2024-17099. Scientific Advisory Committee on Alternative Toxicological Methods; Notice of Public Meeting; Request for Public Input

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Department of Health and Human Services

National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises 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) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

DATES:

Meeting: September 17, 2024, 10 a.m. to approximately 4 p.m. EDT; September 18, 2024, 9:30 a.m. to approximately 4 p.m. EDT.

Registration for Onsite Meeting: Deadline is September 11, 2024, 5 p.m. EDT.

Registration for Webcast Viewing: Deadline is September 18, 2024, 4 p.m. EDT.

Registration for Oral Statements: Deadline is September 11, 2024, 5 p.m. EDT.

Registration to attend in person, view the webcast, and present oral public statements is required.

ADDRESSES:

Interested individuals may attend the meeting in person or view the meeting webcast. Registration is required to attend in person, view the webcast, and/or present oral comments. Written public comments will be accepted. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/​go/​32822.

Meeting Location: Building 35A, Room 620/630, National Institutes of Health (NIH), 35 Convent Dr., Bethesda, MD 20892.

Meeting Web Page: The preliminary agenda, registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/​go/​32822.

Virtual Meeting: A link to access the meeting webcast will be emailed to registrants with their registration confirmation.

FOR FURTHER INFORMATION CONTACT:

Dr. Milene Brownlow, Designated Federal Officer for SACATM, Office of Policy, Review, and Outreach, Division of Translational Toxicology, NIEHS. Phone: [phone], Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Meeting and Registration: SACATM will provide input to ICCVAM, NICEATM, and NIEHS on programmatic activities and issues. Preliminary agenda items for the upcoming meeting include: (1) a review of the 2022-2023 ICCVAM Biennial Progress Report with a focus on activity gaps and future directions; (2) updates on validation and consideration of the new approach methodologies pipeline; (3) ICCVAM agency activities in the area of developmental neurotoxicity; and (4) update on NICEATM computational resources.

The preliminary agenda, roster of SACATM members, background materials, public comments, and any additional information will be posted when available on the SACATM meeting web page ( https://ntp.niehs.nih.gov/​go/​32822) or may be requested from the Designated Federal Officer for SACATM. Individuals are encouraged to visit this web page often to stay abreast of the most current information regarding the meeting. Following the meeting, summary minutes will be prepared and made available on the SACATM meeting web page. Slides and video from the meeting will also be posted on this page once they have been formatted to meet government accessibility standards.

This meeting is open to the public. The public may attend the meeting at NIH, where attendance is limited only by the space available, or view remotely by webcast. Those planning to attend the meeting in person are encouraged to register at https://ntp.niehs.nih.gov/​go/​32822 by September 11, 2024, to facilitate planning for appropriate meeting space. Those planning to view the webcast may register at https://ntp.niehs.nih.gov/​go/​32822 any time before the meeting ends on September 18, 2024. A link to access the meeting webcast will be provided to registrants in a confirmation email.

NIH visitor and security information is available at https://www.nih.gov/​about-nih/​visitor-information. Individuals with disabilities who need accommodation to participate in this event should contact Robbin Guy at phone: [phone] or email: [e-mail]. TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at least five business days in advance of the event.

Request for Public Comments: The preliminary agenda allows for several public comment periods, each allowing up to six commenters a maximum of five minutes per speaker. Registration for those wishing to provide oral public comments is required and is open through September 11, 2024, 5 p.m. EDT, at https://ntp.niehs.nih.gov/​go/​32822. Registration is on a first-come, first-served basis. If the maximum number of speakers per comment period is exceeded, individuals registering to submit an oral comment for the topic will be placed on a wait list and notified should an opening become available. Commenters will be notified after September 11, 2024, to provide logistical information for their presentations. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Robbin Guy by email: [e-mail] by September 11, 2024, 5 p.m. EDT.

Written statements on topics relevant to ICCVAM's mission may be submitted to support an oral public comment or as standalone documents. These should be emailed to Robbin Guy at [e-mail] by September 11, 2024, 5 p.m. EDT. Materials submitted to accompany oral public statements or standalone written statements should include the submitter's name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document. Guidelines for public statements are at http://ntp.niehs.nih.gov/​ntp/​about_​ntp/​guidelines_​public_​comments_​508.pdf.

Responses to this notice are voluntary. No proprietary, classified, confidential, or sensitive information should be included in statements submitted in response to this notice or presented during the meeting. This request for input is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.

Background Information on ICCVAM, NICEATM, and SACATM: ICCVAM is an interagency committee composed of representatives from 18 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine animal use.

The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l -3) establishes ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at https://ntp.niehs.nih.gov/​go/​iccvam.

NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM can be found at https://ntp.niehs.nih.gov/​go/​niceatm.

SACATM, established by the ICCVAM Authorization Act [Section 285 l -3(d)], 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 to ICCVAM, NICEATM, and Director of NIEHS and NTP. SACATM is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. ch.10), which sets forth standards for the formation and use of advisory committees.

Additional information about SACATM, including link to the charter, roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/​go/​167.

Dated: July 30, 2024.

Richard P. Woychik,

Director, National Institute of Environmental Health Sciences and National Toxicology Program, National Institutes of Health.