Request for Information: The National Toxicology Program Requests Information On Assays and Approaches Useful for Screening Compounds for Potential Neurotoxicity, 19499-19500 [2013-07420]

Download as PDF Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices Contact Person: Martin H. Goldrosen, Ph.D., Director, Division of Extramural Activities, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Blvd., Ste. 401, Bethesda, MD 20892–5475, (301) 594–2014, goldrosm@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: nccam.nih.gov/about/naccam/, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Minna Liang, Ph.D., Scientific Review Officer, Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4226, MSC 9550, Bethesda, MD 20892–9550, 301– 435–1432, liangm@nida.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: March 26, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. National Institutes of Health BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health pmangrum on DSK3VPTVN1PROD with NOTICES National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 USC, as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel PAR– 12–297: Mechanism for Time-Sensitive Drug Abuse Research. Date: April 9, 2013. Time: 12:00 p.m. to 2:00 p.m. 15:34 Mar 29, 2013 Jkt 229001 [FR Doc. 2013–07424 Filed 3–29–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute on Drug Abuse; Notice of Closed Meeting [FR Doc. 2013–07421 Filed 3–29–13; 8:45 am] VerDate Mar<15>2010 Dated: March 26, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 USC, as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Profile Screening and Predictive Toxicology (8909). Date: April 29, 2013. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Lyle Furr, Contract Review Specialist, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892– 9550, (301) 435–1439, lf33c.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 19499 Addiction Research Programs, National Institutes of Health, HHS) Dated: March 26, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2013–07423 Filed 3–29–13; 8:45 am] BILLING CODE 4140–01–P 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 biochemicalor cell-based assays or alternative (nonrodent) 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 barbourp@niehs.nih.gov. 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: barbourp@niehs.nih.gov. 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 E:\FR\FM\01APN1.SGM 01APN1 19500 Federal Register / Vol. 78, No. 62 / Monday, April 1, 2013 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES 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 timecourse 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® 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 VerDate Mar<15>2010 15:34 Mar 29, 2013 Jkt 229001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/ IITF’s certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http://www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, Room 2– 1042, One Choke Cherry Road, Rockville, Maryland 20857; 240–276– 2600 (voice), 240–276–2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. The ‘‘Mandatory Guidelines for Federal Workplace Drug Testing Programs’’, as amended in the revisions listed above, requires strict standards that Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant Laboratory/IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a Laboratory/IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories and Instrumented Initial Testing Facilities (IITF) in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A Laboratory/ E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19499-19500]
From the Federal Register Online via the Government Printing 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 barbourp@niehs.nih.gov.
    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: barbourp@niehs.nih.gov.

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