Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Webcast; Request for Public Input, 18547-18548 [2021-07315]
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Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
Inventors: Jeffery Taubenberger
(NIAID).
Intellectual Property: HHS Reference
No. E–195–2014—U.S. Provisional
Application No. 62/014,814, filed June
20, 2014; PCT Application No. PCT/
US2015/029843, filed May 8, 2015; U.S.
Patent No. 10,130,700, issued November
20, 2018; European Application No.
#15724151.4, filed May 8, 2015
(pending); Chinese Application No.
201580037799.4, filed May 8, 2015
(pending); and Indian Application No.
201617043281, filed May 8, 2015
(pending).
Licensing Contact: To license this
technology, please contact Elizabeth
Pitts, Ph.D., 240–669–5299;
elizabeth.pitts@nih.gov.
Dated: March 12, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–07312 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods; Notice of Public Webcast;
Request for Public Input
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 view the presentations by webcast.
Time will be set aside for questions and
public statements on the topics
discussed. Registration is required for
both webcast viewing and oral
statements. Information about the
meeting and registration is available at
https://ntp.niehs.nih.gov/go/
iccvamforum-2021.
DATES:
Webcast: May 27, 2021, 9:00 a.m. to
approximately 3:00 p.m. EDT.
Registration for Webcast: April 12,
2021, until 3:00 p.m. EDT May 27, 2021.
Registration for Oral Statements:
April 12, 2021, until 4:00 p.m. EDT May
14, 2021.
Registration to view the webcast and
present oral public statements is
required.
SUMMARY:
VerDate Sep<11>2014
17:45 Apr 08, 2021
Jkt 253001
ADDRESSES:
Webinar web page: A preliminary
agenda will be posted by May 3 at
https://ntp.niehs.nih.gov/go/
iccvamforum-2021. Information to
connect to the webcast will be provided
to those who register for viewing.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Acting Director,
National Toxicology Program
Interagency Center for the Evaluation of
Alternative Toxicological Methods
(NICEATM), Division of NTP, NIEHS,
P.O. Box 12233, K2–17, Research
Triangle Park, NC 27709. Phone: 984–
287–3150, Email: nicole.kleinstreuer@
nih.gov. Hand Deliver/Courier address:
530 Davis Drive, Room K2021,
Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM, a
congressionally mandated committee,
promotes the development and
validation of alternative testing
strategies 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 convenes
an annual public forum to share
information and facilitate direct
communication of ideas and suggestions
from stakeholders (79 FR 25136).
This year’s meeting will be held on
May 27, 2021. Due to restrictions on inperson gatherings amid ongoing public
health concerns, the public forum will
be presented via webcast only.
NICEATM and ICCVAM members will
give presentations on current activities
related to the development and
validation of alternative test methods
and approaches, including activities
relevant to implementation of the
strategic roadmap for establishing new
approaches to evaluate the safety of
chemicals and medical products in the
United States (83 FR 7487).
There will be opportunities for
registered participants to ask clarifying
or follow-up questions of the ICCVAM
members about their presentations
during the meeting. Instructions for
submitting these questions will be
provided via email prior to the webcast.
The agenda will also include time for
public oral statements relevant to the
ICCVAM mission and current activities
from participants who have registered to
do so in advance.
Preliminary Agenda and Other
Meeting Information: A preliminary
agenda will be posted by May 3 at
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
18547
https://ntp.niehs.nih.gov/go/
iccvamforum-2021. Interested
individuals are encouraged to visit this
web page to stay abreast of the most
current meeting information.
Webcast and Registration: This
webcast is open to the public.
Registration for the webcast is required
and is open from April 12, 2021,
through 3:00 p.m. EDT on May 27, 2021
at https://ntp.niehs.nih.gov/go/
commprac-2021. Registrants will
receive instructions on how to access
and participate in the webcast in the
email confirming their registration.
Request for Oral or Written Public
Statements: In addition to time for
clarifying or follow-up questions
following scheduled presentations, time
will be allotted during the meeting for
oral public statements with associated
slides on topics relevant to ICCVAM’s
mission. Any participant registered for
the webcast may ask clarifying
questions during the appropriate times
in the agenda. The additional
registration is only required for those
who wish to give separate public
statements. Written public statements
on topics relevant to ICCVAM’s mission
will also be accepted.
