[Federal Register Volume 87, Number 35 (Tuesday, February 22, 2022)]
[Notices]
[Pages 9620-9621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                     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