[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Page 74458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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