81 FR 14865 - Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range		14865-14866
FR Document		2016-06076

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or remotely by webcast. Time will be set aside for public statements and questions on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/iccvamforum-2016.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14865-14866]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06076]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods; Notice of Public Meeting; Request for Public Input

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) will hold a public forum to share 
information and facilitate direct communication of ideas and 
suggestions from stakeholders. Interested persons may attend in person 
or remotely by webcast. Time will be set aside for public statements 
and questions on the topics discussed. Registration is requested for 
both public attendance and oral statements, and required for remote 
access. Information about the meeting and registration are available at 
http://ntp.niehs.nih.gov/go/iccvamforum-2016.

DATES: Meeting: May 25, 2016, 9:00 a.m. to approximately 4:00 p.m. 
Eastern Daylight Time (EDT).

    Registration for Onsite Meeting: Deadline is May 13, 2016.
    Registration for Webcast: Deadline is May 25, 2016.
    Submission of Oral Public Statements: Deadline is May 13, 2016.

ADDRESSES: 
    Meeting Location: William H. Natcher Conference Center, National 
Institutes of Health, Bethesda, MD 20892.
    Meeting Web page: The preliminary agenda, registration, and other 
meeting materials are at http://ntp.niehs.nih.gov/go/iccvamforum-2016.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National 
Toxicology Program Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM); email: [email protected]; 
telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION:
    Background: ICCVAM promotes the development and validation of 
chemical safety testing methods that protect human health and the 
environment while replacing, reducing, or refining animal use.
    ICCVAM's goals include promotion of national and international 
partnerships between governmental and nongovernmental groups, including 
academia, industry, advocacy groups, and other key stakeholders. To 
foster these partnerships ICCVAM initiated annual public forums in 2014 
to share information and facilitate direct communication of ideas and 
suggestions from stakeholders (79 FR 25136).
    The third of these forums will be held on May 25, 2016, at the 
National Institutes of Health (NIH) in Bethesda, MD. The meeting will 
include presentations by NICEATM and ICCVAM members on current 
activities related to the development and validation of alternative 
test methods and approaches. Following each presentation, there will be 
an opportunity for participants to ask questions of the ICCVAM members. 
Instructions for submitting questions will be provided to remote 
participants prior to the webcast.
    The agenda will also include periods dedicated to discussion of 
specific topics relevant to the ICCVAM mission, and time for 
participants to make public oral statements on topics relevant to the 
ICCVAM mission and current ICCVAM activities.
    Preliminary Agenda and Other Meeting Information: The preliminary 
agenda, list of discussion topics, ICCVAM roster and other background 
materials, and public statements submitted prior to the meeting should 
be posted by May 18, 2016, at http://ntp.niehs.nih.gov/go/iccvamforum-2016. Interested individuals are encouraged to visit this Web page to 
stay abreast of the most current meeting information.
    Meeting and Registration: This meeting is open to the public with 
time scheduled for oral public statements and for questions following 
ICCVAM's and NICEATM's presentations. The public may attend the meeting 
at NIH, where attendance is limited only by the space available, or 
view remotely by webcast. Those planning to attend the meeting in 
person are encouraged to register at http://ntp.niehs.nih.gov/go/iccvamforum-2016 by May 13, 2016, to facilitate planning for 
appropriate meeting space. Those planning to view the webcast must 
register at http://ntp.niehs.nih.gov/go/iccvamforum-2016 by May 25, 
2016. The URL for the webcast will be provided in the email confirming 
registration.
    Visitor and security information for visitors to NIH is available 
at http://www.nih.gov/about/visitor/index.htm. Individuals with 
disabilities who need accommodation to participate in this event should 
contact Dr. Elizabeth Maull at phone: (919) 316-4668 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 Oral Public Statements: Time will be allotted during 
the meeting for oral public statements with associated slides relevant 
to ICCVAM's mission and current activities. The number and length of 
presentations may be limited based on available time. Submitters will 
be identified by their name and affiliation and/or sponsoring 
organization, if applicable. Persons submitting public statements and/
or associated slides should include their name, affiliation (if any), 
mailing address, telephone, email, and sponsoring organization (if any) 
with the document. Guidelines for public statements are at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Persons wishing to present oral statements are encouraged to 
indicate the topic(s) on which they plan to speak on the registration 
form. They should also provide a copy of their statement to Dr. 
Elizabeth Maull at email: [email protected] by May 13, 2016, to allow 
time for review by NICEATM and ICCVAM and posting to the meeting page 
prior to the forum. Written statements may supplement and expand the 
oral presentation. Public statements will be distributed to NICEATM and 
ICCVAM members before the meeting.
    Registration for oral public statements will be available onsite, 
although onsite registration and time allotted for these

