[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72238-72239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22BG; Docket No. CDC-2021-0131]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comments on a proposed 
information collection project titled Characteristics of Patients with 
Environmentally-derived Triazole-resistant Aspergillus fumigatus. This 
case report form collects information on demographics, underlying 
conditions, treatments, and outcomes of patients with triazole-
resistant A. fumigatus to inform clinical and public health practice.

DATES: CDC must receive written comments on or before February 22, 
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0131 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8 Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

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 (A. 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

[[Page 72239]]

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 detailed epidemiologic data are critical to inform public 
health response.
    Through the Antibiotic Resistance Laboratory Network (ARLN), CDC is 
already receiving A. fumigatus isolates from laboratories across the 
nation. 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 8 annual burden hours 
annually for collection from 15 respondents. There are no costs to 
respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total Burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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State and Local Health Department..............  Characteristics of Patients with                     15              15           30/60               8
                                                  Environmentally-derived Triazole-
                                                  resistant Aspergillus fumigatus.
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    Total......................................  .......................................  ..............  ..............  ..............               8
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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. 2021-27599 Filed 12-20-21; 8:45 am]
BILLING CODE 4163-18-P