[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Pages 65553-65554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-12MW]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS D74, 
Atlanta, GA 30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is 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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Hepatitis Testing and Linkage to Care Monitoring & Evaluation 
System--New-National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention is 
requesting a three-year OMB approval for establishing a Hepatitis 
Testing and Linkage to Care (HEPTLC) Monitoring and Evaluation System 
to collect standardized, non-identifying, client-level and test-level 
hepatitis testing information from funded testing sites at multiple 
settings. Grantees will be required to use this web-based HEPTLC 
software application to collect and report testing and linkage to care 
activities.
    The HEPTLC data collection and reporting system will enable CDC to 
receive standardized, non-identifying information from funded grantees, 
including: (1) Information about test sites that provide HEPTLC 
services and laboratories that provide lab testing; (2) Information 
about testing participants, including demographics, risk 
characteristics, vaccination history, etc. (3) Information related to 
diagnostic test results; and (4)Information about post-test follow-ups, 
including notification of test result, post-test-counseling, linkage to 
care and preventive services, and case report to surveillance 
authorities. CDC will use HEPTLC data for the following purposes: (1) 
Monitor the implementation activities of the HEPTLC initiative, as well 
as evaluate the progress and performance made by the grantees. Findings 
will further inform strategic planning and program improvement; (2) 
Inform recommendations and strategies of increasing early 
identification of infected persons and linkage to care, based on 
participant characteristics and linkage to care among those persons who 
are infected; (3) Identify best practices and gaps in implementing 
HEPTLC in various testing settings, and guide CDC in providing 
technical assistance to the grantees; (4) Produce standardized and 
specialized reports that will inform grantees, CDC Project Officers, 
HHS, Congress and other stakeholders of the process, outcome and 
accountability measures; (5)Assess public health prevention funds and 
resources allocations with respect to prioritized risk populations; (6) 
Advocate the needs for priority setting and budget allocation for 
hepatitis prevention.
    Funded sites will use HEPTLC data for the following purposes: (1) 
Understand targeted populations (demographics, risk behaviors, 
vaccination histories, etc) and assess the

[[Page 65554]]

extent to which the targeted populations have been reached; (2) 
Document how well the project is progressing in meeting goals/
objectives set forth by CDC (e.g. who delivered what to whom, how many, 
where, when, and how well), as well as performance indicators related 
to testing, counseling and linkage to care; (3) Highlight opportunities 
for local program collaboration and service integration (PCSI) to 
prevent hepatitis: (4)Fulfill data collection and reporting 
requirements outlined in the cooperative agreements.
    The data will enable CDC to be accountable for the funding it 
provides, the populations that are served, the services being provided, 
and for the strategies and practices effectiveness in implementing 
HEPTLC. The data will also enable CDC to be accountable to the 
administration, Congress, or other stakeholders for the proper use of 
public money or provide transparency for the programs it funds.
    Respondents will be testing sites at multiple settings, including 
health departments, community based organizations (CBOs), community 
health centers (CHCs), person who inject drugs (PWID) treatment 
centers, and other settings, e.g. HIV or STD clinics, Federally 
Qualified Health Centers (FQHCs). They will routinely collect, enter, 
and report information about the test site, client demographics and 
behaviors, testing results and linkage to care follow up information 
within the web-based HEPTLC system. CDC anticipates that routine 
information collection will begin once OMB approval is received and 
will be carried out through the project period September 2012-September 
2013.
    There are no costs to respondents other than their time. The total 
estimated annual burden hours are 6000.

                                        Estimated Annualized Burden Hours
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                                                                                                  Average burden
         Type of respondents                   Form name            Number of     Responses per    per response
                                                                   respondents     respondent       (in hours)
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HBV--CBOs/Health Jurisdictions.......  HEPTLC Data Variables &               40              12             12
HCV--multiple sites (IDU, CHCs,         Values (test-level
 Others, ECHO).                         monthly reporting).
HBV--CBOs/Health Jurisdictions.......  HEPTLC Template (program-             40               4              1.5
HCV--multiple sites (IDU, CHCs,         level reporting/
 Others, ECHO).                         quarterly).
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    Dated: October 22, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-26498 Filed 10-26-12; 8:45 am]
BILLING CODE 4163-18-P