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 


ddrumheller on DSK120RN23PROD with NOTICES1
13724 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 

living organ donors in their decision to 

pursue living donation. 

Likely Respondents: Potential and 

actual living donors, transplant 

programs, medical and scientific 

organizations, and public organizations, 

including patient advocacy groups. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Potential Living Donor Registration Form ............................ a 16 c 112 c 1,792 e 0.27 484 

Potential Living Donor Follow-up Form ............................... b 754 1 d 754 f 0.50 377 

Reasons Did Not Donate Form (Liver or Kidney) ............... a 16 c 106 c 1,696 g 0.23 390 

Total .............................................................................. a 786 ........................ 4,242 ........................ 1,251 

a Number of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to participate. b Number of living donor candidates that submitted follow-up forms in 2019. 

c Derived from the number of forms submitted by transplant programs in 2019. 

dTotal number of Living Donor Collective follow-up forms submitted by living donor candidates in 2019. 

eBased on a 2019 survey of transplant programs submitting data to the Living Donor Collective. 

fBased on internal testing and user feedback. 

gBased on discussion and interviews with staff at participating transplant programs in 2019–2020. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–03759 Filed 2–22–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Allergy, Immunology, and 

Transplantation Research Committee (AITC) 

Special Emphasis Panel. 

Date: March 18, 2024. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G31B, 

Rockville, MD 20852 (Video Assisted 

Meeting). 

Contact Person: James T. Snyder, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G31B, Rockville, MD 

20852, (240) 669–5060, james.snyder@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 16, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–03669 Filed 2–22–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Center for Scientific 

Review Advisory Council. 

This will be held in-person and will 

be open to the public as indicated 

below. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

register at: https://public.csr.nih.gov/ 

AboutCSR/Organization/CSRAdvisory

Council/Registration. 

The meeting can be viewed remotely 

via the NIH Videocasting website: 

https://videocast.nih.gov/watch=54186. 

Name of Committee: Center for Scientific 

Review Advisory Council. 

Date: March 25, 2024. 

Time: 9:30 a.m. to 3:30 p.m. 

Agenda: Provide advice to the Director, 

Center for Scientific Review (CSR), on 

matters related to planning, execution, 

conduct, support, review, evaluation, and 

receipt and referral of grant applications at 

CSR. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Conference Room 160–A, Bethesda, MD 

20892. 

Contact Person: Bruce Reed, Ph.D., Deputy 

Director, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Bethesda, MD 20892, (301) 594–9159, 

reedbr@mail.nih.gov. 

Any interested person may file written 

comments with the committee by 

forwarding the statement to the Contact 

Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. In 

the interest of security, NIH has 


ddrumheller on DSK120RN23PROD with NOTICES1