8264 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 

report, please visit https://www.fda.gov/ 

media/154873/download. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://pdufa-hrassessment.eventbrite.com. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by March 14, 2022, 11:59 p.m. 

Eastern Time. We will let registrants 

know if registration closes before the 

day of the public meeting. 

If you need special accommodations 

due to a disability, please contact 

Patricia Stewart (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 8, 2022. 

Requests for Oral Presentations: 

During online registration, you may 

indicate if you wish to present during a 

public comment session, and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and request time for a 

joint presentation. Following the close 

of registration, we will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

March 11, 2022. All requests to make 

oral presentations must be received by 

March 8, 2022, 11:59 p.m. Eastern Time. 

If selected for presentation, any 

presentation materials must be emailed 

to Patricia Stewart (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 11, 2022. No commercial or 

promotional material will be permitted 

to be presented at the public meeting. 

Streaming Webcast of the public 

meeting: The webcast for this public 

meeting is accessible at https://pdufahr-assessment.eventbrite.com. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03097 Filed 2–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0304] 

Brian Michael Parks: 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 

Brian Michael Parks for a period of 5 

years from importing or offering for 

import any article of food (including 

dietary supplements) or drug into the 

United States. FDA bases this order on 

a finding that Mr. Parks was convicted 

of one felony count under Federal law 

for distribution of an unapproved new 

drug with the intent to defraud and 

mislead. The factual basis supporting 

Mr. Parks’ conviction, as described 

below, is conduct relating to the 

importation into the United States of 

any food and of any drug or controlled 

substance. Mr. Parks 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 November 17, 2021 (30 days after 

receipt of the notice), Mr. Parks had not 

responded. Mr. Parks’ 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, 2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

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

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) 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 food. 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 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 16, 2021, Mr. Parks 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 

Virginia, after his plea of guilty, when 

the court entered judgment against him 

for the offense of distribution of an 

unapproved new drug with the intent to 

defraud and mislead, in violation of 

sections 301(d) and 303(a)(2) of the 

FD&C Act 21 U.S.C. 331(d) and 

333(a)(2). The 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 information in 

Mr. Parks’ case, filed on November 23, 

2020, he was the owner and operator of 

MedFitRX Inc., later known as MedFit 

Sarmacuticals Inc. (collectively referred 

to as MedFitRX herein), a purported 

sport supplement company based in 

North Carolina. MedFitRX imported 

Selective Androgen Receptor 

Modulators (SARMs) in order to use 

them in MedFitRx products. SARMs are 

synthetic chemicals designed to mimic 

the effects of testosterone and other 

anabolic steroids. From approximately 

March 2016 to September 2019, Mr. 

Parks imported SARMs and other drug 

active ingredients from China on 

multiple occasions. The drug active 

ingredients he imported included MK– 

677, S–4, MK–2866, GW–501516, LGD– 

4033, and RAD140, among others. In 

addition, on or about May 17, 2018, Mr. 

Parks sold two MedFitRX products to 

undercover FDA Office of Criminal 

Investigation agents posing as 

consumers. The first product Mr. Parks 

sold to these undercover agents, Lucky 

SARMS Magical AF, contained the 

drugs S–23 and SR9009, which he had 

caused to be imported into the United 

States. The second product, Estrovert, 


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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices 8265 

contained the anabolic steroid 

Methyldienolone, a controlled 

substance prohibited under the Designer 

Steroid Act, 21 U.S.C. 802(41), which 

Mr. Parks also caused to be imported 

into the United States. Mr. Parks worked 

with others to conceal the importation 

of these and other unapproved drugs as 

they were disguised and misdeclared as 

articles of food, specifically ‘‘biscuit mix 

powder,’’ ‘‘corn powder,’’ ‘‘grain mix 

powder,’’ ‘‘bread mix powder,’’ and 

‘‘milk tea powder.’’ Mr. Parks then 

included these drug active ingredients 

in MedFitRX products, which were 

unapproved drugs that he introduced 

and delivered for introduction into 

interstate commerce. Mr. Parks 

knowingly marketed these MedFitRX 

products as ‘‘dietary supplements’’ and 

‘‘sports supplements’’ to create the 

impression they were safe and legal to 

use, and otherwise intentionally failed 

to include certain drug active 

ingredients on the product labels. 

