[Federal Register Volume 73, Number 225 (Thursday, November 20, 2008)]
[Notices]
[Page 70354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0263]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary.
    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 information collection request 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 referenced above, e-mail your 
request, including your address, phone number, OMB number, and OS 
document identifier, to [email protected], or call the 
Reports Clearance Office on (202) 690-5683.
    Written comments and recommendations for the proposed information 
collections must be directed to the OS Paperwork Clearance Officer at 
the above e-mail address within 30 days.
    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 70,000 health or human research studies supported each year, 
meaning an average of 7 certifications per institution annually, 
requiring an estimated one-half hour per certification for a total 
burden of 35,000 hours. Data is collected as needed.

                        Estimated Annualized Burden in Hours for IRB Certification Burden
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                                                                            Number of     Average
                                                               Number of    responses    burden per     Total
                          Form name                           respondents      per        response      burden
                                                                            respondent   (in hours)     hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance Identification/IRB         10,000            7          0.5       35,000
 Certification/Declaration of Exemption.....................
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John Teeter,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. E8-27628 Filed 11-19-08; 8:45 am]
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