Center for Scientific Review; Notice of Closed Meetings, 51355-51356 [2024-13252]
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Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
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 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
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received, go to https://
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heading of this document, into the
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You may submit comments on any
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Submit written requests for single
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Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Anuradha Ramamoorthy, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 240–402–6426,
Anuradha.Ramamoorthy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Clinical Pharmacology Considerations
for the Development of Oligonucleotide
Therapeutics.’’ Oligonucleotide
therapeutics are an emerging
therapeutic modality with increasing
numbers of drugs in development.
While antisense and siRNA
oligonucleotide therapeutics have been
approved in recent years to treat rare
diseases, many oligonucleotide
therapeutics are in development to treat
common chronic diseases. This
guidance provides recommendations to
assist industry in the development of
oligonucleotide therapeutics.
Specifically, this guidance represents
FDA’s recommendations for certain
pharmacokinetic and pharmacodynamic
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investigations including characterizing
QT interval prolongation potential,
performing immunogenicity risk
assessment, characterizing the impact of
hepatic and renal impairment, and
assessing the potential for drug-drug
interactions during oligonucleotide
therapeutic development. This guidance
provides recommendations on when
these assessments may be appropriate
and what types of assessments can help
address these issues.
This guidance finalizes the draft
guidance of the same name issued on
June 27, 2022 (87 FR 38161). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include: (1) updates to
terms used in the guidance to provide
clarity, (2) additional references to FDA
guidance that have been published since
publication of the draft guidance, and
(3) editorial changes to improve clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Clinical
Pharmacology Considerations for the
Development of Oligonucleotide
Therapeutics.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 for
investigational new drug applications
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 314 for new
drug applications have been approved
under OMB control number 0910–0001.
The collections of information in 21
CFR part 601 for biologics license
applications have been approved under
OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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51355
Dated: June 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13271 Filed 6–14–24; 8:45 am]
BILLING CODE 4164–01–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; Member
Conflict: Topics in Nephrology and Urology.
Date: July 10, 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: Stacey Nicole Williams,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 867–5309, stacey.williams@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Respiratory Sciences Activities.
Date: July 10–11, 2024.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015 (In-Person Meeting).
Contact Person: Imoh S. Okon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20817, 301–347–8881, imoh.okon@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Infectious Diseases and
Immunology B Review Panel.
Date: July 10–11, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: North Bethesda Marriott Hotel &
Conference Center, Montgomery County
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Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852 (In-Person
Meeting).
Contact Person: Diana Maria Ortiz-Garcia,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–5614, diana.ortiz-garcia@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Instrumentation, Environmental,
and Occupational Safety.
Date: July 10–11, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: North Bethesda Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852 (In-Person
Meeting).
Contact Person: Joonil Seog, SCD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–402–9791, joonil.seog@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Musculoskeletal, Skin and Oral
Sciences.
Date: July 10–11, 2024.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814 (InPerson Meeting).
Contact Person: Richard Ingraham, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116,
MSC 7814, Bethesda, MD 20892, (301) 496–
8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Transformative Research to Address Health
Disparities and Advance Health Equity.
Date: July 10–11, 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: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Skeletal Muscle and Exercise
Physiology/Musculoskeletal Rehabilitation
Sciences Study Sections.
Date: July 10, 2024.
Time: 9:30 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: Yanming Bi, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, (301) 451–
0996, ybi@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business Innovation Research/Small
Business Technology Transfer: Clinical Care
and Health Interventions.
Date: July 10–11, 2024.
Time: 9:30 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: Joann Wu Shortt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–3333, shorttjw@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Basic Cancer Immunobiology.
Date: July 10–11, 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: Sarita Kandula Sastry,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20782, 301–402–4788, sarita.sastry@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Anti-Infective Therapeutics.
Date: July 10–11, 2024.
Time: 10:00 a.m. to 10:00 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: Marcus Ferrone, PHARMD
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–2371, marcus.ferrone@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; HAMI
Hypersensitivity and Mucosal Immunology.
