Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102917 

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. 6200, 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, BYLVAY 

(odevixibat) indicated for the treatment 

of pruritis in patients 3 months of age 

and older with progressive familial 

intrahepatic cholestasis. Subsequent to 

this approval, the USPTO received 

patent term restoration applications for 

BYLVAY (U.S. Patent Nos. 9,694,018, 

10,011,633, and 10,093,697) from 

Albireo Pharma, Inc. (agent for Albireo 

AB) and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated January 18, 2024, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of BYLVAY 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 

BYLVAY is 1,868 days. Of this time, 

1,625 days occurred during the testing 

phase of the regulatory review period, 

while 243 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: June 10, 2016. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 10, 2016. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: November 20, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

BYLVAY (NDA 215498) was initially 

submitted on November 20, 2020. 

3. The date the application was 

approved: July 20, 2021. FDA has 

verified the applicant’s claim that NDA 

215498 was approved on July 20, 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 applications for patent extension, 

this applicant seeks 630 days, 679 days, 

or 861 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 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29966 Filed 12–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; 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 


khammond on DSK9W7S144PROD with NOTICES
102918 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel: Mechanism for TimeSensitive Research Opportunities in 

Environmental Health Sciences (R21). 

Date: January 15, 2025. 

Time: 11:30 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute of 

Environmental Health Sciences, Keystone 

Building, 530 Davis Drive, Durham, NC 

27709. 

Meeting Format: Virtual Meeting. 

Contact Person: Murali Ganesan, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training (DERT), National Institute of 

Environmental Health Sciences, National 

Institutes of Health, Keystone Building, 

Room 3097, Research Triangle Park, NC 

27713, Phone: 984–287–4674, Email: 

murali.ganesan@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: December 12, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–29836 Filed 12–17–24; 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; EarlyStage Dissemination and Implementation 

Research in Communication Disorders. 

Date: January 16, 2025. 

Time: 12:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: Virtual Meeting. 

Contact Person: Andrea B. Kelly, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Boulevard, Room 8351, Bethesda, 

MD 20892, (301) 451–6339, kellya2@nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Inner Ear 

Imaging RFA Review. 

Date: January 30, 2025. 

Time: 1:30 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: 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: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; NIDCD 

Institutional Research Training Opportunities 

Review. 

Date: January 31, 2025. 

Time: 1:00 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: Virtual Meeting. 

Contact Person: Andrea B. Kelly, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Boulevard, Room 8351, Bethesda, 

MD 20892, (301) 451–6339, kellya2@nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; NIDCD 

Clinical Research Center Grant (P50) Review. 

Date: February 6, 2025. 

Time: 1:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: 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: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; 

Chemosensory Fellowship Review Meeting. 

Date: February 11, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Meeting Format: 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; Hearing 

and Balance Fellowship Review. 

Date: February 21, 2025. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Hilton Garden Inn Seaworld 

Orlando, FL. 

Meeting Format: Virtual Meeting. 

Contact Person: Martin Basch, Ph.D., 

Scientific Review Officer, NIH/NIDCD, 

Scientific Review Branch, 6001 Executive 

Blvd., Suite 8300, Bethesda, MD 20892, (301) 

496–9693, martin.basch@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: December 12, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–29910 Filed 12–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 

Drug Abuse Special Emphasis Panel; HEAL 

Initiative: Translating Research to Practice to 

End the Overdose Crisis. 


khammond on DSK9W7S144PROD with NOTICES