Flow Cytometry Standards Consortium, 64444-64445 [2020-22620]

Download as PDF 64444 Federal Register / Vol. 85, No. 198 / Tuesday, October 13, 2020 / Notices Dated: October 6, 2020. Jeffrey I. Kessler, Assistant Secretary for Enforcement and Compliance, Alternate Chairman, ForeignTrade Zones Board. [FR Doc. 2020–22541 Filed 10–9–20; 8:45 am] BILLING CODE 3510–DS–P DEPARTMENT OF COMMERCE National Institute of Standards and Technology Flow Cytometry Standards Consortium National Institute of Standards and Technology, Department of Commerce. ACTION: Notice of research consortium. AGENCY: The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, in support of efforts to develop standards for regenerative medicine and advanced therapies, is establishing the Flow Cytometry Standards Consortium (‘‘Consortium’’). The Consortium will bring together stakeholders to identify and address measurement and standards needs related to flow cytometry used in the characterization and testing of cell and gene therapies. The Consortium efforts are intended to develop measurement solutions and standards to improve measurement confidence, establish measurement traceability, and enable comparability in flow cytometry measurements. Participation fees will be at least $25,000 annually or in-kind contributions of equivalent value. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA). DATES: The Consortium’s activities will commence on December 1, 2020 (‘‘Commencement Date’’). NIST will accept letters of interest to participate in this Consortium on an ongoing basis. ADDRESSES: Completed letters of interest or requests for additional information about the Consortium can be directed via mail to the Consortium Manager, Dr. Lili Wang, Biosystems and Biomaterials Division of NIST’s Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8312, Gaithersburg, Maryland 20899, or via electronic mail to flowcytometry@nist.gov, or by telephone at (301) 975–2447. FOR FURTHER INFORMATION CONTACT: J’aime Maynard, CRADA Administrator, National Institute of Standards and Technology’s Technology Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by electronic mail to khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:52 Oct 09, 2020 Jkt 253001 Jaime.maynard@nist.gov, or by telephone at (301) 975–8408. SUPPLEMENTARY INFORMATION: Advances in cell and gene-based therapeutics as well as other regenerative medicine products have increased the need for high quality, robust, and validated measurements for cell characterization. Flow cytometry, including imaging cytometry, has emerged as an important platform due to its ability to rapidly and simultaneously characterize heterogeneous cell populations and subcellular analytes. For example, flow cytometry has been critical for establishing identity, purity, and potency for Chimeric Antigen Receptor (CAR)-T cell manufacturing; and associated data to support the approval of Biological License Applications (BLA) by the U.S. Food and Drug Administration (FDA) and the approval by the European Medicines Agency (EMA). In addition, multiparameter flow cytometric measurements are routinely carried out in vaccine, drug and cancer research, clinical diagnosis, and immunotherapies. However, challenges remain with respect to measurement confidence and comparability of measurement results from different instrument platforms, locations, and over time, hindering critical decisionmaking based on flow cytometry data in research and clinical settings. NIST has extensively engaged with stakeholders to identify measurement needs. These include hosting joint workshops with the U.S. FDA and with the International Society for Advancement of Cytometry (ISAC) that brought together experts and stakeholders from industry, academia and government to discuss unique challenges for cell and gene therapy. The workshops identified three common, pre-competitive measurement needs: (1) High-quality reference materials, (2) confidence in the procedures from standardization/interlaboratory studies, and (3) uncertainty associated with specimen quality and/or pre-analytical processes. This Consortium aims to develop measurement solutions and standards for flow cytometry, including improving measurement confidence by establishing traceability and assisting measurement comparability. Measurement applications to be addressed may include the use of flow cytometry for the characterization and testing for cell identity, purity, count, activity, potency, and biomarker expression. The working cell types will be determined based on the collective input of the Consortium members and can start with common immunotherapy cell types, e.g., T cells, PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 iPSCs, and NK cells. To fulfill the objectives of the Consortium, associated critical reagents, such as antibodies, plasmids, and viral vectors pertaining to the development of the high-quality measurements and reference materials, will be characterized using orthogonal measurement capabilities, e.g., ddPCR, qPCR, NGS, Flow-FISH, nanoflow cytometry, and mass spectrometry, most of which are available at NIST as a part of the NIST Advanced Therapy Program. NIST may also leverage current capabilities such as the state-ofthe-art flow cytometry and automation capabilities and expertise, ERF measurement service, blood cell characterization, cell counting expertise, as well as existing collaborations with calibration bead and cytometer manufacturers, international metrological institutions, and Standards Development Organizations (SDOs) such as CLSI to advance the goals of this Consortium. The Consortium is expected to form several Working Groups to continuously identify and address needs and gaps in quantitative cytometry through workshops, public meetings, and other collaborative efforts. The scope of Working Groups can include: (1) Equivalent Number of Reference Fluorophores (ERF) Measurement Service: a. Develop reference standards including reference materials, reference data, reference methods, and measurement service for assigning the ERF to calibration microspheres and assessing the associated uncertainties and utilities. This is the first step towards reliable quantitative measurements in flow cytometry. (2) Reference Material Selection and Design: a. Develop candidate reference standards including biological reference