[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39438-39439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. HHS-OASH-2022-0014]


Draft Guidance on Frequently Asked Questions: Limited 
Institutional Review Board Review and Related Exemptions

AGENCY: The Office for Human Research Protections, Office of the 
Assistant Secretary for Health, Office of the Secretary, HHS.

ACTION: Notice of availability.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health, is announcing the availability of a 
draft guidance document titled, ``Frequently Asked Questions: Limited 
Institutional Review Board Review and Related Exemptions.''

DATES: Submit written comments by August 15, 2023.

ADDRESSES: You may send comments, identified by docket number HHS-OASH-
2022-0014, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Email: [email protected].
     Fax: 240-453-8420.
     Mail/Hand Delivery/Courier: Division of Policy and 
Assurances, Office for Human Research Protections, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852.
    Instructions: All submissions received must include the docket 
number. All comments received, including attachments and any personal 
information, will be posted without change to https://www.regulations.gov.
    Submit written requests for a single copy of the guidance document 
titled, ``Frequently Asked Questions: Limited Institutional Review 
Board Review and Related Exemptions'' to the Division of Policy and 
Assurances, Office for Human Research Protections, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed 
adhesive label to assist that office in processing your request or fax 
your request to 240-453-8420. See the SUPPLEMENTARY INFORMATION section 
for information on access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Natalie Klein, Ph.D., Office for Human 
Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 
20852, 240-453-6700; email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP is announcing the availability of a draft guidance document 
for public comment titled ``Frequently Asked Questions: Limited 
Institutional Review Board Review and Related Exemptions.'' The draft 
guidance document applies to research activities involving human 
subjects that are conducted or supported by HHS. It is intended 
primarily to help

[[Page 39439]]

entities implement the requirement for limited review of research by an 
IRB to meet the conditions of four exemptions found at 45 CFR 46.104(d) 
of the 2018 Requirements (the Common Rule). The draft guidance 
discusses the concept of limited IRB review, which appears in these 
exemptions, and provides information about how limited review may be 
conducted. When finalized, this will provide OHRP's first formal 
guidance on this topic. This draft guidance was developed after taking 
into consideration input received from HHS and other Common Rule 
departments and agencies.

II. Equity and Justice Considerations

    OHRP is particularly interested in public comments on any impact 
this guidance may have on considerations for equity and justice in 
human research protections.

III. Electronic Access

    Persons with access may obtain the draft guidance documents on 
OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html.

Julie A. Kaneshiro,
Acting Director, Office for Human Research Protections.
[FR Doc. 2023-12924 Filed 6-15-23; 8:45 am]
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