83 FR 20082 - Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range		20082-20082
FR Document		2018-09661

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.

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Page 20082]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09661]


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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.

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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 http://ntp.niehs.nih.gov/go/niceatm and http://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]
 BILLING CODE 4140-01-P

20082 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices

mice, NIAMS inventors have shown that DEPARTMENT OF HEALTH AND Respondents to this request for
the interaction between the TNF family HUMAN SERVICES information should include their name,
ligand TL1A with its receptor, DR3, is affiliation (if applicable), mailing
critical for development of disease in National Institutes of Health address, telephone, email, and
asthma, inflammatory bowel disease sponsoring organization (if any) with
Request for Data and Information on their communications. The deadline for
and multiple sclerosis. They have also Technologies Used for Identifying
developed anti-TL1A antibodies that receipt of the requested information is
Potential Developmental Toxicants June 15, 2018. Responses to this notice
prevent disease in mouse models of
rheumatoid arthritis and inflammatory AGENCY: National Institutes of Health, will be posted at: https://
bowel disease. This invention describes HHS. ntp.niehs.nih.gov/go/dev-nonanimal.
anti-human TL1A monoclonal ACTION: Notice. Persons submitting responses will be
antibodies that may be useful for the identified on the web page by name and
SUMMARY: The National Toxicology affiliation or sponsoring organization, if
development of diagnostics and Program (NTP) Interagency Center for applicable.
therapeutics for autoimmune the Evaluation of Alternative Responses to this request are
inflammatory diseases, as well as Toxicological Methods (NICEATM) voluntary. No proprietary, classified,
methods of treating such diseases by requests available data and information confidential, or sensitive information
blocking the interaction between TL1A on approaches and/or technologies should be included in responses. This
and DR3 by the described antibodies. currently used for identifying potential request for information is for planning
This specific immunomodulatory effect developmental toxicants. Submitted purposes only and is not a solicitation
provides potential for potent therapy information will be used to assess the for applications or an obligation on the
without inducing global state of the science and determine part of the U.S. Government to provide
immunosuppression. technical needs for non-animal test support for any ideas identified in
This notice is made in accordance methods used to evaluate the potential response to the request. Please note that
with 35 U.S.C. 209 and 37 CFR part 404. of chemicals to induce adverse effects in the U.S. Government will not pay for
offspring. the preparation of any information
The prospective Exclusive Patent
DATES: Receipt of information: Deadline submitted or for its use of that
License will be royalty bearing and may
for receipt of information is June 15, information.
be granted unless within fifteen (15)
2018. Background Information on
days from the date of this published
ADDRESSES: Data and information NICEATM: NICEATM conducts data
notice, the NHLBI Office of Technology analyses, workshops, independent
Transfer and Development receives should be submitted electronically to
niceatm@niehs.nih.gov. validation studies, and other activities
written evidence and argument that to assess new, revised, and alternative
establishes that the grant of the license FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Deputy Director, test methods and strategies. NICEATM
would not be consistent with the also provides support for the
requirements of 35 U.S.C. 209 and 37 NICEATM; email: nicole.kleinstreuer@
nih.gov; telephone: (984) 287–3150. Interagency Coordinating Committee on
CFR part 404. the Validation of Alternative Methods
SUPPLEMENTARY INFORMATION:
The public may file comments or (ICCVAM). The ICCVAM Authorization
Background: NICEATM fosters the
objections in response to this Notice. evaluation and promotion of alternative Act of 2000 (42 U.S.C. 285l–3) provides
Comments and objections, other than test methods for regulatory use and authority for ICCVAM and NICEATM
those in the form of a license supports efforts to develop, validate, involvement in activities relevant to the
application, will not be treated and implement alternative approaches development of alternative test
confidentially and may be made for identifying potential developmental methods. Information about NICEATM
publicly available. toxicants that replace, reduce, or refine and ICCVAM can be found at http://
animal use. Testing a chemical’s ntp.niehs.nih.gov/go/niceatm and
License applications submitted in http://ntp.niehs.nih.gov/go/iccvam.
response to this Notice will be potential to cause developmental
toxicity is required by multiple federal Dated: April 27, 2018.
presumed to contain business
agencies for regulatory and other Brian R. Berridge,
confidential information and any release
of information in these license decision contexts, and can use large Associate Director, National Toxicology
numbers of animals. Program.
applications will be made only as
Request for Information: NICEATM [FR Doc. 2018–09661 Filed 5–4–18; 8:45 am]
required and upon a request under the requests available data and information BILLING CODE 4140–01–P
Freedom of Information Act, 5 U.S.C. on approaches and/or technologies
552. currently used to identify potential
Dated: April 27, 2018. developmental toxicants. Respondents DEPARTMENT OF HEALTH AND
Cristina Thalhammer-Reyero, should provide information on any HUMAN SERVICES
Senior Licensing and Patenting Manager, activities relevant to the development or
validation of alternatives to in vivo National Institutes of Health
Office of Technology Transfer and
Development, National Heart, Lung, and developmental toxicity test methods
currently used by federal agencies for Center For Scientific Review; Notice of
Blood Institute. Closed Meetings
[FR Doc. 2018–09654 Filed 5–4–18; 8:45 am] regulatory and other decision contexts.
daltland on DSKBBV9HB2PROD with NOTICES

NICEATM also requests available data Pursuant to section 10(d) of the
BILLING CODE 4140–01–P
from in vivo developmental studies, Federal Advisory Committee Act, as
human or animal studies, or accidental amended, notice is hereby given of the
human exposures, using the same following meetings.
chemicals used to evaluate the The meetings will be closed to the
alternative developmental toxicity test public in accordance with the
methods. provisions set forth in sections

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Document Created: 2018-05-05 02:48:51
Document Modified: 2018-05-05 02:48:51

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
Action		Notice.
Dates		Receipt of information: Deadline for receipt of information is June 15, 2018.
Contact		Dr. Nicole Kleinstreuer, Deputy Director, NICEATM; email: [email protected]; telephone: (984) 287-3150.
FR Citation		83 FR 20082

83 FR 20082 - Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 88 (May 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health