materials, reference data, reference methods; b. Evaluate common reagents and control materials including various types of compensation controls; c. Design and carry out interlaboratory testing to characterize and evaluate the reference materials using multiple methods, including orthogonal methods. (3) Assay and Protocol Selection and Design: a. Establish an inventory of existing protocols, shared data, existing standards; b. Generate standard operating procedures/methods for cross platform assay standardization and data analysis; c. Test the robustness of assays and associated uncertainties. No proprietary information will be shared as part of the Consortium. E:\FR\FM\13OCN1.SGM 13OCN1 Federal Register / Vol. 85, No. 198 / Tuesday, October 13, 2020 / Notices Participation Process: Interested parties with relevant flow cytometry associated capabilities (see below), products, and/or technical expertise to support this Consortium should contact NIST using the information provided in the ADDRESSES section of this notice. NIST will then provide each interested party with a letter of interest template, which the party must complete, and submit to NIST. NIST will contact interested parties if there are questions regarding the responsiveness of the letters. NIST will determine the eligibility to participate in the Consortium based on the requirements listed below. NIST will select participants based on information provided by interested organizations in their letter of interest and upon the availability of necessary resources to NIST. Requirements: Each letter of interest should provide the following information: (1) A description of the experience in flow cytometry/imaging cytometry, production and characterization of microparticles, antibodies, biological cells, other critical reagents of cytometric applications, and analysis of large data sets and related expertise to contribute to the Consortium. (2) Subgroups or topic areas of interest for participation. khammond on DSKJM1Z7X2PROD with NOTICES (3) List of interested party’s anticipated participants. Letters of interest must not include business proprietary information. NIST will not treat any information provided in response to this Notice as proprietary information. NIST will notify each organization of its eligibility. In order to participate in this Consortium, each eligible organization must sign a CRADA for this Consortium. All participants to this Consortium will be bound by the same terms and conditions. Participants will be required to contribute at least $25,000 annually as participation fees or in-kind resources of equivalent value, as determined by NIST. NIST does not guarantee participation in the Consortium to any organization submitting a Letter of interest. Authority: 15 U.S.C. 272; 21 U.S.C. 356g. Kevin Kimball, Chief of Staff. [FR Doc. 2020–22620 Filed 10–9–20; 8:45 am] BILLING CODE 3510–13–P VerDate Sep<11>2014 18:52 Oct 09, 2020 Jkt 253001 64445 [RTID 0648–XA548] 1. Provide fishing level recommendations using the previously reviewed Southeast Data, Assessment, and Review (SEDAR) 64 assessment for yellowtail snapper; Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings 2. Approve the schedule, Terms of Reference (ToR), and make appointments for the upcoming mutton snapper assessment. DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of a public meeting. AGENCY: The South Atlantic Fishery Management Council’s (SAFMC) and the Gulf of Mexico Fishery Management Council (GMFMC) will hold a joint meeting of their Scientific and Statistical Committees (SSC) via webinar. See SUPPLEMENTARY INFORMATION. SUMMARY: The joint SSC meeting will take place from 9 a.m. to 1 p.m., Friday, October 30, 2020. ADDRESSES: The meeting will be held via webinar. Council addresses: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405; Gulf of Mexico Fishery Management Council, 4107 West Spruce Street, Suite 200, Tampa, FL 33607. FOR FURTHER INFORMATION CONTACT: Kim Iverson, Public Information Officer, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571– 4366 or toll free: (866) SAFMC–10; fax: (843) 769–4520; email: kim.iverson@ safmc.net. DATES: The meeting is open to the public via webinar as it occurs. Webinar registration is required. Information regarding webinar registration will be posted to the SAFMC’s website at: http://safmc.net/safmc-meetings/ scientific-and-statistical-committeemeetings/ as it becomes available. The meeting agenda, briefing book materials, and online comment form will be posted to the SAFMC’s website two weeks prior to the meeting. Written comment on SSC agenda topics is to be distributed to the Committees through the Council office, similar to all other briefing materials. For this meeting, the deadline for submission of written comment is 12 p.m., Friday, October 23, 2020. The following agenda items will be addressed by the SSCs during the meeting: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 The SSCs will provide guidance to staff and recommendations for Council consideration as appropriate. Multiple opportunities for comment on agenda items will be provided during SSC meeting. Open comment periods will be provided at the start of the meeting and near the conclusion. Those interested in providing comment should indicate such in the manner requested by the Chair, who will then recognize individuals to provide comment. Additional opportunities for comment on specific agenda items will be provided, as each item is discussed, between initial presentations and SSC discussion. Those interested in providing comment should indicate such in the manner requested by the Chair, who will then recognize individuals to provide comment. All comments are part of the record of the meeting. Although non-emergency issues not contained in the meeting agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency. Special Accommodations This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 3 business days prior to the meeting. Note: The times and sequence specified in this agenda are subject to change. Authority: 16 U.S.C. 1801 et seq. Dated: October 7, 2020. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2020–22555 Filed 10–9–20; 8:45 am] BILLING CODE 3510–22–P E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64444-64445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22620]


