Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report, 57926-57927 [2016-20159]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES 57926 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 http://ntp.niehs.nih.gov/iccvamreport/ 2015/index.html. 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 Frm 00050 Fmt 4703 Sfmt 4703 • 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 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 24AUN1 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 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 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 24AUN1

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 http://ntp.niehs.nih.gov/iccvamreport/2015/index.html.

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 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