[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Notices]
[Pages 21745-21746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-0990-0260-30D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary, Department of 
Health and Human Services (HHS), announces plans to submit an 
Information Collection Request (ICR), described below, to the Office of 
Management and Budget (OMB). The ICR is for extending the use of the 
approved information collection assigned OMB control number 0990-0260, 
which expires on April 30, 2015. Prior to submitting that ICR to OMB, 
OS seeks comments from the public regarding the burden estimate, below, 
or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before May 20, 2015.

ADDRESSES: Submit your comments to 
[email protected] or by calling (202) 690-6162.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the document identifier 0990-0260 for 
reference.
    Information Collection Request Title: Protection of Human Subjects: 
Assurance of Compliance with Federal Policy/IRB Review/IRB 
Recordkeeping/Informed Consent/Consent Documentation--Extension OMB No. 
0990-0260, Assistant Secretary for Health, Office for Human Research 
Protections.
    OMB No.: 0990-0260.
    Abstract: The information collected through the Protection of Human 
Subjects: Assurance.
    Identification/IRB Certification/Declaration of Exemption Form 
Protection of Human Subjects: Assurance of Compliance with Federal 
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent 
Documentation collection requirement is the minimum necessary to 
satisfy the assurance, certification, reporting, disclosure, 
documentation and recordkeeping requirements of Section 491(a) of the 
Public Health Service Act and HHS Regulations for the protection of 
human subjects at 45 CFR part 46.
    Likely Respondents: Research institutions engaged in HHS-conducted 
or -supported research involving human subjects. 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).

                                    Total Estimated Annualized Burden--Hours
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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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[[Page 21746]]

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2015-08959 Filed 4-17-15; 8:45 am]
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