NIH Comments to FDA Docket #2006D-0331From: Patterson, Amy (NIH/OD) [E] [PattersA@OD.NIH.GOV] Sent: Tuesday, November 21, 2006 8:51 AM To: Dockets, FDA 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 Attachments: NIH Comments on FDA Guidance - Emergency Research 11-20-06.doc Please find attached NIH comments on FDA’s August 2006 draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research.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. <> 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