81 FR 74458 - Short-Term Alternative Animal Models or In Vitro Tests Used To Identify Substances With the Potential To Cause Excessive Inflammation or Exaggerated Immune Responses; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range		74458-74458
FR Document		2016-25924

The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) requests available data and information on approaches and/or technologies currently used to identify substances with the potential to cause excessive inflammation or exaggerated immune responses leading to tissue injury when swallowed, inhaled, or absorbed through the skin. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that could be used to evaluate the potential of chemicals to induce inflammation and immune-related conditions.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Page 74458]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Short-Term Alternative Animal Models or In Vitro Tests Used To 
Identify Substances With the Potential To Cause Excessive Inflammation 
or Exaggerated Immune Responses; Request for Information

SUMMARY: The National Toxicology Program (NTP) at the National 
Institute of Environmental Health Sciences (NIEHS) requests available 
data and information on approaches and/or technologies currently used 
to identify substances with the potential to cause excessive 
inflammation or exaggerated immune responses leading to tissue injury 
when swallowed, inhaled, or absorbed through the skin. Submitted 
information will be used to assess the state of the science and 
determine technical needs for non-animal test methods that could be 
used to evaluate the potential of chemicals to induce inflammation and 
immune-related conditions.

DATES: Receipt of information: Deadline is December 12, 2016.

ADDRESSES: Data and information should be submitted electronically at 
http://ntp.niehs.nih.gov/go/input.

FOR FURTHER INFORMATION CONTACT: Dr. Dori Germolec, Toxicology Branch, 
Division of NTP, NIEHS; email: [email protected]; telephone: (919) 
541-3230.

SUPPLEMENTARY INFORMATION: 
    Background: NTP has an interest in developing more efficient and 
scalable test platforms to provide the scientific basis for predictive 
models of chemical effects on human disease. Short-term toxicity tests 
may be conducted to determine the potential for a single or short-term 
dose of a substance to cause inflammation-related responses or impact 
local and systemic immune function when inhaled (inhalation toxicity 
testing), swallowed (oral toxicity testing), or absorbed through the 
skin (dermal toxicity testing). A number of observations support a role 
for environmental influences on inflammatory and immune-related 
diseases such as diabetes. One specific use of information received in 
response to this request is to assist NTP in identifying in vitro or 
alternative animal model screens that might be used to assess the 
potential for chemicals to cause outcomes related to Type 1 diabetes. 
In addition, information received from this request will provide 
fundamental knowledge on the use of these in vitro platforms for 
identifying environmental triggers of excessive inflammation and 
exaggerated immune responses that could lead to tissue injury.
    Request for Information: NTP requests available data and 
information on approaches and/or technologies currently used to 
identify substances with the potential to cause excessive inflammation 
or exaggerated immune responses leading to tissue injury. Respondents 
should provide information on any activities relevant to the 
development or validation of alternatives to in vivo tests currently 
used in the assessment of immune toxicity and autoimmunity.
    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 December 12, 2016.
    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 NTP: NTP is an interagency program 
established in 1978 (43 FR 53060) to strengthen the Department's 
activities in toxicology research and testing and to develop and 
validate new and better testing methods. Other activities of the 
program focus on strengthening the science base in toxicology and 
providing information about potentially toxic chemicals to health-
regulatory and research agencies, scientific and medical communities, 
and the public. NTP is located administratively at the NIEHS. 
Information about NIEHS and NTP is available at http://www.niehs.nih.gov and http://ntp.niehs.nih.gov, respectively.

    Dated: October 20, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-25924 Filed 10-25-16; 8:45 am]
 BILLING CODE 4140-01-P

