Chronic Q Fever in the United States: Enhanced Clinical Surveillance

Forms and Documents

Document Name	Status
Form 0920-1305 Chronic Q Fever Enhanced Surveillance (Follow-up0 Form	New
Form 0920-1305 Chronic Q Fever-Enhanced Surveillance Report Form Form	Modified
Att 5 Consent Script.docx Supplementary Document	2023-09-13
Att 9 Human Subjects Determination.pdf Supplementary Document	2023-09-25
Att 8 Privacy Impact Assessment.pdf Supplementary Document	2023-09-13
Att 2 60-Day FRN.pdf Supplementary Document	2023-09-13
Att 1 - Authorizing Legislation-Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2023-09-13
SSB.docx Supporting Statement B	2023-09-13
SSA.docx Supporting Statement A	2023-09-13

IC Document Collections

IC ID	Document Title	Status
262134	Chronic Q Fever Enhanced Surveillance (Follow-up0 Form	New
242016	Chronic Q Fever-Enhanced Surveillance Report Form Form	Modified

ICR Details

OMB Control No: 0920-1305	ICR Reference No: 202309-0920-006
Status: Received in OIRA	Previous ICR Reference No: 202004-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1305
Title: Chronic Q Fever in the United States: Enhanced Clinical Surveillance
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/26/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2023
Responses	100	15
Time Burden (Hours)	34	5
Cost Burden (Dollars)	0	0

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Abstract: The goal of this tool is to establish enhanced medical surveillance for chronic Q fever by gathering additional and more specific clinical data not otherwise collected during the course of routine public health surveillance for chronic Q fever. This information will allow for better characterization of the clinical presentation and risk factors of chronic Q fever in the United States and help educate physicians on identifying and diagnosing these cases.

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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 41629	06/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 66003	09/26/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Chronic Q Fever Enhanced Surveillance (Follow-up0	0920-1305	Chronic Q Fever - Enhanced Surveillance Follow-up Instrument
Chronic Q Fever-Enhanced Surveillance Report Form	0920-1305	Q Fever Case Report

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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	100	15	0	35	50	0
Annual Time Burden (Hours)	34	5	0	12	17	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 of a currently approved collection. Recently, there has been an increased volume of clinical consultation requests. To reflect this, we are proposing an increase in the number of respondents to 50 each year. Additionally, the clinical course for these patients is often complex, and clinical relapse or prolonged infection has been reported. To capture these important clinical details, we propose increasing the number of total instruments to 2 (two), with a follow-up survey that will take five minutes each at 6, 12, 18, and 24 months from the date of the initial consult.

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Annual Cost to Federal Government: $5,000

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: 09/26/2023

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