[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Page 12693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-OS-21524-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the 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 0990-0278, 
which expires on June 30, 2014. 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 May 5, 2014.

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 HHS-OS-21524-60D 
for reference.
    Information Collection Request Title: Federalwide Assurance Form--
Extension OMB No. 0990-0278, Assistant Secretary for Health, Office for 
Human Research Protections.
    OMB No.: 0990-0278
    Abstract: The Office for Human Research Protections is requesting a 
three year extension of the Federalwide Assurance (FWA). The FWA is 
designed to provide a simplified procedure for institutions engaged in 
HHS-conducted or supported research to satisfy the assurance 
requirements of Section 491(a) of the Public Health Service Act and HHS 
Regulations for the protection of human subjects at 45 CFR 46.103. The 
respondents are institutions engaged in human subjects research that is 
conducted or supported by HHS.
    Need and Proposed Use of the Information: The information collected 
by OHRP through the FWA is the minimum necessary to satisfy the 
assurance requirements of the Public Health Service Act and the 
requirements of HHS regulations at 45 CFR 46.103.
    Likely Respondents: Research institutions engaged in HHS-conducted 
or -supported research involving human subjects.
    Burden Statement: The estimate of the hours per response assumes 
that virtually all respondents will complete the FWA form via the 
internet on an interactive page on the OHRP Web site. The time estimate 
includes an estimate of the time needed to (i) read and understand the 
instructions for completing the FWA; (ii) read and understand the FWA 
terms of assurance; and (iii) enter the information requested on the 
FWA form. The total annual burden hours estimated for this ICR are 
summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
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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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Federalwide Assurance (FWA).....................          11,050               2           30/60          11,050
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    Total.......................................  ..............  ..............  ..............          11,050
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    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.

Darius Taylor,
Deputy, Information Collection Clearance Officer.
[FR Doc. 2014-04933 Filed 3-5-14; 8:45 am]
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