ICCVAM Agency Activities

The NIEHS Small Business Program is accepting applications for its Applicant Assistance Program (AAP). This free, 10-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 September 5, 2024, 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. Two webinars are being presented on April 25 and May 14 to provide information about the program and answer questions from potential participants.

The application portal opens April 25. Submit applications by May 21, 5:00 pm ET.

EPA is hosting a free New Approach Methods (NAMs) Tools Training Workshop on April 24–25 from 9:00 a.m.–5:30 p.m. (EDT) both days. The workshop will be presented in-person only at EPA’s Research Triangle Park campus in Durham, NC. Space is limited. Preference will be given to registrants who are able to attend both days of the workshop.

This workshop builds on EPA’s ongoing NAMs virtual trainings and will give participants the opportunity to advance their knowledge on EPA NAMs tools through overview sessions, in-depth learning, interactions with tool and data owners, and tool-specific case studies. EPA NAMs tools featured in the workshop include:

• Adverse Outcome Pathway (AOP) Wiki
• Chemical Exposure (ChemExpo) Knowledgebase
• Cheminformatics Modules
• CompTox Chemicals Dashboard
• Ecotoxicology (ECOTOX) Knowledgebase
• Generalized Read-Across (GenRA) tool
• High-Throughput Toxicokinetics (httk) R package
• Sequence Alignment to Predict Across-Species Susceptibility (SeqAPASS) tool
• Toxicity Estimation Software Tool (TEST)
• Toxicity Forecasting (ToxCast)

Attendees will have an opportunity to get a sneak peek at a new Non-Targeted Analysis (NTA) Web Application and RapidTox, a new suite of workflows to address targeted human health data needs in support of decision-making.

The next webinar in the EPIC series on the use of NAMs in risk assessment, co-organized by the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CPDR), will cover “Establishing confidence in new approach methodologies.” The webinar will be held on Wednesday, February 21 from 11:00 a.m.–12:30 p.m. EST. ICCVAM member Elijah Petersen, National Institute of Standards and Technology, will discuss the forthcoming ICCVAM document, “Validation, Qualification, and Regulatory Acceptance of New Approach Methods.” Corrie Ellison, Procter & Gamble, will present a case study discussing the process of gaining confidence in alternative approaches for assessing the toxicity of branched carboxylic acids. 

The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series began in August 2023 and will continue quarterly. 

A February 1 statement from NIH Director Monica Bertagnolli announced NIH acceptance of a working group’s recommendations on NAMs activities.

A working group of the Advisory Committee to the Director was charged with identifying areas in which the development and use of novel alternative methods would provide maximal value to biomedical research. The working group’s activities culminated in a December 2023 report to the Advisory Committee with seven specific recommendations on how NIH should work with the scientific community to support development and use of NAMs. In her statement, Bertagnolli noted how the recommendations build on an existing foundation of NIH investment in NAMs projects as NIH continues to advance the validation and regulatory implementation of NAMs in partnership with other federal agencies via ICCVAM.

On January 25, the NIH Council of Councils approved the concept for the new NIH Common Fund's Complement Animal Research In Experimentation (Complement-ARIE) program. Complement-ARIE will speed the development, standardization, validation, and use of human-based new approach methodologies (NAMs), and significantly advance understanding of human health and disease by providing a range of ready and standardized biomedical research models. Developing these models will require expertise in disease research, personalized medicine, and in screening therapeutics for safety and effectiveness. The Complement-ARIE program will bring together experts in these areas via efforts such as technology development projects and centers, resource coordinating centers, validation networks, community engagement and training, and strategic key-partner engagement.

Registration is open for upcoming workshops on “Meeting the Requirements of the Animal Welfare Act” offered by the USDA Animal Welfare Information Center. Live virtual workshops will be offered on Wednesday and Thursday, March 6-7, from 1:00-4:00 p.m. EST each day, and on Wednesday and Thursday, May 8-9, from 1:00-4:00 p.m. EDT each day. There is also a self-paced asynchronous version of the workshop available.

The Animal Welfare Information Center was established to help the regulated community comply with the Animal Welfare Act. The Center provides information on approaches to prevent duplication of animal experimentation and alternative methods that replace, reduce, or refine animal use. More information about the Center, including an introductory video, is available on the Center’s website.

The National Center for Biotechnology Information (NCBI) is hosting a codeathon on “Building Transparent ML/AI Solutions to Advance Biological Research.” The event will address the growing need for collaboration, knowledge sharing, and exploration of the transparent deployment of machine learning (ML) and artificial intelligence (AI) in research. The codeathon will be held virtually from February 26 to March 1; those interested in participating should register by Monday, January 15. 

