[Federal Register: December 14, 2006 (Volume 71, Number 240)]
[Notices]
[Page 75256-75257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de06-63]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-05AJ]
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 omb@cdc.gov.
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
[[Page 75257]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (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.
[FR Doc. E6-21269 Filed 12-13-06; 8:45 am]
BILLING CODE 4163-18-P