Notice2022-03708
Agency Forms Undergoing Paperwork Reduction Act Review
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
February 22, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 35 (Tuesday, February 22, 2022)</title>
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[Federal Register Volume 87, Number 35 (Tuesday, February 22, 2022)]
[Notices]
[Pages 9620-9621]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-21HD]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled the ``One Health Surveillance for Zoonotic
SARS-CoV-2 Events'' to the Office of Management and Budget (OMB) for
review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
August 13, 2021 to obtain comments from the public and affected
agencies. CDC received one comment related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
One Health Surveillance for Zoonotic SARS-CoV-2 Events--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
NCEZID seeks OMB approval for One Health Surveillance for Zoonotic
SARS-CoV-2 Events through the use of two forms: One Health Case
Investigation Form for Animals with SARS-CoV-2, and Zoonotic SARS-CoV-2
Event Form. Description of these forms and activities associated with
this study, including burden to respondents can be found below.
Zoonotic SARS-CoV-2 Event Form: Although it is now well established
that SARS-CoV-2 is a zoonotic virus (i.e., can be spread between people
and animals), little information exists on the prevalence or likelihood
of zoonotic transmission events. Currently, reporting of zoonotic SARS-
CoV-2 transmission events is not systematically reported. Without this
crucial information, however, interpreting data on SARS-CoV-2 infection
in animals, especially the overall contribution of zoonotic
transmission to the spread of COVID-19, is incomplete. The information
gathered using this surveillance mechanism will provide insight into
the role of animals in SARS-CoV-2 transmission and will also provide
context for understanding prevalence of linked human and animal
infections throughout the nation.
Positive SARS-CoV-2 animal samples must be confirmed by United
States Department of Agriculture (USDA) National Veterinary Services
Lab (NVSL); however, without the proposed surveillance mechanism, data
on linked human and animal transmission events which yield negative
results would not be tracked at the national level. CDC and USDA
guidance recommends state-level health authorities, namely state public
health veterinarians and state animal health officials, are involved in
approving and coordinating animal SARS-CoV-2 testing. These officials
are therefore the primary target audience for this surveillance form,
in addition to tribal, local and territorial health authorities. The
Zoonotic SARS-CoV-2 Event form includes questions intended to improve
our understanding of the number of cases state officials are asked to
consult upon regarding SARS-CoV-2 testing for potential zoonotic
transmission events, the proportion of those events that are tested for
SARS-CoV-2, and corresponding relevant epidemiological data
(epidemiological links to other cases of SARS-CoV-2 in people or
animals, clinical signs, etc.), results, etc. This form will fill a
needed gap over the next three years.
In addition to the primary reason for the Zooonotic SARS-CoV-2
Event form, it will also be used to replace paper-based reporting for
CDC-funded research. Currently, CDC's One Health Office has funded
surveillance and research at sites throughout the nation. This
surveillance form will be used to report all linked human and animal
testing for SARS-CoV-2 to CDC that is occurring through funded
surveillance activities, including the status and circumstances for
testing. This will relieve the requirement for less secure reporting
such as paper-based reporting forms sent through email.
More broadly, we expect this form may be generalized in the future
to encapsulate surveillance for other zoonotic respiratory viruses.
This surveillance form therefore offers the opportunity to test and
iterate upon surveillance mechanisms prior to the advancement of a
broader surveillance system.
One Health Case Investigation Form for Animals with SARS-CoV-2:
Currently, most animal samples that test positive for SARS-CoV-2 are
confirmed by USDA NVSL, and are reported to the World Organization for
Animal Health (OIE). However, the information collected is largely
restricted to
[[Page 9621]]
information on the animal case, including animal species, number of
affected animals, and clinical signs. Richer epidemiological data,
including the routes that animals become exposed to SARS-CoV-2 and
potential transmission events back to people, are needed to better
understand the zoonotic potential of SARS-CoV-2, whether transmission
is becoming sustained among animal populations, and the public health
risks that infected animals may pose. Through this data collection
tool, state and local public health and animal health officials will be
able to use a standardized approach to collect epidemiological data
while conducting One Health epidemiologic investigations over the
tool's expected reporting lifespan of three years.
CDC and USDA guidance recommends state-level health authorities,
namely state public health veterinarians and state animal health
officials, conduct follow-up investigations if and when an animal is
identified as positive for SARS-CoV-2. These officials, in addition to
other state, tribal, local, and territorial (STLT) collaborators
conducting research or surveillance within their jurisdiction are
therefore an appropriate target audience for this surveillance form.
This form involves voluntary reporting from STLT health officials
conducting epidemiological investigations to enter case information and
return it to CDC. This tool was designed by CDC staff at the request of
STLT partners.
These data will be used to describe the transmission dynamics and
natural history of SARS-CoV-2 infection. Specifically, this tool will
assist in collecting and compiling data to better understand the
zoonotic potential of SARS-CoV-2 from humans or other sources, and the
role animals infected with SARS-CoV-2 may play in onward transmission
to humans or other animals.
CDC requests approval for an estimated 9,000 annual burden hours
for this collection. There are no costs to respondents other than their
time to participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (hours)
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State, tribal, local, and territorial One Health Case 50 20 1
health officials. Investigation Form for
Animals with SARS-CoV-2.
State, tribal, local, and territorial One Health Consultation 80 400 15/60
health officials. Form.
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Jeffrey M. Zirger,
Lead,Information Collection Review Office,Office of Scientific
Integrity,Office of Science,Centers for Disease Control and Prevention.
[FR Doc. 2022-03708 Filed 2-18-22; 8:45 am]
BILLING CODE 4163-18-P
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