This event will bring together developers, data scientists, and tech enthusiasts to build equitable and transparent ML/AI solutions that tackle various problems in healthcare, research, education, and more. During the week-long codeathon, teams of 5-10 people will collaborate virtually to design and build innovative solutions that promote fairness, transparency, and accountability in AI/ML algorithms and models. Teams that want to leverage NCBI databases or publicly available scientific data for deep learning are encouraged to apply. Priority will be given to projects that make use of NCBI data and tools. At the end of the event, teams will present their work to each other, representatives from the National Institutes of Health (NIH), and the public. Team products will be made publicly available, and participants will be encouraged to co-author a joint manuscript and share their work online and at conferences.

In a January 2024 Federal Register notice, EPA announced a new framework for identifying eye irritation and corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA).

With this new framework, EPA will place increased weight on data from non-animal test methods that are more reproducible and provide results more relevant to humans. This will streamline the decision-making process and increase efficiency through a standard process for EPA to use each time it evaluates eye irritation or corrosion hazards test data. The new framework supports EPA’s mandate under TSCA to promote the development and implementation of alternative test methods and strategies that can provide information on chemical hazards without animal testing. This framework also supports EPA’s ongoing efforts to reduce the use of animal testing and make the Agency’s review of new chemicals more efficient, helping to bring new chemicals to market more quickly while protecting human health.

A March 2023 workshop explored the feasibility of using historical control data rather than concurrent control groups in animal toxicity studies, which would enable reduction of animal use in these studies. Participants included stakeholders from the FDA, pharmaceutical and chemical industry, academia, contract research organizations, and non-governmental organizations. A report from the workshop summarizes the pros and cons of such a concept and what would have to be done to implement it without threatening the reliability of the study outcome or the resulting human risk assessment.

Golden et al. 2023. Toward implementing virtual control groups in nonclinical safety studies: workshop report and roadmap to implementation. ALTEX. https://doi.org/10.14573/altex.2310041

FDA has published guidance on “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform “in silico” device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of CM&S used in medical device regulatory submissions. The guidance is intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions. Publication of the guidance was announced in a November 17 Federal Register notice. 

FDA scientists have published an analysis of data from studies that used dogs to test food additives. While the study found that in nearly 40% of studies, the dog data were considered to be decisive to the safety decision, most studies did not rely upon dog studies to set an Acceptable Daily Intake. The study conclusion encourages future research to investigate the use and value of alternative animal models as replacements for the use of a second species in food and color additive safety assessments.

Flannery et al. 2023. Retrospective analysis of dog study data from food and color additive petitions. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2023.105523.

An EPA webinar will consider combining use of new approach methodologies (NAMs) and adverse outcome pathways (AOPs) for ecological risk-based screening prioritization. Daniel Villeneuve, EPA Center for Computational Toxicology and Exposure, will present four case studies to illustrate the complementary use of NAMs and AOPs to help prioritize higher tiers of testing and support efficient ecological risk assessment. The webinar is Thursday, December 7 at 11:00 a.m. EST.

The second webinar in the EPIC series on the use of NAMs in risk assessment will cover “Development and application of NAMs workflows and tools.” The webinar will be held on Wednesday, November 29 from 11:00 a.m.–12:30 p.m. EST. The series is co-organized by EPA, PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CPDR). The EPIC series covers timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series began in August 2023 and will continue quarterly.

The speakers for the November 29 webinar include Alistair Middleton, Unilever, on “Evaluating a systemic safety toolbox for use in NGRA,” and Tara Barton-Maclaren, Health Canada, on “In vitro bioactivity workflows for enhanced prioritization and rapid screening of existing chemicals in Canada: a journey of insights and learnings.”

EPA has committed to developing and implementing a work plan to reduce the use of animals in chemical testing. EPA will prioritize ongoing efforts and direct existing resources toward activities that will demonstrate measurable impacts in the reduction of animal 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. Planning for the next EPA New Approach Methodologies (NAMs) conference, to be held in the fall of 2024, is underway. This will be a hybrid meeting in Research Triangle Park, NC. Attendees will hear from representatives from EPA, other federal agencies, industry, universities, and international organizations on the state of the science on the development and use of NAMs for chemical safety testing.

EPA is soliciting ideas for topics to highlight during the 2024 EPA NAMs Conference. To provide input, please complete a survey by January 5, 2024.

