Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 87785 

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 27, 2023, Mr. Funaro 

was convicted, as defined in section 

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

District Court for the Western District of 

Michigan, when the court entered 

judgment against him for the offense 

conspiracy to launder money in 

violation of 18 U.S.C. 1956(h), 

1956(a)(1)(A)(i), and 1956(a)(1)(B)(i). 

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. 

Funaro’s case, filed on March 1, 2022, 

and July 29, 2022, respectively, 

beginning in or about 2018 and 

continuing until in or about October 

2021 several individuals ran a website, 

www.ExpressPCT.com, which sold 

misbranded prescription drugs as well 

as some Schedule III and Schedule IV 

controlled substances in the United 

States without requiring a prescription. 

The drugs were manufactured overseas 

and then shipped in bulk to the United 

States to domestic redistributors. The 

packages did not declare their illicit 

contents and instead took steps to 

conceal their true nature. Once the 

packages entered the United States, the 

redistributors sent the bulk orders to 

second tier U.S. based distributors who 

then finally shipped the drugs to the 

customers, making the purchasers think 

their drugs came from the United States 

and not from overseas. Part of Mr. 

Funaro’s role in the scheme was to route 

some of the customer payments for the 

misbranded drugs made through 

www.ExpressPCT.com through a series 

of accounts in an effort to conceal the 

source of the funds. Mr. Funaro also 

converted proceeds into cryptocurrency 

which he used, in part, to pay 

redistributors of the misbranded drugs. 

Mr. Funaro also sent some of the funds 

to various pharmaceutical companies in 

India in order to purchase additional 

drugs and thus continue the scheme. 

As a result of this conviction, FDA 

sent Mr. Funaro, by certified mail, on 

September 6, 2023, a notice proposing 

to debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Funaro’s felony conviction 

under Federal law for conspiracy to 

launder money in violation of 18 U.S.C. 

1956(h), 1956(a)(1)(A)(i), and 

1956(a)(1)(B)(i), was for conduct relating 

to the importation into the United States 

of any drug or controlled substance 

because he was involved in a scheme to 

illegally import and introduce 

misbranded prescription drugs into the 

United States. 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. Funaro’s offense and concluded 

that the offense warranted the 

imposition of a 5-year period of 

debarment. 

The proposal informed Mr. Funaro 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. 

Funaro received the proposal and notice 

of opportunity for a hearing on 

September 11, 2023. Mr. Funaro 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 Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. James 

Funaro has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

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. Funaro is debarred for a period of 

5 years from importing or offering for 

import any drug 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 any 

drug by, with the assistance of, or at the 

direction of Mr. Funaro is a prohibited 

act. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27854 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2080] 

Jeremy Walenty: 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 (the FD&C Act) debarring 

Jeremy Walenty 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. 

Walenty was convicted of one felony 

count under Federal law for conspiracy 

to smuggle goods into the United States. 

The factual basis supporting Mr. 

Walenty’s conviction, as described 

below, is conduct relating to the 

importation into the United States of a 

drug or controlled substance. Mr. 

Walenty 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 

October 15, 2023 (30 days after receipt 

of the notice), Mr. Walenty had not 

responded. Mr. Walenty’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is effective December 

19, 2023. 

ADDRESSES: Any application by Mr. 

Walenty for termination of debarment 


lotter on DSK11XQN23PROD with NOTICES1
87786 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 

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

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

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 

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–2023–N– 

2080. 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. 

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 

(21 U.S.C. 335a(b)(1)(D)) permits 

debarment of an individual from 

importing or offering for import any 

drug into the United States if the 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 24, 2023, Jeremy 

Walenty was convicted as defined in 

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

U.S. District Court for Western District 

of Michigan when the court accepted 

his plea of guilty and 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. 

The underlying facts supporting the 

conviction are as follows: 

As contained in the indictment and 

plea agreement from Mr. Walenty’s case, 

filed on March 1, 2022, and July 15, 

2022, respectively, Brendon Gagne 

owned and operated 

www.ExpressPCT.com, which sold 

misbranded prescription drugs, 

obtained from overseas suppliers, and 

sold to customers in the United States 

without requiring a prescription. Mr. 

