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ICCVAM Agency Activities

News Published Since Last Biennial Report

This page contains ICCVAM agency activities announced in NICEATM News, an email list that distributes announcements of interest to those developing alternatives to animal use for chemical safety testing. Subscribe to NICEATM News

ICCVAM agency activities occurring since the last ICCVAM Biennial Report are listed below. Activities that occurred before January 2022 will be described in ICCVAM Biennial Reports.

List of ICCVAM Agency Activities
Date Agency Activity
Nov 2022 FDA
FDA Issues Final Guidance on Carcinogenicity Testing

In a November 2 Federal Register notice, FDA announced availability of a final guidance document, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and offers an integrative approach that provides specific weight-of-evidence criteria that inform whether a 2-year rat study is likely to add value in completing a human carcinogenicity risk assessment. This final guidance considered comments received from the public in response to release of the draft guidance in October 2021.

Nov 2022 NIEHS
NIEHS Offers Assistance Applying for Small Business Grants; Apply by December 12

The NIEHS Small Business Program will soon begin accepting applications for its Applicant Assistance Program (AAP). This free, 10.5-week program is designed to assist small businesses in preparing a Small Business Innovation Research or Small Business Technology Transfer grant application in time for the April 2023 deadline. AAP provides participants with services such as application needs assessment, mentoring, application preparation support, and application review. AAP aims to increase the number of applications from underrepresented small businesses, especially women-owned and socially and economically disadvantaged companies and offers support and resources to help those applicants maximize their chances of success. Submit applications by Thursday, December 12.

Nov 2022 EPA
December 7 Webinar to Discuss Scientific Confidence in NAMs

An upcoming webinar, “Frameworks for Establishing Scientific Confidence in New Approach Methodologies, Part 1” will be Wednesday, December 7 from 10:00-11:30 a.m. EST. This webinar is a joint presentation of the PCRM DyNAMic Discussions series and the P.E.P. Webinar Series on NAMs for Risk Assessment, co-organized by PETA Science Consortium International, EPA, and PCRM.

This event will feature two presentations from authors of a recently published paper on building scientific confidence in NAMs: Nicole Kleinstreuer, NICEATM, and Tala Henry, EPA Office of Pollution Prevention and Toxics. Presentations will be followed by a panel discussion with panelists João Barroso, European Commission Joint Research Centre, and Warren Casey, NIEHS. The paper proposes a “framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review” (van der Zalm et al., 2022; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9525335/).

To submit a question for the panelists about establishing scientific confidence in NAMs in advance of the event, visit www.slido.com and enter #TSCA-NAMs.

Oct 2022 FDA/NIH
FDA and NCATS Offering Grants to Develop Tissue Chips for Botulinum Toxin Testing

FDA and the National Center for Advancing Translational Sciences (NCATS) are offering Small Business Innovation Research and Small Business Technology Transfer grants for the development of neuromuscular junction tissue chips to replace the mouse lethality bioassay as a potency assay for botulinum toxin. A main objective for this funding opportunity would be to position these tissue chips as an alternative test method as a standalone replacement for mouse lethality bioassay.

Applicants are encouraged to contact FDA and NCATS to ensure their study design, qualification plan and objectives are in line with the goals of the funding opportunity. Grantees will be expected to work with FDA and NCATS post-award to develop and implement the final validation plan for the proposed alternative test method.

The key dates are as follows:

  • Open Date (Earliest Submission Date): October 20
  • Letter of Intent Due Date: October 21
  • Application Due Date: November 21 by 5:00 p.m. local time of applicant organization

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Application instructions are available on the NIH Grants website.

Sept 2022 NIEHS
Environmental Health Language Collaborative Hosts Webinar October 7

The Environmental Health Language Collaborative (EHLC) is hosting a webinar on Friday, October 7, 2:00-3:00 p.m. EDT. In this webinar, Karamarie Fecho of Copperline Professional Solutions and the University of North Carolina and Sierra Moxon of Lawrence Berkeley National Laboratory will be presenting on Biolink Model, an open-source standardized data model for semantic harmonization across datasets. The presenters will discuss the potential application of Biolink Model to environmental health science research, with a case study examining the EHLC use case on airborne pollutant exposures and asthma. The presentation will include a discussion on the pros and cons of adopting Biolink Model to support the data harmonization needs of the EHLC community. 

