81 FR 46054 - Flow Cytometry Quantitation Consortium
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology Federal Register Volume 81, Issue 136 (July 15, 2016)
National Institute of Standards and Technology
Federal Register Volume 81, Issue 136 (July 15, 2016)
| Page Range | 46054-46055 | |
| FR Document | 2016-16761 |
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)] [Notices] [Pages 46054-46055] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16761] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE National Institute of Standards and Technology Flow Cytometry Quantitation Consortium AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice; request for information. ----------------------------------------------------------------------- SUMMARY: The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, is establishing the Flow Cytometry Quantitation Consortium and invites organizations to participate in this Consortium. The Consortium will develop reference materials including reference fluorophore solutions and biological reference materials, reference data and reference methods for assigning equivalent number of reference fluorophores (ERF) values and for assessing the associated uncertainties and utilities. Participation in this Consortium is open to all eligible organizations, as described below. DATES: NIST will accept responses for participation in this Consortium on an ongoing basis. The Consortium's activities will commence on August 15, 2016 (``Commencement Date''). Acceptance of participants into the Consortium after the Commencement Date will depend on the availability of NIST resources. ADDRESSES: Information in response to this notice and 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, Gaithersburg, Maryland 20899-8312, or via electronic mail to [email protected]. FOR FURTHER INFORMATION CONTACT: For further information about partnership opportunities or about the terms and conditions of NIST's Cooperative Research and Development Agreement (CRADA), please contact Honeyeh Zube, CRADA and License Officer, 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- 2209. SUPPLEMENTARY INFORMATION: Flow cytometry is a widely used technique for a single cell and particle analysis. It is an essential tool for immunological research, drug and device development, clinical trials, disease diagnosis, and therapy monitoring. The annual expenditure on flow cytometry-related diagnostics is upwards of $1.2 Billion and growing at more than 10 percent per year, testifying to the economic importance of this technology. The measurements made on the different instrument platforms at different times and locations, however, cannot be compared accurately, which makes diagnostic decisions unreliable and slows down advances in biomedical research. In response to this limitation, NIST and International Society for Advancement of Cytometry (ISAC) have developed a methodology to implement quantitation in flow cytometry. The first step is to calibrate the fluorescence signal from microparticles in terms of a unit of equivalent number of reference fluorophores (ERF) on three laser excitations, 405 nm, 488 nm, and 633 nm. The ERF unit gives the number of reference fluorophores in solution which produce the same fluorescence signal as a single dyed microsphere. The second step uses a biological cell, with known number of specific biomarkers, as a reference material to translate the ERF unit to a unit of antibodies bound per cell (ABC). The ABC unit is most relevant to immunological measurements. To support the calibration of microparticles in terms of ERF, NIST has developed standard reference material (SRM 1934), which includes four solutions of fluorophore: Fluorescein, Nile Red, Coumarin 30 and Allophycocyanin. Microparticles that have been assigned ERF values using SRM 1934 will enable the calibration and characterization of flow cytometers, and the standardization of the fluorescence intensity scale in quantitative ERF units. The results of the collaboration under this Consortium will allow the industry to further research, develop and adopt reference fluorophore solutions for other laser excitations and reference material standards recommended by the expert user community. NIST is establishing this five-year Consortium to collaborate with manufacturers of microparticles to develop methodologies for assigning ERF values for the microparticles provided to NIST under the scope of the Consortium. The results from this Consortium will also allow NIST to develop the capability that NIST would require to provide a calibration service. The certificate of analysis for NIST SRM 1934 and NIST's finalized standard operating procedure (SOP) for assigning ERF value will be used for performing the ERF value assignments for participants' microparticles. This SOP includes four steps and is published at J. Res. Natl. Inst. Stand. Technol. 121: 269-286 (2016). As described in the SOP, the ERF value of the major microparticle population is calculated on the basis of the ratio of mean fluorescence intensity values of the major microparticle population to all microparticle populations. A summary of the ERF value assignments will include ERF values of major microparticle populations, associated combined uncertainties per laser excitation, and reference fluorophore. The combined uncertainty will be derived from all steps of the ERF value assignment, from weighing reference solutions, spectrofluorimeter calibration, CCD response calibration, microparticle concentration measurements by flow cytometer and light obscuration, and measurement of the emission spectrum of microparticles to determine ERF values for major microparticle populations. NIST will also share with each participant any digital emission spectral data of the major microparticle populations. In addition, a participant may request reports for