| | | | | | | | | | |
|
| |
|
| Dockets Entered
On January 6, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
|
|
| 2004N-0556
|
| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
|
|
|
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| 2005D-0391
|
| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
|
|
|
|
|
| 2005N-0220
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
|
|
|
|
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
|
|
| 2005N-0479
|
| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
|
|
|
|
|
|
| 2005N-0500
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
|
|
|
|
|
|
|
|
|
| 2005P-0076
|
| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006E-0005
|
| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
|
|
|
|
|
| 2006E-0006
|
| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
|
|
|
|
|
| 2006E-0008
|
| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
|
|
|
|
|
| 2006P-0002
|
| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
|
|
|
|
|
| 2006P-0007
|
| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
|
|
|
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
|
|
|
|
| SUP
48
|
| Northfield Laboratories BB IND #10719
|
| Vol #:
|
| 51
|
|
| |
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
17088
|
| Apex Fitness Group
|
| Vol #:
|
| 154
|
|
|
|
|
| LET
17089
|
| Apex Fitness Group
|
| Vol #:
|
| 154
|
|
|
|
|
| LET
17090
|
| Enzymatic Therapy
|
| Vol #:
|
| 154
|
|
|
|
|
| LET
17091
|
| Enzymatic Therapy
|
| Vol #:
|
| 154
|
|
|
|
|
| LET
17092
|
| Enzymatic Therapy
|
| Vol #:
|
| 155
|
|
| | | | | | | | |
|
| |
|
| LET
17093
|
| Enzymatic Therapy
|
| Vol #:
|
| 155
|
|
|
|
|
| LET
17094
|
| Enzymatic Therapy
|
| Vol #:
|
| 155
|
|
|
|
|
| LET
17095
|
| Enzymatic Therapy
|
| Vol #:
|
| 155
|
|
| |
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 622
|
| B. Witt
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 623
|
| B. Witt
|
| Vol #:
|
| 24
|
|
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
|
|
| EMC
24
Attachment
|
| U.S. Apple Association (USApple)
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
|
|
| EMC 131
|
| K. Cheek
|
| Vol #:
|
| 14
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 585
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 586
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 1187
|
| M. Hallinan
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1188
|
| B. Talmage
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1189
|
| K. Hayes
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1190
|
| T. Hurley
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1191
|
| Eligible
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1192
|
| D. Varney
|
| Vol #:
|
| 12
|
|
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
|
|
| C 41
|
| D. Herr
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0556
|
| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
|
|
|
|
|
| REF
1
|
| OMB Review for Designation of Special Control for Condom and Condom with Spermicidal Lubrican
|
| Vol #:
|
| 3
|
|
| |
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
|
|
| C 13
|
| L. Smith
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| M
1
|
| HFS-832
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005D-0330
|
| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
|
|
|
|
|
| C
36
|
| Gulf Coast Regional Blood Center
|
| Vol #:
|
| 4
|
|
|
|
|
| C
37
|
| Indiana Blood Center
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
|
|
| C
38
|
| Johnston Memorial Hospital
|
| Vol #:
|
| 4
|
|
|
|
|
| C
39
|
| Puget Sound Blood Center
|
| Vol #:
|
| 4
|
|
|
|
|
| C 40
|
| M. Johnson
|
| Vol #:
|
| 4
|
|
|
|
|
| C
41
|
| Community Blood Bank
|
| Vol #:
|
| 4
|
|
|
|
|
| C
42
|
| Michigan Community Blood Centers (MCBC)
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
2
|
| City of Hope National Medical Center
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
3
|
| New Jersey Blood Services
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
4
|
| Hoag Memorial Hospital Presbyterian
|
| Vol #:
|
| 4
|
|
|
|
|
| 2005D-0391
|
| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
|
|
|
|
|
| C
2
|
| Interventional Rhythm Management, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0220
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
|
|
|
|
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporing Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| EMC 77
|
| Ryan Arnold
|
| Vol #:
|
| 4
|
|
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
| C
1
|
| The Assembly State of New York, Albany
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0479
|
| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
|
|
|
|
|
|
|
|
|
|
|
| EXT
1
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0500
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0076
|
| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
|
|
|
|
|
| EMC 1
|
| L. Farris
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 170
|
| M. Guess
|
| Vol #:
|
| 3
|
|
|
|
|
| C 171
|
| T. Crawford
|
| Vol #:
|
| 3
|
|
|
|
|
| C 172
|
| S. Williams
|
| Vol #:
|
| 3
|
|
|
|
|
| C 173
|
| Dr. T. Fourre
|
| Vol #:
|
| 3
|
|
|
|
|
| C 174
|
| D. Bergin
|
| Vol #:
|
| 3
|
|
|
|
|
| C 175
|
| P. Fontaine
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
| |
|
| C 176
|
| J. Nichols
|
| Vol #:
|
| 3
|
|
|
|
|
| C 177
|
| K. Jeffries
|
| Vol #:
|
| 3
|
|
|
|
|
| C 178
|
| K. Albers
|
| Vol #:
|
| 3
|
|
|
|
|
| C
179
|
| Steven E. Pillow, M.D., P.A., FACOG and Associates
|
| Vol #:
|
| 3
|
|
|
|
|
| C 180
|
| J. Bell
|
| Vol #:
|
| 3
|
|
|
|
|
| C 181
|
| C. Hazel
|
| Vol #:
|
| 3
|
|
|
|
|
| C 182
|
| D. Minocchi
|
| Vol #:
|
| 3
|
|
|
|
|
| C 183
|
| P. Davis
|
| Vol #:
|
| 3
|
|
|
|
|
| C 184
|
| L. Ballard
|
| Vol #:
|
| 3
|
|
|
|
|
| C 185
|
| G. Howton
|
| Vol #:
|
| 3
|
|
|
|
|
| C 186
|
| Eligible
|
| Vol #:
|
| 3
|
|
|
|
|
| C 187
|
| P. Menser
|
| Vol #:
|
| 3
|
|
|
|
|
| C 188
|
| E. Wright
|
| Vol #:
|
| 3
|
|
|
|
|
| C 189
|
| P. Ayres
|
| Vol #:
|
| 3
|
|
|
|
|
| C 190
|
| C. Fisher
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 2
|
| M. Jacobs
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 3
|
| D. Barone
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 4
|
| S. Novas
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 5
|
| D. Doyle
|
| Vol #:
|
| 3
|
|
| |
|
| 2006E-0005
|
| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
|
|
|
|
|
| APP
1
|
| Warner-Lambert Company LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006E-0006
|
| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
|
|
|
|
|
| APP
1
|
| Warner-Lambert Company LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006E-0008
|
| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
|
|
|
|
|
| APP
1
|
| Pfizer Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0002
|
| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Conusltant Services, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0007
|
| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