EHLC is an NIEHS-supported community-driven initiative to advance integrative environmental health research by developing and promoting adoption of a harmonized language.

Background reading: Unni DR., et al. Biolink Model: a universal schema for knowledge graphs in clinical, biomedical, and translational science. Clin Transl Sci 15(8): 1848-1855. https://doi.org/10.1111/cts.13302

Sept 2022 EPA/NIEHS/NIH
Recent Publication Describes Computational Model for Developmental Toxicity

A new publication by EPA, NIEHS, and NIH scientists and collaborators describes a computational model to identify chemicals associated with both retinoic acid pathway bioactivity and prenatal skeletal defects. The model confirms current understanding of the relevance of this pathway to this type of developmental toxicity while also identifying new pathway elements.
Pierro et al. 2022. Computational model for fetal skeletal defects potentially linked to disruption of retinoic acid signaling. Front Pharmacol. https://doi.org/10.3389/fphar.2022.971296

Sept 2022 FDA/NIEHS
Register Now for Pan-American Workshop on Biologicals Testing

The World Health Organization (WHO) and NC3Rs are conducting a review of animal use requirements within WHO guidelines for biologics. As part of that effort, NC3Rs is hosting a series of regional workshops to better understand the potential impact of these changes on manufacturers and regulators globally.

A virtual workshop on Monday, September 26 will focus on requirements in North and South America. Biologicals regulatory agencies and manufacturers from the region will discuss their perspectives on current testing strategies and how changes to WHO guidelines could be implemented to support wider adoption of 3Rs and non-animal approaches. Although the discussions are focused on Pan-America, relevant stakeholders from any region are welcome to attend and participate.

Biologicals such as vaccines, cytokines, enzymes, and hormones are tested routinely after approval to ensure the safety and potency of products. Many of these tests currently require the use of animals, and a large number of animals are used for this purpose each year. The WHO/NC3Rs project, which is receiving support from NICEATM and FDA, is intended to support recommendations for where non-animal approaches can be adopted.

Sept 2022 EPA/NIEHS
OECD Publishes New Case Studies for Integrated Approaches to Testing and Assessment

OECD has published seven new case studies on the use of integrated approaches for testing and assessment (IATA). OECD develops case studies on IATA to increase understanding and experience with these alternatives to animal testing and support their application to regulatory use. The case studies are issued as publications within the OECD Series on Testing and Assessment.

Two of the new case studies are relevant to recent NICEATM and ICCVAM activities.

  • Series on Testing and Assessment No. 364, Case Study on the Use of Integrated Approaches for Testing and Assessment for DNT to Prioritize a Class of Organophosphorus Flame Retardants. This case study was prepared by a group of NICEATM scientists in collaboration with other NIEHS and EPA scientists. The case study uses a battery of in vitro and complementary non-mammalian animal models (e.g., zebrafish) to prioritize a class of compounds, organophosphorus flame retardants, for further developmental neurotoxicity (DNT) testing.
  • Series on Testing and Assessment No. 367, Case Study on the Use of an Integrated Approach for Testing and Assessment (IATA) for New Approach Methodology (NAM) for Refining Inhalation Risk Assessment from Point of Contact Toxicity of the Pesticide, Chlorothalonil. This case study was developed from an investigation of how an in vitro respiratory model might improve on existing animal models to develop an inhalation exposure risk assessment for the pesticide chlorothalonil. The investigation was discussed in detail at a presentation given by EPA to the 2019 SACATM meeting.
Aug 2022 NIEHS
Register for October 26-27 Symposium on Population Variability

NICEATM is organizing an October 26-27 symposium webinar to discuss “Using New Approach Methodologies to Address Variability and Susceptibility Across Populations.” Registration is now open.

Different human populations exhibit different levels of susceptibility to toxic effects from chemical exposure, presenting a complex problem for chemical risk assessment. Human cell-based and computational NAMs could potentially be used effectively to characterize susceptibility of different human populations. The October 26-27 symposium will identify:

  • Opportunities for NAMs to provide relevant information on population variability and susceptibility to environmental chemicals.
  • Information needs for population variability and susceptibility where NAMs could be designed or improved to fill those needs.

Invited speakers will present case studies where NAMs are applied to address variability and susceptibility. The program will also include speakers highlighting the concerns associated with environmental chemicals in specific communities. Presentations will be followed by panel discussions among experts to identify specific topics for follow-up activities.

