[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Page 12615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: 0990-0278-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, 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 (OS), Department of 
Health and Human Services, 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 August 31, 2017. Prior to submitting the 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, 2017.

ADDRESSES: Submit your comments to 
[email protected] and [email protected] or 
by calling (202) 795-7714.
    Information Collection Request Title: Federal-wide Assurance Forms.
    Abstract: Assistant Secretary for Health, Office for Human Research 
Protections is requesting Office of Management and Budget, OMB approval 
on a three year extension of the Federal-wide 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 subject research that is 
conducted or supported by HHS.
    Need and Proposed Use of the Information: OHRP is the HHS component 
charged with fulfilling the statutory mandates of these provisions of 
the PHS Act and enforcing HHS regulations at 45 CFR part 46. The FWA 
provides a simplified assurance process that replaced the prior 
assurance mechanisms used by OHRP, all of which were more complicated 
and burdensome than the FWA. The information collected by OHRP through 
the FWA is the minimum necessary to satisfy the assurance requirements 
of the PHS Act and the requirements of HHS regulations at 45 CFR 
46.103.
    Likely Respondents: Individuals or households, business or other 
for-profit, not-for-profit institutions, Federal, State, Local, or 
Tribal Governments.
    The total annual burden hours estimated for this ICR are summarized 
in the table below.

                                   Estimated Annualized Burden in Hours Table
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                                                                  Number of
                  Form name                      Number of      responses  per     Hours per         Response
                                                respondents       respondent        response       burden hours
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Federal-wide Assurance (FWA)................          14,000              2.0             0.50           14,000
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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.

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2017-04249 Filed 3-3-17; 8:45 am]
 BILLING CODE 4150-28-P