Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report, 57926-57927 [2016-20159]
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
to producing viral DNA templates and
for chromatographic purification of
nucleic acid-containing compositions,
in which the nucleic acid is quantified
in chromatography fractions with the
rapid detection of one or more nucleic
acid sequences (e.g., using real time RTqPCR detection). In addition, the
invention includes improved processes
for production and purification of
oncolytic poliovirus, such as PVSRIPO.
Compositions generated using these
methods are also described.
Potential Commercial Applications:
• Large-scale manufacturing for
producing highly purified, live virus.
• Improved viral purification process
that:
Æ Increases the yield and/or purity of
the resulting product, while decreasing
the purification time;
Æ is generally applicable to
purification of any nucleic acid
molecule-containing composition, such
as virus-based composition, and can be
used for the purification of live native
or recombinant viruses necessary for
clinical applications.
• Improved process for generating
viral template plasmid (such as one that
includes a DNA template for an RNA
virus), which addresses the problem of
genetic instability of the plasmids
containing the viral genome (e.g., of a
recombinant polio virus) in host (e.g.,
bacterial) cells, in which the plasmids
are typically propagated.
Value Proposition:
• Cost- and time-effective means of
producing highly purified virus-based
GMP products, such as oncolytic
viruses, for regulatory approval.
Development Stage: Clinical Phase I.
Inventor(s): Trevor Broadt (NCI),
Samir Shaban (NCI), Yueqing Xie (NCI),
Jianwei Zhu (NCI), George Mitra (NCI).
Intellectual Property: HHS Ref. No. E–
267–2014/0–US–01, corresponding to
US Provisional Patent App. No. 62/
173,777, filed June 10, 2015, entitled
‘‘Processes for Production and
Purification of Nucleic Acid Containing
Compositions.’’.
HHS Ref. No. E–267–2014/0–PCT–02,
corresponding to International Patent
App. No. PCT/US2016/036888, filed
June 10, 2016, entitled ‘‘Processes for
Production and Purification of Nucleic
Acid Containing Compositions’’.
Publications: Ouellette et al.,
BioProcessing J. 2005 4(2):31–38.
Related Technologies: HHS Reference
#E–240–2015/0 entitled ‘‘Methods of
Analyzing Virus-Derived Therapeutics’’.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
VerDate Sep<11>2014
20:16 Aug 23, 2016
Jkt 238001
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–20160 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Biennial Progress Report:
2014–2015; Availability of Report
The National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces availability of the
Interagency Coordinating Committee on
the Validation of Alternative Methods
(ICCVAM) Biennial Progress Report:
2014–2015. This report, prepared in
accordance with requirements of the
ICCVAM Authorization Act of 2000 (42
U.S.C. 285l–3), describes activities and
accomplishments from January 2014
through December 2015.
ADDRESSES: The report is available at
https://ntp.niehs.nih.gov/iccvamreport/
2015/.
FOR FURTHER INFORMATION CONTACT: Dr.
Warren Casey, Director, NICEATM;
email: warren.casey@nih.gov; telephone:
(919) 316–4729.
SUPPLEMENTARY INFORMATION:
Background: The ICCVAM
Authorization Act of 2000 established
ICCVAM as a permanent interagency
committee of the National Institute of
Environmental Health Sciences (NIEHS)
under NICEATM. ICCVAM’s mission is
to facilitate development, validation,
and regulatory acceptance of new and
revised regulatory test methods that
reduce, refine, or replace the use of
animals in testing while maintaining
and promoting scientific quality and the
protection of human health, animal
health, and the environment.
A provision of the ICCVAM
Authorization Act states that ICCVAM
shall prepare ‘‘reports to be made
available to the public on its progress
under this Act.’’ The eighth ICCVAM
progress report is now available, which
describes ICCVAM activities and
accomplishments from January 2014
through December 2015.
