Dockets Entered on August 1, 2007

Dockets Management



Dockets Entered On August 1, 2007



Docket #	Title

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

2003N-0573	Draft Animal Cloning Risk Assessment

2005D-0062	Draft Guidance FDAs Drug Watch for Emerging Drug Safety

2005N-0272	Irradiation in the Production, Processing & Handling of Food

2005N-0329	Designation of New Animal Drugs for Minor Uses or Minor Species

2006D-0079	Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables

2006D-0246	Manufactured Food Regulatory Program Standards

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

2007M-0298	P060002 - FLAIR Endovascular Stent Graft

2007P-0065	To increase print size of direct-to-consumer advertisements

2007P-0301	Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Peition

2007P-0302	Require all manufacturers of a generic verision of CANASA (mesalamine) rectal suppositories to perform an adequate and well-controlled clinical safety and effectiveness trial

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

C 263	Elk Mountain Herbs	Vol #:	43

C 264	Form Letter Count 68 individual signatures	Vol #:	53

REF 2	OMB Review for October 25, 2005	Vol #:	54

2003N-0573	Draft Animal Cloning Risk Assessment

C 4064	S. Power	Vol #:	238

2005D-0062	Draft Guidance FDAs Drug Watch for Emerging Drug Safety

EC 36	Avandia for type II diabetes	Vol #:	2

2005N-0272	Irradiation in the Production, Processing & Handling of Food

C 2653	M. And R. Garcia	Vol #:	36

C 2654	E. Giovando	Vol #:	36

C 2655	M. Lagana	Vol #:	36

C 2656	E. Kailin, M.d.	Vol #:	36

C 2657	C. Okimoto	Vol #:	36

C 2658	S. Puckett	Vol #:	36

C 2659	N. Mcdonald	Vol #:	36

C 2660	G. Reed	Vol #:	36

C 2661	L. Mccall	Vol #:	36

C 2662	J. Bayley	Vol #:	36

C 2663	C. Dodd	Vol #:	36



C 2664	N. Dean	Vol #:	36

C 2665	J. & G.	Vol #:	36

C 2666	K. Rawal	Vol #:	36

C 2667	D. Hudspeth	Vol #:	36

C 2668	C. Leibowitz	Vol #:	36

C 2669	D. Magee	Vol #:	36

C 2670	D. W. Bruck Jr.	Vol #:	36

C 2671	S. Holt	Vol #:	36

C 2672	B. Lueer	Vol #:	36

C 2673	E. C.	Vol #:	36

C 2674	S. Mull	Vol #:	36

C 2675	J. Mccarty	Vol #:	36

C 2676	E. Hebert	Vol #:	36

C 2677	D. Kissinger	Vol #:	36

C 2678	C. Harvey	Vol #:	36

C 2679	P. Gump	Vol #:	36

C 2680	J. Stiegleiter	Vol #:	36

C 2681	V. Moghadam	Vol #:	36

C 2682	J. Willett	Vol #:	36

C 2683	F. Sandok	Vol #:	36

C 2684	S. F. Kislock	Vol #:	36

C 2685	B. Brooks	Vol #:	36

C 2686	J. Harvey	Vol #:	36

C 2687	S. Wade	Vol #:	36

C 2688	S. Adamson	Vol #:	36

C 2689	S. Melchi	Vol #:	36

C 2690	P. Krathaus	Vol #:	36

C 2691	D. Noe-murdock	Vol #:	36

C 2692	B. Neidlinger	Vol #:	36

C 2693	A. Logue	Vol #:	36

C 2694	J. A. Avellan	Vol #:	36

C 2695	D. Noeker	Vol #:	36

C 2696	A. Fitz-gerald	Vol #:	36

C 2697	J. S. Jaroch	Vol #:	36

C 2698	J. M. Cape	Vol #:	36

C 2699	W. A. Chengelis	Vol #:	36

C 2700	S.r. Mckenna	Vol #:	36



