May 25-26, 2017 - SACHRP Meeting

May 25, 2017 - May 26, 2017

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Welcome and Introducton of New Members: Sandra H. Berry, M.A. James J. Giordano, Ph.D. Aviva L. Katz, M.D., M.A. Leslie E. Wolf, J.D., M.P.H.	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:15 a.m.	Overview of New Final Rule Sections §§__.101(I), __,104(d)(3), and __.110	Jerry Menikoff, M.D., J.D. Director, OHRP
9:15 a.m. - 10:45 a.m.	Subcommittee on Harmonization Topic: Compliance and Transition Provisions, § __.101(I)	David Forster, J.D. SOH Co-chair
10:45 a.m. - 11:00 a.m.	BREAK
11:00 a.m. - 11:30 a.m.	Subcommittee on Harmonization Compliance andTransition Provisions,§ __.101(I)	David Forster, J.D. SOH Co-chair
11:30 a.m. - 12:30 p.m.	Subpart A Subcommittee Topic: Benign Behavioral Interventions, §__ .104(d)(3)	Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair
12:30 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 2:15 p.m.	Subpart A Subcommittee Topic: Benign Behavioral Interventions, §__ .104(d)(3)	Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair
2:15 p.m - 4:15 p.m.	Subpart A Subcommittee Topic: Expedited Review List, §__ .110	Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair
4:15 p.m. - 4:30 p.m.	Public Comment
4:30 p.m. - 4:45 p.m.	Summary and Adjournment

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Opening Remarks	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:00 a.m.	Overview of New Final Rule Section, §__ .116 (d)	Jerry Menikoff, M.D., J.D. Director, OHRP
9:00 a.m. - 10:30 a.m.	Subcommittee on Harmonization Topic: Broad Consent, §__ .116 (d)	Mark Barnes, J.D. SOH Co-chair
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 11:30 a.m.	Subcommittee on Harmonization Topic: Broad Consent, §__ .116 (d)	Mark Barnes, J.D. SOH Co-chair
11:30 a.m. - 12:15 p.m.	Subcommittee on Harmonization Topic: Report of Incidental Findings	David Forster, J.D. SOH Co-chair
12:15 p.m. - 1:00 p.m.	LUNCH
1:00 p.m. - 2:00 p.m.	Subcommittee on Harmonization Topic: FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices"	David Forster, J.D. SOH Co-chair
2:00 p.m. - 3:30 p.m.	Reserved for Discussion of Revised Recommendations
3:30 p.m. - 3:45 p.m.	Public Comment
3:35 p.m. - 4:00 p.m.	Wrap and Adjournment