69372
Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Notices
Rifampin and pyrazinamide should
Atlanta, GA 30333 or send an e-mail to
Guam
continue to be administered in
omb@cdc.gov.
Agana Power Plant--(PB2004100066).
Comments are invited on: (a) Whether
multidrug regimens for the treatment of
Illinois
the proposed collection of information
persons with active TB disease.
is necessary for the proper performance
Reports of severe adverse events
Bordner Manufacturing Company--
of the functions of the agency, including
related to RZ and other older LTBI
(PB2005100067).
whether the information shall have
regimens have prompted a need for this
Northern Mariana Islands,
practical utility; (b) the accuracy of the
project--a national surveillance system
Commonwealth of the
agency's estimate of the burden of the
of such events. The objective of the
proposed collection of information; (c)
Saipan Capacitors [a/k/a Tanapag
project is to determine the annual
ways to enhance the quality, utility, and
Village (Saipan)]--(PB2005100063).
number and temporal trends of severe
clarity of the information to be
adverse events (hospitalization or death)
Ohio
collected; and (d) ways to minimize the
associated with any treatment for LTBI
burden of the collection of information
Gentile Air Force Station (a/k/a USDOD
in the United States. Surveillance of
on respondents, including through the
Defense Electronics Supply Center)--
such events will provide data to support
use of automated collection techniques
(PB2004107098).
periodic evaluation of guidelines for
or other forms of information
treatment of persons with LTBI and
Tennessee
technology. Written comments should
revision, as needed.
be received within 60 days of this
This project will set up a passive
(PB2005100065).
notice.
reporting system for severe adverse
events (death or hospitalization) to
Texas
Proposed Project
therapy for LTBI. The system will rely
National Surveillance for Severe
Kelly Air Force Base--(PB2004
on medical chart review of already
Adverse Events (Hospitalization or
106801).
existing data by TB control staff.
Death) Associated with Treatment of
Dated: November 19, 2004.
Potential respondents are any of the
Latent Tuberculosis Infection (LTBI)--
Georgi Jones,
60 reporting areas for the national TB
New--National Center for HIV, STD,
Director, Office of Policy, Planning, and
surveillance system (the 50 states, the
and TB Prevention (NCHSTP), Centers
Evaluation, National Center for
District of Columbia, New York City,
for Disease Control and Prevention
Environmental Health, Agency for Toxic
and 8 jurisdictions in the Pacific and
(CDC).
Substances and Disease Registry.
Caribbean). Data will be collected using
The Centers for Disease Control and
[FR Doc. 0426318 Filed 112604; 8:45 am]
the data collection form for adverse
Prevention proposes to collect data for
BILLING CODE 416370P
events associated with LTBI treatment
the National Surveillance for Severe
(AELT). Based on previous reporting,
Adverse Events (Hospitalization or
CDC anticipates receiving an average of
Death) Associated with Treatment of
DEPARTMENT OF HEALTH AND
12 responses per year from the 60
Latent Tuberculosis Infections. CDC is
HUMAN SERVICES
reporting areas. The AELT form will be
requesting OMB approval for three years
completed for each reported
for this proposed data collection.
Centers for Disease Control and
hospitalization or death related to
As part of the national TB elimination
Prevention
treatment of LTBI and contains
strategy, the American Thoracic Society
[60Day05AJ]
demographic, clinical, and laboratory
and CDC have published
information. CDC will analyze and
recommendations for targeted testing for
Proposed Data Collections Submitted
periodically publish reports
TB and treatment for latent TB infection
for Public Comment and
summarizing national LTBI treatment
(LTBI). However, between October 2000
Recommendations
adverse events statistics and also will
and September 2004, the CDC received
conduct special analyses for publication
reports of 50 patients with severe
In compliance with the requirement
in peer-reviewed scientific journals to
adverse events associated with the use
of Section 3506(c)(2)(A) of the
further describe and interpret these
of the two or three-month regimen of
Paperwork Reduction Act of 1995 for
data.
rifampin and pyrazinamide (RZ) for the
opportunity for public comment on
The Food and Drug Administration
treatment of LTBI; 12 (24%) patients
proposed data collection projects, the
(FDA) collects data on adverse events
died (Morbidity and Mortality Weekly
Centers for Disease Control and
related to drugs through the FDA
Report 2003;52[31]:7359). A severe
Prevention (CDC) will publish periodic
MedWatch Program. CDC is planning to
adverse event is defined as
summaries of proposed projects. To
collaborate with FDA in developing the
hospitalization or death of a person
request more information on the
national surveillance system for adverse
receiving treatment for LTBI. On the
proposed projects or to obtain a copy of
events associated with LTBI. Reporting
basis of these data, the American
the data collection plans and
will be conducted through telephone, e-
Thoracic Society and CDC
instruments, call (404) 4981210 or
mail, or during CDC site visits. The only
recommended that RZ should generally
send comments to Sandi Gambescia,
cost to respondents is their time to
not be offered for treatment of persons
CDC Assistant Reports Clearance
complete the form.
with LTBI, regardless of HIV status.
Officer, 1600 Clifton Road, MSE11,
Average bur-
Responses
Number of
den per
Total burden
Respondents
per
respondents
response
(in hours)
respondent
(in hours)
Health Departments .........................................................................................
12
1
1
12
Total ..........................................................................................................
........................
........................
........................
12
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