View Information Collection Request (ICR) Package

OMB Control No: 0920-1446	ICR Reference No: 202410-0920-025
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25AU
Title: [NCEZID] Oropouche Virus Disease Outbreak
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 10/28/2024
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/28/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/28/2024
Terms of Clearance: OMB is approving this Emergency ICR with the understanding that within 5 months from the approval date, CDC will complete a 60d and 30d public comment request to support the approval of the ICR ahead of the expiration date.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2025	6 Months From Approved
Responses	2,850	0	0
Time Burden (Hours)	663	0	0
Cost Burden (Dollars)	0	0	0

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.

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.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	2,850	2,850
Annual Time Burden (Hours)	663	663
Annual Cost Burden (Dollars)	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 an EMERGENCY information clearance request.

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

Agency Contact: Thelma Sims 4046394771

View ICR - OIRA Conclusion