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

• Published date: 21 December 2021
• Citation: 86 FR 72251
• Record Number: 2021-27581
• Section: Notices
• Court: National Institutes Of Health

Federal Register, Volume 86 Issue 242 (Tuesday, December 21, 2021)

[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]
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