[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Page 78111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected].

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


