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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 FR Page Comment Date Files 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       htm  
EC17 09/18/2006 09/17/2006 Individual Consumer Mr. Peter Bodenbach       htm  
EC18 09/18/2006 09/16/2006 Individual Consumer Mr. Rick Heidel       htm  
EC19 09/18/2006 09/16/2006 Individual Consumer Mr. Luis Howard f Howard fami       htm  
EC20 09/18/2006 09/17/2006 Individual Consumer Mr. Dave Lowe       htm
Attachment 		 
EC21 09/19/2006 09/18/2006 Health Professional Dr. Mark Slagle       htm  
EC22 09/19/2006 09/18/2006 Academia Oregon Health & Sciences University       pdf  
Signature: Schmidt, Terri
EC23 09/19/2006 09/18/2006 Individual Consumer Ms. J. Eastus Evans       htm  
C2 09/18/2006 09/15/2006 Academia John Hopkins School of Medicine       pdf  
Signature: Myron L. Weisfeldt, M.D.
C3 09/19/2006 09/18/2006 Academia Oregon Health & Sciences University       pdf  
Signature: Terri Schmidt MD, MS
EC24 09/20/2006 09/19/2006 Academia NIH Resuscitation Outcomes Consortium       htm
Attachment 		 
Signature: Ornato, Joseph
EC25 09/20/2006 09/19/2006 Academia NIH Resuscitation Outcomes Consortium       htm
Attachment 		 
Signature: Ornato, Joseph
EC26 09/20/2006 09/19/2006 Health Professional The Children's Hospital of Philadelphia       pdf  
Signature: Nelson, Robert
EC27 09/21/2006 09/20/2006 Consumer Group U.S. Metropolitan Emerg Med Svcs Medical Directors
       htm  
Signature: Pepe, Paul
EC28 09/21/2006 09/20/2006 Drug Industry Novo Nordisk Inc       htm  
Signature: McElligott, Mary Ann
EC29 09/21/2006 09/20/2006 Health Professional Department of Emergency Medicine, Univ.of Michigan
       pdf  
Signature: Maio, Ronald
EC30 09/21/2006 09/20/2006 Individual Consumer Mrs. Sandra Sells       htm  
EC31 09/21/2006 09/20/2006 Health Care Association
 American Heart Association/American Stroke Association
       htm
Letter
Abstract 		 
Signature: Solis, Penelope
EC32 09/21/2006 09/20/2006 Academia Neurological Emergencies Treatment Trials network
       pdf  
Signature: Silbergleit, Robert
EC33 09/28/2006 09/27/2006 Health Care Association
 National Organization for Rare Disorders (NORD)       txt  
Signature: Meyers, Abbey
APE1 09/08/2006 09/08/2006 Academia University of Maryland School of Medicine        
Signature: Richard P. Dutton, MD MBA
APE2 09/15/2006 09/15/2006 Private Industry CIRCARE        
Signature: Elizabeth Woeckner
C4 09/15/2006 09/15/2006 Health Care Association
 Society for Academic Emergency Medicine (SAEM)
       pdf  
Signature: Michelle H. Biros, MD
C5 09/20/2006 09/20/2006 Health Care Association
 American College of Emergency Physicians (ACEP)
       pdf  
Signature: Edward P. Sloan, MD, FACEP
TS1 09/27/2006 09/27/2006 Academia University of Texas Southwestern Medical Center and the Parkland Health and Hospital System
       pdf
Attachment 		 
Signature: Paul E. Pepe, MD, MPH, FCCM, FACE
EC34 09/29/2006 09/28/2006 Individual Consumer Mrs. Bonnie Klein       htm  
EC35 09/29/2006 09/28/2006 Individual Consumer Mrs. Malinda Rauschert       htm  
C6 10/03/2006 09/28/2006 Consumer Group National Organization for Rare Disorders, Inc. (NORD)       pdf
 		 
Signature: Abbey S. Meyers
APE3 10/03/2006 10/03/2006 Academia T. Schmidt MD MS          
LST1 10/04/2006 10/04/2006 Federal Government List of Presenters at Part 15 Public Hearing - Conduct of Emergency Clinical Research (10/11/2006)
       pdf  
LST2 10/04/2006 10/04/2006 Federal Government List of Panelists at Part 15 Public Hearing - Conduct of Emergency Clinical Research (10/11/2006)       pdf  
LST3 10/04/2006 10/04/2006 Federal Government Agenda for the Conduct of Emergency Clinical Research;Public Hearing held on October 11, 2006
       pdf  
CR1 10/04/2006 10/04/2006 Academia University of Texas Southwestern Medical Center and the Parkland Health and Hospital System
       pdf
ppt
htm 		 
Signature: Paul E. Pepe, MD, MPH, FCCM, FACE
TS2 10/05/2006 10/05/2006 Federal Government FDA/OC      

pdf
ppt
htm

  
Signature: Sara F. Goldkind, MD, MA, and Michael Carome, MD
EC36 10/10/2006 10/07/2006 Individual Consumer Mr. Warren Dowler       htm  

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