Date: July 10–11, 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: Deanna C. Bublitz, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–4005, deanna.bublitz@
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)
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Dated: June 11, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–13252 Filed 6–14–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2008–0010]
Board of Visitors for the National Fire
Academy
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice of Federal advisory
committee meeting.
AGENCY:
The Board of Visitors for the
National Fire Academy (Board) will
meet in person at the National
Emergency Training Center in
Emmitsburg, MD, and virtually on
Monday, August 5, 2024. The meeting
will be open to the public.
DATES: The meeting will take place on
Monday, August 5, 2024, 8 a.m. to 4
p.m. eastern time. Please note that the
meeting may close early if the Board has
completed its business.
ADDRESSES: Members of the public who
wish to participate in the virtual
conference should contact Deborah
Gartrell-Kemp as listed in the FOR
FURTHER INFORMATION CONTACT section
by close of business on August 1, 2024,
to obtain the call-in number and access
code for the August 5th in-person and
virtual meeting. For more information
on services for individuals with
disabilities or to request special
assistance, contact Deborah GartrellKemp as soon as possible. The Board is
committed to ensuring all participants
have equal access regardless of
disability status. If you require a
reasonable accommodation due to a
disability to fully participate, please
contact Deborah Gartrell-Kemp as listed
in the FOR FURTHER INFORMATION
CONTACT section as soon as possible.
To facilitate public participation, we
are inviting public comment on the
issues to be considered by the Board as
listed in the SUPPLEMENTARY
INFORMATION section. Participants
seeking to have their comments
considered during the meeting should
submit them in advance or during the
public comment segment. Comments
submitted up to 30 days after the
meeting will be included in the public
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51355-51356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13252]
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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 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; Member Conflict: Topics in Nephrology and Urology.
Date: July 10, 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: Stacey Nicole Williams, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 867-5309,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Respiratory Sciences Activities.
Date: July 10-11, 2024.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015 (In-Person Meeting).
Contact Person: Imoh S. Okon, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20817, 301-347-8881,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Infectious Diseases and Immunology B Review
Panel.
Date: July 10-11, 2024.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: North Bethesda Marriott Hotel & Conference Center,
Montgomery County
[[Page 51356]]
Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD
20852 (In-Person Meeting).
Contact Person: Diana Maria Ortiz-Garcia, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-5614,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Instrumentation, Environmental, and
Occupational Safety.
Date: July 10-11, 2024.
Time: 8:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: North Bethesda Marriott Hotel & Conference Center,
Montgomery County Conference Center Facility, 5701 Marinelli Road,
North Bethesda, MD 20852 (In-Person Meeting).
Contact Person: Joonil Seog, SCD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, 301-402-9791,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Musculoskeletal, Skin and Oral Sciences.
Date: July 10-11, 2024.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814 (In-Person Meeting).
Contact Person: Richard Ingraham, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD
20892, (301) 496-8551, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Transformative Research to Address Health Disparities and
Advance Health Equity.
Date: July 10-11, 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: Sara Louise Hargrave, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, (301)
443-7193, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Skeletal Muscle and Exercise Physiology/
Musculoskeletal Rehabilitation Sciences Study Sections.
Date: July 10, 2024.
Time: 9:30 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: Yanming Bi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, (301) 451-
0996, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business Innovation Research/Small Business Technology
Transfer: Clinical Care and Health Interventions.
Date: July 10-11, 2024.
Time: 9:30 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: Joann Wu Shortt, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-3333,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Topics in Basic Cancer Immunobiology.
Date: July 10-11, 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: Sarita Kandula Sastry, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20782, 301-402-4788,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Anti-Infective Therapeutics.
Date: July 10-11, 2024.
Time: 10:00 a.m. to 10:00 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: Marcus Ferrone, PHARMD Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 402-2371,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; HAMI Hypersensitivity and Mucosal Immunology.
Date: July 10-11, 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: Deanna C. Bublitz, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-4005,
[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: June 11, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-13252 Filed 6-14-24; 8:45 am]
BILLING CODE 4140-01-P
