[NCEZID] Risk factors, clinical course, presence and persistence of virus in various bodily fluids, and risk of sexual transmission among U.S. adults with Oropouche virus disease

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-25AU Sexual Contact Interview	Form	Modified	Available
Form 0920-25AU Sexual Contact Interview form	Form	Modified	Missing upstream
Form 0920-25AU Contact Tracing Survey	Form	Modified	Available
Form 0920-25AU Contact Tracing Survey	Form	Modified	Missing upstream
Form 0920-25AU Symptom Diary	Form	Modified	Available
Form 0920-25AU Symptom Diary	Form	Modified	Repair queued
Form 0920-25AU Follow-up Clinical Survey	Form	Modified	Available
Form 0920-25AU Follow-up clinical survey	Form	Modified	Repair queued
Form 0920-25AU Initial Clinical Survey	Form	Modified	Repair queued
Form 0920-25AU Baseline survey	Form	Modified	Repair queued
CSTE OROV Comments 7-11-2025.pdf	Public Comments	Uploaded 2025-07-11	Available
PC_202506-0920-008_071125_055555_1.pdf	Public Comments	Uploaded 2025-07-11	Available
Attachment_11_Consent_sexual_interview.docx	Supplementary Document	Uploaded 2025-06-18	Available
Attachment_11_Consent_sexual_interview.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Attachment_10_Consent_sample_collection.docx	Supplementary Document	Uploaded 2025-06-18	Available
Attachment_10_Consent_sample_collection.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Attachment_9_Consent_med_social.docx	Supplementary Document	Uploaded 2025-06-18	Available
Attachment_9_Consent_med_social.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Attachment_8_Background_info_FAQ.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Attachment_8_Background_info_FAQ.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Emergency Request Memo_OROV Response_10.25.24.docx	Supplementary Document	Uploaded 2025-06-18	Available
Emergency Request Memo_OROV Response_10.25.24.docx	Supplementary Document	Uploaded 2025-06-18	Repair queued
Att. 13 Privacy Impact Assessment-2.pdf	Supplementary Document	Uploaded 2025-06-18	Repair queued
Att. 13 Privacy Impact Assessment-2.pdf	Supplementary Document	Uploaded 2025-06-18	Repair queued
Att. 12 Human Subjects Determination.pdf	Supplementary Document	Uploaded 2025-06-18	Available
Att. 12 Human Subjects Determination.pdf	Supplementary Document	Uploaded 2025-06-18	Missing upstream
Att. 1 Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2025-06-18	Available
Att. 1 Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2025-06-18	Repair queued
Att A_Explanation for Program Changes_0920-1446_non-sub_29Nov2024.docx	Supplementary Document	Uploaded 2024-12-04	Repair queued
Att A_Explanation for Program Changes_0920-1446_non-sub_29Nov2024.docx	Supplementary Document	Uploaded 2024-12-04	Repair queued
0920-1446 Change Request-2024 Oropouche Response_11.29.2024.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-12-04	Available
0920-1446 Change Request-2024 Oropouche Response_11.29.2024.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-12-04	Repair queued
Att. 13 Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2024-10-25	Repair queued
Att. 13 Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2024-10-25	Missing upstream
Att. 13 Privacy Impact Assessment-2.pdf	Supplementary Document	Uploaded 2024-10-25	Available
Att. 13 Privacy Impact Assessment-2.pdf	Supplementary Document	Uploaded 2024-10-25	Missing upstream
Att. 12 Human Subjects Determination.pdf	Supplementary Document	Uploaded 2024-10-25	Available
Att. 12 Human Subjects Determination.pdf	Supplementary Document	Uploaded 2024-10-25	Repair queued
Emergency Request Memo_OROV Response_10.25.24.docx	Supplementary Document	Uploaded 2024-10-25	Available
Emergency Request Memo_OROV Response_10.25.24.docx	Supplementary Document	Uploaded 2024-10-25	Repair queued
Att. 11 Script and consent for sexual partner interview and OROV testing .docx	Supplementary Document	Uploaded 2024-10-24	Available
Att. 11 Script and consent for sexual partner interview and OROV testing .docx	Supplementary Document	Uploaded 2024-10-24	Missing upstream
Att. 9 Consent for medical and social information .docx	Supplementary Document	Uploaded 2024-10-24	Available
Att. 9 Consent for medical and social information .docx	Supplementary Document	Uploaded 2024-10-24	Available
Att. 8 Background information and frequently asked questions for participants .docx	Supplementary Document	Uploaded 2024-10-24	Available
Att. 8 Background information and frequently asked questions for participants .docx	Supplementary Document	Uploaded 2024-10-24	Repair queued
Supporting Statement B_OROV Response_Revised_June_12__2025_clean.docx	Supporting Statement B	Uploaded 2025-06-17	Available
Supporting Statement B_OROV Response_Revised_June_12__2025_clean.docx	Supporting Statement B	Uploaded 2025-06-17	Repair queued
Supporting Statement A_OROV Response_Revised_June_12_2025_clean.docx	Supporting Statement A	Uploaded 2025-06-17	Available
Supporting Statement A_OROV Response_Revised_June_12_2025_clean.docx	Supporting Statement A	Uploaded 2025-06-17	Missing upstream
Att. 1 Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2024-10-24	Available
Att. 1 Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2024-10-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
271899	Sexual Contact Interview form	Form	Modified	Sexual Contact Interview
271899	Sexual Contact Interview form	Form	Modified
271898	Contact Tracing Survey	Form	Modified	Contact Tracing Survey
271898	Contact Tracing Survey	Form	Modified
271897	Symptom Diary	Form	Modified	Symptom Diary
271897	Symptom Diary	Form	Modified
271896	Follow-up clinical survey	Form	Modified	Follow-up Clinical Survey
271896	Follow-up clinical survey	Form	Modified
271895	Baseline survey	Form	Modified	Initial Clinical Survey
271895	Baseline survey	Form	Modified

ICR Details

OMB Control No: 0920-1446	ICR Reference No: 202506-0920-008
Status: Active	Previous ICR Reference No: 202412-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1446 -25AU
Title: [NCEZID] Risk factors, clinical course, presence and persistence of virus in various bodily fluids, and risk of sexual transmission among U.S. adults with Oropouche virus disease
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/08/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/26/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2028	36 Months From Approved
Responses	2,850	0	0
Time Burden (Hours)	663	0	0
Cost Burden (Dollars)	0	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 re-instatement is submitted for 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.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 87585	11/04/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 24615	06/11/2025
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Baseline survey	0920-25AU	Initial Clinical Survey
Contact Tracing Survey	0920-25AU	Contact Tracing Survey
Follow-up clinical survey	0920-25AU	Follow-up Clinical Survey
Sexual Contact Interview form	0920-25AU	Sexual Contact Interview
Symptom Diary	0920-25AU	Symptom Diary

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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	2,850	0	0	0	0	2,850
Annual Time Burden (Hours)	663	0	0	0	0	663
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: $34,888

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: 06/26/2025

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