In advance of the symposium, a webinar series is being convened to highlight NAMs that incorporate variability and susceptibility into the evaluation of chemical safety. The webinar series is being co-organized by NICEATM and PCRM. Information about the webinar series, including recordings of past webinars, is available on the PCRM website.

Aug 2022 NIEHS
October 3-4 Workshop to Focus on Clustering and Classification

NIEHS is organizing “Clustering and Classification Workshop: Applications to Investigate Adverse Effects of Chemicals on Human Health and Environment.” The workshop will be October 3-4, 8:30 a.m.-3:30 p.m. EDT each day. A preliminary agenda, other information, and a link to register are available on the NIEHS website.

The workshop will introduce the concept of chemical similarity and explore the uses of different classification and clustering approaches for toxicity research and risk assessment. The invited speakers and expert discussants will identify best practices and guidelines for the application of these approaches. Participation from attendees to round table discussions will be encouraged.

Aug 2022 NIH
Apply by September 22 for NIH Small Business Applicant Assistance Program

Applications are being accepted for the NIH small business Applicant Assistance Program. Apply by September 22.

The Applicant Assistance Program assists small businesses in preparing and submitting a SBIR or STTR application to NIEHS and other NIH Institutes and Centers. The goal of this program is to increase the number of applications submitted by underrepresented small businesses and to increase the number of these applications that are free of errors or omissions and are deemed complete, compliant, and responsive to the review criteria. Only U.S. for-profit companies are eligible for the program, and participating companies must not have received an SBIR or STTR award since 2013.

Aug 2022 EPA
EPA to Hold NAMs Conference October 12-13

A draft agenda is available for EPA’s “2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing.” The conference will be held in-person at EPA headquarters in Washington, DC on October 12-13. A virtual option will also be available. Registration will open soon.

In 2019, EPA committed to developing and implementing a work plan to reduce the use of vertebrate animals in chemical testing while ensuring protection of human health and the environment. To report progress on these activities, EPA hosts regular conferences to provide updates and solicit input from interested stakeholders. The conferences highlight the state of the science on the development and use of NAMs for chemical safety testing.

Aug 2022 EPA
EPA Requests Comment on Nominees for FIFRA Advisory Panel

In a July 28 Federal Register notice, EPA requested comment on a slate of nominees for the Scientific Advisory Panel (SAP) established under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submit comments by August 29.

The FIFRA SAP serves as a scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. Members are scientists who have sufficient professional qualifications, including training and experience, to provide expert comments on the impact of pesticides on human health and the environment. The current slate of nominees was assembled in response to a request for scientists with specific expertise in areas including computational toxicology (new approach methodologies and in vitro to in vivo extrapolation), allergenicity, population modeling, cheminformatics, bioinformatics, and genomics.

July 2022 NIEHS
NIEHS Funding Approaches to Incorporate Genetic Diversity into Toxicity Testing

NIEHS is offering small businesses funding to develop resources and approaches that reflect the variability in responses to chemical exposures based on genetic diversity in the human population. The goal of this funding opportunity is to enhance the capability of introducing genetic diversity in toxicity testing.

Applicants should propose test chemicals or compounds that are relevant for developing and applying genetic diversity resources and provide a rationale for the proposed dose ranges in these studies. Applicants should provide clear, measurable goals (milestones), particular for Phase I applications and Phase I components of fast-track applications.

The key dates are as follows:

  • Open Date (Earliest Submission Date): October 8
  • Letter of Intent Due Date: October 8
  • Application Due Date: November 8 by 5:00 p.m. local time of applicant organization

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

June 2022 NIEHS
SBIR/STTR Omnibus Grant Funding Opportunity Announcements

The Department of Health and Human Services has released the 2022 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus Grant Solicitations. This funding is available for small business grant applications to support development and commercialization of innovative technologies.

Projects being funded by NIEHS under these solicitations include development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Tools for exposure assessments such as sensors and computational tools and methods.
  • Tools for evaluating environmental health and safety of engineered nanomaterials.
  • Biomonitoring technologies and biological response markers of exposure and response.
  • Assays and model systems for screening compounds for toxicity.

The first deadline for applications under this announcement is September 5. Applicants are strongly encouraged to visit  to subscribe to the NIH Guide for Grants and Contracts LISTSERV. You may also subscribe to the SBIR-STTR LISTSERV to get timely information about the NIH SBIR and STTR Programs.

