[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Page 59772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23664]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.


SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's 
Advisory Committee on Human Research Protections (SACHRP) will hold a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP Web site at: 

DATES: The meeting will be held on Wednesday, October 29, 2014, from 
8:30 a.m. until 5:00 p.m. and Thursday, October 30, 2014, from 8:30 
a.m. until 4:00 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, 
Office for Human Research Protections (OHRP), or Julia Gorey, J.D., 
Executive Director, SACHRP; U.S. Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 
240-453-8141; fax: 240-453-6909; email address: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services and the Assistant Secretary for 
Health on issues and topics pertaining to or associated with the 
protection of human research subjects.
    The meeting will open to the public at 8:30 a.m., Wednesday, 
October 29. Following opening remarks from Dr. Jerry Menikoff, 
Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey 
Botkin, SACHRP Chair, new members will be introduced. The Subpart A 
Subcommittee (SAS) will then give their report on the new SAS 
initiative examining informed consent. SAS is charged with developing 
recommendations for consideration by SACHRP regarding the application 
of subpart A of 45 CFR part 46 in the current research environment. SAS 
was established by SACHRP in October 2006. Following this report, an 
OHRP staff member will present and discuss OHRP data addressing 
incidental findings and corrective action plans.
    On October 30, the Subcommittee on Harmonization (SOH) will discuss 
their work on the topic of the intersection of the HHS and FDA 
regulations and ``big data''; this will be followed by a presentation 
of SOH work on the topic of return of general results. SOH was 
established by SACHRP at its July 2009 meeting. SOH is charged with 
identifying and prioritizing areas in which regulations and/or 
guidelines for human subjects research adopted by various agencies or 
offices within HHS would benefit from harmonization, consistency, 
clarity, simplification and/or coordination.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the SACHRP at the address/phone number listed above at least one 
week prior to the meeting. Pre-registration is required for 
participation in the on-site public comment session; individuals may 
pre-register the day of the meeting. Individuals who would like to 
submit written statements should email or fax their comments to SACHRP 
at [email protected] at least five business days prior to the meeting.

    Dated: September 29, 2014.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Director, Office for Human Research Protections.
[FR Doc. 2014-23664 Filed 10-2-14; 8:45 am]