Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Office of the Secretary, HHS.

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: Existing collection in use without OMB Control Number;

Title of Information Collection: Federal wide Assurance (FWA)

Form/OMB No.: OS-0990-;

Use: The FWA is designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of Section 491(a) of the Public Health Service Act and of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents are institutions engaged in human subjects research conducted or supported by HHS.

Frequency: On occasion, Reporting;

Affected Public: Individuals or households, business or other for-profit, Not-for-profit institutions, Federal, State, local, or tribal governments;

Annual Number of Respondents 15,000;

Total Annual Responses: 30,000;

Average Burden Per Response: 2 hours;

Total Annual Hours: 22,500;

#2 Type of Information Collection Request: Existing collection in use without an OMB control number;

Title of Information Collection: Institutional Review Board/Independent Ethics Committee Registration Form

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

Use: The Institutional Review Board (IRB)/Independent Ethics committee (IEC) Registration Forms designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of Section 491(a) of the Public Health Service Act and of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents are IRBs or IECs designed by an Institution under an assurance of compliance approved for federal wide use by the Office for Human Research Protections (OHRP), under HHS protection of human subjects regulations at 45 CFR 46.103(a), and that review human subjects research conducted or supported by HHS.

Frequency: On occasion, Reporting;

Affected Public: Individuals or households, business or other for-profit, Not-for-profit institutions, Federal, State, local, or tribal governments;

Annual Number of Respondents: 5,000;

Total Annual Responses: 5,000;

Average Burden Per Response: 2 hours;

Total Annual Hours: 3,500;

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 Naomi.Cook@hhs.gov. or call the Reports Clearance Office on (202) 690-6162. Written comments and recommendations for the proposed information collections must be mailed within 30 days of this notice directly to the OMB Desk Officer at the address below:

OMB Desk Officer: John Kraemer. OMB Human Resources and Housing Branch, Attention: (OMB #0990-NEW), New Executive Office Building, Room 10235, Washington DC 20503.