Dockets Entered on April 24, 2006

Dockets Management



Dockets Entered On April 24, 2006 Table of Contents



Docket #	Title

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

2001N-0464	Vaccine Adverse Event Reporting System

2003E-0030	Patent Term Extension Application for FASLODEX No. 4,659,516

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

2005D-0481	Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do


2005N-0355	Revocation of Status of Specific Products; Group A Streptococcus

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

2006N-0029	Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to-Consumer Prescription Drug Prin

2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

2006V-0171	Laser Light Show

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

CR 1	Statistical Report - Month of February 2006	Vol #:	55

RPT 765	Statistical Report - Month of March 2006	Vol #:	55

2001N-0464	Vaccine Adverse Event Reporting System

NWL 1	FDA	Vol #:	1

2003E-0030	Patent Term Extension Application for FASLODEX No. 4,659,516

NCR 1	FDA	Vol #:	1

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

BRF 1	GCF-1	Vol #:	10

2005D-0481	Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do


C 10	Centers for Disease Control and Prevention	Vol #:	1

2005N-0355	Revocation of Status of Specific Products; Group A Streptococcus

NCD 1	FDA	Vol #:	1

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

C 6654	S. Caruso	Vol #:	90

C 6655	P. Kennedy	Vol #:	90

C 6656	L. Newman	Vol #:	90

C 6657	R. Eldred	Vol #:	90

C 6658	D. Bradley	Vol #:	90

C 6659	j. Mosier	Vol #:	90



C 6660	N. Nalley	Vol #:	90

C 6662	B. Vargason	Vol #:	90

C 6663	Betty D. Madi;;	Vol #:	90

C 6664	K L. Wavering	Vol #:	90

C 6665	L. D. Eagan 11	Vol #:	90

C 6666	D. Mertz	Vol #:	90

C 6667	B. Morales	Vol #:	90

C 6668	R Kitchen	Vol #:	90

C 6669	I. Flugrath	Vol #:	90

C 6670	J. Haman	Vol #:	90

C 6671	D. G. Garner	Vol #:	90

C 6672	B. Hart	Vol #:	90

C 6674	L. Griess	Vol #:	90

C 6675	S. Ruffing	Vol #:	90

C 6677	B. J. Cotton-Jeffords	Vol #:	90

C 6678	E. Brase	Vol #:	90

C 6679	J. Stubblefileld	Vol #:	90

C 6680	D. Koss	Vol #:	90

C 6681	M. Webster	Vol #:	90

C 6682	P. Petrucci	Vol #:	90

C 6683	S. Forsyth	Vol #:	90

C 6684	M. Kutz	Vol #:	90

C 6685	T. Hartcourt -Heaver	Vol #:	90

C 6686	W. J. Cook	Vol #:	90

C 6687	Norah Roadman	Vol #:	90

C 6688	V. Stewart	Vol #:	90

C 6689	G. Marin	Vol #:	90

C 6690	N. Carper	Vol #:	90

C 6691	P. Reed	Vol #:	90

C 6692	D. Johnson	Vol #:	90

C 6693	K. Graig	Vol #:	90

C 6694	C. Garner	Vol #:	90

C 6695	R. Curci	Vol #:	90

C 6696	C. Lee	Vol #:	90

C 6697	A. Corell	Vol #:	90

C 6698	T. L. Anderson	Vol #:	90

C 6699	D. Davis	Vol #:	112



C 6700	P. Vetter	Vol #:	112

C 6701	D. Davis	Vol #:	112