C 2701	K. Talbert-hill	Vol #:	36

C 2702	J. Howard	Vol #:	36

C 2703	S. Portuges	Vol #:	36

C 2704	B. Waltrip	Vol #:	36

C 2705	G. Seman	Vol #:	36

C 2706	D. And J. Faulk	Vol #:	36

C 2707	C. Houtakker	Vol #:	36

C 2708	N. Nguyen	Vol #:	36

C 2709	M. Villa	Vol #:	36

C 2710	L. Pacheco-theard	Vol #:	36

C 2711	A. Boyadzhyan	Vol #:	36

C 2712	M. Stevenson	Vol #:	36

C 2713	C. Barron	Vol #:	36

C 2714	D. James-saxton	Vol #:	36

C 2715	D. Deans	Vol #:	36

C 2716	C. Simmons	Vol #:	36

C 2717	M. S. Bonds	Vol #:	36

C 2718	K. Buttles	Vol #:	36

C 2719	J. R. Formisano	Vol #:	36

C 2720	T. Spaeth	Vol #:	36

C 2721	K. Mcadam	Vol #:	36

C 2722	P. Shafchuk	Vol #:	36

C 2723	Reverend K. A. Howard	Vol #:	36

C 2724	D. S. Daniel	Vol #:	36

C 2725	T. Lapoint	Vol #:	36

C 2726	P. Mayfield	Vol #:	36

C 2727	G. Hafner	Vol #:	36

C 2728	M. Chepuru	Vol #:	36

C 2729	C. E. Jones	Vol #:	36

C 2730	S. White	Vol #:	36

C 2731	C. Abramsky	Vol #:	36

C 2732	M. Jordan	Vol #:	36

C 2733	M. Y. Dokey	Vol #:	36

C 2734	T. Slattery	Vol #:	36

C 2735	B. Marchessault	Vol #:	36

C 2736	D. Marquess	Vol #:	36

C 2737	J. Doeden	Vol #:	36



C 2738	M. Campbell Charlebois	Vol #:	36

C 2739	G. Caserta	Vol #:	36

C 2740	A. Bratakos	Vol #:	36

C 2741	D. Sickles	Vol #:	36

C 2742	T. Duffy	Vol #:	36

C 2743	M. Brown	Vol #:	36

C 2744	M. Gargan	Vol #:	36

C 2745	J. Mccullough	Vol #:	36

C 2746	A. Hammond	Vol #:	36

C 2747	J. Watts	Vol #:	36

C 2748	S. Baker	Vol #:	36

C 2749	L. Miller	Vol #:	36

C 2750	C. Faunt	Vol #:	36

C 2751	C. Hall	Vol #:	36

C 2752	A. Anyonymous	Vol #:	36

C 2753	A. Fraga	Vol #:	36

C 2754	A. D. Houser	Vol #:	36

C 2755	J. Erwin	Vol #:	36

C 2756	G. Hoffman	Vol #:	36

C 2757	M. Griffith	Vol #:	36

C 2758	D. Lisle	Vol #:	36

C 2759	L. Markworth	Vol #:	36

C 2760	S. Culver	Vol #:	36

C 2761	K. Varney	Vol #:	36

C 2762	S. Thompson	Vol #:	36

C 2763	J. Hopkins	Vol #:	36

C 2764	J. Burgett	Vol #:	36

C 2765	Z. Barnes	Vol #:	36

C 2766	D. Finkelstein	Vol #:	36

C 2767	S. Schwartz	Vol #:	36

C 2768	K. Clune	Vol #:	36

C 2769	P. Martinson	Vol #:	36

C 2770	A. Van Nostrand	Vol #:	36

C 2771	E. Salter	Vol #:	36

C 2772	D. Lech	Vol #:	36

C 2773	M. Romeo	Vol #:	36

C 2774	G. Sowards	Vol #:	36



C 2775	S. Lissabet	Vol #:	36

C 2776	T. Greve	Vol #:	36

C 2777	B. Woeste	Vol #:	36

C 2778	G. Smith	Vol #:	36

C 2779	K. Wenban	Vol #:	36

C 2780	B. P. Burnham	Vol #:	36

C 2781	L. S. James Toll	Vol #:	36

C 2782	B. L. Fulmer	Vol #:	36

C 2783	C. M. Johnson	Vol #:	36

C 2784	M. Geci-black	Vol #:	36

C 2785	M. Timpson	Vol #:	36

C 2786	L. Stone	Vol #:	36

C 2787	M. Gilman	Vol #:	36

C 2788	M. Kim	Vol #:	36

C 2789	C. Leib	Vol #:	36

C 2790	J. Mascord	Vol #:	36

C 2791	W. Ground	Vol #:	36

C 2792	M. Bucell	Vol #:	69

C 2793	K. Nicholson	Vol #:	36

C 2794	M. J. Whateley	Vol #:	36

C 2795	L. Gittinger	Vol #:	36

C 2796	C. W.	Vol #:	36

C 2797	J. Kelly	Vol #:	36

