[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5103-5104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0773]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled National Surveillance for Severe Adverse 
Events Among Persons on Treatment of Latent Tuberculosis Infection to 
the Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on August 22, 2017 to obtain 
comments from the public and affected agencies. CDC received one 
substantive comments related to the previous notice. This notice serves 
to allow an additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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 [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    National Surveillance for Severe Adverse Events Associated with 
Treatment of Latent Tuberculosis Infection--(0920-0773, expiration 01/
31/2018)--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

    This project seeks a three-year extension to continue the passive 
reporting system for severe adverse events (SAEs) associated with 
therapy for Latent Tuberculosis Infection (LTBI). The system will rely 
on medical chart review and/or onsite investigations by TB control 
staff. 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. 
Reports of SAEs related to rifampicin plus pyrazinamide (RZ) and 
isoniazid (INH) 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.
    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. 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. Reporting of SAEs will be conducted through telephone, 
email, or during CDC site visits.

[[Page 5104]]

    CDC will analyze and periodically publish reports summarizing 
national LTBI treatment adverse events statistics and will conduct 
special analyses for publication in peer-reviewed scientific journals 
to further describe and interpret these data.
    In this extension request, CDC is requesting approval for 
approximately 60 burden hours annually. There is no cost to 
respondents.

Estimated Annualized Burden Hours

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                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                    Form name            respondents    responses per   response  (in
                                                                                    respondent        hours)
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Physician...........................  NSSAE.....................              10               1               1
Nurse...............................  NSSAE.....................              10               1               4
Medical Clerk.......................  NSSAE.....................              10               1               1
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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. 2018-02206 Filed 2-2-18; 8:45 am]
 BILLING CODE 4163-18-P