Dockets Entered on June 9, 2006

Dockets Management



Dockets Entered On June 9, 2006 Table of Contents



Docket #	Title

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

1998P-0724	Prohibition of Cochineal Extract and Carmine Color Additives

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

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

2004Q-0201	Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers

2005D-0310	Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events

2005N-0364	Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting

2005N-0393	Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations

2005N-0426	Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006D-0191	Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

2006E-0240	Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517

2006M-0233	H040002, INTACS Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm)

2006N-0081	Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203

2006N-0187	Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women

2006N-0215	Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon


2006P-0089	Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)

2006P-0241	Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy

2006P-0242	Approval of any Budesonide Inhalation Suspension Product usin PULMICORT RESPULES

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

RPT 337	Global Cancer Strategies	Vol #:	264

RPT 338	The Pryde Company	Vol #:	263

RPT 339	The Pryde Company	Vol #:	263

RPT 340	TJ Panorama Inc	Vol #:	263

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 17826	Ortho Molecular Products, Inc.	Vol #:	164

LET 17827	Ortho Molecular Products, Inc.	Vol #:	164

LET 17828	Ortho Molecular Products, Inc.	Vol #:	164

LET 17829	Ortho Molecular Products, Inc.	Vol #:	164

LET 17830	Ortho Molecular Products, Inc.	Vol #:	164

LET 17831	Iovate Health Sciences U.S.A., Inc.	Vol #:	164

LET 17832	ZeaVision LLC	Vol #:	164



LET 17833	Enzymatic Therapy	Vol #:	164

LET 17834	Enzymatic Therapy	Vol #:	164

LET 17835	Enzymatic Therapy	Vol #:	164

LET 17836	Enzymatic Therapy	Vol #:	164

LET 17837	Enzyamtc Therapy	Vol #:	164

LET 17838	Enzymatic Therapy	Vol #:	164

LET 17839	Enzymatic Therapy	Vol #:	164

LET 17840	Enzymatic Therapy	Vol #:	164

LET 17841	Enzymatic Therapy	Vol #:	164

LET 17842	Enzymatic Therapy	Vol #:	164

LET 17843	Enzymatic Therapy	Vol #:	164

LET 17844	Enzymatic Therapy	Vol #:	164

LET 17845	Enzymatic Therapy	Vol #:	164

LET 17846	Enzymatic Therapy	Vol #:	164

LET 17847	Enzymatic Therapy	Vol #:	164

LET 17848	Infinity 2, Inc.	Vol #:	164

1998P-0724	Prohibition of Cochineal Extract and Carmine Color Additives

EMC 25	M. Murphy	Vol #:	3

EMC 26	L. Gracia	Vol #:	3

EMC 27	Form Letters	Vol #:	4

EMC 28	R. Martin	Vol #:	3

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

PDN 1	FDA to Center for Reproductive Rights	Vol #:	348

REF 1	Petition Response References	Vol #:	348

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 658	Mission Possible International	Vol #:	9

