[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Page 72251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on New Approach Methodologies 
for Efficacy Testing of Ectoparasiticide Products To Meet Regulatory 
Data Requirements

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Toxicology Program Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM) requests 
available data and information on approaches and/or technologies 
currently used for efficacy testing of ectoparasiticide products. 
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 efficacy of ectoparasiticides on dogs and cats and to 
facilitate their incorporation into a testing strategy for regulatory 
purposes.

DATES: Receipt of information: Deadline for receipt of information is 
January 28, 2022.

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

FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting 
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. As part of this activity, 
NICEATM supports efforts to develop, validate, and implement 
alternative approaches for chemicals and medical products. These 
include approaches used to evaluate the efficacy of ectoparasiticides 
on dogs and cats, such as products to prevent flea and tick 
infestations. Tests on such products are required by multiple federal 
agencies for regulatory and other decision contexts. Currently, the 
standard tests for this endpoint use animals that can experience 
significant discomfort and distress during the study.
    Request for Information: NICEATM requests available data and 
information on approaches and/or technologies currently used to predict 
the efficacy of ectoparasiticides without using animals. Respondents 
should provide information on any activities relevant to the 
development or validation of alternatives to in vivo test methods 
currently used by federal agencies for regulatory and other decision 
contexts.
    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 January 28, 2022. 
Responses to this notice will be posted at: https://ntp.niehs.nih.gov/go/niceatm-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 involvement in activities relevant to the 
development of alternative test methods. Information about NICEATM and 
ICCVAM can be found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam.

    Dated: December 13, 2021.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2021-27581 Filed 12-20-21; 8:45 am]
BILLING CODE 4140-01-P