81 FR 57926 - Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 164 (August 24, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 164 (August 24, 2016)
| Page Range | 57926-57927 | |
| FR Document | 2016-20159 |
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)] [Notices] [Pages 57926-57927] From the Federal Register Online [www.thefederalregister.org] [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 http://ntp.niehs.nih.gov/iccvamreport/2015/index.html. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; email: [email protected]; 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 http://ntp.niehs.nih.gov/iccvamreport/2015/index.html. Links to this report and all past ICCVAM annual and biennial reports are available at http://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 http://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 http://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
![57926 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
to producing viral DNA templates and Hewes, Ph.D., email: john.hewes@ • A computational approach that
for chromatographic purification of nih.gov. integrates several types of data to
nucleic acid-containing compositions, Dated: August 16, 2016. predict human skin sensitization
in which the nucleic acid is quantified John D. Hewes, hazard without using animals
in chromatography fractions with the (ICCVAM)
Technology Transfer Specialist, Technology
rapid detection of one or more nucleic Transfer Center, National Cancer Institute.
• A plan to adopt high throughput
acid sequences (e.g., using real time RT- assays and computational models for
[FR Doc. 2016–20160 Filed 8–23–16; 8:45 am]
qPCR detection). In addition, the detecting and measuring estrogen
BILLING CODE 4140–01–P
invention includes improved processes receptor bioactivity as an alternative
for production and purification of for three Tier 1 tests currently used in
oncolytic poliovirus, such as PVSRIPO. the Endocrine Disruptor Screening
DEPARTMENT OF HEALTH AND
Compositions generated using these Program to assess estrogen receptor
HUMAN SERVICES
methods are also described. activity (U.S. Environmental
Potential Commercial Applications: National Institutes of Health Protection Agency [EPA])
• Large-scale manufacturing for • Establishment of a Communities of
producing highly purified, live virus. Interagency Coordinating Committee Practice webinar seminar series
• Improved viral purification process on the Validation of Alternative discussing relevant topics (ICCVAM)
that: Methods Biennial Progress Report: • Evaluation of acute oral and dermal
Æ Increases the yield and/or purity of 2014–2015; Availability of Report toxicity data to determine if oral
the resulting product, while decreasing toxicity tests are sufficient to assign
the purification time; SUMMARY: The National Toxicology U.S. EPA dermal hazard
Æ is generally applicable to Program (NTP) Interagency Center for classifications, eliminating the need
purification of any nucleic acid the Evaluation of Alternative for separate acute dermal toxicity tests
molecule-containing composition, such Toxicological Methods (NICEATM) (NICEATM)
as virus-based composition, and can be announces availability of the • A series of workshops that drafted
used for the purification of live native Interagency Coordinating Committee on recommendations on use of an in vitro
or recombinant viruses necessary for the Validation of Alternative Methods test with potential to replace animal
clinical applications. (ICCVAM) Biennial Progress Report: use for pertussis vaccine testing
• Improved process for generating 2014–2015. This report, prepared in (NICEATM, U.S. Food and Drug
viral template plasmid (such as one that accordance with requirements of the Administration, other ICCVAM
includes a DNA template for an RNA ICCVAM Authorization Act of 2000 (42 agencies).
virus), which addresses the problem of U.S.C. 285l–3), describes activities and Availability of Report: The report is
genetic instability of the plasmids accomplishments from January 2014 available at http://ntp.niehs.nih.gov/
containing the viral genome (e.g., of a through December 2015. iccvamreport/2015/index.html. Links to
recombinant polio virus) in host (e.g., ADDRESSES: The report is available at this report and all past ICCVAM annual
bacterial) cells, in which the plasmids http://ntp.niehs.nih.gov/iccvamreport/ and biennial reports are available at
are typically propagated. 2015/index.html. http://ntp.niehs.nih.gov/go/iccvam-bien.
