Dockets Entered on June 5, 2006

Dockets Management



Dockets Entered On June 5, 2006 Table of Contents



Docket #	Title

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

2000D-1400	Reproductive Toxicity Studies preventive vaccines Disease

2000D-1632	Management of Adverse Event Reports (AER's) (VICH GL24)

2005D-0183	Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency

2005N-0347	Biological Products for Treatment of Rare Plasma Protein Disorders

2005N-0467	Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

2005P-0070	ANDA Suitability for Oral Salmon Calcitonin

2005P-0095	ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP

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

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

2006D-0088	Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

2006D-0150	Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp


2006D-0170	International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal


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

2006N-0104	Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

2006N-0107	FDA-Regulated Products Containing Nanotechnology Materials

2006N-0180	Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs

2006P-0092	Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded

2006P-0095	ANDA suitability for a Piperacillin and Tazobactam for Injection, 13.5 g pharmacy bulk vial

2006Q-0091	Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease

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

LET 17778	NOW Foods	Vol #:	164

LET 17779	NOW Foods	Vol #:	164

LET 17780	NOW Foods	Vol #:	164

LET 17781	NOW Foods	Vol #:	164

LET 17782	NOW Foods	Vol #:	164

LET 17783	NOW Foods	Vol #:	163

LET 17784	NOW Foods	Vol #:	164

LET 17785	NOW Foods	Vol #:	164

LET 17786	NOW Foods	Vol #:	164

LET 17787	NOW Foods	Vol #:	164

LET 17788	NOW Foods	Vol #:	164

LET 17789	NOW Foods	Vol #:	164

LET 17790	NOW Foods	Vol #:	164



LET 17791	NOW Foods	Vol #:	164

LET 17792	NOW Foods	Vol #:	164

LET 17793	NOW Foods	Vol #:	164

LET 17794	NOW Foods	Vol #:	164

LET 17795	NOW Foods	Vol #:	164

LET 17796	NOW Foods	Vol #:	164

LET 17797	NOW Foods	Vol #:	164

LET 17798	NOW Foods	Vol #:	164

LET 17799	NOW Foods	Vol #:	164

LET 17800	NOW Foods	Vol #:	164

LET 17801	NOW Foods	Vol #:	164

LET 17802	NOW Foods	Vol #:	164

LET 17803	NOW Foods	Vol #:	164

2000D-1400	Reproductive Toxicity Studies preventive vaccines Disease

EC 1	Ms. Rebecca Jackson	Vol #:	1

2000D-1632	Management of Adverse Event Reports (AER's) (VICH GL24)

EC 1	Animal Health Institute	Vol #:	1

2005D-0183	Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2005N-0347	Biological Products for Treatment of Rare Plasma Protein Disorders

