[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Notices]
[Pages 63404-63405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0773]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to <a href="/cdn-cgi/l/email-protection#8ee1e3ecceedeaeda0e9e1f8"><span class="__cf_email__" data-cfemail="d9b6b4bb99babdbaf7beb6af">[email protected]</span></a>. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 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 (OMB No. 0920-0773, expires 
11/30/2014)--Extension--Division of Tuberculosis Elimination (DTBE), 
National Center for HIV, Viral 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 (MMWR) 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 
(MMWR 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 (MMWR 2010; 59:224-9).
    Reports of SAEs related to RZ and INH have prompted a need for this

[[Page 63405]]

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 or potential revision of guidelines for treatment of persons 
with LTBI.
    On December 9, 2011, CDC published the Recommendations for Use of 
an Isoniazid-Rifapentine Regimen with Direct Observation to Treat 
Latent Mycobacterium tuberculosis Infection in MMWR 2011;60(48);1650-
1653. Isoniazid-Rifapentin (3HP) is a new biweekly 3-month treatment 
regimen for LTBI. Since 2011, there have been 28 reports of SAE; 26 of 
these were associated with 3HP.
    The CDC requests approval for a 3-year extension of the previously 
approved National Surveillance for Severe Adverse Events Associated 
with Treatment of Latent Tuberculosis Infection. 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 MedWatch: The FDA Medical Products 
Reporting Program (OMB#0910-0291, exp. 6/30/2015). CDC is encouraging 
health departments and healthcare providers to report SAEs to FDA. 
Reporting will be conducted through telephone, email, or during CDC 
site visits.
    CDC is requesting approval for approximately 60 burden hours 
annually. The only cost to respondents is time to gather medical 
records and time to complete the reporting form. There are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Physician.............................  NSSAE...................              10               1               1
Nurse.................................  NSSAE...................              10               1               4
Medical Clerk.........................  NSSAE...................              10               1               1
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-25250 Filed 10-22-14; 8:45 am]
BILLING CODE 4163-18-P


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