13722 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 

Charlene Parks at (410)-786–8684 or 

Charlene.Parks@cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03676 Filed 2–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2113] 

Taylor McLaren: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Taylor McLaren 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. McLaren was 

convicted of one felony count under 

Federal law for conspiracy to smuggle 

goods into the United States. The factual 

basis supporting Mr. McLaren’s 

conviction, as described below, is 

conduct relating to the importation into 

the United States of a drug or controlled 

substance. Mr. McLaren 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 January 8, 2024 (30 days 

after receipt of the notice), Mr. McLaren 

had not responded. Mr. McLaren’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 

23, 2024. 

ADDRESSES: Any application by Mr. 

McLaren 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 

• 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– 

2113. 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, 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 March 2, 2023, Mr. McLaren 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 his case, filed on March 1, 2022, 

and August 22, 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. 

McLaren was recruited by Brendon 

Gagne to receive, repackage, and reship 

prescription drugs Mr. McLaren 

received from co-conspirators outside of 

the United States that were purchased 

by customers on the website 

www.ExpressPCT.com. In Mr. 

McLaren’s plea agreement, he 

acknowledged he knew that receiving 

and reshipping prescription drugs in 

this manner was illegal. Later on, Mr. 

McLaren recruited at least one other 

person to be involved in the scheme by 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 13723 

also receiving misbranded prescription 

drugs from overseas suppliers. 

As a result of this conviction, FDA 

sent Mr. McLaren, by certified mail, on 

November 30, 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. McLaren’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. McLaren’s 

offense and concluded that the offense 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. McLaren 

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. 

McLaren received the proposal and 

notice of opportunity for a hearing on 

December 9, 2023. Mr. McLaren 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. Taylor 

McLaren 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. McLaren 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. McLaren is a prohibited 

act. 

Dated: February 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03650 Filed 2–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Scientific Registry of 

Transplant Recipients Information 

Collection Effort for Potential Donors 

for Living Organ Donation OMB No. 

0906–0034—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. The initial notice 

was published on November 17, 2023, 

with a 60-day comment period. No 

comments were received. OMB will 

accept comments from the public during 

the 30-day comment period for this 

notice. OMB may act on HRSA’s ICR 

only after the 30-day comment period 

for this notice has closed. 

DATES: Comments on this ICR should be 

received no later than March 25, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Scientific Registry of Transplant 

Recipients Information Collection Effort 

for Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension. 

Abstract: The Scientific Registry of 

Transplant Recipients (SRTR) is 

administered under contract with 

HRSA, an agency within HHS. HHS is 

authorized to establish and maintain 

mechanisms to evaluate the long-term 

effects associated with living organ 

donations (42 U.S.C. 273a) and is 

required to submit to Congress an 

annual report on the long-term health 

effects of living donation (42 U.S.C. 

273b). The Organ Procurement and 

Transplantation Network final rule, 42 

CFR part 121.11(b)(2), requires organ 

procurement organizations and 

transplant hospitals, ‘‘as specified from 

time to time by the Secretary,’’ to submit 

to the SRTR, as appropriate, information 

regarding ‘‘donors of organs’’ and ‘‘other 

information that the Secretary deems 

appropriate.’’ 

In 2018, a pilot living donor registry 

was implemented by the SRTR, and 

each participating transplant program 

registered all potential candidates for 

living donation who provided informed 

consent to enroll. In 2019, an updated 

version of the data collection instrument 

was approved, followed by the latest 

data collection forms which were 

approved on February 26, 2021. These 

data collection modifications were 

intended to improve the quality of the 

data and reduce the administrative 

burden for respondents. This Federal 

Register notice requests an extension of 

the last approved data collection forms 

(February 2021) with no changes to the 

total estimated annualized burden 

hours. 

A 60-day notice published in the 

Federal Register on November 17, 2023, 

vol. 88, No. 221; pp. 80318–19. There 

were no public comments. 

Need and Proposed Use of the 

Information: The transplant programs 

submit health information collected at 

the time of donation evaluation through 

a secure web-based data collection tool 

developed by the SRTR contractor. The 

SRTR contractor maintains contact with 

registry participants and collects data on 

long-term health outcomes through 

surveys. The data collection includes 

outcomes of evaluation, including 

reasons for non-donation. The living 

donor registry is an ongoing effort, and 

the goal is to continue to collect data on 

living organ donor transplant programs 

in the United States over time. 

Monitoring and reporting of long-term 

health outcomes of living organ donors 

post-donation will continue to provide 

useful information to transplant 

programs for their future donor 

selection process and to aid potential 


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