Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 45229-45230 [2023-14957]
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Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Notices
application. FDA is issuing this order
because the U.S. Court of Appeals for
the First Circuit vacated Mr. Moffett’s
convictions and sentence.
DATES:
The order is applicable July 14,
2023.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743,
debarments@fda.hhs.gov.
In a
document published in the Federal
Register on January 25, 2023 (88 FR
4826), Mark Moffett was permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application
under sections 505, 512, or 802 of the
FD&C Act (21 U.S.C. 355, 360b, or 382),
or under section 351 of the Public
Health Service Act (42 U.S.C. 262). The
debarment was based on FDA’s finding,
under section 306(a)(2)(B) of the FD&C
Act (21 U.S.C. 335a(a)(2)(B)), that Mr.
Moffett had been convicted of a felony
under Federal law for conduct relating
to the regulation of any drug product.
Mr. Moffett appealed the judgment of
the District Court, and on November 18,
2022, the U.S. Court of Appeals for the
First Circuit issued a judgment vacating
Mr. Moffett’s convictions as to all
counts. On January 26, 2023, Mr.
Moffett petitioned FDA for withdrawal
of his debarment, citing section
306(d)(3)(B)(i) of the FD&C Act.
Pursuant to section 306(d)(3)(B)(i) of the
FD&C Act, ‘‘If the conviction which
served as the basis for the debarment of
an individual under subsection (a)(2)
. . . is reversed, the Secretary shall
withdraw the order of debarment.’’
FDA has concluded that because the
U.S. Court of Appeals for the First
Circuit vacated Mr. Moffett’s
convictions, the order of debarment
must be withdrawn. Accordingly, the
Assistant Commissioner, Office of
Human and Animal Food Operations,
under section 306(d)(3)(B)(i) of the
FD&C Act, under authority delegated to
the Assistant Commissioner, is issuing
this order withdrawing the order that
permanently debarred Mark Moffett
from providing services in any capacity
to a person with an approved or
pending drug product application.
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14929 Filed 7–13–23; 8:45 am]
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17:54 Jul 13, 2023
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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 Public
Health Service Act and the Federal
Advisory Committee Act, this notice
announces that the Advisory Committee
on Heritable Disorders in Newborns and
Children (ACHDNC or Committee)
scheduled a public meeting to be held
Thursday, August 10, 2023, and Friday,
August 11, 2023. Information about
ACHDNC and the agenda for this
meeting can be found on ACHDNC’s
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: Thursday, August 10, 2023, from
10:00 a.m. to 3:00 p.m. Eastern Time
(ET) and Friday, August 11, 2023, from
10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required. Persons wishing to register to
attend the meeting can do so via this
link: https://achdncmeetings.org/
registration/. Registration closes at 12:00
p.m. ET on August 9, 2023. Instructions
on how to access the meeting via
webcast will be provided upon
registration.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; 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. ACHDNC reviews
and reports regularly on newborn and
childhood screening practices,
recommends improvements in the
national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
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45229
additional conditions for screening on
the Recommended Uniform Screening
Panel (RUSP), 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 10–11, 2023,
meeting, ACHDNC will hear from
experts in the fields of public health,
medicine, heritable disorders, rare
disorders, and newborn screening.
Agenda items include the following:
• A presentation on health equity and
newborn screening;
• An update on the Duchenne
muscular dystrophy 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 RUSP;
• A presentation, discussion, and
vote on an ACHDNC expedited review
process for resubmitted condition
nomination packages; and
• A potential presentation and vote
on whether to consider Krabbe disease
through the ACHDNC expedited review
process described above.
The agenda for this meeting includes
a potential vote on whether to
recommend a nominated condition
(Duchenne muscular dystrophy) to full
evidence-based review. In addition, as
noted in the agenda items, the
Committee may hold a vote on whether
to recommend a nominated condition
(Krabbe disease) be considered through
the ACHDNC expedited review process
described above. Both votes may lead to
a recommendation to add or not add
these conditions to the RUSP at a future
time.
Agenda items are subject to change as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website listed
above.
Members of the public will have an
opportunity to provide comments on
any or all of the above agenda items.
Public participants may request to
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45230
Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Notices
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. Subject to change: members of
the public registered to submit oral
public comments are tentatively
scheduled to provide their statements
on Thursday, August 10, 2023. 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 Wednesday, July 26,
2023. Written comments will be shared
with the Committee, so that they have
an opportunity to consider them prior to
the meeting.
Individuals who need special
assistance or another reasonable
accommodation should notify Alaina
Harris at the address and phone number
listed above at least 10 business days
prior to the meeting.
[FR Doc. 2023–14957 Filed 7–13–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
lotter on DSK11XQN23PROD with NOTICES1
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 Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA Collaborative and
Innovative Acceleration Awards.
Date: September 27, 2023.