[[Page 14866]]

statements may be limited based on the number of individuals who 
register to make statements and available time. If registering onsite 
and reading from written text, please bring 20 copies of the statement 
for distribution and to supplement the record.
    In addition to in-person oral statements at the meeting, public 
statements may be presented by teleconference line. Directions for 
accessing the meeting by teleconference line will be provided to 
registered participants prior to the meeting date.
    Responses to this notice are voluntary. No proprietary, classified, 
confidential, or sensitive information should be included in statements 
submitted in response to this notice or presented during the meeting. 
This request for input is for planning purposes only and is not a 
solicitation for applications or an obligation on the part of the U.S. 
Government to provide support for any ideas identified in response to 
the request. Please note that the U.S. Government will not pay for the 
preparation of any information submitted or for its use of that 
information.
    Background Information on ICCVAM and NICEATM: 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 and integrated testing strategies with regulatory 
applicability and promotes the scientific validation and regulatory 
acceptance of testing methods that both more accurately assess the 
safety and hazards of chemicals and products and replace, reduce, or 
refine (enhance animal well-being and minimize or prevent 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 the 
NIEHS and provides the authority for ICCVAM involvement in activities 
relevant to the development of alternative test methods. ICCVAM acts to 
ensure that new and revised test methods are validated to meet the 
needs of Federal agencies, increase the efficiency and effectiveness of 
federal agency test method review, and optimize utilization of 
scientific expertise outside the federal Government. 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 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 testing approaches for validation studies 
and technical evaluations. Additional information about NICEATM can be 
found at http://ntp.niehs.nih.gov/go/niceatm.

    Dated: March 14, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-06076 Filed 3-17-16; 8:45 am]
BILLING CODE 4140-01-P

