[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]
[Page 42096-42097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au07-75]
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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 omb@cdc.gov.
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]
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