[NCEZID] Characteristics of Cases of Priority Fungal Diseases

Forms and Documents

Document Name	Status
Form 0920-1385 Sporotrichosis case report form Form	New
Form 0920-1385 Mycetoma case report form Form	New
Form 0920-1385 Chromoblastomycosis case report form Form	New
Form 0920-1385 Antifungal-resistant dermatophytosis case report form Form	Modified
Form 0920-1385 Candida auris Case Report Form Form	Modified
Form 0920-1385 Blastomycosis Case Report Form Form	Modified
Form 0920-1385 Histoplasmosis Case Report Form Form	Modified
Form 0920-1385 Coccidioidomycosis Case Report Form Form	Modified
Form 0920-1385 Triazole-resistant Aspergillus fumigatus Case Report Form Form	Modified
Att 1 Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2025-01-16
Att. 4 Non Research Determination.pdf Supplementary Document	2025-01-16
Att. 5- Privacy Impact Assessment.pdf Supplementary Document	2024-03-14
Att 4- Human Subjects Determination.pdf Supplementary Document	2024-03-14
Att 2-Published 60-day FRN.pdf Supplementary Document	2024-03-14
Att 1 Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2024-03-14
SSB FungiSurv1_Revision_FINAL.docx Supporting Statement B	2025-01-16
SSA FungiSurv1_Revision_FINAL.docx Supporting Statement A	2025-01-16

IC Document Collections

IC ID	Document Title	Status
273720	Sporotrichosis case report form Form	New
273719	Mycetoma case report form Form	New
273717	Chromoblastomycosis case report form Form	New
266002	Antifungal-resistant dermatophytosis case report form Form	Modified
266001	Candida auris Case Report Form Form	Modified
266000	Blastomycosis Case Report Form Form	Modified
265999	Histoplasmosis Case Report Form Form	Modified
265998	Coccidioidomycosis Case Report Form Form	Modified
254011	Triazole-resistant Aspergillus fumigatus Case Report Form Form	Modified

ICR Details

OMB Control No: 0920-1385	ICR Reference No: 202501-0920-004
Status: Received in OIRA	Previous ICR Reference No: 202402-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1385
Title: [NCEZID] Characteristics of Cases of Priority Fungal Diseases
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/16/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2027
Responses	2,855	1,375
Time Burden (Hours)	1,564	1,138
Cost Burden (Dollars)	0	0

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Abstract: For patients involving triazole-resistant A. fumigatus isolates detected through passive public health surveillance, we will use a standardized case report form to collect public health surveillance data regarding demographics, underlying medical conditions, treatments, and outcomes. Health departments would be asked to voluntarily fill out the de-identified form. Proposed changes for this Revision include the addition of five new CRFs and changes to a current form.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 85215	10/25/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 2704	01/13/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Antifungal-resistant dermatophytosis case report form	0920-1385	Antifungal-resistant dermatophytosis case report form
Blastomycosis Case Report Form	0920-1385	Blastomycosis Case Report Form
Candida auris Case Report Form	0920-1385	Candida auris Case Report Form
Chromoblastomycosis case report form	0920-1385	Chromoblastomycosis case report form
Coccidioidomycosis Case Report Form	0920-1385	Coccidioidomycosis Case Report Form
Histoplasmosis Case Report Form	0920-1385	Histoplasmosis Case Report Form
Mycetoma case report form	0920-1385	Mycetoma case report form
Sporotrichosis case report form	0920-1385	Sporotrichosis case report form
Triazole-resistant Aspergillus fumigatus Case Report Form	0920-1385	Triazole-resistant Aspergillus fumigatus case reporting

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,855	1,375	0	1,480	0	0
Annual Time Burden (Hours)	1,564	1,138	0	426	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a revision to a currently approved collection. Proposed changes include the addition of three new CRFs, corresponding to chromoblastomycosis, mycetoma, and sporotrichosis. The proposed changes increased the annualized burden by 426 hours for a total of 1564 hours.

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Annual Cost to Federal Government: $5,463

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/16/2025

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