2015-08528. Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input

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 attend in person or remotely. Time will be set aside for public statements and questions on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration is available at http://ntp.niehs.nih.gov/​go/​iccvamforum-2015.

DATES:

Meeting: May 27, 2015, 9:00 a.m. to approximately 12:00 p.m. Eastern Daylight Time (EDT).

Registration for Onsite Meeting: Deadline is May 15, 2015.

Registration for Webcast: Deadline is May 27, 2015

Submission of Oral Public Statements: Deadline is May 15, 2015.

ADDRESSES:

Meeting Location: William H. Natcher Conference Center, National Institutes of Health, Bethesda, MD 20892.

Meeting Web page: The preliminary agenda, registration, and other meeting materials are at http://ntp.niehs.nih.gov/​go/​iccvamforum-2015.

FOR FURTHER INFORMATION CONTACT:

Dr. Warren S. Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: [e-mail]; telephone: [phone].

SUPPLEMENTARY INFORMATION:

Background: ICCVAM promotes the development and validation of chemical safety testing methods 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 initiated annual public forums in 2014 to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136).

The second of these forums will be held on May 27, 2015, at the National Institutes of Health (NIH) in Bethesda, MD. The meeting will begin with presentations by NICEATM and ICCVAM members on current activities related to the development and validation of alternative test methods and approaches for assessing acute systemic toxicity, endocrine activity, vaccine safety, and skin sensitization potential, as well as updates on ICCVAM processes. Following each presentation, there will be an opportunity for participants to ask questions of the ICCVAM members. Instructions for submitting questions will be provided to remote participants prior to the webcast. The agenda also includes time for participants to make public oral statements to inform ICCVAM on topics relevant to its mission and current activities.

Preliminary Agenda and Other Meeting Information: The preliminary agenda, ICCVAM roster and other background materials, and public statements submitted prior to the meeting will be posted at http://ntp.niehs.nih.gov/​go/​iccvamforum-2015 to allow remote participation. Public statements will be distributed to NICEATM and ICCVAM members. Interested individuals are encouraged to visit this Web page to stay abreast of the most current meeting information.

Meeting and Registration: This meeting is open to the public with time scheduled for oral public statements and for questions following ICCVAM's and NICEATM's presentations. 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 http://ntp.niehs.nih.gov/​go/​iccvamforum-2015 by May 15, 2015, to facilitate planning for appropriate meeting space. Those planning to view the webcast must register at http://ntp.niehs.nih.gov/​go/​iccvamforum-2015 by May 27, 2015. The URL for the webcast will be provided in the email confirming registration.

Visitor and security information for visitors to NIH is available at http://www.nih.gov/​about/​visitor/​index.htm. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull 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 Oral Public Statements: Time will be allotted during the meeting for oral public statements with associated slides relevant to ICCVAM's mission and current activities. The number and length of presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting public statements and/or associated slides should include their name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document.

Persons wishing to present oral statements are encouraged to indicate the topic(s) on which they plan to speak on the registration form. They should also provide a copy of their statement to Dr. Elizabeth Maull at email: [e-mail] by May 15, 2015, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements may supplement and expand the oral presentation.

Registration for oral public statements will be available onsite, although onsite registration and time allotted for these statements may be limited based on the number of individuals who register to make statements and available time. If registering onsite and reading from written text, please bring 20 copies of the statement for distribution and to supplement the record.

In addition to in-person oral statements at the meeting, public statements may be presented by teleconference line. Directions for accessing the meeting by teleconference line will be provided to registered participants prior to the meeting date.

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 15 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 both more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine (enhance animal well-being and minimize or prevent 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 the NIEHS and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. ICCVAM acts to ensure that new and revised test methods are validated to meet the needs of Federal agencies, increase the efficiency and effectiveness of federal agency test method review, and optimize utilization of scientific expertise outside the federal Government. 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 testing approaches for validation studies and technical evaluations. Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/​go/​niceatm.

Dated: April 6, 2015.

John R. Bucher,

Associate Director, National Toxicology Program.