[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56470-56471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: HHS-OS-0990-0279-30D]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, has submitted an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB) for review and approval. The ICR is for renewal of the approved 
information collection assigned OMB control number 0990-0279, scheduled 
to expire on September 30, 2015. Comments submitted during the first 
public review of this ICR will be provided to OMB. OMB will accept 
further comments from the public on this ICR during the review and 
approval period.

DATES: Comments on the ICR must be received on or before October 19, 
2015.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the OMB control number 0990-0279 and 
document identifier HHS-OS-30D for reference.
    Information Collection Request Title: Institutional Review Board 
Form--OMB No. 0990-0279, Assistant Secretary for Health, Office for 
Human Research Protections.
    Abstract: Section 491(a) of Public Law 99-158 states that the 
Secretary of HHS shall by regulation require that each entity applying 
for HHS support (e.g., a grant, contract, or cooperative

[[Page 56471]]

agreement) to conduct research involving human subjects submit to HHS 
assurances satisfactory to the Secretary that it has established an 
institutional review board (IRB) to review the research in order to 
ensure protection of the rights and welfare of the human research 
subjects. IRBs are boards, committees, or groups formally designated by 
an entity to review, approve, and have continuing oversight of research 
involving human subjects.
    The Office for Human Research Protections (OHRP) and the Food and 
Drug Administration (FDA) are requesting a three-year extension of the 
OMB No. 0990-0279, Institutional Review Board (IRB) Registration Form. 
This form was modified in 2009 to be consistent with IRB registration 
requirements, 45 CFR 46, subpart E and 21 CFR 56.106 that were adopted 
in July 2009 OHRP and FDA, respectively.
    Need and Proposed Use of the Information: The information collected 
through the Institutional Review Board registration collection 
requirements is the minimum necessary to satisfy the registration 
requirements of Section 491(a) of the Public Health Service Act, 45 CFR 
part 46, subpart E and 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 regulations, IRBs in the United States that review 
clinical investigations regulated by FDA under sections 505(i) or 
520(g) of the Federal Food, Drug and Cosmetic Act; and, IRBs in the 
United States that review clinical investigations that are intended to 
support applications for research or marketing permits for FDA-
regulated products.
    Burden Statement: The burden estimates for the IRB registration 
form include those approved by OMB in March 2015 under Control Number 
0990-0263, the Assurance Identification/IRB Certification/Declaration 
of Exemption form (former Optional Form 310). Those burden estimates 
are not included as part of the burden estimate presented below.

                                        Estimated Annualized Burden Table
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                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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IRB Registration 0990-0279......................           5,900               2               1          11,800
New Registratration.............................             500               2               1           1,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          12,800
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Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-23453 Filed 9-17-15; 8:45 am]
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