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

Dockets Management

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

Document #	Received Date	Filed Date	Submitter Code	Submitter		FR Date				Remarks


NAD1		08/25/2006	FDA	FDA		08/29/2006	51198-51199	10/30/2006	pdf htm
				Signature:	Jeffrey Shuren

GDL1	08/29/2006	08/29/2006	Federal Government	Guidance					pdf


NHC1		08/25/2006	FDA	FDA		08/29/2006	51143-51146	11/27/2006	pdf htm	Hearing on 10/11/06 Presentation by 9/20/06
				Signature:	Jeffrey Shuren

EMC1	08/29/2006	08/29/2006	Individual Consumer	B. Sachau

EC1	09/05/2006	09/01/2006	Individual Consumer	Mr. Darryl Wellinghoff					htm

EC2	09/11/2006	09/06/2006	Individual Consumer	Ms. Debra Jo Endres-Ard					htm

EC3	09/11/2006	09/07/2006	Other Organization	La Cesta Consultants, LLC					pdf
				Signature:	LLanusa-Cestero , Renee

EC4	09/11/2006	09/08/2006	Individual Consumer	Citizen of The United States					htm
				Signature:	Martin, William

EC5	09/11/2006	09/08/2006	Health Professional	R Adams Cowley Shock Trauma Center					htm
				Signature:	Dutton, Richard

EC6	09/11/2006	09/08/2006	Individual Consumer	Ms. Elaine Daly					htm

EC7	09/11/2006	09/06/2006	Health Professional	Boston Universtity School of Medicine					pdf
				Signature:	Feldman, James

EC8	09/11/2006	09/06/2006	Individual Consumer	Ms. Debra Jo Endres-Ard					htm

EC9	09/11/2006	09/06/2006	State Government	Wisconsin State EMS Medical Director					htm
				Signature:	Wesley, Keith

EC10	09/11/2006	09/08/2006	Individual Consumer	Ms. Elaine Daly					htm

EC11	09/11/2006	09/08/2006	Individual Consumer	Citizen					htm
				Signature:	Kehoe, Lillian

EC12	09/12/2006	09/11/2006	Health Care Association	American Heart Association					htm Attachment
				Signature:	Halperin, Henry


EC13	09/13/2006	09/12/2006	Other Organization	American Life League					htm
				Signature:	Brown, Judie

EMC2	09/11/2006	09/11/2006	Individual Consumer	A. Williams

EC14	09/15/2006	09/14/2006	Individual Consumer	Mr. David Thiel					htm

EC15	09/15/2006	09/14/2006	Health Professional	Johns Hopkins University School of Medicine					pdf Abstract
				Signature:	Weisfeldt, Myron L.

C1	09/15/2006	09/12/2006	Consumer Group	American Life League, Inc. (ALL)					pdf
				Signature:	Judie Brown

EC16	09/18/2006	09/16/2006	Individual Consumer	Mr. Rick Heidel