EMC 659	Calorie Control Council	Vol #:	9

EMC 660	Mission Possible International	Vol #:	9

EMC 661	Mission Possible International	Vol #:	9

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1303	V. Jaynes	Vol #:	12

2004Q-0201	Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers

REF 2	References - Administrative File	Vol #:	24



2005D-0310	Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events

EMC 5	O. Hagenauer	Vol #:	1

2005N-0364	Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting

TR 2	Transcript of the May 22, 2006 Meeting	Vol #:	3

TS 12	Barnett Intro for MDUFMA	Vol #:	3

TS 13	Linda Kahan Remarks for 05/22/2006 meeting	Vol #:	3

2005N-0393	Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations

NAL 1	FDA	Vol #:	1

SS 1	SUPPORTING STATEMENT	Vol #:	1

2005N-0426	Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation

NAL 1	FDA	Vol #:	1

SS 1	SUPPORTING STATEMENT	Vol #:	1

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 12143	C.Brown	Vol #:	150

C 12144	S. Mason	Vol #:	150

C 12145	S. M Helfers	Vol #:	150

C 12146	R. Brack	Vol #:	150

C 12147	D. Robin	Vol #:	150

C 12148	L. M. Sills	Vol #:	150

C 12149	J. Heath	Vol #:	150

C 12150	D. Heath	Vol #:	150

C 12151	D. Weils	Vol #:	150

C 12152	D. G. Schwartz, MD	Vol #:	150

C 12153	L. Brown	Vol #:	150

C 12154	M. Bradley	Vol #:	150

C 12155	V. Grimmes	Vol #:	150

C 12156	S. E. Raisen	Vol #:	150

C 12157	M. L. Macomb	Vol #:	150

C 12158	M. Holland	Vol #:	150

C 12159	L. Amsbaugh	Vol #:	150

C 12160	J. Hoots	Vol #:	150

C 12161	L. L. MacElree	Vol #:	150

C 12162	T. Murphy	Vol #:	150

C 12163	L. McFletcher	Vol #:	150



C 12164	C. Lamberti	Vol #:	150

C 12165	K. Kozolanka	Vol #:	150

C 12166	H. W. Jones Sr	Vol #:	150

C 12167	J. Chandra	Vol #:	150

C 12168	L. J. Kind	Vol #:	150

C 12169	M. Hanna	Vol #:	150

C 12170	A. Lark	Vol #:	150

C 12171	D. Atone	Vol #:	150

C 12172	K. B. Savarese	Vol #:	150

C 12173	P/ A. Aron	Vol #:	150

C 12174	H. Smith Jones	Vol #:	150

C 12175	K. Troup	Vol #:	150

C 12176	S. Bush	Vol #:	150

C 12177	D. McCloe	Vol #:	150

C 12178	M. Wolf	Vol #:	150

C 12179	G. Salisbury	Vol #:	150

C 12180	C. Barken-Reid	Vol #:	150

C 12181	C. Kilanowski	Vol #:	150

C 12182	S. Moore	Vol #:	150

C 12183	C. Tatoe	Vol #:	150

C 12184	J. Jackson	Vol #:	150

C 12185	V. Jackson	Vol #:	150

C 12186	E. M. Taylor	Vol #:	150

C 12187	V. J. Clemis	Vol #:	150

C 12188	L. J. Kind	Vol #:	150

C 12189	S. Church	Vol #:	150

C 12190	J. Cocuran	Vol #:	150

C 12191	G. Broucanum	Vol #:	150

C 12192	D. Williams	Vol #:	150

C 12193	M. Flay	Vol #:	150

C 12194	B. Colletta	Vol #:	150

C 12195	A. Jackson	Vol #:	150

C 12196	G. Von Elekes	Vol #:	150

C 12197	D. Stepanovich	Vol #:	150

C 12198	P. Hamiltion	Vol #:	150

C 12199	O. Tarin Duff	Vol #:	150

C 12200	M. Slovak	Vol #:	150



C 12201	O. Tarin Duff	Vol #:	150

C 12202	H. Perlmutter	Vol #:	150

C 12203	L. Grunewald	Vol #:	150

C 12204	P. Pierce	Vol #:	150

C 12205	P. Picrce	Vol #:	150

C 12206	S. Hawtrey	Vol #:	150

