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, 22321-22322 [2012-8942]

Download as PDF Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices (60) days from the effective date of this Agreement until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that this supervisory plan provided by any institution employing him shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent was involved was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; and (3) to exclude himself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. John Dahlberg, Director, Division of Investigative Oversight, Office of Research Integrity. [FR Doc. 2012–8903 Filed 4–12–12; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the President’s Council on Fitness, Sports, and Nutrition Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office of the President’s Council on Fitness, Sports, and Nutrition. ACTION: Notice of meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President’s Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public. DATES: The meeting will be held on May 1, 2012, from 10 a.m. to 3 p.m. ADDRESSES: Department of Health and Human Services, 200 Independence Ave. SW., Room 800, Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Ms. Shellie Pfohl, Executive Director, President’s Council on Fitness, Sports, pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:16 Apr 12, 2012 Jkt 226001 and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276–9866. Information about PCFSN, including details about the upcoming meeting, can be obtained at www.fitness.gov and/or by calling (240) 276–9567. SUPPLEMENTARY INFORMATION: On June 23, 2010, the President established Executive Order 13545 to amend Executive Order 13265, dated June 6, 2002. Under Executive Order 13545, direction is given for the scope of the President’s Council on Physical Fitness and Sports to be expanded to recognize that good nutrition goes hand in hand with fitness and sports participation. Executive Order 13545 gives authority for the title of the Council to be revised to include nutrition. The primary functions of the PCFSN include (1) Advising the President, through the Secretary, concerning progress made in carrying out the provisions of Executive Order 13545 and shall recommend to the President, through the Secretary, actions to accelerate progress; (2) advising the Secretary on ways to promote regular physical activity, fitness, sports participation, and good nutrition. Recommendations may address, but are not necessarily limited to, public awareness campaigns; Federal, State, and local physical activity; fitness, sports participation, and nutrition initiatives; and partnership opportunities between public- and private-sector health promotion entities; (3) functioning as a liaison to relevant State, local, and private entities in order to advise the Secretary regarding opportunities to extend and improve physical activity, fitness, sports, and nutrition programs and services at the local, State, and national levels; and (4) monitoring the need to enhance programs and educational and promotional materials sponsored, overseen, or disseminated by the Council, and shall advise the Secretary, as necessary, concerning such need. In performing its functions, the Council shall take into account the Federal Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans. The PCFSN will hold, at a minimum, one meeting in a calendar year. The meeting will be held to (1) assess ongoing Council activities and (2) discuss and plan future projects and programs. The agenda for the planned meeting is being developed and will be posted at www.fitness.gov when it has been finalized. The meeting that is scheduled to be held May 1, 2012 is open to the public. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 22321 Every effort will be made to provide reasonable accommodations for persons with disabilities and/or special needs who wish to attend the meeting. Persons with disabilities and/or special needs should call (240) 276–9567 no later than close of business on April 23, 2012, to request accommodations. Members of the public who wish to attend the meeting are asked to pre-register by calling (240) 276–9567. Registration for public attendance must be completed before close of business on April 23, 2012. Dated: March 9, 2012. Shellie Y. Pfohl, Executive Director, President’s Council on Fitness, Sports, and Nutrition. [FR Doc. 2012–8900 Filed 4–12–12; 8:45 am] BILLING CODE 4150–35–P 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 Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Call for nominations. AGENCY: 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. SUMMARY: 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. DATES: E:\FR\FM\13APN1.SGM 13APN1 22322 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices FOR FURTHER INFORMATION CONTACT: Nominations of assays should be submitted online at https:// iccvam.niehs.nih.gov/contact/Tox21nomination.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) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: pmangrum on DSK3VPTVN1PROD with NOTICES 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. 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. 1 https://nctt.nih.gov/27543703. 2 https://ntp.niehs.nih.gov/go/28213. 3 https://www.epa.gov/ncct/Tox21/. 4 https://www.fda.gov/. VerDate Mar<15>2010 14:16 Apr 12, 2012 Jkt 226001 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 (https://nctt.nih.gov/27543703), (2) high throughput capability of the assay (96well 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 cellbased assays is available at https:// nctt.nih.gov/27545107. Assay nominations should be submitted electronically using the online form (https:// iccvam.niehs.nih.gov/contact/Tox21nomination.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). 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 safetytesting 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 (https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Patient Safety Data Collection and Event Reporting Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Availability—New Common Format. AGENCY: As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats Background Information on NICEATM (Common Formats) for reporting patient NICEATM was established in 1998 to safety events to Patient Safety administer and provide scientific Organizations (PS0s). The purpose of support for the Interagency this notice is to announce the Coordinating Committee on the availability of new Common Formats— Validation of Alternative Methods Hospital Version 1.2 for public review (ICCVAM), which is composed of 15 and comment. member Federal agencies and includes DATES: Ongoing public input. the EPA, FDA, NIEHS, and NIH. The ADDRESSES: The new Common ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–2, 285l-5, available at https:// Formats—Hospital Version 1.2, version dated April 2012, and the remaining iccvam.niehs.nih.gov/about/ Common Formats can be accessed PL106545.htm) established ICCVAM as electronically at the following HHS Web a permanent interagency committee of the NIEHS under NICEATM. NICEATM site: https://www.PSO.AHRQ.gov/ index.html. 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 SUMMARY: FOR FURTHER INFORMATION CONTACT: Cathryn Niane, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22321-22322]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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) niceatm@niehs.nih.gov. 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.
---------------------------------------------------------------------------

    \1\ https://nctt.nih.gov/27543703.
    \2\ https://ntp.niehs.nih.gov/go/28213.
    \3\ https://www.epa.gov/ncct/Tox21/.
    \4\ https://www.fda.gov/.
---------------------------------------------------------------------------

    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 (https://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 https://nctt.nih.gov/27545107.
    Assay nominations should be submitted electronically using the 
online form (https://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 https://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 (https://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
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