Dockets Entered on October 17, 2007

Dockets Management



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2007P-0352	FDA withdrawn the commercial marketing authorization for oral sodium phosphate (OSP) products for bowel cleansing and reclassify all OSP products for bowel cleansing as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



C 243	D. Kenny	Vol #:	10

C 244	B. Danielson	Vol #:	10

C 245	A. Robb	Vol #:	10

C 246	K. Urtfer	Vol #:	10

C 247	V. Stevens	Vol #:	10

C 248	J. Berry	Vol #:	10

C 249	K. Cummings	Vol #:	10

C 250	J. Hawkins	Vol #:	10

C 251	C. Mirle	Vol #:	10

C 252	C. McFeeley	Vol #:	10

C 253	T. Lake	Vol #:	10

C 254	J. Flores	Vol #:	10

C 255	M. Hefner	Vol #:	10

C 256	J. Shackelford	Vol #:	10

C 257	J. Seitz	Vol #:	10

C 258	L. Kearney	Vol #:	10

C 259	C. Patterson	Vol #:	10

C 260	Unknown	Vol #:	10

C 261	C. Davis	Vol #:	10

C 262	R. Anderson	Vol #:	10

C 263	D. Ball	Vol #:	10

C 264	K. Procope	Vol #:	10

C 265	Unknown	Vol #:	10

C 266	A. M. King	Vol #:	10

C 267	N. Lim	Vol #:	10

C 268	A. Hirtle	Vol #:	10

C 269	Unknown	Vol #:	10

C 270	J. Pedelty	Vol #:	10

C 271	C. Gregoire	Vol #:	10

C 272	C. Small	Vol #:	10

C 273	F. Bigda-Peyton	Vol #:	10

C 274	C Korns	Vol #:	10

C 275	R. Hunt	Vol #:	10

C 276	P. Rodriguez	Vol #:	10

C 277	R. Wick	Vol #:	10

C 278	C. Sun	Vol #:	10

C 279	J.C. Rovenolt	Vol #:	10



C 280	S. Hamilton	Vol #:	10

C 281	J. Culp	Vol #:	10

C 282	B. Bendler	Vol #:	10

C 283	G. Keyser	Vol #:	10

C 284	E. Preton	Vol #:	10

C 285	Unknown	Vol #:	10

C 286	H. Einseln	Vol #:	10

C 287	D. DeFries	Vol #:	10

C 288	B. Morean	Vol #:	10

C 289	A. R. Staton	Vol #:	10

C 290	A. Rogers	Vol #:	10

C 291	S. Nocella	Vol #:	10

C 292	L. Hensley	Vol #:	10

C 293	J. Farrell	Vol #:	10

C 294	J. Haptas	Vol #:	10

C 295	M. Barton-Rowledge	Vol #:	10

C 296	M. Dixon	Vol #:	10

C 297	L. Fitzgerald	Vol #:	10

C 298	M. Hillary	Vol #:	10

C 299	N. Merjian	Vol #:	10

C 300	K. Moore	Vol #:	10

C 301	E. Richards	Vol #:	10

C 302	S. Mooe	Vol #:	10

C 303	R. Clement	Vol #:	10

C 304	K. Lynch	Vol #:	10

C 305	Unknown	Vol #:	10

C 306	R.Diener	Vol #:	10

C 307	E. Fleyshgakker	Vol #:	10

2007D-0201	Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents

C 2	BECKER & ASSOCIATES	Vol #:	1

EC 3	Zimmer, Inc.	Vol #:	1

EC 4	Ms. Michelle Gudith	Vol #:	1

EC 5	Advanced Medical Technology Association	Vol #:	1

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


REF 1	References	Vol #:	1



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

Page created on October 17, 2007 ue

FDA/Dockets Management