80 FR 70827 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 220 (November 16, 2015)

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: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70827-70828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

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

ACTION: Notice.

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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: 
http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

DATES: The meeting will be held on Thursday, December 3, 2015, from 
8:30 a.m. until 5:00 p.m. and Friday, December 4, 2015, from 8:30 a.m. 
until 4:30 p.m.

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

[[Page 70828]]


FOR FURTHER INFORMATION CONTACT:  Julia Gorey, J.D., Executive 
Secretary, SACHRP, or Jerry Menikoff, M.D., J.D., Director, Office for 
Human Research Protections (OHRP); 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: 
[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, 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 Thursday, 
December 3, followed by opening remarks from Dr. Jerry Menikoff, 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) 
entitled 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. on December 4, 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 as public 
comment should email or fax their comments to SACHRP at [email protected] 
at least five business days prior to the meeting. Public comment should 
be relevant to agenda topics being discussed.

    Dated: November 9, 2015.
Julia Gorey,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2015-29001 Filed 11-13-15; 8:45 am]
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