Separate registration for those wishing
to provide oral public statements is
required and is open from April 12,
2021 through May 14, 2021 at https://
ntp.niehs.nih.gov/go/commprac-2021.
The number and length of public
statement presentations may be limited
based on available time. Submitters will
be identified by their name and
affiliation and/or sponsoring
organization, if applicable. Participants
registered to present oral public
statements must email their statement to
ICCVAMquestions@niehs.nih.gov by
May 14, 2021, to allow time for review
by NICEATM and ICCVAM and posting
to the meeting page prior to the forum.
Persons presenting oral public
statements will be contacted to arrange
the logistics of their presentations. If
participants registered to present oral
public statements wish to use
accompanying slides and/or submit
supplementary written material, they
must email these materials to
ICCVAMquestions@niehs.nih.gov by
May 14, 2021. This deadline is to allow
time for review by NICEATM and
ICCVAM and posting to the meeting
page prior to the forum.
Written statements on topics relevant
to ICCVAM’s mission may be submitted
to support an oral public statement or as
standalone documents. These should be
emailed to ICCVAMquestions@
niehs.nih.gov by May 14, 2021. Public
statements received prior to the May 14,
2021 deadline will be distributed to
E:\FR\FM\09APN1.SGM
09APN1
18548
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
NICEATM and ICCVAM members
before the meeting. Written public
statements received after the deadline
may be reviewed by NICEATM and
ICCVAM at a future date.
Materials submitted to accompany
oral public statements or standalone
written statements should include the
submitters name, affiliation (if any),
mailing address, telephone, email, and
sponsoring organization (if any) with
the document. National Toxicology
Program guidelines for public
statements are at https://
ntp.niehs.nih.gov/ntp/about_ntp/
guidelines_public_comments_508.pdf.
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 17 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 wellbeing 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 https://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
VerDate Sep<11>2014
17:45 Apr 08, 2021
Jkt 253001
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 https://ntp.niehs.nih.gov/go/
niceatm.
Dated: March 26, 2021.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2021–07315 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Data and Specimen
Hub (DASH) (Eunice Kennedy Shriver
National Institute of Child Health and
Human Development)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Regina Bures,
Ph.D., Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, 6710B Rockledge
Drive, Room 2160, Bethesda, MD 20817,
or call non-toll-free number (301)–496–
9485 or Email your request, including
ADDRESSES:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
your address to: NICHD.DASH@
mail.nih.gov.
This
proposed information collection was
previously published in the Federal
Register on January 14, 2021, page
3160–3162 (86 FR 3160–3162) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Data and
Specimen Hub (DASH)-0925–0744
expiration date 01/31/2022, REVISION,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This is a request to revise the
previously approved submission (OMB
number: 0925–0744) to add the
collection of additional information
from Users who will submit information
to NICHD Data and Specimen Hub
(DASH) about studies, and data
collections stored in publicly accessible
external archives—a process hereinafter
referred to as ‘cataloging’ in DASH.
DASH has been established by NICHD
as a data sharing mechanism for
biomedical research investigators. It
serves as a centralized resource for
investigators to share and access deidentified study data from studies
funded by NICHD. DASH also serves as
a portal for requesting biospecimens
from selected DASH studies.
NICHD also supports other public
archives, data collections, and
resources, such as Data Sharing for
Demographic Research (DSDR), NICHD/
DIPHR Biospecimen Repository Access
and Data Sharing (BRADS), the Down
Syndrome Registry (DS-Connect),
Zebrafish Information Network (ZFIN),
etc. In addition to these NICHD-funded
public archives, many collaborative
studies funded through NICHD are
dispersed across other National
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09APN1.SGM
09APN1
Agencies
[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18547-18548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07315]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee on the Validation of
Alternative Methods; Notice of Public Webcast; Request for Public Input
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 view the
presentations by webcast. Time will be set aside for questions and
public statements on the topics discussed. Registration is required for
both webcast viewing and oral statements. Information about the meeting
and registration is available at https://ntp.niehs.nih.gov/go/iccvamforum-2021.
DATES:
Webcast: May 27, 2021, 9:00 a.m. to approximately 3:00 p.m. EDT.
