11296 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 

(PMA) for VIVISTIM SYSTEM (PMA 

P210007) was initially submitted March 

2, 2021. 

3. The date the application was 

approved: August 27, 2021. FDA has 

verified the applicant’s claim that PMA 

P210007 was approved on August 27, 

2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,359 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03025 Filed 2–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4094] 

Kalpen D. Patel: 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) permanently 

debarring Kalpen D. Patel from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Mr. Patel 

was convicted of a felony under Federal 

law for conduct that relates to the 

regulation of any drug product under 

the FD&C Act. Mr. Patel was given 

notice of the proposed permanent 

debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred within 

the timeframe prescribed by regulation. 

Mr. Patel responded to the notice by 

submitting correspondence to FDA, but 

he did not request a hearing. Mr. Patel’s 

failure to request a hearing within the 

prescribed timeframe constitutes a 

waiver of his right to a hearing 

concerning this action. 

DATES: This order is applicable February 

14, 2024. 

ADDRESSES: Any application by Mr. 

Patel for special termination of 

debarment under section 306(d)(4) of 

the FD&C Act (21 U.S.C. 335a(d)(4)) may 

be submitted as follows: 

Electronic Submissions 

D 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. 

D If you want to submit an application 

with confidential information that you 

do not wish to be made available to the 

public, submit the application as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

D 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. 

D 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–2023–N– 

4094. 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. 

D 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 Compliance 

and Enforcement, Office of Policy, 

Compliance, and Enforcement, Office of 

Regulatory Affairs, Food and Drug 

Administration, 240–402–8743, 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 11297 

I. Background 

Section 306(a)(2)(B) of the FD&C Act 

requires debarment of an individual 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application if 

FDA finds that the individual has been 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

any drug product under the FD&C Act. 

On September 7, 2023, Mr. Patel was 

convicted, as defined in section 

306(l)(1) of the FD&C Act, in the U.S. 

District Court for the Eastern District of 

Texas-Beaumont Division, when the 

court accepted his plea of guilty and 

entered a judgment against him for the 

felony offense of conspiracy to traffick 

in drugs with counterfeit mark in 

violation of 18 U.S.C. 371 and 18 U.S.C. 

2320(a)(4). 

The factual basis for this conviction is 

as follows: as contained in the Second 

Superseding Indictment and in the 

Factual Basis, between approximately 

April 2014 and February 2021, Mr. Patel 

conspired with drug traffickers to 

distribute misbranded and counterfeit 

cough syrup. Specifically, Mr. Patel 

worked for Pernix Manufacturing LLC 

(Pernix) as a product-development 

scientist. Pernix had, in January 2014, 

entered into an agreement with Byron 

A. Marshall and his drug trafficking 

organization (DTO) to copy and 

manufacture cough syrup according to 

the directions of Marshall and his 

associates. Marshall was not licensed or 

authorized to distribute cough syrup, 

and any background check of the 

personal information provided by 

Marshall to Pernix would have revealed 

that he was not a licensed physician as 

he claimed. Marshall sought to copy 

Actavis Prometh VC with Codeine 

(Actavis). Actavis is a purple, peachmint flavor prescription cough syrup 

that was in demand as a street drug. 

Marshall and his associates wanted to 

mass produce and traffic a counterfeit 

version of Actavis that contained 

promethazine, but not codeine. 

On April 24, 2014, Actavis Holdco US 

discontinued production of Actavis due 

to its widespread abuse by recreational 

drug users. In his role at Pernix as a 

product-development scientist, Mr. 

Patel worked with Marshall and his 

associates to recreate Actavis without 

codeine and promethazine in order to 

recreate the syrup base, which is a 

necessary component of cough syrup. 

Mr. Patel referred to the new product as 

a ‘‘placebo.’’ Marshall and his associates 

would then add promethazine to this 

counterfeit ‘‘placebo’’ substance prior to 

bottling and distribution in order to 

create the street drug. 

On April 25, 2014, as Pernix was 

scaling-up production of the ‘‘placebo’’ 

syrup base, Pernix was acquired by 

Woodfield Pharmaceutical LLC, a 

contract manufacturing company, and 

Woodfield Distribution LLC, a thirdparty logistics company (collectively, 

Woodfield). Mr. Patel was subsequently 

promoted to Woodfield’s Research and 

Development Manager. In that role he 

supervised Woodfield’s chemical 

formulation development, optimization, 

and scale-up for clients, and he worked 

with Marshall and his associates to 

develop and distribute the misbranded 

and counterfeit cough syrup. When 

Marshall and his DTO had difficulty 

dissolving promethazine into the 

‘‘placebo’’ syrup base, Mr. Patel, along 

with others, worked to resolve that 

issue. 

In or about July 2017, Marshall and 

his DTO asked Mr. Patel to reformulate 

another cough syrup to use in their drug 

trafficking scheme: Hi-Tech 

Promethazine Hydrocholoride and 

Codeine Phosphate Oral Solution (HiTech). Mr. Patel reformulated Hi-Tech 

without the promethazine and codeine, 

and Woodfield began producing it for 

Marshall and his DTO. Later, Mr. Patel 

was promoted to Woodfield’s Director of 

Technical Operations, and in that role, 

he agreed with other Woodfield 

employees to create additional 

‘‘placebo’’ syrup base supply not 

authorized by Woodfield’s ownership in 

order to sell that additional supply to 

Marshall and DTO at a reduced price 

and split the fee with other Woodfield 

employees. 

