Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 40537 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, RINVOQ 

(upadacitinib) indicated for the 

treatment of adults with moderately to 

severely active rheumatoid arthritis who 

have had an inadequate response or 

intolerance to methotrexate. Subsequent 

to this approval, the USPTO received a 

patent term restoration application for 

RINVOQ (U.S. Patent Nos. 8,962,629; 

RE47221) from AbbVie and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

April 5, 2021, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of RINVOQ 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

RINVOQ is 2,604 days. Of this time, 

2,365 days occurred during the testing 

phase of the regulatory review period, 

while 239 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: July 1, 2012. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on July 1, 2012. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 21, 2018. 

FDA has verified the applicant’s claim 

that new drug application (NDA) for 

RINVOQ (NDA 211675) was initially 

submitted on December 21, 2018. 

3. The date the application was 

approved: August 16, 2019. FDA has 

verified the applicant’s claim that NDA 

211675 was approved on August 16, 

2019. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 939 days or 989 

days of patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14431 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–2018–N–3728] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Collection of 

Conflict-of-Interest Information for 

Participation in Food and Drug 

Administration Non-Employee 

Fellowship and Traineeship Programs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on collection of 

conflict-of-interest information for 

participation in FDA employee 

fellowship and traineeship programs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 6, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 6, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 6, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 


khammond on DSKJM1Z7X2PROD with NOTICES
40538 Federal Register / Vol. 87, No. 129 / Thursday, July 7, 2022 / Notices 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• 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 written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3728 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Collection of Conflict-of-Interest 

Information for Participation in Food 

and Drug Administration Non-Employee 

Fellowship and Traineeship Programs.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 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.’’ The 

Agency 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 to 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 this 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Collection of Conflict-of-Interest 

Information for Participation in Food 

and Drug Administration NonEmployee Fellowship and Traineeship 

Programs 

OMB Control Number 0910–0882— 

Extension 

Section 742 (b) of the Food, Drug and 

Cosmetic Act (21 U.S.C. 379l) allows 

FDA to conduct and support intramural 

training programs through fellowship 

and traineeship programs. Prospective 

participants in these programs must 

complete financial disclosure forms to 

determine if there is a conflict of 

interest that would preclude 

participation. These new forms provide 

the FDA with information about 

financial investments and relationships 

from non-employee scientists who 

participate in FDA fellowship and 

traineeship programs. Participants in 

FDA fellowship and traineeship 

programs will be asked for certain 

information about financial interests 

and current relationships: (1) 

description of the financial interest; (2) 

the type of financial interest (e.g., 

stocks, bonds, stock options); (3) if the 

financial interest is an employee benefit 

from prior employment; (4) value of 

financial interest; (5) who owns the 

financial interest (e.g., self, spouse, 

minor children); (6) employment 

relationship with an FDA significantly 

regulated organization (SRO); and (7) 

service as a consultant to an FDA SRO, 

and/or proprietary interest(s) in one of 

more product(s) regulated by FDA, 

including a patent, trademark, 


khammond on DSKJM1Z7X2PROD with NOTICES
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