Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments

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. This SACATM meeting will be a virtual meeting only and available to the public for remote viewing. Registration is required to access the virtual meeting and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

DATES:

Meeting: September 28, 2021, 10:00 a.m.-3:30 p.m. EDT; September 29, 2021, 10:00 a.m.-4:00 p.m. EDT. Ending times are approximate; meeting may end earlier or run later.

Registration for Virtual Meeting: Deadline is September 29, 2021, 4:00 p.m. EDT.

Written Public Comment Submissions: Deadline is September 17, 2021.

Register to Present Oral Comments: Deadline is September 17, 2021.

Registration to view the virtual meeting and present oral public comments is required.

ADDRESSES:

Meeting web page: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/go/32822.

Virtual Meeting: The URL for viewing the virtual meeting will be provided to those who register for viewing.

FOR FURTHER INFORMATION CONTACT:

Dr. Sheena Scruggs, Designated Federal Official for SACATM, Office of Policy, Review, and Outreach, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 984-287-3355, Email: sheena.scruggs@nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2126, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Meeting and Registration: The meeting is open to the public with time scheduled for oral public comments. Due to restrictions on in-person gatherings amid ongoing public health concerns, the meeting will be convened as a virtual meeting.

SACATM will provide input to ICCVAM, NICEATM, and NIEHS on programmatic activities and issues. Preliminary agenda items for the upcoming meeting include: (1) Major ICCVAM accomplishments in 2021; (2) regulatory needs and research applications for ecotoxicity testing; (3) evolving approaches to validation; and (4) update on NICEATM computational resources. Please see the preliminary agenda for information about specific presentations.

The preliminary agenda, roster of SACATM members, background materials, public comments, and any additional information will be posted when available on the SACATM meeting website ( https://ntp.niehs.nih.gov/go/32822 ) or may be requested in hardcopy from the Designated Federal Official for SACATM. Following the meeting, summary minutes will be prepared and made available on the SACATM meeting website.

Registration is required to attend the virtual meeting and is open to all interested persons. Registrants will receive instructions on how to access the virtual meeting in the email confirming their registration. Individuals who plan to provide oral comments (see below) are required to register online at the SACATM meeting website ( https://ntp.niehs.nih.gov/go/32822 ) by September 17, 2021, to facilitate planning for the meeting. Individuals are encouraged to visit the website often to stay abreast of the most current information regarding the meeting.

Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Ms. Robbin Guy at phone: (984) 287-3136 or email: robbin.guy@nih.gov in advance of the meeting. 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.

Written Public Comments: Written and oral public comments are invited for the agenda topics. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. The deadline for submission of written comments is September 17, 2021. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any).

Oral Public Comment Registration: The preliminary agenda allows for several public comment periods, each allowing up to six commenters a maximum of five minutes per speaker. Registration for oral comments is on or before September 17, 2021, at https://ntp.niehs.nih.gov/go/32822. Registration is on a first-come, first-served basis. Each organization is allowed one time slot per comment period. After 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 17, 2021, to provide logistical information for their presentations. If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Robbin Guy by email: guyr2@niehs.nih.gov by September 17, 2021.

Meeting Materials: The preliminary meeting agenda will be posted when available on the meeting web page at https://ntp.niehs.nih.gov/go/32822 and will be updated one week before the meeting. Individuals are encouraged to visit this web page often to stay abreast of the most current information regarding the meeting.

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 17 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, and 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 (enhance animal well-being and lessen or avoid pain and distress) animal use.

The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3) establishes ICCVAM as a permanent interagency committee of NIEHS 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 http://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 http://ntp.niehs.nih.gov/go/niceatm.

SACATM, established by the ICCVAM Authorization Act [Section 285l-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. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.