Notice2023-14929
Mark Moffett; Conviction Reversal; Final Order Withdrawing Debarment Order
Primary source
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Published
July 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 application. FDA is issuing this order because the U.S. Court of Appeals for the First Circuit vacated Mr. Moffett's convictions and sentence.
Full Text
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<title>Federal Register, Volume 88 Issue 134 (Friday, July 14, 2023)</title>
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[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45228-45229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#395d5c5b584b545c574d4a795f5d581751514a175e564f"><span class="__cf_email__" data-cfemail="eb8f8e898a99868e859f98ab8d8f8ac5838398c58c849d">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 14, 2023.
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