[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19499-19500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07420]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information: The National Toxicology Program Requests 
Information On Assays and Approaches Useful for Screening Compounds for 
Potential Neurotoxicity

SUMMARY: The National Toxicology Program (NTP) requests information on 
medium- or high-throughput technologies/assay systems, which allow for 
the batch screening of compounds (e.g., 25-50) in biochemical- or cell-
based assays or alternative (non-rodent) animal models, that might be 
used to prioritize compounds for in vivo neurotoxicity testing.

DATES: The deadline for receipt of information is May 1, 2013.

ADDRESSES: Information may be submitted electronically or as printed 
copy.
    Electronic submissions: Email to [email protected].
    Print submissions: Send 4 copies to Patrick J. Barbour, Contract 
Specialist, National Institute of Environmental Health Sciences 
(NIEHS), P.O. Box 12233 (MD K1-05), Research Triangle Park, NC 27709. 
Courier address: 530 Davis Drive, Keystone Building, Room 1059, 
Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT: Patrick J. Barbour, Contract 
Specialist, NIEHS, P.O. Box 12233 (MD K1-05), Research Triangle Park, 
NC 27709. Courier address: 530 Davis Drive, Keystone Building, Room 
1059, Morrisville, NC 27560. Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    For the purposes of this request for information (RFI), 
neurotoxicity means adverse outcomes to the nervous system resulting 
from exposure during any life stage. Special emphasis is placed on 
identifying assay systems that interrogate cellular and molecular 
events that are critical to the development and/or function of the 
nervous system. The NTP is also interested in receiving

[[Page 19500]]

recommendations on molecular targets within critical cellular toxicity 
pathways in biochemical- or cell-based assays or alternative animal 
models that assess the potential ability of compounds to act as 
toxicants to the developing or adult nervous systems.

Request for Information

    1. Information on technologies/assays currently available for 
screening critical pathways involved in neurotoxicity where the 
endpoint is associated with a phenotypic manifestation of toxicity in 
vivo (adverse outcome).
    a. The referred technologies/assays should have the ability to 
batch screen sets of at least 20 compounds to produce a concentration 
response curve suitable for defining the potency and efficacy of a 
response and have been demonstrated to be both reliable and relevant.
    b. Specific information requested for each assay includes the 
robustness of the assay, dose-response and time-course toxicity 
profiles, as well as to what extent the assay informs on specific 
neurotoxicity life-stage windows (i.e., developmental, juvenile, 
ageing).
    2. Information on assays that can be used to measure the activity 
of a compound on a molecular initiating event or key event within a 
neurotoxicity adverse outcome pathway.
    3. Information on the best molecular or cellular targets that 
accurately characterize the activity of a compound within a specific 
pathway resulting in an adverse neurotoxic outcome.
    4. Information on assays, technologies, or methods that will aid in 
identifying neurotoxic compounds, which are activated or deactivated by 
metabolic activity.
    Respondents to this RFI are asked to provide the following: the 
Data Universal Numbering System or DUNS[supreg] number, organization 
name, address, technical and administrative points of contact 
(including names, titles, addresses, telephone and fax numbers, and 
email address), the North American Industry Classification System 
(NAICS) code, and size and type of business (e.g., 8(a), HUBZone, WOSB, 
SDVOSB, etc.). Information packages should not exceed one (1) page in 
length, excluding standard brochures. Telephone and facsimile responses 
will not be accepted. Electronic information should be submitted in 
Microsoft Office (Word, PowerPoint, Excel), Adobe PDF, or compatible 
formats sufficient to clearly read the information provided. Please 
include a cover page identifying the technical and administrative 
points of contact for the organization, including names, titles, 
addresses, telephone and fax numbers, email addresses, and organization 
name. The deadline for receipt of the requested information is May 1, 
2013.
    Responses to this request are voluntary. This notice does not 
obligate the U.S. Government to award a contract or otherwise pay for 
the information provided in response to this request. The U.S. 
Government reserves the right to use information provided by 
respondents for any purpose deemed necessary and legally appropriate. 
Any organization responding to this request should ensure that its 
response is complete and sufficiently detailed. Respondents are advised 
that the U.S. Government is under no obligation to acknowledge receipt 
of the information received or provide feedback to respondents with 
respect to any information submitted. No proprietary, classified, 
confidential, or sensitive information should be included in your 
response.

Background Information on the NTP

    The NTP is an interagency program established in 1978 (43 FR 53060) 
to coordinate toxicology research and testing across the Department of 
Health and Human Services. Other activities of the program focus on 
strengthening the science base in toxicology, developing and validating 
improved testing methods, and providing information about potentially 
toxic chemicals to health regulatory and research agencies, scientific 
and medical communities, and the public. Information about the NTP is 
found at http://ntp.niehs.nih.gov.

    Dated: March 25, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-07420 Filed 3-29-13; 8:45 am]
BILLING CODE 4140-01-P