Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Biomarkers and Immunogenic Compositions for Filarial Parasites, 35101-35102 [2021-14128]
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Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices
Scientists at NIAID have developed
novel topical formulations that promote
the growth of health-associated strains
of commensal bacteria and inhibit
disease-associated bacteria, thereby
enhancing skin health.
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.
Potential Commercial Applications:
• Over-the-counter formulations—this
invention could be readily
incorporated into popular body
lotions or other skincare products to
make ‘‘enhanced’’/‘‘microbiomefriendly’’ versions that promote the
growth of health associated bacterial
Competitive Advantages:
• Benign safety profile with multiple
mechanisms of action
• Proven enhancement of beneficial
microbiota
• Can be readily incorporated into
existing products
Development Stage:
khammond on DSKJM1Z7X2PROD with NOTICES
• Pre-clinical
Inventors: Carlos Castillo and Ian
Myles, MD, MPH, both of NIAID.
Publications: Castillo, Carlos, et al.
‘‘Assessing the effects of common
topical exposures on skin bacteria
associated with atopic dermatitis’’, Skin
Health and Disease, 2021.05.07.
Intellectual Property: HHS Reference
No. E–100–2021–0; US provisional
application No. 63/175,368 filed on
April 15, 2021.
Licensing Contact: To license this
technology, please contact David Yang
at 240–695–6406 or yangp3@
mail.nih.gov and reference E–100–
2021–0.
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 this technology. For
collaboration opportunities, please
contact David Yang at 240–695–6406 or
yangp3@mail.nih.gov.
Dated: June 24, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–14129 Filed 6–30–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License, Inter-Institutional AgreementInstitution Lead: Biomarkers and
Immunogenic Compositions for Filarial
Parasites
National Institutes of Health,
National Institute of Allergy and
Infectious Diseases, HHS.
ACTION: Notice.
AGENCY:
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive, sublicensable
patent license to New York Blood
Center, Inc. (‘‘NYBC’’), located in New
York, New York, in its rights to the
technologies and patent applications
listed in the SUPPLEMENTARY
INFORMATION section of this notice.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases, on or before July 16,
2021 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive License should be directed to:
Theodoric Mattes, Ph.D., Technology
Transfer and Patent Specialist,
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Suite 6D, MSC9804,
Rockville, MD 20852–9804, phone
number 240–627–3827, or
theodoric.mattes@nih.gov.
SUPPLEMENTARY INFORMATION: The
following and all continuing U.S.
patents/patent applications thereof are
the intellectual properties to be licensed
under the prospective agreement to
NYBC: United States Provisional Patent
Application Number 62/317,342, filed
May 1, 2016, the title of which is
‘‘Biomarkers and Immunogenic
Compositions for Filarial Parasites’’
(HHS Reference No. E–288–2016–0–US–
01); PCT Patent Application Number
PCT/US2017/025554, filed March 31,
2017, the title of which is ‘‘Biomarkers
and Immunogenic Compositions for
Filarial Parasites’’ (HHS Reference No.
E–288–2016–00–PCT–02); United States
Patent Application Number 16/090,013,
filed September 28, 2018, the title of
which is ‘‘Biomarkers and Immunogenic
Compositions for Filarial Parasites’’
SUMMARY:
PO 00000
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35101
(HHS Reference No. E–288–2016–0–US–
03); and United States Patent
Application Number 17/076,616, filed
October 21, 2020, the title of which is
‘‘Biomarkers and Immunogenic
Compositions for Filarial Parasites’’
(HHS Reference No. E–288–2016–0–US–
04).
The patent rights to this technology
have been assigned to New York Blood
Center, Inc. and the Government of the
United States of America as represented
by the Secretary, Department of Health
& Human Services, by each institution’s
respective inventors.
The prospective patent license will be
for the purpose of consolidating the
patent rights to New York Blood Center,
Inc., for the development and
commercialization of the technology.
Consolidation of these co-owned
rights is intended to expedite
development of the technology,
consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212.
The prospective interinstitutional
agreement may include an exclusive
license for NIAID’s rights in these
jointly owned patents. It will be
sublicensable, and any sublicenses
granted by NYBC will be subject to the
provisions of 37 CFR part 404. NIAID
will retain its rights to non-exclusively
license its rights to the patent
applications to third parties for internal
research use.
