[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18820-18821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0260; 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 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. 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 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.
[[Page 18821]]
Total Estimated Annualized Burden--Dollars
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Average
Number of Number of burden per Total burden
Title respondents responses per response (in hours
respondent hours)
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.103(b)(4), .109(d) IRB Actions, .116 and .117 6,000 39.33 1 235,980
Informed Consent...............................
.115(a) IRB Recordkeeping....................... 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension 6,000 0.5 45/60 2,250
or Termination Reporting.......................
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Total....................................... .............. .............. .............. 1,138,230
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Keith A. Tucker,
Paperwork Reduction Act Clearance Officer, Office of the Secretary.
[FR Doc. 2012-7464 Filed 3-27-12; 8:45 am]
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