Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Reverse Toxicokinetics; Notice of Public Webinar and Registration Information, 73603-73604 [2014-29018]

Download as PDF Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: One Washington Circle One Washington Circle NW., Washington, DC 20037. Contact Person: Raul A. Saavedra, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– 9223, saavedrr@ninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group; Neurological Sciences and Disorders A. Date: March 2–3, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Olympic Hotel, 411 University Street, Seattle, WA 98101. Contact Person: Natalia Strunnikova, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–402–0288, natalia.strunnikova@nih.gov. (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: December 5, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–29021 Filed 12–10–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Reverse Toxicokinetics; Notice of Public Webinar and Registration Information The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ‘‘Reverse Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be Associated with Adverse Effects In Vivo.’’ The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation Alternative Toxicological Methods (NICEATM) and hosted by the Environmental Protection Agency’s National Center for Computational Toxicology (NCCT). Interested persons may participate via mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:07 Dec 10, 2014 Jkt 235001 Adobe® ConnectTM. Time is allotted for questions from participants. DATES: Webinar: January 27, 2015, 1:00 p.m. to approximately 2:30 p.m. Eastern Standard Time (EST). Registration for Webinar: December 3, 2014, until 2:30 p.m. January 27, 2015. ADDRESSES: Webinar Web page: http:// ntp.niehs.nih.gov/go/ivive-webinar. FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: ICCVAM promotes the development and validation of toxicity testing methods that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM also provides guidance to test method developers and facilitates collaborations that promote the development of new test methods. To address these goals, ICCVAM will hold the communities of practice webinar ‘‘Reverse Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be Associated with Adverse Effects In Vivo.’’ Many commercial and environmental chemicals lack toxicity data necessary for users and risk assessors to make fully informed decisions about potential health effects. Generating these data using high throughput in vitro cell- or biochemical-based tests would be faster and less expensive than testing in animals; tests that use human cells or cellular components would also potentially be more relevant to human health. However, correlating test chemical concentrations that produce effects in vitro to exposure levels that cause toxicity in vivo is complicated, since factors that can significantly influence toxicity in vivo (such as plasma protein binding and metabolic clearance) are often not replicated in in vitro assays. Mathematical models known as reverse toxicokinetic models provide a framework for making these correlations. Reverse toxicokinetic models provide an estimate of the exposure level that would result in a blood concentration equal to a chemical concentration causing an in vitro adverse outcome. The ICCVAM webinar will feature presentations by two experts in the development and application of reverse toxicokinetic models to high throughput screening data: John Wambaugh, Ph.D., physical scientist at NCCT, and Barbara Wetmore, Ph.D., senior research investigator at the Hamner Institutes for Health Sciences. Their presentations will provide an overview of the development of reverse toxicokinetic PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 73603 models and discuss the consideration of population variability and sensitive subpopulations in the use of these models. Webinar and Registration: This webinar is open to the public with time scheduled following each presentation for questions by participants. Registration for the webinar is required and is open from December 3, 2014, through 2:30 p.m. on January 27, 2015. A link to registration is available at http://ntp.niehs.nih.gov/go/ivivewebinar. Registrants will receive instructions on how to access and participate in the webinar in the email confirming their registration. The preliminary agenda is available at http://ntp.niehs.nih.gov/go/ivivewebinar. Interested individuals are encouraged to visit this Web page to stay abreast of the most current webinar information. Individuals with disabilities who need accommodation to participate in this event should contact Ms. LaCresha Styles at phone: (919) 541–3282 or email: styles.lacresha@epa.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. Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) establishes ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences and provides the authority for ICCVAM’s involvement in activities relevant to the development of new and revised toxicological tests. ICCVAM conducts technical evaluations of new, revised, and alternative test methods and integrated testing strategies with regulatory applicability and promotes the scientific validation and regulatory acceptance of test methods that both more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine (enhance animal wellbeing and lessen or avoid pain and distress) animal use. ICCVAM acts to ensure that new and revised test methods are validated to meet the needs of federal agencies, to increase the efficiency and effectiveness of federal agency test method review, and to optimize utilization of scientific expertise outside the federal government. Additional information E:\FR\FM\11DEN1.SGM 11DEN1 73604 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices about ICCVAM can be found at http:// ntp.niehs.nih.gov/go/iccvam. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/go/ niceatm. Dated: December 5, 2014. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2014–29018 Filed 12–10–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2014–0034; OMB No. 1660–0040] Agency Information Collection Activities: Proposed Collection; Comment Request; Standard Flood Hazard Determination Form Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the renewal of the Standard Flood Hazard Determination Form which is used by federally regulated lending institutions to determine if a structure is located mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:07 Dec 10, 2014 Jkt 235001 within an identified Special Flood Hazard Area (SFHA) and whether flood insurance is available. DATES: Comments must be submitted on or before February 9, 2015. ADDRESSES: To avoid duplicate submissions to the docket, please use only one of the following means to submit comments: (1) Online. Submit comments at www.regulations.gov under Docket ID FEMA–2013–0034. Follow the instructions for submitting comments. (2) Mail. Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street SW., Room 8NE, Washington, DC 20472– 3100. (3) Facsimile. Submit comments to (703) 483–2999. All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice that is available via the link in the footer of www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Susan Bernstein, Program Specialist, FEMA, Federal Insurance and Mitigation Administration (FIMA), 202– 212–2113 for additional information. You may contact the Records Management Division for copies of the proposed collection of information at facsimile number (202) 212–4701 or email address: FEMA-InformationCollections-Management@fema.dhs.gov. SUPPLEMENTARY INFORMATION: On September 23, 1994, Section 303(a) of the Riegle Community Development and Regulatory Improvement Act of 1994 was signed into law. Section 303(a) of this Act requires the Federal bank and thrift regulatory agencies to conduct a systematic review of their regulation and written policies in order to improve efficiency, reduce unnecessary costs, and eliminate inconsistencies and outmoded and duplicative requirements. Title V of this Act is the National Flood Insurance Reform Act (NFIRA). Section 528 of the NFIRA requires that FEMA develop a standard PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 hazard determination form for recording the determination of whether a structure is located within an identified Special Flood Hazard Area (SFHA) and whether flood insurance is available. Section 528 of the NFIRA also requires the use of this form by regulated lending institutions, federal agency lenders, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Government National Mortgage Association for any loan made, increased, extended, renewed or purchased by these entities. The requirement for federally regulated lending institutions to determine whether a building or mobile home securing a loan is located in an area having special flood hazards and whether flood insurance is available has been in effect since the enactment of the Flood Disaster Protection Act of 1973, although the use of a standard form was not required until the enactment of the Riegle Community Development and Regulatory Improvement Act of 1994. The establishment of the Standard Flood Hazard Determination form has enabled lenders to provide consistent information. Collection of Information Title: Standard Flood Hazard Determination Form. Type of Information Collection: Revision of a currently approved information collection. OMB Number: 1660–0040. FEMA Form: FEMA Form 086–0–32, Standard Flood Hazard Determination Form (SFHDF). Abstract: FEMA Form 086–0–32, SFHDF is used by regulated lending institutions, federal agency lenders, related lenders/regulators, and the Government. Federally regulated lending institutions complete this form when making, increasing, extending, renewing or purchasing each loan for the purpose is of determining whether flood insurance is required and available. The form may also be used by property owner, insurance agents, realtors, community officials for flood insurance related documentation. Affected Public: Business or other forprofit. Number of Respondents: 46,456,460. Number of Responses: 46,456,460. Estimated Total Annual Burden Hours: 15,330,632 hours. E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73603-73604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29018]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods Communities of Practice Webinar on Reverse 
Toxicokinetics; Notice of Public Webinar and Registration Information

