National Human Genome Research Institute; Notice of Closed Meeting, 58266-58267 [2018-25108]
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58266
Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Division of Intramural
Research Board of Scientific Counselors,
NIAID.
Date: December 10–12, 2018.
Time: 8:00 a.m. to 10:00 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 50, 50 Center Drive, Bethesda, MD
20892.
Contact Person: Steven M. Holland, MD,
Ph.D., Chief, Laboratory of Clinical Infectious
Diseases, National Institutes of Health/
NIAID, Hatfield Clinical Research Center,
Bethesda, MD 20892–1684, 301–402–7684,
sholland@mail.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 14, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
Optimized Variants of the Broadly
Neutralizing HIV–1 gp41 Antibody,
10E8
Description of Technology
Scientists at the National Institute of
Allergy and Infectious Diseases (NIAID)
recently discovered a human
neutralizing antibody, 10E8, that binds
to the GP41 protein of HIV–1 and
prevents infection by HIV–1. 10E8
potently neutralizes up to 98% of
genetically diverse HIV–1 strains.
By engineering the 10E8 antibody,
NIAID scientists have improved the
properties of 10E8 that affect
manufacturability, such as solubility,
while preserving its neutralizing
breadth and potency.
10E8 variants are useful for passive
protection from infection, as
therapeutics, and as a tool for vaccine
development.
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
Connors (NIAID), Amarendra Pegu
(NIAID), Lisa Kueltzo (NIAID), Tatyana
Gindin (Columbia University), and
Lawrence Shapiro (Columbia
University).
Publications: Kwon, Y.D. et al. (2016)
Optimization of the Solubility of HIV-1Neutralizing Antibody 10E8 through
Somatic Variation and Structure-Based
Design. J Virol. 90(13): 5899–914.
[PMID: 27053554]
Intellectual Property: HHS Reference
Number E–133–2015 includes Patent
Cooperation Treaty Application Number
PCT/US2016/060390 filed November 3,
2016; Canadian Patent Application
Number 3003878 filed May 1, 2018;
China Patent Application Number TBD
filed May 1, 2018; European Patent
Application Number 16801639.2 filed
June 1, 2018; India Patent Application
Number 20187016184 filed 30 April
2018; U.S. Patent Application Number
15/772,443 filed 30 April 2018; South
Africa Patent Application Number 2018/
02875 filed 2 May 2018; Australia
Patent Application Number 2016349392
filed 4 May 2018.
Related Intellectual Property: HHS
Reference Number E–253–2011.
Licensing Contact: Dr. Vince
Contreras, 240–669–2823;
vince.contreras@nih.gov.
Dated: November 7, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
• Passive protection to prevent HIV
infection
• Passive protection to prevent
mother-to-infant HIV transmission
• Gene-based vectors for anti-gp41
antibody expression
• Therapeutics for elimination of HIV
infected cells that are actively
producing virus
National Institutes of Health
Competitive Advantages
National Institutes of Health
• Among the most potent and broadly
neutralizing human antibodies isolated
to date
• Broad reactivity and high affinity to
most HIV–1 strains
• Improved manufacturability
relative to the natural 10E8 antibody
National Human Genome Research
Institute; Notice of Closed Meeting
[FR Doc. 2018–25190 Filed 11–16–18; 8:45 am]
BILLING CODE 4140–01–P
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.
FOR FURTHER INFORMATION CONTACT: Dr.
Vince Contreras, 240–669–2823;
vince.contreras@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
SUMMARY:
khammond on DSK30JT082PROD with NOTICES
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.
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Development Stage
• In vivo data available (animal)
Inventors: Peter D. Kwong (NIAID),
Young Do Kwon (NIAID), Ivelin S.
Georgiev (NIAID), Gilad A. Ofek
(NIAID), Baoshan Zhang (NIAID), Krisha
McKee (NIAID), John Mascola (NIAID),
Gwo-Yu Chuang (NIAID), Sijy O’Dell
(NIAID), Robert Bailer (NIAID), Mark
Louder (NIAID), Mangaiarkarasi Asokan
(NIAID), Richard Schwartz (NIAID),
Jonathan Cooper (NIAID), Kevin Carlton
(NIAID), Michael Bender (NIAID), Mark
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[FR Doc. 2018–25189 Filed 11–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of National Advisory Council
for Human Genome Research.
