[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Notices]
[Page 10260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 276-1243.

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:
    <bullet> Demographics (age, gender, ethnicity) of designated OTP 
site.
    <bullet> History (screening) of Hepatitis C exposure.
    <bullet> Results of Rapid Hepatitis C Testing (Kit) and follow-up 
information.
    <bullet> Service provided (type of vaccine given) Divalent vaccine 
(Twinrix--combination HAV and HBV) or Monovalent vaccine (HAV or/and 
HBV).
    <bullet> Substance abuse treatment outcomes (information regarding 
the beginning, continuing or completion of vaccination series).
    <bullet> 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.

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                                                                  Responses/                       Total burden
                Number of respondents screened                    respondent      Burden hours        hours
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50,000.......................................................               1             0.05            2,500
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    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.
[FR Doc. E9-5029 Filed 3-9-09; 8:45 am]
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