Center for Scientific Review; Notice of Closed Meetings, 13459-13460 [2017-04807]
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Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices
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submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Food and Drug
Administration, Center for Drug
Evaluation and Research, Office of
Strategic Programs, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176,
Silver Spring MD, 20993, 301–796–
4548, email:
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the
International Conference on
Harmonisation, was established in 1990
as a joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
and registering new medicinal products
in Europe, Japan, and the United States
without compromising the regulatory
obligations of safety and effectiveness.
In 2015 the ICH was reformed to make
the ICH a true global initiative that
expands beyond the previous ICH
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members. More involvement from
regulators around the world is expected,
as they will join their counterparts from
Europe, Japan, USA, Canada, and
Switzerland as ICH regulatory members.
The reforms build on a 25-year track
record of successful delivery of
harmonized guidelines for global
pharmaceutical development, and their
regulation. In recent years, many
important initiatives have been
undertaken by regulatory authorities
and industry associations to promote
international harmonization of
regulatory requirements. FDA has
participated in many meetings designed
to enhance harmonization and is
committed to seeking scientifically
based harmonized technical procedures
for pharmaceutical development. One of
the goals of harmonization is to identify
and then reduce differences in technical
requirements for medical product
development among regulatory
Agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. The ICH process has
achieved significant harmonization of
the technical requirements for the
approval of pharmaceuticals for human
use in the ICH regions over the past two
decades. The current ICH process and
structure can be found at the following
Web site: https://www.ich.org. (FDA has
verified the Web site addresses as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.)
II. Webinar Attendance and
Participation
A. Registration
If you wish to attend the meeting,
please register at the following Web site:
https://ich_regional_consultation.
eventbrite.com. Registrations may be
limited, so early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, the number of
participants from each organization may
be limited based on space limitations.
Registrants will receive confirmation
once they have been accepted. If you
need special accommodations because
of a disability, please contact Amanda
Roache (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
meeting.
B. Requests for Oral Presentations
Interested persons may present data,
information, or views orally or in
writing on issues pending at the public
meeting. Public oral presentations will
be scheduled between approximately
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1:30 p.m. and 2 p.m. Time allotted for
oral presentations may be limited to 5
minutes. Those desiring to make oral
presentations should notify Amanda
Roache (see FOR FURTHER INFORMATION
CONTACT) by April 19, 2017, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present; the names and addresses,
telephone number, fax, and email of
proposed participants; and an
indication of the approximate time
requested to make their presentation.
The agenda for the public Webinar will
be made available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm536015.htm.
Dated: March 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04839 Filed 3–10–17; 8:45 am]
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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 (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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Immunology.
Date: March 9, 2017.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alok Mulky, Ph.D.,
Scientific Review Officer, Center for
Scientific Review (CSR), National Institutes
of Health (NIH), 6701 Rockledge Dr, Room
4203, Bethesda, MD 20817, (301) 435–3566,
alok.mulky@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuropharmacology.
Date: March 28, 2017.
Time: 2:00 p.m. to 5:30 p.m.
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Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Mary Custer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4148,
MSC 7850, Bethesda, MD 20892, (301) 435–
1164, custerm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Neural Regulation of Cancer.
Date: March 29, 2017.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Rolf Jakobi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7806, Bethesda, MD 20892, 301–495–
1718, jakobir@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 16–
218: Provocative Questions in Pediatric
Cancer.
Date: April 4, 2017.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Charles Morrow, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202,
MSC 7804, Bethesda, MD 20892, 301–451–
4467, morrowcs@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)
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.
N6, A Novel, Broad, Highly Potent HIVSpecific Antibody
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Description of Technology
The N6 antibody has evolved a
unique mode of binding that depends
less on a variable area of the HIV
envelope known as the V5 region and
focuses more on conserved regions,
which change relatively little among
HIV strains. This allows N6 to tolerate
changes in the HIV envelope, including
the attachment of sugars in the V5
region, a major mechanism by which
HIV develops resistance to other VRC01class antibodies. N6 was shown in preclinical studies to neutralize
approximately 98 percent of HIV
isolates tested. The studies also
demonstrate that N6 neutralizes
approximately 80 percent of HIV
isolates which were resistant to other
antibodies of the same class, and does
so very potently. Its breadth and
potency makes N6 a highly desirable
candidate for development in
therapeutic or prophylactic strategies.
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
development and evaluation under a
research collaboration.
National Institutes of Health
Potential Commercial Applications
[FR Doc. 2017–04807 Filed 3–10–17; 8:45 am]
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National Institutes of Health,
HHS.
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
SUMMARY:
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[FR Doc. 2017–04834 Filed 3–10–17; 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 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
• Neutralized 98 percent of HIV
isolates tested.
• Neutralized 80 percent of HIV
isolates which were resistant to other
antibodies of the same class, and does
so very potently.
Development Stage: Pre-Clinical.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID; Investigator Initiated
Program Project Applications (P01).
Date: March 29, 2017.
Time: 11:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
• HIV therapeutic
• HIV prophylactic
Government-Owned Inventions;
Availability for Licensing
ACTION:
Dated: March 3, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
Competitive Advantages
Dated: March 7, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
AGENCY:
Inventors: Mark Connors, Jinghe
Huang, Byong Ha Kang, John Mascola,
Elise Ishida, Tongqing Zhou, Peter
Kwong, Anqi Zheng, all of NIAID.
Publications: Huang, Jinghe, et al.
‘‘Identification of a CD4-binding-site
antibody to HIV that evolved near-pan
neutralization breadth.’’ Immunity 45.5
(2016): 1108–1121.
Intellectual Property: HHS Reference
No. E–131–2015 et seq.—US provisional
application 62/136,228, US provisional
application 62/250,378, and PCT
application PCT/US2016/023145.
Licensing Contact: Chris Kornak, 240–
627–3705, chris.kornak@nih.gov.
Collaborative Research Opportunity:
The Technology Transfer and
Intellectual Property Office (TTIPO) is
seeking parties interested in
collaborative research to further codevelop this technology. For
collaboration opportunities, please
contact Chris Kornak, 240–627–3705,
chris.kornak@nih.gov.
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Agencies
[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13459-13460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04807]
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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 (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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AREA: Immunology.
Date: March 9, 2017.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Alok Mulky, Ph.D., Scientific Review Officer,
Center for Scientific Review (CSR), National Institutes of Health
(NIH), 6701 Rockledge Dr, Room 4203, Bethesda, MD 20817, (301) 435-
3566, alok.mulky@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neuropharmacology.
Date: March 28, 2017.
Time: 2:00 p.m. to 5:30 p.m.
[[Page 13460]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Mary Custer, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892, (301) 435-
1164, custerm@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Neural Regulation of Cancer.
Date: March 29, 2017.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301-495-
1718, jakobir@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR 16-218: Provocative Questions in Pediatric Cancer.
Date: April 4, 2017.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Charles Morrow, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD
20892, 301-451-4467, morrowcs@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: March 7, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-04807 Filed 3-10-17; 8:45 am]
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