83_FR_7522 83 FR 7487 - A Strategic Roadmap for Establishing New Approaches To Evaluate the Safety of Chemicals and Medical Products in the United States; Availability of Report

83 FR 7487 - A Strategic Roadmap for Establishing New Approaches To Evaluate the Safety of Chemicals and Medical Products in the United States; Availability of Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 35 (February 21, 2018)

Page Range7487-7487
FR Document2018-03476

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinated the development of a strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. This document, prepared with support from the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is now available.

Federal Register, Volume 83 Issue 35 (Wednesday, February 21, 2018) 
[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)]
[Notices]
[Page 7487]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


A Strategic Roadmap for Establishing New Approaches To Evaluate 
the Safety of Chemicals and Medical Products in the United States; 
Availability of Report

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) coordinated the development of a strategic 
roadmap for establishing new approaches to evaluate the safety of 
chemicals and medical products in the United States. This document, 
prepared with support from the National Toxicology Program Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM), is now available.

ADDRESSES: The report is available at https://ntp.niehs.nih.gov/go/natl-strategy.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: warren.casey@nih.gov; telephone: (984) 287-3118.

SUPPLEMENTARY INFORMATION: 
    Background: Scientific and technological advances in toxicology can 
significantly improve and protect public health. However, a national 
strategy is required to ensure the safe, effective, and timely 
implementation of human-based, predictive approaches in toxicity 
testing.
    The goal of the U.S. Strategic Roadmap is to realize the vision set 
forth in the seminal National Research Council report ``Toxicity 
Testing in the 21st Century: A Vision and a Strategy.'' This 2007 
report envisioned using human-based assays and model information to 
provide a more efficient, predictive, and economic system for assessing 
the effects of chemicals on human health.
    The U.S. Strategic Roadmap was developed with participation from 
the 16 ICCVAM member agencies and multiple interagency workgroups, as 
well as input from a broad range of stakeholder groups. It describes a 
new framework that will enable development, establish confidence in, 
and ensure use of new approaches to toxicity testing that improve human 
health relevance and reduce or eliminate the need for testing in 
animals.
    Summary of Report Contents: The successful development and 
implementation of new approaches to toxicity testing will require 
coordinated efforts that address three strategic goals:

 Connect end users with developers of new approach 
methodologies
 Foster the use of efficient, flexible, and robust practices to 
establish confidence in new methods
 Encourage the adoption and use of new methods and approaches 
by federal agencies and regulated industries