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

DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Flow Cytometry Standards Consortium

AGENCY: National Institute of Standards and Technology, Department of 
Commerce.

ACTION: Notice of research consortium.

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

SUMMARY: The National Institute of Standards and Technology (NIST), an 
agency of the United States Department of Commerce, in support of 
efforts to develop standards for regenerative medicine and advanced 
therapies, is establishing the Flow Cytometry Standards Consortium 
(``Consortium''). The Consortium will bring together stakeholders to 
identify and address measurement and standards needs related to flow 
cytometry used in the characterization and testing of cell and gene 
therapies. The Consortium efforts are intended to develop measurement 
solutions and standards to improve measurement confidence, establish 
measurement traceability, and enable comparability in flow cytometry 
measurements. Participation fees will be at least $25,000 annually or 
in-kind contributions of equivalent value. Participants will be 
required to sign a Cooperative Research and Development Agreement 
(CRADA).

DATES: The Consortium's activities will commence on December 1, 2020 
(``Commencement Date''). NIST will accept letters of interest to 
participate in this Consortium on an ongoing basis.

ADDRESSES: Completed letters of interest or requests for additional 
information about the Consortium can be directed via mail to the 
Consortium Manager, Dr. Lili Wang, Biosystems and Biomaterials Division 
of NIST's Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 
8312, Gaithersburg, Maryland 20899, or via electronic mail to 
[email protected], or by telephone at (301) 975-2447.

FOR FURTHER INFORMATION CONTACT: J'aime Maynard, CRADA Administrator, 
National Institute of Standards and Technology's Technology 
Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, 
Gaithersburg, Maryland 20899, by electronic mail to 
[email protected], or by telephone at (301) 975-8408.