In the subject technology, researchers
at NIAID and NYBC isolated and
analyzed the transcriptome and
proteome of the parasite at various life
stages as well as its Wolbachia sp.
endosymbiont to identify potential
biomarkers for diagnostic assays and
vaccine candidates. In all, they
identified forty-seven (47) biomarkers.
The associated patents claim the use of
two or more of these biomarkers in
conjunction with an adjuvant as an
immunological composition, or the
detection of any of these biomarkers in
a serological-type assay.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and may be granted
unless within fifteen (15) days from the
date of this published notice the
National Institute of Allergy and
Infectious Diseases receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
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35102
Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices
confidentially, and may be made
publicly available.
Complete license applications
submitted in response to this Notice
will be presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: June 25, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–14128 Filed 6–30–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: In
accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing
all currently HHS-certified laboratories
and IITFs is published in the Federal
Register during the first week of each
month. If any laboratory or IITF
certification is suspended or revoked,
the laboratory or IITF will be omitted
from subsequent lists until such time as
it is restored to full certification under
the Mandatory Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
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SUMMARY:
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at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
of the laboratories currently certified to
meet the standards of the Mandatory
Guidelines using Oral Fluid.
The Mandatory Guidelines using
Urine were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in
the Federal Register on June 9, 1994 (59
FR 29908); September 30, 1997 (62 FR
51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858);
December 10, 2008 (73 FR 75122); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral
Fluid were first published in the
Federal Register on October 25, 2019
(84 FR 57554) with an effective date of
January 1, 2020.
The Mandatory Guidelines were
initially developed in accordance with
Executive Order 12564 and section 503
of Public Law 100–71 and allowed urine
drug testing only. The Mandatory
Guidelines using Urine have since been
revised, and new Mandatory Guidelines
allowing for oral fluid drug testing have
been published. The Mandatory
Guidelines require strict standards that
laboratories and IITFs must meet in
order to conduct drug and specimen
validity tests on specimens for federal
agencies. HHS does not allow IITFs to
conduct oral fluid testing.
To become certified, an applicant
laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITFs in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines using Urine and/
or Oral Fluid. An HHS-certified
laboratory or IITF must have its letter of
certification from HHS/SAMHSA
(formerly: HHS/NIDA), which attests
that the test facility has met minimum
standards. HHS does not allow IITFs to
conduct oral fluid testing.
PO 00000
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HHS-Certified Laboratories Approved
To Conduct Oral Fluid Drug Testing
In accordance with the Mandatory
Guidelines using Oral Fluid dated
October 25, 2019 (84 FR 57554), the
following HHS-certified laboratories
meet the minimum standards to conduct
drug and specimen validity tests on oral
fluid specimens:
At this time, there are no laboratories
certified to conduct drug and
specimen validity tests on oral fluid
specimens.
HHS-Certified Instrumented Initial
Testing Facilities Approved To Conduct
Urine Drug Testing
In accordance with the Mandatory
Guidelines using Urine dated January
23, 2017 (82 FR 7920), the following
HHS-certified IITFs meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
Dynacare, 6628 50th Street NW,
Edmonton, AB Canada T6B 2N7, 780–
784–1190 (Formerly: GammaDynacare Medical Laboratories)
HHS-Certified Laboratories Approved
To Conduct Urine Drug Testing
In accordance with the Mandatory
Guidelines using Urine dated January
23, 2017 (82 FR 7920), the following
HHS-certified laboratories meet the
minimum standards to conduct drug
and specimen validity tests on urine
specimens:
Alere Toxicology Services, 1111 Newton
St., Gretna, LA 70053, 504–361–8989/
800–433–3823 (Formerly: Kroll
Laboratory Specialists, Inc.,
Laboratory Specialists, Inc.)
Alere Toxicology Services, 450
Southlake Blvd., Richmond, VA
23236, 804–378–9130 (Formerly:
Kroll Laboratory Specialists, Inc.,
Scientific Testing Laboratories, Inc.;
Kroll Scientific Testing Laboratories,
Inc.)
