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Notice

Request for Data and Information on Zebrafish Embryo Chemical Screening

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Information about this document as published in the Federal Register.

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SUMMARY:

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests data and information on zebrafish embryo screening tests and protocol design, including pharmacokinetics measurements. 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 developmental effects in offspring.

DATES:

Receipt of information: Deadline is December 30, 2016.

ADDRESSES:

Data and information should be submitted electronically to niceatm@niehs.nih.gov.

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FOR FURTHER INFORMATION CONTACT:

Dr. Warren Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316-4729.

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SUPPLEMENTARY INFORMATION:

Background: NICEATM, which fosters the evaluation and promotion of alternative test methods for regulatory use, supports efforts to develop, validate, and implement alternative approaches for identifying potential developmental toxicants that replace, reduce, or refine animal use. Multiple regulatory agencies require testing a substance's potential to cause developmental toxicity, which may necessitate the use of large numbers of animals.

Request for Information: NICEATM requests data and information related to chemical screening in the zebrafish embryo. Respondents should provide information on any activities relevant to the development or validation of zebrafish embryo screening assays. NICEATM is particularly interested in how the study design may influence measures of toxicity/bioactivity and the kinetics associated with chemical uptake. For comparative purposes, NICEATM also requests any available data from in vivo developmental studies using the same chemicals.

NICEATM specifically requests information on efforts to optimize zebrafish embryo screening tests and protocol design including comparison of (1) zebrafish strains, (2) embryos with and without an intact chorion, and (3) static and static renewal exposures. NICEATM also requests available data on chemical uptake for developing a better understanding of pharmacokinetics in the zebrafish embryo model.

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 30, 2016. Please contact NICEATM at niceatm@niehs.nih.gov if you have questions or concerns about your submission. 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 Start Printed Page 76621submitted 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. 285 l-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.

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Dated: October 27, 2016.

Linda S. Birnbaum,

Director, National Institute of Environmental, Health Sciences and National Toxicology Program.

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[FR Doc. 2016-26605 Filed 11-2-16; 8:45 am]

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