NICEATM and U.S. Environmental Protection Agency (EPA) scientists and collaborators have published results from testing 29 agrochemical formulations in defined approaches (DAs) for eye irritation. Hazard classification concordance was assessed using orthogonal validation rather than direct concordance analysis with the historical in vivo rabbit eye data, the standard used for agrochemical formulations in some countries. The in vitro and ex vivo methods used in the DAs were demonstrated to be as or more fit for purpose and reliable and relevant than the in vivo rabbit test, thereby increasing scientific confidence in the use of these DAs for assessing eye corrosion/irritation potential of agrochemical formulations.

van der Zalm et al. 2023. Defined approaches to classify agrochemical formulations into EPA hazard categories using EpiOcularTM reconstructed human corneal epithelium and bovine corneal opacity and permeability assays. Cut Ocular Toxicol. https://doi.org/10.1080/15569527.2023.2275029.

In an October 2 Federal Register notice, the EPA Office of Pesticide Programs announced a public meeting of the Pesticide Program Dialogue Committee (PPDC) on November 15 and 16. The meeting will be held in person and limited opportunities for virtual participation will be offered. The PPDC provides a public forum to discuss a wide variety of pesticide regulatory developments and reform initiatives, evolving public policy and program implementation issues associated with evaluating and risks from the use of pesticides. 

The NIH Common Fund is planning a program to catalyze the development, standardization, validation, and use of new approach methodologies (NAMs) that will more accurately model human outcomes. As part of the Complement-Animal Research In Experimentation (Complement-ARIE) strategic planning process, the Office of Strategic Coordination intends to publish a prize competition announcement to solicit entries for new methods and approaches that would complement, make more efficient, or in some cases replace traditional animal models, transforming the way biomedical researchers conduct basic, translational, and clinical sciences.

A September 21 notice provides potential solvers with available details about the Complement-ARIE Challenge. Publication of the Challenge announcement and launch of the submission portal are planned for November 7. Potential applicants are encouraged to sign up for the Complement-ARIE listserv to receive updates about the Challenge. The estimated submission deadline for submissions is January 11, 2024.

The NIH Common Fund intends to award up to $1,000,000 to up to 20 winners (up to $50,000 each). To be eligible to win prizes, participants must be led by a citizen or permanent resident of the United States or be an entity incorporated in and maintaining a primary place of business in the United States.

EPA will offer training on use of its high-throughput toxicokinetics (httk) package in two two-hour virtual sessions on Wednesday, November 8, and Thursday, November 9, from 10:00 a.m.-12 noon EST both days. To get updates on the training, sign up for EPA email updates or contact [email protected].

Toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. Traditional TK methods can be resource-intensive and require chemical-specific data. EPA’s freely available httk R package uses data from in vitro high-throughput screening datasets, which can be used to fill data gaps in traditional TK methods. This training will familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for TK, including reverse dosimetry and physiologically based pharmacokinetic modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2).

The NIEHS Small Business Program is accepting applications for its Applicant Assistance Program (AAP). This free, 10-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 January 5, 2024, 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.

The application portal opens August 4. Submit applications by September 12, 5:00 pm ET.

NIH will hold a virtual workshop on approaches, challenges, and opportunities relating to the development of NAMs. The workshop will feature discussion on identifying incentives and barriers to successful implementation of NAM technologies. Speakers will include NICEATM Director Nicole Kleinstreuer and ICCVAM members Elijah Petersen (National Institute of Standards and Technology), Donna Mendrick (U.S. Food and Drug Administration), and Jessie Carder (U.S. Department of Agriculture). The workshop will be August 21 from 9:00 a.m. to 5:00 p.m. Viewers are asked to preregister to view the workshop.

In a related Request for Information published June 12, NIH requested public input on challenges and opportunities for the further development and use of NAMs in biomedical research. Building on recommendations of the Advisory Committee to the Director on high priority areas for NAMs development, NIH requested input on the following areas:

• Use of NAMs to study human biology, circuits, systems, and disease states.
• Approaches for catalyzing the development and validation of NAM technologies.
• Strategies for maximizing the research value of NAM technologies.

NIH will accept responses through August 16.

The Department of Health and Human Services has released the 2023-24 SBIR/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:

• Informatics tools and platforms to organize, store, retrieve, extract, and integrate information on exposures and health effects data.
• Application of machine learning methods and natural language processing for extracting and integrating diverse data types and for generating causal networks from experimental data and public knowledgebases.
• Adapting or developing new methods and tools for automating environmental health-related literature and systematic reviews, including article selection and prioritization, data extraction, study quality evaluation, and summarization of for environmental health impacts.
• Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity, and metabolic toxicity.
• Human and rodent organotypic culture models and microphysiological systems.
• Approaches to characterize and integrate key molecular and cellular changes related to effects of toxicant exposures in carcinogenicity, developmental neurotoxicity, or cardiotoxicity.
• Screening systems that incorporate genetic diversity into toxicology testing.
• Short-term tests, assays, or systems designed specifically to reduce or replace existing regulatory animal studies for acute toxicity (oral or inhalation), reproductive or developmental toxicity, carcinogenicity, or ocular toxicity.

