83 FR 38712 - Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 152 (August 7, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38712-38713 | |
| FR Document | 2018-16840 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38712-38713] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16840] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. DATES: 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. ADDRESSES: 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. 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 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 event. 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 [[Page 38713]] 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 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. Dated: July 24, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018-16840 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
![38712 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
2016; PCT Application No. PCT/ Oral Comments: Deadline is August Individuals who plan to provide oral
US2017/039595 filed 06/27/2017 29, 2018. comments (see below) are encouraged to
(pending). Registration for Meeting: Deadline register online at the SACATM meeting
Related Intellectual Property: HHS September 6, 2018. website (https://ntp.niehs.nih.gov/go/
Reference Number E–531–2013, E–293– Registration to view the meeting via 32822) by August 29, 2018, to facilitate
2011, E–060–2015. the webcast is required. planning for the meeting. Individuals
Licensing Contact: Barry Buchbinder, ADDRESSES: are encouraged to access the website to
Ph.D., 240–627–3678; Meeting Location: Rodbell stay abreast of the most current
barry.buchbinder@nih.gov. Auditorium, Rall Building, National information regarding the meeting.
Institute of Environmental Health Visitor and security information for
Dated: July 20, 2018.
Sciences (NIEHS), 111 T.W. Alexander those attending in-person is available at
Suzanne M. Frisbie, niehs.nih.gov/about/visiting/index.cfm.
Drive, Research Triangle Park, NC
Deputy Director, Technology Transfer and 27709. Individuals with disabilities who need
Intellectual Property Office, National Institute Meeting web page: The preliminary accommodation to participate in this
of Allergy and Infectious Diseases.
agenda, registration, and other meeting event should contact Ms. Robbin Guy at
[FR Doc. 2018–16841 Filed 8–6–18; 8:45 am] phone: (984) 287–3136 or email: guyr2@
materials are at https://
BILLING CODE 4140–01–P ntp.niehs.nih.gov/go/32822. niehs.nih.gov. TTY users should contact
Webcast: The meeting will be the Federal TTY Relay Service at 800–
webcast; the URL will be provided to 877–8339. Requests should be made at
DEPARTMENT OF HEALTH AND those who register for viewing. least five business days in advance of
HUMAN SERVICES the event.
FOR FURTHER INFORMATION CONTACT: Dr.
Mary Wolfe, Designated Federal Official Written Public Comments: Written
National Institutes of Health and oral public comment are invited for
for the SACATM, Office of Liaison,
Scientific Advisory Committee on Policy and Review, Division of NTP, the agenda topics. Guidelines for public
Alternative Toxicological Methods; NIEHS, P.O. Box 12233, K2–03, comments are available at https://
Announcement of Meeting; Request Research Triangle Park, NC 27709. ntp.niehs.nih.gov/ntp/about_ntp/
for Comments Phone: 984–287–3209, Fax: 301–451– guidelines_public_comments_508.pdf.
5759, Email: wolfe@niehs.nih.gov. Hand The deadline for submission of
AGENCY: National Institutes of Health, Deliver/Courier address: 530 Davis written comments is August 29, 2018.
HHS. Drive, Room K2130, Morrisville, NC Written public comments should be
27560. submitted through the meeting website.
ACTION: Notice.
Persons submitting written comments
SUPPLEMENTARY INFORMATION: should include name, affiliation,
SUMMARY: This notice announces the
Meeting and Registration: The mailing address, phone, email, and
next meeting of the Scientific Advisory
meeting is open to the public with time sponsoring organization (if any). Written
Committee on Alternative Toxicological
scheduled for oral public comments; comments received in response to this
Methods (SACATM). SACATM, a
attendance at the meeting is limited notice will be posted on the NTP
federally chartered, external advisory
only by the space available. website, and the submitter will be
group composed of scientists from the SACATM will provide input to
public and private sectors, including identified by name, affiliation, and
ICCVAM, NICEATM, and NIEHS on sponsoring organization (if any).
representatives of regulated industry programmatic activities and issues.
and national animal protection Oral Public Comment Registration:
Preliminary agenda includes the US The preliminary agenda allows for
organization, will review and provide Strategic Roadmap including challenges
advice on programmatic activities. several public comment periods with
to and opportunities for implementing each allowing for up to 4 commenters
SACATM advises the Interagency non-animal approaches to evaluate for up to 5 minutes per speaker. Oral
Coordinating Committee on the chemicals and medical products and the comments may be presented in person
Validation of Alternative Methods importance of international at NIEHS or by teleconference line.
