Request for Information: The National Institute of Environmental Health Sciences/National Toxicology Program Requests the Nomination and Prioritization of Environmentally Responsive Genes for Use in Screening Large Numbers of Substances Using Toxicogenomic Technologies, 45542-45543 [2013-18058]

Download as PDF 45542 Federal Register / Vol. 78, No. 145 / Monday, July 29, 2013 / Notices Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Karin F Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD 20892, (301) 254– 9975, helmersk@csr.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. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 23, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–18053 Filed 7–26–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Information: The National Institute of Environmental Health Sciences/National Toxicology Program Requests the Nomination and Prioritization of Environmentally Responsive Genes for Use in Screening Large Numbers of Substances Using Toxicogenomic Technologies The National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP) is interested in the identification and prioritization of a comprehensive list of environmentally responsive genes that might be targets for screening cells or tissues obtained from humans, rats, mice, zebrafish, and Caenorhabditis elegans against large numbers of substances. The goal is to generate a minimum list of 1000 genes for each species that would provide the maximal toxicogenomic information on (1) effects that reflect general cellular responses, independent of cell type or species, and (2) gene expression changes that are specific by organ and/or cell type. The NIEHS/NTP also seeks recommendations on criteria to use for prioritizing the genes in order to identify those potentially most useful in a screening paradigm. Such a list of environmentally responsive genes may be useful also in biomarker development and basic research efforts. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:00 Jul 26, 2013 Jkt 229001 The deadline for receipt of information is August 23, 2013. ADDRESSES: Nominated genes and/or recommendations on prioritization criteria should be submitted electronically in Microsoft Excel or Word formats to Genelist@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT: Dr. Elizabeth Maull, NIEHS, P. O. Box 12233 (MD K2–17), Research Triangle Park, NC 27709; email: maull@niehs.nih.gov. SUPPLEMENTARY INFORMATION: DATES: Background: In 2008, the NIEHS/NTP, the U.S. Environmental Protection Agency’s (EPA) National Center for Computational Toxicology (NCCT), and the National Human Genome Research Institute (NHGRI)/NIH Chemical Genomics Center (NCGC) (now located within the National Center for Advancing Translational Sciences (NCATS)) entered into a formal agreement to develop a vision and devise an implementation strategy to shift the assessment of chemical hazards from traditional, experimental animal, toxicology studies to target-specific, mechanism-based, biological observations largely obtained using in vitro assays. In mid-2010, the U.S. Food and Drug Administration (FDA) joined the collaboration that is known informally as Tox21. In Tox21, the agencies collaborate to research, develop, validate, and translate innovative testing methods for characterization of toxicity pathways; identify compounds, assays, informatic analyses, and targeted testing needed to support the development of new methods; identify patterns of compound-induced biological response(s) in order to characterize toxicity pathways; facilitate crossspecies and low-dose extrapolation; prioritize compounds for more extensive toxicological evaluation; and develop predictive models for biological response in humans. Currently, the primary Tox21 activity is the screening of a 10,000 compound library in a number of nuclear receptor agonist/ antagonist and stress response pathway assays primarily using reporter gene platforms. In the next phase, the focus will be on assaying large numbers of chemicals in high content screens and mid to high throughput, targeted gene expression platforms. To conduct the next phase, the NIEHS/NTP in collaboration with its Tox21 partners seeks to identify a prioritized