9158 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments 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.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. 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. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ 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 to 

read background documents or the 

electronic and written/paper comments 

received, 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. 

FOR FURTHER INFORMATION CONTACT: 

Sussan Paydar or Valerie Vashio, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Silver 

Spring, MD 20993–0002, 202–657–8533, 

CBERVRBPAC@fda.hhs.gov or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. On March 5, 

2024, the committee will meet in open 

session to discuss and make 

recommendations on the selection of 

strains to be included in the influenza 

virus vaccines for the 2024 to 2025 

influenza season. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at: https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before February 26, 

2024, will be provided to the 

Committee. Comments received on or 

after February 26, 2024, and by March 

4, 2024, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 1:30 p.m. and 2:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, along 

with their names, email addresses, and 

direct contact phone numbers of 

proposed participants, on or before 12 

p.m. Eastern Time on Friday, February 

16, 2024. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by 6 p.m. Wednesday, 

February 21, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Sussan Paydar 

or Valerie Vashio (See FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02709 Filed 2–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4717] 

Brendon Gagne: 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 

Brendon Gagne 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. 

Gagne was convicted of one felony 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 9159 

count under Federal law for conspiracy 

to smuggle goods into the United States. 

The factual basis supporting Mr. 

Gagne’s conviction, as described below, 

is conduct relating to the importation 

into the United States of a drug or 

controlled substance. Mr. Gagne 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 5, 2024 (30 days 

after receipt of the notice), Mr. Gagne 

had not responded. Mr. Gagne’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 February 

9, 2024. 

ADDRESSES: Any application by Mr. 

Gagne 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– 

4717. 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. 

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 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 August 31, 2023, Mr. Gagne 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 two offenses, one of which was for 

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 

from Mr. Gagne’s case, filed on March 

1, 2022, in the transcript from his guilty 

plea proceeding which was held on 

February 27, 2023, and from the 

Defendant’s sentencing brief filed on 

August 15, 2023, 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. 

Gagne’s role in the scheme was to 

receive, repackage, and reship 

prescription drugs he received from 

other co-conspirators outside of the 

United States that were purchased by 

customers on the website 

www.ExpressPCT.com. In addition, Mr. 

Gagne recruited, managed and, using 

the profits from the sale of the 

misbranded prescription drugs, paid 

others engaged in the scheme who also 

received, repackaged, and reshipped 

prescription drugs they received from 

other co-conspirators outside of the 

United States. 

As a result of this conviction, FDA 

sent Mr. Gagne, 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. Gagne’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 


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9160 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 

for conduct relating to the importation 

of any drug or controlled substance into 

the United States because Mr. Gagne 

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. 

Gagne’s offense and concluded that the 

offense warranted the imposition of a 5- 

year period of debarment. 

The proposal informed Mr. Gagne 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. 

Gagne received the proposal and notice 

of opportunity for a hearing on 

December 6, 2023. Mr. Gagne 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. Brendon 

Gagne 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. Gagne 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. Gagne is a prohibited 

act. 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02706 Filed 2–8–24; 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; HRSA Grantee Satisfaction 

Survey 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

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. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 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 11, 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: 

HRSA Grantee Satisfaction Survey: 

OMB No. 0906–0006—Revision. 

Abstract: HRSA plans to survey HRSA 

grant recipients to better understand 

their opinions about HRSA’s grants 

processes and to improve the way HRSA 

conducts business with them. This 

survey will focus on grantee customer 

satisfaction areas related to the grant life 

cycle, grantee relationships with HRSA 

staff (e.g., Project Officers, Grants 

Management Officers), technical 

assistance received from HRSA Bureaus 

and Offices, availability of grant 

resources, and grantee access to 

guidance and instructional documents, 

etc. The seven grants management areas, 

which are directly related to the grants 

life cycle, are: Customer Service/ 

Cooperation; Policies and Procedures; 

Pre-Award Phase; Award Phase; 

Reporting/Post-Award Administration; 

Technical Assistance; and Priorities for 

Improvement. Receiving this 

information from external customers 

will provide HRSA with a repository of 

information that will be incorporated 

into strategic efforts to improve grants 

management services and customer 

service. 

HRSA revised the planned survey to 

reflect a change in the sampling 

methodology. In past survey 

administration cycles, HRSA sent a 

single survey to each organization and 

asked them to complete the survey for 

the award they had received from HRSA 

for the longest time period. This past 

approach did not allow for a range of 

program-specific feedback from HRSA 

grantees. In this survey administration 

cycle, HRSA will send the survey to 

each individual grant project director 

and ask them to complete the survey for 

a specific award. This new approach 

will enable HRSA to obtain more 

granular and actionable information 

regarding the full range of grant awards 

received by HRSA awardees. 

Compared to the 60-day Federal 

Register notice, HRSA anticipates the 

number of potential survey respondents 

will increase from 3,690 to 7,813 due to 

the change in the sampling 

methodology. HRSA also anticipates an 

increase in the burden hours compared 

to the 60-day Federal Register notice, 

based on a reassessment of the time 

completion of the survey conducted 

during a pre-test. The adjusted average 

of completing the survey is 0.34 hours 

per response. 

A 60-day notice for this information 

collection was published in the Federal 

Register on March 10, 2023, Vol. 88, No. 

47; pp. 15053. There were no public 

comments. 

Need and Proposed Use of the 

Information: The HRSA Grantee 

Satisfaction Survey will provide 

meaningful and relevant results to 

agency decision-makers about various 

customer satisfaction domains (e.g., 

efficiency, timeliness, usefulness, 

responsiveness, quality of and overall 

satisfaction with HRSA project officers, 

products and services). The information 

collected will assist HRSA in its efforts 

to gauge, understand and respond to the 

needs and concerns of its customers, 

especially as they relate to the 

aforementioned areas. The survey 

results will provide HRSA with concrete 

indicators regarding the best areas in 

which to dedicate resources to improve 


ddrumheller on DSK120RN23PROD with NOTICES1