Walenty was recruited by Brendon 

Gagne to receive, repackage, and reship 

the misbranded prescription drugs he 

received from coconspirators outside of 

the United States that were purchased 

by customers on the website 

www.ExpressPCT.com. In Mr. Walenty’s 

plea agreement he acknowledged that he 

knew that receiving and reshipping 

prescription drugs in this manner was 

illegal. Later on, Mr. Walenty also began 

receiving bulk shipments of prescription 

drugs from coconspirators in the U.S. 

which had originally been sent to these 

coconspirators from overseas suppliers. 

Mr. Walenty then would use these 

shipments to fulfill orders that 

customers had placed on 

www.ExpressPCT.com, without ever 

seeing a prescription from these 

customers. In exchange for Mr. 

Walenty’s participation in the scheme, 

Mr. Walenty received monetary 

compensation. 

As a result of this conviction, FDA 

sent Mr. Walenty, by certified mail, on 

September 6, 2023, a notice proposing 

to debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Walenty’s felony conviction 

under Federal law for conspiracy to 

smuggle goods into the United States in 

violation of 18 U.S.C. 371 and 545, was 

for conduct relating to the importation 

into the United States of any drug or 

controlled substance because he was 

involved in a scheme to illegally import 

and introduce prescription drugs into 

the United States. 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. Walenty’s 

offense and concluded that the offense 

warranted the imposition of a 5 year 

period of debarment. 

The proposal informed Mr. Walenty 

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. 

Walenty received the proposal and 

notice of opportunity for a hearing on 

September 15, 2023. Mr. Walenty failed 

to request a hearing within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 87787 

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(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Jeremy 

Walenty has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

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. Walenty is debarred for a period of 

5 years from importing or offering for 

import any drug 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 any 

drug by, with the assistance of, or at the 

direction of Mr. Walenty is a prohibited 

act. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27855 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5431] 

Hospira, Inc., et al.; Withdrawal of 

Approval of Eight Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of eight 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

January 18, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived the 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 063081 ........ Tobramycin Sulfate, Injectable, Equivalent to (EQ) 1.2 milligrams (mg) base/milliliters (mL), EQ 1.6 mg base/mL, EQ 

80 mg base/100 mL.

Hospira, Inc., 275 North Field Dr., Building H1–3S, Lake 

Forest, IL 60045. 

ANDA 063112 ........ Tobramycin Sulfate, Injection, EQ 10 mg base/mL ............... Do. 

ANDA 078907 ........ Fentanyl Citrate, Troche/Lozenges, EQ 0.2 mg base, EQ 

0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2 

mg base, EQ 1.6 mg base.

SpecGx LLC, 385 Marshall Ave., Webster Groves, MO 

63119. 

ANDA 080629 ........ Promethazine Hydrochloride (HCl), Injectable, 50 mg/mL .... Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Parkway, Building A, Parsippany, NJ 07054. 

ANDA 091170 ........ Zoledronic Acid, Injectable, EQ 4 mg base/5 mL .................. Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 

201, Berlin, CT 06037. 

ANDA 201846 ........ Azelastine HCl, Metered Spray, 0.2055 mg/spray ................. Apotex Corp, U.S. Agent for Apotex Inc., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. 

ANDA 207698 ........ Nevirapine Extended-Release Tablets, 400 mg .................... Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo 

Pharma Limited, 279 Princeton-Hightstown Rd., East 

Windsor, NJ 08520. 

ANDA 208616 ........ Nevirapine Extended-Release Tablets, 100 mg .................... Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 18, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in the table without an approved 

new drug application or ANDA violates 

sections 505(a) and 301(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 

are listed in the table that are in 

inventory on January 18, 2024 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27853 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0026] 

Apothecon, et al.; Withdrawal of 

Approval of 103 New Drug 

Applications and 35 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on February 11, 2009. The 


lotter on DSK11XQN23PROD with NOTICES1