On or about December 10, 2019, 

Marshall and his DTO asked Mr. Patel 

to reformulate another cough syrup to 

use in their drug trafficking scheme: 

Wockhardt Promethazine Syrup Plain 

(Wockhardt). Mr. Patel reformulated 

Wockhardt, and Woodfield eventually 

produced the ‘‘placebo’’ syrup base for 

Marshall and his DTO. 

Initially, there were no batch records 

to document the production of the 

‘‘placebo’’ cough syrups as required; 

Woodfield provided the syrup to 

Marshall and his DTO without any 

corresponding documentation that 

identified the ingredients of the syrup. 

This practice continued until February 

2019, when Mr. Patel started creating 

paper records for some of the cough 

syrup batches Woodfield made for the 

DTO. Based on the records that do exist 

and Mr. Patel’s own statements, from 

2014 through February 2021, the 

conspiracy with the Marshall DTO 

produced and distributed, or attempted 

to produce and distribute, 

approximately 65,920 gallons of 

counterfeit cough syrup. 

Based on this conviction, FDA sent 

Mr. Patel by certified mail on October 

30, 2023, a notice proposing to 

permanently debar him 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)(B) of the FD&C Act, that Mr. 

Patel was convicted, as set forth in 

section 306(l)(1) of the FD&C Act, of a 

felony under Federal law for conduct 

relating to the regulation of a drug 

product under the FD&C Act. The 

proposal also offered Mr. Patel 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 

file a timely request for a hearing would 

constitute an election not to use the 

opportunity for a hearing and a waiver 

of any contentions concerning this 

action. Mr. Patel received the proposal 

on November 8, 2023. On December 12, 

2023, Mr. Patel submitted 

correspondence to FDA explaining the 

reasons why he believed he was not 

guilty of the offenses he pled guilty to 

in court. However, in his request he did 

not request a hearing and has, therefore, 

waived his opportunity for a hearing 

and any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Patel has 

been convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. 

As a result of the foregoing finding, 

Mr. Patel 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)(B) 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 Mr. 

Patel during his 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 Mr. Patel provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment, he 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 


ddrumheller on DSK120RN23PROD with NOTICES1
11298 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 

drug application from Mr. Patel during 

his period of debarment, other than in 

connection with an audit under 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, or 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: February 9, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03036 Filed 2–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2180] 

Ross Lucien: 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 Ross 

Lucien for a period of 5 years from 

importing or offering for import any 

drug into the United States. FDA bases 

this order on a finding that Mr. Lucien 

was convicted of one felony count 

under Federal law for conspiracy to 

smuggle goods into the United States. 

The factual basis supporting Mr. 

Lucien’s conviction, as described below, 

is conduct relating to the importation 

into the United States of a drug or 

controlled substance. Mr. Lucien was 

given notice of the proposed debarment 

and was given an opportunity to request 

a hearing to show why he should not be 

debarred. As of December 20, 2023 (30 

days after receipt of the notice), Mr. 

Lucien had not responded. Mr. Lucien’s 

failure to respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is applicable February 

14, 2024. 

ADDRESSES: Any application by Mr. 

Lucien for termination of debarment 

under section 306(d)(1) of the FD&C Act 

(21 U.S.C. 335a(d)(1)) may be submitted 

as follows: 

Electronic Submissions 

D 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. 

D If you want to submit an application 

with confidential information that you 

do not wish to be made available to the 

public, submit the application as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

D 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. 

D 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–2023–N– 

2180. 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. 

D 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, 240–402–7500, 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

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, at 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(D) of the FD&C Act 

permits debarment of an individual 

from importing or offering for import 

any drug into the United States if FDA 

finds, as required by section 306(b)(3)(C) 

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 drug or controlled 

substance. 

On February 23, 2023, Mr. Lucien was 

convicted, as defined in section 

306(l)(1) of FD&C Act, in the United 

States District Court for Western District 

of Michigan, when the court entered 

judgment against him for the offense of 

conspiracy to smuggle goods into the 

United States in violation of 18 U.S.C. 

371 and 545. FDA’s finding that 

debarment is appropriate is based on the 

felony conviction referenced herein. 

The factual basis for this conviction is 

as follows: as contained in the 

indictment and plea agreement in Mr. 

Lucien’s case, both filed on May 6, 

2022, Mr. Lucien agreed to participate 

in a scheme to receive, repackage, and 

reship misbranded prescription drugs 

purchased by customers on the website 

www.ExpressPCT.com, without a 

prescription, and shipped to the United 

States from foreign countries. Mr. 

Lucien received approximately 11 

packages containing bulk quantities of 

misbranded prescription drugs, all 

shipped mostly from India but also from 


ddrumheller on DSK120RN23PROD with NOTICES1