Dockets Entered on July 31, 2007

Dockets Management



Dockets Entered On July 31, 2007



Docket #	Title

1992P-0250	Refrain from action against Genetic Systems HIV-1 test kits

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

1998D-1232	Points to consider guidance documents on assayed&unassayed

2003N-0573	Draft Animal Cloning Risk Assessment

2005D-0112	Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

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

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

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

2007D-0223	Guidance for Industry on Use of the Computer Crossmatch

2007N-0050	Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study

2007N-0204	Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

2007P-0300	To determine that is suitable for B Braum Medical , Inc. to package a 15% Amino Acid Injection product in a package size not covered under the Reference Listed Drug's (RLD) application

1992P-0250	Refrain from action against Genetic Systems HIV-1 test kits

ACK 1	FDA, DMB	Vol #:	1

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

C 260	L. Olson	Vol #:	43

C 261	D. Smith	Vol #:	43

C 262	D. Olson	Vol #:	43

1998D-1232	Points to consider guidance documents on assayed&unassayed

EC 1	Spirals of LIfe	Vol #:	1

EC 2	Jaw ease	Vol #:	1

2003N-0573	Draft Animal Cloning Risk Assessment

EMC 734	E. Desipris	Vol #:	22

EMC 735	F. Hoffman	Vol #:	22

EMC 736	C. Katz	Vol #:	22

EMC 737	M. Thrantell	Vol #:	22

EMC 738	P. Kremer	Vol #:	22

EMC 739	P. Barron	Vol #:	22

EMC 740	F. Wiewel	Vol #:	22

EMC 741	Form Letter Count 518	Vol #:	247

EMC 742	Form Letter Count 14	Vol #:	248

EMC 743	Form Letter Count 23	Vol #:	249



2005D-0112	Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

EC 42	Ms. Stephanie Thomas	Vol #:	1

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

C 2451	D. & R. Cross	Vol #:	29

C 2452	B. Lorraine	Vol #:	29

C 2453	N. Gambill	Vol #:	29

C 2454	C. Chalmers	Vol #:	29

C 2455	P. Hopkins	Vol #:	29

C 2456	H. Lucas	Vol #:	29

C 2457	T. M. Hoaglin	Vol #:	29

C 2458	N. Ferguson	Vol #:	29

C 2459	T. Evans	Vol #:	29

C 2460	B. Fletcher	Vol #:	29

C 2461	G. Driebe	Vol #:	29

C 2462	K. Johnson	Vol #:	29

C 2463	L. Taylor	Vol #:	29

C 2464	V. Favero	Vol #:	29

C 2465	R. Marranca	Vol #:	29

C 2466	J. Rose	Vol #:	29

C 2467	V. Wilhelmy	Vol #:	29

C 2468	J. Biondi	Vol #:	29

C 2469	S. Warwick	Vol #:	29

C 2470	G. M. Hoare	Vol #:	29

C 2471	M. Engelman	Vol #:	29

C 2472	R. Lipovec	Vol #:	29

C 2473	R. M. Drucker	Vol #:	29

C 2474	C. C. Muller	Vol #:	29

C 2475	M. Yannell	Vol #:	29

C 2476	K. Brochu	Vol #:	29

C 2477	S. Clanton	Vol #:	29

C 2478	S. Mcfaul	Vol #:	29

C 2479	F. R. Scott	Vol #:	29

C 2480	M. Blumenshine	Vol #:	29

C 2481	T. Hollocher	Vol #:	29

C 2482	P. Leneve	Vol #:	29

C 2483	M. Rapp	Vol #:	29



C 2484	Z. Cipris	Vol #:	29

C 2485	S. Rasheed	Vol #:	29

C 2486	P. Korp	Vol #:	29

C 2487	S. Merry	Vol #:	29

C 2488	S. Goller	Vol #:	29

C 2489	B. Stahl	Vol #:	29

C 2490	D. Boito	Vol #:	29

