[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Page 58212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26568]


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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.

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 February 9, 
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: 0990-0263-Extension Protection of Human 
Subjects Assurance Identification/IRB Certification/Declaration of 
Exemption (Common Rule) form.
    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, OMB, on 
the Protection of Human Subjects: Assurance Identification/IRB 
Certification/Declaration of Exemption Form. That form is designed to 
provide a simplified procedure for institutions engaged in research 
conducted or supported by the Department of Health and Human Services 
(HHS) to satisfy the requirements of HHS regulations for the protection 
of human subjects at 45 CFR 46.103. The respondents for this collection 
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) which is identical to 45 CFR part 46, subpart A.
    Likely Respondents: Individuals, business or other for-profit, not 
for-profit institutions, Federal, State, Local or Tribal Governments.

                                    Estimate Annualized Burden in Hours Table
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response (in        hours
                                                                    respondent        hours)
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Protection of Human Subjects: Assurance                   14,000               2             0.5          14,000
 Identification/IRB Certification/Declaration of
 Exemption......................................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................  ..............  ..............  ..............          14,000
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Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2017-26568 Filed 12-8-17; 8:45 am]
 BILLING CODE 4150&ndash36-P