Notice2022-27673
Enforcement Policy Regarding Federal Veterinarian-Client-Patient Relationship Requirements To Facilitate Veterinary Telemedicine During the COVID-19 Outbreak; Withdrawal of Guidance
Primary source
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Published
December 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the guidance document entitled "Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak," which was issued in March 2020. FDA is withdrawing this guidance document in recognition that the conditions that created the need for the enforcement policy have evolved, such that the policy is no longer needed.
Full Text
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<title>Federal Register, Volume 87 Issue 244 (Wednesday, December 21, 2022)</title>
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[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Page 78111]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1140]
Enforcement Policy Regarding Federal Veterinarian-Client-Patient
Relationship Requirements To Facilitate Veterinary Telemedicine During
the COVID-19 Outbreak; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance document entitled ``Enforcement Policy
Regarding Federal VCPR Requirements to Facilitate Veterinary
Telemedicine During the COVID-19 Outbreak,'' which was issued in March
2020. FDA is withdrawing this guidance document in recognition that the
conditions that created the need for the enforcement policy have
evolved, such that the policy is no longer needed.
DATES: The withdrawal date is February 21, 2023.
FOR FURTHER INFORMATION CONTACT: William Flynn, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-5704, <a href="/cdn-cgi/l/email-protection#b1f0c2daf2e7fcf1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="5f1e2c341c09121f393b3e7137372c71383029">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in March 2020, the Agency published the guidance
document GFI #269, ``Enforcement Policy Regarding Federal VCPR
Requirements to Facilitate Veterinary Telemedicine During the COVID-19
Outbreak,'' recognizing the vital role veterinarians play in protecting
public health. In accordance with the process announced by the Agency
in the Federal Register on March 25, 2020 (85 FR 16949) for making
COVID-19-related guidances available to the public, the notice of
availability for the guidance published on May 12, 2020 (85 FR 28010).
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\1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
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When the COVID-19 public health emergency began in January 2020,
FDA understood that veterinarians might face challenges affecting their
ability to make on-premises examination of their patients. Given that
the Federal veterinarian-client-patient relationship (VCPR) definition
(21 CFR 530.3(i)) requires animal examination and/or medically
appropriate and timely visits to the premises where the animal(s) are
kept, the Federal VCPR definition cannot be met solely through
telemedicine. To facilitate veterinarians' ability to utilize
telemedicine to address animal health needs during the COVID-19
outbreak, FDA published GFI #269, stating that it intended to
temporarily suspend enforcement of a portion of the Federal VCPR
requirements. Specifically, FDA generally intended not to enforce the
animal examination and premises visit VCPR requirements relevant to FDA
regulations governing Extralabel Drug Use in Animals (21 CFR part 530)
and Veterinary Feed Directive Drugs (21 CFR 558.6).
FDA stated in the guidance that, given the temporary nature of this
policy, we planned to reassess it periodically and provide revision or
withdrawal of this guidance as necessary. The Agency acknowledges that
the public health emergency declared by the Secretary of Health and
Human Services for the COVID-19 pandemic continues to exist. However,
the conditions that created the need for the temporary enforcement
policy outlined in GFI #269 have evolved, such that the policy is no
longer needed. After careful review of current industry practices with
regard to on-premises animal examination and comments submitted to the
public docket associated with the guidance, the Agency has determined
the guidance document should be withdrawn.
Therefore, in accordance with 21 CFR 10.115(k), FDA is withdrawing
the ``Enforcement Policy Regarding Federal VCPR Requirements to
Facilitate Veterinary Telemedicine During the COVID-19 Outbreak''
guidance in its entirety.
II. Withdrawal Date
The withdrawal date for the guidance document discussed in this
document is February 21, 2023.
Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27673 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P
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