[NCEZID] Oropouche Virus Disease Outbreak

Forms and Documents

Document Name	Status
Form 0920-25AU Sexual Contact Interview form Form and Instruction	Modified
Form 0920-25AU Contact Tracing Survey Form	Modified
Form 0920-25AU Symptom Diary Form	Unchanged
Form 0920-25AU Follow-up clinical survey Form and Instruction	Unchanged
Form 0920-25AU Baseline survey Form and Instruction	Modified
Att A_Explanation for Program Changes_0920-1446_non-sub_29Nov2024.docx Supplementary Document	2024-12-04
0920-1446 Change Request-2024 Oropouche Response_11.29.2024.docx Justification for No Material/Nonsubstantive Change	2024-12-04
Att. 13 Privacy Impact Assessment.pdf Supplementary Document	2024-10-25
Att. 13 Privacy Impact Assessment-2.pdf Supplementary Document	2024-10-25
Att. 12 Human Subjects Determination.pdf Supplementary Document	2024-10-25
Emergency Request Memo_OROV Response_10.25.24.docx Supplementary Document	2024-10-25
Att. 11 Script and consent for sexual partner interview and OROV testing .docx Supplementary Document	2024-10-24
Att. 9 Consent for medical and social information .docx Supplementary Document	2024-10-24
Att. 8 Background information and frequently asked questions for participants .docx Supplementary Document	2024-10-24
Supporting Statement B_OROV Response.docx Supporting Statement B	2024-10-24
Supporting Statement A_OROV Response_Revised.docx Supporting Statement A	2024-10-24
Att. 1 Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2024-10-24

IC Document Collections

IC ID	Document Title	Status
271899	Sexual Contact Interview form Form and Instruction	Modified
271898	Contact Tracing Survey Form	Modified
271897	Symptom Diary Form	Unchanged
271896	Follow-up clinical survey Form and Instruction	Unchanged
271895	Baseline survey Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1446	ICR Reference No: 202412-0920-003
Status: Received in OIRA	Previous ICR Reference No: 202410-0920-025
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1446 25BP
Title: [NCEZID] Oropouche Virus Disease Outbreak
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 10/28/2024
Date Submitted to OIRA: 12/05/2024

	Requested	Previously Approved
Expiration Date	03/31/2025	03/31/2025
Responses	2,850	2,850
Time Burden (Hours)	663	663
Cost Burden (Dollars)	0	0

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Abstract: Beginning in late 2023, Oropouche virus was identified as the cause of multiple outbreaks with over 10,000 cases from 6 countries reported in 2024 as of October 15. With these outbreaks, the virus was reported to cause disease cases in new non-endemic areas, result in the first reported deaths, be associated with fetal demise and congenital anomalies, and be found in the semen of an infected traveler. Although local transmission of the virus has not been detected yet in the United States, the vectors capable of transmitting the virus are present in many states and at least 90 cases of U.S. travelers returning to the United States while infected with the virus have been reported. All of these findings and factors, raise concerns about the broader threat this virus represents to the United States. There are numerous gaps in our understanding of this emerging virus, including the urgent need to evaluate the possibility of sexual transmission to inform prevention recommendations, especially for pregnant people and their partners, or those considering pregnancy. This Non-Substantive Change Request is submitted to CDC is requesting non-substantive changes to the Initial Clinical and Social Survey, Contract Tracing Survey, and Sexual Contact Interview forms. The purpose of this change is to address feedback from state partners and streamline the data collection by providing clarifying language regarding the timeframes of interest for both individuals who consent to participate and staff conducting the interviews. There is no change to the overall burden hours previously approved for the 0920-1446 data collection.

Emergency Justfication: This is an emergency request for a new information collection for six months (180 days). This information is essential to CDC’s mission to protect America from health, safety, and security threats. The purpose of this investigation is to better define the risk factors, clinical course, viral shedding, and potential for sexual transmission among patients with Oropouche virus disease. The findings of this investigation will inform prevention guidance, improve clinical recognition and diagnosis, ultimately aiding our ability to detect and respond to Oropouche virus disease outbreaks. This information collection request (ICR) needs to go forward as an Emergency to avoid any delays in collecting essential actionable information in this rapidly evolving situation. Beginning in late 2023, Oropouche virus was identified as the cause of multiple outbreaks with over 10,000 cases from 6 countries reported in 2024 as of October 15. With these outbreaks, the virus was reported to cause disease cases in new non-endemic areas, result in the first reported deaths, be associated with fetal demise and congenital anomalies, and be found in the semen of an infected traveler. Although local transmission of the virus has not been detected yet in the United States, the vectors capable of transmitting the virus are present in many states and at least 90 cases of U.S. travelers returning to the United States while infected with the virus have been reported. All of these findings and factors, raise concerns about the broader threat this virus represents to the United States. There are numerous gaps in our understanding of this emerging virus, including the urgent need to evaluate the possibility of sexual transmission to inform prevention recommendations, especially for pregnant people and their partners, or those considering pregnancy.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Baseline survey	0920-25AU, 0920-1446	INITIAL CLINCAL AND SOCIAL SURVEY ,   INITIAL CLINCAL AND SOCIAL SURVEY_04DEC2024
Contact Tracing Survey	0920-25AU, 0920-1446	Contact Tracing Survey ,   Contact Tracing Survey_04DEC2024
Follow-up clinical survey	0920-25AU	FOLLOW-UP CLINICAL SURVEY
Sexual Contact Interview form	0920-25AU, 0920-1446	Sexual Contact Interview form ,   Sexual Contact Interview Form_04DEC2024
Symptom Diary	0920-25AU	Symptom Dairy

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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	2,850	2,850	0	0	0	0
Annual Time Burden (Hours)	663	663	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $34,897

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: 12/05/2024

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