| | | | | | | | | | |
|
| |
|
| Dockets Entered
On February 13, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| 2000P-1466
|
| Non-Approvable Letters for Neurontin
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| 2004D-0555
|
| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
|
|
|
|
|
| 2004N-0556
|
| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
|
|
|
|
|
| 2005N-0353
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Development Study
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| 2005N-0479
|
| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
|
|
|
|
|
|
| 2005N-0510
|
| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
|
|
|
|
|
| 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
|
|
|
|
|
| 2005Q-0298
|
| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
|
|
|
|
|
| 2006D-0011
|
| Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents
|
|
|
|
|
| 2006FL-0017
|
| Food Allergen Labeling Notification for Purity Foods Vita Spelt
|
|
|
|
|
| 2006P-0074
|
| Determine whether Doxycycline Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| 2006V-0073
|
| Projector for a Laser Light Show
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| RPT
310
|
| Global Cancer Strategies Ltd
|
| Vol #:
|
| 246
|
|
|
|
|
| RPT
311
|
| Kedeyoung Industry (Shanghai) Co. Ltd
|
| Vol #:
|
| 247
|
|
|
|
|
| RPT
312
|
| Zephantech LLC
|
| Vol #:
|
| 248
|
|
|
|
|
| RPT
313
|
| Shannon Minerals Ltd
|
| Vol #:
|
| 249
|
|
|
|
|
| RPT
314
|
| Shannon Minerals Ltd
|
| Vol #:
|
| 250
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7518
|
| L. Abadie
|
| Vol #:
|
| 319
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| C 18248
|
| J. Buma
|
| Vol #:
|
| 516
|
|
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
|
|
| C 12842
|
| J. Buma
|
| Vol #:
|
| 806
|
|
|
|
|
| 2000P-1466
|
| Non-Approvable Letters for Neurontin
|
|
| | | | | | | | |
|
| |
|
| WDL
1
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| C 1366
|
| J. Buma
|
| Vol #:
|
| 259
|
|
| |
|
| 2004D-0555
|
| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
|
|
|
|
|
| C
7
|
| Church & Dwight Co., Inc. (CHurch & Dwight)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0556
|
| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
|
|
|
|
|
| C
3
|
| Church & Dwight Co., Inc. (CHurch & Dwight)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0353
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Development Study
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| EMC 275
|
| A. Gorecki
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 276
|
| W. Sternman
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 277
|
| D. Andrews
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 278
|
| E. Cyr
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 279
|
| B. Munden
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 280
|
| B. Tooth
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 281
|
| J. Levy
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 282
|
| M. Weatherby
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 283
|
| M. Maheux
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 284
|
| C. Olson
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 285
|
| L. Diaz
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 286
|
| C. Fanelli
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 287
|
| K. Ross
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 288
|
| R. Johnson
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 289
|
| S. Waldron
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 290
|
| F. Geiger
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 291
|
| J. Russell
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 292
|
| M. Wasielewski
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 293
|
| L. Bartos
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 294
|
| F. Wiewel
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 295
|
| C. Ross
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 296
|
| D. Billings
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 297
|
| V. Varges
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 298
|
| E. Stinson
|
| Vol #:
|
| 11
|
|
| | | | | | | | |
|
| |
|
| EC
1922
|
| Mrs. Claire Marcus
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1923
|
| Mrs. Tammie Binderup
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1924
|
| Dr. Doug Valentine
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1925
|
| Texas Institute fo Functional Medicines
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1926
|
| Mrs. karen olgren
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1927
|
| Ms. Karen Zinke
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1928
|
| Miss. Tracy Crawford
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1929
|
| Chakras Spa
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1930
|
| Mrs. MaryAnn Campbell
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1931
|
| Mr. FRANKLIN rOSS, JR.
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1932
|
| Mrs. Michelle Mahan-Palmer
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1933
|
| Mrs. Marianna Sewejkis
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1934
|
| Mrs. Alexandra Akemann
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1935
|
| Mrs. CYNTHIA COUEY
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1936
|
| Mrs. Sharolyn Smidt
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1937
|
| Ms. Marguerite Gaffney
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
1938
|
| Mrs. Connie Meyers
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 18
|
| D. Zunke
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 19
|
| A. Halpern
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 20
|
| A. Guest
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 21
|
| M. M.
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 22
|
| M. Benko
|
| Vol #:
|
| 12
|
|
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
|
| EMC
1
|
| Kalsec, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005Q-0298
|
| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
|
|
|
|
|
| C
1
|
| Abbott Laboratories, Ross Products Division
|
| Vol #:
|
| 7
|
|
|
|
|
| 2006D-0011
|
| Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents
|
|
|
|
|
| EMC
1
|
| Dental Trade Alliance
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006FL-0017
|
| Food Allergen Labeling Notification for Purity Foods Vita Spelt
|
|
|
|
|
| EMC 1
|
| F. Kelley
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0074
|
| Determine whether Doxycycline Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
