Notice2024-24922
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
October 25, 2024
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 (CRF) 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, chromoblastomycosis, mycetoma, and sporotrichosis.
Full Text
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<title>Federal Register, Volume 89 Issue 207 (Friday, October 25, 2024)</title>
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[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Notices]
[Pages 85215-85216]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24922]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-1385; Docket No. CDC-2024-0084]
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 (CRF) 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,
chromoblastomycosis, mycetoma, and sporotrichosis.
DATES: CDC must receive written comments on or before December 24,
2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0084 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#127d7f70527176713c757d64"><span class="__cf_email__" data-cfemail="87e8eae5c7e4e3e4a9e0e8f1">[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 Cases of Priority Fungal Diseases (OMB Control
No. 0920-1385, Exp. 4/30/2027)--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.
CDC plans 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 to the information collection project
Characteristics of Cases of Priority Fungal Diseases (OMB Control No.
0920-1385). The Revision will expand the number of fungal diseases for
which data may be collected. In addition to triazole-resistant A.
fumigatus infections, coccidioidomycosis, histoplasmosis,
blastomycosis, C. auris, and antifungal-resistant dermatophytosis, Case
Report Forms (CRF) have also been developed for chromoblastomycosis,
mycetoma, and sporotrichosis.
CDC plans 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, local or tribal health departments, federal agencies, and
members of the private sector (e.g., academic institutions), 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.
[[Page 85216]]
CDC requests OMB approval for an estimated 1,564 annual burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Avg. burden
Number of Number per Total
Form name Type of respondent respondents responses per response burden (in
respondent (in hrs.) hrs.)
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Triazole-resistant Aspergillus State and Local 15 15 0.5 113
fumigatus Case Report Form. Health Departments.
Coccidioidomycosis Case Report State and Local 10 25 1.0 250
Form. Health Departments.
Private Sectors..... 3 10 1.0 30
Histoplasmosis Case Report Form.. State and Local 10 25 1.0 250
Health Departments.
Private Sectors..... 3 10 1.0 30
Blastomycosis Case Report Form... State and Local 10 25 1.0 250
Health Departments.
Private Sectors..... 3 10 1.0 30
Candida auris Case Report Form... State and Local 15 20 0.75 225
Health Departments.
Private Sectors..... 3 10 0.75 23
Antifungal-resistant State and Local 10 10 0.5 50
dermatophytosis case report form. Health Departments.
Chromoblastomycosis case report Private Sectors..... 25 10 0.5 125
form.
Mycetoma case report form........ Private Sectors..... 25 5 0.5 63
Sporotrichosis case report form.. Private Sectors..... 25 10 0.5 125
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Total........................ .................... ............ ............... ........... 1,564
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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. 2024-24922 Filed 10-24-24; 8:45 am]
BILLING CODE 4163-18-P
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