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[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Page 71102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-0990-0263-60D]

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 0990-0263, 
which expires on March 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 January 30, 
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 0990-0263 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.
    OMB No.: 0990-0263
    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 
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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                                                                  Number of     Average  burden
                  Form name                      Number of      responses per    per  response     Total burden
                                                respondents       respondent       (in hours)         hours
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Protection of Human Subjects: Assurance               12,000                2            30/60           12,000
 Identification/IRB Certification/
 Declaration of Exemption...................
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    Total...................................  ...............  ...............  ...............          12,000
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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.

Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2014-28194 Filed 11-28-14; 8:45 am]
BILLING CODE 4150-36-P
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