[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71279-71280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-1102]


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 Panel Physicians'' 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 June 4, 2024 to obtain comments from the public and affected 
agencies. CDC received two 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 Panel Physicians 
(OMB Control No. 0920-1102, Exp. 12/31/2024)--Revision--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention's (CDC), National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division 
of Global Migration Health (DGMH), Immigrant and Refugee Health Branch 
(IRHB), requests approval for Revision to an approved information 
collection. CDC requests this data collection approval for three years.
    Respondents for this data collection request are U.S. panel 
physicians. Panel physicians are medically trained, licensed, and 
experienced medical doctors practicing overseas who are appointed by 
the local U.S. Embassy or Consulate General to perform medical 
examinations for prospective immigrants to the United States. More than 
760 panel physicians perform overseas pre-departure medical 
examinations at 333 panel sites, in accordance with requirements, 
referred to as Technical Instructions, provided by the CDC's DGMH, 
Quality Assessment Program (QAP). The QAP is housed in the IRHB. The 
role of QAP is to assist and guide panel physicians in the 
implementation of the Technical Instructions; evaluate the quality of 
the overseas medical examination for U.S.-bound immigrants and 
refugees; assess potential panel physician sites; and provide 
recommendations to the U.S. Department of State in matters of immigrant 
medical screening.
    Screening for tuberculosis (TB) is a particularly important 
component of the immigration medical exam and allows panel physicians 
to diagnose active TB disease prior to arrival in the United States. As 
part of the Technical Instructions requirements, panel physicians 
perform chest x-rays and laboratory tests that aid in the 
identification of tuberculosis infection (Class B1 applicants) and 
diagnosis of active tuberculosis disease (Class A, inadmissible 
applicants). CDC uses these classifications to report new immigrant and 
refugee arrivals with a higher risk of developing TB disease to U.S. 
state and local health departments for further follow-up. Some 
information that panel physicians collect as part of the medical exam 
is not reported on the standard Department of State forms (DS-forms), 
thereby preventing CDC from evaluating TB trends in globally mobile 
populations and monitoring program effectiveness.
    In 2007, CDC revised the Tuberculosis Technical Instructions to 
include several new requirements for Mycobacteria tuberculosis (MTB) 
testing and treatment. Important changes included the requirements for: 
(1) sputum cultures in addition to sputum smears; (2) tuberculin skin 
tests or interferon gamma release assays (beginning in 2009) for 
certain children aged 2-14 years examined in countries where the World 
Health Organization (WHO) estimated TB incidence is >=20 per 100,000 
persons; (3) drug-susceptibility testing of positive isolates; and (4) 
treatment being delivered as directly observed therapy (DOT) throughout 
the entire course.
    Since implementation of these new Culture and Directly Observed 
Therapy TB Technical Instructions (CDOT TB TI), overseas TB case 
detection has increased by an estimated 60% and allowed U.S. public 
health programs to save millions of dollars annually. Overseas TB 
screening data (referred to by DGMH as `TB Indicator data') is critical 
to support the continued analysis of these trends and the monitoring of 
TB control efforts in the U.S. DGMH's TB Indicator data provides 
valuable epidemiologic data on globally mobile populations and allows 
CDC to monitor the effectiveness and impact of CDC's Technical 
Instructions in diagnosing applicants with TB disease. This data will 
be used to:
    [cir] Improve quality assurance efforts and monitor proficiency of 
TB screening programs overseas
    [cir] Estimate the impact of the CDOT TB TI on the immigrant 
screening program by analyzing the number of smear negative/culture 
positive TB

[[Page 71280]]

cases. These cases represent the number of TB cases that would have 
been missed under the old screening program.
    [cir] Compare TB Indicator incidence rates to WHO country-specific 
TB incidence rates for internal quality assessment purposes only.
    [cir] Detect and resolve problems at panel sites demonstrating 
lower than expected TB detection rates.
    Data will primarily be used internally to monitor program impact, 
but may also be shared with state and local health authorities involved 
in TB control. Information dissemination may include abstract 
submission to scientific conferences, including the Union World 
Conference on Lung Health, the National TB Controllers Association and 
the Panel Physician Training Summits.
    Information will be collected from each Panel Physician site using 
a web form created with REDCap on an annual basis. The TB-related 
information that is sent to CDC is aggregate in nature, and no personal 
identifying information (PII) from any applicant for U.S. immigration 
is included. Information to be collected using the spreadsheet 
includes:
     number of applicants screened,
     age categories of applicants,
     number of abnormal chest x-rays,
     acid fast bacilli (AFB) smear results,
     mycobacterium tuberculosis (MTB) cultures,
     drug susceptibility test (DST) results, and
     TB treatment disposition.
    The changes in this Revision include the additional collection of 
molecular testing data. CDC requests OMB approval for an estimated 999 
annual burden hours. There is no cost to respondents other than their 
time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of      Average burden
         Type of respondents                 Form name            Number of      responses per     per response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
International Panel Physicans.......  TB Indicators REDCap                333                1                3
                                       Web Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-19612 Filed 8-30-24; 8:45 am]
BILLING CODE 4163-18-P