[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Notices]
[Pages 69372-69373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26319]


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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 [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

    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
                                                 -----------------
    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