2012-15414. 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].

Project: Enhancing Substance Abuse Treatment Services To Address Hepatitis Infection Among Intravenous Drug Users Hepatitis Testing and Vaccine Tracking Form (OMB No. 0930-0300)—Reinstatement and Extension

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center Substance Abuse Treatment (CSAT), is responsible for the Hepatitis Testing and Vaccine Tracking Form for the prevention of Viral Hepatitis in patients in designated Opioid Treatment Programs (OTPs). There are no changes to the form or added burden.

This form allows 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 solicits 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 and/or 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 form increases the screening and reporting of viral hepatitis in high risk minorities in OTPs. The information collected allows 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 supports 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 July 25, 2012 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: [e-mail]. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503.

Summer King,

Statistician.