FACACLASSIC

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”

HHS - 12153 - Scientific Advisory Committee on Alternative Toxicological Methods - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Scientific Advisory Committee on Alternative Toxicological Methods	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	12153
Original Establishment Date	12/19/2000	Committee Status	Chartered
Actual Termination Date		Committee URL	https://ntp.niehs.nih.gov/whoweare/advisory/ind...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	32
Terminated This FY	No	Designated Fed Officer Position Title*	Health Scientist
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	12/18/2023	Designated Federal Officer First Name*	Mary
Date Of Renewal Charter	12/18/2025	Designated Federal Officer Middle Name	S.
Projected Termination Date		Designated Federal Officer Last Name*	Wolfe
Exempt From Renewal*	No	Designated Federal Officer Suffix	Ph.D.
Specific Termination Authority		Designated Federal Officer Phone*	984-287-3209
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*	(919) 541-0295
Specific Establishment Authority*	42USC 285l-3(d), as amended	Designated Federal Officer Email*	wolfe@niehs.nih.gov
Effective Date Of Authority*	12/19/2000
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The scope and objectives of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are to advise the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, and national and international harmonization of new, revised, and alternative toxicological test methods. Alternative methods are those that reduce, refine (lessen or avoid pain and/or distress), or replace the use of animals in testing. SACATM also provides input on ways to foster partnerships and communication with interested parties. Meeting information can be found at http://ntp.niehs.nih.gov/go/32822.
How is membership balanced?*	The Committee will consist of up to 15 members, including the Chair, selected by the Director, NIEHS and NTP, plus non-voting ex officio members, as described below. Members are selected from recognized authorities knowledgeable in academia, industry, state government, public health, environmental communities or organizations using new or alternative test methods, as appropriate, in accordance with the statutorily mandated requirements for representation on the SACATM. In accordance with 42 U.S.C. 285l-3(c) and 285l-3(d)(2)(B), the membership of SACATM will also include, as nonvoting ex officio members, the agency heads or their designees from the Federal agencies represented on ICCVAM, as follows: (1) Agency for Toxic Substances and Disease Registry; (2) Consumer Product Safety Commission; (3) Department of Agriculture; (4) Department of Defense; (5) Department of Energy; (6) Department of the Interior; (7) Department of Transportation; (8) Environmental Protection Agency; (9) Food and Drug Administration; (10) National Institute for Occupational Safety and Health; (11) National Institutes of Health; (12) National Cancer Institute; (13) NIEHS; (14) National Library of Medicine; (15) Occupational Safety and Health Administration; and (16) National Institute of Standards and Technology; (17) Department of Veterans Affairs Research and Development Office, and (18) Any other agency that develops, or employs tests or test data using animals, or regulates on the basis of the use of animals in toxicity testing.
How frequent & relevant are cmte mtgs?*	Meetings are held at least once each fiscal year. The NIEHS Director appoints voting members to the SACATM, and membership is defined in the ICCVAM Authorization Act of 2000 to include representatives from academia, state government, industry, and animal protection organizations. There was one FY2025 meeting.
Why advice can't be obtained elsewhere?*	The quality, scope and balance of advice provided cannot be obtained from NIH staff or from other established sources. Membership is constituted to meet the specific requirements of the mandated mission of the committee and the Institute.
Why close or partially close meetings?	NA
Recommendation Remarks	The DFO and Committee Decision Maker positions are held by the same individual due to the assignment of responsibilities within this Institute. This committee did not produce any reports this fiscal year. Ex Officio Members: According to the charter language NIH has determined there are 17 Ex Officio positions associated with this committee and the max number of positions includes these members. Currently, no Ex Officio members have been identified and there are no Ex Officio members in the list of current members in this report. It has been the practice of ICCVAM members to send ad hoc attendees according to the topics being discussed rather than having ex officio members formally identified.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	The Committee makes recommendations to federal staff regarding the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Alternative methods are those that reduce, refine (lessen or avoid pain and/or distress), or replace the use of animals in testing. SACATM also provides input on ways to foster partnerships and communication with interested parties.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	Many of the alternative test methods promoted by SACATM may in theory reduce the cost of individual toxicity tests, but it is unclear whether reduced cost per agent tested will be offset by increasing number of agents tested.	Grants Review Comment	NA
