E8-17336. Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget

The Substance Abuse and Mental Health Services Administration (SAMHSA) has submitted the following request (see below) for emergency OMB review under the Paperwork Reduction Act (44 U.S.C. Chapter 35). OMB approval has been requested by August 8, 2008. A copy of the information collection plans may be obtained by calling the SAMHSA Reports Clearance Officer on [phone].

Title: Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for American Indians and Alaska Natives at Risk for Substance Use and HIV/AID, (MIA) Rapid HIV Testing Clinical Information Form—NEW.

OMB Number: 0930-New.

Frequency: One-time-only

Affected Public: Tribes, Non-Profit Tribal Organization and Urban Indian Health Centers.

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center Substance Abuse Treatment (CSAT), is requesting an emergency OMB review and approval of the Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for American Indians and Alaska Natives at Risk for Substance Use and HIV/AID, (MIA) Rapid HIV Testing Clinical Information Form. The MAI HIV Rapid Testing Clinical Information Form would allow SAMHSA/CSAT to collect essential clinical information that will be used for quality assurance, quality performance, and product monitoring on approximately 50,000 Rapid HIV Test Kits to be provided to American Indian and Alaska Native (AI/AN) communities at no cost to the recipient provider organizations. This Program is authorized under section 509 of the Public Health Service (PHs) Act [42 U.S.C. 290bb-2] .

The purpose of the MAI is to increase HIV/Screening to American Indians and Alaska Natives at risk for substance use and thus HIV/AIDS in 13 States; build and or strengthen tribes, tribal organizations and urban Indian health centers capacity to provide HIV/AIDS education and prevention services to American Indians and Alaska Natives; reduce the stigma associated with HIV/AIDS screening through outreach and education and increase the number of American Indians and Alaska Natives who know their HIV/AIDS status.

The target population for the initiative is tribes, tribal organizations, and urban Indian organizations that reside in Alaska, Arizona, California, Florida, Michigan, Nevada, New Mexico, New York, North Carolina, Oklahoma, Texas, Utah and Washington who are at risk for substance use and HIV/AIDS. The selected states are those with the highest concentration of AI/AN population based on United States Census 2000. It should be noted that 6 of these states (California, Florida, Nevada, North Carolina, and New York) are also designated Block Grant HIV State-aside states (reported 10 HIV cases per 100,000 to CDC). Additionally, the top five AI/AN AIDS Case states are—California, Oklahoma, Washington, Arizona and Alaska, which also are part of the target population.

Given the history, SAMHSA could not have anticipated the need for the MAI Rapid HIV Testing Clinical Information Form earlier and is requesting an emergency OMB approval. Due to the six month shelf-life of the Rapid HIV Test Kits it is unlikely that SAMHSA will be able to distribute the kits and collect the essential clinical information prior to the expiration of the existing 20,000 Rapid HIV Test Kits without the emergency OMB approval. Emergency OMB approval will make available the immediate distribution of up to 50,000 no cost Rapid HIV Test kits to American Indian and Alaska Native communities. The MAI Rapid HIV Testing Clinical Information Form would support quality of care, provide minimum but adequate clinical and product monitoring, and provide appropriate safeguards against fraud, waste and abuse of Federal funds. SAMHSA's approach would avoid unnecessary delay in informing any person potentially adversely affected by a test kit recall or public health advisory.

The following table is the estimated hour burden:

Number of respondents	Responses/ respondent	Burden hours	Total burden hours
50,000	1	.167	8,350

Written comments and recommendations concerning the proposed information collection should be sent within 30 Days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974.

Date: July 24, 2008.

Christine Chen,

Director, Division of Grants Management.