set of at least 1000 genes that would provide comprehensive toxicogenomic information on (1) gene PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 induction or repression reflecting general cellular responses that are largely independent of cell type or species, and (2) gene expression changes that are organ and/or cell type specific. Examples of processes likely to be celltype independent include genes involved in stress-response pathways (e.g., DNA repair, hypoxia, heat shock), chromatin remodeling, and those that regulate cell division and death. Examples of processes more likely to be cell-type specific include induction or repression of expression of enzymes that modify or activate chemical toxicants, regulation of the hypothalamicpituitary-adrenal axis, and inflammatory responses. In keeping with the Tox21 goal of facilitating cross-species extrapolation, the NIEHS/NTP is especially interested in the nomination of genes or gene sets specifically relevant for comparisons between humans, rats, mice, zebrafish, and C. elegans and especially those for which complementary functional pathways exist. Such a list of environmentally responsive genes may be useful also in biomarker development and basic research efforts. To facilitate identification of the most useful genes to include in a screening paradigm, the NIEHS/NTP also requests recommendations on criteria to use for their prioritization. Request for Information The NIEHS/NTP seeks to establish a prioritized list of environmentally responsive genes to screen cells/tissues from humans, rats, mice, zebrafish, and C. elegans for agent-induced alterations using mid to high throughput, targeted transcriptomics platforms. The goal is to screen a large number of compounds and obtain information useful for understanding the potential for adverse health outcomes. To that end, the NIEHS/NTP requests that respondents provide information for either or both of the following: • Nominations of specific genes or gene sets. Nominated genes should be identified using Entrez and/or Ensembl gene IDs. Desirable supporting information for the nominated gene(s) would include the associated pathway(s) or biological process(s), the cellular context(s) where demonstrated, and the technology used to measure expression of the nominated gene. If available, please include relevant citations as a part of the supporting information. • Criteria for prioritization of the genes or gene sets. The NIEHS/NTP is interested in criteria that could be used to develop a prioritized list of genes that would provide the greatest level of E:\FR\FM\29JYN1.SGM 29JYN1 Federal Register / Vol. 78, No. 145 / Monday, July 29, 2013 / Notices insight and discrimination of toxicological response in a variety of applications including cross-species comparisons and differential tissue responses. The nominated genes and/or criteria recommendations should be submitted electronically in Microsoft Excel or Word format. Respondents to this request for information are asked also to provide their name, affiliation, address, and contact information (including telephone and fax numbers, and email address). The deadline for receipt of the requested information is August 23, 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. mstockstill on DSK4VPTVN1PROD with NOTICES Background Information on the NTP The NTP is an interagency program established in 1978 (43 FR 53060) to strengthen the Department’s activities in toxicology research and testing, and develop and validate new and better testing methods. Other activities of the program focus on strengthening the science base in toxicology and providing information about potentially toxic chemicals to health regulatory and research agencies, scientific and medical communities, and the public. The NTP is located administratively at the NIEHS. Information about the NTP and NIEHS is found at https:// www.niehs.nih.gov and https:// ntp.niehs.nih.gov, respectively. Dated: July 23, 2013. John R. Bucher, Associate Director, National Toxicology Program. