[NCEZID] Characteristics of Cases of Priority Fungal Diseases

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Antifungal-resistant dermatophytosis case report form rev	Form and Instruction	New	Available
Antifungal-resistant dermatophytosis case report form	Form and Instruction	New	Available
Antifungal-resistant dermatophytosis case report form	Form and Instruction	New	Repair queued
Candida auris Case Report Form rev	Form and Instruction	New	Available
Candida auris Case Report Form	Form and Instruction	New	Available
Candida auris Case Report Form	Form and Instruction	New	Repair queued
Blastomycosis Case Report Form rev	Form and Instruction	New	Available
Blastomycosis Case Report Form	Form and Instruction	New	Available
Blastomycosis Case Report Form	Form and Instruction	New	Repair queued
Histoplasmosis Case Report Form rev	Form and Instruction	New	Available
Histoplasmosis Case Report Form	Form and Instruction	New	Available
Histoplasmosis Case Report Form	Form and Instruction	New	Repair queued
Coccidioidomycosis Case Report Form rev	Form and Instruction	New	Available
Coccidioidomycosis Case Report Form	Form and Instruction	New	Available
Coccidioidomycosis Case Report Form	Form and Instruction	New	Repair queued
Triazole-resistant Aspergillus fumigatus Case Report Form rev	Form and Instruction	Modified	Available
Triazole-resistant Aspergillus fumigatus Case Report Form	Form and Instruction	Modified	Available
Triazole-resistant Aspergillus fumigatus Case Report Form	Form and Instruction	Modified	Repair queued
Att. 5- Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2024-03-14	Repair queued
Att 4- Human Subjects Determination.pdf	Supplementary Document	Uploaded 2024-03-14	Repair queued
Att 2-Published 60-day FRN.pdf	Supplementary Document	Uploaded 2024-03-14	Repair queued
Att 1 Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2024-03-14	Repair queued
Supporting Statement B.docx	Supporting Statement B	Uploaded 2024-03-14	Repair queued
Supporting Statement A_final.docx	Supporting Statement A	Uploaded 2024-03-14	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
266002	Antifungal-resistant dermatophytosis case report form	Form and Instruction	New	Antifungal-resistant dermatophytosis case report form rev
266002	Antifungal-resistant dermatophytosis case report form	Form and Instruction	New	Antifungal-resistant dermatophytosis case report form
266002	Antifungal-resistant dermatophytosis case report form	Form and Instruction	New
266001	Candida auris Case Report Form	Form and Instruction	New	Candida auris Case Report Form rev
266001	Candida auris Case Report Form	Form and Instruction	New	Candida auris Case Report Form
266001	Candida auris Case Report Form	Form and Instruction	New
266000	Blastomycosis Case Report Form	Form and Instruction	New	Blastomycosis Case Report Form rev
266000	Blastomycosis Case Report Form	Form and Instruction	New	Blastomycosis Case Report Form
266000	Blastomycosis Case Report Form	Form and Instruction	New
265999	Histoplasmosis Case Report Form	Form and Instruction	New	Histoplasmosis Case Report Form rev
265999	Histoplasmosis Case Report Form	Form and Instruction	New	Histoplasmosis Case Report Form
265999	Histoplasmosis Case Report Form	Form and Instruction	New
265998	Coccidioidomycosis Case Report Form	Form and Instruction	New	Coccidioidomycosis Case Report Form rev
265998	Coccidioidomycosis Case Report Form	Form and Instruction	New	Coccidioidomycosis Case Report Form
265998	Coccidioidomycosis Case Report Form	Form and Instruction	New
254011	Triazole-resistant Aspergillus fumigatus Case Report Form	Form and Instruction	Modified	Triazole-resistant Aspergillus fumigatus Case Report Form rev
254011	Triazole-resistant Aspergillus fumigatus Case Report Form	Form and Instruction	Modified	Triazole-resistant Aspergillus fumigatus Case Report Form
254011	Triazole-resistant Aspergillus fumigatus Case Report Form	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1385	ICR Reference No: 202402-0920-008
Status: Historical Active	Previous ICR Reference No: 202205-0920-013
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/18/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/14/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	03/31/2026
Responses	1,375	0	15
Time Burden (Hours)	1,138	0	8
Cost Burden (Dollars)	0	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:
	88 FR 85887	12/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 18637	03/14/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Antifungal-resistant dermatophytosis case report form	n/a, n/a	Antifungal-resistant dermatophytosis case report form ,   Antifungal-resistant dermatophytosis case report form rev
Blastomycosis Case Report Form	n/a, n/a	Blastomycosis Case Report Form ,   Blastomycosis Case Report Form rev
Candida auris Case Report Form	n/a, n/a	Candida auris Case Report Form ,   Candida auris Case Report Form rev
Coccidioidomycosis Case Report Form	n/a, n/a	Coccidioidomycosis Case Report Form ,   Coccidioidomycosis Case Report Form rev
Histoplasmosis Case Report Form	n/a, n/a	Histoplasmosis Case Report Form ,   Histoplasmosis Case Report Form rev
Triazole-resistant Aspergillus fumigatus Case Report Form	n/a, n/a	Triazole-resistant Aspergillus fumigatus Case Report Form ,   Triazole-resistant Aspergillus fumigatus Case Report Form rev

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	1,375	15	0	1,360	0	0
Annual Time Burden (Hours)	1,138	8	0	1,130	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: Several collection instruments were added and the respondent frequency was modified for the residual instrument.

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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: 03/14/2024

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