National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 24022 [2024-07277]
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Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
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Section III–D–3. Experiments Involving
the Use of Infectious DNA or RNA
Viruses or Defective DNA or RNA
Viruses in the Presence of a Helper
System in Tissue Culture Systems
Caution: The potential for reversion
or generation of replication competent
virus should be considered when
generating or using defective viruses or
vectors in the presence of helper
systems (e.g., helper viruses, packaging
cell lines, transient transfection systems,
replicon systems). Special care should
be used in the evaluation of
containment levels for experiments
which are likely to either enhance the
pathogenicity (e.g., insertion of a host
oncogene) or to extend the host range
(e.g., introduction of novel control
elements) of viral vectors under
conditions that permit a productive
infection. In such cases, serious
consideration should be given to
increasing physical containment by at
least one level.
Note: Recombinant or synthetic
nucleic acid molecules or nucleic acid
molecules derived therefrom, which
contain less than two-thirds of the
genome of any eukaryotic virus (all
viruses from a single Family (see
Section V–J, Footnotes and References
of Sections I–IV) being considered
identical (see Section V–K, Footnotes
and References of Sections I–IV)), are
considered defective and may be used
in the absence of helper systems under
the conditions specified in Section III–
E–1, Experiments Involving the
Formation of Recombinant or Synthetic
Molecules Containing No More than
Two-Thirds of the Genome of any
Eukaryotic Virus.
Section III–D–3–a. Experiments
involving the use of infectious or
defective Risk Group 2 viruses (see
Appendix B–II, Risk Group 2 Agents) in
the presence of a helper system may be
conducted at BL2.
Section III–D–3–b. Experiments
involving the use of infectious or
defective Risk Group 3 viruses (see
Appendix B–III–D, Risk Group 3
(RG3)—Viruses and Prions) in the
presence of a helper system may be
conducted at BL3.
Section III–D–3–c. Experiments
involving the use of infectious or
defective Risk Group 4 viruses (see
Appendix B–IV–D, Risk Group 4
(RG4)—Viral Agents) in the presence of
a helper system may be conducted at
BL4.
Section III–D–3–d. Experiments
involving the use of infectious or
defective restricted poxviruses (see
Sections V–A and V–L, Footnotes and
References of Sections I–IV) in the
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presence of a helper system shall be
determined on a case-by-case basis
following NIH OSP review. A U.S.
Department of Agriculture permit is
required for work with plant or animal
pathogens (see Section V–G, Footnotes
and References of Sections I–IV).
Section III–D–3–e. Experiments
involving the use of infectious or
defective viruses in the presence of a
helper system which are not covered in
Sections III–D–3–a through III–D–3–d
may be conducted at BL1.
Section III–E–1 will be amended as
follows:
Section III–E–1. Experiments Involving
the Formation of Recombinant or
Synthetic Nucleic Acid Molecules
Containing No More Than Two-Thirds
of the Genome of Any Eukaryotic Virus
Recombinant or synthetic nucleic acid
molecules containing no more than twothirds of the genome of any eukaryotic
virus (all viruses from a single Family
being considered identical [see Section
V–J, Footnotes and References of
Sections I–IV]) may be propagated and
maintained in cells in tissue culture
using BL1 containment. For such
experiments, it must be demonstrated
that the cells lack a helper system for
the specific Families of defective viruses
being used. If a helper system is present,
procedures specified under Section III–
D–3, Experiments Involving the Use of
Infectious Animal or Plant DNA or RNA
Viruses or Defective Animal or Plant
DNA or RNA Viruses in the Presence of
Helper Systems in Tissue Culture
Systems, should be used. The DNA may
contain fragments of the genome of
viruses from more than one Family but
each fragment shall be less than twothirds of a genome.
Appendix B–II–D will be amended as
follows:
Appendix B–II–D. Risk Group 2
(RG2)—Viruses
Flaviviruses—Group B Arboviruses
—Saint Louis Encephalitis Virus (SLEV)
—West Nile virus (WNV)
Appendix B–IV–D
(RG4)—Viruses
Risk Group 4
Filoviruses
—Ebola viruses
—Marburg viruses
Hemorrhagic fever viruses as yet undefined
Dated: March 25, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2024–07082 Filed 4–4–24; 8:45 am]
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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 Clinical Trial
Planning Grants (R34 Clinical Trial Not
Allowed).
Date: May 1, 2024.
Time: 2:00 p.m. to 4:00 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 3G22,
Rockville, MD 20852 (Virtual Meeting).
Contact Person: Michael M. Opata, 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 3G22, Rockville, MD
20852, 240–627–3319, michael.opata@
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: April 2, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07277 Filed 4–4–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Page 24022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07277]
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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 Clinical Trial Planning
Grants (R34 Clinical Trial Not Allowed).
Date: May 1, 2024.
Time: 2:00 p.m. to 4:00 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 3G22,
Rockville, MD 20852 (Virtual Meeting).
Contact Person: Michael M. Opata, 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 3G22,
Rockville, MD 20852, 240-627-3319, [email protected].
(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: April 2, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-07277 Filed 4-4-24; 8:45 am]
BILLING CODE 4140-01-P