June 2022 FDA
Meeting of the FDA Science Board

The FDA Science Board met June 14 in a public online session. Topics considered included:

  • Challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.
  • Enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that can replace, reduce, and refine animal testing and have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.
  • Enhanced efforts to ensure optimal organization, infrastructure, and expertise for data science efforts in alignment with its regulatory scope and evidence-based decision making, in support of FDA’s public health priorities.
June 2022 EPA
EPA Offers Small Businesses Grants to Develop Applications for Chemical Safety Assessment

EPA has released its 2022-2023 Small Business Innovation Research Phase I Broad Agency Announcement solicitation. A list of topics is available on the EPA website. Among other areas, EPA will support development of software tools and machine-learning applications for systematic review in science assessment for chemical evaluation. Apply by August 23.

June 2022 NIH
June 7-8 Workshop on 3D Tissue Models for Antiviral Drug Development

Registration is still open for the Assay Guidance Workshop on 3D Tissue Models for Antiviral Drug Development, which will be held virtually on June 7-8. The two-day workshop will cover a broad range of critical concepts, including practical approaches and best practices, for developing standardized 3D cellular assays for testing of therapeutics for future pandemic threats.

Session topics:

  • Session I: 3D Tissue Models: Utility & Limitations
  • Session II: Utility of the Existing 3D Tissue Models for Antiviral Drug Development
  • Session III: Use of Robust & Reproducible 3D Tissue Models from Drug Discovery
  • Session IV: Summary of Discussions & Perspectives on the Challenges Ahead

The overall goal of this workshop is to help scientists establish robust, reproducible, scalable, consistent, advanced 3D tissue models to study pandemic threat viruses. Acting NICEATM Director Nicole Kleinstreuer will be speaking in Sessions III and IV. The workshop is organized by the National Center for Advancing Translational Sciences. Registration is free.

June 2022 DOT/OSHA
DOT and OSHA Seek Public Input in Advance of International Meetings

The U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration and the Occupational Safety and Health Administration (OSHA) will hold virtual public meetings on Wednesday, June 15. The purpose of the June 15 meetings is to consider public comments and gather information in advance of:

  • The 60th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on June 27-July 6.
  • The 42nd session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals on July 6-8.

General information about both meetings is available in a May 31 Federal Register notice. Interested parties may submit written comments between June 4 and July 5. Details on submitting written comments are available in the Federal Register notice.

May 2022 EPA
May 25-26 Workshop to Focus on Artificial Intelligence and Open Data in Chemical Hazard Assessment

The National Academies of Sciences, Engineering, and Medicine will present a workshop on “Artificial Intelligence and Open Data Practices in Chemical Hazard Assessment.” This two-day workshop will be held on Wednesday and Thursday, May 25 and 26. It is one of two workshops being convened on topics pertinent to the assessment of human health effects by the U.S. Environmental Protection Agency. Registration is required.

Practical application of systematic review methods to the peer-reviewed literature and other data sources for chemical hazard identification is labor-intensive and costly. Advances in artificial intelligence hold promise to ease those constraints through semi-automation of systematic review workflows. Through presentations, discussions, poster sessions, and software tool demonstrations, workshop participants will consider the following questions:

  • What are the key practical hurdles for applying systematic review methods, especially with respect to data extraction, and what computational tools have been applied to address them?
  • What strengths and limitations have been identified through application of artificial intelligence (AI) solutions in systematic review?
  • What are the key opportunities for furthering application of AI in chemical hazard assessment?

This workshop will feature live panel discussions on various tools used to automate and streamline data extraction and evidence synthesis for systematic reviews. Nicole Kleinstreuer, Acting NICEATM Director, will be presenting in a session on “AI and Data Science Applications: Promises and Prospects."

May 2022 EPA
EPA Ecotoxicology Data Resource

EPA's ECOTOXicology Knowledgebase (ECOTOX) is a publicly available tool providing single chemical environmental toxicity data on aquatic and terrestrial species. ECOTOX was developed to provide risk assessors and researchers with relevant toxicity data that have been identified and curated from peer-reviewed literature and government reports. New data are added every quarter and are available on a public-facing website.