Number Of Recommendations*		Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	SACATM met on September 11-12, 2025, virtually. The meeting was divided into four session: Session 1 – Organization, Roadmaps, and Collaborations; Session 2 – Data Standards, Validation, and Qualification; Session 3: Computational Resources; and Session 4: ICCVAM Public Forum and Education. SACATM recognized that NICEATM in support of ICCVAM actively communicate its work and facilitates access through newsletters, on-line resources, in-person/virtual events, and a comprehensive website. SACATM provided thoughtful input on the discussion questions for each session. They had 5 recommendations: (1) maintain metrics for tracking use of NAMs, (2) implement centralized hub/portal for NICEATM resources that clearly communicates what’s available, (3) identify common data elements and clarify content of use for NAMs, (4) continue activities like Public Forum and Communities of Practice, and as possible, hold trainings and meetings in person, in addition to virtual, and (5) look broadly at stakeholder groups to identify new opportunities for training and outreach. In Session 1, SACATM offered suggestions on how ICCVAM might enhance engagement with stakeholders around its Roadmap principles of connecting end users with New Approach Methodologies (NAMs) developers and clarifying testing requirements. They noted that priorities across the ICCVAM agencies seem to align. They also proposed endpoints where NAMs might be developed, which would support the HHS Secretary’s MAHA priorities related to understanding and addressing environmental contributions to chronic diseases so to improve Americans’ health. Finally, following a presentation of the FDA Roadmap focused on reducing animal testing in preclinical safety studies, SACATM offered ideas on how ICCVAM and NICEATM might optimize collaborative efforts with FDA and further ICCVAM goals. SACATM emphasized the importance of all 3 Rs (reduce, refine, replace) in research and development activities for NAMS and recommended careful implementation and evaluation of metrics in determining their success and usage. In Session 2, SACATM was excited about the progress of COMPLEMENT-Arie, including the accelerate update and integrated data environment. The Committee emphasized the importance of common data elements and understanding context of use for NAMS, which would facilitate maximum utility and allow for cross-comparisons of data across methods. SACATM also recommended that expectations for a NAM be clearly articulated to inform its qualification. Attention was given to discussing potential application of regulatory validation practices to biomedical methods. In Session 3, SACATM was updated on computational resources including updates to the ICE database and new apps for skin sensitization. The Committee offered suggestions on areas for novel datasets that might drive innovations in toxicological assessments and on tools that could improve computational models. SACATM responded positively to demonstrations of the new apps for skin sensitization and was very pleased to learn about CAMERA, the publicly available, web-based application that is designed to provide streamlined access to validated and qualified NAMs for regulatory and other contexts of use. SACATM noted that more clarity is needed around all the available tools/resources and how each might be used. They also proposed a portal or central hub to facilitate access and again emphasized the importance of metrics to evaluate NAMs. SACATM recommended expanding outreach efforts to inform about NICEATM’s many resources and NAMs. Finally, in Session 4, SACATM members heard about NICEATM’s and ICCVAM’s effort to expand public outreach and educational opportunities around NAMs. The applauded ICCVAM’s 10-year effort to host an annual public forum where ICCVAM agencies share ongoing activities and engage directly with stakeholders. They also noted the high attendance at ICCVAM Communities of Practice. This high level of interest punctuates the importance of disseminating information about alternative methods and offering opportunity to showcase efforts and foster discussion around both scientific and regulatory issues. Importantly, the training activities, including on-line and/or in-person, were exemplified as positive efforts to develop and further acceptance of NAMs and promotion of the 3Rs – refinement, reduction, and replacement of animal use in research and testing. SACATM noted that while virtual might reach a broad audience, they recommended, to the extent possible, in-person, hands-on engagements for trainings.	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Due to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	No
% of Recs Partially Implemented Comment	Due to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	Information is provided to the public at each meeting. The public can view information related to the Committee through the committee’s official website. Staff identifies key outcomes of the meeting and reports back to SACATM at the next meeting on developments on the recommendations or advice (either by formal presentation or during discussion).	Narrative Description*	This committee advises the NIEHS, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicology Methods (Center) regarding ICCVAM activities. They also advise the NIEHS and the NTP Center on the NTP Center's activities. “NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH works toward that mission by supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. Section 492 of the PHS Act states that The Secretary ...shall by regulation require appropriate technical and scientific peer review of (A) applications...; and (B) biomedical and behavioral research and development contracts...”

COSTS

1. Payments to Non-Federal Members*	$0.00	1. Est Paymnts to Non-Fed Membrs Nxt FY*	$0.00
2. Payments to Federal Members*	$0.00	2. Est. Payments to Fed Members Next FY*	$0.00
3. Payments to Federal Staff*	$0.00	3. Estimated Payments to Federal Staff*	$0.00
4. Payments to Consultants*	$0.00	4. Est. Payments to Consultants Next FY*	$0.00
5. Travel Reimb. For Non-Federal Membrs*	$0.00	5. Est Travel Reimb Non-Fed Membr nxtFY*	$0.00
6. Travel Reimb. For Federal Members*	$0.00	6. Est Travel Reimb For Fed Members*	$0.00
7. Travel Reimb. For Federal Staff*	$0.00	7. Est. Travel Reimb to Fed Staf Nxt FY*	$0.00
8. Travel Reimb. For Consultants*	$0.00	8. Est Travel Reimb to Consltnts Nxt FY*	$0.00
10. Other Costs	$0.00	10. Est. Other Costs Next FY*	$0.00
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	4/17/2025 11:05 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Medicine Health and Health Research

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