In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making; Notice of Webinars and Public Workshop; Registration Information, 56476-56477 [2015-23386]

Download as PDF 56476 Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington National Airport, 1489 Jefferson Davis Hwy, Arlington, VA 22202. Contact Person: Ryan G Morris, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892, 301–435– 1501, morrisr@csr.nih.gov. (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: September 14, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–23387 Filed 9–17–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Meeting tkelley on DSK3SPTVN1PROD with NOTICES Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). The meeting will be open to the public and accessible by live webcast. Name of Committee: Muscular Dystrophy Coordinating Committee. Type of meeting: Open Meeting. Date: November 13, 2015. Time: 8:30 a.m. to 4:30 p.m. *Eastern Time*—Approximate end time. Agenda: The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and reduced disease burden. Prior to the meeting, an agenda will be posted to the MDCC meeting registration Web site: https://meetings.ninds.nih.gov/ meetings/MDCC13Nov2015/. Registration: To register, please go to: https://meetings.ninds.nih.gov/meetings/ MDCC13Nov2015/. Webcast Live: For those not able to attend in person, this meeting will be webcast at: https://videocast.nih.gov/. Place: Neuroscience Center, Conference Room C/D, 6001 Executive Boulevard, Rockville, Maryland 20852. Contact Person: Glen H. Nuckolls, Ph.D., Executive Secretary, Muscular Dystrophy VerDate Sep<11>2014 19:33 Sep 17, 2015 Jkt 235001 Coordinating Committee, National Institute of Neurological Disorders and Stroke, NIH, 6001 Executive Boulevard, NSC 2203, Rockville, MD 20852, (301) 496–5739, glen.nuckolls@ninds.nih.gov. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their 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. Attendance is limited to seating space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed above in advance of the meeting. All visitors must go through a security check at the meeting site to receive a visitor’s badge. A valid, government issued photo ID must be presented before a visitor’s badge can be issued. Further information can be found at the registration Web site: https://meetings.ninds.nih.gov/meetings/ MDCC13Nov2015/. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: September 14, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–23443 Filed 9–17–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making; Notice of Webinars and Public Workshop; Registration Information The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the U.S. Environmental Protection Agency (EPA) announce the workshop, ‘‘In Vitro to In Vivo Extrapolation for SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 High Throughput Prioritization and Decision Making.’’ Attendees at the inperson workshop and four webinar presentations leading up to the workshop will discuss the state of the science and best practices for using in vitro to in vivo extrapolation (IVIVE) in a tiered risk decision context. DATES: Webinars: October 7, 2015, at 11:00 a.m. Eastern Daylight Time (EDT); and November 4, 2015; December 2, 2015; and January 6, 2016; at 11:00 a.m. Eastern Standard Time (EST). Webinar Registration: Deadline is two business days prior to each webinar. Workshop: February 17–18, 2016, from 9:00 a.m. to approximately 5:00 p.m. (EST). Workshop Registration: Deadline is February 5, 2016 at 5:00 p.m. (EST). ADDRESSES: Workshop Location: U.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Durham, NC, 27709. Web page: The preliminary agenda, registration, and other meeting materials will be available at https:// ntp.niehs.nih.gov/go/ivive-wksp-2016. FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: Data from high throughput in vitro tests are being generated for many chemicals of environmental and commercial interest, with the expectation that in vitro assay data could ultimately be used to predict adverse effects of chemical exposures in vivo. Translating values obtained from in vitro assays into estimates of in vivo outcomes is a complex process involving the use of mathematical modeling and increasingly complex test systems. The series of four webinars and in-person workshop aim to address the capabilities and limitations of IVIVE within the context of risk decisionmaking. The webinar series will present the current science, and the in-person workshop will facilitate discussions that follow-up and build on information presented in the webinars. During the workshop, participants will (1) review the state of the science to form recommendations on best practices for using IVIVE in chemical screening and risk-based decision making, (2) identify areas that require additional data and/or research, and (3) highlight examples of how best to apply IVIVE in a tiered risk decision-making strategy. Preliminary Agenda and Other Meeting Information: A preliminary agenda and additional information will E:\FR\FM\18SEN1.SGM 18SEN1 Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES be available at https://ntp.niehs.nih.gov/ go/ivive-wksp-2016. Meeting and Registration: This workshop is open to the public, free of charge, with attendance limited only by the space available. Registration is required to attend both the webinars and the workshop. Those persons attending the workshop should plan to participate in all four webinars. However, viewing the webinars does not require attendance at the workshop. Individuals who plan to attend the workshop must register at https:// ntp.niehs.nih.gov/go/ivive-wksp-2016 by February 5, 2016. Individuals who plan to participate in the webinars must register at https://ntp.niehs.nih.gov/go/ ivive-wksp-2016 two business days prior to the webinar date to ensure access. Please visit this Web page for the most current information about the webinars and workshop. For those who register, information about how to access the webinar will be emailed within two business days of each webinar. Individuals with disabilities who need accommodation to participate in these events should contact Dr. Elizabeth Maull at phone: (919) 316– 4668 or email: maull@niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at (800) 877–8339. Requests should be made at least five business days in advance of the event. Visitor and security information for those attending the workshop can be found at https://www2.epa.gov/ aboutepa/about-epas-campus-researchtriangle-park-rtp-north-carolina. 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 in the development of alternative test methods. Information about NICEATM and ICCVAM is found at https:// ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam, respectively. Dated: September 14, 2015. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2015–23386 Filed 9–17–15; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 18:47 Sep 17, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 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: National Institute on Aging Special Emphasis Panel; Aging of the Lung. Date: October 20, 2015. Time: 3:00 p.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Room 2c218, Bethesda, MD 20892, 301–496–9374, grimaldim2@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: September 14, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–23388 Filed 9–17–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; United States and Global Human Influenza Surveillance in At-Risk Settings (NIAID) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 56477 collection was previously published in the Federal Register on April 9, 2015, page 19090 and allowed 60-days for public comment. One comment was received. However, it was not applicable to this data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Dr. Diane Post, Program Officer, Respiratory Diseases Branch, NIAID, NIH, 5601 Fishers Lane, Bethesda, MD or call non-toll-free number at 240–627– 3348 or email your request, including your address to: postd@niaid.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: United States and Global Human Influenza Surveillance in at-Risk Settings, 0925— NEW, National Institute of Allergies and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: These studies will identify individuals with or at risk for influenza through focused surveillance in at-risk settings within the United States and internationally, rapidly identify circulating influenza strains to identify those with pandemic potential and create an invaluable bank of human samples from influenza patients to allow the characterization of the determinants of influenza transmission to and among humans, the immune response to influenza, and the basis of severe disease—critical knowledge gaps impacting effectiveness of decisionmaking around patient care and E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56476-56477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23386]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