May 2022 EPA/NIEHS/NIST
Proceedings Available from Workshop on NAMs for Human Health Risk Assessment; Next Workshop May 12

A December 9, 2021, workshop considered the potential utility and expectations for the future use of new approach methodologies (NAMs) in risk assessment and to reflect on the challenges to their implementation. Proceedings of the workshop are now available.

During the workshop, experts from academia, industry, government, and other organizations discussed current scientific knowledge with regard to traditional toxicity studies and NAMs. The workshop addressed three critical questions:

  • How are traditional toxicity studies used in informing chemical safety decisions?
  • What do we know about the variability and concordance of traditional mammalian toxicity studies?
  • What are the needs and expectations of different stakeholders?

The workshop was convened by an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine exploring the topic of “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods for use in Human Health Risk Assessment.” The panel’s goal is to set data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models. Acting NICEATM Director Nicole Kleinstreuer and ICCVAM Member Elijah Petersen (National Institute of Standards and Technology) are serving on the committee. The panel’s next public workshop will be held on May 12.

Apr 2022 EPA
Webinar Discusses Approaches to Reduce Animal Use for Ecotoxicity Testing

In a May 11 webinar on “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity,” two EPA scientists discuss computational tools and analyses that EPA is using to reduce animal use for ecotoxicity testing. Carlie LaLone, EPA Office of Research and Development, will describe how the SeqAPASS tool, which uses existing protein sequence data for cross-species extrapolation, can be applied to understanding conservation of biology and predicting chemical susceptibility. Michael Lowit, EPA Office of Pesticide Programs, will discuss an ongoing retrospective analysis of fish acute toxicity test data, which will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions. The webinar is the latest in a series on use of new approach methodologies in risk assessment co-organized by the PETA Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine.

Apr 2022 NIH
MPS World Summit May 30-June 3

The MPS World Summit 2022 will be held at the Hilton New Orleans Riverside and virtually from May 30-June 3. Late-breaking abstracts for poster presentations are due Saturday, April 30. Abstracts should describe new developments and applications of MPS.

Summit attendees will present the latest scientific achievements in the area of MPS and discuss advances and challenges. This is the latest in a series of events convened to facilitate stakeholder communication, enable networking among young scientists and MPS thought leaders, promote international standardization and harmonization of MPS, and serve as a global training environment. These events will also lay the groundwork for establishing an international MPS society. The National Center for Advancing Translational Sciences (part of NIH, an ICCVAM member agency) is a major sponsor of the summit.

ESTIV is sponsoring a best poster award and best oral presentation award (500 EUR each), to be awarded to Ph.D. students or early career scientists presenting their research in the field of in vitro toxicology as first author during the MPS World Summit. An application is required to be considered for the awards and must be submitted by April 30.

The summit will include an education and training workshop to be held Tuesday, May 31, from 9:00-11:45 a.m. Central Time. Workshop participants will attend up to four presentations and demonstrations from leaders in the MPS field. Participants will have a unique opportunity to interact directly with international speakers and to receive a hands-on training on some of the most cutting-edge MPS technologies. Attendance is free but separate registration is required.

Apr 2022 EPA
EPA Releases httk 2.1.0

On March 26, EPA released version 2.1.0 of the High-throughput Toxicokinetics tool (httk). This R software package enables estimation of chemical concentrations in various parts of the human body from a given exposure. The latest update of httk includes:

More information about EPA’s high-throughput exposure and dose research activities is available on their website.

Mar 2022 FDA
ICCVAM Member Honored by SOT Specialty Section

In an awards ceremony on Wednesday, March 30, ICCVAM member Suzanne Fitzpatrick (FDA) was presented with the inaugural Outstanding Contribution to Regulatory Safety Evaluation Award by the SOT Regulatory and Safety Evaluation Specialty Section. This award recognizes an individual who has made significant contributions in the areas of regulatory and safety evaluation.

Fitzpatrick is the Senior Advisor for Toxicology at the FDA Foods Program. She is co-chair of an international work group on advancing new predictive toxicology test methods for food safety and also chairs the FDA’s Alternative Methods Work Group, which is currently focusing on in vitro microphysiological systems. A longtime ICCVAM member, Fitzpatrick is the principal FDA representative to ICCVAM and to the Tox 21 partnership.

