Notice2021-27599
Proposed Data Collection Submitted for Public Comment and Recommendations
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
December 21, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 242 (Tuesday, December 21, 2021)</title>
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[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72238-72239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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:
<a href="/cdn-cgi/l/email-protection#47282a250724232469202831"><span class="__cf_email__" data-cfemail="315e5c53715255521f565e47">[email protected]</span></a>.
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
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