National Institute on Drug Abuse; Notice of Closed Meeting, 10178-10179 [2020-03444]
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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Notices
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:
Jenish Patel, Ph.D., 240–669–2894;
jenish.patel@nih.gov. Licensing
information and copies of the U.S.
patent application 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to receive copies of unpublished patent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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Monoclonal Antibodies Against
Bacillus Anthracis Antigens
Description of Technology: Anthrax,
whether resulting from natural or
bioterrorist-associated exposure, is a
constant threat to human health.
Bacillus anthracis is the causative agent
of anthrax. It is surrounded by a
polypeptide capsule of poly-gamma-Dglutamic acid (gamma-D-PGA), which is
essential for virulence, is poorly
immunogenic and has anti-phagocytic
properties. Antibodies to the capsule
have been shown to enhance
phagocytosis and killing of
encapsulated bacilli. The lethality of
anthrax is primarily the result of the
effects of anthrax toxin, which has 3
components: A receptor-binding protein
known as ‘‘protective antigen’’ (PA) and
2 catalytic proteins known as ‘‘lethal
factor’’ (LF) and ‘‘edema factor’’ (EF).
Although production of an efficient
anthrax vaccine is an ultimate goal, the
benefits of vaccination can be expected
only if a large proportion of the
population at risk is immunized. The
low incidence of anthrax suggests that
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large-scale vaccination may not be the
most efficient means of controlling this
disease. In contrast, passive
administration of neutralizing human or
chimpanzee monoclonal antibody to a
subject at risk for anthrax or exposed to
anthrax could provide immediate
efficacy for emergency prophylaxis
against or treatment of anthrax.
Several monoclonal antibodies
(mAbs) against gamma-D-PGA, PA, LF
and EF of anthrax were isolated from a
phage display library generated from
immunized chimpanzees. Two anti-PA,
and two anti-LF mAbs efficiently
neutralized the cytotoxicity of lethal
toxin in a macrophage lysis assay. One
anti-EF mAb efficiently neutralized
edema toxin in cell culture. All of these
five neutralizing mAbs protected
animals from anthrax toxin challenge.
There are two anti-gamma-D-PGA mAbs
that showed strong opsonophagocytic
killing of bacilli in vitro assays. These
two mAbs were also tested for
protection of mice challenged with
virulent anthrax spores and results
showed that both mAbs provided full or
nearly full protection. Since
chimpanzee immunoglobulins are
virtually identical to human
immunoglobulins, these chimeric
chimpanzee mAbs may have clinically
useful applications.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• Prophylaxis, therapeutics or
diagnostics against B. anthracis
antigens
Competitive Advantages:
• Strongly neutralizing antibodies
• Known regulatory pathway
• Potential for use as both a prophylaxis
and therapy
Development Stage:
• In vivo (animal)
Inventors:
Anti-PGA mAbs: Zhaochun Chen
(NIAID), Robert Purcell (NIAID), Rachel
Schneerson (NIACHD), Joanna Kublerkielb (NICHD), Lily Zhongdong Dai
(NICHD).
All other mAbs: Zhaochun Chen
(NIAID), Stephen Leppla (NIAID),
Suzanne Emerson (NIAID), Robert
Purcell (NIAID), and Mahtab Moayeri
(NIDCR).
Publications:
• Z Chen et al. Efficient
neutralization of anthrax toxin by
chimpanzee monoclonal antibodies
against protective antigen. J Infect Dis.
2006 Mar 1;193(5): 625–633.
• Z Chen et al. Bacillus anthracis
Capsular Conjugates Elicit Chimpanzee
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Polyclonal Antibodies That Protect Mice
from Pulmonary Anthrax. Clin Vaccine
Immunol. 2015 Aug; 22(8): 902–908.
Intellectual Property: HHS Reference
Nos. E–146–2004, E–123–2007 and E–
125–2008.
Licensing Contact: To license this
technology, please contact Jenish Patel,
Ph.D., 240–669–2894; jenish.patel@
nih.gov.
Dated: February 7, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–03443 Filed 2–20–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) 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 on
Drug Abuse Special Emphasis Panel; The
National Drug Abuse Treatment Clinical
Trials Network (UG1 Clinical Trial Required).
Date: March 5, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building, 6001
Executive Blvd., Rockville, MD 20852.
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, 6001 Executive Blvd., Room 4235,
MSC 9550, Bethesda, MD 20892–9550, 301–
827–5819, gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Notices
Dated: February 14, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–03444 Filed 2–20–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2020–0043]
National Commercial Fishing Safety
Advisory Committee; Initial Solicitation
for Members
U.S. Coast Guard, Department
of Homeland Security.
ACTION: Request for applications.
AGENCY:
The Coast Guard is requesting
applications from persons interested in
serving in membership on the National
Commercial Fishing Safety Advisory
Committee (‘‘Committee’’). This recently
established Committee will advise the
Secretary of the Department of
Homeland Security on matters relating
to national commercial fishing safety.
Please read this notice for a description
of the 18 Committee positions we are
seeking to fill.
DATES: Your completed application
should reach the Coast Guard on or
before April 21, 2020.
ADDRESSES: Applicants should send a
cover letter expressing interest in an
appointment to the National
Commercial Fishing Safety Advisory
Committee and a resume detailing the
applicant’s experience. We will not
accept a biography. Applications should
be submitted via one of the following
methods:
• By Email: CGfishsafe@uscg.mil
(preferred).
• By Mail: Commandant (CG–CVC–3),
Attn: CFSAC ADFO, U.S. Coast Guard
Stop 7501, 2703 Martin Luther King Jr.