Mar 2022 EPA
Paper Considers New Approach for Carcinogenicity Assessment of Agrochemicals

A new paper in Regulatory Toxicology and Pharmacology describes development of a framework for a risk assessment-based weight of evidence determination of the need for rodent cancer bioassays for safety assessment. The reporting framework was developed to support a chronic toxicity and carcinogenicity study waiver rationale for agrochemicals but could also be applied to endpoints other than chronic toxicity and carcinogenicity, and for chemicals other than agrochemicals. Coauthors on the paper include ICCVAM member Warren Casey, NIEHS, and ICCVAM co-chair Anna Lowit, EPA.

Hilton et al. 2022. Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays. Regu Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2022.105160.

Mar 2022 USDA
USDA AWIC Updates Website

The Animal Welfare Information Center (AWIC) of the USDA National Agricultural Library is reorganizing and modernizing its webpages to improve user experience and streamline information discovery. AWIC’s webpages that discuss topics such as the Animal Welfare Act and Housing, Care, and Welfare of Animals have been updated with new content and design. Updates of other pages, including those on Animal Use Alternatives and AWIC Workshops & Trainings will be published throughout 2022.

AWIC provides a variety of resources for exploring alternatives to animal use for research, teaching, and testing, including assistance with literature searching for alternatives to animal use and workshops on meeting the requirements of the Animal Welfare Act. The next virtual workshop (free) is scheduled for May 11.

Mar 2022 EPA
EPA Launches New Chemicals Collaborative Research Program; Workshop April 20-21

EPA is launching an effort to bring innovative science to the review of new chemicals before they enter the marketplace. A virtual workshop on this effort, the New Chemicals Collaborative Research Program, will be held April 20-21 from 1:00-5:00 p.m. EDT each day. This multi-year research program will refine existing approaches and develop and implement new approach methodologies to ensure the best available science is for new chemical evaluations conducted under the Toxic Substances Control Act. Workshop attendees will hear an overview of the program and have an opportunity to provide input during topic-focused breakout sessions and a general public comment period.

Feb 2022 NCI
Grants Will Support Development of Tissue Models for Cancer Research

NCI is offering grants to support the development and characterization of state-of-the-art biomimetic tissue-engineered technologies for cancer research. Projects supported by this funding will become part of the Cancer Tissue Engineering Collaborative (TEC) Research Program. The goals of the Cancer TEC Program are to (1) catalyze the advancement of innovative, well-characterized in vitro and ex vivo systems available for cancer research, (2) expand the breadth of these systems to several cancer types, and (3) promote the exploration of cancer phenomena with biomimetic tissue-engineered systems.

Applications for funding will be accepted beginning on May 5, with applications due June 5 and quarterly thereafter through February 2025. Grants of up to $400,000 will be awarded to fund projects that can continue up to five years. Eligibility for these grants is open to for-profit and nonprofit institutions within and outside the United States.

Feb 2022 FDA
Workshop Report Provides FDA and Industry Perspectives on MPS Applications

A report recently published in ALTEX summarizes a workshop at which FDA and the pharmaceutical industry’s Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate considered drug development applications of complex in vitro models (CIVMs) such as MPS. Participants were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. They also determined that use of CIVM technologies in drug development applications will require qualification which will vary depending on the specific context of use. ICCVAM members Paul Brown, Suzanne Fitzpatrick, and Donna Mendrick co-authored the report.

Baran et al. 2022. Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate). ALTEX. https://doi.org/10.14573/altex.2112203.

Feb 2022 FDA/NIEHS
WHO Seeks Information on Application of 3Rs to Biologicals Testing

The World Health Organization (WHO) and NC3Rs are conducting a review of animal use requirements within WHO guidelines for biologics. As part of that effort, NC3Rs is surveying national regulatory authorities and national control laboratories about opportunities and barriers to adoption of replacement, reduction, and refinement alternatives and use of non-animal approaches in quality control, batch, and lot release testing of biologicals. Please respond by March 4.

Biologicals such as vaccines, cytokines, enzymes, and hormones are tested routinely after approval to ensure the safety and potency of products. Many of these tests currently require the use of animals, and a large number of animals are used for this purpose each year. The WHO/NC3Rs project, which is receiving support from NICEATM and FDA, is intended to support recommendations for where non-animal approaches can be adopted. The project is currently in an information-gathering phase, with a survey of biologicals manufacturers having been conducted in 2021. Data collected will be anonymized and published in a peer-reviewed journal or as a report on the NC3Rs website, and/or presented at scientific meetings or webinars.