[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40072-40074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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SUMMARY: This notice announces the next meeting of the Scientific 
Advisory Committee on Alternative Toxicological Methods (SACATM). 
SACATM, a federally chartered external advisory group of scientists 
from the public and private sectors, including representatives of 
regulated industry and national animal protection organizations, 
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

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Environmental 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 attendance and oral 
comments and required to access the webcast. Information about the 
meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

DATES: 
    Meeting: September 19-20, 2019; begins at 9:00 a.m. (EDT) each day 
and continues until adjournment.
    Written Public Comment Submissions: Deadline is September 12, 2019.
    Register to Present Oral Comments: Deadline is September 12, 2019.
    Registration for Meeting: Deadline is September 12, 2019 to attend 
in person and September 20, 2019 to view the webcast.
    Registration to view the meeting via the webcast is required.

ADDRESSES: 
    Meeting Location: Crowne Plaza Crystal City--Washington, DC, 1480 
Crystal Drive, Arlington, Virginia 22202.
    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. Elizabeth Maull, Designated 
Federal Official for SACATM, Office of Liaison, Policy and Review, 
Division of NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park, 
NC 27709. Phone: 984-287-3157, Fax: 301-480-3008, Email: 
[email protected]. Hand Deliver/Courier address: 530 Davis Drive, 
Room K2021, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
    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 items for the 
upcoming meeting include: (1) New approaches to the principles and 
practice of validation, (2) developing a next generation data 
infrastructure to support the development and implementation of new 
approach methodologies (NAMs) for complex endpoints, and (3) 
translational impact and human relevance of NAMs. 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 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.
    Interested persons 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 September 12, 2019, 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 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 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 12, 2019. 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 four commenters a 
maximum of five minutes per speaker. Oral comments may be presented in 
person at Crowne Plaza Crystal City--Washington, DC, 1480 Crystal 
Drive, Arlington, Virginia 22202 or by teleconference line. 
Registration for oral comments is on or before September 12, 2019, at 
https://ntp.niehs.nih.gov/go/32822. Registration is on a first-come, 
first-served basis, and each registrant 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 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 
12, 2019, 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 Guy by email: [email protected] by September 12, 2019.
    Meeting Materials: The preliminary meeting agenda will be posted 
when 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 visit this web page often 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 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. 285l-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

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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.

Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-17269 Filed 8-12-19; 8:45 am]
BILLING CODE 4140-01-P