The first deadline for applications under this announcement is September 5. Complete information about eligibility, applying, and deadlines is available at:

• PA-23-230 (SBIR opportunities)
• PA-23-232 (STTR opportunities)

A new webinar series on the use of NAMs in risk assessment is being co-organized by EPA, PETA Science Consortium International, Institute for In Vitro Sciences, and the California Department of Pesticide Regulation (CDPR). The “EPIC” series will cover timely topics on the use of NAMs for risk assessment within EPA and CDPR. The series will begin in August and will continue quarterly.

The first webinar will be Wednesday, August 23 from 11:00 a.m.–12:30 p.m. ET. Charles Kovatch and Tim Shafer, both from EPA, will discuss recent updates from the Organisation for Economic Co-operation and Development, including information about an in vitro test battery for developmental neurotoxicity. 

The EPA Office of Pesticide Programs invites nominations to be considered for its Pesticide Program Dialogue Committee (PPDC). The PPDC provides EPA with advice on a range of pesticide regulatory developments and reform initiatives, evolving public policy, and program implementation issues associated with evaluating and reducing risks from pesticide use. Nominees will be considered from a range of stakeholder groups representing industry, academia, government, and nongovernmental organizations. The PPDC usually meets twice a year, and members may be asked to serve on work groups to develop recommendations to address specific policy issues. Nominations must be received by August 10.

A virtual workshop on June 29-30 organized by NIEHS and NCI will assess the current state of the science of using signatures from “omic” data types to link environmental exposures to cancer. Participants will explore potential uses of such signatures of carcinogenic exposure to aid cancer prevention. Computational biologists, epidemiologists, exposure scientists, and cancer researchers will identify key questions, knowledge gaps, and opportunities for the field. While the meeting will focus on linking exposure signatures to cancer, a range of technologies, models, and exposures will be considered.  

The Department of Defense (DoD) report, “Future Directions Workshop: Advancing the Next Scientific Revolution in Toxicology,” is now available on the Office of the Under Secretary of Defense for Research and Engineering (OUSD R&E) website. Click the icon to download the report.

The Future Directions Workshop series, sponsored by the Basic Research Office of the OUSD R&E, examines emerging research and engineering areas that are most likely to transform future technology capabilities. These workshops are designed primarily around small-group breakout sessions and large-group discussions for scientists and engineers from academia, national laboratories, and industry. An intent is to encourage participants to express their perspectives and outlooks over areas of rapid progress in fundamental research and shed insight on three overarching questions:

• How might the research impact science and technology capabilities of the future?
• What is the possible trajectory of scientific achievement over the next 10-15 years?
• What are the most fundamental challenges to progress?

Interested persons can submit ideas for future workshop topics on the OUSD R&E website.

NIH seeks public input on challenges and opportunities for the further development and use of new approach methodologies (NAMs) in biomedical research. Building on recommendations of the Advisory Committee to the Director on high priority areas for NAMs development, NIH requests input on the following areas:

• Use of NAMs to study human biology, circuits, systems, and disease states.
• Approaches for catalyzing the development and validation of NAM technologies.
• Strategies for maximizing the research value of NAM technologies.

Responses must be received by August 16.

FDA has finalized the guidance document, “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of drug products and biopharmaceuticals.

The guidance addresses evaluation of topical pharmaceuticals for skin sensitization potential. Specifically, the guidance states that, for individual chemicals, “FDA will consider a battery of studies (e.g., in silico, in chemico, in vitro) that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.”

The DOT Pipeline and Hazardous Materials Safety Administration (PHMSA) and OSHA will hold a hybrid public meeting on Wednesday, June 21. The purpose of the June 21 meeting is to consider public comments and gather information in advance of:

• The 62nd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on July 3-7.
• The 44th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals on July 10-12.

Specific information about the OSHA meeting will be posted when available on the OSHA website. Specific information on the PHSMA meeting and links to access the conference call will be posted when available on the PHSMA International Program Overview page under Upcoming Events.

General information about both meetings, including specific information about all attendance options, is available in a May 24 Federal Register notice. Interested parties may submit written comments by July 2. Details on submitting written comments are available in the Federal Register notice. If you are going to attend in person you must register with PHMSA. 

The U.S. Consumer Product Safety Commission (CPSC) has updated its Animal Testing web page. It has been re-designed to be more user friendly and have direct access to necessary information and documents.