C 2	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

2005N-0467	Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

EC 1	International Society for Clinical Densitometry	Vol #:	1

2005P-0070	ANDA Suitability for Oral Salmon Calcitonin

PDN 1	FDA/CDER to Latham & Watkins LLP	Vol #:	1

2005P-0095	ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP

C 1	King & Spalding, LLP	Vol #:	2

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

C 11698	R. Baggstrom	Vol #:	145

C 11699	K Zadik	Vol #:	145

C 11700	J M. Rakfeldt	Vol #:	145



C 11701	L. S. Bresee	Vol #:	145

C 11702	J. Carlson	Vol #:	145

C 11703	L. Roemer	Vol #:	145

C 11704	D. Durham	Vol #:	145

C 11705	K. J. Sakry	Vol #:	145

C 11706	K. J. Sakry	Vol #:	145

C 11707	C. Stafforf	Vol #:	145

C 11708	C. Spence	Vol #:	145

C 11709	L. Jones	Vol #:	145

C 11710	N. Tashnek	Vol #:	145

C 11711	R. A. MacGaren Moser	Vol #:	145

C 11712	A. Prestus	Vol #:	145

C 11713	N. Gruber	Vol #:	145

C 11714	M. Jessee	Vol #:	145

C 11715	D. Phillips	Vol #:	145

C 11716	S. E. Loughnane	Vol #:	145

C 11717	S. Crane	Vol #:	145

C 11718	S. Crane	Vol #:	145

C 11719	B. Chall	Vol #:	145

C 11720	C. Walters	Vol #:	145

C 11721	R. R. Totl	Vol #:	145

C 11722	B. Sehtichter	Vol #:	145

C 11723	R. Clarl	Vol #:	149

C 11724	B Hanskin-Mcelunn	Vol #:	149

C 11725	J. Lee	Vol #:	149

C 11726	C. Hejl	Vol #:	149

C 11727	L. Dennis	Vol #:	149

C 11728	B. Ingram	Vol #:	149

C 11729	S. Sunft	Vol #:	149

C 11730	D. Halveson	Vol #:	149

C 11731	S. Oliver	Vol #:	149

C 11732	J. Keiitz	Vol #:	149

C 11733	H. Groen	Vol #:	149

C 11734	J. Steinberg	Vol #:	149

C 11735	S. Stisser	Vol #:	149

C 11736	Sharon Polkowsi	Vol #:	149

C 11737	R. Opitz	Vol #:	149



C 11738	J. Hettinger	Vol #:	149

C 11739	M. Vogelman	Vol #:	149

C 11740	P. Roberts	Vol #:	149

C 11741	J. Smith	Vol #:	149

C 11742	K. Lauck	Vol #:	149

C 11743	D. Pacosa	Vol #:	149

C 11744	J. R. Bowen	Vol #:	149

C 11745	J. R. Bowen	Vol #:	149

C 11746	S. Lyons	Vol #:	149

C 11747	K. Cope	Vol #:	149

C 11748	B. Bilyeau	Vol #:	149

C 11749	J. Bell	Vol #:	149

C 11750	D. Clark	Vol #:	149

C 11751	P. Hughes	Vol #:	149

C 11752	A. Darneille-Lail	Vol #:	149

C 11753	J. Lancaster	Vol #:	149

C 11754	D. Steiner	Vol #:	149

C 11755	A. J. Champ	Vol #:	149

C 11756	C. M. Evans	Vol #:	149

C 11757	D. A. Johnson-Zeman	Vol #:	149

C 11758	D. J. Thompson	Vol #:	149

C 11759	D. Bell	Vol #:	149

C 11760	L. Seward	Vol #:	149

C 11761	J. Long	Vol #:	149

C 11762	S. Robertson	Vol #:	149

C 11763	L. Ortman	Vol #:	149

C 11764	R. Kline	Vol #:	149

C 11765	K. Young	Vol #:	149

C 11766	S. Dar	Vol #:	149

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

C 2	Novartis Vaccines	Vol #:	1

2006D-0088	Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

C 2	Novartis Vaccines	Vol #:	1

2006D-0150	Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp



EC 1	Duke University	Vol #:	1

EC 2	OncoMethylome Sciences, Inc.	Vol #:	1

2006D-0170	International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal



EC 1	Animal Health Institute	Vol #:	1

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

EC 1	Texas Tech University	Vol #:	1

2006N-0104	Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format


EC 2	Pharm Res	Vol #:	1

EC 3	Animal Health Institute	Vol #:	1

2006N-0107	FDA-Regulated Products Containing Nanotechnology Materials

EC 1	HV d }sterreichischen Sozialversicherungstr}ger	Vol #:	1

EC 2	F. Hoffmann-La Roche	Vol #:	1

EC 3	Alnis BioSciences, Inc.	Vol #:	1

EC 4	Customized Therapeutics	Vol #:	1

EC 5	Mrs. Heather Drake	Vol #:	1

2006N-0180	Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs

C 1	American Veterinary Medical Association (AVMA)	Vol #:	1

EC 1	American Veterinary Medical Association	Vol #:	1

EC 2	American Veterinary Medical Association	Vol #:	1

2006P-0092	Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded

EC 1	Ms. Margaret Keegan	Vol #:	1

2006P-0095	ANDA suitability for a Piperacillin and Tazobactam for Injection, 13.5 g pharmacy bulk vial

EC 1	Mr. Dave Lowe	Vol #:	1

2006Q-0091	Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease

EC 1	Institute of Shortening and Edible Oils	Vol #:	5

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FDA/Dockets Management