Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 11299 

other countries. Mr. Lucien then 

reshipped the misbranded prescription 

drugs according to instructions he 

received from co-conspirators. In 

exchange for Mr. Lucien’s participation 

in the scheme, he received free or 

discounted prescription drugs. 

As a result of this conviction, FDA 

sent Mr. Lucien, by United Parcel 

Service, on November 17, 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. Lucien’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. Lucien’s 

offense and concluded that the offense 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. Lucien 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. 

Lucien received the proposal and notice 

of opportunity for a hearing at his 

residence on November 20, 2023. Mr. 

Lucien 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. Ross 

Lucien 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. Lucien 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. Lucien is a prohibited 

act. 

Dated: February 9, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03020 Filed 2–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–2205; FDA– 

2022–E–2206; FDA–2022–E–2207; FDA– 

2022–E–2208; FDA–2022–E–2243; FDA– 

2022–E–2244; and FDA–2022–E–2246] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; WINLEVI 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for WINLEVI and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of 

patents which claim that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by April 15, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 12, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 15, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 Nos. FDA– 

2022–E–2205; FDA–2022–E–2206; 

FDA–2022–E–2207; FDA–2022–E–2208; 

FDA–2022–E–2243; FDA–2022–E–2244; 

and FDA–2022–E–2246 for 

‘‘Determination of Regulatory Review 

Period for Purposes of Patent Extension; 

WINLEVI.’’ 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. 


ddrumheller on DSK120RN23PROD with NOTICES1
11300 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 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.’’ 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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

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 or biological 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 WINLEVI 

(clascoterone). WINLEVI is indicated for 

the topical treatment of acne vulgaris in 

patients 12 years of age and older. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for WINLEVI (U.S. Patent 

Nos. 8,143,240; 8,785,427; 8,865,690; 

9,211,295; 9,433,628; 9,486,458; and 

10,159,682) from Cassiopea S.p.A., and 

the USPTO requested FDA’s assistance 

in determining the patents’ eligibility 

for patent term restoration. In a letter 

dated September 21, 2022, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

WINLEVI 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 

WINLEVI is 3,102 days. Of this time, 

2,736 days occurred during the testing 

phase of the regulatory review period, 

while 366 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: March 1, 2012. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on March 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: August 27, 2019. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

WINLEVI (NDA 213433) was initially 

submitted on August 27, 2019. 

3. The date the application was 

approved: August 26, 2020. FDA has 

verified the applicant’s claim that NDA 

213433 was approved on August 26, 

2020. 

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 489 days, 877 days, 

909 days, 1,042 days, 1,252 days, 1,297 

days, or 1,721 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: February 9, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03022 Filed 2–13–24; 8:45 am] 

BILLING CODE 4164–01–P 


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