Center for Scientific Review; Notice of Closed Meeting, 85646-85647 [2023-26942]
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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
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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
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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]
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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 / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Epidemiology and Population Sciences.
Date: December 15, 2023.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rebecca I Tinker, MS,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20817, (301) 435–0637,
tinkerri@csr.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. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 4, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–26942 Filed 12–7–23; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2023–0673]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0024
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0024, Safety Approval of Cargo
Containers; without change. Our ICR
describes the information we seek to
collect from the public. Before
submitting this ICR to OIRA, the Coast
Guard is inviting comments as
described below.
DATES: Comments must reach the Coast
Guard on or before February 6, 2024.
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SUMMARY:
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You may submit comments
identified by Coast Guard docket
number [USCG–2023–0673] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–6P), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, Stop
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: A.L.
Craig, Office of Privacy Management,
telephone 202–475–3528, or fax 202–
372–8405, for questions on these
documents.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. 3501 et seq., chapter 35, as
amended. An ICR is an application to
OIRA seeking the approval, extension,
or renewal of a Coast Guard collection
of information (Collection). The ICR
contains information describing the
Collection’s purpose, the Collection’s
likely burden on the affected public, an
explanation of the necessity of the
Collection, and other important
information describing the Collection.
There is one ICR for each Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) the practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology.
In response to your comments, we
may revise this ICR or decide not to seek
an extension of approval for the
Collection. We will consider all
comments and material received during
the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
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85647
ICR and the docket number of this
request, [USCG–2023–0673], and must
be received by February 6, 2024.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
submissions in response to this
document, see DHS’s eRulemaking
System of Records notice (85 FR 14226,
March 11, 2020).
Information Collection Request
Title: Safety Approval of Cargo
Containers.
OMB Control Number: 1625–0024.
Summary: This information collection
is associated with requirements for
owners and manufacturers of cargo
containers to submit information and
keep records associated with the
approval and inspection of those
containers. This information is required
to ensure compliance with the
International Convention for Safe
Containers (CSC), see 46 U.S.C. 80503.
Need: This collection of information
addresses the reporting and
recordkeeping requirements for
containers in 49 CFR parts 450 through
453. These rules are necessary since the
U.S. is signatory to the CSC. The CSC
requires all containers to be safety
approved prior to being used in trade.
These rules prescribe only the minimum
requirements of the CSC.
Forms: None.
Respondents: Owners and
manufacturers of containers, and
organizations that the Coast Guard
delegates to act as an approval
authority.
Frequency: On occasion.
Hour Burden Estimate: The estimated
burden has increased from 129,345
hours to 159,678 hours a year, due to an
increase in the estimated annual
number of responses.
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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85646-85647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26942]
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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
[[Page 85647]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Topics in Epidemiology and Population Sciences.
Date: December 15, 2023.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rebecca I Tinker, MS, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, Bethesda, MD 20817, (301) 435-0637, [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. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: December 4, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2023-26942 Filed 12-7-23; 8:45 am]
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