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) announces a public webinar ``Reverse 
Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be 
Associated with Adverse Effects In Vivo.'' The webinar is organized on 
behalf of ICCVAM by the National Toxicology Program Interagency Center 
for the Evaluation Alternative Toxicological Methods (NICEATM) and 
hosted by the Environmental Protection Agency's National Center for 
Computational Toxicology (NCCT). Interested persons may participate via 
Adobe[supreg] ConnectTM. Time is allotted for questions from 
participants.

DATES: Webinar: January 27, 2015, 1:00 p.m. to approximately 2:30 p.m. 
Eastern Standard Time (EST).
    Registration for Webinar: December 3, 2014, until 2:30 p.m. January 
27, 2015.

ADDRESSES:  Webinar Web page: http://ntp.niehs.nih.gov/go/ivive-webinar.

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

SUPPLEMENTARY INFORMATION:
    Background: ICCVAM promotes the development and validation of 
toxicity testing methods that protect human health and the environment 
while replacing, reducing, or refining animal use. ICCVAM also provides 
guidance to test method developers and facilitates collaborations that 
promote the development of new test methods. To address these goals, 
ICCVAM will hold the communities of practice webinar ``Reverse 
Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be 
Associated with Adverse Effects In Vivo.''
    Many commercial and environmental chemicals lack toxicity data 
necessary for users and risk assessors to make fully informed decisions 
about potential health effects. Generating these data using high 
throughput in vitro cell- or biochemical-based tests would be faster 
and less expensive than testing in animals; tests that use human cells 
or cellular components would also potentially be more relevant to human 
health. However, correlating test chemical concentrations that produce 
effects in vitro to exposure levels that cause toxicity in vivo is 
complicated, since factors that can significantly influence toxicity in 
vivo (such as plasma protein binding and metabolic clearance) are often 
not replicated in in vitro assays. Mathematical models known as reverse 
toxicokinetic models provide a framework for making these correlations. 
Reverse toxicokinetic models provide an estimate of the exposure level 
that would result in a blood concentration equal to a chemical 
concentration causing an in vitro adverse outcome.
    The ICCVAM webinar will feature presentations by two experts in the 
development and application of reverse toxicokinetic models to high 
throughput screening data: John Wambaugh, Ph.D., physical scientist at 
NCCT, and Barbara Wetmore, Ph.D., senior research investigator at the 
Hamner Institutes for Health Sciences. Their presentations will provide 
an overview of the development of reverse toxicokinetic models and 
discuss the consideration of population variability and sensitive 
subpopulations in the use of these models.
    Webinar and Registration: This webinar is open to the public with 
time scheduled following each presentation for questions by 
participants. Registration for the webinar is required and is open from 
December 3, 2014, through 2:30 p.m. on January 27, 2015. A link to 
registration is available at http://ntp.niehs.nih.gov/go/ivive-webinar. 
Registrants will receive instructions on how to access and participate 
in the webinar in the email confirming their registration.
    The preliminary agenda is available at http://ntp.niehs.nih.gov/go/ivive-webinar. Interested individuals are encouraged to visit this Web 
page to stay abreast of the most current webinar information.
    Individuals with disabilities who need accommodation to participate 
in this event should contact Ms. LaCresha Styles at phone: (919) 541-
3282 or email: styles.lacresha@epa.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.
    Background Information on ICCVAM and NICEATM: ICCVAM is an 
interagency committee composed of representatives from 15 federal 
regulatory and research agencies that require, use, generate, or 
disseminate toxicological and safety testing information. The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) establishes ICCVAM as a 
permanent interagency committee of the National Institute of 
Environmental Health Sciences and provides the authority for ICCVAM's 
involvement in activities relevant to the development of new and 
revised toxicological tests.
    ICCVAM conducts technical evaluations of new, revised, and 
alternative test methods and integrated testing strategies with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of test methods that both more accurately assess 
the safety and hazards of chemicals and products and replace, reduce, 
or refine (enhance animal well-being and lessen or avoid pain and 
distress) animal use. ICCVAM acts to ensure that new and revised test 
methods are validated to meet the needs of federal agencies, to 
increase the efficiency and effectiveness of federal agency test method 
review, and to optimize utilization of scientific expertise outside the 
federal government. Additional information

[[Page 73604]]

about ICCVAM can be found at http://ntp.niehs.nih.gov/go/iccvam.
    NICEATM administers ICCVAM, provides scientific and operational 
support for ICCVAM activities, and conducts independent validation 
studies to assess the usefulness and limitations of new, revised, and 
alternative test methods and strategies. NICEATM and ICCVAM work 
collaboratively to evaluate new and improved test methods and 
strategies applicable to the needs of U.S. federal agencies. NICEATM 
and ICCVAM welcome the public nomination of new, revised, and 
alternative test methods and strategies for validation studies and 
technical evaluations. Additional information about NICEATM can be 
found at http://ntp.niehs.nih.gov/go/niceatm.

    Dated: December 5, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-29018 Filed 12-10-14; 8:45 am]
BILLING CODE 4140-01-P