Avenue SE, Washington, DC 20593–
7501.
SUMMARY:
Mr.
Jonathan Wendland, Alternate
Designated Federal Officer of the
National Commercial Fishing Safety
Advisory Committee; Telephone 202–
372–1245 or Email at CGfishsafe@
uscg.mil.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
The
National Commercial Fishing Safety
Advisory Committee is a federal
advisory committee. It will operate
under the provisions of the Federal
Advisory Committee Act, 5 U.S.C.
Appendix, and the administrative
SUPPLEMENTARY INFORMATION:
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provisions contained in Section 601 of
the Frank LoBiondo Coast Guard
Authorization Act of 2018 (specifically,
46 U.S.C. 15109).
The Committee was established on
December 4, 2018, by the Frank
LoBiondo Coast Guard Authorization
Act of 2018, which added section
15102, National Commercial Fishing
Safety Advisory Committee, to Title 46
of the U.S. Code (46 U.S.C. 15102). The
Committee will advise the Secretary of
Homeland Security on matters relating
to national commercial fishing safety.
In accordance with 46 U.S.C section
15109(a), the Committee is required to
hold meetings at least once a year, but
it may meet more frequently as needs
may require. The meetings are held at a
location selected by the U.S. Coast
Guard.
All members will serve at their own
expense and receive no salary or other
compensation from the Federal
Government, with the exception that
members may be reimbursed for travel
and per diem in accordance with
Federal Travel Regulations.
Under 46 U.S.C. 15109 (f) (6),
membership terms expire on December
31 of the third full year after the
effective date of your appointment. The
Secretary may require an individual to
have passed an appropriate security
background examination before
appointment to the Committee, 46
U.S.C. 15109(f)(4). In this initial
solicitation for Committee members, we
will consider applications for all 18
positions:
(A) Ten members shall represent the
commercial fishing industry and—
(i) as a group, shall together reflect a
regional and representational balance;
and (ii) as individuals each shall have
experience—
(I) in the operation in which chapter
45 of this title applies; or
(II) as a crew member or processing
line worker on a fish processing vessel.
(B) One member shall represent naval
architects and marine engineers.
(C) One member shall represent
manufacturers of equipment for vessels
to which
Chapter 45 of this title applies.
(D) One member shall represent
education and training professionals
related to fishing vessels, fish
processing vessels, and fish tender
vessels safety and personnel
qualifications.
(E) One member shall represent
underwriters that insure vessels to
which chapter 45 of this title applies.
(F) One member shall represent
owners of vessels to which chapter 45
of this title applies.
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(G) Three members shall represent the
general public and to the extent
possible, shall include—
(i) an independent expert or
consultant in maritime safety,
(ii) a marine surveyor who provides
services to vessels to which chapter 45
of this title applies; and
(iii) a person familiar with issues
affecting fishing communities and the
families of fishermen.
Each member of the Committee must
have particular expertise, knowledge,
and experience in matters relating to the
function of the Committee, which is to
advise the Secretary of Homeland
Security on matters related to national
commercial fishing safety.
If you are selected as a member drawn
from the general public, you will be
appointed and serve as a Special
Government Employee as defined in 18
U.S.C. 202(a). Applicants for
appointment as a Special Government
Employee are required to complete a
Confidential Financial Disclosure
Report (OGE Form 450) for new entrants
and if appointed as a member must
submit Form 450 annually. The Coast
Guard may not release the reports or the
information in them to the public except
under an order issued by a Federal
Court or as otherwise provided under
the Privacy Act (5 U.S.C 552a). Only the
Designated U.S. Coast Guard Ethics
Official or his or her designee may
release a Confidential Financial
Disclosure Report. Applicants can
obtain this form by going to the website
of the Office of Government Ethics
(www.oge.gov), or by calling or emailing
the individual listed above in the FOR
FURTHER INFORMATION CONTACT section.
Applications for member drawn from
the general public must be accompanied
by a completed OGE Form 450.
Registered lobbyists are not eligible to
serve on Federal Advisory Committees
in an individual capacity. See ‘‘Revised
Guidance on Appointment of Lobbyists
to Federal Advisory Committees, Boards
and Commissions’’ (79 FR 47482,
August 13, 2014). Registered lobbyists
are ‘‘lobbyists,’’ as defined in 2 U.S.C.
1602, who are required by 2 U.S.C. 1603
to register with the Secretary of the
Senate and the Clerk of the House of
Representatives.
The Department of Homeland
Security does not discriminate in
selection of Committee members on the
basis of race, color, religion, sex,
national origin, political affiliation,
sexual orientation, gender identity,
marital status, disabilities and genetic
information, age, membership in an
employee organization, or any other
non-merit factor. The Department of
Homeland Security strives to achieve a
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Agencies
[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10178-10179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Pursuant to section 10(d) 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 on Drug Abuse Special
Emphasis Panel; The National Drug Abuse Treatment Clinical Trials
Network (UG1 Clinical Trial Required).
Date: March 5, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center
Building, 6001 Executive Blvd., Rockville, MD 20852.
Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, National Institutes of Health, 6001 Executive Blvd.,
Room 4235, MSC 9550, Bethesda, MD 20892-9550, 301-827-5819,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug
Abuse Scientist Development Award for Clinicians, Scientist
Development Awards, and Research Scientist Awards; 93.278, Drug
Abuse National Research Service Awards for Research Training;
93.279, Drug Abuse and Addiction Research Programs, National
Institutes of Health, HHS)
[[Page 10179]]
Dated: February 14, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-03444 Filed 2-20-20; 8:45 am]
BILLING CODE 4140-01-P