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Substance Abuse and Mental Health Services Administration Center for Mental Health Services; Notice of Meeting National Advisory Councils; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Mental Health Services (CMHS) National Advisory Council will meet August 14, 2013, 9:00 a.m. to 5:00 p.m. The meeting will include discussion and evaluation of grant applications reviewed by Initial Review Groups. Therefore, the meeting will be closed to the public from 9:00 a.m.–10:30 a.m. as determined by the SAMHSA Administrator, in accordance with Title 5 U.S.C. 552b(c)(9)(b) and 5 U.S.C. App. 2, Section 10(d). The remainder of the meeting is open and will include discussion of the Center’s policy issues, and current administrative, legislative, and program developments. Substantive program information, a summary of the meeting and a roster of Council members may be obtained as soon as possible after the meeting, by accessing the SAMHSA Committee Web site at https://nac.samhsa.gov/ CMHScouncil/index.aspx, or by contacting the CMHS National Advisory Council Designated Federal Official, Ms. Deborah DeMasse-Snell (see contact information below). Committee Name: SAMHSA’s Center for Mental Health Services National Advisory Council. Date/Time/Type: August 14, 2013, 9:00 a.m.–10:30 a.m. Closed. August 14, 2013, 10:30 a.m.–5:00 p.m. Open. Place: SAMHSA Building, 1 Choke Cherry Road, Great Falls Room, Rockville, Maryland 20857. Contact: Deborah DeMasse-Snell M.A. (Than), Designated Federal Official, SAMHSA CMHS National Advisory Council, 1 Choke Cherry Road, Room 6–1084, Rockville, Maryland 20857, Telephone: (240) 276–1861, Fax: (240) 276–1830, Email: Deborah.DeMasse-Snell@samhsa.hhs.gov. Cathy J. Friedman, Public Health Analyst, SAMHSA. [FR Doc. 2013–18113 Filed 7–26–13; 8:45 am] BILLING CODE 4162–20–P [FR Doc. 2013–18058 Filed 7–26–13; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 18:00 Jul 26, 2013 Jkt 229001 45543 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Pursuant to Public Law 92–463, notice is hereby given of the combined meeting on August 15, 2013, of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) four National Advisory Councils (the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC), and the two SAMHSA Advisory Committees (Advisory Committee for Women’s Services, and the Tribal Technical Advisory Committee). The Councils were established to advise the Secretary, Department of Health and Human Services (HHS), the Administrator, SAMHSA, and Center Directors, concerning matters relating to the activities carried out by and through the Centers and the policies respecting such activities. Under Section 501 of the Public Health Service Act, the Advisory Committee for Women’s Services (ACWS) is statutorily mandated to advise the SAMHSA Administrator and the Associate Administrator for Women’s Services on appropriate activities to be undertaken by SAMHSA and its Centers with respect to women’s substance abuse and mental health services. Pursuant to Presidential Executive Order No. 13175, November 6, 2000, and the Presidential Memorandum of September 23, 2004, SAMHSA established the Tribal Technical Advisory Committee (TTAC) for working with Federally-recognized Tribes to enhance the government-togovernment relationship, honor Federal trust responsibilities and obligations to Tribes and American Indian and Alaska Natives. The SAMHSA TTAC serves as an advisory body to SAMHSA. The August 15 combined meeting will include discussions regarding the future of SAMHSA, National Behavioral Health Quality Framework and Barometer, Prevention in Healthcare, SAMSHA’s Role as a Clinical Leader, and Advisory Members’ Views from the Field regarding the National Dialogue. The meeting is open to the public and will be held at the SAMHSA building, 1 Choke Cherry Road, Rockville, MD 20857 in the 1st floor Conference Rooms. Attendance by the public will E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Notices]
[Pages 45542-45543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18058]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information: The National Institute of Environmental 
Health Sciences/National Toxicology Program Requests the Nomination and 
Prioritization of Environmentally Responsive Genes for Use in Screening 
Large Numbers of Substances Using Toxicogenomic Technologies

