Agency Information Collection Request; 60-Day Public Comment Request

• Published date: 01 April 2024
• Record Number: 2024-06803
• Citation: 89 FR 22413
• Court: Health And Human Services Department
• Section: Notices

Federal Register, Volume 89 Issue 63 (Monday, April 1, 2024)

[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
                [Notices]
                [Page 22413]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2024-06803]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                [Document Identifier: OS-0990-0263]
                Agency Information Collection Request; 60-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 May 31, 2024.
                ADDRESSES: Submit your comments to [email protected] or by calling
                (202) 264-0041 and [email protected].
                FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
                information, please include the document identifier 0990-0263-60D and
                project title for reference, to Sherrette A. Funn, email:
                [email protected], [email protected] or call (202) 264-0041 the Reports
                Clearance Officer.
                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: Protection of Human Subjects: Assurance
                Identification/IRB Certification/Declaration of Exemption Form.
                 Type of Collection: Renewal, three-year extension with non-
                substantive changes for the Protection of Human Subjects: Assurance
                Identification/IRB Certification/Declaration of Exemption Form OMB No.
                0990-0263 Office of the Assistant Secretary for Health, Office for
                Human Research Protections.
                 Abstract: The Office of the Assistant Secretary for Health, Office
                for Human Research Protections is requesting is requesting a three-year
                extension with non-substantive changes of the Protection of Human
                Subjects: Assurance Identification/IRB Certification/Declaration of
                Exemption Form, OMB No. 0990-0263.
                 The information collected on the form is to provide a simplified
                method for institutions engaged in research conducted or supported by
                the Department of Health and Human Services (HHS) to satisfy the
                requirements of HHS regulations for the protection of human subjects at
                45 CFR 46.103 for assurance identification and institutional review
                board (IRB) certification and declare exemption status. Non-substantive
                changes include adding instructions that, if additional assurances
                apply, those details can be indicated in the ``Comments'' section and
                clarifying that the form element for IRB expiration date does not apply
                to all projects.
                 Likely Respondents: Institutions engaged in research involving
                human subjects where the research is supported by HHS. Institutional
                use of the form is also relied upon by other Federal departments and
                agencies that have codified or follow the Federal Policy for the
                Protection of Human Subjects (Common Rule), which is codified for HHS
                at 45 CFR part 46, subpart A.
                 Annualized Burden Hour Table
                ----------------------------------------------------------------------------------------------------------------
                 Number of
                 Form name Number of responses per Hours per Response burden
                 respondents respondent response hours
                ----------------------------------------------------------------------------------------------------------------
                Protection of Human Subjects: Assurance 13,000 2 0.5 13,000
                 Identification/IRB Certification/
                 Declaration of Exemption...................
                ----------------------------------------------------------------------------------------------------------------
                Sherrette A. Funn,
                Paperwork Reduction Act Reports Clearance Officer, Office of the
                Secretary.
                [FR Doc. 2024-06803 Filed 3-29-24; 8:45 am]
                BILLING CODE 4150-36-P