82 FR 60373 - Accurate Fluorescence Measurements Consortium

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range		60373-60374
FR Document		2017-27353

The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, is establishing the Accurate Fluorescence Measurements Consortium and invites organizations to participate in this Consortium. The Consortium will develop tools for improving the accuracy of quantitative fluorescence measurements including reference materials, reference data and reference methods for relative spectral correction of spectra, lifetimes and quantum yields and for assessing the associated uncertainties and utilities. Participation in this Consortium is open to all eligible organizations, as described below.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017)

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60373-60374]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27353]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Accurate Fluorescence Measurements Consortium

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

ACTION: Notice; request for information.

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SUMMARY: The National Institute of Standards and Technology (NIST), an 
agency of the United States Department of Commerce, is establishing the 
Accurate Fluorescence Measurements Consortium and invites organizations 
to participate in this Consortium. The Consortium will develop tools 
for improving the accuracy of quantitative fluorescence measurements 
including reference materials, reference data and reference methods for 
relative spectral correction of spectra, lifetimes and quantum yields 
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 
January 2, 2018 (``Commencement Date''). Acceptance of participants 
into the Consortium after the Commencement Date will depend on 
eligibility and the availability of NIST resources.

ADDRESSES: Information in response to this notice and request for 
additional information about the Consortium can be directed via mail to 
the NIST Consortium Manager, Dr. Paul DeRose, 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 
Jeffrey DiVietro, 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) 
975-8779.

SUPPLEMENTARY INFORMATION: Quantitative fluorescence measurements are 
used for instrument qualification and method validation in the 
pharmaceutical and chemical industries. It is also increasingly being 
used for detection of antibodies in clinical diagnostics and biomedical 
research. The measurements made on different instrument platforms at 
different times and locations cannot be compared accurately, which 
makes diagnostic decisions unreliable and slows down advances in these 
areas. In response to this limitation, NIST, secondary standards 
manufacturers and other stakeholders have developed methodologies to 
implement quantitation fluorescence measurements.
    NIST produced SRMs 2940 through 2944 in the past nine years as 
relative intensity correction standards for fluorescence spectroscopy. 
These standards are needed by fluorescence instrument manufacturers and 
regulated communities that use quantitative fluorescence detection. For 
instance, the pharmaceutical and biotechnology communities use SRMs 
2940 through 2944 to calibrate and verify the performance of their 
fluorescence instruments, which is required to achieve accurate results 
in secondary screening of drugs and in quantitative analysis of 
bioassays. Many other communities that use fluorescence detection need 
similar standards, but cannot afford the price of these SRMs or require 
different sample formats.
    Few secondary standards of this type have been produced by industry 
because most companies do not have the fluorescence measurement 
capabilities and expertise to make high accuracy measurements. This 
Consortium is intended to give secondary standard manufacturers, as 
well as other stakeholders in the fluorescence measurement community, 
access to highly accurate fluorescence measurement capabilities 
available at NIST. In return, these manufacturers provide NIST 
information about new materials, future material needs, and new 
customer bases. These manufacturers know the needs of different 
communities and have developed new materials to meet these needs. Many 
of the fluorescent materials to be measured have not been used as 
standards and the suitability of these materials as standards is of 
great interest to NIST. NIST's understanding of the fluorescent 
characteristics of such materials through collaborative research and 
information exchange may lead to new NIST standards in this and other 
related areas. It is also important for NIST to know about additional 
standards needed in emerging technologies. Collaborators will supply 
NIST with this knowledge and work with NIST to design and characterize 
the best standards for such emerging technologies. Through this 
process, collaborators will assist NIST to develop better reference 
materials.

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 Reference Materials: Format of the sample (e.g., 
standard cuvette, microwell plate, microscope

[[Page 60374]]

slide); and Quantitative Target for Improved Accuracy (e.g., relative 
spectral correction of emission, fluorescence lifetime, fluorescence 
quantum yield).
    (2) Types of Applications: Fluorescence measurements are used for 
detection in many areas, but how will the proposed reference materials 
address the quantitative needs of high impact communities requiring 
better accuracy and reproducibility?
    (3) Experience in production and characterization of reference 
materials for quantitative fluorescence.
    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.

Authority

    15 U.S.C. 3710a.

Kevin Kimball,
NIST Chief of Staff.
[FR Doc. 2017-27353 Filed 12-19-17; 8:45 am]
 BILLING CODE 3510-13-P

Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices 60373

Notification to Importers participate in this Consortium. The fluorescence spectroscopy. These
This notice also serves as a Consortium will develop tools for standards are needed by fluorescence
preliminary reminder to importers of improving the accuracy of quantitative instrument manufacturers and regulated
their responsibility under 19 CFR fluorescence measurements including communities that use quantitative
351.402(f) to file a certificate regarding reference materials, reference data and fluorescence detection. For instance, the
the reimbursement of antidumping reference methods for relative spectral pharmaceutical and biotechnology
duties prior to liquidation of the correction of spectra, lifetimes and communities use SRMs 2940 through
relevant entries during this review quantum yields and for assessing the 2944 to calibrate and verify the
period. Failure to comply with this associated uncertainties and utilities. performance of their fluorescence
requirement could result in the Participation in this Consortium is open instruments, which is required to
Department’s presumption that to all eligible organizations, as described achieve accurate results in secondary
reimbursement of antidumping duties below. screening of drugs and in quantitative
occurred and the subsequent assessment DATES: NIST will accept responses for analysis of bioassays. Many other
participation in this Consortium on an communities that use fluorescence
of double antidumping duties.
These preliminary results of ongoing basis. The Consortium’s detection need similar standards, but
administrative review are issued and activities will commence on January 2, cannot afford the price of these SRMs or
published in accordance with sections 2018 (‘‘Commencement Date’’). require different sample formats.
Acceptance of participants into the Few secondary standards of this type
751(a)(1) and 777(i)(1) of the Act and 19
Consortium after the Commencement have been produced by industry
CFR 351.213(h)(1).
Date will depend on eligibility and the because most companies do not have
Dated: December 13, 2017. the fluorescence measurement
availability of NIST resources.
Gary Taverman, capabilities and expertise to make high
ADDRESSES: Information in response to
Deputy Assistance Secretary for Antidumping this notice and request for additional accuracy measurements. This
and Countervailing Duty Operations, Consortium is intended to give
performing the non-exclusive functions and
information about the Consortium can
be directed via mail to the NIST secondary standard manufacturers, as
duties of the Assistant Secretary for well as other stakeholders in the
Enforcement and Compliance. Consortium Manager, Dr. Paul DeRose,
Biosystems and Biomaterials Division of fluorescence measurement community,
Appendix NIST’s Material Measurement access to highly accurate fluorescence
Laboratory, 100 Bureau Drive, measurement capabilities available at
List of Topics Discussed in the Preliminary
Decision Memorandum Gaithersburg, Maryland 20899–8312, or NIST. In return, these manufacturers
via electronic mail to lili.wang@nist.gov. provide NIST information about new
1. Summary materials, future material needs, and
2. Background FOR FURTHER INFORMATION CONTACT: For
3. Scope of the Order new customer bases. These
further information about partnership manufacturers know the needs of
4. Selection of Respondents opportunities or about the terms and
5. Affiliation and Collapsing of Affiliates different communities and have
conditions of NIST’s Cooperative developed new materials to meet these
6. Unexamined Respondents
7. Discussion of Methodology Research and Development Agreement needs. Many of the fluorescent materials
8. Product Comparisons (CRADA), please contact Jeffrey to be measured have not been used as
9. Date of Sale DiVietro, CRADA and License Officer, standards and the suitability of these
10. Export Price National Institute of Standards and materials as standards is of great interest
11. Normal Value Technology’s Technology Partnerships to NIST. NIST’s understanding of the
12. Revisions to SAS-Solartech’s Reported Office, by mail to 100 Bureau Drive,
Home Market Sales fluorescent characteristics of such
Mail Stop 2200, Gaithersburg, Maryland materials through collaborative research
13. Cost of Production Analysis 20899, by electronic mail to
14. Calculation of NV Based on Comparison- and information exchange may lead to
Market Prices jeffrey.divietro@nist.gov, or by new NIST standards in this and other
15. Currency Conversions telephone at (301) 975–8779. related areas. It is also important for
16. Conclusion SUPPLEMENTARY INFORMATION: NIST to know about additional
[FR Doc. 2017–27405 Filed 12–19–17; 8:45 am] Quantitative fluorescence measurements standards needed in emerging
BILLING CODE 3510–DS–P are used for instrument qualification technologies. Collaborators will supply
and method validation in the NIST with this knowledge and work
pharmaceutical and chemical with NIST to design and characterize
DEPARTMENT OF COMMERCE industries. It is also increasingly being the best standards for such emerging
used for detection of antibodies in technologies. Through this process,
National Institute of Standards and clinical diagnostics and biomedical collaborators will assist NIST to develop
Technology research. The measurements made on better reference materials.
different instrument platforms at
Accurate Fluorescence Measurements different times and locations cannot be Participation Process
Consortium compared accurately, which makes Eligibility will be determined by NIST
AGENCY: National Institute of Standards diagnostic decisions unreliable and using the information provided by an
and Technology, Department of slows down advances in these areas. In organization in response to this notice
Commerce. response to this limitation, NIST, based on the information requested
sradovich on DSK3GMQ082PROD with NOTICES

ACTION: Notice; request for information. secondary standards manufacturers and below.
other stakeholders have developed An organization responding to this
SUMMARY: The National Institute of methodologies to implement notice should provide the following
Standards and Technology (NIST), an quantitation fluorescence information to NIST’s Consortium
agency of the United States Department measurements. Manager:
of Commerce, is establishing the NIST produced SRMs 2940 through (1) Type of Reference Materials:
Accurate Fluorescence Measurements 2944 in the past nine years as relative Format of the sample (e.g., standard
Consortium and invites organizations to intensity correction standards for cuvette, microwell plate, microscope

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Document Created: 2018-10-25 10:56:18
Document Modified: 2018-10-25 10:56:18

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 January 2, 2018 (``Commencement Date''). Acceptance of participants into the Consortium after the Commencement Date will depend on eligibility and 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 Jeffrey DiVietro, 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) 975-8779.
FR Citation		82 FR 60373

82 FR 60373 - Accurate Fluorescence Measurements Consortium

DEPARTMENT OF COMMERCENational Institute of Standards and Technology

Federal Register Volume 82, Issue 243 (December 20, 2017)

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology