38712 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

2016; PCT Application No. PCT/ 

US2017/039595 filed 06/27/2017 

(pending). 

Related Intellectual Property: HHS 

Reference Number E–531–2013, E–293– 

2011, E–060–2015. 

Licensing Contact: Barry Buchbinder, 

Ph.D., 240–627–3678; 

barry.buchbinder@nih.gov. 

Dated: July 20, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–16841 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

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: wolfe@niehs.nih.gov. 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: 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. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38713 

Guy by email: guyr2@niehs.nih.gov 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Interagency Autism 

Coordinating Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Type of Meeting: Open Meeting. 

Date: Wednesday, October 17, 2018. 

Time: 9:00 a.m. to 5:00 p.m. *Eastern 

Time* Approximate end time. 

Agenda: To discuss business, updates, and 

issues related to ASD research and services 

activities. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Conference Room C and D, 

Rockville, MD 20852. 

Webcast Live: https://videocast.nih.gov. 

Conference Call Access: Dial: 800–369– 

3190. 

Access Code: 1724926. 

Cost: The meeting is free and open to the 

public. 

Registration: A registration web link will 

be posted on the IACC website 

(www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended to expedite 

check-in. Seating in the meeting room is 

limited to room capacity and on a first come, 

first served basis. Onsite registration will also 

be available. 

Deadlines: Notification of interest to 

present oral comments: Friday, October 5, 

2018 by 5:00 p.m. ET 

Submission of written/electronic statement 

for oral comments: Tuesday, October 9, 2018 

by 5:00 p.m. ET 

Submission of written comments: Tuesday, 

October 9, 2018 by 5:00 p.m. ET 

For IACC Public Comment guidelines 

please see: https://iacc.hhs.gov/meetings/ 

public-comments/guidelines/ 

Access: White Flint Metro Station (Red 

Line) in combination with a brief walk. 

Contact Person: Ms. Angelice Mitrakas, 

Office of Autism Research Coordination, 

National Institute of Mental Health, NIH, 

6001 Executive Boulevard, Room 6182A, 

Bethesda, MD 20892–9669, Phone: 301–435– 

9269, Email: IACCPublicInquiries@

mail.nih.gov. 

Public Comments: Any member of the 

public interested in presenting oral 

comments to the IACC must notify the 

Contact Person listed on this notice by 

5:00 p.m. ET on Friday, October 5, 2018 

with their request to present oral 

comments at the meeting, and a written/ 

electronic copy of the oral presentation/ 

statement must be submitted by 5:00 

p.m. ET on Tuesday, October 9, 2018. A 

limited number of slots for oral 

comment are available, and in order to 

ensure that as many different 

individuals are able to present 

throughout the year as possible, any 

given individual only will be permitted 

to present oral comments once per 

calendar year (2018). Only one 

representative of an organization will be 

allowed to present oral comments in 

any given meeting; other representatives 

of the same group may provide written 

comments. If the oral comment session 

is full, individuals who could not be 

accommodated are welcome to provide 

written comments instead. Comments to 

be read or presented in the meeting will 

be assigned a 3–5 minute time slot 

depending on the number of comments, 

but a longer version may be submitted 

in writing for the record. Commenters 

going beyond their allotted time in the 

meeting may be asked to conclude 

immediately in order to allow other 

comments and presentations to proceed 

on schedule. 

Any interested person may submit 

written public comments to the IACC 

prior to the meeting by emailing the 

comments to IACCPublicInquiries@

mail.nih.gov or by submitting comments 

at the web link: https://iacc.hhs.gov/ 

meetings/public-comments/submit/ 

index.jsp by 5:00 p.m. ET on Tuesday, 

October 9, 2018. The comments should 

include the name, address, telephone 

number, and when applicable, the 

business or professional affiliation of 

the interested person. National Institute 

on Mental Health (NIMH) anticipates 

written public comments received by 

5:00 p.m. ET on Tuesday, October 9, 

2018 will be presented to the IACC prior 

to the meeting for the IACC’s 

consideration. Any written comments 

received after the 5:00 p.m. ET, October 

9, 2018 deadline through October 15, 


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