Summary of Report Contents: Key
ICCVAM, ICCVAM agency, and
NICEATM accomplishments
summarized in the report include:
SUMMARY:
PO 00000
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Fmt 4703
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• A computational approach that
integrates several types of data to
predict human skin sensitization
hazard without using animals
(ICCVAM)
• A plan to adopt high throughput
assays and computational models for
detecting and measuring estrogen
receptor bioactivity as an alternative
for three Tier 1 tests currently used in
the Endocrine Disruptor Screening
Program to assess estrogen receptor
activity (U.S. Environmental
Protection Agency [EPA])
• Establishment of a Communities of
Practice webinar seminar series
discussing relevant topics (ICCVAM)
• Evaluation of acute oral and dermal
toxicity data to determine if oral
toxicity tests are sufficient to assign
U.S. EPA dermal hazard
classifications, eliminating the need
for separate acute dermal toxicity tests
(NICEATM)
• A series of workshops that drafted
recommendations on use of an in vitro
test with potential to replace animal
use for pertussis vaccine testing
(NICEATM, U.S. Food and Drug
Administration, other ICCVAM
agencies).
Availability of Report: The report is
available at https://ntp.niehs.nih.gov/
iccvamreport/2015/. Links to
this report and all past ICCVAM annual
and biennial reports are available at
https://ntp.niehs.nih.gov/go/iccvam-bien.
Background Information on ICCVAM
and NICEATM: ICCVAM is an
interagency committee composed of
representatives from 15 federal
regulatory and research agencies that
require, use, generate, or disseminate
toxicological and safety testing
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and replace,
reduce, or refine (enhance animal wellbeing and lessen or avoid pain and
distress) animal use.
The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) establishes
ICCVAM as a permanent interagency
committee of NIEHS and provides the
authority for ICCVAM involvement in
activities relevant to the development of
alternative test methods. ICCVAM acts
to ensure that new and revised test
methods are validated to meet the needs
of federal agencies, increase the
efficiency and effectiveness and federal
agency test method review, and
optimize utilization of scientific
E:\FR\FM\24AUN1.SGM
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
expertise outside the federal
government. Additional information
about ICCVAM can be found at https://
ntp.niehs.nih.gov/go/iccvam.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
and conducts and publishes analyses
and evaluations of data from new,
revised, and alternative testing
approaches. NICEATM and ICCVAM
work collaboratively to evaluate new
and improved testing approaches
applicable to the needs of U.S. federal
agencies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative testing
approaches for validation studies and
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
Dated: August 16, 2016.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2016–20159 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
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 and/or co-development in the
U.S. in accordance with 35 U.S.C. 209
and 37 CFR part 404 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 and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:16 Aug 23, 2016
Jkt 238001
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Methods of
Analyzing Virus-Derived Therapeutics.
Description of Technology:
Researchers at the National Cancer
Institute’s Biopharmaceutical
Development Program recently
developed massively parallel
sequencing methods for virus-derived
therapeutics such as viral vaccines and
oncolytic immunotherapies. The
methods allow for the determination of
micro-heterogeneity and quantitation of
low frequency sequence variants, which
have the possibility of supplanting
monkey neurovirulence safety testing
(MNVT), mutant analysis by PCR, and
restriction enzyme cleavage (MAPREC)
methods that are currently used to
screen RNA virus-derived therapeutics.
Potential Commercial Applications:
• Improved methods for detecting
mutations in GMP-manufactured virusderived therapeutics, including viruses,
viral template plasmids, or vaccines;
• The method allows for at least two
different virus-derived therapeutics to
be assayed simultaneously.
Value Proposition:
• Provides a cost- and time-effective
means of assaying a virus-derived
therapeutic, such as oncolytic viruses,
for viral sequence variants, for
regulatory approval;
• RNA virus preparation steps
increase the amount of viral RNA
obtained;
• Demonstrated superiority of
massively parallel sequencing (‘‘MPS’’)
over mutant analysis by PCR and
restriction enzyme cleavage
(‘‘MAPREC’’) analysis.
Development Stage: Clinical Phase I.
Inventor(s): Trevor Broadt (NCI),
Michael D. Harwich (American
International Biotechnology, LLC),
William T. Budd (American
International Biotechnology, LLC),
Gregory A. Myers (American
International Biotechnology, LLC).
Intellectual Property:
HHS Ref. No. E–240–2015/0–U.S.–01,
corresponding to U.S. Provisional
Patent App. No. 62/199,663, filed July
31, 201562/173,777, entitled
‘‘Methods of Analysis of RNA VirusDerived Therapeutics’’
HHS Ref. No. E–240–2015/0–PCT–02,
corresponding to International Patent
App. No. PCT/US2016/044788, filed
July 29, 2016, entitled ‘‘Methods of
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
57927
Analyzing Virus-Derived
Therapeutics’’
Related Technologies: HHS Reference
#E–267–2014/0 entitled ‘‘Processes for
Production and Purification of Nucleic
Acid Containing Compositions’’.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–20162 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
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.