specific ERF value assignments for its microparticles under this Consortium. NIST intends to [[Page 46055]] publish anonymized results of the research under this Consortium. In accordance with 15 U.S.C. 3710a(c)(7)(B), NIST will withhold from public disclosure the data that specifically identifies a participant's microparticles for a period of five (5) years from the date any ERF values are generated, or until the participants grants NIST permission to disclose such data. NIST will not require the participants to pay a membership fee to participate in this Consortium. NIST will, however, require participants to contribute funds to reimburse NIST for the generation of any report requested by a participant for the ERF value assignments of participant's microparticles. Participation Process: Eligibility will be determined by NIST using the information provided by an organization in response to this notice based on the information requested below. An organization responding to this notice should provide the following information to NIST's Consortium Manager: (1) Type of microparticles: Optimal sizes of microparticles are from 2 to 10 microns. If there are needs of characterization and ERF value assignment to other size particles (<2 microns or >10 microns), the present standard operating procedure can be modified to accommodate the requests. (2) Type of Instrument: The Consortium is to assign ERF values for microparticles used primarily for flow cytometers. Any information about other instruments used by the organization is helpful to ensure that there is diversity in participants. For example, please indicate if the microparticles are used by the organization with fluorescence microscopes and spectrophotometers/spectrofluorimeters. (3) Experience in production and characterization of microparticles, antibodies, and biological cells, and analysis of large data sets. A responding organization should not include any business proprietary information in its response to this request for information. NIST will not treat any information provided in response to this request as proprietary information. NIST will notify each organization of its eligibility. In order to participate in this Consortium, each eligible organization must sign a Cooperative Research and Development Agreement (CRADA) for this Consortium. All participants to this Consortium will be bound by the same terms and conditions. Kent Rochford, Associate Director for Laboratory Programs. [FR Doc. 2016-16761 Filed 7-14-16; 8:45 am] BILLING CODE 3510-13-P
![46054 Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices
August 23, 2016, from 3:00 p.m. until ongoing basis. The Consortium’s ABC unit is most relevant to
3:15 p.m. Central Time. Speakers will be activities will commence on August 15, immunological measurements. To
selected on a first-come, first-served 2016 (‘‘Commencement Date’’). support the calibration of microparticles
basis. Each speaker will be limited to Acceptance of participants into the in terms of ERF, NIST has developed
five minutes. Questions from the public Consortium after the Commencement standard reference material (SRM 1934),
will not be considered during this Date will depend on the availability of which includes four solutions of
period. Members of the public who are NIST resources. fluorophore: Fluorescein, Nile Red,
interested in speaking are requested to ADDRESSES: Information in response to Coumarin 30 and Allophycocyanin.
contact Sara Kerman at the contact this notice and requests for additional Microparticles that have been assigned
information indicated in the FOR information about the Consortium can ERF values using SRM 1934 will enable
FURTHER INFORMATION CONTACT section of be directed via mail to the Consortium the calibration and characterization of
this notice. Manager, Dr. Lili Wang, Biosystems and flow cytometers, and the
Speakers who wish to expand upon Biomaterials Division of NIST’s Material standardization of the fluorescence
their oral statements, those who had Measurement Laboratory, 100 Bureau intensity scale in quantitative ERF units.
wished to speak but could not be Drive, Gaithersburg, Maryland 20899– The results of the collaboration under
accommodated on the agenda, and those 8312, or via electronic mail to this Consortium will allow the industry
who were unable to attend in person are lili.wang@nist.gov. to further research, develop and adopt
invited to submit written statements. In FOR FURTHER INFORMATION CONTACT: For reference fluorophore solutions for other
addition, written statements are invited further information about partnership laser excitations and reference material
and may be submitted to the opportunities or about the terms and standards recommended by the expert
Commission at any time. All written conditions of NIST’s Cooperative user community.
statements should be directed to the Research and Development Agreement NIST is establishing this five-year
Commission Executive Director, Consortium to collaborate with
(CRADA), please contact Honeyeh Zube,
Information Technology Laboratory, 100 manufacturers of microparticles to
CRADA and License Officer, National
Bureau Drive, Stop 8900, National develop methodologies for assigning
Institute of Standards and Technology’s
Institute of Standards and Technology, ERF values for the microparticles
Technology Partnerships Office, by mail
Gaithersburg, MD 20899–8900 or by provided to NIST under the scope of the
to 100 Bureau Drive, Mail Stop 2200,
email at: cybercommission@nist.gov. Consortium. The results from this
Gaithersburg, Maryland 20899, by
Please use subject line ‘‘Open Meeting of Consortium will also allow NIST to
electronic mail to honeyeh.zube@
the Commission on Enhancing National develop the capability that NIST would
nist.gov, or by telephone at (301) 975–
Cybersecurity—MN’’. require to provide a calibration service.