C 12207	M. Kaauanio	Vol #:	150

C 12208	M. Ancra	Vol #:	150

C 12209	E. Sushman	Vol #:	150

C 12210	C. Boen	Vol #:	150

C 12211	D. Jacques	Vol #:	150

C 12212	L. Tillotson	Vol #:	150

C 12213	P. Parker	Vol #:	150

C 12214	C. Hubbard	Vol #:	150

C 12215	E. Patc	Vol #:	150

C 12216	K. Vilendrer	Vol #:	150

C 12217	A. Russ	Vol #:	150

C 12218	L. Q. Rasmussen	Vol #:	150

C 12219	K. Bissell	Vol #:	150

C 12220	S. Danner	Vol #:	150

C 12221	K. Keigl	Vol #:	150

C 12222	K. M.H. McCaay	Vol #:	150

C 12223	KE. Marcu	Vol #:	150

C 12224	A. L. Stoweu	Vol #:	150

C 12225	J. Piccarett	Vol #:	150

C 12226	M. Ronnfeldt	Vol #:	150

C 12227	S. Gaskins	Vol #:	150

C 12228	R. Penc-Watson	Vol #:	150

C 12229	S. Pipan	Vol #:	150

C 12230	A. M. Rossi	Vol #:	150

C 12231	J. L. Boyce	Vol #:	150

C 12232	N. G. Loyola	Vol #:	150

C 12233	D. Keller	Vol #:	150

C 12234	D. M. Danko	Vol #:	150

C 12235	L. L. Heil	Vol #:	150

C 12236	S. Pollock	Vol #:	150

C 12237	J. Dixon	Vol #:	150



C 12238	C. Phelps	Vol #:	150

C 12239	P. Davidson	Vol #:	150

C 12240	L. McGuire	Vol #:	150

C 12241	C. Hanwright	Vol #:	150

C 12242	J. Archar	Vol #:	150

C 12243	C. Martin	Vol #:	150

C 12244	J. Wood	Vol #:	150

C 12245	A. Rice	Vol #:	150

C 12246	P. Starm	Vol #:	150

C 12247	N. Kreider	Vol #:	150

C 12248	L.Lovell	Vol #:	150

C 12249	P. J. Steely	Vol #:	150

C 12250	C. Ennis	Vol #:	150

C 12251	M. I. Lyon	Vol #:	150

C 12252	L. E. Davis	Vol #:	150

C 12253	R. Cannon	Vol #:	150

C 12254	D. Doheny	Vol #:	150

C 12255	M. Casay	Vol #:	150

C 12256	N. Eskijiaz	Vol #:	150

C 12257	J. Conley	Vol #:	150

C 12258	C. Converse	Vol #:	150

C 12259	N. Wegmann	Vol #:	150

C 12260	E. Rassdale	Vol #:	150

C 12261	C. Kojch	Vol #:	150

C 12262	G. Nelson	Vol #:	150

C 12263	S. Pepo	Vol #:	150

C 12264	R. Baker	Vol #:	150

C 12265	C.Carter	Vol #:	150

C 12266	C. Batchelor	Vol #:	150

C 12267	C. Cooluy	Vol #:	150

C 12268	C.Doherty	Vol #:	150

C 12269	P. Hargrove	Vol #:	150

C 12270	S. Sudholt	Vol #:	150

C 12271	N. McMahor	Vol #:	150

C 12272	P. Liston	Vol #:	150

C 12273	D. Mize	Vol #:	150

C 12274	B. Roye	Vol #:	150



C 12275	P. Bricku	Vol #:	150

C 12276	E. M. Stocktor	Vol #:	150

C 12277	F. Brizi0	Vol #:	150

C 12278	E. C. Nelson	Vol #:	150

C 12279	G. Milks	Vol #:	150

C 12280	K. Prozd	Vol #:	150

C 12281	S. J Van Wyhe	Vol #:	150

C 12282	J. Endin	Vol #:	150

C 12283	J. McGrigg	Vol #:	150

C 12284	J. Hartman	Vol #:	150

C 12285	S. Hinojossa	Vol #:	150

C 12286	J. Stazenski	Vol #:	150

C 12287	K. Robinson	Vol #:	150

C 12288	T. Hechlel	Vol #:	150

C 12289	J. R. McLaughlin	Vol #:	150

C 12290	W. A. Scott	Vol #:	150

C 12291	J. Sciabbarrasi	Vol #:	150

C 12292	S. Scott	Vol #:	150

C 12293	K. Stockbauer	Vol #:	150

C 12294	R. Kennedy	Vol #:	150

C 12295	M. J. Burough	Vol #:	150

C 12296	M. A. Edward	Vol #:	150

C 12297	C. Hill	Vol #:	150

C 12298	V. Welch	Vol #:	150

C 12299	G. Garccia	Vol #:	150

C 12300	L. R. Hecker	Vol #:	150

C 12301	D. D. Summers	Vol #:	151

C 12302	F. Figarotta	Vol #:	151

