| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On December 6, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 2001D-0025
|
| Guidance for Industry - Yellow Corn & Dry-Milled
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| 2006N-0067
|
| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
|
|
|
|
|
| 2006N-0168
|
| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
|
|
|
|
| 2006N-0221
|
| Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
|
|
|
|
|
| 2007D-0364
|
| Impact-Resistant Lenses: Questions and Answers Guidance
|
|
|
|
|
| 2007E-0440
|
| Patent Term Extension Application for SYMBICORT Inhalation Aerosol (formoterol fumarate dihydrate and budesonide), U.S. Patent No. 5,674,860
|
|
|
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
|
|
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| 2007P-0232
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| EC 2710
|
| Mr. Mark Guttenplan
|
| Vol #:
|
| 176
|
|
|
|
|
| EC 2711
|
| Ms. Lauren O'Malley
|
| Vol #:
|
| 176
|
|
|
|
|
| 2001D-0025
|
| Guidance for Industry - Yellow Corn & Dry-Milled
|
|
|
|
|
| EC 1
|
| National Corn Growers Association
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| EC 26
|
| Ms. Larisa Stephan
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 27
|
| Australian Division of World Action on Salt and He
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 28
|
| Mr. Chris Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 29
|
| Ms. Kristen Proffitt
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 30
|
| Austin Health
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| C 27
|
| United Healthcare
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006N-0067
|
| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0168
|
| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
|
|
|
|
| EC 106
|
| Ms. Lisa Bouley
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006N-0221
|
| Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
|
|
|
|
|
| EC 2
|
| AABB
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| FDA/ORA/PAR
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| American Red Cross
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0364
|
| Impact-Resistant Lenses: Questions and Answers Guidance
|
|
|
|
|
| EC 2
|
| Mr. Harry Chilinguerian
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007E-0440
|
| Patent Term Extension Application for SYMBICORT Inhalation Aerosol (formoterol fumarate dihydrate and budesonide), U.S. Patent No. 5,674,860
|
|
|
|
|
| LET 2
|
| FDA/CDER tp the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
|
|
|
|
| EC 20
|
| American Veterinary Medical Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 21
|
| Mr. Robert Corbin
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
|
|
|
|
| EC 11
|
| International Pharmaceutical Aerosol Consortium
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| EC 119
|
| Miss. Lisa Treumuth
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 120
|
| Consumers Union
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 121
|
| Ms. Rose Baran
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007P-0232
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
|
|
| LET 1
|
| FDA/CDER to Perdue Pharma L.P.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| EC 147
|
| Mrs. Jeanne Legge
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 148
|
| Mr. Edward Legge
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
|
|
|
|
|
|
| |
|
|
|
| EC 16
|
| Ms. Lucinda Hodges
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 17
|
| Mr. Mark Hanson
|
| Vol #:
|
| 3
|
|