Clinical Reference Laboratory, Inc., 8433
Quivira Road, Lenexa, KS 66215–
2802, 800–445–6917
Cordant Health Solutions, 2617 East L
Street, Tacoma, WA 98421, 800–442–
0438 (Formerly: STERLING Reference
Laboratories)
Desert Tox, LLC, 5425 E Bell Rd., Suite
125, Scottsdale, AZ 85254, 602–457–
5411/623–748–5045
DrugScan, Inc., 200 Precision Road,
Suite 200, Horsham, PA 19044, 800–
235–4890
Dynacare *, 245 Pall Mall Street,
London, ONT, Canada N6A 1P4, 519–
679–1630 (Formerly: GammaDynacare Medical Laboratories)
E:\FR\FM\01JYN1.SGM
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[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35101-35102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14128]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License, Inter-Institutional
Agreement-Institution Lead: Biomarkers and Immunogenic Compositions for
Filarial Parasites
AGENCY: National Institutes of Health, National Institute of Allergy
and Infectious Diseases, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an exclusive,
sublicensable patent license to New York Blood Center, Inc. (``NYBC''),
located in New York, New York, in its rights to the technologies and
patent applications listed in the Supplementary Information section of
this notice.
DATES: Only written comments and/or applications for a license which
are received by the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, on or
before July 16, 2021 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive License should be
directed to: Theodoric Mattes, Ph.D., Technology Transfer and Patent
Specialist, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases, 5601 Fishers
Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone number 240-
627-3827, or [email protected].
SUPPLEMENTARY INFORMATION: The following and all continuing U.S.
patents/patent applications thereof are the intellectual properties to
be licensed under the prospective agreement to NYBC: United States
Provisional Patent Application Number 62/317,342, filed May 1, 2016,
the title of which is ``Biomarkers and Immunogenic Compositions for
Filarial Parasites'' (HHS Reference No. E-288-2016-0-US-01); PCT Patent
Application Number PCT/US2017/025554, filed March 31, 2017, the title
of which is ``Biomarkers and Immunogenic Compositions for Filarial
Parasites'' (HHS Reference No. E-288-2016-00-PCT-02); United States
Patent Application Number 16/090,013, filed September 28, 2018, the
title of which is ``Biomarkers and Immunogenic Compositions for
Filarial Parasites'' (HHS Reference No. E-288-2016-0-US-03); and United
States Patent Application Number 17/076,616, filed October 21, 2020,
the title of which is ``Biomarkers and Immunogenic Compositions for
Filarial Parasites'' (HHS Reference No. E-288-2016-0-US-04).
The patent rights to this technology have been assigned to New York
Blood Center, Inc. and the Government of the United States of America
as represented by the Secretary, Department of Health & Human Services,
by each institution's respective inventors.
The prospective patent license will be for the purpose of
consolidating the patent rights to New York Blood Center, Inc., for the
development and commercialization of the technology.
Consolidation of these co-owned rights is intended to expedite
development of the technology, consistent with the goals of the Bayh-
Dole Act codified as 35 U.S.C. 200-212.
The prospective interinstitutional agreement may include an
exclusive license for NIAID's rights in these jointly owned patents. It
will be sublicensable, and any sublicenses granted by NYBC will be
subject to the provisions of 37 CFR part 404. NIAID will retain its
rights to non-exclusively license its rights to the patent applications
to third parties for internal research use.
In the subject technology, researchers at NIAID and NYBC isolated
and analyzed the transcriptome and proteome of the parasite at various
life stages as well as its Wolbachia sp. endosymbiont to identify
potential biomarkers for diagnostic assays and vaccine candidates. In
all, they identified forty-seven (47) biomarkers. The associated
patents claim the use of two or more of these biomarkers in conjunction
with an adjuvant as an immunological composition, or the detection of
any of these biomarkers in a serological-type assay.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and may be granted unless within fifteen (15) days from the date of
this published notice the National Institute of Allergy and Infectious
Diseases receives written evidence and argument that establishes that
the grant of the license would not be consistent with the requirements
of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated
[[Page 35102]]
confidentially, and may be made publicly available.
Complete license applications submitted in response to this Notice
will be presumed to contain business confidential information and any
release of information in these license applications will be made only
as required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: June 25, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-14128 Filed 6-30-21; 8:45 am]
BILLING CODE 4140-01-P
