Notice2024-25553
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 4, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 213 (Monday, November 4, 2024)</title>
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[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87585-87586]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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.
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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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