[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63924-63925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-12-0773]


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

[[Page 63925]]

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) 395-5806. 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 (NSSAE)--Reinstatement with 
change--Division of Tuberculosis Elimination (DTBE), National Center 
for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Between October 2000 and September 2004, the CDC received reports 
of 50 patients with severe adverse events (SAEs) 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). In 2004, CDC began 
collecting reports of SAEs associated with any treatment regimen for 
LTBI. For surveillance purposes, an SAE was defined as any drug-
associated reaction resulting in a patient's hospitalization or death 
after at least one treatment dose for LTBI. During 2004-2008, CDC 
received 17 reports of SAEs in 15 adults and two children; all patients 
had received isoniazid (INH) and had experienced severe liver injury 
(Morbidity and Mortality Weekly Report 2010; 59:224-9).
    The CDC requests approval for a 3-year reinstatement with change of 
the previously approved National Surveillance for Severe Adverse Events 
Associated with Treatment of Latent Tuberculosis Infection (OMB No. 
0920-0773, expired April 31, 2011). The changes include a shortened 
data collection form and an increase in the number of respondents. This 
project will continue the passive reporting system for SAEs associated 
with therapy for LTBI. The system will rely on medical chart review 
and/or onsite investigations by TB control staff.
    The purpose of this information collection request is to determine 
the annual number and trends of SAEs associated with treatment of LTBI 
and identify common characteristics of patients with SAEs 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 7 jurisdictions 
in the Pacific and Caribbean). Data will be collected using the data 
collection form for adverse event associated with LTBI treatment 
(NSSAE). The NSSAE 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 
collaborating with FDA in the reporting of SAEs. Reporting will be 
conducted through telephone, e-mail, or during CDC site visits. In this 
request, CDC is requesting approval for approximately 60 burden hours 
annually, an estimated increase of 36 hours from the previously 
approved 24 hours. This is due to an estimated increase of reports of 
SAEs after the publication of the MMWR report on SAEs in 2010. There 
are no costs to respondents other than their time to gather medical 
records to complete the reporting form.

                                       Estimate of Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
                       Type of respondents                          respondents    responses per   response  (in
                                                                                    respondent        hours)
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Physicians......................................................              10               1               1
Nurses..........................................................              10               1               4
Medical Clerk...................................................              10               1               1
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    Dated: October 7, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-26595 Filed 10-13-11; 8:45 am]
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