C 2491	P. D. Mitchell	Vol #:	29

C 2492	M. Killion	Vol #:	29

C 2493	J. Emerson	Vol #:	29

C 2494	S. R. Scott	Vol #:	29

C 2495	D. Pape	Vol #:	29

C 2496	E. Zakrewski	Vol #:	29

C 2497	B. Bedore	Vol #:	29

C 2498	G. Wickline	Vol #:	29

C 2499	C. Reading	Vol #:	29

C 2500	C. Vallone	Vol #:	29

C 2501	C. De Krafft	Vol #:	29

C 2502	J. Harlan	Vol #:	29

C 2503	S. Lippman	Vol #:	29

C 2504	T. Mandler	Vol #:	29

C 2505	E. Lauran	Vol #:	29

C 2506	D. Pettigrew	Vol #:	29

C 2507	J. Clemons	Vol #:	29

C 2508	A. Watstein	Vol #:	29

C 2509	R. Whitcomb	Vol #:	29

C 2510	J. & P. Berglund & Searcy	Vol #:	29

C 2511	T. Matarrese	Vol #:	29

C 2512	R. Randall	Vol #:	29

C 2513	M. Mcgibbon	Vol #:	29

C 2514	D. S. Goldman	Vol #:	29

C 2515	D. Nelson	Vol #:	29

C 2516	D. Lockner	Vol #:	29

C 2517	M. & C. Faust	Vol #:	29

C 2518	S. Litteral	Vol #:	29

C 2519	R. M. Conway	Vol #:	29

C 2520	M. Case	Vol #:	29



C 2521	N. Filoteo-Iacayo	Vol #:	29

C 2522	C. Clark	Vol #:	29

C 2523	M. Welke	Vol #:	29

C 2524	T. Lippert	Vol #:	29

C 2525	P. Brouse	Vol #:	29

C 2526	S. Derose	Vol #:	29

C 2527	C. J. Gandy	Vol #:	29

C 2528	L. Speaks	Vol #:	29

C 2529	B. Ghatit	Vol #:	29

C 2530	G. Belluardo	Vol #:	29

C 2531	A. Espenschied	Vol #:	29

C 2532	M. Kerman	Vol #:	29

C 2533	M. Koryto	Vol #:	29

C 2534	M. Arnold	Vol #:	29

C 2535	T. Schram	Vol #:	29

C 2536	V. Faust	Vol #:	29

C 2537	B. Polacca	Vol #:	29

C 2538	B. Papa	Vol #:	29

C 2539	R. Frey	Vol #:	29

C 2540	K. Lund	Vol #:	29

C 2541	R. Bescript	Vol #:	29

C 2542	M. Hawkins	Vol #:	29

C 2543	D. Laverty	Vol #:	29

C 2544	H. Ickes	Vol #:	29

C 2545	M. Cruz	Vol #:	29

C 2546	P. Morris	Vol #:	29

C 2547	J. Knight	Vol #:	29

C 2548	L. Mbanik	Vol #:	29

C 2549	V. Winters	Vol #:	29

C 2550	S. Miller	Vol #:	29

C 2551	A. Gillies	Vol #:	29

C 2552	J. Cotter	Vol #:	29

C 2553	B. Pedersen, M.d.	Vol #:	29

C 2554	C. Wiley	Vol #:	29

C 2555	J. Milton	Vol #:	29

C 2556	E. Guise	Vol #:	29

C 2557	F. Halverson-ramos	Vol #:	29



C 2558	F. J. Pappas	Vol #:	29

C 2559	A. Klohr	Vol #:	29

C 2560	C. Hawkins	Vol #:	29

C 2561	B. Wendt	Vol #:	29

C 2562	S. Doherty	Vol #:	29

C 2563	S. Iverson	Vol #:	29

C 2564	B. Snyder	Vol #:	29

C 2565	S. E. Owens	Vol #:	29

C 2566	J. Jackson	Vol #:	29

C 2567	M. Meyer	Vol #:	29

C 2568	H. Post	Vol #:	29

C 2569	V. Palagano	Vol #:	29

C 2570	C. Sell	Vol #:	29

C 2571	T. Fulton	Vol #:	29

C 2572	C. Small	Vol #:	29

C 2573	P. S. Wacker	Vol #:	29

C 2574	W. Lynn	Vol #:	29

C 2575	J. Weaver	Vol #:	29

C 2576	A. Dunn	Vol #:	29

C 2577	K. Heninger	Vol #:	29

C 2578	G. Johnson	Vol #:	29

C 2579	B. Mascali	Vol #:	29

C 2580	T. Carroll	Vol #:	29

C 2581	Y. Demisse	Vol #:	29

C 2582	E. French	Vol #:	29

C 2583	D. Pam	Vol #:	29

C 2584	A. Graham	Vol #:	29

C 2585	K. Lapel	Vol #:	29

C 2586	T. Foster-carter	Vol #:	29

C 2587	N. Stout	Vol #:	29

C 2588	T. St.clair	Vol #:	29

C 2589	B. Rowe	Vol #:	29

C 2590	B. Kelsey	Vol #:	29

C 2591	N. Heron	Vol #:	29

C 2592	W. Schneider	Vol #:	29

C 2593	M. Stevens	Vol #:	29

C 2594	N. Palagano	Vol #:	29



C 2595	J. Mittl	Vol #:	29

C 2596	M. J. Hammond	Vol #:	29

