Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 40539 

copyright, or licensing agreement. The 

purpose of the financial information is 

for FDA to determine if there is a 

conflict of interest between the Fellow’s 

or Trainee’s financial and relationship 

interests and their activities at FDA. The 

collection of information is mandatory 

to participate in FDA’s fellowship and 

traineeship programs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Oak Ridge Institute for Science and Education Fellowship 500 500 500 1 500 

Traineeship Program ........................................................... 500 500 500 1 500 

Reagan Udall Fellowship at FDA ........................................ 50 50 50 1 50 

Total .............................................................................. ........................ ........................ ........................ ........................ 1050 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: June 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14439 Filed 7–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1358] 

Jhanna Novikov: 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 

Jhanna Novikov 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 Ms. 

Novikov was convicted of one felony 

count under Federal law for smuggling 

goods into the United States. The factual 

basis supporting Ms. Novikov’s 

conviction, as described below, is 

conduct relating to the importation into 

the United States of a drug or controlled 

substance. Ms. Novikov was given 

notice of the proposed debarment and 

was given an opportunity to request a 

hearing to show why she should not be 

debarred. As of April 8, 2022 (30 days 

after receipt of the notice), Ms. Novikov 

had not responded. Ms. Novikov’s 

failure to respond and request a hearing 

within the prescribed timeframe 

constitutes a waiver of her right to a 

hearing concerning this matter. 

DATES: This order is applicable July 7, 

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)(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 December 9, 2021, Ms. Novikov 

was convicted, as defined in section 

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

District Court for the Southern District 

of Florida-West Palm Beach Division, 

when the court accepted her guilty plea 

and entered judgment against her for the 

offense of smuggling goods into the 

United States, in violation of 18 U.S.C. 

545. 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, 

filed on July 28, 2021, and the plea 

agreement, filed on September 30, 2021, 

both from Ms. Novikov’s case, on July 

25, 2018, Ms. Novikov agreed to treat 

the facial wrinkles of an individual who 

was an undercover investigator with the 

Florida Department of Health with 

‘‘fillers’’ for $600 and ‘‘BOTOX’’ for 

$300. BOTOX, or botulinum neurotoxin 

Type A, is the most well-known 

neurotoxin approved by FDA to treat 

facial wrinkles. On August 10, 2018, the 

investigator returned to Ms. Novikov’s 

residence for her ‘‘BOTOX’’ treatment, 

and as Ms. Novikov made preparations 

and drew a liquid into a syringe, agents 

from FDA’s Office of Criminal 

Investigations (OCI) entered and took 

control of her residence. After obtaining 

a warrant, OCI agents searched Ms. 

Novikov’s home. Agents seized various 

vials of white powder from Ms. 

Novikov’s residence, including two 

labeled ‘‘NEUROXIN Botulinum Toxin 

Type A,’’ 14 labeled ‘‘CASPIS,’’ and one 

with no label. Analysis by the FDA 

Forensic Chemistry Center determined 

that the two Neuroxin vials, a sample of 

four of the Caspis vials, and the 

unlabeled vial all contained botulinum 

toxin, the active ingredient in BOTOX; 

however, a search of FDA records 

revealed that these drugs had not been 

approved by FDA and were unapproved 

new drugs as well as misbranded drugs. 

Agents did not find any BOTOX or other 

FDA-approved drugs containing 

botulinum toxin in Ms. Novikov’s home. 

A subsequent forensic examination of 

Ms. Novikov’s cell phone, which had 

been seized by OCI agents, revealed that 

she had imported these unapproved 

new drugs from Mexico, in violation of 

the FD&C Act, and Ms. Novikov had 

been importing such drugs since 2016. 

As a result of this conviction, FDA 

sent Ms. Novikov, by certified mail, on 

March 1, 2022, a notice proposing to 

debar her 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 Ms. Novikov’s felony conviction 

under Federal law for smuggling goods 

into the United States, in violation of 18 


khammond on DSKJM1Z7X2PROD with NOTICES
40540 Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 

U.S.C. 545, was for conduct relating to 

the importation into the United States of 

any drug or controlled substance 

because she illegally imported 

unapproved new drugs containing 

botulinum toxin to use in treatments she 

conducted on individuals for money. 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 Ms. 

Novikov’s offense and concluded that 

the offense warranted the imposition of 

a 5-year period of debarment. 

