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)

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, 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