E6-21269. 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 [e-mail].

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 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

Type of respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Physicians	3	1	3	9
Nurses	3	1	4	12
Medical Clerk	3	1	1	3
Total				24

Dated: December 8, 2006.

Joan F. Karr,

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