Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), 4365-4366 [2017-00766]
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
and related dementias and recruitment
challenges. Additional presentations in
the afternoon will include updates on
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Summit, federal workgroup updates,
and preparation for the Advisory
Council’s 2017 Recommendations, due
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Procedure and Agenda: This meeting
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panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: January 5, 2017.
Kathryn E. Martin,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2017–00606 Filed 1–12–17; 8:45 am]
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National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Advisory Board.
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
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting Web site (https://
videocast.nih.gov).
The meeting will be closed to the
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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 Cancer
Advisory Board.
Date: February 15, 2017.
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Open: 1:00 p.m. to 2:00 p.m.
Agenda: Program reports and
presentations; business of the Board.
Closed: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove 9609 Medical Center Drive, Room
TE406 Rockville, MD 20850 (Virtual
Meeting).
Contact Person: Paulette S. Gray, Ph.D.,
Executive Secretary, Division of Extramural
Activities, National Cancer Institute—Shady
Grove National Institutes of Health, 9609
Medical Center Drive, Room 7W444,
Bethesda, MD 20892, 240–276–6340, grayp@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/ncab/ncab.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: January 9, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
4365
Name of Committee: National Institute on
Aging Special Emphasis Panel; Predictors
and Determinants of Age-Related Resiliencies
to Physical Stressors, RFA–AG–014 (UH2).
Date: February 23, 2017.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Carmen Moten, Ph.D.,
MPH, National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7703,
cmoten@mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Late Onset of
Alzheimer’s Disease (LOAD), PAR–16–205
(U24).
Date: March 7, 2017.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Carmen Moten, Ph.D.,
MPH, National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7703,
cmoten@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: January 10, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
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National Institutes of Health
Action Under the NIH Guidelines for
Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (NIH
Guidelines)
National Institutes of Health
(NIH), HHS.
ACTION: Notice of action under the NIH
Guidelines.
AGENCY:
The National Institutes of
Health (NIH) considered a proposal to
conduct research involving the
deliberate transfer of a chloramphenicol
resistance trait to Rickettsia typhi,
conorii, rickettsii, and felis. The
acquisition of this antibiotic resistance
trait could possibly compromise the use
of a class of antibiotics for the treatment
of Rickettsia infections in humans.
Under the NIH Guidelines (https://
www.osp.od.nih.gov/sites/default/files/
SUMMARY:
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
NIH_Guidelines.html), these
experiments can proceed only after they
are reviewed by the NIH Recombinant
DNA Advisory Committee (RAC) and
specifically approved by the NIH
Director as Major Actions. This proposal
was discussed at the December 4, 2015,
RAC meeting. The proposal was
published in the Federal Register on
December 29, 2015, (80 FR 81346) with
a request for public comment; one
comment was received. This notice
announces the final NIH action
regarding this proposal.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional background information
about this action, please contact the NIH
by email at SciencePolicy@od.nih.gov,
or by telephone at 301–496–9838 and
reference this notice.
SUPPLEMENTARY INFORMATION: This final
action does not allow an investigator at
the University of Chicago to transfer
chloramphenicol resistance to three
different Rickettsia species: Rickettsia
typhi, rickettsii, and felis. The
investigator also proposed to transfer
chloramphenicol resistance to a fourth
Rickettsia species, R. conorii. Transfer of
chloramphenicol resistance to R. conorii
was previously approved by the NIH
Director as a Major Action (see 73 FR
32719) and therefore did not need to be
reviewed and approved under Section
III–A–1–a of the NIH Guidelines. Thus,
the University of Chicago investigator
was allowed to proceed with the
transfer of chloramphenicol resistance
to R. conorii under Section III–B–2 of
the NIH Guidelines.
The proposal to transfer
chloramphenicol resistance to R. typhi,
rickettsii, and felis was discussed with
a working group of the RAC via a
teleconference call on October 22, 2015.
The recommendations of this group
were presented to and discussed with
the RAC at its December 4, 2015,
meeting. At the March 8, 2016, meeting,
the RAC continued the discussion
which included consideration of the one
comment received to the December 29,
2015, notice and unanimously
recommended (by a vote of 11 in favor,
none opposed, and no abstentions) that
the transfer of chloramphenicol
resistance to R. typhi, rickettsii, and felis
should not be allowed to proceed. On
August 23, 2016, the NIH Director
disapproved the proposal to transfer
chloramphenicol resistance to R. typhi,
rickettsii, and felis.
