National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting, 85646 [2023-26943]
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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.
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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
VerDate Sep<11>2014
16:50 Dec 07, 2023
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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]
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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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Page 85646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26943]
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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, [email protected].
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
