| | | | | | | | | | |
|
|
| Dockets Entered
On October 17, 2007
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
| 1977N-0094L
|
| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
|
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
|
|
| 2001D-0025
|
| Guidance for Industry - Yellow Corn & Dry-Milled
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
|
|
| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| 2007D-0201
|
| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
|
|
|
| 2007D-0388
|
| Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protec
|
|
|
|
| 2007N-0036
|
| Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study
|
|
|
|
|
|
| 2007N-0092
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
|
|
|
| 2007N-0240
|
| Agency Information Collection Activities: Proposed collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60) Exte
|
|
|
|
| 2007N-0241
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
|
|
| 2007N-0311
|
| Midodrine Exclusivity Issues
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
| 2007P-0074
|
| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
| 2007P-0235
|
| Change the labeling requirements for eggs sold in the United States
|
|
|
| 2007P-0352
|
| FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as prescription only medicines
|
|
|
|
| 2007P-0399
|
| Adopt, announce, and implement a consistent, CDER-wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products
|
|
|
| 2007P-0400
|
| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
| AMD 1
|
| Number not used
|
| Vol #:
|
|
|
|
|
| 1977N-0094L
|
| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
|
|
|
|
| |
|
| SUP 1
|
| McNeil Consumer Healthcare
|
| Vol #:
|
| 1
|
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
|
|
| EC 63
|
| Mr. Mark Alfredson
|
| Vol #:
|
| 2
|
|
|
| 2001D-0025
|
| Guidance for Industry - Yellow Corn & Dry-Milled
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| EMC 3388
|
| C. Neiman
|
| Vol #:
|
| 261
|
|
|
| EMC 3389
|
| C. Schaeffer
|
| Vol #:
|
| 261
|
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to Pharmacia Corporation
|
| Vol #:
|
| 1
|
|
|
| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
|
|
|
| CEP 1
|
| U.S. Patent and Trademark Office to OSI Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| EC 125
|
| GeneWISE
|
| Vol #:
|
| 3
|
|
|
| EC 126
|
| Mrs. Miriam Breslauer
|
| Vol #:
|
| 3
|
|
|
| EC 127
|
| Intermountain Healthcare
|
| Vol #:
|
| 3
|
|
|
| EC 128
|
| AviaraDx, Inc.
|
| Vol #:
|
| 3
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| C 222
|
| C. K. Bile
|
| Vol #:
|
| 10
|
|
|
| C 223
|
| Unknown
|
| Vol #:
|
| 10
|
|
|
| C 224
|
| T. Shoabi
|
| Vol #:
|
| 10
|
|
|
| C 225
|
| L Turner
|
| Vol #:
|
| 10
|
|
|
| C 226
|
| M. Galinsky
|
| Vol #:
|
| 10
|
|
|
| C 227
|
| L. Garretson
|
| Vol #:
|
| 10
|
|
|
| C 228
|
| M. Mohl
|
| Vol #:
|
| 10
|
|
|
| C 229
|
| K. Repash
|
| Vol #:
|
| 10
|
|
|
| C 230
|
| J. A. Kivlin
|
| Vol #:
|
| 10
|
|
|
| C 231
|
| Unknown
|
| Vol #:
|
| 10
|
|
|
| C 232
|
| V. Schmidt
|
| Vol #:
|
| 10
|
|
|
| C 233
|
| D. Pohedra
|
| Vol #:
|
| 10
|
|
|
| C 234
|
| L. A. Kenepp
|
| Vol #:
|
| 10
|
|
|
| C 235
|
| L. Bieber-ham
|
| Vol #:
|
| 10
|
|
|
| C 236
|
| E. Clark
|
| Vol #:
|
| 10
|
|
|
| C 237
|
| S. Jain
|
| Vol #:
|
| 10
|
|
|
| C 238
|
| L. P. Heyl
|
| Vol #:
|
| 10
|
|
|
| C 239
|
| J. Weber
|
| Vol #:
|
| 10
|
|
|
| C 240
|