SUMMARY: The National Institute of Environmental Health Sciences 
(NIEHS)/National Toxicology Program (NTP) is interested in the 
identification and prioritization of a comprehensive list of 
environmentally responsive genes that might be targets for screening 
cells or tissues obtained from humans, rats, mice, zebrafish, and 
Caenorhabditis elegans against large numbers of substances. The goal is 
to generate a minimum list of 1000 genes for each species that would 
provide the maximal toxicogenomic information on (1) effects that 
reflect general cellular responses, independent of cell type or 
species, and (2) gene expression changes that are specific by organ 
and/or cell type. The NIEHS/NTP also seeks recommendations on criteria 
to use for prioritizing the genes in order to identify those 
potentially most useful in a screening paradigm. Such a list of 
environmentally responsive genes may be useful also in biomarker 
development and basic research efforts.

DATES: The deadline for receipt of information is August 23, 2013.

ADDRESSES: Nominated genes and/or recommendations on prioritization 
criteria should be submitted electronically in Microsoft Excel or Word 
formats to Genelist@niehs.nih.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Elizabeth Maull, NIEHS, P. O. Box 
12233 (MD K2-17), Research Triangle Park, NC 27709; email: 
maull@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Background:

    In 2008, the NIEHS/NTP, the U.S. Environmental Protection Agency's 
(EPA) National Center for Computational Toxicology (NCCT), and the 
National Human Genome Research Institute (NHGRI)/NIH Chemical Genomics 
Center (NCGC) (now located within the National Center for Advancing 
Translational Sciences (NCATS)) entered into a formal agreement to 
develop a vision and devise an implementation strategy to shift the 
assessment of chemical hazards from traditional, experimental animal, 
toxicology studies to target-specific, mechanism-based, biological 
observations largely obtained using in vitro assays. In mid-2010, the 
U.S. Food and Drug Administration (FDA) joined the collaboration that 
is known informally as Tox21.
    In Tox21, the agencies collaborate to research, develop, validate, 
and translate innovative testing methods for characterization of 
toxicity pathways; identify compounds, assays, informatic analyses, and 
targeted testing needed to support the development of new methods; 
identify patterns of compound-induced biological response(s) in order 
to characterize toxicity pathways; facilitate cross-species and low-
dose extrapolation; prioritize compounds for more extensive 
toxicological evaluation; and develop predictive models for biological 
response in humans. Currently, the primary Tox21 activity is the 
screening of a 10,000 compound library in a number of nuclear receptor 
agonist/antagonist and stress response pathway assays primarily using 
reporter gene platforms. In the next phase, the focus will be on 
assaying large numbers of chemicals in high content screens and mid to 
high throughput, targeted gene expression platforms.
    To conduct the next phase, the NIEHS/NTP in collaboration with its 
Tox21 partners seeks to identify a prioritized set of at least 1000 
genes that would provide comprehensive toxicogenomic information on (1) 
gene induction or repression reflecting general cellular responses that 
are largely independent of cell type or species, and (2) gene 
expression changes that are organ and/or cell type specific. Examples 
of processes likely to be cell-type independent include genes involved 
in stress-response pathways (e.g., DNA repair, hypoxia, heat shock), 
chromatin remodeling, and those that regulate cell division and death. 
Examples of processes more likely to be cell-type specific include 
induction or repression of expression of enzymes that modify or 
activate chemical toxicants, regulation of the hypothalamic-pituitary-
adrenal axis, and inflammatory responses. In keeping with the Tox21 
goal of facilitating cross-species extrapolation, the NIEHS/NTP is 
especially interested in the nomination of genes or gene sets 
specifically relevant for comparisons between humans, rats, mice, 
zebrafish, and C. elegans and especially those for which complementary 
functional pathways exist. Such a list of environmentally responsive 
genes may be useful also in biomarker development and basic research 
efforts. To facilitate identification of the most useful genes to 
include in a screening paradigm, the NIEHS/NTP also requests 
recommendations on criteria to use for their prioritization.

Request for Information

    The NIEHS/NTP seeks to establish a prioritized list of 
environmentally responsive genes to screen cells/tissues from humans, 
rats, mice, zebrafish, and C. elegans for agent-induced alterations 
using mid to high throughput, targeted transcriptomics platforms. The 
goal is to screen a large number of compounds and obtain information 
useful for understanding the potential for adverse health outcomes. To 
that end, the NIEHS/NTP requests that respondents provide information 
for either or both of the following:
     Nominations of specific genes or gene sets. Nominated 
genes should be identified using Entrez and/or Ensembl gene IDs. 
Desirable supporting information for the nominated gene(s) would 
include the associated pathway(s) or biological process(s), the 
cellular context(s) where demonstrated, and the technology used to 
measure expression of the nominated gene. If available, please include 
relevant citations as a part of the supporting information.
     Criteria for prioritization of the genes or gene sets. The 
NIEHS/NTP is interested in criteria that could be used to develop a 
prioritized list of genes that would provide the greatest level of

[[Page 45543]]

insight and discrimination of toxicological response in a variety of 
applications including cross-species comparisons and differential 
tissue responses.
    The nominated genes and/or criteria recommendations should be 
submitted electronically in Microsoft Excel or Word format.
    Respondents to this request for information are asked also to 
provide their name, affiliation, address, and contact information 
(including telephone and fax numbers, and email address). The deadline 
for receipt of the requested information is August 23, 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 strengthen the Department's activities in toxicology research and 
testing, and develop and validate new and better testing methods. Other 
activities of the program focus on strengthening the science base in 
toxicology and providing information about potentially toxic chemicals 
to health regulatory and research agencies, scientific and medical 
communities, and the public. The NTP is located administratively at the 
NIEHS. Information about the NTP and NIEHS is found at https://www.niehs.nih.gov and https://ntp.niehs.nih.gov, respectively.

    Dated: July 23, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-18058 Filed 7-26-13; 8:45 am]
BILLING CODE 4140-01-P