[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