Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input, 14953-14954 [2019-07269]

Download as PDF jbell on DSK30RV082PROD with NOTICES Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices Place: Crowne Plaza Washington National Airport, 1480 Crystal Drive, Arlington, VA 22202. Contact Person: William J. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892–7924, 301–827–7938, johnsonw@ nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Mechanisms of Blood Pressure Regulation Program Project Grant Review. Date: May 23, 2019. Time: 1:00 p.m. to 3:30 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: Shelley S. Sehnert, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7206, Bethesda, MD 20892–7924, 301–435–0303, ssehnert@ nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Short-Term Experience in Research. Date: May 29, 2019. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Giuseppe Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892, 301–827–7969, Pintuccig@ nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Institutional Training Grants. Date: May 30, 2019. Time: 12:00 p.m. to 3:00 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: Giuseppe Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892, 301–827–7969, Pintuccig@ nhlbi.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. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) VerDate Sep<11>2014 18:18 Apr 11, 2019 Jkt 247001 Dated: April 8, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. 14953 the environment while replacing, reducing, or refining animal use. ICCVAM’s goals include promotion of national and international partnerships between governmental and [FR Doc. 2019–07250 Filed 4–11–19; 8:45 am] nongovernmental groups, including BILLING CODE 4140–01–P academia, industry, advocacy groups, and other key stakeholders. To foster DEPARTMENT OF HEALTH AND these partnerships ICCVAM initiated HUMAN SERVICES annual public forums in 2014 to share information and facilitate direct National Institutes of Health communication of ideas and suggestions from stakeholders (79 FR 25136). Interagency Coordinating Committee This year’s meeting will be held on on the Validation of Alternative May 23, 2019, at the National Institutes Methods; Notice of Public Meeting; of Health (NIH) in Bethesda, MD. The Request for Public Input meeting will include presentations by NICEATM and ICCVAM members on AGENCY: National Institutes of Health, current activities related to the HHS. development and validation of ACTION: Notice. alternative test methods and SUMMARY: The Interagency Coordinating approaches, including activities relevant Committee on the Validation of to implementation of the strategic Alternative Methods (ICCVAM) will roadmap for establishing new hold a public forum to share approaches to evaluate the safety of information and facilitate direct chemicals and medical products in the communication of ideas and suggestions United States (83 FR 7487). from stakeholders. Interested persons Following each presentation, there may attend in person or view the will be an opportunity for participants meeting remotely by webcast. Time will to ask questions of the ICCVAM be set aside for questions and public members. Instructions for submitting statements on the topics discussed. questions will be provided to remote Registration is requested for both public participants prior to the webcast. The attendance and oral statements, and agenda will also include time for required for remote access. Information participants to make public oral about the meeting and registration are statements relevant to the ICCVAM available at https://ntp.niehs.nih.gov/go/ mission and current activities. iccvamforum-2019. Preliminary Agenda and Other DATES: Meeting: May 23, 2019, 9:00 a.m. Meeting Information: The preliminary to approximately 4:00 p.m. Eastern agenda, list of discussion topics, Daylight Time (EDT). background materials, ICCVAM roster, Registration for Onsite Meeting: and public statements submitted prior Deadline is May 10, 2019. to the meeting will be posted by May 17 Registration for Webcast: Deadline is at https://ntp.niehs.nih.gov/go/ May 23, 2019. iccvamforum-2019. Interested Submission of Oral Public Statements: individuals are encouraged to visit this Deadline is May 10, 2019. web page to stay abreast of the most ADDRESSES: Meeting Location: William current meeting information. H. Natcher Conference Center, National Meeting and Registration: This Institutes of Health, Bethesda, MD meeting is open to the public with time 20892. scheduled for questions and oral public Meeting web page: The preliminary statements following presentations from agenda, registration, and other meeting ICCVAM and NICEATM. The public materials are at https://ntp.niehs.nih.gov/ may attend the meeting at NIH, where go/iccvamforum-2019. attendance is limited only by the space FOR FURTHER INFORMATION CONTACT: Dr. available, or view remotely by webcast. Warren Casey, Director, National Those planning to attend the meeting in Toxicology Program Interagency Center person are encouraged to register at for the Evaluation of Alternative https://ntp.niehs.nih.gov/go/ Toxicological Methods (NICEATM); iccvamforum-2019 by May 10, 2019, to email: warren.casey@nih.gov; telephone: facilitate planning for appropriate (984) 287–3118. meeting space. Those planning to view the webcast must register at https:// SUPPLEMENTARY INFORMATION: ntp.niehs.nih.gov/go/iccvamforumBackground: ICCVAM, a 2019; registration will be available congressionally mandated committee, through May 23, 2019. The URL for the promotes the development and webcast will be provided in the email validation of alternative testing strategies that protect human health and confirming registration. