[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22399-22400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9671]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-0773]
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 Daniel Holcomb, CDC Reports Clearance Officer,
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to
[email protected].
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--(0920-0773 exp. 04/31/
2011)--Reinstatement with change--Division of Tuberculosis Elimination
(DTBE), National Center for HIV, Viral
[[Page 22400]]
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
As part of the national tuberculosis (TB) elimination strategy, the
American Thoracic Society and CDC have published recommendations for
targeted testing for TB and treatment for latent TB infection
(LTBI)(Morbidity and Mortality Weekly Report 2000;49[RR06];1-54).
However, 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).
Reports of SAEs related to RZ and INH have prompted a need for this
project--a national surveillance system of such events. The objective
of the project is to determine the annual number and temporal trends of
SAEs 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.
The Centers for Disease Control and Prevention request 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, expires 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.
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 7 jurisdictions in the
Pacific and Caribbean). Data will be collected using the data
collection form for SAEs associated with LTBI treatment. Based on
previous reporting, CDC anticipates receiving an average of 10
responses per year from the 60 reporting areas. The data collection
form is completed by healthcare providers and health departments 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. 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.
Estimate of Annualized Burden Table
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Average
Number of Number of burden per Total burden
Type of respondents respondents responses per response (in (in hours)
respondent hours)
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Physicians...................................... 10 1 1 10
Nurses.......................................... 10 1 4 40
Medical Clerk................................... 10 1 1 10
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Total....................................... .............. .............. .............. 60
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Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-9671 Filed 4-20-11; 8:45 am]
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