80 FR 41047 - 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 80, Issue 134 (July 14, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 134 (July 14, 2015)
| Page Range | 41047-41048 | |
| FR Document | 2015-17165 |
[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)] [Notices] [Pages 41047-41048] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17165] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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. 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 2, 2015, beginning at 8:30 a.m. Eastern Daylight Time (EDT) and continuing until adjournment at approximately 5:00 p.m. Written Public Comments Submissions: Deadline is August 19, 2015. Registration for Meeting and/or Oral Comments: Deadline is August 26, 2015. Registration to View Webcast: Deadline is September 2, 2015. Registration to view the meeting via the webcast is required. ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 Meeting Web page: The preliminary agenda, registration, and other meeting materials will be at http://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. Lori White, Designated Federal Officer for SACATM, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 919-541-9834, fax: (301) 480-3272, email: [email protected]. Hand Deliver/Courier address: 530 Davis Drive, Room K2136, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Preliminary Agenda and Other Meeting Information: A preliminary agenda, roster of SACATM members, background materials, public comments, and any additional information, when available, will be posted on the SACATM meeting Web site (http://ntp.niehs.nih.gov/go/32822) or is available upon request from the Designated Federal Officer. Following the meeting, summary minutes will be prepared and available on the SACATM Web site or upon request. Meeting and Registration: This meeting is open to the public with time scheduled for oral public comments. The public may attend the meeting at NIEHS, 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 August 26, 2015, to facilitate planning for the meeting. Individuals interested in the meeting are encouraged to access this Web site 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: (919) 541-4363 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. 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 August 19, 2015. Comments will be posted on the 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. Time is allotted during the meeting for presentation of oral comments and each organization (sponsoring organization or affiliation) is allowed one time slot per [[Page 41048]] topic. At least 7 minutes will be allotted for each speaker, and if time permits, may be extended up to 10 minutes at the discretion of the chair. Registration for oral comments will also be available on-site, although time allowed for presentation by on-site registrants may be less than for registered speakers and will be determined by the number of persons who register at the meeting. In addition to in-person oral comments at the meeting, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The lines will be open from 8:30 a.m. until approximately 5:00 p.m., although public comments will be received only during the formal public comment periods, which will be indicated on the preliminary agenda. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Persons wishing to present oral comments are encouraged to register using the SACATM meeting registration form (http://ntp.niehs.nih.gov/go/32822), indicate the topic(s) on which they plan to comment, and, if possible, send a copy of their statement to [email protected] by August 26, 2015, 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. If registering on-site and reading from written text, please bring 20 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 15 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 8, 2015. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2015-17165 Filed 7-13-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41047
heading of this document. Received Dated: July 7, 2015. Triangle Park, NC 27709. Phone: 919–
comments may be seen in the Division Carolyn Baum, 541–9834, fax: (301) 480–3272, email:
of Dockets Management between 9 a.m. Program Analyst, Office of Federal Advisory whiteld@niehs.nih.gov. Hand Deliver/
and 4 p.m., Monday through Friday, and Committee Policy. Courier address: 530 Davis Drive, Room
will be posted to the docket at http:// [FR Doc. 2015–17164 Filed 7–13–15; 8:45 am] K2136, Morrisville, NC 27560.
www.regulations.gov. BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION:
Dated: July 8, 2015. Preliminary Agenda and Other
Leslie Kux, Meeting Information: A preliminary
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND agenda, roster of SACATM members,
HUMAN SERVICES background materials, public comments,
[FR Doc. 2015–17250 Filed 7–13–15; 8:45 am]
and any additional information, when
BILLING CODE 4164–01–P National Institutes of Health available, will be posted on the
Scientific Advisory Committee on SACATM meeting Web site (http://
DEPARTMENT OF HEALTH AND Alternative Toxicological Methods; ntp.niehs.nih.gov/go/32822) or is
HUMAN SERVICES Announcement of Meeting; Request available upon request from the
for Comments Designated Federal Officer. Following
National Institutes of Health the meeting, summary minutes will be
SUMMARY: This notice announces a prepared and available on the SACATM
National Institute of Environmental meeting of the Scientific Advisory Web site or upon request.