C 6702	T. L. Anderson	Vol #:	112

C 6703	A. Watkins	Vol #:	112

C 6704	A. Piassa	Vol #:	112

C 6705	R. Saifer	Vol #:	112

C 6706	J. Lewis	Vol #:	112

C 6707	P. Engen	Vol #:	112

C 6708	L. Friday	Vol #:	112

C 6709	B. Strewler	Vol #:	112

C 6710	M. Gura	Vol #:	112

C 6711	S. Vega	Vol #:	112

C 6712	M. D. Giles	Vol #:	112

C 6713	J. Parks	Vol #:	112

C 6714	J. Kohne	Vol #:	112

C 6715	J.D. Smith	Vol #:	112

C 6716	K. Bryant	Vol #:	112

C 6717	C. Kimball	Vol #:	112

C 6718	J. Broder	Vol #:	112

C 6719	S. Wilson	Vol #:	112

C 6720	M. G. LoBele	Vol #:	112

C 6721	A. Newconb	Vol #:	112

C 6722	S. Mccoy	Vol #:	112

C 6723	S. Mccoy	Vol #:	112

C 6724	L. Vickroy	Vol #:	112

C 6725	S. Mcfarlane	Vol #:	112

C 6726	N. L. Gabbard	Vol #:	112

C 6727	J. L. Blankenburg	Vol #:	112

C 6728	V. S. Halstensgard	Vol #:	112

C 6729	T. W. Hilger, MD	Vol #:	112

C 6730	K. Beck	Vol #:	112

C 6731	D. Dawson	Vol #:	112

C 6732	M. Gura	Vol #:	112

C 6733	M. Gura	Vol #:	112

C 6734	J. A. Smith	Vol #:	112

C 6735	V. Peterson	Vol #:	112

C 6736	M. J. Love	Vol #:	112



C 6737	Maureen Goldstein	Vol #:	112

C 6738	S. Morse	Vol #:	112

C 6739	D. A. Hnole	Vol #:	112

C 6740	N. A. Shriner	Vol #:	112

C 6741	C. Cummings	Vol #:	112

C 6742	C. Cummings	Vol #:	112

C 6743	V. Ross, MD	Vol #:	112

C 6744	L. J. Covey	Vol #:	112

C 6745	B. Grayek	Vol #:	112

C 6746	N. Ridgway	Vol #:	112

C 6747	J. Eggenberg	Vol #:	112

C 6748	J. Bynum	Vol #:	112

C 6749	M. Fehrenbacher	Vol #:	112

C 6750	B. Prutinsky	Vol #:	112

C 6751	C. Sorce	Vol #:	112

C 6752	L. Beck	Vol #:	112

C 6753	T. Aubuchon	Vol #:	112

C 6754	P. Smith	Vol #:	112

C 6755	J. Littleton	Vol #:	112

C 6756	C. Davis	Vol #:	112

C 6757	Y. Ayoub	Vol #:	112

C 6758	D. Holm	Vol #:	112

C 6759	N. Reese	Vol #:	112

C 6760	N. Bishop	Vol #:	112

C 6761	L. Boseoc	Vol #:	112

C 6762	Delaine Douglas	Vol #:	112

C 6763	A. Rogers	Vol #:	112

C 6764	J. Orlo	Vol #:	112

C 6765	Peggy House	Vol #:	112

C 6766	D. Eide	Vol #:	112

C 6767	A. Diepenbrock	Vol #:	112

C 6768	S. Hill	Vol #:	112

C 6769	B. Lamblin	Vol #:	112

C 6770	V. H. Nase	Vol #:	112

C 6771	J. Graves	Vol #:	112

C 6772	K. Webb	Vol #:	112

C 6773	J. Johnson	Vol #:	112



C 6774	B. Hobbs	Vol #:	112

C 6775	L. Ashburn	Vol #:	112

C 6776	L.. Wehr	Vol #:	112

C 6777	A. Fettig	Vol #:	112

C 6778	L. Kirby	Vol #:	112

C 6779	C. Woody	Vol #:	112

C 6780	J. R. Sams	Vol #:	112

C 6781	K. Hocevar	Vol #:	112

C 6782	J. Harvilie	Vol #:	112

C 6783	K. Rickland	Vol #:	112

C 6784	L. Collier	Vol #:	112

C 6785	J. Barry	Vol #:	112

C 6786	G, Latham	Vol #:	112

C 6787	K. Lampros	Vol #:	112

C 6788	G. Hendricks Ph.D	Vol #:	112

C 6789	G. Hendricks Ph.D	Vol #:	112

C 6790	L. Cohen	Vol #:	112

C 6791	R. Smalling	Vol #:	112

C 6792	C Geer	Vol #:	112

C 6793	J. Wilson-Osterland	Vol #:	112

