[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36066-36067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0773]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send 
an email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. 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 (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 
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

[[Page 36067]]

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
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                                                                     Number of    Average burden
      Type of respondent           Form name        Number  of     responses per   per response    Total  burden
                                                    respondents     respondent      (in hours)         hours
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Physician....................  NSSAE............              10               1               1              10
Nurse........................  NSSAE............              10               1               4              40
Medical Clerk................  NSSAE............              10               1               1              10
                              ----------------------------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............              60
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Leroy 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. 2014-14787 Filed 6-24-14; 8:45 am]
BILLING CODE 4163-18-P