[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34688-34689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

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