Center for Scientific Review; Notice of Closed Meetings, 11307-11308 [2024-02987]
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Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
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-201509-18/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. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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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
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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, QULIPTA
(atogepant) indicated for the preventive
treatment of episodic migraine in adults.
Subsequent to this approval, the USPTO
received a patent term restoration
application for QULIPTA (U.S. Patent
Nos. 8,754,096 and 9,499,545) from
Merck Sharp & Dohme Corp., and the
USPTO requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
June 14, 2022, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of QULIPTA
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
QULIPTA is 3,374 days. Of this time,
3,130 days occurred during the testing
phase of the regulatory review period,
while 244 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: July 5, 2012.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 5, 2012
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: January 28, 2021. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
QULIPTA (NDA 215206) was initially
submitted on January 28, 2021.
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3. The date the application was
approved: September 28, 2021. FDA has
verified the applicant’s claim that NDA
215206 was approved on September 28,
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 1,008 days or 1,166
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: February 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–03019 Filed 2–13–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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
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11308
Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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: Healthcare Delivery
and Methodologies Integrated Review Group;
Population and Public Health Approaches to
HIV/AIDS Study Section.
Date: March 11–12, 2024.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Aubrey Spriggs Madkour,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000C,
Bethesda, MD 20892, (301) 594–6891,
madkouras@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Social and Community Influences
Across the Life Course.
Date: March 11–12, 2024.
Time: 9:00 a.m. to 8:00 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: David E. Pollio, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1006F,
Bethesda, MD 20892, (301) 594–4002,
polliode@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Musculoskeletal Sciences in
Diagnostics, Devices, and Rehabilitation.
Date: March 12–13, 2024.
Time: 10:00 a.m. to 8:00 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: Amber Taylor Collins,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 827–5245, amber.collins@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Kidney and Urological Sciences.
Date: March 14, 2024.
Time: 8:00 a.m. to 8:00 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: Ganesan Ramesh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, 301–827–
5467, ganesan.ramesh@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
The Cellular and Molecular Biology of
Complex Brain Disorders.
Date: March 14, 2024.
Time: 9:00 a.m. to 7:00 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: Adem Can, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, (301) 435–
1042, cana2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Biomaterials, Delivery, and
Nanotechnology.
Date: March 14–15, 2024.
Time: 9:00 a.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: David R. Filpula, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6181,
MSC 7892, Bethesda, MD 20892, 301–435–
2902, filpuladr@mail.nih.gov
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cardiovascular and Surgical
Devices.
Date: March 14–15, 2024.
Time: 9:00 a.m. to 8:00 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: Willard Wilson, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20817, 301–867–5309,
willard.wilson@nih.gov.
(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: February 8, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–02987 Filed 2–13–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 of
Allergy and Infectious Diseases Special
Emphasis Panel; Sex Differences in Radiation
Research: Models, Underlying Pathways,
Biomarkers of Injury, and Medical
Countermeasure Responses (U01 Clinical
Trial Not Allowed).
Date: March 11–12, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Maryam Rohani, Ph.D.,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, Room 3G56, Rockville, MD 20852,
(301) 761–6656d, maryam.rohani@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource Related
Research Projects (R24 Clinical Trial Not
Allowed).
Date: April 3, 2024.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Maryam Rohani, Ph.D.,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers
Lane, Room 3G56, Rockville, MD 20852,
(301) 761–6656d, maryam.rohani@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
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]]>Agencies
[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11307-11308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02987]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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
[[Page 11308]]
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: Healthcare Delivery and Methodologies
Integrated Review Group; Population and Public Health Approaches to
HIV/AIDS Study Section.
Date: March 11-12, 2024.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Bethesdan Hotel, 8120 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Aubrey Spriggs Madkour, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000C, Bethesda, MD 20892, (301)
594-6891, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Social and Community Influences Across the
Life Course.
Date: March 11-12, 2024.
Time: 9:00 a.m. to 8:00 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: David E. Pollio, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1006F, Bethesda, MD 20892, (301)
594-4002, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Musculoskeletal Sciences in Diagnostics,
Devices, and Rehabilitation.
Date: March 12-13, 2024.
Time: 10:00 a.m. to 8:00 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: Amber Taylor Collins, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 827-5245,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Kidney and Urological Sciences.
Date: March 14, 2024.
Time: 8:00 a.m. to 8:00 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: Ganesan Ramesh, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD
20892, 301-827-5467, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: The Cellular and Molecular Biology of Complex
Brain Disorders.
Date: March 14, 2024.
Time: 9:00 a.m. to 7:00 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: Adem Can, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4190, MSC 7850, Bethesda, MD 20892, (301) 435-
1042, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Biomaterials, Delivery, and Nanotechnology.
Date: March 14-15, 2024.
Time: 9:00 a.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: David R. Filpula, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6181, MSC 7892, Bethesda, MD
20892, 301-435-2902, [email protected]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Cardiovascular and Surgical Devices.
Date: March 14-15, 2024.
Time: 9:00 a.m. to 8:00 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: Willard Wilson, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20817, 301-867-5309,
[email protected].
(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: February 8, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-02987 Filed 2-13-24; 8:45 am]
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