2021-07315. Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Webcast; Request for Public Input

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may view the presentations by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is required for both webcast viewing and oral statements. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/​go/​iccvamforum-2021.

DATES:

Webcast: May 27, 2021, 9:00 a.m. to approximately 3:00 p.m. EDT.

Registration for Webcast: April 12, 2021, until 3:00 p.m. EDT May 27, 2021.

Registration for Oral Statements: April 12, 2021, until 4:00 p.m. EDT May 14, 2021.

Registration to view the webcast and present oral public statements is required.

ADDRESSES:

Webinar web page: A preliminary agenda will be posted by May 3 at https://ntp.niehs.nih.gov/​go/​iccvamforum-2021. Information to connect to the webcast will be provided to those who register for viewing.

FOR FURTHER INFORMATION CONTACT:

Dr. Nicole Kleinstreuer, Acting Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Division of NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park, NC 27709. Phone: [phone], Email: [e-mail]. Hand Deliver/Courier address: 530 Davis Drive, Room K2021, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Background: ICCVAM, a congressionally mandated committee, promotes the development and validation of alternative testing strategies that protect human health and the environment while replacing, reducing, or refining animal use.

ICCVAM's goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships ICCVAM convenes an annual public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136).

This year's meeting will be held on May 27, 2021. Due to restrictions on in-person gatherings amid ongoing public health concerns, the public forum will be presented via webcast only. NICEATM and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States (83 FR 7487).

There will be opportunities for registered participants to ask clarifying or follow-up questions of the ICCVAM members about their presentations during the meeting. Instructions for submitting these questions will be provided via email prior to the webcast. The agenda will also include time for public oral statements relevant to the ICCVAM mission and current activities from participants who have registered to do so in advance.

Preliminary Agenda and Other Meeting Information: A preliminary agenda will be posted by May 3 at https://ntp.niehs.nih.gov/​go/​iccvamforum-2021. Interested individuals are encouraged to visit this web page to stay abreast of the most current meeting information.

Webcast and Registration: This webcast is open to the public. Registration for the webcast is required and is open from April 12, 2021, through 3:00 p.m. EDT on May 27, 2021 at https://ntp.niehs.nih.gov/​go/​commprac-2021. Registrants will receive instructions on how to access and participate in the webcast in the email confirming their registration.

Request for Oral or Written Public Statements: In addition to time for clarifying or follow-up questions following scheduled presentations, time will be allotted during the meeting for oral public statements with associated slides on topics relevant to ICCVAM's mission. Any participant registered for the webcast may ask clarifying questions during the appropriate times in the agenda. The additional registration is only required for those who wish to give separate public statements. Written public statements on topics relevant to ICCVAM's mission will also be accepted.

Separate registration for those wishing to provide oral public statements is required and is open from April 12, 2021 through May 14, 2021 at https://ntp.niehs.nih.gov/​go/​commprac-2021. The number and length of public statement presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Participants registered to present oral public statements must email their statement to [e-mail] by May 14, 2021, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Persons presenting oral public statements will be contacted to arrange the logistics of their presentations. If participants registered to present oral public statements wish to use accompanying slides and/or submit supplementary written material, they must email these materials to [e-mail] by May 14, 2021. This deadline is to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum.

Written statements on topics relevant to ICCVAM's mission may be submitted to support an oral public statement or as standalone documents. These should be emailed to [e-mail] by May 14, 2021. Public statements received prior to the May 14, 2021 deadline will be distributed to NICEATM and ICCVAM members before the meeting. Written public statements received after the deadline may be reviewed by NICEATM and ICCVAM at a future date.

Materials submitted to accompany oral public statements or standalone written statements should include the submitters name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document. National Toxicology Program 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 and NICEATM: 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 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.

Dated: March 26, 2021.

Brian R. Berridge,

Associate Director, National Toxicology Program.