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.
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58267
Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel; H3Africa Biorepository.
Date: December 14, 2018.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NHGRI, Greider Conference Room
3321, 6700B Rockledge Dr., Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Rudy O. Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, 5635 Fishers Lane, Suite 4076, MSC
9306, Rockville, MD 20852, (301) 402–0838,
pozzattr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: November 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–25108 Filed 11–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and, (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: 2019 National Survey
on Drug Use and Health (OMB No.
0930–0110)—Extension
Agency Information Collection
Activities: Proposed Collection;
Comment Request
The data are used to determine the
prevalence of use of tobacco products,
alcohol, illicit substances, and illicit use
of prescription drugs. The results are
used by SAMHSA, the Office of
National Drug Control Policy (ONDCP),
federal government agencies, and other
organizations and researchers to
establish policy, to direct program
activities, and to better allocate
resources.
This is an extension to the 2019
National Survey on Drug Use and
Health (NSDUH). There are no
substantive changes to the questionnaire
or changes in burden. The 2019 NSDUH
will continue to include questions on
medication-assisted treatment (MAT)
and kratom.
As with all NSDUH surveys
conducted since 1999, including those
prior to 2002 when the NSDUH was
referred to as the National Household
Survey on Drug Abuse, the sample size
of the survey for 2019 will be sufficient
to permit prevalence estimates for each
of the 50 states and the District of
Columbia. The total annual burden
estimate is shown below in Table 1.
The National Survey on Drug Use and
Health (NSDUH) is a survey of the U.S.
civilian, non-institutionalized
population aged 12 years old or older.
In compliance with section
3506(c)(2)(A) of the Paperwork
TABLE 1—ANNUALIZED ESTIMATED BURDEN FOR 2019 NSDUH
Number of
respondents
Instrument
Total number
of responses
Hours per
response
Total burden
hours
Household Screening ...........................................................
Interview ...............................................................................
Screening Verification ..........................................................
Interview Verification ............................................................
137,231
67,507
4,116
10,126
1
1
1
1
137,231
67,507
4,116
10,126
0.083
1.000
0.067
0.067
11,390
67,507
276
678
Total ..............................................................................
137,231
........................
218,980
........................
79,851
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 15E57B, 5600 Fishers Lane,
Rockville, MD 20857 or email a copy to
summer.king@samhsa.hhs.gov.
Written comments should be received
by January 18, 2019.
Summer King,
Statistician.
khammond on DSK30JT082PROD with NOTICES
Responses
per
respondent
[FR Doc. 2018–25142 Filed 11–16–18; 8:45 am]
BILLING CODE 4162–20–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention’s
(CSAP) Drug Testing Advisory Board
(DTAB) will convene via in person and
web conference on December 4, 2018,
from 9:00 a.m. EST to 3:30 p.m. EST and
December 5, 2018, from 9:00 a.m. EST
to 4:00 p.m.
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The Board will meet in open-session
in-person on December 4, 2018, from
9:00 a.m. EST to 3:30 p.m. EST to
discuss the proposed Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (urine specimens)
with updates from the Department of
Transportation, Nuclear Regulatory
Commission, and the Department of
Defense. There will be additional
presentations from the Division of
Workplace Programs’ staff on urine, oral
fluid, hair Mandatory Guidelines and
future direction, updates on electronic
chain of custody and standard variables,
and emerging issues surrounding
marijuana legalization. The board will
meet in closed-session in-person on
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Agencies
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58266-58267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Human Genome Research Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of National Advisory
Council for Human Genome Research.
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.
[[Page 58267]]
Name of Committee: National Human Genome Research Institute
Special Emphasis Panel; H3Africa Biorepository.
Date: December 14, 2018.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: NHGRI, Greider Conference Room 3321, 6700B Rockledge Dr.,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Rudy O. Pozzatti, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Human Genome Research
Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD
20852, (301) 402-0838, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human
Genome Research, National Institutes of Health, HHS)
Dated: November 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-25108 Filed 11-16-18; 8:45 am]
BILLING CODE 4140-01-P