One of the resources available on this page is CPSC’s “Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.” CPSC developed this guidance, building on its Animal Testing Policy, to assist stakeholders in determining what test methods are deemed reliable for determining compliance with the labeling requirements under the Federal Hazardous Substances Act (FHSA). This includes clarification of CPSC informational requirements and process for evaluating new approach methodologies and integrated approaches to testing and assessment.

The Environmental Health Language Collaborative (EHLC) will present its next webinar, “Methods2AOP: An International and Interdisciplinary Effort to Strengthen the Role of Test Methods in the Adverse Outcome Pathway (AOP) Framework.” on Thursday, June 1, from noon-1:00 p.m. ET. Clemens Wittwehr, group leader in the Systems Toxicology Unit of the European Commission’s Joint Research Centre, will present collaborative work on the Methods2AOP project. Anna Maria Masci, NIEHS, will describe how ontologies and controlled vocabularies are being applied in the project. No registration is required.

EHLC is a NIEHS-supported community-driven initiative to advance integrative environmental health research by developing and promoting adoption of a harmonized language. More information about EHLC and links to join its email list and view past webinars and workshops are available on the project webpage.

The Methods2AOP project is an international effort to annotate assay data according to internationally accepted guidance to better relate these assays to key events in AOPs. The goal is to facilitate the incorporation of assays into AOP-based defined approaches for chemical safety testing, which will in turn support increased regulatory uptake of these approaches. NICEATM supports the Methods2AOP project along with the U.S. Environmental Protection Agency and other partners. 

The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas on how to best collaborate with FDA to encourage and incentivize public-private partnerships in the health ecosystem, with the goal of accelerating better health outcomes for everyone. Review the full Request for Information: Accelerating Innovation through ARPA-H and FDA Collaboration and Instructions on the ARPA-H website.

Topics of interest include:

• New and innovative models to accelerate pre-competitive development of platform technologies to support downstream development of products resulting from those platform approaches in a disease agnostic manner.
• Strategies to accelerate alternatives to traditional human or animal research for medical product development.
• Case studies on the development of innovative technologies that highlight best practices for using existing FDA regulatory pathways.

Interested persons and organizations are invited to submit comments on or before May 30 by 5 p.m. ET. Early submissions are encouraged as materials will be reviewed on a rolling basis. Submit comments electronically to [email protected] and include “RFI Response: Accelerating Innovation through ARPA-H and FDA Collaboration” in the subject line of the email.

FDA will hold its virtual 2023 Science Forum Tuesday, June 13 from 9:00 a.m. – 3:30 p.m. EDT and Wednesday, June 14 from 9:00 a.m. – 2:00 p.m. EDT. This event is presented to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health.

The theme for the 2023 FDA Science Forum, ‘‘Advancing Regulatory Science Through Innovation,’’ will highlight areas of FDA research, including advancing products based on novel technologies, food and cosmetic safety, and tools to effectively use big data.

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 September 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. The application portal opens April 25; a course outline, eligibility requirements, and key dates are now available. Submit applications by May 22, 5:00 pm EDT.

NIEHS is offering funding to develop resources, new methods, and approaches that can be applied in testing strategies to better understand the role of environmental chemicals in the etiology of neurodevelopmental disorders. Specifically, this funding opportunity will support the development and application of novel and innovative approaches including new approach methodologies (NAMs) that expand the framework to evaluate environmental chemicals with neurodevelopmental toxicity potential. Specific objectives to be addressed by the funding include:

• Approaches using human cells or alternative model systems modeling neurodevelopment.
• Focus on one or more developmental neurotoxicity-relevant endpoints to gain reliable knowledge.

Only U.S. small business concerns are eligible for this funding. Letters of intent are due June 7, with funding applications due July 7 by 5:00 p.m. local time of applicant organization.

EPA's Generalized Read-Across (GenRA) tool is a publicly available, automated approach to make reproducible read-across predictions of toxicity. Read-across is a commonly used data gap-filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities. While read-across is sometimes reliant on subjective or expert judgement, the GenRA tool can provide more objective and reproducible read-across predictions.

A free virtual training session on GenRA will be presented on Tuesday, May 23, from 11:00 a.m.-1:30 p.m. EDT. Specifically targeted for decision-makers, this training will provide:

• An overview of GenRA's purpose and scope.
• Demonstration of GenRA's interface and navigation.
• Opportunities for participatory learning and engagement.

This training will feature Grace Patlewicz of the EPA Center for Computational Toxicology and Exposure (CCTE). It will include a plenary presentation, small group discussions, and a chance to try out your skills with GenRA. The training is divided into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is required.

