Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41725 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product ENSPRYNG 

(satralizumab-mwge). ENSPRYNG is 

indicated for the treatment of 

neuromyelitis optica spectrum disorder 

in adult patients who are antiaquaporin-4 antibody positive. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for ENSPRYNG (U.S. 

Patent Nos. 8,562,991; 10,022,319; 

10,662,245) from Genentech, Inc., and 

the USPTO requested FDA’s assistance 

in determining the patents’ eligibility 

for patent term restoration. In a letter 

dated March 1, 2021, FDA advised the 

USPTO that this human biological 

product had undergone a regulatory 

review period and that the approval of 

ENSPRYNG 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 

ENSPRYNG is 2,495 days. Of this time, 

2,128 days occurred during the testing 

phase of the regulatory review period, 

while 367 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 (21 U.S.C. 355(i)) 

became effective: October 18, 2013. The 

applicant claims October 20, 2013, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 18, 2013, 

which was the first date after receipt of 

the IND that the investigational studies 

were allowed to proceed. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): August 15, 2019. FDA has 

verified the applicant’s claims that the 

biologics license application (BLA) for 

ENSPRYNG (BLA 761149) was initially 

submitted on August 15, 2019. 

3. The date the application was 

approved: August 14, 2020. FDA has 

verified the applicant’s claims that BLA 

761149 was approved on August 14, 

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 81 days, 563 days, 

or 1,428 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: July 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14930 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food And Drug Administration 

[Docket No. FDA–2021–N–1322] 

Kris A. Hampton-Bey II: 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 Kris 

A. Hampton-Bey II 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. Hampton-Bey II engaged in a 

pattern of importing or offering for 

import misbranded drugs (i.e. in an 

amount, frequency, or dosage that is 

inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 

regulated by FDA. Mr. Hampton-Bey II 

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 

May 8, 2022 (30 days after receipt of the 

notice), Mr. Hampton-Bey II had not 

responded. Mr. Hampton-Bey II’s failure 

to respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is applicable July 13, 

2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 


jspears on DSK121TN23PROD with NOTICES1
41726 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

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 FDA finds, 

as required by section 306(b)(3)(D) of 

the FD&C Act, that the individual has 

engaged in a pattern of importing or 

offering for import adulterated or 

misbranded drugs (i.e. in an amount, 

frequency, or dosage that is inconsistent 

with personal or household use by the 

importer) that are not designated in an 

entry in an authorized electronic data 

interchange system as products 

regulated by FDA. 

After an investigation, FDA 

discovered that Mr. Hampton-Bey II has 

engaged in numerous instances of 

importing or offering for import 

misbranded drugs; all the parcels 

containing the misbranded drugs 

serving as the basis for this action, 

described in further detail below, were 

intercepted by FDA at either the Newark 

or Chicago International Mail Facilities 

(IMF) and were addressed to Mr. 

Hampton-Bey II at an address connected 

to him. 

On or about March 11, 2019, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

550 tablets of sildenafil citrate and was 

a misbranded drug because the article 

was determined to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label and because the 

article was determined to lack adequate 

directions for use. The product was 

refused entry on April 8, 2019. 

On or about June 25, 2019, Mr. 

Hampton-Bey II offered for import two 

parcels intercepted and processed by 

FDA at the Chicago IMF and which 

were addressed to him. FDA determined 

that the product contained in the first 

parcel was 850 tablets of Sildenafil Tabs 

100 MG and was a misbranded drug 

because the article was determined to 

lack adequate directions for use and 

because the article was determined to be 

a prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label. FDA 

determined that the product contained 

in the second parcel was 850 tablets of 

Sildenafil 100 MG Tabs and was a 

misbranded drug because the article was 

determined to lack adequate directions 

for use and because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. Both products were refused 

entry on July 17, 2019. 

On or about August 19, 2019, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

900 tablets of Sildenafil Tabs 100 MG 

and was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

because the article was determined to 

lack adequate directions for use. The 

product was refused entry on September 

12, 2019. 