Value Proposition: FOR FURTHER INFORMATION CONTACT: Dr. Background Information on ICCVAM
• Cost- and time-effective means of Warren Casey, Director, NICEATM; and NICEATM: ICCVAM is an
producing highly purified virus-based email: warren.casey@nih.gov; telephone: interagency committee composed of
GMP products, such as oncolytic (919) 316–4729. representatives from 15 federal
viruses, for regulatory approval. SUPPLEMENTARY INFORMATION: regulatory and research agencies that
Development Stage: Clinical Phase I. Background: The ICCVAM require, use, generate, or disseminate
Inventor(s): Trevor Broadt (NCI), Authorization Act of 2000 established toxicological and safety testing
Samir Shaban (NCI), Yueqing Xie (NCI), ICCVAM as a permanent interagency information. ICCVAM conducts
Jianwei Zhu (NCI), George Mitra (NCI). committee of the National Institute of technical evaluations of new, revised,
Intellectual Property: HHS Ref. No. E– Environmental Health Sciences (NIEHS) and alternative safety testing methods
267–2014/0–US–01, corresponding to under NICEATM. ICCVAM’s mission is and integrated testing strategies with
US Provisional Patent App. No. 62/ to facilitate development, validation, regulatory applicability and promotes
173,777, filed June 10, 2015, entitled and regulatory acceptance of new and the scientific validation and regulatory
‘‘Processes for Production and revised regulatory test methods that acceptance of testing methods that more
Purification of Nucleic Acid Containing reduce, refine, or replace the use of accurately assess the safety and hazards
Compositions.’’. animals in testing while maintaining of chemicals and products and replace,
HHS Ref. No. E–267–2014/0–PCT–02, and promoting scientific quality and the reduce, or refine (enhance animal well-
corresponding to International Patent protection of human health, animal being and lessen or avoid pain and
App. No. PCT/US2016/036888, filed health, and the environment. distress) animal use.
June 10, 2016, entitled ‘‘Processes for A provision of the ICCVAM The ICCVAM Authorization Act of
Production and Purification of Nucleic Authorization Act states that ICCVAM 2000 (42 U.S.C. 285l–3) establishes
Acid Containing Compositions’’. shall prepare ‘‘reports to be made ICCVAM as a permanent interagency
Publications: Ouellette et al., available to the public on its progress committee of NIEHS and provides the
BioProcessing J. 2005 4(2):31–38. under this Act.’’ The eighth ICCVAM authority for ICCVAM involvement in
Related Technologies: HHS Reference progress report is now available, which activities relevant to the development of
mstockstill on DSK3G9T082PROD with NOTICES
#E–240–2015/0 entitled ‘‘Methods of describes ICCVAM activities and alternative test methods. ICCVAM acts
Analyzing Virus-Derived Therapeutics’’. accomplishments from January 2014 to ensure that new and revised test
Contact Information: Requests for through December 2015. methods are validated to meet the needs
copies of the patent application or Summary of Report Contents: Key of federal agencies, increase the
inquiries about licensing, research ICCVAM, ICCVAM agency, and efficiency and effectiveness and federal
collaborations, and co-development NICEATM accomplishments agency test method review, and
opportunities should be sent to John D. summarized in the report include: optimize utilization of scientific
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![Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57927
expertise outside the federal Drive, Mail Stop 9702, Rockville, MD Analyzing Virus-Derived
government. Additional information 20850–9702, Tel. 240–276–5515 or Therapeutics’’
about ICCVAM can be found at http:// email ncitechtransfer@mail.nih.gov. A
ntp.niehs.nih.gov/go/iccvam. signed Confidential Disclosure Related Technologies: HHS Reference
NICEATM administers ICCVAM, Agreement may be required to receive #E–267–2014/0 entitled ‘‘Processes for
provides scientific and operational copies of the patent applications. Production and Purification of Nucleic
support for ICCVAM-related activities, SUPPLEMENTARY INFORMATION: Acid Containing Compositions’’.
and conducts and publishes analyses Technology description follows. Contact Information: Requests for
and evaluations of data from new, Title of invention: Methods of copies of the patent application or
revised, and alternative testing Analyzing Virus-Derived Therapeutics. inquiries about licensing, research
approaches. NICEATM and ICCVAM Description of Technology: collaborations, and co-development
work collaboratively to evaluate new Researchers at the National Cancer opportunities should be sent to John D.
and improved testing approaches Institute’s Biopharmaceutical
applicable to the needs of U.S. federal Hewes, Ph.D., email: john.hewes@
Development Program recently nih.gov.
agencies. NICEATM and ICCVAM developed massively parallel
welcome the public nomination of new, sequencing methods for virus-derived Dated: August 16, 2016.
revised, and alternative testing therapeutics such as viral vaccines and John D. Hewes,
approaches for validation studies and oncolytic immunotherapies. The Technology Transfer Specialist, Technology
technical evaluations. Additional methods allow for the determination of Transfer Center, National Cancer Institute.