    Implementation of the roadmap goals, already underway in specific 
testing areas, will include key elements needed for advancement of 
alternative methods.
    Availability of Report: The report is available at https://ntp.niehs.nih.gov/go/natl-strategy.
    Background Information on ICCVAM and NICEATM: ICCVAM is an 
interagency committee composed of representatives from 16 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 the National Institute 
of Environmental Health Sciences 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 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: February 9, 2018.
Brian Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-03476 Filed 2-20-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices 7487 Dated: January 23, 2018. framework that will enable and conducts and publishes analyses Karla Bailey, development, establish confidence in, and evaluations of data from new, Project Clearance Liaison, National Cancer and ensure use of new approaches to revised, and alternative testing Institute, National Institutes of Health. toxicity testing that improve human approaches. NICEATM and ICCVAM [FR Doc. 2018–03471 Filed 2–20–18; 8:45 am] health relevance and reduce or work collaboratively to evaluate new BILLING CODE 4140–01–P eliminate the need for testing in and improved testing approaches animals. applicable to the needs of U.S. federal Summary of Report Contents: The agencies. NICEATM and ICCVAM DEPARTMENT OF HEALTH AND successful development and welcome the public nomination of new, HUMAN SERVICES implementation of new approaches to revised, and alternative testing toxicity testing will require coordinated approaches for validation studies and National Institutes of Health efforts that address three strategic goals: technical evaluations. Additional • Connect end users with developers of information about NICEATM can be A Strategic Roadmap for Establishing found at http://ntp.niehs.nih.gov/go/ new approach methodologies New Approaches To Evaluate the • Foster the use of efficient, flexible, niceatm. Safety of Chemicals and Medical and robust practices to establish Dated: February 9, 2018. Products in the United States; confidence in new methods Brian Berridge, Availability of Report • Encourage the adoption and use of Associate Director, National Toxicology AGENCY: National Institutes of Health, new methods and approaches by Program. HHS. federal agencies and regulated [FR Doc. 2018–03476 Filed 2–20–18; 8:45 am] ACTION: Notice. industries BILLING CODE 4140–01–P Implementation of the roadmap goals, SUMMARY: The Interagency Coordinating already underway in specific testing Committee on the Validation of DEPARTMENT OF HEALTH AND areas, will include key elements needed Alternative Methods (ICCVAM) HUMAN SERVICES for advancement of alternative methods. coordinated the development of a Availability of Report: The report is strategic roadmap for establishing new available at https://ntp.niehs.nih.gov/ National Institutes of Health approaches to evaluate the safety of go/natl-strategy. chemicals and medical products in the National Institute of Neurological Background Information on ICCVAM United States. This document, prepared Disorders and Stroke: Notice of Closed and NICEATM: ICCVAM is an with support from the National Meetings interagency committee composed of Toxicology Program Interagency Center representatives from 16 federal Pursuant to section 10(d) of the for the Evaluation of Alternative regulatory and research agencies that Federal Advisory Committee Act, as Toxicological Methods (NICEATM), is require, use, generate, or disseminate amended, notice is hereby given of the now available. toxicological and safety testing following meetings. ADDRESSES: The report is available at information. ICCVAM conducts The meetings will be closed to the https://ntp.niehs.nih.gov/go/natl- technical evaluations of new, revised, public in accordance with the strategy. and alternative safety testing methods provisions set forth in sections FOR FURTHER INFORMATION CONTACT: Dr. and integrated testing strategies with 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Warren Casey, Director, NICEATM; regulatory applicability and promotes as amended. The grant applications and email: warren.casey@nih.gov; telephone: the scientific validation and regulatory the discussions could disclose (984) 287–3118. acceptance of testing methods that more confidential trade secrets or commercial SUPPLEMENTARY INFORMATION: accurately assess the safety and hazards property such as patentable material, Background: Scientific and of chemicals and products and replace, and personal information concerning technological advances in toxicology reduce, or refine (enhance animal well- individuals associated with the grant can significantly improve and protect being and lessen or avoid pain and applications, the disclosure of which public health. However, a national distress) animal use. would constitute a clearly unwarranted strategy is required to ensure the safe, The ICCVAM Authorization Act of invasion of personal privacy. effective, and timely implementation of 2000 (42 U.S.C. 285l–3) establishes Name of Committee: National Institute of human-based, predictive approaches in ICCVAM as a permanent interagency Neurological Disorders and Stroke Initial toxicity testing. committee of the National Institute of Review Group; Neurological Sciences and The goal of the U.S. Strategic Environmental Health Sciences and Disorders K; NSD–K Review Meeting. Roadmap is to realize the vision set provides the authority for ICCVAM Date: March 2, 2018. forth in the seminal National Research involvement in activities relevant to the Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant Council report ‘‘Toxicity Testing in the development of alternative test applications. 21st Century: A Vision and a Strategy.’’ methods. ICCVAM acts to ensure that Place: National Institutes of Health, This 2007 report envisioned using new and revised test methods are Neuroscience Center, 6001 Executive human-based assays and model validated to meet the needs of federal Boulevard, Rockville, MD 20852 (Telephone information to provide a more efficient, agencies, increase the efficiency and Conference Call). predictive, and economic system for effectiveness and federal agency test Contact Person: Shanta Rajaram, Ph.D., assessing the effects of chemicals on method review, and optimize utilization Scientific Review Officer, Scientific Review daltland on DSKBBV9HB2PROD with NOTICES of scientific expertise outside the federal Branch, NINDS/NIH/DHHS, Neuroscience human health. Center, 6001 Executive Blvd., Suite 3208, The U.S. Strategic Roadmap was government. Additional information MSC 9529, Bethesda, MD 20892–9529, 301– developed with participation from the about ICCVAM can be found at http:// 435–6033, rajarams@mail.nih.gov. 16 ICCVAM member agencies and ntp.niehs.nih.gov/go/iccvam. This notice is being published less than 15 multiple interagency workgroups, as NICEATM administers ICCVAM, days prior to the meeting due to the timing well as input from a broad range of provides scientific and operational limitations imposed by the review and stakeholder groups. It describes a new support for ICCVAM-related activities, funding cycle. VerDate Sep<11>2014 19:57 Feb 20, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\21FEN1.SGM 21FEN1


Document Created: 2018-02-21 01:48:39
Document Modified: 2018-02-21 01:48:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (984) 287-3118.
FR Citation83 FR 7487 
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