Center for Scientific Review; Notice of Closed Meetings, 41093 [2018-17785]
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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
additional contact information is also
available here and on the OSP website
(www.osp.od.nih.gov). The NIH Director may
rescind the certification of a host-vector
system (see Section IV–C–1–b–(2)–(g), Minor
Actions). If certification is rescinded, NIH
will instruct investigators to transfer cloned
DNA into a different system or use the clones
at a higher level of physical containment
level, unless NIH determines that the already
constructed clones incorporate adequate
biological containment. Certification of a
host-vector system does not extend to
modifications of either the host or vector
component of that system. Such modified
systems shall be independently certified by
the NIH Director. If modifications are minor,
it may only be necessary for the investigator
to submit data showing that the
modifications have either improved or not
impaired the major phenotypic traits on
which the containment of the system
depends. Substantial modifications to a
certified host-vector system requires
submission of complete testing data.
Appendix I–II–B. Data To Be Submitted
for Certification
Appendix I–II–B–1. Host-Vector 1
Systems Other than Escherichia coli
K–12
containment and utility, including
information on yields of phage or plasmid
molecules, ease of DNA isolation, and ease of
transfection or transformation; and (vi) in
some cases, the investigator may be asked to
submit data on survival and vector
transmissibility from experiments in which
the host-vector is fed to laboratory animals or
one or more human subjects. Such in vivo
data may be required to confirm the validity
of predicting in vivo survival on the basis of
in vitro experiments. Data shall be submitted
to the Office of Science Policy, National
Institutes of Health, preferably by email to:
NIHGuidelines@od.nih.gov; additional
contact information is also available here and
on the OSP website (www.osp.od.nih.gov).
Investigators are encouraged to publish their
data on the construction, properties, and
testing of proposed Host Vector 2 systems
prior to consideration of the system by NIH.
Specific instructions concerning the
submission of data for proposed Escherichia
coli K–12 Host-Vector 2 system (EK2)
involving either plasmids or bacteriophage in
Escherichia coli K–12, are available from the
Office of Science Policy, National Institutes
of Health, preferably by submitting a request
for this information to: NIHGuidelines@
od.nih.gov; additional contact information is
also available here and on the OSP website
(www.osp.od.nih.gov).
Appendix L, GENE THERAPY
POLICY CONFERENCES (GTPCS), is
proposed to be deleted in its entirety.
Appendix M, Points to Consider in
the Design and Submission of Protocols
for the Transfer of Recombinant or
Synthetic Nucleic Acid Molecules into
One or More Human Research
Participants (Points to Consider), is
proposed to be deleted in its entirety.
Appendix I–II–B–2. Host-Vector 2
Systems
amozie on DSK3GDR082PROD with NOTICES1
The following types of data shall be
submitted, modified as appropriate for the
particular system under consideration: (i) A
description of the organism and vector; the
strain’s natural habitat and growth
requirements; its physiological properties,
particularly those related to its reproduction,
survival, and the mechanisms by which it
exchanges genetic information; the range of
organisms with which this organism
normally exchanges genetic information and
the type of information is exchanged; and
any relevant information about its
pathogenicity or toxicity; (ii) a description of
the history of the particular strains and
vectors to be used, including data on any
mutations which render this organism less
able to survive or transmit genetic
information; and (iii) a general description of
the range of experiments contemplated with
emphasis on the need for developing such an
Host-Vector 1 system.
National Institutes of Health
Investigators planning to request HostVector 2 systems certification may obtain
instructions from NIH OSP concerning data
to be submitted (see Appendices I–III–N and
O, Footnotes and References of Appendix I).
In general, the following types of data are
required: (i) Description of construction steps
with indication of source, properties, and
manner of introduction of genetic traits; (ii)
quantitative data on the stability of genetic
traits that contribute to the containment of
the system; (iii) data on the survival of the
host-vector system under non-permissive
laboratory conditions designed to represent
the relevant natural environment; (iv) data on
transmissibility of the vector and/or a cloned
DNA fragment under both permissive and
non-permissive conditions; (v) data on all
other properties of the system which affect
Center for Scientific Review; Notice of
Closed Meetings
VerDate Sep<11>2014
18:00 Aug 16, 2018
Jkt 244001
Dated: August 7, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
41093
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–17–
144: Limited Competition: National Primate
Research Centers (P51).
Date: September 11–14, 2018.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Vintage Portland, 422 SW
Broadway, Portland, OR 97205.
Contact Person: Brian H. Scott, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–7490, brianscott@mail.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 13–14, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Orlando at SeaWorld,
6677 Sea Harbor Drive, Orlando, FL 32821.
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 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–17785 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2018–17760 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) 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
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National Institutes of Health
Draft Report on Carcinogens
Monograph on Night Shift Work and
Light at Night; Availability of
Document; Request for Comments;
Notice of Peer-Review Meeting
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Toxicology
Program (NTP) announces a meeting to
peer review the Draft Report on
Carcinogens Monograph on Night Shift
Work and Light at Night. NTP has
conducted a literature-based assessment
to determine whether night shift work
(e.g., working at least three hours
between 12 a.m. and 6 a.m.) and light
at night are cancer hazards and should
SUMMARY:
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Page 41093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17785]
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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 10(d) 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; PAR-17-144: Limited Competition: National Primate Research
Centers (P51).
Date: September 11-14, 2018.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Vintage Portland, 422 SW Broadway, Portland, OR
97205.
Contact Person: Brian H. Scott, Ph.D., Scientific Review
Officer, National Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-7490,
[email protected].
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 13-14, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Orlando at SeaWorld, 6677 Sea Harbor Drive,
Orlando, FL 32821.
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 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-17785 Filed 8-16-18; 8:45 am]
BILLING CODE 4140-01-P
