```

[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Notices]
[Page 658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31615]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0481]

Agency Information Collection Request; 60-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 March 7, 2025.

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 0990-0481-60D 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: For HHS/OASH Consultation Process, 
Institutional Review Board (IRB) Records.
    Type of Collection: Renewal, 3-year extension without change.
    OMB No.: 0990-0481
    Abstract: The Office of the Assistant Secretary for Health (OASH), 
Office for Human Research Protections (OHRP) is requesting a 3-year 
extension without change to the currently approved information 
collection request, For OASH/HHS Consultation Process, Institutional 
Review Board (IRB) Records, OMB No. 0990-0481. The purpose of the 
collection is for OHRP to receive IRB records when an IRB or an 
institution requests an HHS consultation process for proposed research 
that is not otherwise approvable by an IRB involving, respectively: (1) 
pregnant women, human fetuses and neonates; (2) prisoners; or, (3) 
children, as subjects. The information that must be submitted to OHRP 
by an IRB or institution includes the research protocol, consent form, 
parental permission and child assent forms (if relevant), and other 
relevant IRB records (e.g., IRB minutes). The Office of the Assistant 
Secretary for Health, on behalf of the Secretary of HHS, may determine 
that such research can be conducted or supported by HHS after 
consulting with experts and meeting other procedural requirements.
    Likely Respondents: IRBs.

                                          Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
     45 CFR part 46--HHS                             Number of       Number of      burden per     Total  burden
    consultation process        Respondent type     respondents     respondents    response  (in       hours
          provision                                                                   hours)
----------------------------------------------------------------------------------------------------------------
subpart B, Sec.   46. 207...  IRBs..............               3               1               1               3
subpart C, Sec.   46.306      IRBs..............               3               1               1               3
 (iii) and (iv).
subpart D, Sec.   46.407....  IRBs..............               4               1               1               4
                                                 ---------------------------------------------------------------
    Total...................  ..................  ..............  ..............  ..............              10
----------------------------------------------------------------------------------------------------------------

Vivianna P. Cowl,
Paperwork Reduction Act Reports Clearance Officer, Health and Human 
Services, Office of the Secretary.
[FR Doc. 2024-31615 Filed 1-3-25; 8:45 am]
BILLING CODE 4150-31-P
```