C 2798	J. Downing-ford	Vol #:	36

C 2799	A. Coates	Vol #:	36

C 2800	L. Burlingame	Vol #:	36

C 2801	M. Kunert	Vol #:	36

C 2802	J. Howard	Vol #:	36

C 2803	J. Crawford	Vol #:	36

C 2804	L. Jetzer	Vol #:	36

C 2805	M. Bagwell	Vol #:	36

C 2806	T. Rademaker	Vol #:	36

C 2807	A. Shepherd	Vol #:	36

C 2808	L. L. Holasek	Vol #:	36

C 2809	V. Coleman	Vol #:	36

C 2810	S. B.	Vol #:	36

C 2811	T. F. Box	Vol #:	36



C 2812	A. Fassi-fihri	Vol #:	36

C 2813	S. Savini	Vol #:	36

C 2814	L. Mccomas	Vol #:	36

C 2815	K. Bonnet	Vol #:	36

C 2816	D. Mcclure	Vol #:	36

C 2817	M. Garrett	Vol #:	36

C 2818	T. Ouellette	Vol #:	36

C 2819	M. James	Vol #:	36

C 2820	K. Potterfield	Vol #:	36

C 2821	J. Gibson	Vol #:	36

C 2822	J. Potamites	Vol #:	36

C 2823	N. Manuel	Vol #:	36

C 2824	R. Seekatz	Vol #:	36

C 2825	C. Kemski	Vol #:	36

C 2826	P. Layden	Vol #:	36

C 2827	J. Taruni	Vol #:	36

C 2828	E. Abril	Vol #:	36

C 2829	S. L. Smith	Vol #:	36

C 2830	B. Mulder	Vol #:	36

C 2831	P. Baratti	Vol #:	36

C 2832	J. Gloe	Vol #:	36

C 2833	S. Milne	Vol #:	36

C 2834	E. Engler	Vol #:	36

C 2835	L. Carroll	Vol #:	36

C 2836	G. Gloss	Vol #:	36

C 2837	D. Dolid	Vol #:	36

C 2838	E. Armstrong	Vol #:	36

C 2839	L. Musulman	Vol #:	36

C 2840	S. Brady	Vol #:	36

C 2841	S. Wilber	Vol #:	36

C 2842	T. K.	Vol #:	36

C 2843	A. Dalrymple	Vol #:	36

C 2844	L. Button	Vol #:	36

C 2845	S. Davis	Vol #:	36

C 2846	D. Nelson	Vol #:	36

C 2847	M. Cederholm	Vol #:	36

C 2848	T. Tarbell	Vol #:	36



C 2849	T. Blanks	Vol #:	36

C 2850	M. Moreno	Vol #:	36

C 2851	I. Momesso	Vol #:	36

C 2852	F. E. Blinkhorn	Vol #:	36

C 2853	D. White	Vol #:	36

C 2854	M. E. Avellan	Vol #:	36

C 2855	S. Heneghan	Vol #:	36

C 2856	T. Wells	Vol #:	36

C 2857	M. Sobota	Vol #:	36

C 2858	C. Williams	Vol #:	36

C 2859	G. Amalfitano	Vol #:	36

C 2860	R. Rockey	Vol #:	36

C 2861	C. Castro	Vol #:	36

C 2862	R. Spears	Vol #:	36

C 2863	S. F. Wilnus	Vol #:	36

C 2864	S. Copeland	Vol #:	36

C 2865	B. L. Darwin	Vol #:	36

C 2866	S. Sellers	Vol #:	36

C 2867	K. Mullin	Vol #:	36

C 2868	S. Calvert	Vol #:	36

C 2869	L. A. Wheeler	Vol #:	36

C 2870	K. Curtis	Vol #:	37

C 2871	??	Vol #:	37

C 2872	T. Penhollow	Vol #:	37

C 2873	R. Zegge	Vol #:	37

C 2874	S. Bilyue'	Vol #:	37

C 2875	R. Clarity	Vol #:	37

C 2876	S. Cox	Vol #:	37

C 2877	R. Martin	Vol #:	37

C 2878	A. Tentis	Vol #:	37

C 2879	C. W.	Vol #:	37

C 2880	T. Kyle	Vol #:	37

C 2881	N. Shaw	Vol #:	37

C 2882	M. Podesta	Vol #:	37

C 2883	K. Daly	Vol #:	37

C 2884	M. Thompson	Vol #:	37

C 2885	W. H. Jackson	Vol #:	37



C 2886	J. Gordon	Vol #:	37

C 2887	C. Fielding	Vol #:	37

C 2888	T. Lianzi	Vol #:	37

C 2889	R. Gentry	Vol #:	37

C 2890	C. Barnett	Vol #:	37

C 2891	E. Evans	Vol #:	37

C 2892	L. Ward Aka Peaches	Vol #:	37

C 2893	L. Jankowski	Vol #:	37

C 2894	C. Tocare	Vol #:	37

C 2895	R. Sears	Vol #:	37

C 2896	T. Oates	Vol #:	37

C 2897	K. Yemm	Vol #:	37

