Notice2022-12145
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
June 7, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 109 (Tuesday, June 7, 2022)</title>
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[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34688-34689]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12145]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-22BG]
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 ``Triazole-resistant Aspergillus fumigatus
Case Report Form'' 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
December 21, 2021 to obtain comments from the public and affected
agencies. CDC did not receive 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
Characteristics of Patients with Environmentally-derived Triazole-
resistant Aspergillus fumigatus--New--National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The environmental mold Aspergillus fumigatus is the primary cause
of invasive aspergillosis and is associated with 50% mortality in high-
risk patients, including stem cell and organ transplant recipients. The
use of triazole antifungals has greatly improved survival, however
triazole-resistant A. fumigatus infections are increasingly reported
worldwide and are associated with increased mortality and treatment
failure. Of particular concern are resistant A. fumigatus isolates
carrying the TR34/L98H and TR46/Y121F genetic resistance markers, which
are associated with environmental triazole fungicide use rather than
previous patient exposure to antifungals. Infections with these
triazole-resistant strains have become common among patients with A.
fumigatus infections in Europe, Asia, and South America, and have been
characterized epidemiologically. However, U.S. reports of isolates
carrying TR34/L98H or TR46/Y121F markers are limited, and
[[Page 34689]]
detailed epidemiologic data are critical to inform public health
response.
CDC is already receiving Aspergillus fumigatus isolates from
laboratories across the nation, primarily through Antibiotic Resistance
Laboratory Networks (ARLN) and sometimes directly from submitters.
These isolates undergo testing for triazole resistance (defined using
minimum inhibitory concentrations or epidemiologic cutoff values set
forth by Clinical and Laboratory Standards Institute). For patients
involving triazole-resistant isolates, we plan to use a standardized
case report form (CRF) to collect public health surveillance data
regarding demographics (e.g., age, sex, race/ethnicity, country of
residence), underlying medical conditions, treatments, and outcomes
(e.g., vital status at 30 days for initial positive specimen). The CRF
would be filled out voluntarily by state and local health departments
and contains an optional supplement at the end involving a brief
interview (including data on occupational and environmental exposures)
of a patient or their representative. The findings would be used to
describe the risk factors, clinical features, and outcomes for patients
with triazole-resistance Aspergillus fumigatus. U.S. data on triazole-
resistant Aspergillus fumigatus are lacking, although this problem
constitutes a major public health threat.
CDC requests OMB approval for an estimated eight 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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Public Health Officials, Clinicians... Triazole-resistant 15 1 30/60
Aspergillus fumigatus
Case Report Form.
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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. 2022-12145 Filed 6-6-22; 8:45 am]
BILLING CODE 4163-18-P
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