Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 55629-55630 [2024-14743]
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Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biologic product LUNSUMIO
(mosunetuzumab-axgb). LUNSUMIO is
indicated for the treatment of adult
patients with relapsed or refractory
follicular lymphoma after two or more
lines of systemic therapy. This
indication is approved under
accelerated approval based on response
rate. Subsequent to this approval, the
USPTO received a patent term
restoration application for LUNSUMIO
(U.S. Patent Nos. 10,174,124 and
11,186,650) from Genentech, Inc., and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated January 30, 2024, FDA advised
the USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
LUNSUMIO 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
LUNSUMIO is 2,809 days. Of this time,
2,571 days occurred during the testing
phase of the regulatory review period,
while 238 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 (21 U.S.C. 355(i))
became effective: April 16, 2015. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
April 16, 2015.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): April 29, 2022. FDA has
verified the applicant’s claim that the
VerDate Sep<11>2014
17:16 Jul 03, 2024
Jkt 262001
biologics license application (BLA) for
LUNSUMIO (BLA 761263) was initially
submitted on April 29, 2022.
3. The date the application was
approved: December 22, 2022. FDA has
verified the applicant’s claim that BLA
761263 was approved on December 22,
2022.
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 313 or 842 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: July 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–14728 Filed 7–3–24; 8:45 am]
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55629
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act this
notice announces that the Advisory
Committee on Heritable Disorders in
Newborns and Children (ACHDNC or
Committee) has scheduled a public
meeting. Information about ACHDNC
and the agenda for this meeting can be
found on the ACHDNC website at
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
index.html.
SUMMARY:
Thursday, August 8, 2024, from
10:00 a.m. to 4:00 p.m. Eastern Time
(ET) and Friday, August 9, 2024, from
10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held in
person with webcast options. While this
meeting is open to the public, advance
registration is required. Please visit the
ACHDNC website for information on
registration: https://www.hrsa.gov/
advisory-committees/heritabledisorders/. Please register by
the deadline of 12:00 p.m. ET on
Wednesday, August 6, 2024.
Instructions on how to access the
meeting via webcast will be provided
upon registration.
If you are a non-U.S. citizen who
would like to attend the August meeting
in-person, please contact ACHDNC@
hrsa.gov by July 22, 2024.
FOR FURTHER INFORMATION CONTACT: Kim
Morrison, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room, Rockville, Maryland 20857; 301–
443–6672; or ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of Health and Human
Services (Secretary) on the development
of newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. The ACHDNC
reviews and reports regularly on
newborn and childhood screening
practices, recommends improvements in
the national newborn and childhood
screening programs, and fulfills
DATES:
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ddrumheller on DSK120RN23PROD with NOTICES1
55630
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening on
the Recommended Uniform Screening
Panel, following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA pursuant to section
2713 of the Public Health Service Act
(42 U.S.C. 300gg–13). Under this
provision, non-grandfathered group
health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is 1
year from the Secretary’s adoption of the
condition for screening.
During the August 8–9, 2024, meeting,
ACHDNC will hear from experts in the
fields of public health, medicine,
heritable disorders, rare disorders, and
newborn screening. Possible agenda
items may include the following topics:
(1) A presentation on types of
screening that are a part of the standard
of care in a clinical setting;
(2) An update on the ACHDNC
nomination process;
(3) A presentation on the revisions to
the decision matrix and a potential vote
on whether to adopt the proposed
revisions to the ACHDNC decision
matrix and process; and
(4) An update on the Metachromatic
Leukodystrophy condition nomination
and a potential vote on whether to move
it forward to full evidence-based review,
which, depending on the strength of the
evidence, could lead to a future
recommendation to add this condition
to the Recommended Uniform
Screening Panel.
Agenda items are subject to change as
priorities dictate. Information about
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website.
Members of the public will have the
opportunity to provide comments on
any of the above agenda items. Public
participants may request to provide
general oral comments and may submit
written statements in advance of the
scheduled meeting. Oral comments will
be honored in the order they are
requested and may be limited as time
allows. Requests to provide a written
statement or make oral comments to
ACHDNC must be submitted via the
registration website by 12:00 p.m. ET on
Thursday, July 25, 2024. Written
comments will be shared with the
Committee prior to the meeting so that
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they have an opportunity to consider
them in advance of the meeting.
Individuals who need special
assistance or another reasonable
accommodation should notify Kim
Morrison at the address and phone
number listed above at least 10 business
days prior to the meeting.
Since this meeting occurs in a federal
government building, attendees must go
through a security check to enter the
building. Non-U.S. Citizen attendees
must notify HRSA of their planned
attendance at least 15 business days
prior to the meeting to facilitate their
entry into the building. All attendees are
required to present government-issued
identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–14743 Filed 7–3–24; 8:45 am]
BILLING CODE 4165–15–P
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
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: Center for Scientific
Review Special Emphasis Panel Small
Business: Health Services and Systems B.