C 12303	P. Ralfs	Vol #:	151

C 12304	M. Dedomenico	Vol #:	164

C 12305	R. McMahon	Vol #:	164

C 12306	M. G. Zaragoza	Vol #:	151

C 12307	C. Orjala	Vol #:	151

C 12308	A. Densmore	Vol #:	151

C 12309	K. A. Lynch	Vol #:	151

C 12310	W. Ziprick	Vol #:	151

C 12311	L. Knobloch	Vol #:	151



C 12312	C. Kushner-Cohen	Vol #:	151

C 12313	J. Dean	Vol #:	151

C 12314	R. Davis	Vol #:	151

C 12315	L. Young	Vol #:	151

C 12316	B. Griffith	Vol #:	151

C 12317	P. Eldred	Vol #:	151

C 12318	J. Guetig	Vol #:	151

C 12319	M. Biszmaier	Vol #:	151

C 12320	K. Burgess	Vol #:	151

C 12321	J. Bourgeois	Vol #:	151

C 12322	S. Guidry	Vol #:	151

C 12323	D. Fontane	Vol #:	151

C 12324	T. Adams	Vol #:	151

C 12325	J. Orgeron	Vol #:	151

C 12326	A. Prince	Vol #:	151

C 12327	D. Chiasson	Vol #:	151

C 12328	M. Fran	Vol #:	151

C 12329	H. G. Pere	Vol #:	151

C 12330	M. Guidry	Vol #:	151

C 12331	T. Foret	Vol #:	151

C 12332	T. Daigle	Vol #:	151

C 12333	K. Egan	Vol #:	151

EMC 2689	B. Green	Vol #:	124

EMC 2690	Dr. Kenney	Vol #:	124

EMC 2691	C. Straughn	Vol #:	124

EMC 2692	R. Yates	Vol #:	124

EMC 2693	J. Vajko	Vol #:	124

EMC 2694	S. Chatelain	Vol #:	124

EMC 2695	P. Green	Vol #:	124

EMC 2696	P. Motheral	Vol #:	124

EMC 2697	S. Loeffler	Vol #:	124

EMC 2698	E. Hanan	Vol #:	124

EMC 2699	P. Vlach	Vol #:	124

EMC 2700	S. Barton	Vol #:	124

EMC 2701	N. Lewis	Vol #:	124

EMC 2702	R. Baud	Vol #:	124

EMC 2703	J. Durrett, Jr.	Vol #:	124



EMC 2704	J. Phillips	Vol #:	124

EMC 2705	R. Dees	Vol #:	124

EMC 2706	Dr. M. Sonnenfeld	Vol #:	124

EMC 2707	M. Flynn	Vol #:	124

EMC 2708	C. Brown	Vol #:	124

EMC 2709	E. Houghton	Vol #:	124

EMC 2710	A. Ehlert	Vol #:	124

EMC 2711	L. Romanoff	Vol #:	124

EMC 2712	D. Parad	Vol #:	124

EMC 2713	S. Shearman	Vol #:	124

EMC 2714	B. Taylor	Vol #:	124

EMC 2715	Dr. M. Lewis, PhD	Vol #:	124

EMC 2716	N. Niece	Vol #:	124

2006D-0191	Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

C 1	London School of Hygiene and Tropical Medicine	Vol #:	1

2006E-0240	Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517

APP 1	Celgene Corporation	Vol #:	1

LET 1	U.S. Patent and Trademark Office	Vol #:	1

2006M-0233	H040002, INTACS Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm)

AAV 1	Addition Technology	Vol #:	1

2006N-0081	Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203

N 2	FDA	Vol #:	1

2006N-0187	Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women



N 1	FDA	Vol #:	1

2006N-0215	Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon


N 1	FDA	Vol #:	1

2006P-0089	Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)

C 2	Genentech, Inc. (Genentech) and Idec, Inc. (Biogen)	Vol #:	1

2006P-0241	Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy

CP 1	Zydus Pharmaceuticals Inc	Vol #:	1



2006P-0242	Approval of any Budesonide Inhalation Suspension Product usin PULMICORT RESPULES

ACK 1	FDA/DDMB to Ropes & Gray, LLP	Vol #:	1

CP 1	AstraZeneca LP (AstraZeneca)	Vol #:	1

Page created on October 5, 2006 kk

FDA/Dockets Management