Session 1 (Presentation and Q&A) 11:00 a.m. - 12:30 p.m. EDT
This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.

Session 2 (Breakout Sessions) 12:30 - 1:30 p.m. EDT
This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.

NCI is interested in understanding the processes for storage, preservation, and sharing of scientific data generated by cancer research funded by NIH at academic, research, and medical institutions in order to develop guidance on scientific data management. NCI is also interested in learning the types of services, technologies, and processes relevant to these topics provided by scientific core facilities within an institution.

To that end, NCI invites stakeholders and staff across the cancer research enterprise to complete the “Request for Information on Existing Data Sharing Processes for NIH-Funded Research” by April 3. All participants are encouraged to respond to as many questions as they are able, no matter their role in the research enterprise.

NIEHS is offering funding to support resource projects to enable environmental health sciences (EHS) communities to openly develop, extend, adapt, or refine data and metadata standards as well as associated tools to implement standards. This program is intended to provide catalytic support for a diverse array of EHS-focused standards development activities that address unmet needs within the NIEHS strategic mission. Specific areas of focus to be addressed by the funding include:

• Collaborator, contributor, and user-community engagement.
• Open standards for data and metadata.
• Tools for standards implementation.

Institutions eligible for this funding include U.S. nonprofit and for-profit organizations and government institutions. Letters of intent are due April 10, with funding applications being due May 10.

The National Institute of Allergy and Infectious Diseases (NIAID) will provide up to $9 million in FY 2024 to establish Bioinformatics Resource Centers for Infectious Diseases. Components of the envisioned centers will include:

• Interactive knowledgebase(s) for relevant omics-based data and analysis.
• Research and development of innovative bioinformatics tools, software, and algorithms.
• Access to leading-edge expertise in bioinformatics services for the infectious diseases community for complex or unique situations.
• Cutting-edge informatics support during a public health emergency, outbreak, or pandemic.

NIAID anticipates making one or two awards, with awardees being funded for up to five years. For-profit and nonprofit organizations and government entities both within and outside the U.S. are anticipated to be eligible for this funding. Availability of this funding is being announced in advance to allow potential applicants time to develop meaningful collaborations, interdisciplinary teams, and responsive applications. More information about the funding opportunity, including anticipated opening and due dates, is available on the NIH Grants website.

NCI is hosting a virtual workshop, “Cancer AI Research: Computational Approaches Addressing Imperfect Data”, April 3-4 from 11:00 a.m. to 5:00 p.m. ET. This workshop will highlight the importance of leveraging advances across fields to accelerate cancer research and discovery through artificial intelligence (AI), enable early detection, and improve diagnosis. 

The goals of this workshop are to:

• Examine the state of the science for AI methods designed to operate on noisy, complex, or low-dimensional data.
• Explore how these methods may be applied to key areas of cancer research.
• Discuss processes for identifying the biological questions that will motivate further advances in machine learning.

The workshop will be chaired by Caroline Uhler (Massachusetts Institute of Technology and Broad Institute), and Olivier Gevaert (Stanford University). The event is open and free to attend, but registration is required.

FDA and NIH are offering Small Business Innovation Research and Small Business Technology Transfer grants to support development of neuromuscular junction tissue chips to replace the mouse lethality assay for testing potency of botulinum toxin. The goal is to position the “Botulinum Toxin Potency Assay using Tissue Chips” as an alternative test method that can be used to replace the mouse assay.

Applications are due August 21. Only U.S. small businesses are eligible for this funding. Applicants are encouraged to contact FDA and the NIH National Center for Advancing Translational Sciences (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.

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.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the (Re)Building a Kidney (RBK) Consortium to apply new technologies to understand and treat kidney diseases. Strategies of interest include development of in vitro cultures and organoids.

The Consortium is offering grants of up to $100,000 that may be applied to direct and indirect costs of relevant activities. Researchers affiliated with U.S. and foreign non-profit and for-profit organizations are encouraged to apply. Applications are due Monday, April 3.

The Reagan-Udall Foundation and FDA have launched the Regulatory Science Accelerator. This initiative will convene a series of conversations to engage the scientific community to identify the most pressing scientific gaps, emerging sciences and technologies, goals/objectives, and implementation strategy for regulatory science. The first series of meetings will focus on in silico alternative methods. In silico alternative methods are mathematical and/or computational methods and approaches that may help bring FDA-regulated products to market faster, with improved efficacy, or prevent products with increased toxicological risk from reaching the market. Additionally, these methods may have the potential to replace, reduce, and/or refine animal testing.