Health Sciences Notice of Closed Committee on Alternative Toxicological Meeting and Registration: This
Meeting Methods (SACATM). SACATM advises meeting is open to the public with time
Pursuant to section 10(d) of the the Interagency Coordinating Committee scheduled for oral public comments.
Federal Advisory Committee Act, as on the Validation of Alternative The public may attend the meeting at
amended (5 U.S.C. App.), notice is Methods (ICCVAM), the National NIEHS, where attendance is limited
hereby given of the following meeting. Toxicology Program (NTP) Interagency only by the space available, or view the
The meeting will be closed to the Center for the Evaluation of Alternative webcast. Registration is required to view
public in accordance with the Toxicological Methods (NICEATM), and the webcast; the URL for the webcast
provisions set forth in sections the Director of the National Institute of will be provided in the email
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Environmental Health Sciences (NIEHS) confirming registration. Individuals who
as amended. The grant applications and and NTP regarding statutorily mandated plan to attend and/or provide oral
the discussions could disclose duties of ICCVAM and activities of comments are encouraged to register at
confidential trade secrets or commercial NICEATM. The meeting is open to the http://ntp.niehs.nih.gov/go/32822 by
property such as patentable material, public. Registration is requested for both August 26, 2015, to facilitate planning
and personal information concerning public attendance and oral comment for the meeting. Individuals interested
individuals associated with the grant and required to access the webcast. in the meeting are encouraged to access
applications, the disclosure of which Information about the meeting and this Web site to stay abreast of the most
would constitute a clearly unwarranted registration is available at http:// current information regarding the
invasion of personal privacy. ntp.niehs.nih.gov/go/32822. meeting. Visitor and security
DATES: Meeting: September 2, 2015, information for those attending in
Name of Committee: National Institute of
Environmental Health Sciences Special beginning at 8:30 a.m. Eastern Daylight person is available at niehs.nih.gov/
Emphasis Panel; Undergraduate Research Time (EDT) and continuing until about/visiting/index.cfm. Individuals
Training in Environmental Health Sciences. adjournment at approximately 5:00 p.m. with disabilities who need
Date: August 6, 2015. Written Public Comments accommodation to participate in this
Time: 1:00 p.m. to 2:30 p.m. Submissions: Deadline is August 19, event should contact Ms. Robbin Guy at
Agenda: To review and evaluate grant 2015. phone: (919) 541–4363 or email:
applications. Registration for Meeting and/or Oral guyr2@niehs.nih.gov. TTY users should
Place: National Institute of Environmental
Comments: Deadline is August 26, 2015. contact the Federal TTY Relay Service
Health Sciences, Keystone Building, 530
Davis Drive, Room 3118, Research Triangle
Registration to View Webcast: at 800–877–8339. Requests should be
Park, NC 27709, (Telephone Conference Deadline is September 2, 2015. made at least five business days in
Call). Registration to view the meeting via the advance of the event.
Contact Person: Leroy Worth, Ph.D., webcast is required. Request for Comments: Both written
Scientific Review Officer Scientific Review ADDRESSES: and oral public input on the agenda
Branch, Division of Extramural Research and Meeting Location: Rodbell topics is invited. Written comments
Training, Nat. Institute of Environmental Auditorium, Rall Building, NIEHS, 111 submitted in response to this notice
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC T.W. Alexander Drive, Research should be received by August 19, 2015.
27709, 919/541–0670, worth@niehs.nih.gov. Triangle Park, NC 27709 Comments will be posted on the
(Catalogue of Federal Domestic Assistance
Meeting Web page: The preliminary meeting Web site and persons
Program Nos. 93.115, Biometry and Risk agenda, registration, and other meeting submitting them will be identified by
Estimation—Health Risks from materials will be at http:// their name and affiliation and/or
Environmental Exposures; 93.142, NIEHS ntp.niehs.nih.gov/go/32822. sponsoring organization, if applicable.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Hazardous Waste Worker Health and Safety Webcast: The meeting will be Persons submitting written comments
Training; 93.143, NIEHS Superfund webcast; the URL will be provided to should include their name, affiliation (if
Hazardous Substances—Basic Research and those who register for viewing. applicable), and sponsoring
Education; 93.894, Resources and Manpower
Development in the Environmental Health
FOR FURTHER INFORMATION CONTACT: Dr. organization (if any) with the document.
