| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On December 29, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0065
|
| Skin Bleaching Drug Products
|
|
|
|
|
| 2002D-0260
|
| Prescription drug Samples to Free Clinics
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| 2006D-0226
|
| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
|
|
|
|
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
|
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2006P-0410
|
| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
|
|
|
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
|
|
|
|
| 2006P-0484
|
| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
|
|
|
|
|
| 2006P-0511
|
| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
|
|
|
|
|
| 2006P-0518
|
| Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use
|
|
|
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
|
|
|
|
| 2006P-0536
|
| Amend 21 C.F.R. 312. promotion and charging for investigational drugs re: pandemic vaccine
|
|
| |
|
| 1978N-0065
|
| Skin Bleaching Drug Products
|
|
|
|
|
| EC
551
|
| Pigmentary Disorders Academy
|
| Vol #:
|
| 19
|
|
|
|
|
| EC
552
|
| Mrs. Kathleen Wozniak
|
| Vol #:
|
| 19
|
|
|
|
|
| EC
553
|
| Mrs. Pamela Murray
|
| Vol #:
|
| 19
|
|
|
|
|
| EC
554
|
| Mrs. Cynthia Siegfried
|
| Vol #:
|
| 19
|
|
|
|
|
| 2002D-0260
|
| Prescription drug Samples to Free Clinics
|
|
|
|
|
| EC 2
|
| Mrs. Jennifer Tijerina
|
| 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
|
|
|
|
|
| EC 33
|
| Mrs. Lisa Brewer
|
| Vol #:
|
| 8
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| EC 16
|
| Mrs. Mary Bohl
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| EC 7
|
| Ms. Christine Austen
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
|
|
| EC 518
|
| Ms. Cynthia Cason
|
| Vol #:
|
| 17
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| EC 28
|
| Ms. Nancy Anderson
|
| Vol #:
|
| 4
|
|
|
|
|
| EC 29
|
| Mrs. Jennifer Jones
|
| Vol #:
|
| 4
|
|
|
|
|
| EC 30
|
| Miss. B. Lang
|
| Vol #:
|
| 4
|
|
|
|
|
| EC 31
|
| Mr. BHIMA SHERIDAN
|
| Vol #:
|
| 4
|
|
|
|
|
| EC 32
|
| Ms. Christine Austen
|
| Vol #:
|
| 4
|
|
|
|
|
| RC 1
|
| CoMed, Coalition for Mercury-Free Drugs
|
| Vol #:
|
| 4
|
|
|
|
|
| 2006D-0226
|
| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
|
|
|
|
|
| EC 12
|
| Ms. Roberta Wynn
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Life Choices UFS Pregnancy Resource Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Mr. cary brief
|
| Vol #:
|
| 1
|
|
| |
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
|
|
|
|
|
|
|
|
| EC 5107
|
| Ms. karen fitts
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5108
|
| Mrs. Kelly Roper
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5109
|
| Mrs. Judy Koster
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5110
|
| Dr. Luiz Avila
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5111
|
| Mrs. Susan Bullock
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5112
|
| Mr. Keith Tenhundfeld
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5113
|
| Mrs. Joanna O'Rourke
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5114
|
| Mrs. Amy Shaw
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5115
|
| Mrs. Tina Meyer
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5116
|
| Mr. Richard Beller
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5117
|
| Mrs. Heather Schueckler
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5118
|
| Dr. Swat Pacold
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5119
|
| Dr. Raymond Zolandz
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5120
|
| Ms. Joan Ferris
|
| Vol #:
|
| 26
|
|
|
|
|
| EC
5121
|
| Bucks County Pro Life Coalition
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5122
|
| Mr. Dennis Skirvin
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5123
|
| Mr. Thomas Collins
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5124
|
| Mrs. Jennifer Dzielak
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5125
|
| Mrs. Christie DeTrude
|
| Vol #:
|
| 26
|
|
|
|
|
| EC 5126
|
| Miss. Rosalyn Rapsinski
|
| Vol #:
|
| 26
|
|