Those interested in participating in these conversations should fill out a questionnaire to communicate their interest and to share relevant information about in silico alternative methods. The deadline for the questionnaire is March 1. Contact [email protected] with any questions.

Registration is open for upcoming workshops on “Meeting the Requirements of the Animal Welfare Act” offered by the USDA Animal Welfare Information Center. Live virtual workshops will be offered on Wednesday, March 8, from 10:00 a.m.-3:30 p.m. EST and on Wednesday and Thursday, May 3-4, from 1:00-4:00 p.m. EST each day. There is also a self-paced asynchronous version of the workshop available.

The Animal Welfare Information Center was established to help the regulated community comply with the Animal Welfare Act. The Center provides information on approaches to prevent duplication of animal experimentation and alternative methods that replace, reduce, or refine animal use. More information about the Center, including a new introductory video, is available on the USDA website.

In a January 19 Federal Register notice, EPA announced availability of a draft white paper, “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” The white paper states that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain Tier 1 assays used within the EDSP. Others NAMs may be useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight-of-evidence evaluations. EPA is accepting comment on the draft white paper through March 20; the white paper, other supporting materials and a link to submit comments are available on the Regulations.gov website.

The EDSP was established by the Federal, Food, Drug and Cosmetic Act, which required EPA to develop a screening program to determine whether certain substances may have effects in humans similar to effects produced by naturally occurring estrogens or other endocrine effects. The purpose of Tier 1 EDSP screening is to identify chemicals that have potential biological activity in the estrogen, androgen, or thyroid hormone pathways. Recent EPA research efforts have focused on the development and evaluation of high-throughput in vitro assays and in silico methods as NAMs, including databases and computational models, for use as alternatives to the current suite of assays in the EDSP Tier 1 battery, to accelerate the pace of screening, add efficiencies, decrease costs, and reduce animal testing. More information about use of NAMs in the EDSP is available on the EPA website.

Register now for the 2nd ECOTOX Knowledgebase Encore Virtual Training, scheduled for Tuesday, February 7 from 11:00 a.m. to 1:30 p.m. EST. The EPA Ecotoxicology Knowledgebase (ECOTOX) is a comprehensive, publicly available tool providing environmental toxicology data on aquatic life, terrestrial plants, and wildlife.

The virtual training is specifically targeted for decision-makers, providing:

• An overview of the database content and function.
• Application-oriented use case demonstrations.
• Opportunities for participatory learning and engagement.

The event is an encore of the May 2022 training, presenting the same material with expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required.

Session 1: Presentation and Q&A 11:00 a.m. – 12:30 p.m. EST
This session provides an overview of the knowledgebase content and function with opportunities for participation and Q&A.

Session 2 (Breakout Sessions) 12:30 p.m. – 1:30 p.m. EST
This session includes participant breakout groups to work on case study exercises in small groups, aided by facilitators.

NIEHS encourages data sharing to accelerate the identification of environmental linkages to human disease and translation of that knowledge to improve public health.

A new NIH policy on data management and sharing (DMS) goes into effect on January 25. To prepare the environmental health sciences research community for creation and implementation of this plan, the Environmental Health Language Collaborative (EHLC) is hosting a three-day workshop, “Sharing Your Environmental Health Sciences (EHS) Data: Metadata, Standards, and Tools.”

By the end of the workshop, attendees will be able to:

• Articulate the parts of a DMS Plan and their importance.
• Appreciate how a DMS Plan can aid in their research.
• Understand the basics of standards in the context of data management and sharing, including the value of using community-based standards.
• Know of resources to aid in development and implementation of DMS Plans.

The three workshop sessions will be held on Friday, January 13; Thursday, January 19; and Wednesday, February 1.

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

Three NIH institutes and FDA are offering funding to establish research centers that will accelerate the translational use of MPS in drug development through regulatory acceptance and adoption for industrial use. The envisioned centers will support development of MPS that are fit-for-purpose for industry needs, have defined contexts-of-use, and will be developed with consideration of applicable expectations to achieve regulatory approval. These centers will further the development of MPS as drug development tools that, once qualified, will be made publicly and commercially available to fill unmet needs in drug development. U.S.-based nonprofit and for-profit institutions are encouraged to apply for funding; foreign institutions are not eligible. Applications will be accepted beginning February 27 and are due by March 28.

The EPA Office of Research and Development announces availability of new and updated resources for NAMs development.

