Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants, 20082 [2018-09661]
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices
mice, NIAMS inventors have shown that
the interaction between the TNF family
ligand TL1A with its receptor, DR3, is
critical for development of disease in
asthma, inflammatory bowel disease
and multiple sclerosis. They have also
developed anti-TL1A antibodies that
prevent disease in mouse models of
rheumatoid arthritis and inflammatory
bowel disease. This invention describes
anti-human TL1A monoclonal
antibodies that may be useful for the
development of diagnostics and
therapeutics for autoimmune
inflammatory diseases, as well as
methods of treating such diseases by
blocking the interaction between TL1A
and DR3 by the described antibodies.
This specific immunomodulatory effect
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without inducing global
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Dated: April 27, 2018.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager,
Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2018–09654 Filed 5–4–18; 8:45 am]
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17:38 May 04, 2018
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Data and Information on
Technologies Used for Identifying
Potential Developmental Toxicants
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM)
requests available data and information
on approaches and/or technologies
currently used for identifying potential
developmental toxicants. Submitted
information will be used to assess the
state of the science and determine
technical needs for non-animal test
methods used to evaluate the potential
of chemicals to induce adverse effects in
offspring.
DATES: Receipt of information: Deadline
for receipt of information is June 15,
2018.
ADDRESSES: Data and information
should be submitted electronically to
niceatm@niehs.nih.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Deputy Director,
NICEATM; email: nicole.kleinstreuer@
nih.gov; telephone: (984) 287–3150.
SUPPLEMENTARY INFORMATION:
Background: NICEATM fosters the
evaluation and promotion of alternative
test methods for regulatory use and
supports efforts to develop, validate,
and implement alternative approaches
for identifying potential developmental
toxicants that replace, reduce, or refine
animal use. Testing a chemical’s
potential to cause developmental
toxicity is required by multiple federal
agencies for regulatory and other
decision contexts, and can use large
numbers of animals.
Request for Information: NICEATM
requests available data and information
on approaches and/or technologies
currently used to identify potential
developmental toxicants. Respondents
should provide information on any
activities relevant to the development or
validation of alternatives to in vivo
developmental toxicity test methods
currently used by federal agencies for
regulatory and other decision contexts.
NICEATM also requests available data
from in vivo developmental studies,
human or animal studies, or accidental
human exposures, using the same
chemicals used to evaluate the
alternative developmental toxicity test
methods.
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Respondents to this request for
information should include their name,
affiliation (if applicable), mailing
address, telephone, email, and
sponsoring organization (if any) with
their communications. The deadline for
receipt of the requested information is
June 15, 2018. Responses to this notice
will be posted at: https://
ntp.niehs.nih.gov/go/dev-nonanimal.
Persons submitting responses will be
identified on the web page by name and
affiliation or sponsoring organization, if
applicable.
Responses to this request are
voluntary. No proprietary, classified,
confidential, or sensitive information
should be included in responses. This
request for information 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
NICEATM: NICEATM conducts data
analyses, workshops, independent
validation studies, and other activities
to assess new, revised, and alternative
test methods and strategies. NICEATM
also provides support for the
Interagency Coordinating Committee on
the Validation of Alternative Methods
(ICCVAM). The ICCVAM Authorization
Act of 2000 (42 U.S.C. 285l–3) provides
authority for ICCVAM and NICEATM
involvement in activities relevant to the
development of alternative test
methods. Information about NICEATM
and ICCVAM can be found at https://
ntp.niehs.nih.gov/go/niceatm and
https://ntp.niehs.nih.gov/go/iccvam.
Dated: April 27, 2018.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2018–09661 Filed 5–4–18; 8:45 am]
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E:\FR\FM\07MYN1.SGM
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[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Page 20082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Data and Information on Technologies Used for
Identifying Potential Developmental Toxicants
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Toxicology Program (NTP) Interagency Center for
the Evaluation of Alternative Toxicological Methods (NICEATM) requests
available data and information on approaches and/or technologies
currently used for identifying potential developmental toxicants.
Submitted information will be used to assess the state of the science
and determine technical needs for non-animal test methods used to
evaluate the potential of chemicals to induce adverse effects in
offspring.
DATES: Receipt of information: Deadline for receipt of information is
June 15, 2018.
ADDRESSES: Data and information should be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Deputy
Director, NICEATM; email: [email protected]; telephone: (984)
287-3150.
SUPPLEMENTARY INFORMATION:
Background: NICEATM fosters the evaluation and promotion of
alternative test methods for regulatory use and supports efforts to
develop, validate, and implement alternative approaches for identifying
potential developmental toxicants that replace, reduce, or refine
animal use. Testing a chemical's potential to cause developmental
toxicity is required by multiple federal agencies for regulatory and
other decision contexts, and can use large numbers of animals.
Request for Information: NICEATM requests available data and
information on approaches and/or technologies currently used to
identify potential developmental toxicants. Respondents should provide
information on any activities relevant to the development or validation
of alternatives to in vivo developmental toxicity test methods
currently used by federal agencies for regulatory and other decision
contexts. NICEATM also requests available data from in vivo
developmental studies, human or animal studies, or accidental human
exposures, using the same chemicals used to evaluate the alternative
developmental toxicity test methods.
Respondents to this request for information should include their
name, affiliation (if applicable), mailing address, telephone, email,
and sponsoring organization (if any) with their communications. The
deadline for receipt of the requested information is June 15, 2018.
Responses to this notice will be posted at: https://ntp.niehs.nih.gov/go/dev-nonanimal. Persons submitting responses will be identified on
the web page by name and affiliation or sponsoring organization, if
applicable.
Responses to this request are voluntary. No proprietary,
classified, confidential, or sensitive information should be included
in responses. This request for information 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 NICEATM: NICEATM conducts data analyses,
workshops, independent validation studies, and other activities to
assess new, revised, and alternative test methods and strategies.
NICEATM also provides support for the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3) provides authority for
ICCVAM and NICEATM involvement in activities relevant to the
development of alternative test methods. Information about NICEATM and
ICCVAM can be found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam.
Dated: April 27, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-09661 Filed 5-4-18; 8:45 am]
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