[Federal Register Volume 73, Number 216 (Thursday, November 6, 2008)]
[Notices]
[Page 66054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 276-1243.
    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.

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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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    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 [email protected]. Written comments should be 
received within 60 days of this notice.

    Dated: October 30, 2008.
Elaine Parry,
Acting Director, Office of Program Services.
 [FR Doc. E8-26471 Filed 11-5-08; 8:45 am]
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