Notice2021-27581
Request for Data and Information on New Approach Methodologies for Efficacy Testing of Ectoparasiticide Products To Meet Regulatory Data Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 21, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 242 (Tuesday, December 21, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Page 72251]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27581]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
<a href="/cdn-cgi/l/email-protection#e48a8d8781859089a48a8d818c97ca8a8d8cca838b92"><span class="__cf_email__" data-cfemail="412f28222420352c012f282429326f2f28296f262e37">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting
Director, NICEATM; email: <a href="/cdn-cgi/l/email-protection#6907000a06050c4702050c00071a1d1b0c1c0c1b29070001470e061f"><span class="__cf_email__" data-cfemail="bcd2d5dfd3d0d992d7d0d9d5d2cfc8ced9c9d9cefcd2d5d492dbd3ca">[email protected]</span></a>; 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: <a href="https://ntp.niehs.nih.gov/go/niceatm">https://ntp.niehs.nih.gov/go/niceatm</a>-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 <a href="https://ntp.niehs.nih.gov/go/niceatm">https://ntp.niehs.nih.gov/go/niceatm</a> and <a href="https://ntp.niehs.nih.gov/go/iccvam">https://ntp.niehs.nih.gov/go/iccvam</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 21, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.