|
| FDA/CDRH/OGC
|
| Vol #:
|
| 3
|
|
|
|
|
| RMO 5
|
| TMJ Implants, Inc., and Robert W. Christensen and Maureen K Mooney
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 12825
|
| Unreadable
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12826
|
| S. Fankal
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12827
|
| T. Quina
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12828
|
| L. Hickley
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12829
|
| unreadable
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12830
|
| L. Thompson
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12831
|
| L. Koellman
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12832
|
| C. DiBiaggio
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12833
|
| T. Kiro
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12834
|
| C. Wimen
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12835
|
| illegible
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12836
|
| E. Crutzher
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12837
|
| L. Feundl
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12838
|
| illegible
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12839
|
| H. Hendricks
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12840
|
| D. Arman
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12841
|
| A. MacAulay
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12842
|
| C. E. Contey, M.D.
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12843
|
| B. Roberts
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12844
|
| I. Arnold
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12845
|
| J. A. Levin
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12846
|
| J. Rosini
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12847
|
| S. Ollice
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12848
|
| B. Kistler
|
| Vol #:
|
| 153
|
|
| | | | | | | | |
|
| |
|
| C 12886
|
| A. Brooks
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12887
|
| L. J. Allen
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12888
|
| J. K. Ruyts
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12889
|
| C. Carlucci
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12890
|
| R. Courey
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12891
|
| S. Biondolillo
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12892
|
| B. W. Zuckerman
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12893
|
| R. M. Zuckerman
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12894
|
| M. M. Monti
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12895
|
| T. Zuluaga
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12896
|
| L. K. Rider
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12897
|
| O. De Long
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12898
|
| N. Mooring
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12899
|
| L. de Nuccio
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12900
|
| J. Baptista
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12901
|
| T. Callaris
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12902
|
| P. Pierce
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12903
|
| S. Nichols
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12904
|
| C. Culla
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12905
|
| M. Ackermann
|
| Vol #:
|
| 153
|
|
|
|
|
| C 12906
|
| B. Johnson
|
| Vol #:
|
| 153
|
|
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
|
| LET 1
|
| Kalsec Inc.
|
| Vol #:
|
| 4
|
|
|
|
|
| RC 2
|
| Kalsec Inc.
|
| Vol #:
|
| 4
|
|
|
|
|
| SUP 1
|
| Kalsec Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006E-0250
|
| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
|
|
|
|
|
| APP 1
|
| Savient Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2006F-0225
|
| Filing of Food Additive Petition (FAP 6A4765) to amend the food additive regulations in 172.735 Glycerol ester of wood or gum rosin (21 CFR 172.735)
|
|
|
|
|
| NFL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
|
|
|
|
| EC 2
|
| Weill Medical College of Cornell University
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 3
|
| GermGard Lighting LLC
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 4
|
| The University of Arizona
|
| Vol #:
|
| 2
|
|