Sciences; 93.113, Biological Response to Lori White, Designated Federal Officer Time is allotted during the meeting for
Environmental Health Hazards; 93.114, for SACATM, Office of Liaison, Policy presentation of oral comments and each
Applied Toxicological Research and Testing, and Review, Division of NTP, NIEHS, organization (sponsoring organization or
National Institutes of Health, HHS) P.O. Box 12233, K2–03, Research affiliation) is allowed one time slot per
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![41048 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
topic. At least 7 minutes will be allotted limitations of new, revised, and Name of Committee: National Institute of
for each speaker, and if time permits, alternative test methods and strategies. Allergy and Infectious Diseases Special
may be extended up to 10 minutes at the NICEATM and ICCVAM work Emphasis Panel; NIAID Clinical Trial
discretion of the chair. Registration for collaboratively to evaluate new and Implantation Grant (R01).
oral comments will also be available on- improved test methods and strategies Date: August 17, 2015.
site, although time allowed for applicable to the needs of U.S. federal Time: 2:00 p.m. to 4:00 p.m.
presentation by on-site registrants may agencies. NICEATM and ICCVAM Agenda: To review and evaluate grant
be less than for registered speakers and welcome the public nomination of new, applications.
will be determined by the number of revised, and alternative test methods Place: 5061 Fishers Lane, Conference
persons who register at the meeting. In and strategies for validation studies and Room 3F100, Rockville, MD 20852,
addition to in-person oral comments at technical evaluations. Additional (Telephone Conference Call).
the meeting, public comments can be information about ICCVAM and Contact Person: Paul Roberts, Ph.D.,
presented by teleconference line. There NICEATM can be found at http:// Scientific Review Officer, Scientific Review
will be 50 lines for this call; availability ntp.niehs.nih.gov/go/iccvam and http:// Program, Division of Extramural Activities,
will be on a first-come, first-served ntp.niehs.nih.gov/go/niceatm. Room 3G22, National Institutes of Health/
basis. The lines will be open from 8:30 SACATM was established in response NIAID, 5601 Fishers Lane, MSC 9823,
a.m. until approximately 5:00 p.m., to the ICCVAM Authorization Act Rockville, MD 20852, 240–669–5053,
although public comments will be [Section 285l–3(d)] and is composed of paul.roberts@nih.gov.
received only during the formal public scientists from the public and private Name of Committee: National Institute of
comment periods, which will be sectors. SACATM advises ICCVAM, Allergy and Infectious Diseases Special
indicated on the preliminary agenda. NICEATM, and the Director of the Emphasis Panel; NIAID Clinical Trial
The access number for the NIEHS and NTP regarding statutorily Implantation Grant (R01).
teleconference line will be provided to mandated duties of ICCVAM and Date: August 18, 2015.
registrants by email prior to the meeting. activities of NICEATM. SACATM Time: 2:00 p.m. to 4:00 p.m.
Persons wishing to present oral provides advice on priorities and Agenda: To review and evaluate grant
comments are encouraged to register activities related to the development, applications.
using the SACATM meeting registration validation, scientific review, regulatory Place: 5601 Fishers Lane, Conference
form (http://ntp.niehs.nih.gov/go/ acceptance, implementation, and Room 3F100, Rockville, MD 20852,
32822), indicate the topic(s) on which national and international (Telephone Conference Call).
they plan to comment, and, if possible, harmonization of new, revised, and Contact Person: Paul Roberts, Ph.D.,
send a copy of their statement to alternative toxicological test methods. Scientific Review Officer, Scientific Review
whiteld@niehs.nih.gov by August 26, Additional information about SACATM, Program, Division of Extramural Activities,
2015, to enable review by SACATM, including the charter, roster, and Room 3G22, National Institutes of Health/
NICEATM, ICCVAM, and NIEHS/NTP records of past meetings, can be found NIAID, 5601 Fishers Lane, MSC 9823,
staff prior to the meeting. Written at http://ntp.niehs.nih.gov/go/167. Rockville, MD 20852, 240–669–5053,
statements can supplement and may paul.roberts@nih.gov.
