[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22072-22074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18KG]


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 ``The EDN 
Tuberculosis Follow-Up Worksheet for Newly-Arrived Persons with 
Overseas Tuberculosis Classifications'' 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 January 31, 2018 to obtain comments from 
the public and affected agencies. CDC received nine comments

[[Page 22073]]

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

    Information Collection for ``The EDN Tuberculosis Follow-Up 
Worksheet for Newly-Arrived Persons with Overseas Tuberculosis 
Classifications''--Existing Collection in Use without an OMB Control 
Number--National Center for Emerging and Zoonotic Infectious Diseases 
(NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Division of Global Migration and Quarantine (DGMQ) collaborated 
closely with several partners, including the U.S. tuberculosis 
coordinators in U.S. health departments, National Tuberculosis 
Controllers Association (NTCA), EDN System workgroup, and the CDC 
Division of Tuberculosis Elimination (DTBE) to develop the proposed 
worksheet to capture follow-up medical examination information after a 
person with tuberculosis classification has arrived in the U.S. The 
overseas medical examination determines whether the applicant has an 
inadmissible condition of public health significance (a Class A 
condition) or has a health-related condition that is admissible but 
that might require extensive medical treatment or follow-up (a Class B 
condition), such as treated tuberculosis. Applicants with Class A 
(inadmissible) conditions can only enter the United States if they are 
granted a waiver. Applicants who have Class A conditions include those 
who (1) have a communicable disease of public health significance, (2) 
do not have documentation of having received vaccinations against 
vaccine-preventable diseases, (3) have a physical or mental disorder 
with associated harmful behavior, or (4) abuse or are addicted to drugs 
(42 U.S.C. 252, 8 U.S.C. 1182, and 8 U.S.C. 1222 provide for the 
physical and mental examination of applicants in accordance with 
regulations prescribed by the HHS Secretary.)\1\ CDC highly recommends 
that persons with overseas class A or B tuberculosis receive domestic 
follow-up medical examination information to prevent new transmission 
of tuberculosis. This is the primary rationale for collecting domestic 
tuberculosis follow-up information.
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    The U.S. foreign-born population continuously had the highest 
incidence of tuberculosis compared to the U.S. non-foreign born 
population. CDC strongly recommends U.S.-bound immigrants and refugees 
with class A or B tuberculosis to receive follow-up examinations for 
tuberculosis in the U.S. The purpose of this data collection is to 
methodically gather tuberculosis follow-up outcome data to monitor and 
track U.S.-bound persons with overseas class A and B tuberculosis to 
assist in the national effort to prevent new transmission of 
tuberculosis. To accurately determine recent U.S. arrivals receiving 
domestic follow-up medical examination information, U.S. health 
departments will provide domestic follow-up outcome information to CDC. 
Without this data, DGMQ will not have a method of tracking and 
monitoring newly-arrived persons with overseas class A or B 
tuberculosis. DGMQ will use information reported on the Tuberculosis 
Follow-Up Worksheet to ensure that tuberculosis programs are 
effectively tracking newly-arrived persons and coordinating follow-up 
medical examination information with local clinicians.
    Several indicators will be calculated to measure domestic 
tuberculosis program performance, including the percentage of aliens 
with class B tuberculosis with complete US medical examinations. This 
program performance monitoring activity will be ongoing throughout the 
year. State and local health departments will voluntarily report 
evaluation outcome findings on a continuous basis once evaluation 
results for an individual becomes available.
    Data collected by DGMQ will be used to help evaluate the efficacy 
and efficiency of overseas tuberculosis diagnosis, treatment, and 
prevention activities along with panel physician performance. 
Currently, DGMQ does not have an effective method of determining the 
accuracy of chest x-rays read overseas and the aptness of overseas 
treatment for tuberculosis. This data will provide DGMQ with a method 
of evaluating panel physician performance and overseas treatment and 
prevention activities. The proposed Worksheet contains sections that 
allow U.S. physicians to review overseas chest x-rays and treatment and 
indicate any concerns or errors. A negative consequence of not 
collecting this information is that DGMQ will not be able to quickly 
analyze data to determine which panel physicians have the most 
inaccuracies. Plans for formal evaluations of US panel physicians are 
contingent upon the approval of the Tuberculosis Follow-Up Worksheet.
    If technical instructions for tuberculosis diagnosis and treatment 
are followed properly overseas, persons with overseas classification B 
tuberculosis should not have tuberculosis disease during their US 
follow-up examinations. The form will help DGMQ understand what factors 
may contribute to a domestic diagnosis of tuberculosis. The Worksheet 
contains a section that collects patient diagnoses and treatment 
recommendations. Without this information, DGMQ staff will not be able 
to accurately identify and resolve factors that contribute to 
tuberculosis disease. This form of monitoring is ongoing and will occur 
with every instance an alien is diagnosed with tuberculosis disease 
during follow-up examinations.
    There are no costs to the respondents other than their time. The 
total estimated annual burden is 13,200 hours.

[[Page 22074]]



                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
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EDN data entry staff at state and    The EDN Tuberculosis Follow-            550              48           30/60
 local health departments.            up Worksheet for Newly-
                                      Arrived Persons With
                                      Overseas Tuberculosis
                                      Classifications.
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Jeffrey Zirger,
Acting 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. 2018-10064 Filed 5-10-18; 8:45 am]
 BILLING CODE 4163-18-P