[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60373-60374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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