Proposed Data Collection Submitted for Public Comment and Recommendations

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

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 (OROV) disease—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Oropouche virus is an emerging virus in the Americas that is spread by the bite of midges and some species of mosquitoes. Infection with Oropouche virus generally causes a febrile illness, but more severe disease such as meningitis and hemorrhagic disease can occur. Beginning in late 2023, the geographic range of Oropouche virus has expanded, with over 10,000 cases from six countries reported in 2024 as of October 15. The first U.S. cases were reported in the summer of 2024, all among returning international travelers. This recent geographic expansion, along with reports of deaths among cases, vertical transmission leading to fetal loss and birth defects, and identification of live virus in semen 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.

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. Participants will be interviewed about their symptoms, medical and travel history, potential risk factors for infection, and sexual partners since becoming ill. They will be followed over time to see if their symptoms reoccur, which has been highlighted as a unique feature of Oropouche virus disease among similar viruses. They will also submit specimens of various bodily fluids over a 12-week period to be tested for Oropouche virus RNA. Lastly, sexual contacts of people who have been diagnosed with Oropouche virus disease will be interviewed to see if they experienced any symptoms consistent with Oropouche virus disease after these sexual encounters. Sexual contacts that report symptoms will be asked to have a blood sample collected and tested for evidence of Oropouche virus infection.

The findings of this investigation will inform prevention guidance, improve clinical recognition and diagnosis, and prevent further illnesses of Oropouche virus disease. Preliminary results will be used immediately to inform agency response activities and prevention guidance to help people protect themselves from Oropouche virus disease. CDC requests Emergency OMB approval for an estimated 663 annual burden hours.