E9-5029. 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: Enhancing Substance Abuse Treatment Services To Address Hepatitis Infection Among Intravenous Drug Users Hepatitis Testing and Vaccine Tracking Form—In Use Without OMB Approval

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT) is requesting an OMB approval of a Hepatitis Testing and Vaccine Tracking Form for the prevention of Viral Hepatitis in patients in designated OTPs. This form is similar to the Minority AIDS Initiative HIV Rapid Testing Clinical Form that received an emergency approval (OMB No. 0930-0295) in September 2008.

This form will allow SAMHSA/CSAT to collect essential Clinical information that will be used for quality assurance, quality performance and product monitoring on approximately 264 Rapid Hepatitis C Test kits and 10,628 doses of hepatitis vaccine (Twinrix, HAV, or HBV). The above kits and vaccines will be provided to designated OTPs serving the minority population in their communities. The information collected on the Form will solicit and reflect the following information:

• Demographics (age, gender, ethnicity) of designated OTP site.
• History (screening) of Hepatitis C exposure.
• Results of Rapid Hepatitis C Testing (Kit) and follow-up information.
• Service provided (type of vaccine given) Divalent vaccine (Twinrix—combination HAV and HBV) or Monovalent vaccine (HAV or/and HBV).
• Substance abuse treatment outcomes (information regarding the beginning, continuing or completion of vaccination series).
• Type of referral services indicated (i.e., Gastroenterology, TB; Mental Health, Counseling, Reproductive/Prenatal, etc.).

This program is authorized under Section 509 of the Public Health Service (PHS) Act [42 U.S.C. 290bb-2].

The purpose of the form is to increase the screening and reporting of viral hepatitis in high risk minorities in OTPs. The information collected will allow SAMHSA to address the increased morbidity and mortality of hepatitis in minorities being treated for drug addiction.

The SAMHSA/CSAT Hepatitis Testing and Vaccine Tracking 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.

The table below reflects the annualized hourly burden.

Number of respondents screened	Responses/ respondent	Burden hours	Total burden hours
50,000	1	0.05	2,500

Written comments and recommendations concerning the proposed information collection should be sent by April 9, 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: February 27, 2009.

Elaine Parry,

Director, Office of Program Services.