Dated: July 8, 2015.
expand the oral presentation. If Name of Committee: National Institute of
John R. Bucher,
registering on-site and reading from Allergy and Infectious Diseases Special
Associate Director, National Toxicology
written text, please bring 20 copies of Emphasis Panel; NIAID Clinical Trial
Program.
the statement for distribution and to Implantation Cooperative Agreement (U01).
[FR Doc. 2015–17165 Filed 7–13–15; 8:45 am]
supplement the record. Date: August 19, 2015.
Background Information on ICCVAM, BILLING CODE 4140–01–P Time: 2:00 p.m. to 4:00 p.m.
NICEATM, and SACATM: ICCVAM is Agenda: To review and evaluate grant
an interagency committee composed of applications.
representatives from 15 federal DEPARTMENT OF HEALTH AND Place: 5601 Fishers Lane, Conference
regulatory and research agencies that HUMAN SERVICES Room 3F100, Rockville, MD 20852,
require, use, generate, or disseminate National Institutes of Health (Telephone Conference Call).
toxicological and safety testing Contact Person: Paul Roberts, Ph.D.,
information. ICCVAM conducts National Institute of Allergy and Scientific Review Officer, Scientific Review
technical evaluations of new, revised, Infectious Diseases; Notice of Closed Program, Division of Extramural Activities,
and alternative safety testing methods Meetings Room 3G22, National Institutes of Health/
with regulatory applicability and NIAID, 5601 Fishers Lane, MSC 9823,
promotes the scientific validation and Pursuant to section 10(d) of the Rockville, MD 20852, 240–669–5053,
regulatory acceptance of toxicological Federal Advisory Committee Act, as paul.roberts@nih.gov.
and safety-testing methods that more amended (5 U.S.C. App.), notice is (Catalogue of Federal Domestic Assistance
accurately assess the safety and hazards hereby given of the following meetings. Program Nos. 93.855, Allergy, Immunology,
of chemicals and products and that The meetings will be closed to the and Transplantation Research; 93.856,
reduce, refine (decrease or eliminate public in accordance with the Microbiology and Infectious Diseases
pain and distress), or replace animal provisions set forth in sections Research, National Institutes of Health, HHS)
use. The ICCVAM Authorization Act of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Dated: July 8, 2015.
2000 (42 U.S.C. 285l–3) established as amended. The grant applications and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ICCVAM as a permanent interagency the discussions could disclose David Clary,
committee of the NIEHS under confidential trade secrets or commercial Program Analyst, Office of Federal Advisory
NICEATM. property such as patentable material, Committee Policy.
NICEATM administers ICCVAM, and personal information concerning [FR Doc. 2015–17160 Filed 7–13–15; 8:45 am]
provides scientific and operational individuals associated with the grant BILLING CODE 4140–01–P
support for ICCVAM-related activities, applications, the disclosure of which
and conducts independent validation would constitute a clearly unwarranted
studies to assess the usefulness and invasion of personal privacy.
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Document Created: 2018-02-23 09:19:46
Document Modified: 2018-02-23 09:19:46
| 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 | |
| Dates | Meeting: September 2, 2015, beginning at 8:30 a.m. Eastern Daylight Time (EDT) and continuing until adjournment at approximately 5:00 p.m. | |
| Contact | Dr. Lori White, Designated Federal Officer for SACATM, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 919-541-9834, fax: (301) 480-3272, email: [email protected] | |
| FR Citation | 80 FR 41047 |
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