[Federal Register Volume 90, Number 113 (Friday, June 13, 2025)]
[Notices]
[Pages 25058-25059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0278]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before July 14, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Natalie Klein, [email protected]
or (240) 453-6900. When submitting comments or requesting information,
please include the document identifier 0990-0278-30D and project title,
Federalwide Assurance (FWA) Form, for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Federalwide Assurance (FWA) Form.
Type of Collection: Revision.
OMB No.: 0990-0278.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human
[[Page 25059]]
Research Protections (OHRP) is requesting a revision of the currently
approved collection for the OMB No. 0990-0278, Federalwide Assurance
(FWA) Form. The form is currently approved through October 31, 2026.
The purpose of the FWA form is to provide a simplified procedure for
institutions engaged in research conducted or supported by the
Department of Health and Human Services (HHS) to satisfy the assurance
requirements of (1) Section 491(a) of the Public Health Service Act
(the PHS Act) (42 U.S.C. 289); and (2) HHS regulations for the
protection of human subjects at 45 CFR 46.103. The respondents for this
information collection are institutions engaged in HHS-conducted or
supported research involving human subjects. With this revision, OHRP
is seeking to remove information from the FWA form to adopt the changes
for assurances at 45 CFR 46.103 of the 2018 Requirements and reduce
burden on respondents. The proposed changes to the FWA form include:
(1) removing the Pre-2018 Common Rule requirement that institutions
provide a statement of ethical principles; (2) removing the Pre-2018
Common Rule requirement that an institution designate one or more IRBs
to review the research to which the FWA applies; (3) removing ``check
the box'', or the option for U.S. institutions to voluntarily apply the
Common Rule, or the Common Rule and subparts B, C, and D of the HHS
regulations at 45 CFR part 46, to all of an institution's nonexempt
human subjects research regardless of the source of support; and (4)
eliminating the requirement for institutions outside the U.S. to
provide procedural standards they apply for human subjects research
when assuring compliance with the Terms of the Federalwide Assurance.
Updates to the software applications OHRP uses to manage the FWA
application process will be deployed to enable such changes.
Annualized Burden Hour Table
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Number of Average
Form name Number of responses per burden per Total burden
respondents respondent response hours
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Federalwide Assurance (FWA)..................... 13,000 1.0 0.33 4,290
Total....................................... .............. .............. .............. 4,290
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Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2025-10739 Filed 6-12-25; 8:45 am]
BILLING CODE 4150-36-P