Dockets Entered on November 4, 2006

Dockets Management



Dockets Entered On December 4, 2006 Table of Contents



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

2005N-0494	Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations

2005P-0383	refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006E-0495	Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632

2006N-0414	Suicidality Data from Adult Antidepressant Trials

2006N-0472	Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

2006N-0475	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

2006P-0496	Determine whether the following drugs have been voluntarily withdrawn or withheld for safety or efficacy reasons

2006V-0485	Projector for a Laser Light Show

1978N-0065	Skin Bleaching Drug Products
C 43	A Craig Cattell MD & Associates	Vol #:	15

C 44	American Society for Dermatologic Surgery	Vol #:	15

C 45	Long Island Skin Cancer & Dermatologic Surgeery	Vol #:	15

C 46	Long Island Skin Cancer & Dermatologic Surgeery	Vol #:	15

C 47	Long Island Skin Cancer & Dermatologic Surgeery	Vol #:	15

2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

PDN 1	FDA/CDER to Buchanan Ingersoll PC on behalf of Savient Pharmaceuticals Inc	Vol #:	1

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs


C 9	HollisterStier Laboratories LLC	Vol #:	3

2005N-0494	Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations

N 2	FDA	Vol #:	1

2005P-0383	refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.

PDN 1	FDA/CDER to Buchanan Ingersoll PC on behald of Savient Pharmaceuticals Inc	Vol #:	1

