[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Page 9746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04618]


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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.

ACTION: Notice.

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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.

DATES: Comments on the ICR must be received on or before May 7, 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-60D 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 
subject's research.

                                    Estimate Annualized Burden in Hours Table
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                                                                     Number of    Average burden
                      Title                          Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         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.......................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,138,230
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Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2018-04618 Filed 3-6-18; 8:45 am]
 BILLING CODE 4150-36-P