[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Notices]
[Pages 29190-29191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11659]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier HHS-OS-0990-0278]


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

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

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 extension of the approved 
information collection assigned OMB control number 0990-0278, scheduled 
to expire on June 30, 2014. 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 June 20, 2014.

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 0990-0278 and 
document identifier HHS-OS-0990-0278-30D for reference.
    Information Collection Request Title: Federalwide Assurance Form, 
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: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions, to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information, to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information, and to transmit or otherwise 
disclose the

[[Page 29191]]

information. The total annual burden hours estimated for this ICR are 
summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                   Number of      Average burden
                  Form name                       Number of      responses per     per response    Total burden
                                                 respondents       respondent       (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Federalwide assurance (FWA)..................          11,050                2            30/60           11,050
                                              ------------------------------------------------------------------
    Total....................................  ...............  ...............  ...............          11,050
----------------------------------------------------------------------------------------------------------------


Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014-11659 Filed 5-20-14; 8:45 am]
BILLING CODE 4150-28-P