83 FR 41093 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 160 (August 17, 2018)

Page Range		41093-41093
FR Document		2018-17785

Federal Register, Volume 83 Issue 160 (Friday, August 17, 2018)

[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Page 41093]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41093

additional contact information is also containment and utility, including would constitute a clearly unwarranted
available here and on the OSP website information on yields of phage or plasmid invasion of personal privacy.
(www.osp.od.nih.gov). The NIH Director may molecules, ease of DNA isolation, and ease of
rescind the certification of a host-vector transfection or transformation; and (vi) in Name of Committee: Center for Scientific
system (see Section IV–C–1–b–(2)–(g), Minor some cases, the investigator may be asked to Review Special Emphasis Panel; PAR–17–
Actions). If certification is rescinded, NIH submit data on survival and vector 144: Limited Competition: National Primate
will instruct investigators to transfer cloned transmissibility from experiments in which Research Centers (P51).
DNA into a different system or use the clones the host-vector is fed to laboratory animals or Date: September 11–14, 2018.
at a higher level of physical containment one or more human subjects. Such in vivo Time: 8:00 a.m. to 12:00 p.m.
level, unless NIH determines that the already data may be required to confirm the validity Agenda: To review and evaluate grant
constructed clones incorporate adequate of predicting in vivo survival on the basis of applications.
biological containment. Certification of a in vitro experiments. Data shall be submitted Place: Hotel Vintage Portland, 422 SW
host-vector system does not extend to to the Office of Science Policy, National Broadway, Portland, OR 97205.
modifications of either the host or vector Institutes of Health, preferably by email to: Contact Person: Brian H. Scott, Ph.D.,
component of that system. Such modified NIHGuidelines@od.nih.gov; additional Scientific Review Officer, National Institutes
systems shall be independently certified by contact information is also available here and of Health, Center for Scientific Review, 6701
the NIH Director. If modifications are minor, on the OSP website (www.osp.od.nih.gov). Rockledge Drive, Bethesda, MD 20892, 301–
it may only be necessary for the investigator Investigators are encouraged to publish their 827–7490, brianscott@mail.nih.gov.
to submit data showing that the data on the construction, properties, and Name of Committee: Brain Disorders and
modifications have either improved or not testing of proposed Host Vector 2 systems Clinical Neuroscience Integrated Review
impaired the major phenotypic traits on prior to consideration of the system by NIH. Group; Pathophysiological Basis of Mental
which the containment of the system Specific instructions concerning the Disorders and Addictions Study Section.
depends. Substantial modifications to a submission of data for proposed Escherichia Date: September 13–14, 2018.
certified host-vector system requires coli K–12 Host-Vector 2 system (EK2) Time: 8:00 a.m. to 5:00 p.m.
submission of complete testing data. involving either plasmids or bacteriophage in Agenda: To review and evaluate grant
Escherichia coli K–12, are available from the applications.
Appendix I–II–B. Data To Be Submitted Office of Science Policy, National Institutes Place: Renaissance Orlando at SeaWorld,
for Certification of Health, preferably by submitting a request 6677 Sea Harbor Drive, Orlando, FL 32821.
Appendix I–II–B–1. Host-Vector 1 for this information to: NIHGuidelines@ Contact Person: Boris P. Sokolov, Ph.D.,
od.nih.gov; additional contact information is Scientific Review Officer, Center for
Systems Other than Escherichia coli also available here and on the OSP website Scientific Review, National Institutes of
K–12 (www.osp.od.nih.gov). Health, 6701 Rockledge Drive, Room 5217A,
The following types of data shall be MSC 7846, Bethesda, MD 20892, 301–408–
Appendix L, GENE THERAPY
submitted, modified as appropriate for the 9115, bsokolov@csr.nih.gov.
POLICY CONFERENCES (GTPCS), is
particular system under consideration: (i) A (Catalogue of Federal Domestic Assistance
description of the organism and vector; the
proposed to be deleted in its entirety.
Program Nos. 93.306, Comparative Medicine;
strain’s natural habitat and growth Appendix M, Points to Consider in
93.333, Clinical Research, 93.306, 93.333,
requirements; its physiological properties, the Design and Submission of Protocols 93.337, 93.393–93.396, 93.837–93.844,
particularly those related to its reproduction, for the Transfer of Recombinant or 93.846–93.878, 93.892, 93.893, National
survival, and the mechanisms by which it Synthetic Nucleic Acid Molecules into Institutes of Health, HHS)
exchanges genetic information; the range of One or More Human Research
organisms with which this organism Dated: August 13, 2018.
Participants (Points to Consider), is
normally exchanges genetic information and Sylvia L. Neal,
proposed to be deleted in its entirety.
the type of information is exchanged; and Program Analyst, Office of Federal Advisory
any relevant information about its Dated: August 7, 2018. Committee Policy.
pathogenicity or toxicity; (ii) a description of Lawrence A. Tabak, [FR Doc. 2018–17785 Filed 8–16–18; 8:45 am]
the history of the particular strains and Deputy Director, National Institutes of Health. BILLING CODE 4140–01–P
vectors to be used, including data on any [FR Doc. 2018–17760 Filed 8–16–18; 8:45 am]
mutations which render this organism less
able to survive or transmit genetic BILLING CODE 4140–01–P
information; and (iii) a general description of DEPARTMENT OF HEALTH AND
the range of experiments contemplated with HUMAN SERVICES
emphasis on the need for developing such an DEPARTMENT OF HEALTH AND
Host-Vector 1 system. HUMAN SERVICES National Institutes of Health
Appendix I–II–B–2. Host-Vector 2 National Institutes of Health Draft Report on Carcinogens
Systems Monograph on Night Shift Work and
Investigators planning to request Host- Center for Scientific Review; Notice of Light at Night; Availability of
Vector 2 systems certification may obtain Closed Meetings Document; Request for Comments;
instructions from NIH OSP concerning data
Pursuant to section 10(d) of the Notice of Peer-Review Meeting
to be submitted (see Appendices I–III–N and
O, Footnotes and References of Appendix I). Federal Advisory Committee Act, as AGENCY: National Institutes of Health,
In general, the following types of data are amended, notice is hereby given of the HHS.
required: (i) Description of construction steps following meetings. ACTION: Notice.
with indication of source, properties, and The meetings will be closed to the
manner of introduction of genetic traits; (ii) public in accordance with the SUMMARY: The National Toxicology
quantitative data on the stability of genetic provisions set forth in sections Program (NTP) announces a meeting to
traits that contribute to the containment of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., peer review the Draft Report on
amozie on DSK3GDR082PROD with NOTICES1

the system; (iii) data on the survival of the as amended. The grant applications and Carcinogens Monograph on Night Shift
host-vector system under non-permissive
the discussions could disclose Work and Light at Night. NTP has
laboratory conditions designed to represent
the relevant natural environment; (iv) data on confidential trade secrets or commercial conducted a literature-based assessment
transmissibility of the vector and/or a cloned property such as patentable material, to determine whether night shift work
DNA fragment under both permissive and and personal information concerning (e.g., working at least three hours
non-permissive conditions; (v) data on all individuals associated with the grant between 12 a.m. and 6 a.m.) and light
other properties of the system which affect applications, the disclosure of which at night are cancer hazards and should

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Document Modified: 2018-08-17 03:26:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		September 11-14, 2018.
FR Citation		83 FR 41093

83 FR 41093 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 160 (August 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health