[Federal Register Volume 72, Number 220 (Thursday, November 15, 2007)]
[Notices]
[Page 64228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-08-05AJ]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 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/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHSTP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    Between October 2000 and October 2007, 79 patients receiving 
treatment for Latent TB Infection (LTBI) were reported to the Division 
of Tuberculosis Elimination (DTBE), Centers for Disease Control and 
Prevention (CDC) with severe adverse events to their medications(s). A 
severe adverse event is defined as a drug-related reaction resulting in 
hospitalization or death of a person receiving treatment for LTBI. 
Deaths reported among persons with LTBI included, 2 of 50 persons who 
were on the recommended two-month regimen of rifampin and pyrazinamide 
(RZ); 9 of 22 treated with isoniazid alone, and 2 of 3 patients on 
other regimens (e.g., pyrazinamide and ethambutol). Severe adverse 
events such as hospitalizations, liver transplants, and death related 
to treatment of LTBI continue to be reported to DTBE.
    The purpose of this information collection request is to determine 
the annual number and trends of severe adverse events associated with 
treatment of LTBI and identify common characteristics of patients with 
severe adverse events during treatment of LTBI. Potential 
correspondents 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 event 
associated with LTBI treatment (AELT). 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 but it does 
not include the disease context and risk factors that are essential for 
revising treatment options for LTBI. Reporting will be conducted 
through telephone, e-mail, or during CDC site visits. There is no cost 
to respondents other than their time to gather medical records to 
complete the form. The total estimated annualized burden hours are 32.

                                           Estimated Annualized Burden
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                                                                                                 Average burden
        Type of respondent               Form name           Number of       Number reponses   per response  (in
                                                            respondents       per respondent         hours)
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Physician........................  AELT................                  4                  1                  3
Nurses...........................  AELT................                  4                  1                  4
Medical Clerk....................  AELT................                  4                  1                  1
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    Dated: November 6, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-22308 Filed 11-14-07; 8:45 am]
BILLING CODE 4163-18-P