(ICCVAM), the National Toxicology harmonization through the Organisation Registration for oral comments is on or
Program (NTP) Interagency Center for for Economic Co-operation and before August 29, 2018, at https://
the Evaluation of Alternative Development activites. Please see the ntp.niehs.nih.gov/go/32822. Registration
Toxicological Methods (NICEATM), and preliminary agenda for information is on a first-come, first-served basis, and
the Director of the National Institute of about the specific presentations. The registrants will be assigned a number in
Environmental Sciences (NIEHS) and preliminary agenda, roster of SACATM their confirmation email. Each
NTP regarding statutorily mandated members, background materials, public organization is allowed one time slot
duties of ICCVAM and activites of comments, and any additional per comment period. After the
NICEATM. The meeting is open to the information, when available, will be maximum number of speakers per
public and registration is requested for posted on the SACATM meeting website comment period is exceeded,
both attendance and oral comment and (https://ntp.niehs.nih.gov/go/32822) or individuals registered to provide oral
required to access the webcast. may be requested in hardcopy from the comment will be placed on a wait list
Information about the meeting and Designated Federal Official for and notified should an opening become
registration are available at https:// SACATM. Following the meeting, available. Commenters will be notified
ntp.niehs.nih.gov/go/32822. summary minutes will be prepared and after August 29, 2018, about the actual
daltland on DSKBBV9HB2PROD with NOTICES
DATES: made available on the BSC meeting time allotted per speaker, and the
Meeting: September 5–6, 2018; Begins website. teleconference number will be sent to
at 9:00 a.m. (EDT) each day and The public may attend the meeting in those registered to give oral comments
continues until adjournment. person or view the webcast. Registration by teleconference line.
Written Public Comment is required to view the webcast; the URL If possible, oral public commenters
Submissions: Deadline is August 29, for the webcast will be provided in the should send a copy of their slides and/
2018. email confirming registration. or statement or talking points to Robbin
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38713
Guy by email: guyr2@niehs.nih.gov by harmonization of new, revised, and For IACC Public Comment guidelines
August 29, 2018. alternative toxicological test methods. please see: https://iacc.hhs.gov/meetings/
Meeting Materials: The preliminary public-comments/guidelines/
Additional information about Access: White Flint Metro Station (Red
meeting agenda is available on the SACATM, including the charter, roster, Line) in combination with a brief walk.
meeting web page https:// and records of past meetings, can be Contact Person: Ms. Angelice Mitrakas,
ntp.niehs.nih.gov/go/32822 and will be found at http://ntp.niehs.nih.gov/go/ Office of Autism Research Coordination,
updated one week before the meeting. 167. National Institute of Mental Health, NIH,
Individuals are encouraged to access the 6001 Executive Boulevard, Room 6182A,
Dated: July 24, 2018.
meeting web page to stay abreast of the Bethesda, MD 20892–9669, Phone: 301–435–
Brian R. Berridge, 9269, Email: IACCPublicInquiries@
most current information regarding the
meeting. Associate Director, National Toxicology mail.nih.gov.
Program.
