[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39787-39788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0773; Docket No. CDC-2017-0061]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, 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. This notice invites comments on the information 
collection extension request titled ``Adverse Events among Persons on 
Treatment of Latent Tuberculosis Infection.''

DATES: Written comments must be received on or before October 23, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0061 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comments should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
<a href="/cdn-cgi/l/email-protection#86e9ebe4c6e5e2e5a8e1e9f0"><span class="__cf_email__" data-cfemail="3956545b795a5d5a175e564f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C.3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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, 
Information Collection Request Procedures Manual 33 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.

Proposed Project

    National Surveillance for Severe Adverse Events among Persons on 
Treatment of Latent Tuberculosis Infection--(OMB Control No. 0920-0773, 
expires 01/17/2018)--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

    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 
among persons on 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 2004-2016, CDC 
received 66 reports of SAEs among recipients of isoniazid (INH)-only 
(n=44), INH-rifapentine (RPT) (n=20), rifampin (RIF) (n=1) and INH/
Levofloxacin (n=1) for LTBI. Among INH-only recipients, seven died; 
five, including one child, underwent liver transplantation. Among INH-
RPT, RIF, and INH/Levofloxacin recipients, length of hospitalization 
ranged 1-20 (median: 3) days; no liver transplants or deaths were 
reported. The RIF recipient had an acute kidney injury but recovered 
after three hemodialysis treatments [Severe Adverse Events 
(Hospitalization or Death) Among Persons on Treatment for Latent 
Tuberculosis Infection, United States, January 2004-December 2016. 
Presented at the NAR/IUATLD Conference, Vancouver, Canada, February 
2017]. Ten of the SAEs were published in Powell, K, et al. Severe 
Isoniazid-associated Liver Injuries among Persons Being Treated for 
Latent Tuberculosis Infection-United States, 2004-2008. MMWR 2010; 
59:224-9.
    Reports of SAEs related to LTBI treatment regimens have prompted a 
need for this project--a national

[[Page 39788]]

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.
    The CDC seeks to request OMB approval for a three-year extension of 
the previously approved National Surveillance for Severe Adverse Events 
Associated with Treatment of Latent Tuberculosis Infection--(OMB No. 
0920-0773, expires January 17, 2018). 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).
    CDC will collect data using the data collection form for SAEs 
associated with LTBI treatment. Based on previous reporting, CDC 
anticipates receiving an average of six 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 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 FDA MedWatch Program. 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.
    In this request, CDC is requesting approval for approximately 36 
burden hours annually. The only cost to respondents is time to gather 
medical records and time to complete the reporting form.

                                        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...........               6               1               1               6
Nurse.........................  NSSAE...........               6               1               4              24
Medical Clerk.................  NSSAE...........               6               1               1               6
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              36
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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. 2017-17708 Filed 8-21-17; 8:45 am]
 BILLING CODE 4163-18-P


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