Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Webcast; Request for Public Input, 18547-18548 [2021-07315]

Download as PDF Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices Inventors: Jeffery Taubenberger (NIAID). Intellectual Property: HHS Reference No. E–195–2014—U.S. Provisional Application No. 62/014,814, filed June 20, 2014; PCT Application No. PCT/ US2015/029843, filed May 8, 2015; U.S. Patent No. 10,130,700, issued November 20, 2018; European Application No. #15724151.4, filed May 8, 2015 (pending); Chinese Application No. 201580037799.4, filed May 8, 2015 (pending); and Indian Application No. 201617043281, filed May 8, 2015 (pending). Licensing Contact: To license this technology, please contact Elizabeth Pitts, Ph.D., 240–669–5299; elizabeth.pitts@nih.gov. Dated: March 12, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–07312 Filed 4–8–21; 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; Notice of Public Webcast; Request for Public Input AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 view the presentations by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is required for both webcast viewing and oral statements. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ iccvamforum-2021. DATES: Webcast: May 27, 2021, 9:00 a.m. to approximately 3:00 p.m. EDT. Registration for Webcast: April 12, 2021, until 3:00 p.m. EDT May 27, 2021. Registration for Oral Statements: April 12, 2021, until 4:00 p.m. EDT May 14, 2021. Registration to view the webcast and present oral public statements is required. SUMMARY: VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 ADDRESSES: Webinar web page: A preliminary agenda will be posted by May 3 at https://ntp.niehs.nih.gov/go/ iccvamforum-2021. Information to connect to the webcast will be provided to those who register for viewing. FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Division of NTP, NIEHS, P.O. Box 12233, K2–17, Research Triangle Park, NC 27709. Phone: 984– 287–3150, Email: nicole.kleinstreuer@ nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2021, Morrisville, NC 27560. 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 convenes an annual public forum 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 27, 2021. Due to restrictions on inperson gatherings amid ongoing public health concerns, the public forum will be presented via webcast only. NICEATM and ICCVAM members will give presentations 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). There will be opportunities for registered participants to ask clarifying or follow-up questions of the ICCVAM members about their presentations during the meeting. Instructions for submitting these questions will be provided via email prior to the webcast. The agenda will also include time for public oral statements relevant to the ICCVAM mission and current activities from participants who have registered to do so in advance. Preliminary Agenda and Other Meeting Information: A preliminary agenda will be posted by May 3 at PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 18547 https://ntp.niehs.nih.gov/go/ iccvamforum-2021. Interested individuals are encouraged to visit this web page to stay abreast of the most current meeting information. Webcast and Registration: This webcast is open to the public. Registration for the webcast is required and is open from April 12, 2021, through 3:00 p.m. EDT on May 27, 2021 at https://ntp.niehs.nih.gov/go/ commprac-2021. Registrants will receive instructions on how to access and participate in the webcast in the email confirming their registration. Request for Oral or Written Public Statements: In addition to time for clarifying or follow-up questions following scheduled presentations, time will be allotted during the meeting for oral public statements with associated slides on topics relevant to ICCVAM’s mission. Any participant registered for the webcast may ask clarifying questions during the appropriate times in the agenda. The additional registration is only required for those who wish to give separate public statements. Written public statements on topics relevant to ICCVAM’s mission will also be accepted. Separate registration for those wishing to provide oral public statements is required and is open from April 12, 2021 through May 14, 2021 at https:// ntp.niehs.nih.gov/go/commprac-2021. The number and length of public statement presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Participants registered to present oral public statements must email their statement to ICCVAMquestions@niehs.nih.gov by May 14, 2021, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Persons presenting oral public statements will be contacted to arrange the logistics of their presentations. If participants registered to present oral public statements wish to use accompanying slides and/or submit supplementary written material, they must email these materials to ICCVAMquestions@niehs.nih.gov by May 14, 2021. This deadline is to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements on topics relevant to ICCVAM’s mission may be submitted to support an oral public statement or as standalone documents. These should be emailed to ICCVAMquestions@ niehs.nih.gov by May 14, 2021. Public statements received prior to the May 14, 2021 deadline will be distributed to E:\FR\FM\09APN1.SGM 09APN1 18548 Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices NICEATM and ICCVAM members before the meeting. Written public statements received after the deadline may be reviewed by NICEATM and ICCVAM at a future date. Materials submitted to accompany oral public statements or standalone written statements should include the submitters 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. 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 17 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 and 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 wellbeing 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 NIEHS 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 VerDate Sep<11>2014 17:45 Apr 08, 2021 Jkt 253001 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: March 26, 2021. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2021–07315 Filed 4–8–21; 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 Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Regina Bures, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, 6710B Rockledge Drive, Room 2160, Bethesda, MD 20817, or call non-toll-free number (301)–496– 9485 or Email your request, including ADDRESSES: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 your address to: NICHD.DASH@ mail.nih.gov. This proposed information collection was previously published in the Federal Register on January 14, 2021, page 3160–3162 (86 FR 3160–3162) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Data and Specimen Hub (DASH)-0925–0744 expiration date 01/31/2022, REVISION, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request to revise the previously approved submission (OMB number: 0925–0744) to add the collection of additional information from Users who will submit information to NICHD Data and Specimen Hub (DASH) about studies, and data collections stored in publicly accessible external archives—a process hereinafter referred to as ‘cataloging’ in DASH. DASH has been established by NICHD as a data sharing mechanism for biomedical research investigators. It serves as a centralized resource for investigators to share and access deidentified study data from studies funded by NICHD. DASH also serves as a portal for requesting biospecimens from selected DASH studies. NICHD also supports other public archives, data collections, and resources, such as Data Sharing for Demographic Research (DSDR), NICHD/ DIPHR Biospecimen Repository Access and Data Sharing (BRADS), the Down Syndrome Registry (DS-Connect), Zebrafish Information Network (ZFIN), etc. In addition to these NICHD-funded public archives, many collaborative studies funded through NICHD are dispersed across other National SUPPLEMENTARY INFORMATION: E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18547-18548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07315]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods; Notice of Public Webcast; 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 view the 
presentations by webcast. Time will be set aside for questions and 
public statements on the topics discussed. Registration is required for 
both webcast viewing and oral statements. Information about the meeting 
and registration is available at https://ntp.niehs.nih.gov/go/iccvamforum-2021.

