Notice2024-00886
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
Primary source
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Published
January 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled "Institutional 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.
Full Text
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<title>Federal Register, Volume 89 Issue 12 (Thursday, January 18, 2024)</title>
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[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3408-3409]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#29797b687a5d484f4f694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="653537243611040303250301044b0d0d164b020a13">[email protected]</span></a>.
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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>.
Dated: January 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00886 Filed 1-17-24; 8:45 am]
BILLING CODE 4164-01-P
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