Background Information on ICCVAM, Public Comments: Any member of the
[FR Doc. 2018–16840 Filed 8–6–18; 8:45 am]
NICEATM, and SACATM: ICCVAM is public interested in presenting oral
an interagency committee composed of BILLING CODE 4140–01–P
comments to the IACC must notify the
representatives from 16 federal Contact Person listed on this notice by
regulatory and research agencies that 5:00 p.m. ET on Friday, October 5, 2018
require, use, generate, or disseminate DEPARTMENT OF HEALTH AND
with their request to present oral
toxicological and safety testing HUMAN SERVICES
comments at the meeting, and a written/
information. ICCVAM conducts National Institutes of Health electronic copy of the oral presentation/
technical evaluations of new, revised, statement must be submitted by 5:00
and alternative safety testing methods National Institute of Mental Health; p.m. ET on Tuesday, October 9, 2018. A
with regulatory applicability and Notice of Meeting limited number of slots for oral
promotes the scientific validation and comment are available, and in order to
regulatory acceptance of toxicological Pursuant to section 10(a) of the ensure that as many different
and safety-testing methods that more Federal Advisory Committee Act, as individuals are able to present
accurately assess the safety and hazards amended, notice is hereby given of a throughout the year as possible, any
of chemicals and products and that meeting of the Interagency Autism given individual only will be permitted
reduce, refine (decrease or eliminate Coordinating Committee. to present oral comments once per
pain and distress), or replace animal The meeting will be open to the calendar year (2018). Only one
use. The ICCVAM Authorization Act of public, with attendance limited to space representative of an organization will be
2000 (42 U.S.C. 285l–3) established available. Individuals who plan to allowed to present oral comments in
ICCVAM as a permanent interagency attend and need special assistance, such any given meeting; other representatives
committee of the NIEHS under as sign language interpretation or other of the same group may provide written
NICEATM. reasonable accommodations, should comments. If the oral comment session
NICEATM administers ICCVAM, notify the Contact Person listed below is full, individuals who could not be
provides scientific and operational in advance of the meeting. accommodated are welcome to provide
support for ICCVAM-related activities, written comments instead. Comments to
Name of Committee: Interagency Autism
and conducts independent validation Coordinating Committee (IACC). be read or presented in the meeting will
studies to assess the usefulness and Type of Meeting: Open Meeting. be assigned a 3–5 minute time slot
limitations of new, revised, and Date: Wednesday, October 17, 2018. depending on the number of comments,
alternative test methods and strategies. Time: 9:00 a.m. to 5:00 p.m. *Eastern but a longer version may be submitted
NICEATM and ICCVAM work Time* Approximate end time. in writing for the record. Commenters
collaboratively to evaluate new and Agenda: To discuss business, updates, and going beyond their allotted time in the
improved test methods and strategies issues related to ASD research and services meeting may be asked to conclude
applicable to the needs of U.S. federal activities. immediately in order to allow other
Place: National Institutes of Health,
agencies. NICEATM and ICCVAM comments and presentations to proceed
Neuroscience Center, 6001 Executive
welcome the public nomination of new, Boulevard, Conference Room C and D, on schedule.
revised, and alternative test methods Rockville, MD 20852. Any interested person may submit
and strategies for validation studies and Webcast Live: https://videocast.nih.gov. written public comments to the IACC
technical evaluations. Additional Conference Call Access: Dial: 800–369– prior to the meeting by emailing the
information about ICCVAM and 3190. comments to IACCPublicInquiries@
NICEATM can be found at http:// Access Code: 1724926. mail.nih.gov or by submitting comments
ntp.niehs.nih.gov/go/iccvam and http:// Cost: The meeting is free and open to the at the web link: https://iacc.hhs.gov/
ntp.niehs.nih.gov/go/niceatm. public. meetings/public-comments/submit/
Registration: A registration web link will
SACATM was established in response be posted on the IACC website
index.jsp by 5:00 p.m. ET on Tuesday,
to the ICCVAM Authorization Act (www.iacc.hhs.gov) prior to the meeting. Pre- October 9, 2018. The comments should
[Section 285l–3(d)] and is composed of registration is recommended to expedite include the name, address, telephone
scientists from the public and private check-in. Seating in the meeting room is number, and when applicable, the
sectors. SACATM advises ICCVAM, limited to room capacity and on a first come, business or professional affiliation of
NICEATM, and the Director of the first served basis. Onsite registration will also the interested person. National Institute
NIEHS and NTP regarding statutorily be available. on Mental Health (NIMH) anticipates
daltland on DSKBBV9HB2PROD with NOTICES
mandated duties of ICCVAM and Deadlines: Notification of interest to written public comments received by
activities of NICEATM. SACATM present oral comments: Friday, October 5, 5:00 p.m. ET on Tuesday, October 9,
2018 by 5:00 p.m. ET
provides advice on priorities and Submission of written/electronic statement
2018 will be presented to the IACC prior
activities related to the development, for oral comments: Tuesday, October 9, 2018 to the meeting for the IACC’s
validation, scientific review, regulatory by 5:00 p.m. ET consideration. Any written comments
acceptance, implementation, and Submission of written comments: Tuesday, received after the 5:00 p.m. ET, October
national and international October 9, 2018 by 5:00 p.m. ET 9, 2018 deadline through October 15,
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Document Created: 2018-11-06 10:39:17
Document Modified: 2018-11-06 10:39:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Meeting: September 5-6, 2018; Begins at 9:00 a.m. (EDT) each day and continues until adjournment. | |
| 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] | |
| FR Citation | 83 FR 38712 |
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