| C. B. Shaffer
|
| Vol #:
|
| 10
|
|
|
| C 241
|
| L. Romano
|
| Vol #:
|
| 10
|
|
|
| C 242
|
| P. Leitner
|
| Vol #:
|
| 10
|
|
| | | | | | | | |
|
|
| 2007N-0036
|
| Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study
|
|
|
|
| |
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
| 2007N-0092
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2007N-0240
|
| Agency Information Collection Activities: Proposed collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60) Exte
|
|
|
|
| |
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2007N-0241
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
|
|
| C 1
|
| Unknown
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| L. Delaney
|
| Vol #:
|
| 1
|
|
|
| 2007N-0311
|
| Midodrine Exclusivity Issues
|
|
|
| C 6
|
| Upsher-Smith
|
| Vol #:
|
| 1
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
| EC 15
|
| Mr. Jeffrey Cappo
|
| Vol #:
|
| 1
|
|
|
| 2007P-0074
|
| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
| EC 8
|
| Miss Maria Thorpe
|
| Vol #:
|
| 1
|
|
|
| 2007P-0235
|
| Change the labeling requirements for eggs sold in the United States
|
|
|
| C 124
|
| E. Fleyshgakker
|
| Vol #:
|
| 2
|
|
|
| C 125
|
| J. C. Rovenolt
|
| Vol #:
|
| 2
|
|
|
| C 126
|
| S. Hamilton
|
| Vol #:
|
| 2
|
|
|
| C 127
|
| J. Culp
|
| Vol #:
|
| 2
|
|
|
| C 128
|
| B. Bendler
|
| Vol #:
|
| 2
|
|
|
| C 129
|
| G. Keyser
|
| Vol #:
|
| 2
|
|
|
| C 130
|
| E. Preton
|
| Vol #:
|
| 2
|
|
|
| C 131
|
| Unknown
|
| Vol #:
|
| 2
|
|
|
| C 132
|
| H. Einseln
|
| Vol #:
|
| 2
|
|
|
| C 133
|
| D. DeFries
|
| Vol #:
|
| 2
|
|
|
| C 134
|
| B. Morean
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| C 135
|
| A. R. Staton
|
| Vol #:
|
| 2
|
|
|
| C 136
|
| A. Rogers
|
| Vol #:
|
| 2
|
|
|
| C 137
|
| S. Nocella
|
| Vol #:
|
| 2
|
|
|
| C 138
|
| L. Hensley
|
| Vol #:
|
| 2
|
|
|
| C 139
|
| J. Farrell
|
| Vol #:
|
| 2
|
|
|
| C 140
|
| J. Haptas
|
| Vol #:
|
| 2
|
|
|
| C 141
|
| M. Barton-Rowledge
|
| Vol #:
|
| 2
|
|
|
| C 142
|
| M. Dixon
|
| Vol #:
|
| 2
|
|
|
| C 143
|
| L. Fitzgerald
|
| Vol #:
|
| 2
|
|
|
| C 144
|
| M. Hillary
|
| Vol #:
|
| 2
|
|
|
| C 145
|
| K. Moore
|
| Vol #:
|
| 2
|
|
|
| C 146
|
| E. Richards
|
| Vol #:
|
| 2
|
|
|
| C 147
|
| S. Mooe
|
| Vol #:
|
| 2
|
|
|
| C 148
|
| R. Clement
|
| Vol #:
|
| 2
|
|
|
| C 149
|
| K. Lynch
|
| Vol #:
|
| 2
|
|
|
| C 150
|
| Unknown
|
| Vol #:
|
| 2
|
|
|
| C 151
|
| R. Diener
|
| Vol #:
|
| 2
|
|
|
| C 152
|
| C. Patterson
|
| Vol #:
|
| 2
|
|
|
| 2007P-0352
|
| FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as prescription only medicines
|
|
|
|
|
|
|
| EC 1
|
| Mr. Jeffrey Cappo
|
| Vol #:
|
| 1
|
|
|
| 2007P-0399
|
| Adopt, announce, and implement a consistent, CDER-wide standard for the acceptable level of 14-hydroxycodeinone impurity in oxycodone HCI API approved by FDA for use in drug products
|
|
|
|
| |
|
| ACK 1
|
| FDA/DDM to Purdue Pharma L.P. and Rhodes Technologies
|
| Vol #:
|
| 1
|
|
|
| ACK 2
|
| FDA/DDM to Purdue Pharma L.P. and Rhodes Technologies
|
| Vol #:
|
| 2
|
|
|
| CP 1
|
| Purdue Pharma L.P. and Rhodes Technologies
|
| Vol #:
|
| 1
|
|
|
| PSA 1
|
| Purdue Pharma L.P. and Rhodes Technologies
|
| Vol #:
|
| 2
|
|
|
| 2007P-0400
|
| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
| |
|
| ACK 1
|
| FDA/DDM to Richard Sauerheber, Ph.D.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Richard Sauerheber, Ph.D.
|
| Vol #:
|
| 1
|
|