91408 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 

to participate in the CDAD clinical trial, 

received and taken the study 

medication, provided stool samples, 

completed the required documents and 

journals, and participated in 

assessments conducted by the clinical 

investigator. In addition, Ms. Portela 

Martinez knew that 10 or more 

individuals’ means of identification 

were used unlawfully or without 

authority in furtherance of the 

conspiracy. Specifically, Ms. Portela 

Martinez, along with some of her coconspirators, used the means of 

identification of real persons, to create 

subject identification numbers for those 

persons, and then used those subject 

identification numbers to falsely portray 

the persons as legitimate subjects in the 

CDAD clinical trial, when in fact they 

were not. In addition, Ms. Portela 

Martinez along with her co-conspirators 

submitted her own stool and blood 

samples to make it appear as if they 

came from study participants. 

Furthermore, Ms. Portela Martinez 

was one of only two individuals who 

inputted CDAD clinical trial data in the 

Almac Clinical Technology Integrated 

Response Technology database (Almac 

database). The information in the Almac 

database was the foundation for all 

subsequent subject CDAD clinical trial 

data. Ms. Portela Martinez repeatedly 

entered false and fabricated subject 

screening and randomization 

information in the Almac database. 

Ms. Portela Martinez received $19,620 

in proceeds for the CDAD clinical trial. 

AMB received over $277,000 for the 

CDAD clinical trial. 

FDA sent Ms. Portela Martinez, by 

certified mail, on August 12, 2024, a 

notice proposing to permanently debar 

her from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. The proposal was based on 

a finding, under section 306(a)(2)(A) of 

the FD&C Act, that Ms. Portela Martinez 

was convicted of a felony under Federal 

law for conduct relating to the 

development or approval, including the 

process of development or approval, of 

any drug product. The proposal 

informed Ms. Portela Martinez of the 

proposed debarment and offered her an 

opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Portela Martinez received the proposal 

and notice of opportunity for a hearing 

on August 15, 2024. Ms. Portela 

Martinez failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and 

waived any contentions concerning her 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Division of Field 

Enforcement Director, Office of 

Inspections and Investigations, under 

section 306(a)(2)(A) of the FD&C Act, 

under authority delegated to the 

Division of Field Enforcement Director, 

finds that Ms. Ivette Maria Portela 

Martinez has been convicted of a felony 

under Federal law for conduct relating 

to the development or approval, 

including the process of development or 

approval, of any drug product. 

As a result of the foregoing finding, 

Ms. Portela Martinez is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application, 

effective (see DATES) (see sections 

306(a)(2)(A) and 306(c)(2)(A)(ii) of the 

FD&C Act). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses in any capacity the 

services of Ms. Portela Martinez during 

her debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. 

Portela Martinez provides services in 

any capacity to a person with an 

approved or pending drug product 

application during her period of 

debarment, she will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug application from Ms. Portela 

Martinez during her period of 

debarment, other than in connection 

with an audit under section 306 of the 

FD&C Act (section 306(c)(1)(B) of the 

FD&C Act). Note that, for purposes of 

sections 306 and 307 of the FD&C Act, 

a ‘‘drug product’’ is defined as a ‘‘drug 

subject to regulation under section 505, 

512, or 802 of the FD&C Act [(21 U.S.C. 

355, 360b, 382)] or under section 351 of 

the Public Health Service Act [(42 

U.S.C. 262)]’’ (section 201(dd) of the 

FD&C Act (21 U.S.C. 321(dd))). 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26912 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 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 

debarments@fda.hhs.gov. 

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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