SUPPLEMENTARY INFORMATION: Advances in cell and gene-based therapeutics 
as well as other regenerative medicine products have increased the need 
for high quality, robust, and validated measurements for cell 
characterization. Flow cytometry, including imaging cytometry, has 
emerged as an important platform due to its ability to rapidly and 
simultaneously characterize heterogeneous cell populations and 
subcellular analytes. For example, flow cytometry has been critical for 
establishing identity, purity, and potency for Chimeric Antigen 
Receptor (CAR)-T cell manufacturing; and associated data to support the 
approval of Biological License Applications (BLA) by the U.S. Food and 
Drug Administration (FDA) and the approval by the European Medicines 
Agency (EMA). In addition, multiparameter flow cytometric measurements 
are routinely carried out in vaccine, drug and cancer research, 
clinical diagnosis, and immunotherapies. However, challenges remain 
with respect to measurement confidence and comparability of measurement 
results from different instrument platforms, locations, and over time, 
hindering critical decision-making based on flow cytometry data in 
research and clinical settings.
    NIST has extensively engaged with stakeholders to identify 
measurement needs. These include hosting joint workshops with the U.S. 
FDA and with the International Society for Advancement of Cytometry 
(ISAC) that brought together experts and stakeholders from industry, 
academia and government to discuss unique challenges for cell and gene 
therapy. The workshops identified three common, pre-competitive 
measurement needs: (1) High-quality reference materials, (2) confidence 
in the procedures from standardization/inter-laboratory studies, and 
(3) uncertainty associated with specimen quality and/or pre-analytical 
processes.
    This Consortium aims to develop measurement solutions and standards 
for flow cytometry, including improving measurement confidence by 
establishing traceability and assisting measurement comparability. 
Measurement applications to be addressed may include the use of flow 
cytometry for the characterization and testing for cell identity, 
purity, count, activity, potency, and biomarker expression. The working 
cell types will be determined based on the collective input of the 
Consortium members and can start with common immunotherapy cell types, 
e.g., T cells, iPSCs, and NK cells. To fulfill the objectives of the 
Consortium, associated critical reagents, such as antibodies, plasmids, 
and viral vectors pertaining to the development of the high-quality 
measurements and reference materials, will be characterized using 
orthogonal measurement capabilities, e.g., ddPCR, qPCR, NGS, Flow-FISH, 
nanoflow cytometry, and mass spectrometry, most of which are available 
at NIST as a part of the NIST Advanced Therapy Program. NIST may also 
leverage current capabilities such as the state-of-the-art flow 
cytometry and automation capabilities and expertise, ERF measurement 
service, blood cell characterization, cell counting expertise, as well 
as existing collaborations with calibration bead and cytometer 
manufacturers, international metrological institutions, and Standards 
Development Organizations (SDOs) such as CLSI to advance the goals of 
this Consortium.
    The Consortium is expected to form several Working Groups to 
continuously identify and address needs and gaps in quantitative 
cytometry through workshops, public meetings, and other collaborative 
efforts. The scope of Working Groups can include:
    (1) Equivalent Number of Reference Fluorophores (ERF) Measurement 
Service:
    a. Develop reference standards including reference materials, 
reference data, reference methods, and measurement service for 
assigning the ERF to calibration microspheres and assessing the 
associated uncertainties and utilities. This is the first step towards 
reliable quantitative measurements in flow cytometry.
    (2) Reference Material Selection and Design:
    a. Develop candidate reference standards including biological 
reference materials, reference data, reference methods;
    b. Evaluate common reagents and control materials including various 
types of compensation controls;
    c. Design and carry out interlaboratory testing to characterize and 
evaluate the reference materials using multiple methods, including 
orthogonal methods.
    (3) Assay and Protocol Selection and Design:
    a. Establish an inventory of existing protocols, shared data, 
existing standards;
    b. Generate standard operating procedures/methods for cross 
platform assay standardization and data analysis;
    c. Test the robustness of assays and associated uncertainties.
    No proprietary information will be shared as part of the 
Consortium.

[[Page 64445]]

    Participation Process: Interested parties with relevant flow 
cytometry associated capabilities (see below), products, and/or 
technical expertise to support this Consortium should contact NIST 
using the information provided in the ADDRESSES section of this notice. 
NIST will then provide each interested party with a letter of interest 
template, which the party must complete, and submit to NIST. NIST will 
contact interested parties if there are questions regarding the 
responsiveness of the letters. NIST will determine the eligibility to 
participate in the Consortium based on the requirements listed below. 
NIST will select participants based on information provided by 
interested organizations in their letter of interest and upon the 
availability of necessary resources to NIST.
    Requirements: Each letter of interest should provide the following 
information:
    (1) A description of the experience in flow cytometry/imaging 
cytometry, production and characterization of microparticles, 
antibodies, biological cells, other critical reagents of cytometric 
applications, and analysis of large data sets and related expertise to 
contribute to the Consortium.
    (2) Subgroups or topic areas of interest for participation.
    (3) List of interested party's anticipated participants.
    Letters of interest must not include business proprietary 
information. NIST will not treat any information provided in response 
to this Notice as proprietary information. NIST will notify each 
organization of its eligibility. In order to participate in this 
Consortium, each eligible organization must sign a CRADA for this 
Consortium. All participants to this Consortium will be bound by the 
same terms and conditions. Participants will be required to contribute 
at least $25,000 annually as participation fees or in-kind resources of 
equivalent value, as determined by NIST. NIST does not guarantee 
participation in the Consortium to any organization submitting a Letter 
of interest.

    Authority: 15 U.S.C. 272; 21 U.S.C. 356g.

Kevin Kimball,
Chief of Staff.
[FR Doc. 2020-22620 Filed 10-9-20; 8:45 am]
BILLING CODE 3510-13-P