83 FR 27622 - Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 114 (June 13, 2018)

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that are used to detect the presence of BoNT and measure potency of BoNT preparations.

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27622-27623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Technologies Used To Detect 
and Measure Botulinum Neurotoxin

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) requests 
available data and information on approaches and/or technologies 
currently used to detect and measure botulinum neurotoxin (BoNT). 
Submitted information will be used to assess the state of the science 
and determine technical needs for non-animal test methods that are used 
to detect the presence of BoNT and measure potency of BoNT 
preparations.

DATES: Receipt of information: Deadline is July 11, 2018.

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

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (984) 287-3118.

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 biologics tests, including those used to 
detect the presence of BoNT and measure potency of BoNT preparations. 
Tests to detect and measure BoNT are required by multiple federal 
agencies for regulatory and other decision contexts. Currently, the 
standard test for these endpoints is a mouse lethality assay that can 
use large numbers of animals.
    Request for Information: NICEATM requests available data and 
information on approaches and/or technologies currently used to detect 
the presence of BoNT and measure potency of BoNT preparations. 
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. NICEATM also requests available data from in vivo BoNT tests 
used for similar applications as the proposed alternative, such as 
distinguishing between BoNT serotypes in biological matrix samples or 
measuring the potency of therapeutic BoNT preparations.
    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 July 11, 2018. 
Responses to this notice will be posted at: https://ntp.niehs.nih.gov/go/bont. 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 27623]]

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 http://ntp.niehs.nih.gov/go/niceatm and http://ntp.niehs.nih.gov/go/iccvam.

    Dated: June 6, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-12726 Filed 6-12-18; 8:45 am]
 BILLING CODE 4140-01-P