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1 jbell on DSK30RV082PROD with NOTICES 14954 Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices NIH visitor and security information is available at https://www.nih.gov/ about/visitor/index.htm. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at phone: (984) 287–3157 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. Request for Oral Public Statements: Each presentation will be followed by an opportunity for participants to ask questions of the presenter. Attendees need not register in advance for the opportunity to ask questions or make comments specific to presentations. Instructions for submitting questions or comments will be provided to remote participants prior to the webcast. In addition to time for questions or comments following each scheduled presentation, time will be allotted during the meeting for oral public statements with associated slides on topics relevant to ICCVAM’s mission. The number and length of presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting public statements and/or associated slides should include their name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document. National Toxicology Program guidelines for public statements are at https:// ntp.niehs.nih.gov/ntp/about_ntp/ guidelines_public_comments_508.pdf. Persons wishing to present oral public statements should email their statement to ICCVAMquestions@niehs.nih.gov by May 10, 2019, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements may supplement and expand the oral presentation. Public statements will be distributed to NICEATM and ICCVAM members before the meeting. Registration for oral public statements will be available onsite, although onsite registration and time allotted for these statements may be limited based on the number of individuals who register to make statements and available time. If registering onsite and reading from written text, please bring 20 copies of the statement for distribution and to supplement the record. Persons wishing to present oral public statements are strongly encouraged to present their comments in person to facilitate effective interaction with ICCVAM members. However, there will VerDate Sep<11>2014 18:18 Apr 11, 2019 Jkt 247001 also be the opportunity to present public statements by teleconference line. Persons who are unable to attend the meeting in person and wish to present oral public statements should email ICCVAMquestions@niehs.nih.gov by May 10, 2019 to arrange to present statements via teleconference line. Responses to this notice are voluntary. No proprietary, classified, confidential, or sensitive information should be included in statements submitted in response to this notice or presented during the meeting. This request for input is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information. Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 16 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of testing methods that 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. 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 involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at https:// ntp.niehs.nih.gov/go/iccvam. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 evaluations. Additional information about NICEATM can be found at https:// ntp.niehs.nih.gov/go/niceatm. Dated: April 8, 2019. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2019–07269 Filed 4–11–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: Medical Device for Vascular Dilation A vascular dilator is commonly used in transcatheter cardiovascular intervention procedures. Commercially available vascular dilators have introducer sheaths with a finite thickness and mismatched diameter with the dilators. This causes uneven stretching of the trailing edge of the sheath and severe damage to the target vessels. This technology produces the specialized sheath with a shoulder that can be introduced percutaneously with an enhanced dilator into a broad range of diseased target vessels and chambers with reduced vascular injury. The shoulder helps to match the diameter of the introducer sheath so that there is a smooth transition between the dilator and the introducer sheath. The invention allows the dilator to be withdrawn in segments without disrupting the introducer sheath. E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14953-14954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods; Notice of Public Meeting; Request for Public Input

