[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22987-22988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10511]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement 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.
[[Page 22988]]
DATES: Comments on the ICR must be received on or before June 18, 2018.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-30D and
project title for reference., to [email protected], or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: 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.
Information Collection Request Title: 0990-0260-Extension
Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation.
Abstract: Assistant secretary for Health, Office for Human Research
Protections is requesting an extension on a currently approved
information collection by the Office of Management and Budget, on the
Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation. The purpose of the Federal Policy for the Protection of
Human Subjects (also known as the Common Rule) is to provide a uniform
government-wide standard for institutions engaged in research conducted
or supported by the Department of Health and Human Services (HHS) to
apply regarding the protection of human subjects involved in research.
The HHS codification of the Common Rule is at 45 CFR part 46 subpart A.
The respondents for this collection are institutions engaged in such
research. Institutional adherence to the Common Rule also is required
by other federal departments and agencies that have codified or follow
the Common Rule which is identical to 45 CFR part 46, subpart A.
Likely Respondents: Institutions engaged in nonexempt human
subjects research.
Estimate Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Title Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
.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.......................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................................... .............. .............. .............. 1,138,230
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2018-10511 Filed 5-16-18; 8:45 am]
BILLING CODE 4150-36-P