2023-27081. 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.

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:

• Federal eRulemaking Portal: www.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 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: [phone]; Email: [e-mail].

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. 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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
State and Local Health Departments	Characteristics of Patients with Environmentally-derived Triazole-resistant Aspergillus fumigatus	15	15	30/60	113
State and Local Health Departments	Characteristics of Patients with Coccidioidomycosis	10	25	1	250
State and Local Health Departments	Characteristics of Patients with Histoplasmosis	10	25	1	250
State and Local Health Departments	Characteristics of Patients with Blastomycosis	10	25	1	250
State and Local Health Departments	Characteristics of Patients with Candida auris	15	20	45/60	225
State and Local Health Departments	Characteristics of Patients with Antifungal-resistant Dermatophytosis	10	10	30/60	50
Total					1,138

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.