Dated: January 6, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017–00766 Filed 1–12–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Monoclonal Antibodies That Neutralize
Norovirus
Description of Technology: Vaccines
and therapies to prevent and treat
Norovirus infections do not exist,
despite the worldwide prevalence of
Norovirus infections. Outbreaks of
human gastroenteritis attributable to
Norovirus commonly occur in group
setting, such as hospitals, nursing
homes, schools, dormitories, cruise
ships and military barracks. This
technology relates to chimpanzeehuman chimeric monoclonal antibodies,
which specifically bind to Norovirus
and have therapeutic potential. The
antibodies that were tested in a primate
model of infection have shown
protection against Norovirus. These
Norovirus antibodies may have
application as immunoprophylaxis to
protect individuals from infections or as
a possible treatment for infected
individuals, or can be used to develop
a diagnostic for detection of norovirus
infections.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
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development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Therapeutics
• Diagnostics
Competitive Advantages:
• There are currently no vaccines or
therapeutics available against
Norovirus infections
Development Stage:
• In vivo data available (animal)
Inventors: Zhaochun Chen, Robert H.
Purcell, Lisbeth Kim Green, Stanislav
Sosnovtsev, Karin Bok (all from NIAID).
Publications: Chen Z, et al.,
Development of Norwalk virus-specific
monoclonal antibodies with therapeutic
potential for the treatment of Norwalk
virus gastroenteritis, J Virol. 2013 Sep;
87(17):9547–57. [PMID 23785216].
Intellectual Property: HHS Reference
No. E–226–2011/0—U.S. Provisional
Application No. 61/763,879, filed
February 12, 2013; PCT Application No.
PCT/US2014/015809, filed February 11,
2014; European Application No.
14706239.2, filed August 5, 2015
(pending); U.S. Application No. 14/
767,274, filed August 11, 2015
(allowed); and U.S. Application No. 15/
359,438, filed November 22, 2016
(pending).
Licensing Contact: Dr. Jenish Patel,
240–669–2894; Jenish.Patel@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
therapeutic or a diagnostic for Norovirus
infections. For collaboration
opportunities, please contact Dr. Jenish
Patel, 240–669–2894; Jenish.Patel@
nih.gov.
Dated: January 9, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–00735 Filed 1–12–17; 8:45 am]
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National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4365-4366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Action Under the NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
AGENCY: National Institutes of Health (NIH), HHS.
ACTION: Notice of action under the NIH Guidelines.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) considered a proposal
to conduct research involving the deliberate transfer of a
chloramphenicol resistance trait to Rickettsia typhi, conorii,
rickettsii, and felis. The acquisition of this antibiotic resistance
trait could possibly compromise the use of a class of antibiotics for
the treatment of Rickettsia infections in humans. Under the NIH
Guidelines (https://www.osp.od.nih.gov/sites/default/files/
[[Page 4366]]
NIH_Guidelines.html), these experiments can proceed only after they are
reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and
specifically approved by the NIH Director as Major Actions. This
proposal was discussed at the December 4, 2015, RAC meeting. The
proposal was published in the Federal Register on December 29, 2015,
(80 FR 81346) with a request for public comment; one comment was
received. This notice announces the final NIH action regarding this
proposal.
FOR FURTHER INFORMATION CONTACT: If you have questions, or require
additional background information about this action, please contact the
NIH by email at SciencePolicy@od.nih.gov, or by telephone at 301-496-
9838 and reference this notice.
SUPPLEMENTARY INFORMATION: This final action does not allow an
investigator at the University of Chicago to transfer chloramphenicol
resistance to three different Rickettsia species: Rickettsia typhi,
rickettsii, and felis. The investigator also proposed to transfer
chloramphenicol resistance to a fourth Rickettsia species, R. conorii.
Transfer of chloramphenicol resistance to R. conorii was previously
approved by the NIH Director as a Major Action (see 73 FR 32719) and
therefore did not need to be reviewed and approved under Section III-A-
1-a of the NIH Guidelines. Thus, the University of Chicago investigator
was allowed to proceed with the transfer of chloramphenicol resistance
to R. conorii under Section III-B-2 of the NIH Guidelines.
The proposal to transfer chloramphenicol resistance to R. typhi,
rickettsii, and felis was discussed with a working group of the RAC via
a teleconference call on October 22, 2015. The recommendations of this
group were presented to and discussed with the RAC at its December 4,
2015, meeting. At the March 8, 2016, meeting, the RAC continued the
discussion which included consideration of the one comment received to
the December 29, 2015, notice and unanimously recommended (by a vote of
11 in favor, none opposed, and no abstentions) that the transfer of
chloramphenicol resistance to R. typhi, rickettsii, and felis should
not be allowed to proceed. On August 23, 2016, the NIH Director
disapproved the proposal to transfer chloramphenicol resistance to R.
typhi, rickettsii, and felis.
Dated: January 6, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017-00766 Filed 1-12-17; 8:45 am]
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