[Federal Register Volume 72, Number 147 (Wednesday, August 1, 2007)]
[Notices]
[Pages 42096-42097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-07-0026]


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 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
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

    Report of Verified Case of Tuberculosis (RVCT), (OMB No. 0920-
0026)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    In the United States, an estimated 10 to 15 million people are 
infected with Mycobacterium tuberculosis and about 10% of these persons 
will develop tuberculosis (TB) disease at some point in their lives. 
The purpose of this project is to conduct the first major revision 
since 1993 of the national tuberculosis surveillance form, the Report 
of Verified Case of Tuberculosis (RVCT), to capture changes in the 
diagnosis and treatment of TB, and to better monitor trends in TB 
epidemiology and outbreaks, in order to develop strategies to meet the 
national goal of TB elimination.
    CDC currently conducts and maintains the national surveillance 
system pursuant to the provisions of section 301(a) of the Public 
Service Act [42 U.S.C. 241] and section 306 of the Public Service Act 
[42 U.S.C. 241(a)]. Data are collected by 60 reporting areas (the 50 
states, the District of Columbia, New York City, Puerto Rico, and 7 
jurisdictions in the Pacific and Caribbean). In 2001, CDC's Division of 
Tuberculosis Elimination (DTBE) initiated a comprehensive review of the 
RVCT. A work group with nearly 30 members from 15 TB programs, CDC, and 
the National TB Controllers Association (NTCA) convened 26 conference 
calls to consider variable revisions based on surveillance 
significance, ease of data collection, and ability to yield meaningful 
and useful data. The proposed revision further benefited from review by 
TB experts active in research and field services and was pilot-tested 
in two phases. Revisions resulting from stakeholder input include the 
capture of data on verified TB cases who do not meet the national 
surveillance definition since counted by another U.S. area, TB 
treatment was initiated in another country, or TB recurred less than 12 
months after completion of therapy. The year the case was reported and 
the reporting jurisdiction were incorporated into state case 
identification number with fields for linking state case numbers to 
allow better tracking of such cases. New variables reflecting 
diagnostic updates since 1993 include nucleic acid amplification, 
interferon gamma release assay, computerized tomography, and 
genotyping. The dates of tuberculin skin test and of specimen 
collection for other diagnostic tests, along with result dates by 
laboratory type, were added. The primary reason the patient was 
evaluated for TB disease, and reasons for extending TB therapy beyond 
one year were added. Risk characteristics such as diabetes, end-stage 
renal disease, post-organ transplantation, other immunosuppression, 
anti-tumor necrosis factor-alpha therapy, contact with a drug-resistant 
case, contact with an infectious case, missed contacts, incomplete 
treatment for latent TB infection, immigration status for TB screening, 
and parental origin and international background for pediatric cases 
will also be collected. A variable was added to capture whether the TB 
patient moved during treatment and if so, where, with a check box to 
indicate

[[Page 42097]]

transnational referral. Modifications include updates to drug regimens 
and drug susceptibility tests. Date of death and whether TB was a cause 
of death were added to status at diagnosis. Major site and additional 
sites of TB disease were combined to a single question. Smear, 
pathology, or cytology now capture histology results in addition to 
microbiology, and a single field for anatomic specimen code replaced 
two codes for positive specimens. Initial chest radiograph or other 
chest imaging was updated to capture whether an abnormal chest image 
shows a cavity or miliary TB, replacing miliary as a site of disease 
and simplifying check boxes for radiograph as cavitary, consistent with 
TB, stable, worsening, improving, or unknown. Whether patients were 
under custody of Immigration and Customs Enforcement was added to the 
correctional facility variable, and occupation was modified to capture 
the past year, with check boxes to differentiate persons not eligible 
for employment from the unemployed. Type of health care provider was 
clarified with categories of outpatient care. Reasons for culture 
conversion not being documented were incorporated, and adverse 
treatment event and death were added as reasons TB therapy stopped or 
never started. Deletions include removal of: (1) Soundex, a software 
code; (2) a text field to indicate who submitted the RVCT; (3) a check 
box asking whether the case was anergic; (4) CDC AIDS patient number; 
(5) how HIV positive status was determined; (6) a check box for more 
than one additional site of TB disease; and (7) site of directly 
observed therapy. DTBE is currently working with stakeholders and 
software team members towards development and implementation of an 
updated software module for the transition from the current software 
for RVCT data entry and electronic transmission of reports to CDC to 
collection and reporting of revised RVCT data. Following the 
transition, respondents will be able to use either the CDC associated 
TB module or their own TB surveillance application to collect and 
report RVCT data to CDC. CDC publishes an annual report using RVCT data 
to summarize national TB statistics and also periodically conducts 
special analyses for publication to further describe and interpret 
national TB data. These data assist in public health planning, 
evaluation, and resource allocation. Reporting areas also review and 
analyze their RVCT data to monitor local TB trends, evaluate program 
success, and focus resources to eliminate TB. No other Federal agency 
collects this type of national TB data. In addition to providing 
technical assistance on the use of RVCT, CDC provides technical support 
for reporting software. In this request, CDC is requesting approval for 
approximately 8050 burden hours, an estimated increase of 490 hours. 
This increase is due to the addition of information on new clinical 
diagnostic tests and factors to identify high-risk patients. There is 
no cost to respondents other than their time to participate in the 
survey.

                                       Estimate of Annualized Burden Hours
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                                                                    No. of       Average burden
            Types of respondents                 Number of      responses per     per response     Total burden
                                                respondents       respondent       (in hours)       (in hours)
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Local, state, and territorial health                      60              230            35/60             8050
 departments................................
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    Dated: July 26, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-14886 Filed 7-31-07; 8:45 am]
BILLING CODE 4163-18-P