In Vitro to In Vivo Extrapolation for High Throughput 
Prioritization and Decision Making; Notice of Webinars and Public 
Workshop; Registration Information

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) and the 
U.S. Environmental Protection Agency (EPA) announce the workshop, ``In 
Vitro to In Vivo Extrapolation for High Throughput Prioritization and 
Decision Making.'' Attendees at the in-person workshop and four webinar 
presentations leading up to the workshop will discuss the state of the 
science and best practices for using in vitro to in vivo extrapolation 
(IVIVE) in a tiered risk decision context.

DATES: Webinars: October 7, 2015, at 11:00 a.m. Eastern Daylight Time 
(EDT); and November 4, 2015; December 2, 2015; and January 6, 2016; at 
11:00 a.m. Eastern Standard Time (EST).
    Webinar Registration: Deadline is two business days prior to each 
webinar.
    Workshop: February 17-18, 2016, from 9:00 a.m. to approximately 
5:00 p.m. (EST).
    Workshop Registration: Deadline is February 5, 2016 at 5:00 p.m. 
(EST).

ADDRESSES:
    Workshop Location: U.S. Environmental Protection Agency, 109 T.W. 
Alexander Dr., Durham, NC, 27709.
    Web page: The preliminary agenda, registration, and other meeting 
materials will be available at https://ntp.niehs.nih.gov/go/ivive-wksp-2016.

FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, 
NICEATM; email: warren.casey@nih.gov; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION:
    Background: Data from high throughput in vitro tests are being 
generated for many chemicals of environmental and commercial interest, 
with the expectation that in vitro assay data could ultimately be used 
to predict adverse effects of chemical exposures in vivo. Translating 
values obtained from in vitro assays into estimates of in vivo outcomes 
is a complex process involving the use of mathematical modeling and 
increasingly complex test systems. The series of four webinars and in-
person workshop aim to address the capabilities and limitations of 
IVIVE within the context of risk decision-making.
    The webinar series will present the current science, and the in-
person workshop will facilitate discussions that follow-up and build on 
information presented in the webinars. During the workshop, 
participants will (1) review the state of the science to form 
recommendations on best practices for using IVIVE in chemical screening 
and risk-based decision making, (2) identify areas that require 
additional data and/or research, and (3) highlight examples of how best 
to apply IVIVE in a tiered risk decision-making strategy.
    Preliminary Agenda and Other Meeting Information: A preliminary 
agenda and additional information will

[[Page 56477]]

be available at https://ntp.niehs.nih.gov/go/ivive-wksp-2016.
    Meeting and Registration: This workshop is open to the public, free 
of charge, with attendance limited only by the space available. 
Registration is required to attend both the webinars and the workshop. 
Those persons attending the workshop should plan to participate in all 
four webinars. However, viewing the webinars does not require 
attendance at the workshop. Individuals who plan to attend the workshop 
must register at https://ntp.niehs.nih.gov/go/ivive-wksp-2016 by 
February 5, 2016. Individuals who plan to participate in the webinars 
must register at https://ntp.niehs.nih.gov/go/ivive-wksp-2016 two 
business days prior to the webinar date to ensure access. Please visit 
this Web page for the most current information about the webinars and 
workshop. For those who register, information about how to access the 
webinar will be emailed within two business days of each webinar.
    Individuals with disabilities who need accommodation to participate 
in these events should contact Dr. Elizabeth Maull at phone: (919) 316-
4668 or email: maull@niehs.nih.gov. TTY users should contact the 
Federal TTY Relay Service at (800) 877-8339. Requests should be made at 
least five business days in advance of the event. Visitor and security 
information for those attending the workshop can be found at https://www2.epa.gov/aboutepa/about-epas-campus-research-triangle-park-rtp-north-carolina.
    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 in the development of alternative test methods. 
Information about NICEATM and ICCVAM is found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam, 
respectively.

    Dated: September 14, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-23386 Filed 9-17-15; 8:45 am]
BILLING CODE 4140-01-P
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