[Federal Register: November 29, 2004 (Volume 69, Number 228)]
[Notices]
[Page 69372-69373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no04-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05AJ]
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) 498-1210
or send comments to Sandi Gambescia, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-E11, 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
National Surveillance for Severe Adverse Events (Hospitalization or
Death) Associated with Treatment of Latent Tuberculosis Infection
(LTBI)--New--National Center for HIV, STD, and TB Prevention (NCHSTP),
Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention proposes to collect
data for the National Surveillance for Severe Adverse Events
(Hospitalization or Death) Associated with Treatment of Latent
Tuberculosis Infections. CDC is requesting OMB approval for three years
for this proposed data collection.
As part of the national TB elimination strategy, the American
Thoracic Society and CDC have published recommendations for targeted
testing for TB and treatment for latent TB infection (LTBI). However,
between October 2000 and September 2004, the CDC received reports of 50
patients with severe adverse events associated with the use of the two
or three-month regimen of rifampin and pyrazinamide (RZ) for the
treatment of LTBI; 12 (24%) patients died (Morbidity and Mortality
Weekly Report 2003;52[31]:735-9). A severe adverse event is defined as
hospitalization or death of a person receiving treatment for LTBI. On
the basis of these data, the American Thoracic Society and CDC
recommended that RZ should generally not be offered for treatment of
persons with LTBI, regardless of HIV status. Rifampin and pyrazinamide
should continue to be administered in multidrug regimens for the
treatment of persons with active TB disease.
Reports of severe adverse events related to RZ and other older LTBI
regimens have prompted a need for this project--a national surveillance
system of such events. The objective of the project is to determine the
annual number and temporal trends of severe adverse events
(hospitalization or death) associated with any treatment for LTBI in
the United States. Surveillance of such events will provide data to
support periodic evaluation of guidelines for treatment of persons with
LTBI and revision, as needed.
This project will set up a passive reporting system for severe
adverse events (death or hospitalization) to therapy for LTBI. The
system will rely on medical chart review of already existing data by TB
control staff.
Potential respondents are any of the 60 reporting areas for the
national TB surveillance system (the 50 states, the District of
Columbia, New York City, and 8 jurisdictions in the Pacific and
Caribbean). Data will be collected using the data collection form for
adverse events associated with LTBI treatment (AELT). Based on previous
reporting, CDC anticipates receiving an average of 12 responses per
year from the 60 reporting areas. The AELT form will be completed for
each reported hospitalization or death related to treatment of LTBI and
contains demographic, clinical, and laboratory information. CDC will
analyze and periodically publish reports summarizing national LTBI
treatment adverse events statistics and also will conduct special
analyses for publication in peer-reviewed scientific journals to
further describe and interpret these data.
The Food and Drug Administration (FDA) collects data on adverse
events related to drugs through the FDA MedWatch Program. CDC is
planning to collaborate with FDA in developing the national
surveillance system for adverse events associated with LTBI. Reporting
will be conducted through telephone, e-mail, or during CDC site visits.
The only cost to respondents is their time to complete the form.
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Average burden
Respondents Number of Responses per per response Total burden
respondents respondent (in hours) (in hours)
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Health Departments.............................. 12 1 1 12
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Total....................................... .............. .............. .............. 12
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[[Page 69373]]
Dated: November 19, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-26319 Filed 11-26-04; 8:45 am]
BILLING CODE 4163-18-P