[Federal Register Volume 71, Number 240 (Thursday, December 14, 2006)]
[Notices]
[Pages 75256-75257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-07-05AJ]


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 404-639-5960 
and send comments to Seleda Perryman, CDC Assistant 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

    National Surveillance for Severe Adverse Events Associated with 
Treatment of Latent Tuberculosis Infection--New--Division of 
Tuberculosis Elimination (DTBE), National Center for HIV, STD, and TB 
Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    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

[[Page 75257]]

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 three year 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, Puerto Rico, 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 3 responses per year from the 60 reporting areas. The AELT 
form is 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 treatment for 
LTBI. Reporting will be conducted through telephone, e-mail, or during 
CDC site visits. The only cost to respondents is their time to gather 
medical records to complete the form.

                                       Estimate of Annualized Burden Hours
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                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Physicians......................................               3               1               3               9
Nurses..........................................               3               1               4              12
Medical Clerk...................................               3               1               1               3
                                                                                                 ---------------
    Total.......................................  ..............  ..............  ..............              24
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    Dated: December 8, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-21269 Filed 12-13-06; 8:45 am]
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