Notice2021-15793
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 26, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 140 (Monday, July 26, 2021)</title>
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[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40052-40054]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-1238]
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 ``US Tuberculosis Follow-Up Worksheet for
Newly-Arrived Persons with Overseas Tuberculosis Classifications,''
also commonly known as a ``TB Follow-Up Worksheet'' 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 03/09/2021 to obtain comments from the
public and affected agencies. CDC received one comment 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
The US Tuberculosis Follow-Up Worksheet for Newly-Arrived Persons
with Overseas Tuberculosis Classifications (OMB Control No. 0920-1238,
Exp. 06/30/2021)--Reinstatement with Change--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
with the Division of TB Elimination (DTBE) to revise the proposed
worksheet to capture follow-up medical examination information after a
person with tuberculosis classification has arrived in
[[Page 40053]]
the US. 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 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). 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.
The US foreign-born population continuously had the highest
incidence of tuberculosis compared to the US non-foreign-born
population. According to CDC, the 2019 TB case rate was 14.2 per
100,000 for foreign-born persons compared to 0.9 per 100,000 for US-
born persons. The proportion of TB cases occurring in the foreign-born
population was found to be approximately 70.9% of the national case
total. CDC strongly recommends US-bound immigrants and refugees with
class A or B tuberculosis to receive follow-up examinations for
tuberculosis in the US.
The purpose of this data collection is to methodically gather
tuberculosis follow-up outcome data to monitor and track US-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 US arrivals receiving domestic follow-up
medical examinations, US health departments will provide domestic
follow-up outcome information to CDC by completing The EDN Tuberculosis
Follow-Up Worksheet for Newly-Arrived Persons with Overseas
Tuberculosis Classifications, also commonly known as the TB Follow-Up
Worksheet. 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 TB Follow-Up
Worksheet to ensure that tuberculosis programs are effectively tracking
newly-arrived persons and coordinating follow-up medical examinations
with state and local clinicians in the US.
Since the previous approval of the ``US Tuberculosis Follow-Up
Worksheet for Newly-Arrived Persons with Overseas Tuberculosis
Classifications'' data collection instrument in 2018, there have been
changes made in the data collection instrument to clarify wording, add
additional options for respondents to select, and enhance data
collection quality. There are also clarifications made in the ``Purpose
and Use of Information Collection'' in Supporting Statement A to
further clarify information what the data collection instrument
collects. In the ``Respondent Universe and Sampling Methods'' section
of Supporting Statement B, there are clarifications made to explain how
respondents gain access to and use the Electronic Disease Notification
(EDN) system and the data collection instrument. There is an increase
from 550 respondents to 1548 respondents due to the increase in the
number of individuals throughout the United States requesting access to
the EDN system to access medical records for U.S. arrivals, and
complete the EDN Tuberculosis Follow-Up Worksheet for Newly-Arrived
Persons with Overseas Tuberculosis Classifications for U.S. arrivals
with TB classifications. There is no change to the burden per
respondent to complete a follow-up form.
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 diagnoses, treatments, 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 TB Follow-Up Worksheet contains
sections that allow US 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
efficiently 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 TB 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 TB Follow-
up 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 are 2,322 hours.
[[Page 40054]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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EDN data entry staff at state and US Tuberculosis Follow- 1,548 3 30/60
local health departments. up Worksheet for Newly-
Arrived Persons with
Overseas Tuberculosis
Classifications.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-15793 Filed 7-23-21; 8:45 am]
BILLING CODE 4163-18-P
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