DATES: 
    Webcast: May 27, 2021, 9:00 a.m. to approximately 3:00 p.m. EDT.
    Registration for Webcast: April 12, 2021, until 3:00 p.m. EDT May 
27, 2021.
    Registration for Oral Statements: April 12, 2021, until 4:00 p.m. 
EDT May 14, 2021.
    Registration to view the webcast and present oral public statements 
is required.

ADDRESSES: 
    Webinar web page: A preliminary agenda will be posted by May 3 at 
https://ntp.niehs.nih.gov/go/iccvamforum-2021. Information to connect 
to the webcast will be provided to those who register for viewing.

FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting 
Director, National Toxicology Program Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM), Division of 
NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park, NC 27709. 
Phone: 984-287-3150, Email: [email protected]. Hand Deliver/
Courier address: 530 Davis Drive, Room K2021, Morrisville, NC 27560.

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 convenes an annual public forum 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 27, 2021. Due to 
restrictions on in-person gatherings amid ongoing public health 
concerns, the public forum will be presented via webcast only. NICEATM 
and ICCVAM members will give presentations 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).
    There will be opportunities for registered participants to ask 
clarifying or follow-up questions of the ICCVAM members about their 
presentations during the meeting. Instructions for submitting these 
questions will be provided via email prior to the webcast. The agenda 
will also include time for public oral statements relevant to the 
ICCVAM mission and current activities from participants who have 
registered to do so in advance.
    Preliminary Agenda and Other Meeting Information: A preliminary 
agenda will be posted by May 3 at https://ntp.niehs.nih.gov/go/iccvamforum-2021. Interested individuals are encouraged to visit this 
web page to stay abreast of the most current meeting information.
    Webcast and Registration: This webcast is open to the public. 
Registration for the webcast is required and is open from April 12, 
2021, through 3:00 p.m. EDT on May 27, 2021 at https://ntp.niehs.nih.gov/go/commprac-2021. Registrants will receive 
instructions on how to access and participate in the webcast in the 
email confirming their registration.
    Request for Oral or Written Public Statements: In addition to time 
for clarifying or follow-up questions following scheduled 
presentations, time will be allotted during the meeting for oral public 
statements with associated slides on topics relevant to ICCVAM's 
mission. Any participant registered for the webcast may ask clarifying 
questions during the appropriate times in the agenda. The additional 
registration is only required for those who wish to give separate 
public statements. Written public statements on topics relevant to 
ICCVAM's mission will also be accepted.
    Separate registration for those wishing to provide oral public 
statements is required and is open from April 12, 2021 through May 14, 
2021 at https://ntp.niehs.nih.gov/go/commprac-2021. The number and 
length of public statement presentations may be limited based on 
available time. Submitters will be identified by their name and 
affiliation and/or sponsoring organization, if applicable. Participants 
registered to present oral public statements must email their statement 
to [email protected] by May 14, 2021, to allow time for 
review by NICEATM and ICCVAM and posting to the meeting page prior to 
the forum. Persons presenting oral public statements will be contacted 
to arrange the logistics of their presentations. If participants 
registered to present oral public statements wish to use accompanying 
slides and/or submit supplementary written material, they must email 
these materials to [email protected] by May 14, 2021. This 
deadline is to allow time for review by NICEATM and ICCVAM and posting 
to the meeting page prior to the forum.
    Written statements on topics relevant to ICCVAM's mission may be 
submitted to support an oral public statement or as standalone 
documents. These should be emailed to I[email protected] by 
May 14, 2021. Public statements received prior to the May 14, 2021 
deadline will be distributed to

[[Page 18548]]

NICEATM and ICCVAM members before the meeting. Written public 
statements received after the deadline may be reviewed by NICEATM and 
ICCVAM at a future date.
    Materials submitted to accompany oral public statements or 
standalone written statements should include the submitters 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.
    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 17 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 and 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 NIEHS 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: March 26, 2021.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2021-07315 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P


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