The proposal informed Ms. Novikov 

of the proposed debarment, offered her 

an opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Novikov received the proposal and 

notice of opportunity for a hearing at 

her residence on March 9, 2022. Ms. 

Novikov failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and 

waived any contentions concerning her 

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 Ms. Jhanna 

Novikov 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, 

Ms. Novikov 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 or controlled substance by, with 

the assistance of, or at the direction of 

Ms. Novikov is a prohibited act. 

Any application by Ms. Novikov for 

termination of debarment under section 

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

identified with Docket No. FDA–2021– 

N–1358 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

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: June 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14433 Filed 7–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Lists of Designated Primary Medical 

Care, Mental Health, and Dental Health 

Professional Shortage Areas 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice informs the public 

of the availability of the complete lists 

of all geographic areas, population 

groups, and facilities designated as 

primary medical care, dental health, and 

mental health professional shortage 

areas (HPSAs) in a designated status as 

of April 29, 2022. The lists are available 

on the shortage area topic page on 

HRSA’s data.hrsa.gov website. Given 

the COVID–19 pandemic’s impact on 

the health workforce and health care 

service delivery, HRSA is providing a 

longer transition time for jurisdictions 

and facilities to prepare for potential 

change of HPSA designations. HPSA 

designations that are currently proposed 

for withdrawal will remain in this status 

until they are re-evaluated in 

preparation for the publication of the 

2023 HPSA Federal Register Notice. If 

these HPSAs do not meet the 

requirements for designation at the time 

of the publication of the July 2023 

HPSA Federal Register Notice next 

year, they will be withdrawn. This 

additional time will allow jurisdictions 

to re-evaluate their HPSAs against the 

designation criteria, and plan for 

potential changes in staffing. 

ADDRESSES: Complete lists of HPSAs 

designated as of April 29, 2022, and 

updated information on HPSAs are 

available on the website at https://

data.hrsa.gov/topics/health-workforce/ 

shortage-areas. Information on shortage 

designations is available at https://

bhw.hrsa.gov/workforce-shortage-areas/ 

shortage-designation. 

FOR FURTHER INFORMATION CONTACT: For 

further information on the HPSA 

designations listed on the website or to 

request additional designation, 

withdrawal, or reapplication for 

designation, please contact Janelle D. 

McCutchen, DHEd, MPH, CHES, Chief, 

Shortage Designation Branch, Division 

of Policy and Shortage Designation, 

Bureau of Health Workforce (BHW), 

HRSA, 5600 Fishers Lane, Room 

11W14, Rockville, Maryland 20857, 

sdb@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 332 of the Public Health 

Service (PHS) Act, 42 U.S.C. 254e, 

provides that the Secretary shall 

designate HPSAs based on criteria 

established by regulation. HPSAs are 

defined in section 332 to include (1) 

urban and rural geographic areas with 

shortages of health professionals, (2) 

population groups with such shortages, 

and (3) facilities with such shortages. 

Section 332 further requires that the 

Secretary annually publish lists of the 

designated geographic areas, population 

groups, and facilities. The lists of 

HPSAs are to be reviewed at least 

annually and revised as necessary. 

Final regulations (42 CFR part 5) were 

published in 1980 that include the 

criteria for designating HPSAs. Criteria 

were defined for seven health 

professional types: primary medical 

care, dental, psychiatric, vision care, 

podiatric, pharmacy, and veterinary 

care. The criteria for correctional facility 

HPSAs were revised and published on 

March 2, 1989 (54 FR 8735). The criteria 

for psychiatric HPSAs were expanded to 

mental health HPSAs on January 22, 

1992 (57 FR 2473). Currently funded 

PHS Act programs use only the primary 

medical care, mental health, or dental 

HPSA designations. 

HPSA designation offers access to 

potential federal assistance. Public or 

private nonprofit entities are eligible to 

apply for assignment of National Health 

Service Corps personnel to provide 

primary medical care, mental health, or 

dental health services in or to these 

HPSAs. National Health Service Corps 

health professionals enter into service 

agreements to serve in federally 

designated HPSAs. Entities with clinical 

training sites located in HPSAs are 

eligible to receive priority for certain 

residency training program grants 

administered by HRSA’s Bureau of 

Health Workforce (BHW). Other federal 

programs also utilize HPSA 

designations. For example, under 

authorities administered by the Centers 

for Medicare and Medicaid Services, 

certain qualified providers in 

geographic area HPSAs are eligible for 


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