Office of the Director, National Institutes of Health; Notice of Meeting, 27322-27323 [2014-10909]

Download as PDF 27322 Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, 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 Deafness and Other Communication Disorders Special Emphasis Panel; VSL Fellowship Review. Date: June 9, 2014. Time: 1:00 p.m. to 4:00 p.m. 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: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Chemosensory Fellowship Review. Date: June 11, 2014. Time: 12:00 p.m. to 2:30 p.m. 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: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301–496–8683, singhs@ nidcd.nih.gov. Name of Committee: Communication Disorders Review Committee. Date: June 12–13, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301– 435–1425, yangshi@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Hearing and Balance Fellowship Review. Date: June 18, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Eliane Lazar-Wesley, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural VerDate Mar<15>2010 19:27 May 12, 2014 Jkt 232001 Activities, 6001 Executive Boulevard, Room 8339, MSC 9670, Bethesda, MD 20892–8401, 301–496–8683, el6r@nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; P50 Review. Date: July 17, 2014. Time: 11:00 a.m. to 1:30 p.m. 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: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301–496–8683, singhs@ nidcd.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: May 7, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–10891 Filed 5–12–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of the Council of Councils. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. A portion of 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 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, 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: Council of Councils. Open: June 20, 2014. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Time: 8:15 a.m. to 11:15 a.m. Agenda: Council Business Matters and Updates; Aquatic/Zebrafish Model Resources; NIH Update. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 20892. Closed: June 20, 2014. Time: 12:00 p.m. to 1:00 p.m. Agenda: Review of grant applications. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 20892. Open: June 20, 2014. Time: 1:00 p.m. to 4:00 p.m. Agenda: Updates on Cleared Concepts Being Developed into Common Fund Programs, New Common Fund Concept Clearances, Early Independence Award Process Evaluation and Discussion, Update on Common Fund Planning and Management Evaluation Report. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 20892. Contact Person: Franziska Grieder, DVM, Ph.D., Executive Secretary, Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435–0744. 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. Information is also available on the Council of Council’s home page at https:// dpcpsi.nih.gov/council/where an agenda will be posted before the meeting date. 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. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) E:\FR\FM\13MYN1.SGM 13MYN1 Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices Dated: May 7, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–10909 Filed 5–12–14; 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 Interagency Center for the Evaluation of Alternative Toxicological Methods Requests the Nomination of Reference Chemicals The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests the nomination of reference chemicals, with supporting data, to be used to validate in vitro metabolizing systems with the potential to interact with estrogen receptors (ERs) or androgen receptors (ARs). Specifically, a list of chemicals is needed to characterize the usefulness and limitations of in vitro metabolizing systems for use in conjunction with ER and AR transactivation tests. DATES: The deadline for receipt of information is June 2, 2014. ADDRESSES: Nominated reference chemicals and associated data should be submitted electronically in Microsoft® Excel or Word formats to niceatm@ niehs.nih.gov. A Microsoft® Excel template for data submission is available at https://ntp.niehs.nih.gov/go/ 41493. FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Background Endocrine-active substances (EAS) are chemicals that interfere with normal endocrine hormone function by mimicking, blocking, or increasing their actions, thereby possibly causing adverse health effects. United States legislation (e.g., 7 U.S.C. 136, 110 Stat 1613) requires that chemicals be tested for their ability to disrupt the hormonal systems of mammals; prospective international legislative proposals may have similar requirements. Chemicals found to test positive in vitro as EAS may be in vivo endocrine disruptors. The lack of in vitro tools that mimic in vivo metabolism is the main obstacle to implementation of in vitro tools for EAS toxicity testing. Improved VerDate Mar<15>2010 19:27 May 12, 2014 Jkt 232001 understanding of metabolic capabilities and limitations of in vitro toxicity testing is critical to: • Ensure that no potentially active metabolites are missed • Allow better interpretation of results • Accurately predict species-specific characteristics of absorption, metabolism, and excretion While there is a growing body of international in vitro test guidelines addressing EAS mechanisms and modes of action, there are few or no standardized methods to incorporate metabolic and toxicokinetic aspects into these EAS in vitro tests to date. In vitro assays for EAS should incorporate metabolic enzyme systems to better address the relevance of EAS tests to in vivo adverse outcome pathways. The Organization for Economic Cooperation and Development (OECD) Validation Management Group-NonAnimal (VMG–NA) expert working group develops internationally accepted non-animal test guidelines to support various international regulatory needs for the hazard identification of potential EAS. These test guidelines describe methods and approaches capable of identifying potential EAS without the use of animals. Consistent with its purpose of evaluating alternative