NIH Comments to FDA Docket #2006D-0331From: Carr, Sarah (NIH/OD) [E] [CarrS@OD.NIH.GOV] Sent: Monday, November 27, 2006 7:40 PM To: Dockets, FDA Cc: Patterson, Amy (NIH/OD) [E]; Fennington, Kelly (NIH/OD) [E] Subject: NIH Comments to FDA Docket #2006D-0331 Attachments: NIH Comments on FDA Part 15 Hearing - Issues for Discussion 11-27-06f.doc Please find attached NIH comments on the regulatory framework at 21 CFR 50.24 that provides an exception from informed consent procedures in emergency research. We appreciate the opportunity to provide our perspectives on this important issue as part of FDA’s Part 15 Public Hearing on the Conduct of Emergency Clinical Research. <> _____________________________________________ From: Patterson, Amy (NIH/OD) [E] Sent: Tuesday, November 21, 2006 8:51 AM To: 'fdadockets@oc.fda.gov' Cc: Twyman, Leslie (NIH/OD) [E]; Skirboll, Lana (NIH/OD) [E]; Barratt, Peg (NIH/OD) [C]; Tse, Tony (NIH/OD) [E]; Holzer, Jessica (NIH/OD) [C]; Fennington, Kelly (NIH/OD) [E]; Powell, Penny (NIH/OD) [E]; Carr, Sarah (NIH/OD) [E] Subject: NIH Comments to FDA Docket #2006D-0331 Please find attached NIH comments on FDA’s August 2006 draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. We appreciate the opportunity to comment on this important guidance document. << File: NIH Comments on FDA Guidance - Emergency Research 11-20-06.doc >> Amy P. Patterson, M.D. Director Office of Biotechnology Activities Director, Clinical Research Policy Analysis and Coordination Program Office of Science Policy Office of the Director National Institutes of Health 6705 Rockledge Drive Suite 750 Bethesda, Maryland 20892-7985 E-mail: pattersa@od.nih.gov Telephone; 301.496.9838 Facsimile: 301.496.9839