[Federal Register Volume 73, Number 167 (Wednesday, August 27, 2008)]
[Notices]
[Pages 50627-50628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19849]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0263]
Agency Information Collection Request; 60-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 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) 690-6162. 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 60 days.
Proposed Project: Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form--OMB No.
0990-0263--Extension--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
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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 10,000 7 0.5 35,000
Identification/IRB Certification/Declaration of
Exemption......................................
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[[Page 50628]]
Terry Nicolosi,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. E8-19849 Filed 8-26-08; 8:45 am]
BILLING CODE 4150-36-P