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

SUMMARY:

This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). 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. The meeting is open to the public, and registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at http://ntp.niehs.nih.gov/go/32822.

DATES:

Meeting: September 18-19, 2017; it begins 9:00 a.m. Eastern Daylight Time (EDT) each day and continues until adjournment.

Written Public Comment Submissions: Deadline is September 11, 2017.

Registration for Oral Comments: Deadline is September 11, 2017.

Registration for the meeting and to View Webcast: Deadline is September 19, 2017.

Registration to view the meeting via the webcast is required.

ADDRESSES:

Meeting Location: Natcher Conference Center, Building 45, Room E1 & E2, National Institutes of Health, Bethesda, MD 20984.

Meeting Web page: The preliminary agenda, registration information, and background materials should be posted at http://ntp.niehs.nih.gov/go/32822 by August 15, 2017.

Webcast: The meeting will be webcast; the URL will be provided to those who register for viewing.

FOR FURTHER INFORMATION CONTACT:

Dr. Mary Wolfe, Designated Federal Official for SACATM, Office of Liaison, Policy, and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 919-541-7539, fax: 301-451-6890, email: wolfe@niehs.nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Preliminary Agenda and Other Meeting Information: A preliminary agenda, roster of SACATM members, and background materials should be available by August 15, 2017, on the SACATM meeting Web site ( http://ntp.niehs.nih.gov/go/32822 ) and available upon request from the Designated Federal Official. Public comments and any additional information will be posted when available. The meeting's agenda will focus on the US strategic roadmap for implementation of new approaches to safety evaluation, which is under development, and ICCVAM agencies' activities related to the development and implementation of alternative methods. Following the meeting, summary minutes will be prepared and available on the SACATM Web site or upon request from the Designated Federal Official.

Meeting and Registration: This meeting is open to the public with time scheduled for oral public comments. The public may attend the meeting at Natcher Conference Center, where attendance is limited only by the space available, or view the webcast. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Individuals who plan to attend and/or provide oral comments are encouraged to register at http://ntp.niehs.nih.gov/go/32822 by September 11, 2017, to facilitate planning for the meeting. Individuals are encouraged to access the Web site to stay abreast of the most current information regarding the meeting. Visitor information for those attending in person is available at https://www.nih.gov/about-nih/visitor-information. Campus access and security information is located at https://www.nih.gov/about-nih/visitor-information/campus-access-security. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Robbin Guy at phone: 919-541-4363 or email: guyr2@niehs.nih.gov. 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 Comments: Both written and oral public input on the agenda topics is invited. Written comments submitted in response to this notice should be received by September 11, 2017. Comments will be posted on the SACATM meeting Web site and persons submitting them will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting written comments should include their name, affiliation (if applicable), and sponsoring organization (if any) with the document. Guidelines for public comments are at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.

Time is allotted during the meeting for the public to present oral comments on the agenda topics. Public comments can be presented in-person at the meeting or by teleconference line. There are 50 lines for this call; availability is on a first-come, first-served basis. The lines will be open from 9:00 a.m. until adjournment on September 18 and 19; although SACATM will receive public comments only during the formal public comment periods, as indicated on the preliminary agenda. Each organization is allowed one time slot per agenda topic. Each speaker is allotted at least 7 minutes, which if time permits, may be extended to 10 minutes at the discretion of the SACATM chair.

Persons wishing to present oral comments are encouraged to register using the SACATM meeting registration form ( http://ntp.niehs.nih.gov/go/32822 ) by September 11, 2017. Registrants should indicate the topic(s) on which they plan to comment and whether they will present comments in-person or via the teleconference. The access number for the teleconference line for public comments will be provided to registrants by email prior to the meeting. Registrants are requested to, if possible, send a copy of their statement to wolfe@niehs.nih.gov by September 11, 2017, to enable review by SACATM, NICEATM, ICCVAM, and NIEHS/NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation. Registration for on-site oral comments will also be available on the meeting day, although time allowed for comments by these registrants may be limited and will be determined by the number of persons who register at the meeting. If registering on-site and reading from written text, please bring 30 copies of the statement for distribution and to supplement the record.

Background Information on ICCVAM, NICEATM, and SACATM: ICCVAM is an interagency committee composed of representatives from 16 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 with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety-testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM.

NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies 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 ICCVAM and NICEATM can be found at http://ntp.niehs.nih.gov/go/iccvam and http://ntp.niehs.nih.gov/go/niceatm.

SACATM was established in response to the ICCVAM Authorization Act [Section 285 l-3(d)] and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP 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. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.