[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Pages 69538-69539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24251]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, 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 Tuesday, October 25, 2016, from 8:30 
a.m. until 5:00 p.m. and Wednesday, October 26, 2016, 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: Julia Gorey, J.D., Executive Director, 
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

[[Page 69539]]

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 Tuesday, 
October 25, followed by opening remarks from Dr. Jerry Menikoff, 
Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey 
Botkin, SACHRP Chair. The Subpart A Subcommittee (SAS) will then 
present their report, including recommendations regarding single IRB 
review and the draft joint OHRP-FDA draft guidance, ``Institutional 
Review Board (IRB) Written Procedures: Guidance for Institutions and 
IRBs.'' This will be followed by the Subcommittee on Harmonization's 
(SOH) report, including recommendations involving clustered randomized 
trials, benchmarking, and the ``NIH Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules,'' Appendix M.
    SAS was established by SACHRP in October 2006. The subcommittee 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. On Wednesday, October 26, 
2016, SACHRP will discuss recommendations from the SOH on the FDA Draft 
Guidance ``Use of Real-World Evidence to Support Regulatory Decision-
Making for Medical Devices,'' issued July 27, 2016.
    The meeting will adjourn at 4:30 p.m. October 26, 2016. 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. 
Registration is required for participation in the on-site public 
comment session; individuals may register on 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. Note that public 
comment must be relevant to agenda topics.

    Dated: October 3, 2016.
Julia Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
[FR Doc. 2016-24251 Filed 10-5-16; 8:45 am]