E8-26471. Agency Information Collection Activities: Proposed Collection; Comment Request

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on [phone].

Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

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 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

Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her a copy at [e-mail]. Written comments should be received within 60 days of this notice.

Dated: October 30, 2008.

Elaine Parry,

Acting Director, Office of Program Services.