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

C 13	Public Responsibility in Medicine and Research (PRIMER)	Vol #:	3

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious



	Diseases

C 159	B Woessner	Vol #:	9

C 160	R Woessner	Vol #:	9

C 161	D Damiano	Vol #:	9

C 162	H Nguyen	Vol #:	9

C 163	C Buckley	Vol #:	9

C 164	A Weaver RN	Vol #:	9

C 165	B Gellerup	Vol #:	9

C 166	J Fetsko	Vol #:	9

C 167	G McCormack	Vol #:	9

C 168	L Deahl	Vol #:	9

C 169	E Ackermann	Vol #:	9

C 170	unsigned	Vol #:	9

C 171	M Deavereaux	Vol #:	9

C 172	P Campbell	Vol #:	9

C 173	M Burns	Vol #:	9

C 174	P Juergens	Vol #:	9

C 175	M Hunt	Vol #:	9

C 176	K Dupuis	Vol #:	9

C 177	V Dupuis	Vol #:	9

C 178	A Robichaud	Vol #:	9

C 179	R Robichaud	Vol #:	9

C 180	C Walker	Vol #:	9

C 181	J Kanzenbach	Vol #:	9

C 182	C Fahy	Vol #:	9

C 183	E Adams	Vol #:	9

C 184	R Weaver	Vol #:	9

EC 2446	Mrs. Nora Malone	Vol #:	10

EC 2447	Mrs. Kerry Kibrick	Vol #:	10

EC 2448	Mrs. Megan Walthall	Vol #:	10

EC 2449	Ms. Suni Grosko	Vol #:	10

EC 2450	Ms. Suni Grosko	Vol #:	10

EC 2451	Mrs. Doris Kasprak	Vol #:	10

EC 2452	Mr. John Towle	Vol #:	10

EC 2453	Mrs. Catherine Williams	Vol #:	10

EC 2454	Mr. Thomas Mottola	Vol #:	10



EC 2455	Mrs. Ann Knox	Vol #:	10

EC 2456	Mr. Kent Wendler	Vol #:	10

EC 2457	Mrs. Marlene Burke	Vol #:	10

EC 2458	Mrs. Anne Burke	Vol #:	10

EC 2459	Mr. Randy Schnoebelen	Vol #:	10

EC 2460	Mrs. Mary Cooney	Vol #:	10

EC 2461	St Gregory Parish	Vol #:	10

EC 2462	Mr. Paul Klein	Vol #:	10

EC 2463	US Citizen	Vol #:	10

EC 2464	Mr. Tim Albrethsen	Vol #:	10

EC 2465	Miss. Mary Griffin	Vol #:	10

EC 2466	Mrs. Suzanne Nowak	Vol #:	10

EC 2467	Dr. Christina Burkhart, MD	Vol #:	10

EC 2468	Mrs. Bev Svehlak	Vol #:	10

EC 2469	Mr. Brad Nygaard	Vol #:	10

EC 2470	Mrs. Amber Balistreri	Vol #:	10

EC 2471	Vacccines Distributor	Vol #:	10

EC 2472	US Citizen	Vol #:	10

EC 2473	Murphy Healthcare Associates	Vol #:	10

EC 2474	Miss. Rebecca Mull	Vol #:	10

EC 2475	Mrs. Jeanne Grill	Vol #:	10

EC 2476	Dr. Christopher Cooney	Vol #:	10

EC 2477	Mr. David A. Carlson	Vol #:	10

EC 2478	Dr. Carol Abiragi	Vol #:	10

EC 2479	Dr. John Krcmarik	Vol #:	10

EC 2480	Mrs. Kalene Hankins	Vol #:	10

EC 2481	Mrs. Christine Chambers	Vol #:	10

EC 2482	Mr. Gerald Yeung	Vol #:	10

EC 2483	Ms. Maggie Crow	Vol #:	10

EC 2484	Mrs. Denise Balogh	Vol #:	10

EC 2485	St Philip Neri Parish Respect Life Committee	Vol #:	10

EC 2486	Mrs. Mary Cooney	Vol #:	10

EC 2487	Mrs. Kathleen Schmiedicke	Vol #:	10

EC 2488	Ms. Betty Bogaert	Vol #:	10

EC 2489	PSU	Vol #:	10

EC 2490	University of Nebraska-Lincoln	Vol #:	10

EC 2491	Mrs. Catherine James	Vol #:	10



EC 2492	Pius High School	Vol #:	10

EC 2493	Mr. Darold P. Adami	Vol #:	10

EC 2494	Mrs. Danijela Brekalo	Vol #:	10

EC 2495	Ms. Michael Horzewski	Vol #:	10

EC 2496	Mrs. Michelle Steele	Vol #:	10

EC 2497	Mr. Russell C McWhinney Jr	Vol #:	10

EC 2498	Ms. GraceMarie Rose	Vol #:	10

EC 2499	Mr. Nathan Bickel	Vol #:	10

EC 2500	Mrs. Olivia Leskowicz	Vol #:	10

EC 2501	Mr. Jack Walker	Vol #:	10

EC 2502	Miss. Victress Jenkins	Vol #:	10

EC 2503	Mr. Nathan M. Bickel	Vol #:	10

EC 2504	Mrs. Joyce Bickel	Vol #:	10

EC 2505	None	Vol #:	10

EC 2506	Mr. Jon Haslauer	Vol #:	10

EC 2507	Mr. Richard Lobert	Vol #:	10

EC 2508	Mrs. Anne LeBlanc	Vol #:	10

EC 2509	Mrs. Fran Bauer	Vol #:	10

EC 2510	Miss. Nancy Buss	Vol #:	10

EC 2511	Ms. Christine Pesta	Vol #:	10

EC 2512	Pregnancy Help Center	Vol #:	10

EC 2513	Mr. Larry Schnorr	Vol #:	10

EC 2514	Mrs. Wendy Tanis	Vol #:	10

EC 2515	Mrs. Maureen Avila	Vol #:	10

EC 2516	Mr. John Elshaw	Vol #:	10

EC 2517	Mrs. Annette Dybas	Vol #:	10

EC 2518	Mr. Lee HIltner	Vol #:	10

