E9-14556. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on [phone].

Proposed Project: Rapid HIV Testing Clinical Information Form for the Minority AIDS Initiative (MAI) for Ethnic and Racial Minorities at Risk for Substance Use and HIV/AIDS—Reinstatement

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT), is requesting an OMB review and approval of the Minority AIDS Initiative (MAI) Rapid HIV Testing Clinical Information Form that will be utilized for ethnic and racial minority groups at risk for substance use and HIV/AIDS that are served by CSAT's TCE-HIV grantees. The MAI Rapid HIV 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 30,000 rapid HIV test kits to be provided to ethnic and racial minority communities at no cost to the recipient provider organizations. The MAI Rapid HIV Testing Clinical Information Form would support quality of care, provide 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. This program is authorized under section 509 of the Public Health Service (PHS) Act [42 U.S.C. 290bb-2].

The goals of SAMHSA's MAI initiative are to: (1) Increase the access by racial and ethnic minority communities to HIV testing, prevention, care, and treatment services; (2) implement strategies and activities specifically targeted to the highest risk and hardest-to-serve populations; (3) reduce the stigma associated with HIV/AIDS screening through outreach and education, and (4) establish collaborations or opportunities for programs and/or activities to be integrated.

The target populations for the initiative are African Americans, Hispanic/Latinos, and other racial and ethnic minorities that are disproportionately impacted by the twin epidemics of HIV/AIDS and substance abuse. Since 1981 approximately 1.7 million people are estimated to have been infected with HIV in the U.S., and more than 1.1 million are estimated to be living with HIV/AIDS today. Racial and ethnic minorities have been disproportionately affected by HIV/AIDS, and represent the majority of new AIDS cases (70%), new HIV infections (54%), prevalent HIV/AIDS cases (65%), and AIDS deaths (72%) (CDC, 2006). African Americans have been especially affected by HIV/AIDS. More than half of all new HIV infections and half of new AIDS diagnoses occur in African Americans despite their accounting for approximately 12% of the U.S. population. A similar impact exists among Latinos, who represent 14% of the U.S. population but account for 20% of estimated AIDS diagnoses. Together, Asian/Pacific Islanders and American Indian/Alaska Natives represent 1%-2% of new AIDS diagnoses.

The spread of HIV disease in the United States has been partly fueled by the use of illicit drugs. Injection drug use (IDU) is directly related to HIV transmission through the sharing of drug equipment. According to CDC's latest report on 2006 rates, IDUs accounted for 12 percent of estimated new HIV infections. CDC's historical trend analysis indicates that new infections have declined dramatically in this population over time and confirm the substantial evidence to date of success in reducing HIV infections among IDUs. Despite these declines, rates of HIV and AIDS continue to rise among certain groups including men who have sex with men, high risk heterosexual women and ethnic and racial minority groups due to non-IDU drugs and alcohol that interfere with judgment about sexual and other types of behaviors.

The estimated hour burden is presented in the following table:

Form	Number of respondents	Responses/ respondent	Hours/ response	Total hour burden	Hourly wage cost ($)	Total hour cost ($)
MAI Rapid HIV Testing Clinical Information Form (at Entry)	20,000	1	.133	2,660	30.00	79,800
MAI Rapid HIV Testing Clinical Information Form (second test)	4,000	1	.133	532	30.00	15,960
Total	20,000			3,192		95,760

Written comments and recommendations concerning the proposed information collection should be sent by July 22, 2009 to: SAMHSA Desk Officer, 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.

Dated: June 15, 2009.

Elaine Parry,

Director, Office of Program Services.