2209. The certificate of analysis for NIST
Kevin Kimball, SUPPLEMENTARY INFORMATION: Flow SRM 1934 and NIST’s finalized
Chief of Staff. cytometry is a widely used technique standard operating procedure (SOP) for
[FR Doc. 2016–16742 Filed 7–14–16; 8:45 am] for a single cell and particle analysis. It assigning ERF value will be used for
BILLING CODE 3510–13–P is an essential tool for immunological performing the ERF value assignments
research, drug and device development, for participants’ microparticles. This
clinical trials, disease diagnosis, and SOP includes four steps and is
DEPARTMENT OF COMMERCE therapy monitoring. The annual published at J. Res. Natl. Inst. Stand.
expenditure on flow cytometry-related Technol. 121: 269–286 (2016). As
National Institute of Standards and diagnostics is upwards of $1.2 Billion described in the SOP, the ERF value of
Technology and growing at more than 10 percent per the major microparticle population is
year, testifying to the economic calculated on the basis of the ratio of
Flow Cytometry Quantitation
importance of this technology. The mean fluorescence intensity values of
Consortium
measurements made on the different the major microparticle population to
AGENCY: National Institute of Standards instrument platforms at different times all microparticle populations.
and Technology, Department of and locations, however, cannot be A summary of the ERF value
Commerce. compared accurately, which makes assignments will include ERF values of
ACTION: Notice; request for information. diagnostic decisions unreliable and major microparticle populations,
slows down advances in biomedical associated combined uncertainties per
SUMMARY: The National Institute of research. In response to this limitation, laser excitation, and reference
Standards and Technology (NIST), an NIST and International Society for fluorophore. The combined uncertainty
agency of the United States Department Advancement of Cytometry (ISAC) have will be derived from all steps of the ERF
of Commerce, is establishing the Flow developed a methodology to implement value assignment, from weighing
Cytometry Quantitation Consortium and quantitation in flow cytometry. The first reference solutions, spectrofluorimeter
invites organizations to participate in step is to calibrate the fluorescence calibration, CCD response calibration,
this Consortium. The Consortium will signal from microparticles in terms of a microparticle concentration
develop reference materials including unit of equivalent number of reference measurements by flow cytometer and
reference fluorophore solutions and fluorophores (ERF) on three laser light obscuration, and measurement of
biological reference materials, reference excitations, 405 nm, 488 nm, and 633 the emission spectrum of microparticles
data and reference methods for nm. The ERF unit gives the number of to determine ERF values for major
assigning equivalent number of microparticle populations. NIST will
sradovich on DSK3GMQ082PROD with NOTICES
reference fluorophores in solution
reference fluorophores (ERF) values and which produce the same fluorescence also share with each participant any
for assessing the associated signal as a single dyed microsphere. digital emission spectral data of the
uncertainties and utilities. Participation The second step uses a biological cell, major microparticle populations. In
in this Consortium is open to all eligible with known number of specific addition, a participant may request
organizations, as described below. biomarkers, as a reference material to reports for specific ERF value
DATES: NIST will accept responses for translate the ERF unit to a unit of assignments for its microparticles under
participation in this Consortium on an antibodies bound per cell (ABC). The this Consortium. NIST intends to
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![Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices 46055
publish anonymized results of the Consortium will be bound by the same The Agenda is subject to change, and
research under this Consortium. In terms and conditions. the latest version along with other
accordance with 15 U.S.C. meeting materials will be posted on the
Kent Rochford,
3710a(c)(7)(B), NIST will withhold from Council’s file server. To access the file
Associate Director for Laboratory Programs. server, the URL is https://
public disclosure the data that
[FR Doc. 2016–16761 Filed 7–14–16; 8:45 am] public.gulfcouncil.org:5001/webman/
specifically identifies a participant’s
microparticles for a period of five (5) BILLING CODE 3510–13–P index.cgi, or go to the Council’s Web
years from the date any ERF values are site and click on the FTP link in the
generated, or until the participants lower left of the Council Web site http://
DEPARTMENT OF COMMERCE www.gulfcouncil.org. The username and
grants NIST permission to disclose such
data. NIST will not require the National Oceanic and Atmospheric password are both ‘‘gulfguest.’’ Click on
participants to pay a membership fee to Administration the ‘‘Library Folder,’’ then scroll down
participate in this Consortium. NIST to ‘‘SSC meeting-2016–08.’’
RIN 0648–XE733 The meeting will be webcast over the
will, however, require participants to
contribute funds to reimburse NIST for Internet. A link to the webcast will be
Gulf of Mexico Fishery Management available on the Council’s Web site,
the generation of any report requested Council; Public Meeting
by a participant for the ERF value http://www.gulfcouncil.org.
assignments of participant’s AGENCY: National Marine Fisheries Although other non-emergency issues
microparticles. Service (NMFS), National Oceanic and not on the agenda may come before the
Atmospheric Administration (NOAA), Scientific and Statistical Committee for
Participation Process: Eligibility will Commerce. discussion, in accordance with the
be determined by NIST using the Magnuson-Stevens Fishery
ACTION: Notice of a public meeting via
information provided by an organization Conservation and Management Act,
Webinar.
in response to this notice based on the those issues may not be the subject of
information requested below. SUMMARY: The Gulf of Mexico Fishery formal action during this meeting.
