[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Pages 85887-85888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: www.regulations.gov. 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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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; 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)
----------------------------------------------------------------------------------------------------------------
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.
                                                           -----------------------------------------------------
    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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