information about NICEATM can be micro-heterogeneity and quantitation of [FR Doc. 2016–20162 Filed 8–23–16; 8:45 am]
found at http://ntp.niehs.nih.gov/go/ low frequency sequence variants, which BILLING CODE 4140–01–P
niceatm. have the possibility of supplanting
Dated: August 16, 2016. monkey neurovirulence safety testing
John R. Bucher, (MNVT), mutant analysis by PCR, and DEPARTMENT OF HEALTH AND
Associate Director, National Toxicology restriction enzyme cleavage (MAPREC) HUMAN SERVICES
Program. methods that are currently used to
[FR Doc. 2016–20159 Filed 8–23–16; 8:45 am] screen RNA virus-derived therapeutics. Substance Abuse and Mental Health
BILLING CODE 4140–01–P Potential Commercial Applications: Services Administration
• Improved methods for detecting
mutations in GMP-manufactured virus- Agency Information Collection
DEPARTMENT OF HEALTH AND derived therapeutics, including viruses, Activities: Proposed Collection;
HUMAN SERVICES viral template plasmids, or vaccines; Comment Request
• The method allows for at least two
National Institutes of Health different virus-derived therapeutics to In compliance with Section
be assayed simultaneously. 3506(c)(2)(A) of the Paperwork
Government-Owned Inventions; Value Proposition: Reduction Act of 1995 concerning
Availability for Licensing • Provides a cost- and time-effective opportunity for public comment on
AGENCY: National Institutes of Health, means of assaying a virus-derived proposed collections of information, the
HHS. therapeutic, such as oncolytic viruses, Substance Abuse and Mental Health
ACTION: Notice. for viral sequence variants, for Services Administration (SAMHSA)
regulatory approval; will publish periodic summaries of
SUMMARY: The invention listed below is • RNA virus preparation steps proposed projects. To request more
owned by an agency of the U.S. increase the amount of viral RNA
Government and is available for information on the proposed projects or
obtained;
to obtain a copy of the information
licensing and/or co-development in the • Demonstrated superiority of
U.S. in accordance with 35 U.S.C. 209 collection plans, call the SAMHSA
massively parallel sequencing (‘‘MPS’’)
and 37 CFR part 404 to achieve over mutant analysis by PCR and Reports Clearance Officer on (240) 276–
expeditious commercialization of restriction enzyme cleavage 1243.
results of federally-funded research and (‘‘MAPREC’’) analysis. Comments are invited on: (a) Whether
development. Foreign patent Development Stage: Clinical Phase I. the proposed collections of information
applications are filed on selected Inventor(s): Trevor Broadt (NCI), are necessary for the proper
inventions to extend market coverage Michael D. Harwich (American performance of the functions of the
for companies and may also be available International Biotechnology, LLC), agency, including whether the
for licensing and/or co-development. William T. Budd (American information shall have practical utility;
ADDRESSES: Invention Development and International Biotechnology, LLC), (b) the accuracy of the agency’s estimate
Marketing Unit, Technology Transfer Gregory A. Myers (American of the burden of the proposed collection
Center, National Cancer Institute, 9609 International Biotechnology, LLC). of information; (c) ways to enhance the
Medical Center Drive, Mail Stop 9702, Intellectual Property: quality, utility, and clarity of the
Rockville, MD 20850–9702. HHS Ref. No. E–240–2015/0–U.S.–01, information to be collected; and (d)
FOR FURTHER INFORMATION CONTACT: corresponding to U.S. Provisional ways to minimize the burden of the
Information on licensing and co- Patent App. No. 62/199,663, filed July
mstockstill on DSK3G9T082PROD with NOTICES
collection of information on
development research collaborations, 31, 201562/173,777, entitled respondents, including through the use
and copies of the U.S. patent ‘‘Methods of Analysis of RNA Virus- of automated collection techniques or
applications listed below may be Derived Therapeutics’’ other forms of information technology.
obtained by contacting: Attn. Invention HHS Ref. No. E–240–2015/0–PCT–02,
Development and Marketing Unit, corresponding to International Patent
Technology Transfer Center, National App. No. PCT/US2016/044788, filed
Cancer Institute, 9609 Medical Center July 29, 2016, entitled ‘‘Methods of
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Document Created: 2016-08-24 03:03:05
Document Modified: 2016-08-24 03:03:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Contact | Dr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (919) 316-4729. | |
| FR Citation | 81 FR 57926 |
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