[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Notices]
[Pages 36211-36212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-1186]


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 Information Collection for Tuberculosis Data 
from Referring Entities to CureTB 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 December 23, 2019 to obtain comments from 
the public and affected agencies. CDC did not receive 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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

    Information Collection for Tuberculosis Data from Referring 
Entities to CureTB (OMB Control No. 0920-1186, Exp. 06/30/2020)--
Revision--National Center for Emerging Zoonotic and Infectious Diseases 
(NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CureTB at the Centers for Disease Control and Prevention (CDC) 
works with domestic and international programs to protect the U.S. 
public by preventing tuberculosis (TB) disease transmission 
domestically and internationally, as well as preventing the development 
of drug resistant TB. These goals are accomplished through CureTB 
referral and continuity of care services for mobile TB patients.
    Lack of treatment adherence and inappropriate selection of 
medications are prime reasons for the continued emergence and spread of 
resistant strains of tuberculosis. To combat this, CureTB ensures that 
patients understand how to remain adherent to treatment regimens, 
despite moving between nations. CureTB also provides information to the 
health care team that will be continuing care about each patient's TB 
strain and tailored medication regimen. CureTB gathers demographic and 
clinical information for each patient and connects that individual to 
appropriate clinical care. This information is also provided on a real-
time basis to medical providers and public health authorities in 
receiving nations so that follow-up with the patient can be expedited.
    The respondents are local health departments (LHD) or Immigration 
and Customs Enforcement (ICE) detention centers within the United 
States and foreign national TB programs or healthcare facilities in 
other countries that provide diagnostic and treatment services to 
individuals affected by TB.

[[Page 36212]]

Individual TB patients may also be respondents if critical clinical or 
contact information is missing from their referral and CureTB follows-
up with them to fill-in gaps to complete the referral service. All 50 
US states and territories may refer TB patients to the CureTB program. 
To date, CureTB has also received referrals from Mexico and Guatemala. 
Local health departments or ICE detention facilities will submit CureTB 
referral forms as they request referral services. The number of 
referrals varies widely between respondents.
    To ensure adequate referral to treatment occurs, CDC CureTB may 
need to follow-up with an individual to complete missing data fields 
concerning clinical or contact information. This is done to ensure 
continuity of care. Therefore, individuals with TB are also respondents 
in this information collection. CDC's CureTB program will also continue 
working with our public health partners in notifications and referrals 
for contacts of TB cases. This is a lesser used function of CureTB, but 
burden is included below. These respondents are health departments.
    Finally, CDC staff in the CureTB program also contact the new 
treating physicians to determine patient outcomes using CureTB 
Clinician Public Health Department Follow-up Script. The physicians are 
generally contacted every two months over the course of standard six 
month TB treatment, for a total of three follow-up contacts per 
patient.
    The revision for this information collection includes a small 
number of changes to the CureTB Transnational Notification information 
collection tool for ease of use by the respondents, and adding two 
pieces of additional data important for clinical decision making and 
patient contact. Additionally, CDC is clarifying the specific burden 
attributable to individuals within ICE detention centers by noting this 
in the Estimated Annualized Burden Hours table. Finally, CDC is 
updating the number of respondents and associated burden based on 
program operations over the last 12 months. No other changes are 
proposed.
    OMB approval is requested for three years. Participation in this 
data collection is voluntary. There are no costs to respondents other 
than the time required to complete the referral documents and respond 
to CDC requests for TB patient outcomes. The total estimated annualized 
burden is 1,081 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Local Health Departments (LHD) in the   CureTB Transnational                  70               4           30/60
 United States.                          Notification.
TB patients referred by LHD...........  CureTB Transnational                 187               1            5/60
                                         Notification.
TB patients referred by ICE...........  CureTB Transnational                 587               1           45/60
                                         Notification.
TB treating physicians in new country.  Clinician Public Health              870               3           10/60
                                         Department Follow-up
                                         Script.
LHD in the United States..............  CureTB Contact/Source                 20               5           30/60
                                         Investigation (CI/SI)
                                         Notification.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12806 Filed 6-12-20; 8:45 am]
 BILLING CODE 4163-18-P