[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Page 57627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
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, 5 U.S.C. App 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:
http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.
DATES: The meeting will be held on Wednesday, October 21, 2015, from
8:30 a.m. until 5:00 p.m. and Thursday, October 22, 2015, from 8:30
a.m. until 4:30 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;
telephone: 240-453-8141; fax: 240-453-6909; email address:
SACHRP@hhs.gov.
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, through 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., on Wednesday,
October 21, followed by opening remarks from Dr. Jerry Menikoff,
Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey
Botkin, SACHRP Chair. The Committee will hear the Subpart A
Subcommittee (SAS) and Subcommittee on Harmonization (SOH) reports on
the recent Notice of Proposed Rulemaking (NPRM) titled Federal Policy
for the Protection of Human Subjects (80 FR 53933, Sep. 8, 2015). Both
days will be devoted to the discussion of the NPRM.
SAS was established by SACHRP in October 2006 and 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.
SOH was established by SACHRP at its July 2009 meeting and 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.
The meeting will adjourn at 4:30 p.m. October 22, 2015. Time for
public comment sessions will be allotted both days.
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 one of the designated SACHRP points of contact 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 SACHRP@hhs.gov at least five business
days prior to the meeting.
Dated: September 18, 2015.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research
Protections, Director, Office for Human Research Protections.
[FR Doc. 2015-24264 Filed 9-23-15; 8:45 am]
BILLING CODE 4150-36-P