[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91408-91409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26917]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1178]
Kevin Sheng Hsiang Fang: Final 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) debarring
Kevin Sheng Hsiang Fang for a period of 5 years from importing articles
of food or offering such articles for importation into the United
States. FDA bases this order on a finding that Mr. Fang was convicted
of a felony count under Federal law for conduct relating to the
importation into the United States of an article of food. Mr. Fang was
given notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of July 1,
2024 (30 days after receipt of the notice), Mr. Fang has not responded.
Mr. Fang's failure to respond and request a hearing constitutes a
waiver of Mr. Fang's right to a hearing concerning this matter.
DATES: This order is applicable November 19, 2024.
ADDRESSES: Any application by Mr. Fang for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted at any time as follows:
Electronic Submissions
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the
[[Page 91409]]
application as a written/paper submission and in the manner detailed
(see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2024-N-1178. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, 240-402-
8743, or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act permits FDA to debar an
individual from importing an article of food or offering such an
article for import into the United States if FDA finds, as required by
section 306(b)(3)(A) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any food.
On February 26, 2024, Mr. Fang was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U. S. District Court for the
Central District of California, when the court entered judgment against
him, after his plea of guilty, to the offense of importing merchandise
contrary to law in violation of 18 U.S.C. 545 and 18 U.S.C. 2(b). The
underlying facts supporting the conviction are as follows: As contained
in the information from his case, Mr. Fang worked as a manager at a
company called Heng Xing Foods, Inc., which was a business entity that
imported shipments of Chinese roasted eel as a food wholesaler. Mr.
Fang also imported shipments of Chinese roasted eel as a food
wholesaler and did business as Young Chang Trading Co., Ltd. in or
about October 16, 2017, in Los Angeles County. Mr. Fang knowingly and
fraudulently imported and brought, and willfully caused to be imported
and brought, Chinese roasted eel adulterated with Gentian Violet and
Leucogentian Violent, both being new unsafe animal drugs, into the
United States and contrary to law.
As a result of this conviction, FDA sent Mr. Fang, by certified
mail, on May 29, 2024, a notice proposing to debar him for a 5-year
period from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Fang's felony
conviction under Federal law for importing merchandise contrary to law
in violation of 18 U.S.C. 545 and 18 U.S.C. 2(b), was for conduct
relating to the importation into the United States of an article of
food because the offense involved Mr. Fang and his company importing
roasted eel adulterated with Gentian Violet and Leucogentian Violent,
both being new unsafe animal drugs. In proposing a debarment period,
FDA weighed the considerations set forth in section 306(c)(3) of the
FD&C Act that it considered applicable to Mr. Fang's offense and
concluded that the offense warranted the imposition of a 5-year period
of debarment.
The proposal informed Mr. Fang of the proposed debarment and
offered him an opportunity to request a hearing, providing him 30 days
from the date of receipt of the letter in which to file the request,
and advised him that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Mr. Fang received the proposal and notice of opportunity for a
hearing on June 1, 2024. Mr. Fang failed to request a hearing within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(b)(1)(C) of the FD&C
Act, under authority delegated to the Division of Field Enforcement
Director, finds that Mr. Kevin Sheng Hsiang Fang has been convicted of
a felony under Federal law for conduct relating to the importation into
the United States of an article of food and that he is subject to a 5-
year period of debarment. FDA finds that the offense should be accorded
a debarment period of 5 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding, Mr. Fang is debarred for a
period of 5 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Mr. Fang is
a prohibited act.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26917 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P