OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

[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

ICR 202506-0920-008 · OMB 0920-1446 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-25AU Sexual Contact Interview Form Modified Repair queued
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 Repair queued
Form 0920-25AU Symptom Diary Form Modified Available
Form 0920-25AU Symptom Diary Form Modified Missing upstream
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 Missing upstream
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 Repair queued
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 Missing upstream
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 Repair queued
Att. 12 Human Subjects Determination.pdf Supplementary Document Uploaded 2025-06-18 Repair queued
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 Missing upstream
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 Repair queued
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 Repair queued
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 Missing upstream
Att. 11 Script and consent for sexual partner interview and OROV testing .docx Supplementary Document Uploaded 2024-10-24 Repair queued
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 Repair queued
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 Repair queued
Supporting Statement A_OROV Response_Revised_June_12_2025_clean.docx Supporting Statement A Uploaded 2025-06-17 Repair queued
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
IC IDCollectionTypeStatusForm
271899 Sexual Contact Interview form Form ModifiedSexual Contact Interview
271899 Sexual Contact Interview form Form Modified
271898 Contact Tracing Survey Form ModifiedContact Tracing Survey
271898 Contact Tracing Survey Form Modified
271897 Symptom Diary Form ModifiedSymptom Diary
271897 Symptom Diary Form Modified
271896 Follow-up clinical survey Form ModifiedFollow-up Clinical Survey
271896 Follow-up clinical survey Form Modified
271895 Baseline survey Form ModifiedInitial Clinical Survey
271895 Baseline survey Form Modified
ICR Details
0920-1446 202506-0920-008
Active 202412-0920-003
HHS/CDC 0920-1446 -25AU
[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
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 08/08/2025
Retrieve Notice of Action (NOA) 06/26/2025
  Inventory as of this Action Requested Previously Approved
08/31/2028 36 Months From Approved
2,850 0 0
663 0 0
0 0 0
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.
US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None
Not associated with rulemaking
  89 FR 87585 11/04/2024
90 FR 24615 06/11/2025
No
  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
No
No
$34,888
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Odion Clunis 770 488-0045 [email protected]
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/26/2025