C 2898	J. Calkins	Vol #:	37

C 2899	R. Becker	Vol #:	37

C 2900	J. Sfaelos-shore	Vol #:	37

C 2901	C. T. Cabarrus	Vol #:	37

C 2902	L. Kahn	Vol #:	37

C 2903	L. Augustine	Vol #:	37

C 2904	D. Chertow	Vol #:	37

C 2905	B. Babcock	Vol #:	37

C 2906	A. Knapp	Vol #:	37

C 2907	R. Lewis	Vol #:	37

C 2908	K. Kellner	Vol #:	37

C 2909	J. Wilson	Vol #:	37

C 2910	C. Duncan	Vol #:	37

C 2911	L. H. Schubert	Vol #:	37

C 2912	M. Conrad	Vol #:	37

C 2913	D. Rubin	Vol #:	37

C 2914	R. Warren	Vol #:	37

C 2915	L. Fetter	Vol #:	37

C 2916	M. L. Chase	Vol #:	37

C 2917	F. Hall	Vol #:	37

C 2918	D. Scuturio	Vol #:	37

C 2919	D. Hendricks	Vol #:	37

C 2920	D. K. Lewis	Vol #:	37

C 2921	C. Alois	Vol #:	37

C 2922	B. Dinaberg	Vol #:	37



C 2923	C. Couch	Vol #:	37

C 2924	S. Lowenthal	Vol #:	37

C 2925	J. Bernath	Vol #:	37

C 2926	S. Washburn	Vol #:	37

C 2927	I. M. Hall	Vol #:	37

C 2928	J. A. Crothers	Vol #:	37

C 2929	B. Baker	Vol #:	37

C 2930	A. Semler Gerstman	Vol #:	37

C 2931	P. King	Vol #:	37

C 2932	J. Cashman	Vol #:	37

C 2933	R. E. Knapp Baker	Vol #:	37

C 2934	R. Spadafora	Vol #:	37

C 2935	D. Halzack	Vol #:	37

C 2936	E. Shupak	Vol #:	37

C 2937	T. Santanastasio	Vol #:	37

C 2938	B. Grosse	Vol #:	37

C 2939	C. And D. Tapia	Vol #:	37

C 2940	C. Rendzio	Vol #:	37

C 2941	B. Frazier	Vol #:	37

C 2942	J. W. Vincent	Vol #:	37

C 2943	R. Fishkin	Vol #:	37

C 2944	J. Moore	Vol #:	37

C 2945	T. Falasco	Vol #:	37

C 2946	N. Tirone	Vol #:	37

C 2947	E. Breilid	Vol #:	37

2005N-0329	Designation of New Animal Drugs for Minor Uses or Minor Species

REF 2	OMB Review for July 26, 2007 (72 FR 41010)	Vol #:	1

2006D-0079	Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables

EC 46	Intraocean Trading Corporacion de Costa Rica SA	Vol #:	1

2006D-0246	Manufactured Food Regulatory Program Standards

GDL 2	Guidance	Vol #:	1

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

EXT 2	21st Century Medicine	Vol #:	3

2006P-0394	Revise the labeling requirements for eggs sold in the United States



C 121	T. Glenn	Vol #:	7

C 122	E. Boesing	Vol #:	7

C 123	M.Galinsky	Vol #:	7

C 124	S. Fine	Vol #:	7

C 125	E. Jancso	Vol #:	7

2007M-0298	P060002 - FLAIR Endovascular Stent Graft

AAV 1	Bard Peripheral Vascular, Inc.	Vol #:	1

2007P-0065	To increase print size of direct-to-consumer advertisements

EC 4	Ms. susan bliss	Vol #:	1

2007P-0301	Alkaline and Earth Alkaline Citrates and Osteoporosis; Health Claim Peition

ACK 1	FDA/CFSAN to Immunotec, Inc.	Vol #:	1

CP 1	Immunotec, Inc.	Vol #:	1

MT 1	FDA/CFSAN and Dr. Wulf Droge	Vol #:	1

2007P-0302	Require all manufacturers of a generic verision of CANASA (mesalamine) rectal suppositories to perform an adequate and well-controlled clinical safety and effectiveness trial

ACK 1	FDA/DDM to Axcan Scandipharm, Inc.	Vol #:	1

CP 1	Axcan Scandipharm, Inc.	Vol #:	1

Page created on August 1, 2007 ue

FDA/Dockets Management