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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 April 13, 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—0990-0260, Assistant Secretary for Health, Office for Human Research Protections.

Abstract: Section 491(a) of Public Law 99-158 states that the Secretary of HHS shall by regulation require that each entity applying for HHS support (e.g., a grant, contract, or cooperative agreement) to conduct research involving human subjects submit to HHS assurances satisfactory to the Secretary that it has established an institutional review board (IRB) to review the research in order to ensure protection of the rights and welfare of the human research subjects. IRBs are boards, committees, or groups formally designated by an entity to review, approve, and have continuing oversight of research involving human subjects.

Pursuant to the requirement of the Public Law 99-158, HHS promulgated regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The June 18, 1991 adoption of the common Federal Policy (56 FR 28003) by 15 departments and agencies implements a recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research which was established on November 9, 1974, by Public Law 95-622. The Common Rule is based on HHS regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects.

Need and Proposed Use of the Information: 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 Consent6,00039.3 31235,980
.115(a) IRB Recordkeeping6,0001510900,000
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.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting6,0000.545/602,250

OS specifically requests comments on (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.

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Darius Taylor,

Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary.

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[FR Doc. 2015-02650 Filed 2-9-15; 8:45 am]