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Agency Information Collection Activities; Proposed Collection; Public Comment Request

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Office of the Assistant Secretary for Health, HHS.




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.


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


Submit your comments to or by calling (202) 690-6162.

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Information Collection Clearance staff, or (202) 690-6162.

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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

TitleNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden hours
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent6,00039.331235,980
.115(a) IRB Recordkeeping6,0001510900,000
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting6,0000.545/602,250
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Terry S. Clark,

Asst. Information Collection Clearance Officer.

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[FR Doc. 2015-08959 Filed 4-17-15; 8:45 am]