Time: 11:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Center for Advancing Translational
Sciences, 6701 Democracy Boulevard, Room
1073, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: M. Lourdes Ponce, Ph.D.,
Scientific Review Officer, Office of Scientific
18:44 Jul 13, 2023
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Dated: July 11, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–14956 Filed 7–13–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Amy P. McNulty,
Deputy Director, Executive Secretariat.
VerDate Sep<11>2014
Review, National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1073, Bethesda, MD 20892, 301–435–0810,
lourdes.ponce@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
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 Eye Institute
Special Emphasis Panel; Pathway to
Independence Award (K99).
Date: August 10, 2023.
Time: 12:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute, 6700B
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Ashley Fortress, Ph.D.,
Designated Federal Official, Division of
Extramural Activities, National Eye Institute,
National Institutes of Health, 6700 B
Rockledge Drive, Bethesda, MD 20817, (301)
451–2020, ashley.fortress@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.867, Vision Research,
National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Eye Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Eye Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Eye Institute.
Date: July 31–August 1, 2023.
Time: July 31, 2023, 9:00 a.m. to 6:15 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Claude D. Pepper Building, 6C,
Rooms A and B, 31 Center Drive Bethesda,
MD 20892 (Hybrid Meeting).
Time: August 01, 2023, 9:15 a.m. to 1:30
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Claude D. Pepper Building, 6C,
Rooms A and B, 31 Center Drive, Bethesda,
MD 20892, (Hybrid Meeting).
Contact Person: David M Schneeweis,
Ph.D., Acting Scientific Director, National
Eye Institute, National Institutes of Health,
Building 31, Room 6A22, Bethesda, MD
20892, 301–451–6763, David.schneeweis@
nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nei.nih.gov/about/advisory-committees,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: July 11, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: July 11, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–14975 Filed 7–13–23; 8:45 am]
[FR Doc. 2023–14979 Filed 7–13–23; 8:45 am]
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[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45229-45230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14957]
-----------------------------------------------------------------------
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 Public Health Service Act and the
Federal Advisory Committee Act, this notice announces that the Advisory
Committee on Heritable Disorders in Newborns and Children (ACHDNC or
Committee) scheduled a public meeting to be held Thursday, August 10,
2023, and Friday, August 11, 2023. Information about ACHDNC and the
agenda for this meeting can be found on ACHDNC's website at https://www.hrsa.gov/advisory-committees/heritable-disorders/.
DATES: Thursday, August 10, 2023, from 10:00 a.m. to 3:00 p.m. Eastern
Time (ET) and Friday, August 11, 2023, from 10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held via webinar. While this meeting is
open to the public, advance registration is required. Persons wishing
to register to attend the meeting can do so via this link: https://achdncmeetings.org/registration/. Registration closes at 12:00 p.m. ET
on August 9, 2023. Instructions on how to access the meeting via
webcast will be provided upon registration.
FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland
20857; 301-443-0721; 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. ACHDNC reviews and reports regularly on newborn and
childhood screening practices, recommends improvements in the national
newborn and childhood screening programs, and fulfills requirements
stated in the authorizing legislation. In addition, ACHDNC's
recommendations regarding inclusion of additional conditions for
screening on the Recommended Uniform Screening Panel (RUSP), 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 10-11, 2023, meeting, ACHDNC will hear from
experts in the fields of public health, medicine, heritable disorders,
rare disorders, and newborn screening. Agenda items include the
following:
A presentation on health equity and newborn screening;
An update on the Duchenne muscular dystrophy 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 RUSP;
A presentation, discussion, and vote on an ACHDNC
expedited review process for resubmitted condition nomination packages;
and
A potential presentation and vote on whether to consider
Krabbe disease through the ACHDNC expedited review process described
above.
The agenda for this meeting includes a potential vote on whether to
recommend a nominated condition (Duchenne muscular dystrophy) to full
evidence-based review. In addition, as noted in the agenda items, the
Committee may hold a vote on whether to recommend a nominated condition
(Krabbe disease) be considered through the ACHDNC expedited review
process described above. Both votes may lead to a recommendation to add
or not add these conditions to the RUSP at a future time.
Agenda items are subject to change as priorities dictate.
Information about the ACHDNC, including a roster of members and past
meeting summaries, is also available on the ACHDNC website listed
above.
Members of the public will have an opportunity to provide comments
on any or all of the above agenda items. Public participants may
request to
[[Page 45230]]
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. Subject to
change: members of the public registered to submit oral public comments
are tentatively scheduled to provide their statements on Thursday,
August 10, 2023. 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 Wednesday, July 26, 2023. Written comments will be
shared with the Committee, so that they have an opportunity to consider
them prior to the meeting.
Individuals who need special assistance or another reasonable
accommodation should notify Alaina Harris at the address and phone
number listed above at least 10 business days prior to the meeting.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2023-14957 Filed 7-13-23; 8:45 am]
BILLING CODE 4165-15-P
