82 FR 19071 - Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range		19071-19073
FR Document		2017-08354

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 http://ntp.niehs.nih.gov/go/iccvamforum- 2017.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017)

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19071-19073]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08354]


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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

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 http://ntp.niehs.nih.gov/go/iccvamforum-2017.

DATES: 
    Meeting: May 23, 2017, 9:00 a.m. to approximately 4:00 p.m. Eastern 
Daylight Time (EDT).
    Registration for Onsite Meeting: Deadline is May 12, 2017.
    Registration for Webcast: Deadline is May 23, 2017.
    Submission of Oral Public Statements: Deadline is May 12, 2017.

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 http://ntp.niehs.nih.gov/go/iccvamforum-2017.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National

[[Page 19072]]

Toxicology Program Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM); email: [email protected]; 
telephone: (919) 316-4729.

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, 2017, 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 discussions of the proposed strategic roadmap 
to establish new approaches for evaluating the safety of chemicals and 
medical products in the United States. These new approaches are 
anticipated to increase confidence in alternative methods and improve 
their relevance to human health outcomes while maximizing efficiency 
and maintaining a commitment to replace, reduce, and refine animal use.
    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 16 at http://ntp.niehs.nih.gov/go/iccvamforum-2017. 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 http://ntp.niehs.nih.gov/go/iccvamforum-2017 by May 12, 2017, to facilitate 
planning for appropriate meeting space. Those planning to view the 
webcast must register at http://ntp.niehs.nih.gov/go/iccvamforum-2017; 
registration will be available through May 23, 2017. The URL for the 
webcast will be provided in the email confirming registration.
    Visitor and security information for visitors to NIH is available 
at http://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: (919) 316-4668 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 and topics under discussion including the U.S. 
strategic roadmap. 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 http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Persons wishing to present oral public statements are encouraged to 
indicate on the registration form whether their comments will focus on 
ICCVAM agency activities or the U.S. strategic roadmap. They should 
also email their statement to [email protected] by May 12, 
2017, 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] by May 12, 2017 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 animal use.
    The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) establishes 
ICCVAM as a permanent interagency committee of the NIEHS and provides

[[Page 19073]]

the authority for ICCVAM involvement in activities relevant to the 
development of alternative test methods. ICCVAM acts to ensure that new 
and revised test methods are validated to meet the needs of federal 
agencies, increase the efficiency and effectiveness of federal agency 
test method review, and optimize utilization of scientific expertise 
outside the federal Government. Additional information about ICCVAM can 
be found at http://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 testing approaches for validation studies 
and technical evaluations. Additional information about NICEATM can be 
found at http://ntp.niehs.nih.gov/go/niceatm.

    Dated: April 13, 2017.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2017-08354 Filed 4-24-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19073

