[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31569-31570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11064]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0279]


Agency Information Collection Request; 30-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 June 23, 2022.

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: Sherrette Funn, [email protected] 
or (202) 795-7714. When submitting comments or requesting information, 
please include the document identifier 0990-0279-30D and project title 
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: Department of Health and Human Services 
(HHS) Registration of an Institutional Review Board Form.
    Type of Collection: Reinstatement without change.
    OMB No.: 0990-0279.

[[Page 31570]]

    Abstract: The Office of the Assistant Secretary for Health, Office 
for Human Research Protections is requesting reinstatement of the 
Office of Management and Budget (OMB) No. 0990-0279, Department of 
Health and Human Services (HHS) Institutional Review Board (IRB) 
Registration Form, with no changes, for a three-year period. That form 
was previously approved by OMB on February 4, 2019 and expired on 
February 28, 2022. The purpose of the IRB Registration Form is to 
provide a simplified procedure for: (1) Institutions engaged in 
research conducted or supported by HHS to satisfy the HHS regulations 
for the protection of human subjects at 45 CFR 46.103(b) and 45 CFR 
46.107 as promulgated in 1991 (56 FR 28012, 28022) and amended on June 
23, 2005 (70 FR 36325), and 45 CFR 46, subpart E, Registration of 
Institutional Review Boards; and, (2) IRBs, in the United States (US), 
to satisfy the FDA IRB regulations at 21 CFR 56.106.
    Likely Respondents: Institutions or organizations operating IRBs 
that review human subjects research conducted or supported by HHS; or, 
in the case of FDA's requirements, each IRB in the United States that 
reviews clinical investigations regulated by FDA under sections 505(i) 
or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in 
the United States that reviews clinical investigations that are 
intended to support applications for research or marketing permits for 
FDA-regulated products.

                                          Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
              IRB registration form                  Number of     responses per  Average burden   Total burden
                                                    respondents     respondent     per response        hours
----------------------------------------------------------------------------------------------------------------
Update and Renew Registration...................           5,650               2           30/60           5,650
Initial and Update Registration.................             350               2           45/60             525
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           6,175
----------------------------------------------------------------------------------------------------------------


Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2022-11064 Filed 5-23-22; 8:45 am]
BILLING CODE 4150-36-P