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) will hold a public forum to share 
information and facilitate direct communication of ideas and 
suggestions from stakeholders. Interested persons may attend in person 
or view the meeting remotely by webcast. Time will be set aside for 
questions and public statements on the topics discussed. Registration 
is requested for both public attendance and oral statements, and 
required for remote access. Information about the meeting and 
registration are available at https://ntp.niehs.nih.gov/go/iccvamforum-2019.

DATES: Meeting: May 23, 2019, 9:00 a.m. to approximately 4:00 p.m. 
Eastern Daylight Time (EDT).
    Registration for Onsite Meeting: Deadline is May 10, 2019.
    Registration for Webcast: Deadline is May 23, 2019.
    Submission of Oral Public Statements: Deadline is May 10, 2019.

ADDRESSES: Meeting Location: William H. Natcher Conference Center, 
National Institutes of Health, Bethesda, MD 20892.
    Meeting web page: The preliminary agenda, registration, and other 
meeting materials are at https://ntp.niehs.nih.gov/go/iccvamforum-2019.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National 
Toxicology Program Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM); email: [email protected]; 
telephone: (984) 287-3118.

SUPPLEMENTARY INFORMATION: 
    Background: ICCVAM, a congressionally mandated committee, promotes 
the development and validation of alternative testing strategies that 
protect human health and the environment while replacing, reducing, or 
refining animal use.
    ICCVAM's goals include promotion of national and international 
partnerships between governmental and nongovernmental groups, including 
academia, industry, advocacy groups, and other key stakeholders. To 
foster these partnerships ICCVAM initiated annual public forums in 2014 
to share information and facilitate direct communication of ideas and 
suggestions from stakeholders (79 FR 25136).
    This year's meeting will be held on May 23, 2019, at the National 
Institutes of Health (NIH) in Bethesda, MD. The meeting will include 
presentations by NICEATM and ICCVAM members on current activities 
related to the development and validation of alternative test methods 
and approaches, including activities relevant to implementation of the 
strategic roadmap for establishing new approaches to evaluate the 
safety of chemicals and medical products in the United States (83 FR 
7487).
    Following each presentation, there will be an opportunity for 
participants to ask questions of the ICCVAM members. Instructions for 
submitting questions will be provided to remote participants prior to 
the webcast. The agenda will also include time for participants to make 
public oral statements relevant to the ICCVAM mission and current 
activities.
    Preliminary Agenda and Other Meeting Information: The preliminary 
agenda, list of discussion topics, background materials, ICCVAM roster, 
and public statements submitted prior to the meeting will be posted by 
May 17 at https://ntp.niehs.nih.gov/go/iccvamforum-2019. Interested 
individuals are encouraged to visit this web page to stay abreast of 
the most current meeting information.
    Meeting and Registration: This meeting is open to the public with 
time scheduled for questions and oral public statements following 
presentations from ICCVAM and NICEATM. The public may attend the 
meeting at NIH, where attendance is limited only by the space 
available, or view remotely by webcast. Those planning to attend the 
meeting in person are encouraged to register at https://ntp.niehs.nih.gov/go/iccvamforum-2019 by May 10, 2019, to facilitate 
planning for appropriate meeting space. Those planning to view the 
webcast must register at https://ntp.niehs.nih.gov/go/iccvamforum-2019; 
registration will be available through May 23, 2019. The URL for the 
webcast will be provided in the email confirming registration.

[[Page 14954]]

    NIH visitor and security information is available at https://www.nih.gov/about/visitor/index.htm. Individuals with disabilities who 
need accommodation to participate in this event should contact Dr. 
Elizabeth Maull at phone: (984) 287-3157 or email: [email protected]. 
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.
    Request for Oral Public Statements: Each presentation will be 
followed by an opportunity for participants to ask questions of the 
presenter. Attendees need not register in advance for the opportunity 
to ask questions or make comments specific to presentations. 
Instructions for submitting questions or comments will be provided to 
remote participants prior to the webcast.
    In addition to time for questions or comments following each 
scheduled presentation, time will be allotted during the meeting for 
oral public statements with associated slides on topics relevant to 
ICCVAM's mission. The number and length of presentations may be limited 
based on available time. Submitters will be identified by their name 
and affiliation and/or sponsoring organization, if applicable. Persons 
submitting public statements and/or associated slides should include 
their name, affiliation (if any), mailing address, telephone, email, 
and sponsoring organization (if any) with the document. National 
Toxicology Program guidelines for public statements are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Persons wishing to present oral public statements should email 
their statement to [email protected] by May 10, 2019, to 
allow time for review by NICEATM and ICCVAM and posting to the meeting 
page prior to the forum. Written statements may supplement and expand 
the oral presentation. Public statements will be distributed to NICEATM 
and ICCVAM members before the meeting.
    Registration for oral public statements will be available onsite, 
although onsite registration and time allotted for these statements may 
be limited based on the number of individuals who register to make 
statements and available time. If registering onsite and reading from 
written text, please bring 20 copies of the statement for distribution 
and to supplement the record.
    Persons wishing to present oral public statements are strongly 
encouraged to present their comments in person to facilitate effective 
interaction with ICCVAM members. However, there will also be the 
opportunity to present public statements by teleconference line. 
Persons who are unable to attend the meeting in person and wish to 
present oral public statements should email 
[email protected]hs.nih.gov by May 10, 2019 to arrange to present 
statements via teleconference line.
    Responses to this notice are voluntary. No proprietary, classified, 
confidential, or sensitive information should be included in statements 
submitted in response to this notice or presented during the meeting. 
This request for input is for planning purposes only and is not a 
solicitation for applications or an obligation on the part of the U.S. 
Government to provide support for any ideas identified in response to 
the request. Please note that the U.S. Government will not pay for the 
preparation of any information submitted or for its use of that 
information.
    Background Information on ICCVAM and NICEATM: ICCVAM is an 
interagency committee composed of representatives from 16 federal 
regulatory and research agencies that require, use, generate, or 
disseminate toxicological and safety testing information. ICCVAM 
conducts technical evaluations of new, revised, and alternative safety 
testing methods and integrated testing strategies with regulatory 
applicability. ICCVAM also promotes the scientific validation and 
regulatory acceptance of testing methods that 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.
    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 
involvement in activities relevant to the development of alternative 
test methods. Additional information about ICCVAM can be found at 
https://ntp.niehs.nih.gov/go/iccvam.
    NICEATM administers ICCVAM, provides scientific and operational 
support for ICCVAM-related activities, and conducts and publishes 
analyses and evaluations of data from new, revised, and alternative 
testing approaches. NICEATM and ICCVAM work collaboratively to evaluate 
new and improved testing approaches 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 https://ntp.niehs.nih.gov/go/niceatm.

    Dated: April 8, 2019.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-07269 Filed 4-11-19; 8:45 am]
 BILLING CODE 4140-01-P


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