E:\FR\FM\24AUN1.SGM
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Agencies
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57926-57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee on the Validation of
Alternative Methods Biennial Progress Report: 2014-2015; Availability
of Report
SUMMARY: The National Toxicology Program (NTP) Interagency Center for
the Evaluation of Alternative Toxicological Methods (NICEATM) announces
availability of the Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) Biennial Progress Report:
2014-2015. This report, prepared in accordance with requirements of the
ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), describes
activities and accomplishments from January 2014 through December 2015.
ADDRESSES: The report is available at https://ntp.niehs.nih.gov/iccvamreport/2015/.
FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM;
email: warren.casey@nih.gov; telephone: (919) 316-4729.
SUPPLEMENTARY INFORMATION:
Background: The ICCVAM Authorization Act of 2000 established ICCVAM
as a permanent interagency committee of the National Institute of
Environmental Health Sciences (NIEHS) under NICEATM. ICCVAM's mission
is to facilitate development, validation, and regulatory acceptance of
new and revised regulatory test methods that reduce, refine, or replace
the use of animals in testing while maintaining and promoting
scientific quality and the protection of human health, animal health,
and the environment.
A provision of the ICCVAM Authorization Act states that ICCVAM
shall prepare ``reports to be made available to the public on its
progress under this Act.'' The eighth ICCVAM progress report is now
available, which describes ICCVAM activities and accomplishments from
January 2014 through December 2015.
Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM
accomplishments summarized in the report include:
A computational approach that integrates several types of data
to predict human skin sensitization hazard without using animals
(ICCVAM)
A plan to adopt high throughput assays and computational
models for detecting and measuring estrogen receptor bioactivity as an
alternative for three Tier 1 tests currently used in the Endocrine
Disruptor Screening Program to assess estrogen receptor activity (U.S.
Environmental Protection Agency [EPA])
Establishment of a Communities of Practice webinar seminar
series discussing relevant topics (ICCVAM)
Evaluation of acute oral and dermal toxicity data to determine
if oral toxicity tests are sufficient to assign U.S. EPA dermal hazard
classifications, eliminating the need for separate acute dermal
toxicity tests (NICEATM)
A series of workshops that drafted recommendations on use of
an in vitro test with potential to replace animal use for pertussis
vaccine testing (NICEATM, U.S. Food and Drug Administration, other
ICCVAM agencies).
Availability of Report: The report is available at https://ntp.niehs.nih.gov/iccvamreport/2015/. Links to this report
and all past ICCVAM annual and biennial reports are available at https://ntp.niehs.nih.gov/go/iccvam-bien.
Background Information on ICCVAM and NICEATM: ICCVAM is an
interagency committee composed of representatives from 15 federal
regulatory and research agencies that require, use, generate, or
disseminate toxicological and safety testing information. ICCVAM
conducts technical evaluations of new, revised, and alternative safety
testing methods and integrated testing strategies with regulatory
applicability and promotes the scientific validation and regulatory
acceptance of testing methods that more accurately assess the safety
and hazards of chemicals and products and replace, reduce, or refine
(enhance animal well-being and lessen or avoid pain and distress)
animal use.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) establishes
ICCVAM as a permanent interagency committee of NIEHS and provides the
authority for ICCVAM involvement in activities relevant to the
development of alternative test methods. ICCVAM acts to ensure that new
and revised test methods are validated to meet the needs of federal
agencies, increase the efficiency and effectiveness and federal agency
test method review, and optimize utilization of scientific
[[Page 57927]]
expertise outside the federal government. Additional information about
ICCVAM can be found at https://ntp.niehs.nih.gov/go/iccvam.
NICEATM administers ICCVAM, provides scientific and operational
support for ICCVAM-related activities, and conducts and publishes
analyses and evaluations of data from new, revised, and alternative
testing approaches. NICEATM and ICCVAM work collaboratively to evaluate
new and improved testing approaches applicable to the needs of U.S.
federal agencies. NICEATM and ICCVAM welcome the public nomination of
new, revised, and alternative testing approaches for validation studies
and technical evaluations. Additional information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/niceatm.
Dated: August 16, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-20159 Filed 8-23-16; 8:45 am]
BILLING CODE 4140-01-P