Notice2024-19612
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
September 3, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71279-71280]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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
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:
<bullet> number of applicants screened,
<bullet> age categories of applicants,
<bullet> number of abnormal chest x-rays,
<bullet> acid fast bacilli (AFB) smear results,
<bullet> mycobacterium tuberculosis (MTB) cultures,
<bullet> drug susceptibility test (DST) results, and
<bullet> 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
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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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International Panel Physicans....... TB Indicators REDCap 333 1 3
Web Form.
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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
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