Registration for Webcast: April 12, 2021, until 3:00 p.m. EDT May
27, 2021.
Registration for Oral Statements: April 12, 2021, until 4:00 p.m.
EDT May 14, 2021.
Registration to view the webcast and present oral public statements
is required.
ADDRESSES:
Webinar web page: A preliminary agenda will be posted by May 3 at
https://ntp.niehs.nih.gov/go/iccvamforum-2021. Information to connect
to the webcast will be provided to those who register for viewing.
FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting
Director, National Toxicology Program Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM), Division of
NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park, NC 27709.
Phone: 984-287-3150, Email: [email protected]. Hand Deliver/
Courier address: 530 Davis Drive, Room K2021, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM, a congressionally mandated committee, promotes
the development and validation of alternative testing strategies 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 convenes an annual public forum to
share information and facilitate direct communication of ideas and
suggestions from stakeholders (79 FR 25136).
This year's meeting will be held on May 27, 2021. Due to
restrictions on in-person gatherings amid ongoing public health
concerns, the public forum will be presented via webcast only. NICEATM
and ICCVAM members will give presentations on current activities
related to the development and validation of alternative test methods
and approaches, including activities relevant to implementation of the
strategic roadmap for establishing new approaches to evaluate the
safety of chemicals and medical products in the United States (83 FR
7487).
There will be opportunities for registered participants to ask
clarifying or follow-up questions of the ICCVAM members about their
presentations during the meeting. Instructions for submitting these
questions will be provided via email prior to the webcast. The agenda
will also include time for public oral statements relevant to the
ICCVAM mission and current activities from participants who have
registered to do so in advance.
Preliminary Agenda and Other Meeting Information: A preliminary
agenda will be posted by May 3 at https://ntp.niehs.nih.gov/go/iccvamforum-2021. Interested individuals are encouraged to visit this
web page to stay abreast of the most current meeting information.
Webcast and Registration: This webcast is open to the public.
Registration for the webcast is required and is open from April 12,
2021, through 3:00 p.m. EDT on May 27, 2021 at https://ntp.niehs.nih.gov/go/commprac-2021. Registrants will receive
instructions on how to access and participate in the webcast in the
email confirming their registration.
Request for Oral or Written Public Statements: In addition to time
for clarifying or follow-up questions following scheduled
presentations, time will be allotted during the meeting for oral public
statements with associated slides on topics relevant to ICCVAM's
mission. Any participant registered for the webcast may ask clarifying
questions during the appropriate times in the agenda. The additional
registration is only required for those who wish to give separate
public statements. Written public statements on topics relevant to
ICCVAM's mission will also be accepted.
Separate registration for those wishing to provide oral public
statements is required and is open from April 12, 2021 through May 14,
2021 at https://ntp.niehs.nih.gov/go/commprac-2021. The number and
length of public statement presentations may be limited based on
available time. Submitters will be identified by their name and
affiliation and/or sponsoring organization, if applicable. Participants
registered to present oral public statements must email their statement
to [email protected] by May 14, 2021, to allow time for
review by NICEATM and ICCVAM and posting to the meeting page prior to
the forum. Persons presenting oral public statements will be contacted
to arrange the logistics of their presentations. If participants
registered to present oral public statements wish to use accompanying
slides and/or submit supplementary written material, they must email
these materials to [email protected] by May 14, 2021. This
deadline is to allow time for review by NICEATM and ICCVAM and posting
to the meeting page prior to the forum.
Written statements on topics relevant to ICCVAM's mission may be
submitted to support an oral public statement or as standalone
documents. These should be emailed to I[email protected] by
May 14, 2021. Public statements received prior to the May 14, 2021
deadline will be distributed to
[[Page 18548]]
NICEATM and ICCVAM members before the meeting. Written public
statements received after the deadline may be reviewed by NICEATM and
ICCVAM at a future date.
Materials submitted to accompany oral public statements or
standalone written statements should include the submitters name,
affiliation (if any), mailing address, telephone, email, and sponsoring
organization (if any) with the document. National Toxicology Program
guidelines for public statements are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
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 17 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 https://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 test methods and strategies for
validation studies and technical evaluations. Additional information
about NICEATM can be found at https://ntp.niehs.nih.gov/go/niceatm.
Dated: March 26, 2021.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2021-07315 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P