[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87585-87586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-25-25AU; Docket No. CDC-2024-0088]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
federal agencies the opportunity to comment on a proposed information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled 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. This study will assist in 
the response to this emerging virus by; identifying risk factors for 
infection to inform prevention guidance and messaging, informing 
recognition, diagnosis, follow-up care, and counseling of patients with 
OROV disease, and understanding risks of sexual transmission to inform 
prevention recommendations, especially for pregnant people and their 
partners, or those considering pregnancy.

DATES: CDC must receive written comments on or before January 3, 2025.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0088 by either of the following methods:
    <bullet> Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
    <bullet> Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: <a href="/cdn-cgi/l/email-protection#335c5e51735057501d545c45"><span class="__cf_email__" data-cfemail="8de2e0efcdeee9eea3eae2fb">[email protected]</span></a>.

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).

[[Page 87586]]

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.

                                        Estimated Annualized Burden Hours
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                                                                                       Average
                                                        Number of      Number of      burden per   Total burden
       Type of respondents             Form name       respondents   responses per     response     (in hours)
                                                                       respondent     (in hours)
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General public..................  Baseline survey...           200                1        30/60             100
                                  Follow-up clinical           200                6        15/60             300
                                   survey.
                                  Symptom Diary.....           200                6        10/60             200
                                  Contact tracing              100                1        15/60              25
                                   survey.
                                  Sexual contact               150                1        15/60              38
                                   interview form.
                                                     -----------------------------------------------------------
    Total.......................  ..................  ............  ...............  ...........             663
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-25553 Filed 11-1-24; 8:45 am]
BILLING CODE 4163-18-P


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