Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 11289 

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 ERVEBO (Ebola 

Zaire Vaccine, Live). ERVEBO is 

indicated for the prevention of disease 

caused by Zaire ebolavirus in 

individuals 18 years of age and older. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for ERVEBO (U.S. Patent 

No. 8,012,489) from Merck Sharp & 

Dohme Corp., and the USPTO requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated August 20, 

2020, FDA advised the USPTO that this 

human biological product had 

undergone a regulatory review period 

and that the approval of ERVEBO 

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 

ERVEBO is 1,941 days. Of this time, 

1,783 days occurred during the testing 

phase of the regulatory review period, 

while 158 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: August 28, 2014. The 

applicant claims September 20, 2014, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was August 28, 2014, 

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): July 15, 2019. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

ERVEBO (BLA 125690) was initially 

submitted on July 15, 2019. 

3. The date the application was 

approved: December 19, 2019. FDA has 

verified the applicant’s claim that BLA 

125690/0 was approved on December 

19, 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 application for patent extension, 

this applicant seeks 1,038 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. 2024–03030 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–0771; FDA– 

2022–E–0772; and FDA–2022–E–0780] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; REACTIV8 SYSTEM 

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 REACTIV8 SYSTEM 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 a 

patent which claims that medical 

device. 

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 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 


ddrumheller on DSK120RN23PROD with NOTICES1
11290 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 

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–0771; FDA–2022–E–0772; and 

FDA–2022–E–0780 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

REACTIV8 SYSTEM.’’ 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, 

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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(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 medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device REACTIV8 SYSTEM. 

REACTIV8 SYSTEM is indicated for 

bilateral stimulation of the L2 medial 

branch of the dorsal ramus as it crosses 

the transverse process at L3 as an aid in 

the management of intractable chronic 

low back pain associated with 

multifidus muscle dysfunction, as 

evidenced by imaging or physiological 

testing in adults who have failed 

therapy, including pain medications 

and physical therapy, and are not 

candidates for spine surgery. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for REACTIV8 SYSTEM 

(U.S. Patent Nos. 8,606,358; 9,474,906; 

and 9,861,811) from Mainstay Medical 

Limited, and the USPTO requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated September 

28, 2022, FDA advised the USPTO that 

this medical device had undergone a 

regulatory review period and that the 

approval of REACTIV8 SYSTEM 

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 

REACTIV8 SYSTEM is 1,729 days. Of 

this time, 1,436 days occurred during 

the testing phase of the regulatory 

review period, while 293 days occurred 

during the approval phase. These 

periods of time were derived from the 

following dates: 

1. The date an exemption for this 

device, under section 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360j(g)), became 

effective: September 24, 2015. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption for human tests to begin, as 

required under section 520(g) of the 

FD&C Act, became effective September 

24, 2015. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): August 29, 2019. 

FDA has verified the applicant’s claim 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices 11291 

that the premarket approval application 

(PMA) for REACTIV8 SYSTEM (PMA 

P190021) was initially submitted 

August 29, 2019. 

3. The date the application was 

approved: June 16, 2020. FDA has 

verified the applicant’s claim that PMA 

P190021 was approved on June 16, 

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 591 days, 812 days, 

or 1,011 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. 2024–03026 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–2171; FDA– 

2022–E–2172; and FDA–2022–E–2173] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TACK ENDOVASCULAR 

SYSTEM (4F, 1.5–4.5 MILLIMETERS) 

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 TACK ENDOVASCULAR SYSTEM 

(4F, 1.5–4.5 MILLIMETERS (MM)) 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 a 

patent which claims that medical 

device. 

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–2171; FDA–2022–E–2172; and 

FDA–2022–E–2173 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; TACK 

ENDOVASCULAR SYSTEM (4F, 1.5–4.5 

MM).’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1