81 FR 42718 - 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 81, Issue 126 (June 30, 2016)

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 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42718-42719]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15444]


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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

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 is August 15, 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: NICEATM, which fosters the evaluation and promotion of 
alternative test methods for regulatory use, is supporting efforts to 
develop, validate, and implement alternative approaches for identifying 
potential developmental toxicants. The goal of these alternative 
approaches is to replace, reduce, or refine the use of animals in 
testing. Testing a chemical's potential to cause developmental toxicity 
is required by multiple regulatory agencies and may require the use of 
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 required by regulatory agencies, including data from non-
animal chemical tests for developmental hazard potential. NICEATM also 
requests any available data resulting from in vivo developmental 
studies, ethical human or animal studies, or accidental human 
exposures, using the same chemicals.
    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 August 15, 2016. 
Responses to this notice will be posted at: http://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.

[[Page 42719]]

    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: June 24, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-15444 Filed 6-29-16; 8:45 am]
 BILLING CODE 4140-01-P