the authority for ICCVAM involvement DEPARTMENT OF HEALTH AND development and evaluation under a
in activities relevant to the development HUMAN SERVICES research collaboration.
of alternative test methods. ICCVAM Potential Commercial Applications:
acts to ensure that new and revised test National Institutes of Health New target for HIV therapeutic and
methods are validated to meet the needs vaccine development.
Government-Owned Inventions; Competitive Advantages: A new
of federal agencies, increase the
Availability for Licensing molecular target discovered in this
efficiency and effectiveness of federal
agency test method review, and invention may facilitate the
AGENCY: National Institutes of Health,
optimize utilization of scientific development of next-generation HIV
HHS.
expertise outside the federal therapeutics and vaccines.
ACTION: Notice. Development Stage: Proof-of-concept
Government. Additional information
studies demonstrate that CD4 binding to
about ICCVAM can be found at http:// SUMMARY: The inventions listed below CD4–BD2 is critical for triggering gp120
ntp.niehs.nih.gov/go/iccvam. are owned by an agency of the U.S. conformational changes that enable
NICEATM administers ICCVAM, Government and are available for coreceptor binding and HIV–1
provides scientific and operational licensing to achieve expeditious infectivity. Animal studies are ongoing.
support for ICCVAM-related activities, commercialization of results of Inventors: Paolo Lusso, NIAID, NIH;
and conducts and publishes analyses federally-funded research and and Qingbo Liu, NIAID, NIH.
and evaluations of data from new, development. Foreign patent Publications: Liu, Qingbo, et al.
applications are filed on selected ‘‘Quaternary contact in the initial
revised, and alternative testing
inventions to extend market coverage interaction of CD4 with the HIV–1
approaches. NICEATM and ICCVAM
for companies and may also be available envelope trimer.’’ Nature Structural &
work collaboratively to evaluate new for licensing.
and improved testing approaches Molecular Biology (2017).
applicable to the needs of U.S. federal FOR FURTHER INFORMATION CONTACT: Intellectual Property: HHS Reference
agencies. NICEATM and ICCVAM Chris Kornak, 240–627–3705, No. E–230–2015/0—U.S. Patent
chris.kornak@nih.gov. Licensing Application No. 62/292,750 filed 02/08/
welcome the public nomination of new,
information and copies of the U.S. 2016; PCT Application No. PCT/
revised, and alternative testing
patent applications listed below may be US2017/017038 filed 02/08/2017.
approaches for validation studies and Licensing Contact: Chris Kornak, 240–
obtained by communicating with the
technical evaluations. Additional 627–3705, chris.kornak@nih.gov.
indicated licensing contact at the
information about NICEATM can be Technology Transfer and Intellectual Collaborative Research Opportunity:
found at http://ntp.niehs.nih.gov/go/ Property Office, National Institute of The Technology Transfer and
niceatm. Allergy and Infectious Diseases, 5601 Intellectual Property Office (TTIPO) is
Dated: April 13, 2017. Fishers Lane, Rockville, MD 20852; tel. seeking parties interested in
John R. Bucher, 301–496–2644. A signed Confidential collaborative research to further co-
Disclosure Agreement will be required develop HIV–1 vaccines and/or
Associate Director, National Toxicology
Program. to receive copies of unpublished patent inhibitors that target the newly
applications. recognized region. For collaboration
[FR Doc. 2017–08354 Filed 4–24–17; 8:45 am]
SUPPLEMENTARY INFORMATION:
opportunities, please contact Chris
BILLING CODE 4140–01–P Kornak, 240–627–3705, chris.kornak@
Technology description follows.
nih.gov.
A Second CD4-Binding Region of Dated: April 10, 2017.
DEPARTMENT OF HEALTH AND HIV–1 gp120 Critical for Viral
HUMAN SERVICES Suzanne Frisbie,
Infectivity: New Methods for Treatment
and Vaccine Development Deputy Director, Technology Transfer and
National Institutes of Health Intellectual Property Office, National Institute
Description of Technology: It is of Allergy and Infectious Diseases.
National Cancer Institute; Cancellation believed that immunization with an [FR Doc. 2017–08351 Filed 4–24–17; 8:45 am]
of Meeting effective immunogen based on the HIV– BILLING CODE 4140–01–P
1 envelope glycoprotein can elicit a
Notice is hereby given of the neutralizing antibody response, which
cancellation of the National Cancer may be protective against HIV–1 DEPARTMENT OF HEALTH AND
Institute Special Emphasis Panel, May infection. NIAID researchers have HUMAN SERVICES
1, 2017, 8:00 a.m. to May 2, 2017, 1:00 discovered a new critical component of
p.m., Hyatt Regency Bethesda, One the CD4-binding site in gp120, named National Institutes of Health
Bethesda Metro Center, 7400 Wisconsin CD4–BS2, which is exclusively formed
in the trimeric envelope conformation. National Institute on Aging; Notice of
Avenue, Bethesda, MD 20814 which Closed Meeting
was published in the Federal Register It was further found that this newly
on March 22, 2017, 82 FR 54. recognized region is critical for the Pursuant to section 10(d) of the
progression of the fusogenic mechanism Federal Advisory Committee Act, as
This meeting is being amended to that leads to HIV–1 entry and infection amended (5 U.S.C. App.), notice is
asabaliauskas on DSK3SPTVN1PROD with NOTICES

cancel the meeting on May 1–2, 2017. of the cells. This discovery may lead to hereby given of the following meeting.
Dated: April 20, 2017. new methods of treatment, for treating The meeting will be closed to the
Melanie J. Pantoja, HIV–1, as well as to the production of public in accordance with the
Program Analyst, Office of Federal Advisory
new vaccine immunogens. provisions set forth in sections
Committee Policy. This technology is available for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[FR Doc. 2017–08348 Filed 4–24–17; 8:45 am]
licensing for commercial development as amended. The grant applications and
in accordance with 35 U.S.C. 209 and 37 the discussions could disclose
BILLING CODE 4140–01–P
CFR part 404, as well as for further confidential trade secrets or commercial

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Document Created: 2017-04-25 02:18:29
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		Meeting: May 23, 2017, 9:00 a.m. to approximately 4:00 p.m. Eastern Daylight Time (EDT).
Contact		Dr. Warren Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: [email protected]; telephone: (919) 316-4729.
FR Citation		82 FR 19071

82 FR 19071 - Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 78 (April 25, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health