Change Request Memo_04DEC2024

Change Request for

Oropouche Virus Disease Outbreak

(OMB Control No. 0920-1446)

Expiration Date: 3/31/2025

Contact:  

Rudith Vice 

National Center for Emerging and Zoonotic Infectious Diseases  

Centers for Disease Control and Prevention  

1600 Clifton Road, NE  

Atlanta, Georgia 30333  

Phone: (404) 718-7292  

Email: nhr9@cdc.gov

Submission Date: November 29, 2024

Circumstances of Change Request for OMB 0920-1446

The Centers for Disease Control and Prevention (CDC), Division of Vector-borne Diseases (DVBD) requests a nonmaterial/non-substantive change request of the currently approved emergency Information Collection Request: Oropouche Virus Disease Outbreak (OMB Control 0920-1446). From late 2023–2024, outbreaks of Oropouche virus (OROV) disease have been reported in several countries it had not been previously reported resulting in more than 10,000 cases in the Americas, including close to 100 cases among U.S. travelers. In the last several weeks, cases of Oropouche virus disease have begun to increase in the Southern Hemisphere with >1,000 cases reported in one state of Brazil during November 2024. Given the resurgence of disease cases and anticipated increase in holiday travel to affected areas, CDC requests approval of this change request by 12pm on December 9, 2024.

Change Request

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. CDC is also changing the enrollment criterium from 3 months to 4 months post illness onset. This change is being made as one of the key state partners needed to obtain state approval for the evaluation before any individuals could be approached about the study. During the time needed to get the additional approval, all cases became ineligible for enrollment.

CDC does not consider this change substantive as it does not add or remove a substantial number of questions, will not change the number of people approached about participating in the evaluation, and that they do not change the scope of what was originally approved.

The changes to the Initial Clinical and Social Survey form consist of minor clarifications of what is meant by initial illness (when they first got sick). CDC has added one question to the Initial Clinical and Social Survey form asking about when indoors, how frequently were structural prevention measures (i.e., screens or air conditioning) in place. This question will help advise prevention messages and does not substantially change the estimated burden for this form.

Changes to the Contract Tracing Survey and Sexual Contact Interview forms was based on a request from state partners to allow sexual contacts who traveled with participants who developed Oropouche virus disease to be interviewed, if willing, to determine if they became ill ≥2 weeks after returning to the United States. This change will allow for potential cases of sexual transmission to be captured, if there is ongoing sexual relations and virus shedding in body fluids in the weeks following the case-patients’ illness. On both forms, the period of interest to ask about sexual contracts was clarified, adding table with dates clearly listed. On the Contract Tracing Survey form the time period was modified for the participant to be from illness onset instead of returning from travel and a question was added to ask if their sexual partner who traveled with them became ill within two weeks of returning. On the Sexual Contact Interview form, the list of countries with recent Oropouche virus transmission was modified based on updated epidemiologic data to include Panama. Finally, one question was added to the Sexual Contact Interview form to capture the travel dates to any area with Oropouche virus transmission.

The additional questions (one per form) do not substantially change the estimated burden for these forms.. The change to the enrollment criteria to allow sexual contacts who traveled to be included could result in identifying additional sexual contact for each participant with Oropouche virus disease. However, since the initial interviews of case-patients typically ask about sick contacts and travel partners, we do not anticipate identifying many new individuals to approach about enrollment.

CDC does not anticipate these changes will have a noticeable affect the estimated burden as the changes to the forms are minimal. The data collected from these forms will be used to inform public health officials (CDC, state and local health department) and clinicians about risk factors for infection, optimize disease recognition, diagnosis, follow up care, and counseling of patients infection with Oropouche virus, and the risk of sexual transmission.

Increase in Annualized Total Burden Hours:

The previous burden calculated for this data collection consisted of 663 hours. CDC does not anticipate this update will change the estimated annual burden.

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
General public	Baseline survey (Attachment 3)	200	1	30/60	100
	Follow-up clinical survey (Attachment 4)	200	6	15/60	300
	Symptom Diary (Attachment 5)	200	6	10/60	200
	Contact Tracing Survey (Attachment 6)	100	1	15/60	25
	Sexual Contact Interview form (Attachment 7)	150	1	15/60	38
Total					663

Attachments

Attachment A – Att A_Explanation for Program Changes_0920-1446_non-sub_29Nov2024

Attachment 3 – Att. 3 Initial Clinical and Social Survey_Clean_29Nov2024

Attachment 3 – Att. 3 Initial Clinical and Social Survey_Tracked_29Nov2024

Attachment 6 – Att. 6 Contact Tracing Survey_Clean_29Nov2024

Attachment 6 – Att. 6 Contact Tracing Survey_Tracked_29Nov2024

Attachment 7 – Att. 7 Sexual Contact Interview_Clean_29Nov2024

Attachment 7 – Att. 7 Sexual Contact Interview_Tracked_29Nov2024

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