Center For Scientific Review; Notice of Closed Meetings, 68447-68448 [2024-19061]
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Federal Register / Vol. 89, No. 165 / Monday, August 26, 2024 / Notices
assessment category: ‘‘Incomplete: Need
additional imaging evaluation and/or
prior mammograms for comparison.’’ As
such, it is not clear how a facility would
comply with both the Alternative
Standard and the other applicable
requirements in the amended
regulations.
Moreover, as discussed in the MQSA
small entity compliance guide, FDA has
generally exercised enforcement
discretion regarding the final
assessment category wording where the
variation in wording does not change
the meaning of the assessment category
(e.g., ‘‘benign finding’’ instead of
‘‘benign’’ or ‘‘suspicious abnormality’’
instead of ‘‘suspicious’’), and FDA
intends to continue such a practice.
Thus, FDA has determined that
Alternative Standard #11 is no longer
needed, no longer appropriate, and may
cause confusion, and so withdrawal of
Alternative Standard #11 is justified by
§ 900.12.
FDA also has determined that
withdrawal of Alternative Standard #12
is justified by § 900.12. Alternative
Standard #12 allowed use of an
additional assessment category ‘‘Post
Procedure Mammograms for Marker
Placement.’’ As of the effective date of
the MQSA final rule (September 10,
2024), the nearly identical assessment
statement ‘‘Post-Procedure Mammogram
for Marker Placement’’ is included in
the amended § 900.12(c)(1)(iv)(G).
Because amended § 900.12(c)(1)(iv)(G)
incorporates Alternative Standard #12,
FDA has determined that the alternative
is no longer needed, no longer
appropriate, and may cause confusion,
and so withdrawal of Alternative
Standard #12 is justified by § 900.12.
Finally, FDA is amending Alternative
Standard #8, which permitted
interpreting physicians to provide a
separate assessment of findings for each
breast in the medical report instead of
a single overall assessment of findings
as set forth in § 900.12(c)(1)(iv).
Specifically, the alternative permitted:
‘‘A separate assessment of findings for
each breast, classified in one of the
following categories,’’ instead of ‘‘A
separate final assessment of findings for
each breast, classified in one of the
following categories.’’ This language is
being amended to use the term ‘‘final
assessment’’ to match the updated
language in amended § 900.12(c)(1)(v).
As a result of the amended § 900.12,
amending Alternative Standard #8 is
justified by § 900.12.
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Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19058 Filed 8–23–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) hereby gives notice that
the National Vaccine Advisory
Committee (NVAC) will hold an inperson meeting. The meeting will be
open to the public and public comment
will be heard during the meeting.
DATES: The meeting will be held
September 12–13, 2024. The confirmed
meeting times and agenda will be
posted on the NVAC website at https://
www.hhs.gov/nvpo/nvac/meetings/
index.html as soon as they become
available.
SUMMARY:
Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting in person or
participate in public comment. Please
register at https://www.hhs.gov/nvpo/
nvac/meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, Office of Infectious Disease and
HIV/AIDS Policy, U.S. Department of
Health and Human Services, Tower
Building, Room, 1101 Wootton
Parkway, Rockville, MD 20852. Email:
nvac@hhs.gov. Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: Pursuant
to section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
ADDRESSES:
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68447
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During this meeting, the NVAC will
hear presentations about
implementation of the universal
hepatitis B vaccine recommendations of
adults aged 19–59 years and adults aged
60 years and older with risk factors for
hepatitis B infection, new approaches
for tuberculosis vaccine innovation, and
research to inform future HIV vaccine
development. The NVAC will also host
panels on vaccine equity, provider
payment, and planning for the
development of the next national
vaccine strategy.
Please note that agenda items are
subject to change, as priorities dictate.
Information on the final meeting agenda
will be posted prior to the meeting on
the NVAC website: https://www.hhs.gov/
nvpo/nvac/.
Members of the public will have the
opportunity to provide comment at the
NVAC meeting during the public
comment period designated on the
agenda. Public comments made during
the meeting will be limited to three
minutes per person to ensure time is
allotted for all those wishing to speak.
Members of the public may also submit
written comments. Written comments
should not exceed three pages in length.
Individuals planning to submit
comments should email their written
comments or their request to provide a
comment during the meeting to nvac@
hhs.gov at least five business days prior
to the meeting.
Dated: August 19, 2024.
Ann Aikin,
Acting Designated Federal Official, Office of
the Assistant Secretary for Health.
[FR Doc. 2024–19053 Filed 8–23–24; 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
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
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Federal Register / Vol. 89, No. 165 / Monday, August 26, 2024 / Notices
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; NIH
Research Enhancement Award (R15) in
Oncological Sciences.
Date: September 25, 2024.
Time: 9:00 a.m. to 5:00 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: Byung Min Chung, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–4056, justin.chung@
nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 25–26, 2024.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814 (InPerson meeting).
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@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: August 21, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–19061 Filed 8–23–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
National Institute on Deafness and
Other Communication Disorders;
Notice of 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, NIDCD.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
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reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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 Institute On Deafness And
Other Communication Disorders,
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, NIDCD.
Date: October 21–22, 2024.
Open: October 21, 2024, 9 a.m. to 9:30 a.m.
Agenda: Reports from the Institute staff.
Place: Porter Neuroscience Research
Center, Building 35A, Room 610, 35 Convent
Drive, Bethesda, MD 20892, In Person.
Closed: October 21, 2024, 9:30 a.m. to 5
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Porter Neuroscience Research
Center, Building 35A, Room 610, 35 Convent
Drive, Bethesda, MD 20892, In Person.
Closed: October 22, 2024, 9 a.m. to 5 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Porter Neuroscience Research
Center, Building 35A, Room 610, 35 Convent
Drive, Bethesda, MD 20892, In Person.
Contact Person: Lisa L. Cunningham,
Ph.D., Senior Investigator, National Institute
of Deafness and other Communication
Diseases, National Institutes of Health, 35A
Convent Drive, Rockville, MD 20850, 301–
443–2766, lisa.cunningham@nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcd.nih.gov/about/advisorycommittees, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: August 21, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–19062 Filed 8–23–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
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,
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
General Medical Sciences Special Emphasis
Panel; Review of K99/R00 applications.
Date: October 15–16, 2024.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Lee Warren Slice, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda,
Maryland 20892, 301–435–0807, slicelw@
mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of NIH IDeA Networks of
Biomedical Research Excellence (INBRE)
applications.
Date: October 29, 2024.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Jason M. Chan, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Bethesda, Maryland
20892, 301–594–3663, jason.chan2@nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of NIH IDeA Networks of
Biomedical Research Excellence (INBRE)
applications.
Date: November 4, 2024.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
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Agencies
[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68447-68448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19061]
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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
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
[[Page 68448]]
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; NIH Research Enhancement Award (R15) in Oncological Sciences.
Date: September 25, 2024.
Time: 9:00 a.m. to 5:00 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: Byung Min Chung, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496-4056,
[email protected].
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 25-26, 2024.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814 (In-Person meeting).
Contact Person: Boris P. Sokolov, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD
20892, 301-408-9115, [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: August 21, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-19061 Filed 8-23-24; 8:45 am]
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