Date: July 24, 2024.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Michael J McQuestion,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
Bethesda, MD 20892, 301–480–1276,
mike.mcquestion@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Epidemiology and Population
Health.
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Date: July 25, 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.
Meeting Format: Virtual Meeting.
Contact Person: Steven Michael Frenk,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3141,
Bethesda, MD 20892, (301) 480–8665,
frenksm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR Panel:
Implementation Research on
Noncommunicable Disease Risk Factors
among Low- and Middle-Income Country and
Tribal Populations Living in City
Environments.
Date: July 30, 2024.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Paul Hewett, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room,
Bethesda, MD 20892, (240) 672–8946,
hewettmarxpn@csr.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: June 28, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–14699 Filed 7–3–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; 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
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]]>Agencies
[Federal Register Volume 89, Number 129 (Friday, July 5, 2024)]
[Notices]
[Pages 55629-55630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14743]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Committee on Heritable Disorders in
Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act this
notice announces that the Advisory Committee on Heritable Disorders in
Newborns and Children (ACHDNC or Committee) has scheduled a public
meeting. Information about ACHDNC and the agenda for this meeting can
be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/.
DATES: Thursday, August 8, 2024, from 10:00 a.m. to 4:00 p.m. Eastern
Time (ET) and Friday, August 9, 2024, from 10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held in person with webcast options.
While this meeting is open to the public, advance registration is
required. Please visit the ACHDNC website for information on
registration: https://www.hrsa.gov/advisory-committees/heritable-disorders/. Please register by the deadline of 12:00 p.m. ET
on Wednesday, August 6, 2024. Instructions on how to access the meeting
via webcast will be provided upon registration.
If you are a non-U.S. citizen who would like to attend the August
meeting in-person, please contact [email protected] by July 22, 2024.
FOR FURTHER INFORMATION CONTACT: Kim Morrison, Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Room, Rockville, Maryland
20857; 301-443-6672; or [email protected].
SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations
to the Secretary of Health and Human Services (Secretary) on the
development of newborn screening activities, technologies, policies,
guidelines, and programs for effectively reducing morbidity and
mortality in newborns and children having, or at risk for, heritable
disorders. The ACHDNC reviews and reports regularly on newborn and
childhood screening practices, recommends improvements in the national
newborn and childhood screening programs, and fulfills
[[Page 55630]]
requirements stated in the authorizing legislation. In addition,
ACHDNC's recommendations regarding inclusion of additional conditions
for screening on the Recommended Uniform Screening Panel, following
adoption by the Secretary, are evidence-informed preventive health
services provided for in the comprehensive guidelines supported by HRSA
pursuant to section 2713 of the Public Health Service Act (42 U.S.C.
300gg-13). Under this provision, non-grandfathered group health plans
and health insurance issuers offering non-grandfathered group or
individual health insurance are required to provide insurance coverage
without cost-sharing (a co-payment, co-insurance, or deductible) for
preventive services for plan years (i.e., policy years) beginning on or
after the date that is 1 year from the Secretary's adoption of the
condition for screening.
During the August 8-9, 2024, meeting, ACHDNC will hear from experts
in the fields of public health, medicine, heritable disorders, rare
disorders, and newborn screening. Possible agenda items may include the
following topics:
(1) A presentation on types of screening that are a part of the
standard of care in a clinical setting;
(2) An update on the ACHDNC nomination process;
(3) A presentation on the revisions to the decision matrix and a
potential vote on whether to adopt the proposed revisions to the ACHDNC
decision matrix and process; and
(4) An update on the Metachromatic Leukodystrophy condition
nomination and a potential vote on whether to move it forward to full
evidence-based review, which, depending on the strength of the
evidence, could lead to a future recommendation to add this condition
to the Recommended Uniform Screening Panel.
Agenda items are subject to change as priorities dictate.
Information about ACHDNC, including a roster of members and past
meeting summaries, is also available on the ACHDNC website.
Members of the public will have the opportunity to provide comments
on any of the above agenda items. Public participants may request to
provide general oral comments and may submit written statements in
advance of the scheduled meeting. Oral comments will be honored in the
order they are requested and may be limited as time allows. Requests to
provide a written statement or make oral comments to ACHDNC must be
submitted via the registration website by 12:00 p.m. ET on Thursday,
July 25, 2024. Written comments will be shared with the Committee prior
to the meeting so that they have an opportunity to consider them in
advance of the meeting.
Individuals who need special assistance or another reasonable
accommodation should notify Kim Morrison at the address and phone
number listed above at least 10 business days prior to the meeting.
Since this meeting occurs in a federal government building,
attendees must go through a security check to enter the building. Non-
U.S. Citizen attendees must notify HRSA of their planned attendance at
least 15 business days prior to the meeting to facilitate their entry
into the building. All attendees are required to present government-
issued identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-14743 Filed 7-3-24; 8:45 am]
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