41724 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Templates and Open-ended Requests ........................................................... 1,000 1 10 10,000 

Estimated Total Annual Burden 

Hours: 40,500. 

Authority: Social Security Act, Sec. 

1110 [42 U.S.C. 1310]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–14896 Filed 7–12–22; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2361; FDA– 

2020–E–2362; and FDA–2020–E–2363] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENSPRYNG 

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 ENSPRYNG 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 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 applicants 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, 

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– 

2020–E–2361; FDA–2020–E–2362; and 

FDA–2020–E–2363 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

ENSPRYNG.’’ 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 § 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, 


jspears on DSK121TN23PROD with NOTICES1
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