Notice2023-27081
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 11, 2023
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Characteristics of Cases of Priority Fungal Diseases. These case report forms (CRFs) collect information on patient demographics, underlying conditions, diagnosis, treatments, healthcare utilization, and outcomes of patients with coccidioidomycosis, histoplasmosis, blastomycosis, Candida auris, triazole-resistant Aspergillus fumigatus infection or colonization, or antifungal-resistant dermatophytosis.
Full Text
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<title>Federal Register, Volume 88 Issue 236 (Monday, December 11, 2023)</title>
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[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Pages 85887-85888]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27081]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-1385; Docket No. CDC-2024-0098]
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Characteristics of Cases of Priority Fungal Diseases. These case
report forms (CRFs) collect information on patient demographics,
underlying conditions, diagnosis, treatments, healthcare utilization,
and outcomes of patients with coccidioidomycosis, histoplasmosis,
blastomycosis, Candida auris, triazole-resistant Aspergillus fumigatus
infection or colonization, or antifungal-resistant dermatophytosis.
DATES: CDC must receive written comments on or before February 9, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0098 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#b7d8dad5f7d4d3d499d0d8c1"><span class="__cf_email__" data-cfemail="81eeece3c1e2e5e2afe6eef7">[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;
[[Page 85888]]
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 Cases of Priority Fungal Diseases (OMB Control
No. 0920-1385, Exp. 3/31/2026)--Revision--National Center for Emerging
and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Fungal diseases cause substantial illness, ranging from mild
infection to severe or life-threatening invasive disease. They also
constitute a considerable financial burden on patients and healthcare
systems. Awareness of fungal diseases is low, and data collection has
historically been limited in size, scope, and coordination, which has
hindered our understanding of these diseases. Detailed epidemiologic
and clinical data are critical to inform appropriate public health
responses.
We plan to enhance surveillance of high priority fungal diseases
across the United States to better characterize factors such as disease
burden, geographic scope, patient risk factors, health disparities,
healthcare utilization, outcomes, and emerging trends. This project
will serve as a Revision of the information collections project:
Triazole-resistant Aspergillus fumigatus Case Report Form (CRF). The
Revision will expand the number of fungal diseases for which data may
be collected. In addition to triazole-resistant A. fumigatus
infections, CRFs have also been developed for coccidioidomycosis,
histoplasmosis, blastomycosis, C. auris, and antifungal-resistant
dermatophytosis. CDC is also changing the name of this information
collections project from Triazole-resistant Aspergillus fumigatus Case
Report Form to Characteristics of Cases of Priority Fungal Diseases.
We plan to use standardized CRFs to collect public health
surveillance data for cases of these diseases regarding demographics
(e.g., age, sex, race/ethnicity, location of residence), underlying
medical conditions, diagnosis (e.g., clinical presentation, laboratory
testing), treatments, and outcomes (e.g., hospitalization, vital
status). The corresponding CRF would be filled out voluntarily by State
and local health departments and contains a section for medical chart
review and an optional supplemental interview (including data on
potential occupational or environmental exposures) of the patient or
their representative. Findings can help identify populations at higher
risk of these diseases, detect emerging epidemiologic trends, and guide
prevention and response efforts. They can also help better focus public
and healthcare provider outreach, inform efforts to contain or mitigate
spread, and influence health policy and research on prevention and
treatment.
CDC requests OMB approval for an estimated 1,138 annual burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
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State and Local Health Departments. Characteristics of 15 15 30/60 113
Patients with
Environmentally-
derived Triazole-
resistant
Aspergillus
fumigatus.
State and Local Health Departments. Characteristics of 10 25 1 250
Patients with
Coccidioidomycosis.
State and Local Health Departments. Characteristics of 10 25 1 250
Patients with
Histoplasmosis.
State and Local Health Departments. Characteristics of 10 25 1 250
Patients with
Blastomycosis.
State and Local Health Departments. Characteristics of 15 20 45/60 225
Patients with
Candida auris.
State and Local Health Departments. Characteristics of 10 10 30/60 50
Patients with
Antifungal-resistant
Dermatophytosis.
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Total.......................... ..................... ........... .............. ........... 1,138
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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. 2023-27081 Filed 12-8-23; 8:45 am]
BILLING CODE 4163-18-P
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