C 6794	K. McIntyre Brown	Vol #:	112

C 6795	S. Bue	Vol #:	112

C 6796	D. J. Schmitt	Vol #:	112

C 6797	D. Nnuci	Vol #:	112

C 6798	D. Mullin	Vol #:	112

C 6799	Anna Whiteside	Vol #:	112

C 6800	J. Suber	Vol #:	112

C 6801	M. Pressner	Vol #:	112

C 6802	E. Delli-Pizzi	Vol #:	112

C 6803	C. Blanco	Vol #:	112

C 6804	L. Pairce	Vol #:	112

C 6805	L. H. Capstick	Vol #:	112

C 6806	D. Allen	Vol #:	112

C 6807	A. Rock	Vol #:	112

C 6808	C. Geer	Vol #:	112

C 6809	V. Jensen	Vol #:	112

C 6810	C. Greulich	Vol #:	112



C 6811	M. ONeill	Vol #:	112

C 6812	L. Trebing	Vol #:	112

C 6813	N. Barbera	Vol #:	112

C 6814	C.L. Hall	Vol #:	112

C 6815	M. K. Jones	Vol #:	112

C 6816	C. L. Feaster	Vol #:	112

C 6817	P. Nurges	Vol #:	112

C 6818	K. Carda	Vol #:	112

C 6819	M. M. Gross	Vol #:	112

C 6820	D. Allen	Vol #:	112

C 6821	A. Rock	Vol #:	112

C 6822	K. Greaves	Vol #:	112

C 6823	J. H. Cole	Vol #:	112

C 6824	T. S. Allerson	Vol #:	112

C 6825	D. Cable	Vol #:	112

C 6826	D. Cable	Vol #:	112

C 6827	S. MacDonnell	Vol #:	112

C 6828	B.J. Cotton-Jeffords	Vol #:	112

C 6829	N. Michaud	Vol #:	112

C 6830	S. Redding	Vol #:	112

C 6831	Ethel Cox	Vol #:	112

C 6832	E. Klapon	Vol #:	112

C 6833	K. Sylvester	Vol #:	112

C 6834	J. Farman	Vol #:	112

C 6835	E. Boyle	Vol #:	112

C 6836	unreadable	Vol #:	112

C 6837	J. Bennington	Vol #:	112

C 6838	J. Budd	Vol #:	112

C 6839	C. McOsker	Vol #:	112

C 6840	S. Lovett	Vol #:	112

C 6841	S. Lovett	Vol #:	112

C 6842	R. V. Herpin	Vol #:	112

C 6843	K. Hines	Vol #:	112

C 6844	G. Farnet	Vol #:	112

C 6845	C. D. Dalton	Vol #:	112

C 6846	J. Heffner	Vol #:	112

C 6847	L. A. Lunt	Vol #:	112



C 6848	B. Connolly	Vol #:	112

C 6849	C. Carrodo	Vol #:	112

C 6850	A. S. House	Vol #:	112

C 6851	V. Littlefield	Vol #:	112

C 6852	S. McDermott	Vol #:	112

C 6853	N. Sanders	Vol #:	112

C 6854	M. Marcucci	Vol #:	112

C 6855	S. Yourth	Vol #:	112

C 6856	T. Milasius	Vol #:	112

C 6857	E. Jenkins	Vol #:	112

C 6858	A. Kahn	Vol #:	112

C 6859	B. Pool	Vol #:	112

C 6860	S. McDaniel	Vol #:	112

C 6861	R. Laguzza	Vol #:	112

C 6862	D. K. Claseman	Vol #:	112

C 6863	M. D. Jones	Vol #:	112

C 6864	R. Caudill	Vol #:	112

2006N-0029	Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to- Consumer Prescription Drug Prin


EC 1	Prescription Access Litigation Project,	Vol #:	1

EC 2	McKesson Corporation	Vol #:	1

EC 3	National Research Center for Women & Families	Vol #:	1

EMC 1	Prescription Access Litigation (PAL)	Vol #:	1

2006P-0124	Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules

LET 1	ViroPharm Incorporated	Vol #:	1

2006V-0171	Laser Light Show

ACK 1	HFA-305 t0 Edge Innovations	Vol #:	1

VAR 1	Edge Innovations	Vol #:	1

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FDA/Dockets Management