Meeting of the Secretary's Advisory Committee on Human Research Protections, 12194 [2021-04244]

Download as PDF 12194 Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices and Supporting Regulations; Form Number: CMS–372(S); and OMB Control Number: 0938–0272. Through the publication of this document we are withdrawing that notice (FR document: 2021–03916) in its entirety. While the notice published in error, it will be resubmitted for publication and public comment when ready. Dated: February 25, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–04296 Filed 3–1–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice. AGENCY: 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 https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. DATES: The meeting will be held on Tuesday, March 23rd, 2021, from 11:00 a.m. until 4:30 p.m., and Wednesday, March 24, 2021, from 11:00 a.m. until 4:30 p.m. (times are tentative and subject to change). The confirmed times and agenda will be posted on the SACHRP website when 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 one week prior to the meeting at https://www.hhs.gov/ohrp/ sachrp-committee/meetings/. 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: SACHRP@hhs.gov. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:11 Mar 01, 2021 Jkt 253001 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 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 or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification or coordination. The SACHRP meeting will open to the public at 11:00 a.m., on Tuesday, March 23, 2021, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with presentation of recommendations on Justice as an Ethical Concept in 45 CFR 46, followed by an expert panel discussion of draft recommendations on Mandatory Exploratory Biopsies in Research. The day will conclude with discussion of a new SACHRP topic, IRB Authority to Restrict Use of Data in Research. March 24th will include presentation of Interactions between Sponsors, Clinical Trial Sites, and Research Subjects, and lastly, Consideration of Risks to Bystanders in Research. Other topics may be added; for the full and updated meeting agenda, see https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/. The public will have an opportunity to send comments to SACHRP during the meeting’s public comment session or to submit written public comments in advance. Persons who wish to provide public comments should review instructions at https://www.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html and respond by midnight Wednesday, March 18th, 2021, ET. Individuals submitting written statements as public comment should submit their comments to SACHRP at SACHRP@hhs.gov. Comments are limited to three minutes each. Time will be allotted for public comment on both days. Note that public SUPPLEMENTARY INFORMATION: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 comment must be relevant to topics currently being addressed by SACHRP. Dated: February 22, 2021. Julia G. Gorey, Executive Director, SACHRP, Office for Human Research Protections. [FR Doc. 2021–04244 Filed 3–1–21; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA– L Conflict SEP. Date: March 25, 2021 Time: 11:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892 (Virtual Meeting). Contact Person: Preethy Nayar, Ph.D. Scientific Review Officer Scientific Review Branch National Institute on Drug Abuse, NIH 301 North Stonestreet Avenue Bethesda, MD 20892, 301–443–4577, nayarp2@ csr.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Implementing the HIV Service Cascade for Justice-Involved Populations (U01—Clinical Trial Optional). Date: March 30, 2021. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892, (Virtual Meeting). Contact Person: Sheila Pirooznia, Ph.D.; Scientific Review Officer, Division of Extramural Review, Scientific Review Branch, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue Bethesda, MD 20892, (301) 496–9350 sheila.pirooznia@ nih.gov. E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Page 12194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04244]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

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 https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.

DATES: The meeting will be held on Tuesday, March 23rd, 2021, from 
11:00 a.m. until 4:30 p.m., and Wednesday, March 24, 2021, from 11:00 
a.m. until 4:30 p.m. (times are tentative and subject to change). The 
confirmed times and agenda will be posted on the SACHRP website when 
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 one week prior to the meeting at https://www.hhs.gov/ohrp/sachrp-committee/meetings/.

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.
    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 or guidelines for human subjects research 
adopted by various agencies or offices within HHS would benefit from 
harmonization, consistency, clarity, simplification or coordination.
    The SACHRP meeting will open to the public at 11:00 a.m., on 
Tuesday, March 23, 2021, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The 
meeting will begin with presentation of recommendations on Justice as 
an Ethical Concept in 45 CFR 46, followed by an expert panel discussion 
of draft recommendations on Mandatory Exploratory Biopsies in Research. 
The day will conclude with discussion of a new SACHRP topic, IRB 
Authority to Restrict Use of Data in Research. March 24th will include 
presentation of Interactions between Sponsors, Clinical Trial Sites, 
and Research Subjects, and lastly, Consideration of Risks to Bystanders 
in Research. Other topics may be added; for the full and updated 
meeting agenda, see https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.
    The public will have an opportunity to send comments to SACHRP 
during the meeting's public comment session or to submit written public 
comments in advance. Persons who wish to provide public comments should 
review instructions at https://www.hhs.gov/ohrp/sachrp-committee/meetings/ and respond by midnight Wednesday, March 18th, 
2021, ET. Individuals submitting written statements as public comment 
should submit their comments to SACHRP at [email protected]. Comments are 
limited to three minutes each.
    Time will be allotted for public comment on both days. Note that 
public comment must be relevant to topics currently being addressed by 
SACHRP.

    Dated: February 22, 2021.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2021-04244 Filed 3-1-21; 8:45 am]
BILLING CODE 4150-36-P
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