[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]
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