[Federal Register: November 15, 2007 (Volume 72, Number 220)]
[Notices]
[Page 64228]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no07-77]
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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 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
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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]
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