EC 2519	Ms. Sue Breunig	Vol #:	10

EC 2520	Concerned American	Vol #:	10

EC 2521	Mrs. Lucy Scott	Vol #:	10

EC 2522	Ms. Gloria Conrad	Vol #:	10

EC 2523	Ms. IRENE HALIDAY	Vol #:	10

EC 2524	Mrs. Genevieve Jorgensen	Vol #:	10

EC 2525	Mr. Michael Schoenfuss	Vol #:	10

EC 2526	Ms. Theresa Martin	Vol #:	10

EC 2527	Mr. Nathan Bott	Vol #:	10

EC 2528	Mrs. Karen Pline	Vol #:	10



EC 2529	Mr. Philip Pline	Vol #:	10

EC 2530	Mrs. Marcia Stevenson	Vol #:	10

EC 2531	Mr. James Thane	Vol #:	10

EC 2532	Mrs. Brenda Thane	Vol #:	10

EC 2533	Mrs. Colleen Harris	Vol #:	10

EC 2534	Mrs. Susan Woo	Vol #:	10

EC 2535	Miss. Susan Balogh	Vol #:	10

EC 2536	Mrs. Michelle Bartos	Vol #:	10

EC 2537	Ms. Kasandra Barker	Vol #:	10

EC 2538	CTK Reverence for Life	Vol #:	10

EC 2539	Ms. Heidi Becnel	Vol #:	10

EC 2540	Mrs. Karen Maurer	Vol #:	10

EC 2541	Mr. Arthur J. Gavin	Vol #:	10

EC 2542	Mrs. Roxanna Rubinic	Vol #:	10

EC 2543	Mrs. Nancy Kazmer	Vol #:	10

EC 2544	Mrs. Nancy Hoar	Vol #:	10

EC 2545	Mrs. Mary Beth Jones	Vol #:	10

EC 2546	Mrs. Jane Nagel	Vol #:	10

EC 2547	Mr. Bill Sulzen	Vol #:	10

EC 2548	St. Mary of the Springs Congregation	Vol #:	10

EC 2549	Miss. Helen Sage	Vol #:	10

EC 2550	Mr. Richard Mayer	Vol #:	10

EC 2551	Mrs. Sarah Schunk	Vol #:	10

EC 2552	Mrs. Christine DeMuro	Vol #:	10

EC 2553	Mrs. Nicole Bergert	Vol #:	10

EC 2554	Mrs. Jennifer Fuchs	Vol #:	10

EC 2555	Mr. Jeffrey Fuchs	Vol #:	10

EC 2556	Mr. Joe Duhon	Vol #:	10

2006E-0495	Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632

APP 1	Medtronic, Inc.	Vol #:	1

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

2006N-0414	Suicidality Data from Adult Antidepressant Trials

C 2	W Heck	Vol #:	1

C 3	Maryland Psychiatric Society	Vol #:	1

EC 45	Mrs. Gail Boswell	Vol #:	1



EC 46	Dr. Stephen Warres	Vol #:	1

EC 47	Feeling Blue Suicide Prevention Council	Vol #:	1

EC 48	Dr. Laura Gaffney	Vol #:	1

EC 49	American Foundation for Suicide Prevention	Vol #:	1

EC 50	Pogust	Vol #:	1

EC 51	Siani Hospital	Vol #:	1

EC 52	Mental Health America	Vol #:	1

EC 53	National Alliance on Mental Illness	Vol #:	1

EC 54	Dr. Nada Stotland, MD, MPH	Vol #:	1

EC 55	National Alliance on Mental Illness	Vol #:	1

EC 56	Mr. Andy Vickery	Vol #:	1

EC 57	Mr. Andy Vickery	Vol #:	1

EC 58	National Alliance on Mental Illness	Vol #:	1

EC 59	Eli Lilly and Company	Vol #:	1

EC 60	National Alliance on Mental Illness (NAMI)	Vol #:	1

EC 61	Washington State Psychiatric Association	Vol #:	1

EC 62	Mrs. Laura Milanese-Husband	Vol #:	1

EC 63	Dr. David Fassler	Vol #:	1

EC 64	National Alliance on Mental Illness	Vol #:	1

EC 65	American Academy of Child	Vol #:	1

EC 66	Ms. Sherri Walton	Vol #:	1

EC 67	Mr. Charles Graves	Vol #:	1

EC 68	Mental Health America	Vol #:	1

EC 69	Mrs. Kimberly Porto	Vol #:	1

EC 70	Wyeth Pharmaceuticals	Vol #:	1

EC 71	University of Colorado School of Pharmacy	Vol #:	1

EC 72	Ms. Kim Witczak	Vol #:	1

EC 73	American Psychiatric Association	Vol #:	1

EC 74	SSRI Crusaders	Vol #:	1

EC 75	Baum Hedlund	Vol #:	1

2006N-0472	Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed


N 1	FDA	Vol #:	1

2006N-0475	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

N 1	FDA	Vol #:	1



2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

C 5	K Mottus	Vol #:	1

2006P-0496	Determine whether the following drugs have been voluntarily withdrawn or withheld for safety or efficacy reasons

ACK 1	FDA/DDM to Vintage Pharmaceuticals, LLC	Vol #:	1

CP 1	Vintage Pharmaceuticals, LLC	Vol #:	1

2006V-0485	Projector for a Laser Light Show

CR 1	FDA / DDM	Vol #:	1

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FDA/Dockets Management