An organization responding to this Management Council will hold a Actions of the Scientific and Statistical
notice should provide the following meeting of its Standing and Reef Fish Committee will be restricted to those
information to NIST’s Consortium Scientific and Statistical Committees issues specifically identified in the
Manager: (SSC) via Webinar. agenda and any issues arising after
DATES: The meeting will be held on publication of this notice that require
(1) Type of microparticles: Optimal
Tuesday, August 2, 2016, from 1 p.m. to emergency action under section 305(c)
sizes of microparticles are from 2 to 10
3:30 p.m. (EDT), to view the agenda, see of the Magnuson-Stevens Fishery
microns. If there are needs of
SUPPLEMENTARY INFORMATION. Conservation and Management Act,
characterization and ERF value provided the public has been notified of
assignment to other size particles (<2 ADDRESSES: The meeting will be held
via Webinar; you may registering, at the Council’s intent to take action to
microns or >10 microns), the present address the emergency.
standard operating procedure can be https://attendee.gotowebinar.com/
modified to accommodate the requests. register/3960738127259119362. Special Accommodations
Council address: Gulf of Mexico
(2) Type of Instrument: The Fishery Management Council, 2203 N. This meeting is physically accessible
Consortium is to assign ERF values for Lois Avenue, Suite 1100, Tampa, FL to people with disabilities. Requests for
microparticles used primarily for flow 33607; telephone: (813) 348–1630. sign language interpretation or other
cytometers. Any information about auxiliary aids should be directed to
FOR FURTHER INFORMATION CONTACT:
other instruments used by the Kathy Pereira, at the Gulf Council Office
Steven Atran, Senior Fishery Biologist,
organization is helpful to ensure that (see ADDRESSES), at least 5 working days
Gulf of Mexico Fishery Management
there is diversity in participants. For prior to the meeting.
Council; steven.atran@gulfcouncil.org,
example, please indicate if the telephone: (813) 348–1630. Authority: 16 U.S.C. 1801 et seq.
microparticles are used by the Dated: July 12, 2016.
SUPPLEMENTARY INFORMATION:
organization with fluorescence
Tracey L. Thompson,
microscopes and spectrophotometers/ Agenda
Acting Director, Office of Sustainable
spectrofluorimeters. I. Introductions and adoption of agenda Fisheries, National Marine Fisheries Service.
(3) Experience in production and II. Selection of SSC representative at August, [FR Doc. 2016–16745 Filed 7–14–16; 8:45 am]
characterization of microparticles, 2016 Council meeting
BILLING CODE 3510–22–P
antibodies, and biological cells, and III. Reevaluation of alternative FMSY proxies
(FMAX, F20%SPR, F22%SPR, and F24%SPR) for
analysis of large data sets.
red snapper
A responding organization should not IV. Discussion of next gray triggerfish DEPARTMENT OF COMMERCE
include any business proprietary assessment—benchmark or standard
V. Review of updated SEDAR schedule National Oceanic and Atmospheric
information in its response to this
VI. Other business Administration
request for information. NIST will not
treat any information provided in — Meeting Adjourns—
response to this request as proprietary RIN 0648–XE723
Please register for SSC Meeting:
sradovich on DSK3GMQ082PROD with NOTICES
information. NIST will notify each Standing and Reef Fish on Aug. 2, 2016, South Atlantic Fishery Management
organization of its eligibility. In order to 1 p.m. (EDT), at https:// Council (SAFMC); Public Meetings
participate in this Consortium, each attendee.gotowebinar.com/register/
eligible organization must sign a 3960738127259119362. After AGENCY: National Marine Fisheries
Cooperative Research and Development registering, you will receive a Service (NMFS), National Oceanic and
Agreement (CRADA) for this confirmation email containing Atmospheric Administration (NOAA),
Consortium. All participants to this information about joining the Webinar. Commerce.
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Document Created: 2016-07-15 02:53:13
Document Modified: 2016-07-15 02:53:13
| 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 | |
| Action | Notice; request for information. | |
| Dates | NIST will accept responses for participation in this Consortium on an ongoing basis. The Consortium's activities will commence on August 15, 2016 (``Commencement Date''). Acceptance of participants into the Consortium after the Commencement Date will depend on the availability of NIST resources. | |
| Contact | For further information about partnership opportunities or about the terms and conditions of NIST's Cooperative Research and Development Agreement (CRADA), please contact Honeyeh Zube, CRADA and License Officer, 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- 2209. | |
| FR Citation | 81 FR 46054 |
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