National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 75004-75005 [2023-24117]
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Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices
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drug 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
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, Omegaven (fish
oil triglycerides) indicated as a source of
calories and fatty acids in pediatric
patients with parenteral nutritionassociated cholestasis. Subsequent to
this approval, the USPTO received a
patent term restoration application for
Omegaven (U.S. Patent No. 9,566,260)
from Children’s Medical Center
Corporation 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 Omegaven 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
Omegaven is 4,246 days. Of this time,
4,007 days occurred during the testing
phase of the regulatory review period,
while 239 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: December 13,
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2006. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on December 13, 2006.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 1, 2017.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Omegaven (NDA 210589) was initially
submitted on December 1, 2017.
3. The date the application was
approved: July 27, 2018. FDA has
verified the applicant’s claim that NDA
210589 was approved on July 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 383 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Infant and Maternal Mortality;
Correction
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice; correction.
AGENCY:
HRSA published a notice in
the Federal Register of October 12,
2023, concerning a meeting of the
Advisory Committee on Infant and
Maternal Mortality. The document
contained incorrect location
information. The notice originally stated
that the meeting would be held in
person at HRSA Headquarters (5600
Fishers Lane, Room 5W07, Rockville,
Maryland, 20857) and virtually via
webinar. The meeting will now be fully
virtual via webinar and not held in
person. The webinar link and log-in
information will be available at the
Committee’s website before the meeting:
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room 18N84, Rockville, Maryland,
20857; 301–443–0543; or SACIM@
hrsa.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of October 12,
2023, FR Doc. 2023–22509, page 70682,
column 1, ADDRESSES section, paragraph
1, correct ‘‘This meeting will be held in
person at HRSA Headquarters (5600
Fishers Lane, Room 5W07, Rockville,
Maryland, 20857) and virtually via
webinar’’ to read: ‘‘This meeting will be
held by webinar.’’
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–24080 Filed 10–31–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
[FR Doc. 2023–24124 Filed 10–31–23; 8:45 am]
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices
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 of
Neurological Disorders and Stroke Special
Emphasis Panel; R25 Review.
Date: November 6, 2023.
Time: 4:00 p.m. to 6:00 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: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS, NIH, NSC, 6001 Executive Blvd.,
Suite 3204, MSC 9529 Rockville, MD 20852,
301–496–0660, benzingw@mail.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. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS.)
Dated: October 26, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–24117 Filed 10–31–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Institute of Environmental
Health Sciences; 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,
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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
Environmental Health Sciences Special
Emphasis Panel; SBIR E-Learning for
HAZMAT and Emergency Response.
Date: December 7, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Durham, NC 27709 (Virtual
Meeting).
Contact Person: Alfonso R. Latoni, Ph.D.,
Scientific Review Officer and Chief,
Scientific Review Branch, Division of
Extramural Research and Training, National
Institute of Environmental, Health Sciences,
Research Triangle Park, NC 27709, 984–287–
3279, alfonso.latoni@nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Time-Sensitive Exploratory
Research Support in the Environmental
Health Sciences.
Date: December 12, 2023.
Time: 10:30 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Durham, NC 27709 (Virtual
Meeting).
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 984–287–3340, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 27, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
75005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Research Education
Program Advancing the Careers of a Diverse
Research Workforce (R25 Clinical Trial Not
Allowed).
Date: November 14, 2023.
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 3G51,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G51, Rockville, MD
20852, 240–507–9685, thomas.conway@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: October 26, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–24111 Filed 10–31–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2023–24136 Filed 10–31–23; 8:45 am]
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
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Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75004-75005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice
of Closed Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
[[Page 75005]]
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 of Neurological Disorders
and Stroke Special Emphasis Panel; R25 Review.
Date: November 6, 2023.
Time: 4:00 p.m. to 6:00 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: William C. Benzing, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural
Activities, NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3204, MSC
9529 Rockville, MD 20852, 301-496-0660, [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. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS.)
Dated: October 26, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2023-24117 Filed 10-31-23; 8:45 am]
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