As a result of this conviction, FDA 

sent Mr. Parks, by certified mail, on 

October 12, 2021, a notice proposing to 

debar him for a 5-year period from 

importing or offering for import any 

article of food or drug into the United 

States. The proposal was based on a 

finding under section 306(b)(1)(C) and 

(b)(3)(C) of the FD&C Act that Mr. Parks’ 

felony conviction of distribution of an 

unapproved new drug with the intent to 

defraud and mislead constitutes 

conduct relating to the importation into 

the United States of an article of food 

and any drug or controlled substance 

because Mr. Parks illegally imported 

unapproved drugs into the United 

States, working with others to disguise 

and misdeclare them as articles of food, 

and then distributed those unapproved 

drugs to consumers in the United States, 

marketing them as ‘‘dietary 

supplements’’ and ‘‘sports 

supplements.’’ 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. Parks’ 

offense, and concluded that the felony 

offense warranted the imposition of a 5- 

year period of debarment. 

The proposal informed Mr. Parks 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. 

Parks received the proposal and notice 

of opportunity for a hearing on October 

18, 2021. Mr. Parks 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)(1)(C) and (b)(3)(C) of the FD&C 

Act, under authority delegated to the 

Assistant Commissioner, finds that Mr. 

Brian Michael Parks has been convicted 

of a felony under Federal law for 

conduct relating to the importation into 

the United States of an article of food 

and of a drug or controlled substance, 

and that he is subject to a 5-year period 

of debarment. 

As a result of the foregoing finding, 

Mr. Parks is debarred for a period of 5 

years from importing or offering for 

import articles of food or any drug or 

controlled substances into the United 

States, applicable (see DATES). Pursuant 

to section 301(cc) of the FD&C Act, the 

importing or offering for import into the 

United States of an article of food or of 

any drug or controlled substance by, 

with the assistance of, or at the direction 

of Mr. Parks is a prohibited act. 

Any application by Mr. Parks for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2021– 

N–0304 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: February 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03098 Filed 2–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Infant and Maternal Mortality (Formerly 

the Advisory Committee on Infant 

Mortality) 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Infant and Maternal 

Mortality (ACIMM or Committee) has 

scheduled a public meeting. Information 

about ACIMM and the agenda for this 

meeting can be found on the ACIMM 

website at https://www.hrsa.gov/ 

advisory-committees/infant-mortality/ 

index.html. 

DATES: March 15, 2022, 12:00 p.m. to 

4:00 p.m. Eastern Time and March 16, 

2022, 12:00 p.m. to 4:00 p.m. Eastern 

Time. 

ADDRESSES: This meeting will be held 

virtually via webinar. The webinar link 

and log-in information will be available 

at the ACIMM website before the 

meeting: https://www.hrsa.gov/advisorycommittees/infant-mortality/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Anne Leitch, Maternal and Child Health 

Bureau, HRSA, 5600 Fishers Lane, 

Rockville, Maryland 20857; 301–443– 

1321; or SACIM@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACIMM is 

authorized by section 222 of the Public 

Health Service Act (42 U.S.C. 217a), as 

amended. The Committee is governed 

by provisions of Public Law 92–463, as 

amended, (5 U.S.C. App. 2), which sets 

forth standards for the formation and 

use of Advisory Committees. 

The ACIMM advises the Secretary of 

Health and Human Services (Secretary) 

on department activities, partnerships, 

policies, and programs directed at 

reducing infant mortality, maternal 

mortality and severe maternal 

morbidity, and improving the health 

status of infants and women before, 

during, and after pregnancy. The 

Committee provides advice on how to 

coordinate federal, state, local, tribal, 

and territorial governmental efforts 

designed to improve infant mortality, 

related adverse birth outcomes, and 

maternal health, as well as influence 

similar efforts in the private and 

voluntary sectors. The Committee 

provides guidance and 

recommendations on the policies, 

programs, and resources required to 

address the disparities and inequities in 

infant mortality, related adverse birth 

outcomes and maternal health 

outcomes, including maternal mortality 

and severe maternal morbidity. With its 

focus on underlying causes of the 

disparities and inequities seen in birth 

outcomes for women and infants, the 

Committee advises the Secretary on the 

health, social, economic, and 

environmental factors contributing to 

the inequities and proposes structural, 

policy, and/or systems level changes. 


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