• The EPA CompTox Chemicals Dashboard has been updated. Version 2.1.1 features new Help pages, the ability to visualize structures in Batch Search, updates to production volume data and in vitro to in vivo extrapolation algorithms, and other improvements.
• A video recording, slide deck, and case study worksheets from virtual training on the Dashboard are available on the EPA NAMs Training webpage; filter on “CompTox Chemicals Dashboard” in the second column of the table.
• Save the date for a training webinar on EPA’s ECOTOX Knowledgebase to be presented Tuesday, February 7, from 11:00 a.m. to 1:30 p.m. EST.
• Materials are now available from the October 2022 EPA NAMs Conference. A form to provide feedback on the conference is available.

Regular updates on EPA NAMs activities are distributed via the NAMs Update email list.

The Environmental Mutagenesis and Genomics Society (EMGS) has announced the winners of its 2022 Bioinformatics Challenge. First-place was awarded to Ting Li for “DeepDILI: Deep Learning-Powered Drug-Induced Liver Injury Prediction Using Model-Level Representation.” Xi Chen received the second-place award for “AnimalGAN: A Generative AI Alternative to Animal Clinical Pathology Testing.” Both winners are from the Division of Bioinformatics and Biostatistics, FDA National Center for Toxicological Research. A 2023 Bioinformatics Challenge will be held as part of the 54th EMGS Annual Meeting in Chicago, IL, September 9-13, 2023.

A webinar on “Frameworks for Establishing Scientific Confidence in New Approach Methodologies” will be presented on Wednesday, January 18, 2023, at 10:00–11:30 a.m. EST. The January 18 event will continue presentations focused on a recently published paper on building scientific confidence on new approach methodologies (van der Zalm et al., 2022; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9525335/). This webinar will feature Alistair Middleton, Unilever, speaking on “Are Non-Animal Systemic Safety Assessments Protective? A Toolbox and Workflow”; and Amanda Ulrey, Institute for In Vitro Sciences, Inc., speaking on “How Following GIVIMP Aligns Your Work with the Framework.” Presentations will be followed by a panel discussion with the presenters and panelists Nicole Kleinstreuer, NICEATM; Susanne Kolle, BASF; and Anna Lowit, EPA Office of Pollution Prevention and Toxics.

This webinar is a joint presentation of the Physicians Committee for Responsible Medicine (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. Further information and materials from the first six DyNAMic Discussions events are available on the series website. A recording of a December 7, 2022, webinar focused on the van der Zalm et al. paper is available on this page.

The Environmental Health Language Collaborative (EHLC) is hosting a webinar on Friday, December 16, 1:00-2:00 p.m. EST. Dany Doiron, McGill University Health Centre, will provide an overview of the Canadian Urban Environmental Health Research Consortium (CANUE). CANUE generates, collates, and documents health-relevant standardized urban environmental data for all postal codes in Canada and maintains a working data platform to disseminate these datasets. Doiron’s presentation will describe CANUE’s data holdings and the approach used to gather, document, and disseminate environmental exposure data with researchers from across Canada. EHLC is an community-driven initiative supported by the National Institute of Environmental Health Sciences (NIEHS) to advance integrative environmental health research by developing and promoting adoption of a harmonized language.

Background Reading:
Brook JR, Doiron D, Setton E, and Lakerveld J (2021). Centralizing environmental datasets to support (inter)national chronic disease research: values, challenges, and recommendations. Environ Epidemiol 5(1): e129. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939427/ .
Brook JR, Setton EM, Seed, E, Shooshtari M, Doiron D (2018). The Canadian Urban Environmental Health Research Consortium – a protocol for building a national environmental exposure data platform for integrated analyses of urban form and health. BMC Public Health 18(1):114. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759244/.

The Animal Welfare Information Center (AWIC) within the USDA National Agricultural Library has updated its 3Rs literature search webpage to help scientists find alternatives to replace, reduce, and refine animal use for research and testing. AWIC provides this information to help those conducting animal research comply with Animal Welfare Act requirements for consideration of alternatives. The 3Rs literature search webpage includes step-by-step instructions for conducting a literature search, literature search examples, worksheets and guides, and frequently asked questions.

For additional training on searching for animal use alternatives, register for one of AWIC's workshops on “Meeting the Requirements of the Animal Welfare Act.” Virtual workshops are planned for March and May of 2023.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 60^th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods on June 27-July 6.
• The 42^nd 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.

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."

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.

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.

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.

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.

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:

• Pregnancy models allowing simulations for both mother and fetus (based on Kapraun et al. 2019, https://doi.org/10.1371/journal.pone.0215906).
• Structure-based quantitative structure–activity relationship models for repeat dose toxicity (Pradeep et al. 2020, https://doi.org/10.1016/j.comtox.2020.100139) and pharmacokinetic parameter prediction (Dawson et al. 2021, https://doi.org/10.1021/acs.est.0c06117).

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

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.

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.

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.

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.

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.

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.

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.