14866 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

statements may be limited based on the and conducts and publishes analyses received within 30 days of the date of
number of individuals who register to and evaluations of data from new, this publication.
make statements and available time. If revised, and alternative testing
registering onsite and reading from approaches. NICEATM and ICCVAM FOR FURTHER INFORMATION CONTACT: To
written text, please bring 20 copies of work collaboratively to evaluate new obtain a copy of the data collection
the statement for distribution and to and improved testing approaches plans and instruments, or request more
supplement the record. applicable to the needs of U.S. federal information on the proposed project,
In addition to in-person oral agencies. NICEATM and ICCVAM contact: Rebecca Ferrer, Program
statements at the meeting, public welcome the public nomination of new, Director, Basic Biobehavioral and
statements may be presented by revised, and alternative testing Psychological Sciences Branch,
teleconference line. Directions for approaches for validation studies and Behavioral Research Program, Division
accessing the meeting by teleconference technical evaluations. Additional of Cancer Control and Population
line will be provided to registered information about NICEATM can be Sciences, National Cancer Institute,
participants prior to the meeting date. found at http://ntp.niehs.nih.gov/go/ 9609 Medical Center Dr., Rockville, MD
Responses to this notice are niceatm. 20852 or call non-toll-free number (240)
voluntary. No proprietary, classified, 276–6914 or Email your request,
Dated: March 14, 2016. including your address to:
confidential, or sensitive information
should be included in statements John R. Bucher, ferrerra@mail.nih.gov. Formal requests
submitted in response to this notice or Associate Director, National Toxicology for additional plans and instruments
presented during the meeting. This Program. must be requested in writing.
request for input is for planning [FR Doc. 2016–06076 Filed 3–17–16; 8:45 am]
Proposed Collection: Self-Affirmation
purposes only and is not a solicitation BILLING CODE 4140–01–P
Construct Validity, 0925—NEW,
for applications or an obligation on the National Cancer Institute (NCI),
part of the U.S. Government to provide National Institutes of Health (NIH).
support for any ideas identified in DEPARTMENT OF HEALTH AND
response to the request. Please note that HUMAN SERVICES Need and Use of Information
the U.S. Government will not pay for Collection: This information collection,
National Institutes of Health seeks to refine a theory about how self-
the preparation of any information
submitted or for its use of that competence and values play a role in
Submission for OMB Review; 30-Day defensive responses to health
information. Comment Request; Self-Affirmation
Background Information on ICCVAM communications. Although
Construct Validity theoretically-driven research has shown
and NICEATM: ICCVAM is an
interagency committee composed of SUMMARY: Under the provisions of that self-affirmation—a process by
representatives from 15 federal Section 3507(a)(1)(D) of the Paperwork which individuals reflect on values that
regulatory and research agencies that Reduction Act of 1995, the National are important to them—can improve
require, use, generate, or disseminate Cancer Institute, the National Institutes responses to health and cancer
toxicological and safety testing of Health, has submitted to the Office of communications, the ‘‘active
information. ICCVAM conducts Management and Budget (OMB) a ingredient’’ (or mechanisms underlying
technical evaluations of new, revised, request for review and approval of the effectiveness) of self-affirmations is
and alternative safety testing methods information collection listed below. unknown. Self-affirmation is a potent
and integrated testing strategies with This proposed information collection means of augmenting the effectiveness
regulatory applicability and promotes was previously published in the Federal of threatening health communications.
the scientific validation and regulatory Register on January 14, 2016, Vol. 81 Individuals tend to be defensive against
acceptance of testing methods that both pp. 1985 and allowed 60-days for public information suggesting their behavior
more accurately assess the safety and comment. No public comments were puts them at risk for disease or negative
hazards of chemicals and products and received. The purpose of this notice is health. Previous evidence suggests that
replace, reduce, or refine (enhance to allow an additional 30 days for public self-affirmation may reduce
animal well-being and minimize or comment. The National Cancer Institute, defensiveness to threatening health
prevent pain and distress) animal use. National Institutes of Health, may not information, increasing openness to the
The ICCVAM Authorization Act of 2000 conduct or sponsor, and the respondent message and resulting in increased
(42 U.S.C. 285l–3) establishes ICCVAM is not required to respond to, an disease risk perceptions, disease-related
as a permanent interagency committee information collection that has been worry, intentions to engage in
of the NIEHS and provides the authority extended, revised, or implemented on or preventive behavior, and actual
for ICCVAM involvement in activities after October 1, 1995, unless it displays behavioral change. Understanding the
relevant to the development of a currently valid OMB control number. mechanisms that explain these robust
alternative test methods. ICCVAM acts Direct Comments to OMB: Written effects would yield evidence important
to ensure that new and revised test comments and/or suggestions regarding for dissemination, including ways to
methods are validated to meet the needs the item(s) contained in this notice, refine self-affirmation interventions and
of Federal agencies, increase the especially regarding the estimated make them more potent, which could
efficiency and effectiveness of federal public burden and associated response change the ways that public health
agency test method review, and time, should be directed to the: Office messages are constructed. This research
asabaliauskas on DSK3SPTVN1PROD with NOTICES

optimize utilization of scientific of Management and Budget, Office of can inform NCI scientific priorities and
expertise outside the federal Regulatory Affairs, investments in self-affirmation research.
Government. Additional information OIRA_submission@omb.eop.gov or by The results of the information collection
about ICCVAM can be found at http:// fax to 202–395–6974, Attention: NIH will be used to further develop and
ntp.niehs.nih.gov/go/iccvam. Desk Officer. improve self-affirmation theory. These
NICEATM administers ICCVAM, Comment Due Date: Comments findings may allow future researchers to
provides scientific and operational regarding this information collection are develop and test cancer prevention
support for ICCVAM-related activities, best assured of having their full effect if interventions.

VerDate Sep<11>2014 19:50 Mar 17, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1

Document Created: 2018-02-02 15:14:02
Document Modified: 2018-02-02 15:14:02

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: May 25, 2016, 9:00 a.m. to approximately 4:00 p.m. Eastern Daylight Time (EDT).
Contact		Dr. Warren Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: [email protected]; telephone: (919) 316-4729.
FR Citation		81 FR 14865

81 FR 14865 - Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 53 (March 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health