[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13131-13132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04324]


-----------------------------------------------------------------------

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, 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, the 
full meeting agenda, and instructions for linking to public access will 
be posted on the SACHRP website at http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Wednesday, March 22, 2023 from 11:00 
a.m. until 5:00 p.m., and Thursday, March 23, 2023, from 11:00 a.m. 
until 5:00 p.m. (times are tentative and subject to change). The 
confirmed times and agenda will be posted on the SACHRP website as this 
information becomes available.

ADDRESSES: This meeting will be held via webcast. Members of the public 
may also attend the meeting via webcast. Instructions for attending via 
webcast will be posted at least one week prior to the meeting at 
https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html.

FOR FURTHER INFORMATION CONTACT:  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: [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.

[[Page 13132]]

    The Subpart A Subcommittee (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.
    The Subcommittee on Harmonization (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 SACHRP meeting will open to the public at 11:00 a.m., 
on Wednesday, March 22, 2023, followed by opening remarks from Julie 
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP 
Chair. The meeting will begin with an overview of the recently 
published GAO report #GAO-23-104721, Institutional Review Boards: 
Actions Needed to Improve Federal Oversight and Examine Effectiveness, 
followed by a panel of expert speakers addressing the topic of defining 
stakeholders and evaluating HRPP/IRB quality and effectiveness. SACHRP 
will subsequently discuss recommendations related to the report's 
recommendation #4.
    A second agenda topic will be introduced and discussed at SACHRP in 
the afternoon, the FDA draft guidance on Ethical Considerations for 
Clinical Investigations of Medical Products Involving Children Guidance 
for Industry, Sponsors, and IRBs.
    Discussion of both topics will continue on March 23rd. Other topics 
may be added; for the full and updated meeting agenda, see http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html. The meeting 
will adjourn by 5:00 p.m. March 23, 2022.
    Time will be allotted for public comment on both days of the 
meeting. The public may submit written public comment in advance to 
[email protected] no later than midnight March 20th, 2023, ET. Written 
comments will be shared with SACHRP members and may read aloud during 
the meeting. Comments which are read aloud are limited to three minutes 
each. Public comment must be relevant to topics being addressed by the 
SACHRP.

    Dated: February 23, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2023-04324 Filed 3-1-23; 8:45 am]
BILLING CODE 4150-36-P