Flow Cytometry Quantitation Consortium, 46054-46055 [2016-16761]
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices
August 23, 2016, from 3:00 p.m. until
3:15 p.m. Central Time. Speakers will be
selected on a first-come, first-served
basis. Each speaker will be limited to
five minutes. Questions from the public
will not be considered during this
period. Members of the public who are
interested in speaking are requested to
contact Sara Kerman at the contact
information indicated in the FOR
FURTHER INFORMATION CONTACT section of
this notice.
Speakers who wish to expand upon
their oral statements, those who had
wished to speak but could not be
accommodated on the agenda, and those
who were unable to attend in person are
invited to submit written statements. In
addition, written statements are invited
and may be submitted to the
Commission at any time. All written
statements should be directed to the
Commission Executive Director,
Information Technology Laboratory, 100
Bureau Drive, Stop 8900, National
Institute of Standards and Technology,
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email at: cybercommission@nist.gov.
Please use subject line ‘‘Open Meeting of
the Commission on Enhancing National
Cybersecurity—MN’’.
Kevin Kimball,
Chief of Staff.
[FR Doc. 2016–16742 Filed 7–14–16; 8:45 am]
BILLING CODE 3510–13–P
DEPARTMENT OF COMMERCE
National Institute of Standards and
Technology
Flow Cytometry Quantitation
Consortium
National Institute of Standards
and Technology, Department of
Commerce.
ACTION: Notice; request for information.
AGENCY:
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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:03 Jul 14, 2016
Jkt 238001
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
lili.wang@nist.gov.
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 honeyeh.zube@
nist.gov, 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
PO 00000
Frm 00011
Fmt 4703
Sfmt 4703
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
E:\FR\FM\15JYN1.SGM
15JYN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices
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
VerDate Sep<11>2014
19:03 Jul 14, 2016
Jkt 238001
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
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
RIN 0648–XE733
Gulf of Mexico Fishery Management
Council; Public Meeting
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Notice of a public meeting via
Webinar.
AGENCY:
The Gulf of Mexico Fishery
Management Council will hold a
meeting of its Standing and Reef Fish
Scientific and Statistical Committees
(SSC) via Webinar.
DATES: The meeting will be held on
Tuesday, August 2, 2016, from 1 p.m. to
3:30 p.m. (EDT), to view the agenda, see
SUPPLEMENTARY INFORMATION.
ADDRESSES: The meeting will be held
via Webinar; you may registering, at
https://attendee.gotowebinar.com/
register/3960738127259119362.
Council address: Gulf of Mexico
Fishery Management Council, 2203 N.
Lois Avenue, Suite 1100, Tampa, FL
33607; telephone: (813) 348–1630.
FOR FURTHER INFORMATION CONTACT:
Steven Atran, Senior Fishery Biologist,
Gulf of Mexico Fishery Management
Council; steven.atran@gulfcouncil.org,
telephone: (813) 348–1630.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Agenda
I. Introductions and adoption of agenda
II. Selection of SSC representative at August,
2016 Council meeting
III. Reevaluation of alternative FMSY proxies
(FMAX, F20%SPR, F22%SPR, and F24%SPR) for
red snapper
IV. Discussion of next gray triggerfish
assessment—benchmark or standard
V. Review of updated SEDAR schedule
VI. Other business
— Meeting Adjourns—
Please register for SSC Meeting:
Standing and Reef Fish on Aug. 2, 2016,
1 p.m. (EDT), at https://
attendee.gotowebinar.com/register/
3960738127259119362. After
registering, you will receive a
confirmation email containing
information about joining the Webinar.
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46055
The Agenda is subject to change, and
the latest version along with other
meeting materials will be posted on the
Council’s file server. To access the file
server, the URL is https://
public.gulfcouncil.org:5001/webman/
index.cgi, or go to the Council’s Web
site and click on the FTP link in the
lower left of the Council Web site https://
www.gulfcouncil.org. The username and
password are both ‘‘gulfguest.’’ Click on
the ‘‘Library Folder,’’ then scroll down
to ‘‘SSC meeting-2016–08.’’
The meeting will be webcast over the
Internet. A link to the webcast will be
available on the Council’s Web site,
https://www.gulfcouncil.org.
Although other non-emergency issues
not on the agenda may come before the
Scientific and Statistical Committee for
discussion, in accordance with the
Magnuson-Stevens Fishery
Conservation and Management Act,
those issues may not be the subject of
formal action during this meeting.
Actions of the Scientific and Statistical
Committee will be restricted to those
issues specifically identified in the
agenda 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 Council’s intent to take action to
address the emergency.
Special Accommodations
This meeting is physically accessible
to people with disabilities. Requests for
sign language interpretation or other
auxiliary aids should be directed to
Kathy Pereira, at the Gulf Council Office
(see ADDRESSES), at least 5 working days
prior to the meeting.
Authority: 16 U.S.C. 1801 et seq.
Dated: July 12, 2016.
Tracey L. Thompson,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2016–16745 Filed 7–14–16; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
RIN 0648–XE723
South Atlantic Fishery Management
Council (SAFMC); Public Meetings
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
AGENCY:
E:\FR\FM\15JYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46054-46055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
lili.wang@nist.gov.
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 honeyeh.zube@nist.gov, 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
