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[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
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