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Agency Forms Undergoing Paperwork Reduction Act Review

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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 omb@cdc.gov. 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

Type of respondentForm nameNumber of respondentsNumber reponses per respondentAverage burden per response (in hours)
PhysicianAELT413
NursesAELT414
Medical ClerkAELT411
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Dated: November 6, 2007.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.

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[FR Doc. E7-22308 Filed 11-14-07; 8:45 am]

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