05-10004. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Office of the Secretary.

In compliance with the requirement of section 3506(c)(2)(A) 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 proposed collections for public comment. 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.

#1 Type of Information Collection Request: Extension of Currently Approved Collection;

Title of Information Collection: Protection of Human Subjects Assurance Identification/ Institutional Review Board (IRB) Certification/Declaration of Exemption;

Form/OMB No.: OS-0990-0263;

Use: The Federal Policy for the Protection of Human Subjects, known as the Common Rule, requires that before engaging in non-exempt human subjects research that is conducted or supported by a Common Rule department or agency, each institution must: (1) Hold an applicable assurance of compliance [Section 103(a)]; and (2) certify to the awarding department or agency that the application or proposal for research has been reviewed and approved by an IRB designated in the assurance [Sections 103(b) and (f)].

Frequency: Reporting on occasion;

Affected Public: Federal, State, local, or tribal governments, business or other for-profit, not-for-profit institutions and individuals or households;

Annual Number of Respondents: 5,000; Total Annual Responses: 166,667;

Average Burden per Response: 0.25 hours;

Total Annual Hours: 41,667;

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access the HHS Web site address at http://www.hhs.gov/​oirm/​infocollect/​pending/​ or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to [e-mail], or call the Reports Clearance Office on [phone]. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the OS Paperwork Clearance Officer designated at the following address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Budget, Technology, and Finance, Office of Information and Resource Management, Attention: Naomi Cook (0990-0263), Room 531-H, 200 Independence Avenue, SW., Washington, DC 20201.

Dated: May 11, 2005.

Robert E. Polson,

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