[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3408-3409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2727]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Institutional Review Board Waiver or 
Alteration of Informed Consent for Minimal Risk Clinical Investigations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a collection of information entitled ``Institutional

[[Page 3409]]

Review Board Waiver or Alteration of Informed Consent for Minimal Risk 
Clinical Investigations'' has been approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: On November 27, 2023, the Agency submitted a 
proposed collection of information entitled ``Institutional Review 
Board Waiver or Alteration of Informed Consent for Minimal Risk 
Clinical Investigations'' to OMB for review and clearance under 44 
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0130. 
The approval expires on December 31, 2026. A copy of the supporting 
statement for this information collection is available on the internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: January 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00886 Filed 1-17-24; 8:45 am]
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