[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45228-45229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0198]


Mark Moffett; Conviction Reversal; Final Order Withdrawing 
Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order, 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act), withdrawing 
its January 25, 2023, order debarring Mark Moffett from providing 
services in any capacity to a person with an approved or pending drug 
product

[[Page 45229]]

application. FDA is issuing this order because the U.S. Court of 
Appeals for the First Circuit vacated Mr. Moffett's convictions and 
sentence.

DATES: The order is applicable July 14, 2023.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance 
and Enforcement, Office of Policy, Compliance, and Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn 
Dr., Rockville, MD 20857, 240-402-8743, [email protected].

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on January 25, 2023 (88 FR 4826), Mark Moffett was permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 
351 of the Public Health Service Act (42 U.S.C. 262). The debarment was 
based on FDA's finding, under section 306(a)(2)(B) of the FD&C Act (21 
U.S.C. 335a(a)(2)(B)), that Mr. Moffett had been convicted of a felony 
under Federal law for conduct relating to the regulation of any drug 
product.
    Mr. Moffett appealed the judgment of the District Court, and on 
November 18, 2022, the U.S. Court of Appeals for the First Circuit 
issued a judgment vacating Mr. Moffett's convictions as to all counts. 
On January 26, 2023, Mr. Moffett petitioned FDA for withdrawal of his 
debarment, citing section 306(d)(3)(B)(i) of the FD&C Act. Pursuant to 
section 306(d)(3)(B)(i) of the FD&C Act, ``If the conviction which 
served as the basis for the debarment of an individual under subsection 
(a)(2) . . . is reversed, the Secretary shall withdraw the order of 
debarment.''
    FDA has concluded that because the U.S. Court of Appeals for the 
First Circuit vacated Mr. Moffett's convictions, the order of debarment 
must be withdrawn. Accordingly, the Assistant Commissioner, Office of 
Human and Animal Food Operations, under section 306(d)(3)(B)(i) of the 
FD&C Act, under authority delegated to the Assistant Commissioner, is 
issuing this order withdrawing the order that permanently debarred Mark 
Moffett from providing services in any capacity to a person with an 
approved or pending drug product application.

    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14929 Filed 7-13-23; 8:45 am]
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