[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40052-40054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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