[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41507-41508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-0990-0279-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary, Department of 
Health and Human Services (HHS), announces plans to submit an 
Information Collection Request (ICR), described below, to the Office of 
Management and Budget (OMB). The ICR is for extending the use of the 
approved information collection assigned OMB control number 0990-0279, 
which expires on August 31, 2015. Prior to submitting that ICR to OMB, 
OS seeks comments from the public regarding the burden estimate, below, 
or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before September 14, 
2015.

ADDRESSES: Submit your comments to 
[email protected] or by calling (202) 690-6162.

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 document identifier 0990-0279 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 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 part 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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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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IRB Registration 0990-0279......................           5,900               2               1          11,800
                                                             500               2               1           1,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          12,800
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[[Page 41508]]

    OS specifically requests comments on (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.

Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-17348 Filed 7-14-15; 8:45 am]
 BILLING CODE 4150-28-P