[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Page 46696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Technologies Used To Identify 
Substances With the Potential To Cause Acute Systemic Toxicity

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) requests 
data and information on approaches and/or technologies currently used 
to identify substances with the potential to cause acute systemic 
toxicity 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 used to 
evaluate the potential of chemicals to induce acute systemic toxicity.

DATES: Receipt of information: Deadline is September 1, 2016.

ADDRESSES: Data and information should be submitted electronically to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION: 
    Background: Acute systemic toxicity tests are conducted to 
determine the potential for a single or short-term dose of a substance 
to cause illness or death when inhaled (inhalation toxicity testing), 
swallowed (oral toxicity testing), or absorbed through the skin (dermal 
toxicity testing). These tests are required by multiple regulatory 
agencies and can use large numbers of animals. NICEATM, which fosters 
the evaluation and promotion of alternative test methods for regulatory 
use, supports efforts to develop, validate, and implement alternative 
approaches for acute systemic toxicity testing that replace, reduce, or 
refine use of animals in testing.
    Request for Information: NICEATM requests data and information on 
approaches and/or technologies currently used to identify substances 
with the potential to cause acute systemic toxicity. Respondents should 
provide information on any activities relevant to the development or 
validation of alternatives to in vivo tests currently required by 
regulatory agencies that assess acute oral, dermal, or inhalation 
toxicity. Of specific interest are chemical-specific data from non-
animal tests for acute systemic toxicity hazard, as well as available 
data on the same chemicals from in vivo acute systemic toxicity tests, 
such as ethical human or animal studies or accidental human exposures.
    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 September 1, 2016. 
Responses to this notice will be posted at http://ntp.niehs.nih.gov/go/iv-data. 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 in the development of alternative test methods. 
Information about NICEATM and ICCVAM is found at http://ntp.niehs.nih.gov/go/niceatm and http://ntp.niehs.nih.gov/go/iccvam.

    Dated: July 12, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-16840 Filed 7-15-16; 8:45 am]
 BILLING CODE 4140-01-P