74458 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices

appointed for the Committee leadership. technical needs for non-animal test receipt of the requested information is
The Committee structure has been methods that could be used to evaluate December 12, 2016.
expanded to include ex-officio the potential of chemicals to induce Responses to this request are
representation from the Department of inflammation and immune-related voluntary. No proprietary, classified,
Veterans Affairs (VA). The VA has the conditions. confidential, or sensitive information
largest conglomerate of hospitals in the should be included in responses. This
DATES: Receipt of information: Deadline
United States. The agency has request for information is for planning
is December 12, 2016.
responsibility for the largest patient purposes only and is not a solicitation
population that uses the largest quantity ADDRESSES: Data and information
for applications or an obligation on the
of blood and tissue products in the should be submitted electronically at
part of the U.S. Government to provide
United States. Therefore, it was http://ntp.niehs.nih.gov/go/input.
support for any ideas identified in
determined that involvement of the VA FOR FURTHER INFORMATION CONTACT: Dr. response to the request. Please note that
would be beneficial to the ACBTSA for Dori Germolec, Toxicology Branch, the U.S. Government will not pay for
ensuring that the Committee properly Division of NTP, NIEHS; email: the preparation of any information
addresses current issues and concerns germolec@niehs.nih.gov; telephone: submitted or for its use of that
regarding blood and tissue safety and (919) 541–3230. information.
availability. SUPPLEMENTARY INFORMATION: Background Information on NTP: NTP
On October 5, 2016, the new charter Background: NTP has an interest in is an interagency program established in
for the ACBTSA was approved by the developing more efficient and scalable 1978 (43 FR 53060) to strengthen the
Secretary of Health and Human test platforms to provide the scientific Department’s activities in toxicology
Services, and it was filed with the basis for predictive models of chemical research and testing and to develop and
appropriate Congressional committees effects on human disease. Short-term validate new and better testing methods.
and the Library of Congress on October toxicity tests may be conducted to Other activities of the program focus on
9, 2016. ACBTSA is authorized to determine the potential for a single or strengthening the science base in
operate until October 9, 2018. A copy of short-term dose of a substance to cause toxicology and providing information
the charter can be obtained on the inflammation-related responses or about potentially toxic chemicals to
ACBTSA Web site at http:// impact local and systemic immune health-regulatory and research agencies,
www.hhs.gov/ash/bloodsafety. function when inhaled (inhalation
Copies of the charters for the scientific and medical communities,
toxicity testing), swallowed (oral and the public. NTP is located
designated committees also can be
toxicity testing), or absorbed through the administratively at the NIEHS.
obtained by accessing the FACA
skin (dermal toxicity testing). A number Information about NIEHS and NTP is
database that is maintained by the
of observations support a role for available at http://www.niehs.nih.gov
Committee Management Secretariat
environmental influences on and http://ntp.niehs.nih.gov,
under the General Services
inflammatory and immune-related respectively.
Administration. The Web site address
diseases such as diabetes. One specific Dated: October 20, 2016.
for the FACA database is http://
use of information received in response
facadatabase.gov/. John R. Bucher,
to this request is to assist NTP in
Dated: October 20, 2016. identifying in vitro or alternative animal Associate Director, National Toxicology
Karen B. DeSalvo, Program.
model screens that might be used to
[FR Doc. 2016–25924 Filed 10–25–16; 8:45 am]
Acting Assistant Secretary for Health. assess the potential for chemicals to
cause outcomes related to Type 1 BILLING CODE 4140–01–P
[FR Doc. 2016–25916 Filed 10–25–16; 8:45 am]
BILLING CODE 4150–28–P diabetes. In addition, information
received from this request will provide
fundamental knowledge on the use of DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND these in vitro platforms for identifying HUMAN SERVICES
HUMAN SERVICES environmental triggers of excessive National Institutes of Health
inflammation and exaggerated immune
National Institutes of Health responses that could lead to tissue National Institute of Allergy and
injury. Infectious Diseases; Notice of Closed
Short-Term Alternative Animal Models
Request for Information: NTP requests Meetings
or In Vitro Tests Used To Identify
available data and information on
Substances With the Potential To Pursuant to section 10(d) of the
approaches and/or technologies
Cause Excessive Inflammation or Federal Advisory Committee Act, as
currently used to identify substances
Exaggerated Immune Responses; amended (5 U.S.C. App.), notice is
with the potential to cause excessive
Request for Information hereby given of the following meetings.
inflammation or exaggerated immune
SUMMARY: The National Toxicology responses leading to tissue injury. The meetings will be closed to the
Program (NTP) at the National Institute Respondents should provide public in accordance with the
of Environmental Health Sciences information on any activities relevant to provisions set forth in sections
(NIEHS) requests available data and the development or validation of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
information on approaches and/or alternatives to in vivo tests currently as amended. The grant applications and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

technologies currently used to identify used in the assessment of immune the discussions could disclose
substances with the potential to cause toxicity and autoimmunity. confidential trade secrets or commercial
excessive inflammation or exaggerated Respondents to this request for property such as patentable material,
immune responses leading to tissue information should include their name, and personal information concerning
injury when swallowed, inhaled, or affiliation (if applicable), mailing individuals associated with the grant
absorbed through the skin. Submitted address, telephone, email, and applications, the disclosure of which
information will be used to assess the sponsoring organization (if any) with would constitute a clearly unwarranted
state of the science and determine their communications. The deadline for invasion of personal privacy.

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Document Created: 2016-10-26 02:17:16
Document Modified: 2016-10-26 02:17:16

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		Receipt of information: Deadline is December 12, 2016.
Contact		Dr. Dori Germolec, Toxicology Branch, Division of NTP, NIEHS; email: [email protected]; telephone: (919) 541-3230.
FR Citation		81 FR 74458

81 FR 74458 - Short-Term Alternative Animal Models or In Vitro Tests Used To Identify Substances With the Potential To Cause Excessive Inflammation or Exaggerated Immune Responses; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 207 (October 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health