81 FR 76620 - Request for Data and Information on Zebrafish Embryo Chemical Screening

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 213 (November 3, 2016)

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.

[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76620-76621]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Zebrafish Embryo Chemical 
Screening

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 
[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, 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 [email protected] 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

[[Page 76621]]

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: October 27, 2016.
Linda S. Birnbaum,
Director, National Institute of Environmental, Health Sciences and 
National Toxicology Program.
[FR Doc. 2016-26605 Filed 11-2-16; 8:45 am]
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