[Federal Register Volume 77, Number 14 (Monday, January 23, 2012)]
[Notices]
[Pages 3267-3268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0263; 30-Day Notice]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 
Department of Health and Human Services, is publishing the following 
summary of a proposed collection for public comment. Interested persons 
are invited to send comments regarding this burden estimate or any 
other aspect of this collection of information, including any of the 
following subjects: (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.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections

[[Page 3268]]

referenced above, email your request, including your address, phone 
number, OMB number, and OS document identifier, to 
Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on 
(202) 690-5683. Send written comments and recommendations for the 
proposed information collections within 30 days of this notice directly 
to the OS OMB Desk Officer; faxed to OMB at (202) 395-5806.
    Proposed Project: Protection of Human Subjects: Assurance 
Identification/IRB Certification/Declaration of Exemption Form 
Extension--OMB No. 0990-0263--Office for Human Research Protections.
    Abstract: 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)]. 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. Respondents are institutions engaged in research involving 
human subjects where the research is supported by HHS. 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). There are an estimated 
total of 25,000 human research studies supported each year, an average 
of 2 certifications per institution and an estimated one-half hour per 
certification, for a total burden of 12,000 hours. Data is collected as 
needed.

                        Estimated Annualized Burden in Hours for IRB Certification Burden
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                                                                  Number of
                  Form name                      Number of      responses per      Hours per     Response burden
                                                respondents       respondent        response           hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance               12,000                2            30/60           12,000
 Identification/IRB Certification/
 Declaration of Exemption...................
----------------------------------------------------------------------------------------------------------------


Keith A. Tucker,
Office of the Secretary, Paperwork Reduction Act Clearance Officer.
[FR Doc. 2012-1188 Filed 1-20-12; 8:45 am]
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