On or about December 28, 2020, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of Sildenafil Tabs 100 MG 

and was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

because the article was determined to be 

a drug that was not included in a list 

required by section 510(j) of the FD&C 

Act (21 U.S.C. 360(j)). The product was 

refused entry on January 19, 2021. 

On or about December 29, 2020, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of sildenafil citrate and was 

a misbranded drug because the article 

was determined to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label. The product was 

refused entry on January 21, 2021. 

On or about December 29, 2020, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of sildenafil citrate and was 

a misbranded drug because the article 

was determined to lack adequate 

directions for use. The product was 

refused entry on January 22, 2021. 

On or about January 5, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of sildenafil and was a 

misbranded drug because the article was 

determined to lack adequate directions 

for use and because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. The product was refused 

entry on February 5, 2021. 

On or about January 6, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of Sildenafil Tablets 100 MG 

and was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

because the article had been determined 

to lack adequate directions for use. The 

product was refused entry on February 

1, 2021. 

On or about January 7, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the first product contained in this parcel 

was 850 tablets of sildenafil citrate and 

was a misbranded drug because the 

article was determined to be a 

prescription drug but did not include 

the symbol ‘‘Rx only’’ on its label and 

because the article had been determined 

to lack adequate directions for use. FDA 

determined that the second product 

contained in this parcel was 10 tablets 

of sildenafil citrate tablets and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label and because the article had 

been determined to lack adequate 

directions for use. Both products were 

refused entry on February 3, 2021. 

On or about March 4, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

87 tablets of sildenafil tablets and was 

a misbranded drug because the article 

was determined: (1) to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label; (2) not to bear a label 

containing the name and place of 

business of the manufacturer, packer, or 

distributor; (3) to be a drug that was not 

included in a list required by section 

510(j) of the FD&C Act; and (4) to be a 

drug that was manufactured, prepared, 

propagated, compounded, or processed 

in an establishment not duly registered 

under section 510 of the FD&C Act. The 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41727 

product was refused entry on April 5, 

2021. 

On or about March 17, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Newark IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

364 tablets of BEGMA–100 Sildenafil 

Citrate Tablets 100 MG and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. The product was refused 

entry on April 23, 2021. 

On or about March 24, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of sildenafil citrate and was 

a misbranded drug because the article 

was determined to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label. The product was 

refused entry on April 19, 2021. 

On or about April 20, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

800 tablets of Sildenafil 100 MG Tablets 

and was a misbranded drug because the 

article was determined to be a drug that 

was not included in a list required by 

section 510(j) of the FD&C Act. The 

product was refused entry on May 11, 

2021. 

As a result of this pattern of importing 

or offering for import misbranded drugs 

(i.e. in an amount, frequency, or dosage 

that is inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 

regulated by FDA, in accordance with 

section 306(b)(3)(D) of the FD&C Act, 

FDA sent Mr. Hampton-Bey II, by 

certified mail on April 4, 2022, a notice 

proposing to debar him for a 5-year 

period from importing or offering for 

import any drug 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. 

Hampton-Bey II’s pattern of conduct 

and concluded that his conduct 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. HamptonBey II of the proposed debarment and 

offered him an opportunity to request a 

hearing, providing 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. Hampton-Bey II received the 

proposal and notice of opportunity for 

a hearing on April 8, 2022. Mr. 

Hampton-Bey II 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)(D) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Kris A. 

Hampton-Bey II has engaged in a pattern 

of importing or offering for import 

misbranded drugs (i.e. in an amount, 

frequency, or dosage that is inconsistent 

with his personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. FDA finds 

that this pattern of conduct 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. Hampton-Bey II is debarred for a 

period of 5 years from importing or 

offering for import any drug into the 

United States, applicable (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. 

Hampton-Bey II is a prohibited act. 

Any application by Mr. Hampton-Bey 

II for termination of debarment under 

section 306(d)(1) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–1322 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 http://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: July 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14899 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–2275] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BLENREP 

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 BLENREP and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 12, 2022. 

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 

January 9, 2023. 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 

September 12, 2022. 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, 


jspears on DSK121TN23PROD with NOTICES1