85646 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

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, VIZIMPRO 

(dacomitinib) indicated for the first-line 

treatment of patients with metastatic 

non-small cell lung cancer with 

epidermal growth factor receptor exon 

19 deletion or exon 21 L858R 

substitution mutations as detected by an 

FDA-approved test. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

VIZIMPRO (U.S. Patent No. 7,772,243) 

from Warner-Lambert Co. LLC and the 

USPTO requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

November 29, 2019, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

VIZIMPRO 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 

VIZIMPRO is 4,794 days. Of this time, 

4,554 days occurred during the testing 

phase of the regulatory review period, 

while 240 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: August 14, 

2005. The applicant claims August 15, 

2005, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was August 14, 2005, 

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: January 31, 2018. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

VIZIMPRO (NDA 211288) was initially 

submitted on January 31, 2018. 

3. The date the application was 

approved: September 27, 2018. FDA has 

verified the applicant’s claim that NDA 

211288 was approved on September 27, 

2018. 

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 1,493 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 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27012 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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 on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Research 

Opportunities for New Investigators to 

Promote Workforce Diversity. 

Date: December 12, 2023. 

Time: 12:00 p.m. to 1:00 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: 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. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: December 4, 2023. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–26943 Filed 12–7–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 


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