National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 58117 [2022-20561]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
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 product
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, NURTEC ODT
(rimegepant sulfate). NURTEC ODT is
indicated for the acute treatment of
migraine with or without aura in adults.
Subsequent to this approval, the USPTO
received a patent term restoration
application for NURTEC ODT (U.S.
Patent Nos. 8,314,117 and 8,759,372)
from Biohaven Pharmaceutical Holding
Company Ltd. and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated March 1,
2021, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of NURTEC ODT represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
lotter on DSK11XQN23PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
NURTEC ODT is 3,390 days. Of this
time, 3,144 days occurred during the
testing phase of the regulatory review
period, while 246 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: November 18,
2010. The applicant claims November
20, 2010, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
VerDate Sep<11>2014
17:04 Sep 22, 2022
Jkt 256001
November 18, 2010, 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(b) of the FD&C Act: June 27, 2019.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
NURTEC ODT (NDA 212728) was
initially submitted on June 27, 2019.
3. The date the application was
approved: February 27, 2020. FDA has
verified the applicant’s claim that NDA
212728 was approved on February 27,
2020.
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 368 days or 1,102
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: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) 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
Alcohol Abuse and Alcoholism Initial
Review Group, Neuroscience and Behavior
Study Section.
Date: November 1, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Beata Buzas, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2116, MSC 6902, Bethesda, MD
20892, 301–443–0800, bbuzas@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
Dated: September 19, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–20561 Filed 9–22–22; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2022–20634 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00064
Fmt 4703
Sfmt 9990
58117
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Page 58117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Closed Meeting
Pursuant to section 10(d) 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 Alcohol Abuse and
Alcoholism Initial Review Group, Neuroscience and Behavior Study
Section.
Date: November 1, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Beata Buzas, Ph.D., Scientific Review Officer,
Extramural Project Review Branch, Office of Extramural Activities,
National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2116, MSC 6902, Bethesda, MD 20892, 301-443-0800,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards., National Institutes of
Health, HHS)
Dated: September 19, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-20561 Filed 9-22-22; 8:45 am]
BILLING CODE 4140-01-P
