[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Pages 38712-38713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16840]



National Institutes of Health

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, a federally chartered, external advisory group composed of 
scientists from the public and private sectors, including 
representatives of regulated industry and national animal protection 
organization, will review and provide advice on programmatic 
activities. 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 Sciences (NIEHS) and NTP regarding 
statutorily mandated duties of ICCVAM and activites of NICEATM. The 
meeting is open to the public and registration is requested for both 
attendance and oral comment and required to access the webcast. 
Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

    Meeting: September 5-6, 2018; Begins at 9:00 a.m. (EDT) each day 
and continues until adjournment.
    Written Public Comment Submissions: Deadline is August 29, 2018.
    Oral Comments: Deadline is August 29, 2018.
    Registration for Meeting: Deadline September 6, 2018.
    Registration to view the meeting via the webcast is required.

    Meeting Location: Rodbell Auditorium, Rall Building, National 
Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander 
Drive, Research Triangle Park, NC 27709.
    Meeting web page: The preliminary agenda, registration, and other 
meeting materials are at https://ntp.niehs.nih.gov/go/32822.
    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 the SACATM, Office of Liaison, Policy and Review, Division 
of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. 
Phone: 984-287-3209, Fax: 301-451-5759, Email: [email protected]. 
Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, 
NC 27560.

    Meeting and Registration: The meeting is open to the public with 
time scheduled for oral public comments; attendance at the meeting is 
limited only by the space available.
    SACATM will provide input to ICCVAM, NICEATM, and NIEHS on 
programmatic activities and issues. Preliminary agenda includes the US 
Strategic Roadmap including challenges to and opportunities for 
implementing non-animal approaches to evaluate chemicals and medical 
products and the importance of international harmonization through the 
Organisation for Economic Co-operation and Development activites. 
Please see the preliminary agenda for information about the specific 
presentations. The preliminary agenda, roster of SACATM members, 
background materials, public comments, and any additional information, 
when available, will be posted 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 BSC meeting website.
    The public may attend the meeting in person 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 provide oral comments (see below) are encouraged to register 
online at the SACATM meeting website (https://ntp.niehs.nih.gov/go/32822) by August 29, 2018, to facilitate planning for the meeting. 
Individuals are encouraged to access the website to stay abreast of the 
most current information regarding the meeting. Visitor and security 
information for those attending in-person is available at 
niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities 
who need accommodation to participate in this event should contact Ms. 
Robbin Guy at phone: (984) 287-3136 or email: [email protected]. 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 
    Written Public Comments: Written and oral public comment 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 August 29, 2018. 
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 with each allowing for up to 4 
commenters for up to 5 minutes per speaker. Oral comments may be 
presented in person at NIEHS or by teleconference line. Registration 
for oral comments is on or before August 29, 2018, at https://ntp.niehs.nih.gov/go/32822. Registration is on a first-come, first-
served basis, and registrants will be assigned a number in their 
confirmation email. Each organization is allowed one time slot per 
comment period. After the maximum number of speakers per comment period 
is exceeded, individuals registered to provide oral comment will be 
placed on a wait list and notified should an opening become available. 
Commenters will be notified after August 29, 2018, about the actual 
time allotted per speaker, and the teleconference number will be sent 
to those registered to give oral comments by teleconference line.
    If possible, oral public commenters should send a copy of their 
slides and/or statement or talking points to Robbin

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Guy by email: [email protected] by August 29, 2018.
    Meeting Materials: The preliminary meeting agenda is available on 
the meeting web page https://ntp.niehs.nih.gov/go/32822 and will be 
updated one week before the meeting. Individuals are encouraged to 
access the meeting web page to stay abreast of the most current 
information regarding the meeting.
    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. 285l-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 285l-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 
    Additional information about SACATM, including the charter, roster, 
and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.

    Dated: July 24, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-16840 Filed 8-6-18; 8:45 am]