Chronic Q Fever in the United States: Enhanced Clinical Surveillance

Forms and Documents

Document Name	Status
Form 0920- Att. 7_ChronicQFever Enhanced Surveillance Form and Instruction	New
Att. 9 HSR determination 121718CC-NR-signed.pdf Supplementary Document	2020-05-28
Att. 8 Signed PIA Anonymous RedCap AIREDC-2187-PIA (1).pdf Supplementary Document	2020-05-28
Att. 4 Q fever supplemental case report form.pdf Supplementary Document	2020-05-28
Att 2a. Public Comment.pdf Supplementary Document	2020-05-28
Att 2. 60-Day FRN Publication.pdf Supplementary Document	2020-05-28
Att 3. NNDSS Q fever Case defintion.pdf Supplementary Document	2020-04-20
Att. 1 Authorizing Legislation.pdf Supplementary Document	2020-04-20
SSB Enhanced Q fever surveillance 04202020.docx Supporting Statement B	2020-04-20
SSA Chronic Q fever enhanced surveillance 04202020.docx Supporting Statement A	2020-04-20

IC Document Collections

IC ID	Document Title	Status
242016	Att. 7_ChronicQFever Enhanced Surveillance Form and Instruction	New

ICR Details

OMB Control No: 0920-1305	ICR Reference No: 202004-0920-010
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20DV
Title: Chronic Q Fever in the United States: Enhanced Clinical Surveillance
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2020
	Date Received in OIRA: 05/29/2020
Terms of Clearance: CDC will characterize the scope and limitations of this data in all relevant publications and uses, including acknowledgement that data are not generalizable beyond the particular respondents.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2023	36 Months From Approved
Responses	15	0	0
Time Burden (Hours)	5	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a new Information Collection Request. We are requesting approval for a period of 3 years. Q fever is a worldwide zoonosis caused by Coxiella burnetii with acute and chronic disease presentations. 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:
	84 FR 70552	12/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 30960	05/19/2020
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Att. 7_ChronicQFever Enhanced Surveillance	0920-	Chronic Q Fever Enhanced Surveillance

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ICR Summary 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	15	0	0	15	0	0
Annual Time Burden (Hours)	5	0	0	5	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 information collection request.

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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.     Yes

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.     Yes

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: 05/29/2020

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