[Federal Register Volume 77, Number 20 (Tuesday, January 31, 2012)]
[Notices]
[Pages 4819-4820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2038]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0260]
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 (HHS), 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, email 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 email
address within 60 days.
Proposed Project: Protection of Human Subjects: Assurance of
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed
Consent/Consent Documentation--OMB No. 0990-0260--Office for Human
Research Protections.
Abstract: Section 491(a) of Public Law 99-158 states that the
Secretary of HHS shall by regulation require that each entity applying
for HHS support (e.g., a grant, contract, or cooperative agreement) to
conduct research involving human subjects submit to HHS assurances
satisfactory to the Secretary that it has established an institutional
review board (IRB) to review the research in order to ensure protection
of the rights and welfare of the human research subjects. IRBs are
boards, committees, or groups formally designated by an entity to
review, approve, and have continuing oversight of research involving
human subjects.
Pursuant to the requirement of the Public Law 99-158, HHS
promulgated regulations at 45 CFR part 46, subpart A, the basic HHS
Policy for the Protection of Human Subjects. The June 18, 1991 adoption
of the common Federal Policy (56 FR 28003) by 15 departments and
agencies implements a recommendation of the President's Commission for
the Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research which was established on November 9, 1974, by Public Law 95-
622. The Common Rule is based on HHS regulations at 45 CFR part 46,
subpart A, the basic HHS Policy for the Protection of Human Subjects.
Total Estimated Annualized Burden--Dollars
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Total burden Hourly wage Total burden
hours rate dollars
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Total........................................................... 1,138,000 $23.20 $26,400,000
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[[Page 4820]]
Keith A. Tucker,
Paperwork Reduction Act Clearance Officer, Office of the Secretary.
[FR Doc. 2012-2038 Filed 1-30-12; 8:45 am]
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