C 2597	S. Francis	Vol #:	29

C 2598	J. Smith	Vol #:	29

C 2599	D. Curtis	Vol #:	29

C 2600	C. Cox	Vol #:	29

C 2601	D. Shafer	Vol #:	29

C 2602	J. Jeffries	Vol #:	29

C 2603	J. Ammon	Vol #:	29

C 2604	S. Kelley	Vol #:	29

C 2605	I. Hartfield	Vol #:	29

C 2606	R. Jahnke	Vol #:	29

C 2607	V. Betson	Vol #:	29

C 2608	J. Macclonald	Vol #:	29

C 2609	A. Weldon	Vol #:	29

C 2610	J. Digilarmo	Vol #:	29

C 2611	T. Clark	Vol #:	29

C 2612	S. Kjolhede	Vol #:	29

C 2613	R. L. Gentry	Vol #:	29

C 2614	L. Nelson	Vol #:	29

C 2615	M. Bishop	Vol #:	29

C 2616	A. Shields	Vol #:	29

C 2617	L. Kreuzburg	Vol #:	29

C 2618	E. Sykes-wood	Vol #:	29

C 2619	C. Wright	Vol #:	29

C 2620	J. P. Ruggles	Vol #:	29

C 2621	V. G. Veelle	Vol #:	29

C 2622	D. Phillips	Vol #:	29

C 2623	C. N. Munnerlyn	Vol #:	29

C 2624	C. Simpson	Vol #:	29

C 2625	C. Cerutti	Vol #:	29

C 2626	W. A. Hart	Vol #:	29

C 2627	E. Deibert	Vol #:	29

C 2628	C. Watson	Vol #:	29

C 2629	M. S.	Vol #:	29

C 2630	B. Weaver-pelton	Vol #:	36

C 2631	M. Milcarek	Vol #:	36



C 2632	D. Wyman	Vol #:	36

C 2633	E. Goolsby	Vol #:	36

C 2634	C. Brooks	Vol #:	36

C 2635	M. Tomuta	Vol #:	36

C 2636	F. Yukilevich	Vol #:	36

C 2637	K. Carter	Vol #:	36

C 2638	M. Ruthenberg	Vol #:	36

C 2639	L. Evans	Vol #:	36

C 2640	V. Whittington	Vol #:	36

C 2641	C. North	Vol #:	36

C 2642	C. Blair	Vol #:	36

C 2643	T. Dalton	Vol #:	36

C 2644	T. Olk	Vol #:	36

C 2645	J. Weber	Vol #:	36

C 2646	M. Chacon	Vol #:	36

C 2647	J. Brennan	Vol #:	36

C 2648	J. Grubb	Vol #:	36

C 2649	V. Zeff	Vol #:	36

C 2650	C. Shetterly	Vol #:	36

C 2651	M. Key	Vol #:	36

C 2652	J. Bennet	Vol #:	36

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

C 1367	S. Vallentyne	Vol #:	25

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

C 111	C. Holt	Vol #:	7

C 112	S. Power	Vol #:	7

C 113	D. Ricci	Vol #:	7

C 114	N. Merjian	Vol #:	7

C 115	S. Kaufman	Vol #:	7

C 116	J. Sheehan	Vol #:	7

C 117	A. Fritz	Vol #:	7

C 118	S. Aubuchon-Mendoza	Vol #:	7

C 119	S. Power	Vol #:	7

C 120	S. Kindrick	Vol #:	7

2007D-0223	Guidance for Industry on Use of the Computer Crossmatch



EC 3	DeGowin Blood Center	Vol #:	1

2007N-0050	Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study

EC 4	self	Vol #:	1

2007N-0204	Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

EC 1	Mr. Gerard Roberts	Vol #:	1

EC 2	Northwestern University, Feinberg School of Medici	Vol #:	1

EC 3	Miss. Jennifer Meth	Vol #:	1

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

EC 1	Regulatory Resources, Inc.	Vol #:	1

EC 2	Cascade Regional Blood Services	Vol #:	1

EC 3	Mrs. Melanie Rogerson	Vol #:	1

EC 4	Gambro BCT	Vol #:	1

EC 5	Mr. Richard Robinson	Vol #:	1

EC 6	Americas Blood Centers	Vol #:	1

2007P-0300	To determine that is suitable for B Braum Medical , Inc. to package a 15% Amino Acid Injection product in a package size not covered under the Reference Listed Drug's (RLD) application



ACK 1	FDA/ DDM/ to B Braun Medical, Inc.	Vol #:	1

CP 1	B Braun Medical, Inc.	Vol #:	1

Page created on August 1, 2007 ue

FDA/Dockets Management