Triazole-resistant Aspergillus fumigatus Case Report Form

Forms and Documents

Document Name	Status
Form 0920-22BG Case Report Form Form and Instruction	New
Att 4 NRD-signed.pdf Supplementary Document	2022-06-02
Att 2 Published 60-Day FRN.pdf Supplementary Document	2022-06-02
Att 1 Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2022-06-02
SSB Triazole-resistant Aspergillus fumigatus CRF.docx Supporting Statement B	2022-06-02
SSA Triazole-resistant Aspergillus fumigatus CRF_final jag.docx Supporting Statement A	2022-06-02

IC Document Collections

IC ID	Document Title	Status
254011	Case Report Form Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202205-0920-013
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22BG
Title: Triazole-resistant Aspergillus fumigatus Case Report Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/07/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	15	0
Time Burden (Hours)	8	0
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.

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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:
	86 FR 72238	12/21/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 34688	06/07/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Case Report Form	0920-22BG	Case Report Form

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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	15	0	0	15	0	0
Annual Time Burden (Hours)	8	0	0	8	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 New collection.

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Annual Cost to Federal Government: $4,854

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: 06/07/2022

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