[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22321-22322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods: Call for Nominations 
of High Throughput Screening (HTS) Assays for the Tox21 Initiative

AGENCY: Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health (NIH).

ACTION: Call for nominations.

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SUMMARY: The multiagency Tox21 Initiative aims to improve hazard 
assessment of compounds potentially harmful to humans and the 
environment. This will be accomplished through the use of integrated 
high throughput screens that provide information on the ability of a 
substance to perturb biological pathways related to toxicity. On behalf 
of the Tox21 Consortium and its Assays and Pathways Working Group, the 
NTP Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM) is accepting nominations for HTS biochemical- or 
cell-based assays. Assays selected for further evaluation and found to 
be compatible with the HTS program will support Tox21 by providing data 
on endpoints that serve as markers for initiating or downstream events 
in toxicity pathways.

DATES: The nomination of HTS assays to Tox21 is an ongoing process and 
will continue to remain open. Periodic updates to this notice may be 
posted to reflect new focus areas of the Tox21 HTS program.

[[Page 22322]]


FOR FURTHER INFORMATION CONTACT: Nominations of assays should be 
submitted online at http://iccvam.niehs.nih.gov/contact/Tox21-nomination.htm (preferred means) or to Dr. Warren Casey, Deputy 
Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research 
Triangle Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, 
(email) [email protected]. Courier address: NICEATM, NIEHS, Room 
2034, 530 Davis Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION: 

Background

    The Tox21 Consortium is a collaboration of the NIH Center for 
Translational Therapeutics (NCTT),\1\ NIEHS/NTP,\2\ U.S. Environmental 
Protection Agency (EPA),\3\ and U.S. Food and Drug Administration 
(FDA).\4\ The goal of Tox21 is to develop, validate, and translate 
innovative HTS methods to characterize the impact of chemicals on key 
steps in toxicity pathways and ultimately to provide tools to risk 
assessors to protect human health and the environment.
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    \1\ http://nctt.nih.gov/27543703.
    \2\ http://ntp.niehs.nih.gov/go/28213.
    \3\ http://www.epa.gov/ncct/Tox21/.
    \4\ http://www.fda.gov/.
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    The Tox21 HTS Initiative aims to prioritize substances for in-depth 
toxicological evaluation, identify mechanisms of action for further 
investigation, and develop predictive models for in vivo biological 
responses using efficient, high throughput in vitro assays. Tox21 also 
aims to expand the ability to screen environmental compounds for organ-
specific toxicity, focusing in particular on the liver, kidney, and 
nervous system.
    The current Tox21 inventory of 10,000 chemicals covers a variety of 
classifications, including consumer products, food additives, human and 
veterinary drugs, manufacturing intermediates, and pesticides. These 
10,000 chemicals are being profiled using HTS assays designed to 
estimate toxicity potential and identify the specific perturbations 
they induce in biological pathways.

Request for Nominations of HTS Assays

    NICEATM requests nominations of in vitro HTS toxicity assays that 
might be used in the Tox21 testing program. Tox21 intends to develop a 
systematic view of how chemicals interact with and affect biological 
systems using its collection of 10,000 chemicals. To achieve this goal, 
assays, which target all pathways relevant to toxicity, are needed to 
assess chemicals' effects. Nominated assays will be assessed for their 
overall applicability to the Tox21 HTS program in terms of biological 
relevance, cost, and potential for adaption to a HTS format. Suitable 
assays will then be prioritized for use by the NCTT. Protocol 
information and test data submitted in response to this notice may be 
incorporated into future NCTT and NICEATM reports and publications as 
appropriate.
    Nominations should consider the following general criteria: (1) 
Relevance to the goals of the Tox21 Initiative (http://nctt.nih.gov/27543703), (2) high throughput capability of the assay (96-well format 
or higher, with no obvious impediments to miniaturization to a 1536-
well format), (3) evaluation of preliminary assay performance using 
appropriate reference compounds, (4) validation status of the assay, 
(5) availability of complete detailed protocols, and (6) efficiency and 
cost of the assay. A list of compatibility criteria for 1536-well 
biochemical and cell-based assays is available at http://nctt.nih.gov/27545107.
    Assay nominations should be submitted electronically using the 
online form (http://iccvam.niehs.nih.gov/contact/Tox21-nomination.htm). 
When submitting HTS assay nominations and protocol information, please 
reference this Federal Register notice and provide appropriate contact 
information (name, affiliation, mailing address, phone, fax, email, and 
sponsoring organization as applicable). NICEATM prefers submission of 
the nominations via the Web site identified above; however, submissions 
by mail, fax, or email are acceptable. Questions about the submission 
process should be directed to Dr. Warren Casey (see FOR FURTHER 
INFORMATION CONTACT).

Background Information on NICEATM

    NICEATM was established in 1998 to administer and provide 
scientific support for the Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM), which is composed of 15 
member Federal agencies and includes the EPA, FDA, NIEHS, and NIH. The 
ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-2, 285l-5, available 
at http://iccvam.niehs.nih.gov/about/PL106545.htm) established ICCVAM 
as a permanent interagency committee of the NIEHS under NICEATM. 
NICEATM and ICCVAM conduct technical evaluations of new, revised, and 
alternative safety testing methods with regulatory applicability and 
promote the scientific validation and regulatory acceptance of safety-
testing methods that more accurately assess the safety and hazards of 
chemicals and products and that will reduce, refine (enhance animal 
well-being and decrease or eliminate pain and distress), or replace 
animal use. NICEATM also conducts independent validation studies to 
assess the usefulness and limitations of new, revised, and alternative 
test methods and strategies applicable to the safety-testing needs of 
Federal agencies. In 2012, NICEATM began providing support to Tox21 
regarding HTS assay nomination and review.
    NICEATM and ICCVAM welcome the public nomination of new, revised, 
and alternative test methods and strategies applicable to the needs of 
Federal agencies. Additional information about NICEATM can be found on 
the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).

    Dated: April 5, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-8942 Filed 4-12-12; 8:45 am]
BILLING CODE 4140-01-P