Between October 2000 and October 2007,
79 patients receiving treatment for Latent TB Infection (LTBI) were
reported to the Division of Tuberculosis Elimination (DTBE),
Centers for Disease Control and Prevention (CDC) with severe
adverse events to their medications (s). A severe adverse event is
defined as a drug-related reaction resulting in hospitalization or
death of a person receiving treatment for LTBI. Deaths reported
among persons with LTBI included, 2 of 50 persons who were on the
recommended two-month regimen of rifampin and pyrazinamide (RZ); 9
of 22 treated with isoniazid alone, and 2 of 3 patients on other
regimens (e.g., pyrazinamide and ethambutol). Severe adverse events
such as hospitalizations, liver transplants, and death related to
treatment of LTBI continue to be reported to DTBE. In order to
determine risk factors and to monitor trends of severe adverse
events related to the treatment of LTBI, CDC requests approval for
information collection through the National Surveillance for Severe
Adverse Events Associated with Treatment of LTBI. These reports are
from healthcare providers and health departments
(local/state/territorial) from any of the 60 reporting areas for
the National TB Surveillance System (NTSS). CDC currently conducts
and maintains NTSS pursuant to the provisions of Section 301 (a) of
the Public Service Act [42 U.S.C. 241] and Section 306 of the
Public Service Act [42 U.S.C. 241 (a)] which also authorizes this
proposed information collection (Attachment 1). In compliance with
the recommendations of the Institute of Medicine (IOM), Ending
Neglect: The Elimination of Tuberculosis in the United States
towards reaching the Healthy People (HP) 2010 objective, CDC is
detecting and treating latent TB infection (LTBI) through targeted
testing and administration of LTBI treatment to prevent
transmission. Persons with LTBI are at highest risk for progression
from latent infection to TB disease. However, with the increased
number of persons with LTBI who will be treated with the
recommended regimen of antibiotics, we anticipate that severe
adverse events will occur more frequently. The purpose of this
information collection request is to determine the annual number
and trends of severe adverse events associated with treatment of
LTBI and identify common characteristics of patients with severe
adverse events during treatment of LTBI. The data will also guide
the revision of the TB treatment protocols in order to prevent
severe adverse events associated with treatment of LTBI. CDC will
use the information to monitor trends in LTBI detection and compile
the nature of severe adverse events to treatment regimens
associating patient characteristics, clinical events and the
treatment regimens that the patient has been required to take. Most
importantly, the presence of HIV infections or HIV-related
treatment regimens will be evaluated closely. The data will be used
to generate trends and analyze associations of the severe reactions
with patient characteristics or concurrent medications. CDC will
use the cumulated data on LTBI treatment and severe adverse events
to convene stakeholders and recommend revisions of current LTBI
treatment regimens based on patient's medical history and the
perceived risk of severe adverse events.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
A7_ConsentForm.doc
A1.Legislation.pdf
Adverse Events to LTBI Treatment (AELT) - Clerk