methods for testing chemicals and chemical products, NICEATM participates in the VMG–NA. Test guidelines for in vitro assays for ER activity have been evaluated and accepted by international regulatory authorities; test guidelines for in vitro AR activity assays are currently in development. However, none of these in vitro EAS assays account for whole animal metabolism. Further development of specific tests is needed to optimize the use of in vitro metabolism with EAS assays. Identification of appropriate reference chemicals to check the metabolic capacity of any proposed test method is key to continued assay development. For this purpose, the VMG–NA is developing a robust list of chemicals that, when metabolized, act as ER or AR agonist or antagonists. Request for Information On behalf of the VMG–NA, NICEATM requests nominations of chemicals that can be used to characterize and validate in vitro metabolizing systems for use in conjunction with in vitro tests for ER and AR transactivation. Responses are requested from all interested parties, including the research community, health professionals, educators, policy makers, industry, and the public. Considerations for selection of PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 27323 appropriate chemicals include the ability of a chemical to act as an ER or AR agonist or antagonist and: • Potential for metabolism to make a chemical either more potent (bioactivation) or less potent (detoxification) • Likelihood of metabolism occurring in relevant routes of exposure and target organs • Likelihood of metabolism occurring over a range of doses: Information on the ratio of the half maximal effective or inhibitory concentration (EC50 or IC50, respectively) of parent to daughter metabolites will be useful and there is a particular need for information pertaining to substances where biotransformation yields a very small or very large ratio of EC50/IC50 of parent to daughter metabolites • Stability, preferably with real-time curves and consequent exposure significance of likely metabolites • Diversity of likely and predominant biotransformative pathways • Diversity of chemical types, use classes, and consequent applicability domains The reference chemicals will be used to check the metabolic capacity of the in vitro model, including characterization of the general metabolic capacity of the cell lines. To ensure relevant use in a regulatory context, it will be necessary, where possible, to make correlations to: (a) Relevant in vivo metabolic modeling (accounting for absorption, distribution, metabolism, and excretion, etc.) of plasma/blood metabolites in vertebrate animals (e.g., rat, fish, human). (b) Data from the uterotrophic, Hershberger, and/or other relevant assays with a demonstrated high confidence in prediction of bioactivation of estrogenic or androgenic agonist and antagonist pathways, such that the true systemic in vivo metabolic response is addressed as accurately as possible. When reporting the in vitro dose response for potential reference chemicals, the concentrations of solvent and/or carrier proteins used in the assay buffers to solubilize the reference chemicals should be described to facilitate an understanding of potential differences among new in vitro assays with regard to free concentrations of parent chemical and metabolites versus nominal dosages within each testing system. Nominated reference chemicals and associated data should be submitted electronically in Microsoft® Excel or Word formats to niceatm@niehs.nih.gov. Data submitted can include, but need E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27322-27323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of 
the Council of Councils.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    A portion of 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 U.S.C., as amended. The grant applications and the discussions 
could disclose confidential trade secrets or commercial property such 
as patentable material, 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: Council of Councils.
    Open: June 20, 2014.
    Time: 8:15 a.m. to 11:15 a.m.
    Agenda: Council Business Matters and Updates; Aquatic/Zebrafish 
Model Resources; NIH Update.
    Place: National Institutes of Health, 9000 Rockville Pike, 
Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 
20892.
    Closed: June 20, 2014.
    Time: 12:00 p.m. to 1:00 p.m.
    Agenda: Review of grant applications.
    Place: National Institutes of Health, 9000 Rockville Pike, 
Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 
20892.
    Open: June 20, 2014.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: Updates on Cleared Concepts Being Developed into Common 
Fund Programs, New Common Fund Concept Clearances, Early 
Independence Award Process Evaluation and Discussion, Update on 
Common Fund Planning and Management Evaluation Report.
    Place: National Institutes of Health, 9000 Rockville Pike, 
Building 31, C Wing, 6th Floor, Conference Room 6, Bethesda, MD 
20892.
    Contact Person: Franziska Grieder, DVM, Ph.D., Executive 
Secretary, Director, Office of Research Infrastructure Programs, 
Division of Program Coordination, Planning, and Strategic 
Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, 
Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301-435-0744.

    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. Information is also available 
on the Council of Council's home page at https://dpcpsi.nih.gov/council/where an agenda will be posted before the meeting date.
    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.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.22, Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds; 
93.232, Loan Repayment Program for Research Generally; 93.39, 
Academic Research Enhancement Award; 93.936, NIH Acquired 
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, 
Undergraduate Scholarship Program for Individuals from Disadvantaged 
Backgrounds, National Institutes of Health, HHS)


[[Page 27323]]


    Dated: May 7, 2014.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-10909 Filed 5-12-14; 8:45 am]
BILLING CODE 4140-01-P
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