[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7472-7473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier HHS-OS-0990-0263-30-D]


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 0990-0263, scheduled 
to expire on March 31, 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 March 12, 
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 0990-0263 and 
document identifier HHS-OS-30D for reference.
    Information Collection Request Title: Protection of Human Subjects: 
Assurance Identification/IRB Certification/Declaration of Exemption 
Form--Extension OMB No. 0990-0263, Assistant Secretary for Health, 
Office for Human Research Protections.
    Abstract: The Office for Human Research Protections is requesting a 
three year extension of the Protection of Human Subjects: Assurance 
Identification/IRB Certification/Declaration of Exemption Form. That 
form is designed to promote uniformity among departments and agencies, 
and to help ensure common means of ascertaining institutional review 
board certifications and other reporting requirements relating to the 
protection of human subjects in research. The Federal Policy for the 
Protection of Human Subjects, known as the Common Rule, requires that 
before engaging in non-exempt human subjects research that is conducted 
or supported by a Common Rule department or agency, each institution 
must: (1) Hold an applicable assurance of compliance [Section 103(a)]; 
and (2) certify to the awarding department or agency that the 
application or proposal for research has been reviewed and approved by 
an IRB designated in the assurance [Sections 103(b) and (f)].
    Need and Proposed Use of the Information: The information collected 
through the Protection of Human Subjects: Assurance Identification/IRB

[[Page 7473]]

Certification/Declaration of Exemption Form is the minimum necessary to 
satisfy the assurance and certification 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.
    Likely Respondents: Research institutions engaged in HHS-conducted 
or --supported research involving human subjects. Institutional use of 
the form is also relied upon by other federal departments and agencies 
that have codified or follow the Federal Policy for the Protection of 
Human Subjects (Common Rule).

                                    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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Protection of Human Subjects: Assurance                   12,000               2           30/60          12,000
 Identification/IRB Certification/Declaration of
 Exemption......................................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          12,000
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Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-02649 Filed 2-9-15; 8:45 am]
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