89458 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 

• Ph+ CML in CP with the T315I 

mutation. 

Subsequent to this approval, the 

USPTO received a patent term 

restoration application for SCEMBLIX 

(U.S. Patent No. 8,829,195) from 

Novartis AG, and the USPTO requested 

FDA’s assistance in determining the 

patent’s eligibility for patent term 

restoration. In a letter dated January 10, 

2023, FDA advised the USPTO that this 

human drug product had undergone a 

regulatory review period and that the 

approval of SCEMBLIX 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 

SCEMBLIX is 2,845 days. Of this time, 

2,717 days occurred during the testing 

phase of the regulatory review period, 

while 128 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: January 16, 

2014. The applicant claims December 

17, 2013, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

January 16, 2014, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: June 24, 2021. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SCEMBLIX (NDA 215358) was initially 

submitted on June 24, 2021. 

3. The date the application was 

approved: October 29, 2021. FDA has 

verified the applicant’s claim that NDA 

215358 was approved on October 29, 

2021. 

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 899 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: December 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28519 Filed 12–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–0926] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CYTALUX 

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 CYTALUX 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 drug 

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 February 26, 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 

June 24, 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 

February 26, 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 No. FDA– 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 89459 

2022–E–0926 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; CYTALUX.’’ 

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 biologic 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, CYTALUX 

(pafolacianine), which is indicated in 

adult patients with ovarian cancer as an 

adjunct for intraoperative identification 

of malignant lesions. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

CYTALUX (U.S. Patent No. 9,061,057) 

from Purdue Research Foundation, and 

the USPTO requested FDA’s assistance 

in determining the patent’s 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 

CYTALUX 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 

CYTALUX is 2,610 days. Of this time, 

2,274 days occurred during the testing 

phase of the regulatory review period, 

while 336 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: October 9, 

2014. The applicant claims September 

5, 2014, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

October 9, 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 drug product under section 505 

of the FD&C Act: December 29, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

CYTALUX (NDA 214907) was initially 

submitted on December 29, 2020. 

3. The date the application was 

approved: November 29, 2021. FDA has 

verified the applicant’s claim that NDA 

214907 was approved on November 29, 

2021. 

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 825 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 


ddrumheller on DSK120RN23PROD with NOTICES1
89460 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 

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: December 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28507 Filed 12–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–F–5500] 

Kemin Industries, Inc.; Filing of Food 

Additive Petition (Animal Use); 

Chromium Propionate; Correction 

AGENCY: Food and Drug Administration, 

HHS 

ACTION: Notification of petition; 

correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

entitled ‘‘Kemin Industries, Inc.; Filing 

of Food Additive Petition (Animal Use)’’ 

that appeared in the Federal Register of 

July 27, 2023. The document announced 

that we filed a petition, submitted by 

Kemin Industries, Inc., proposing that 

the food additive regulations be 

amended to provide for the safe use of 

chromium propionate to be used as a 

source of chromium in turkey feed. The 

document was published with an 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Wasima Wahid, Center for Veterinary 

Medicine (HFV–221), Food and Drug 

Administration, 12225 Wilkins Ave., 

Rockville, MD 20852, 240–402–5857, 

wasima.wahid@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Thursday, July 27, 

2023 (88 FR 48406) in FR Doc. 2023– 

15913, the following correction is made: 

On page 48406, in the first column, in 

the header of the document, ‘‘Docket 

No. FDA–2023–F–2415’’ is corrected to 

read ‘‘Docket No. FDA–2023–F–5500’’. 

Dated: December 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28512 Filed 12–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NRRC Member Conflict Meeting. 

Date: February 2, 2024. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Nursing 

Research, 6701 Democracy Boulevard, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Nisan Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of Nursing 

Research, NIH, 6701 Democracy Boulevard, 

Suite 668, Bethesda, MD 20892, 301–451– 

2405, nisan.bhattacharyya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: December 21, 2023. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–28566 Filed 12–26–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Initiation 

of NIDCD Hearing and Balance Translational 

Application. 

Date: January 22, 2024. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Shiguang Yang, DVM, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, NIDCD, NIH, 6001 

Executive Blvd., Room 8349 Bethesda, MD 

20892, 301–496–8683, yangshi@

nidcd.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Review of 

NIDCD Research Grant Applications for 

Translating Basic Research in Voice, Speech, 

and Language into Clinical Tools. 

Date: January 29, 2024. 

Time: 2:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Sonia Elena Nanescu, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, NIDCD, NIH, 6001 

Executive Blvd., Suite 8300, Bethesda, MD 

20892, (301) 496–8683, sonia.nanescu@

nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; NIDCD 

Clinical Research Center Grant (P50) Review. 

Date: January 31, 2024. 

Time: 1:30 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Kausik Ray, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Blvd., Rockville, MD 20852, 301– 

402–3587, rayk@nidcd.nih.gov. 

Name of Committee: Communication 

Disorders Review Committee 

Date: February 1–2, 2024. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Delta Hotels by Marriott at 

Anaheim-Garden Grove, Anaheim, CA 92840. 

Contact Person: Katherine Shim, Ph.D., 

Scientific Review Officer, Division of 


ddrumheller on DSK120RN23PROD with NOTICES1