Notice2025-16929
Intent To Establish Isotope Metallomics Quality Assurance Consortium
Primary source
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Published
September 4, 2025
Issuing agencies
Commerce DepartmentNational Institute of Standards and Technology
Abstract
The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, in support of efforts to develop and evaluate measurement methods and reference standards, including reference materials, to support measurement quality and comparability for the isotope metallomics measurement community, is establishing the Isotope Metallomics Quality Assurance Program (IMQAP) Consortium ("Consortium"). The Consortium will bring together stakeholders to identify and address measurement and standards needs related to isotopic measurements of clinical/biological materials and products. The Consortium efforts are intended to advance measurement capabilities, provide measurement quality assurance strategies, support the development of clinical/biological matrix reference materials, and collect data to support the development of best practices and standard methods. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA). At NIST's discretion, entities that are legally prohibited or not legally authorized to enter into a CRADA may be allowed to participate in the Consortium under an agreement other than a CRADA with terms that may differ, as necessary, from the CRADA terms.
Full Text
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<title>Federal Register, Volume 90 Issue 169 (Thursday, September 4, 2025)</title>
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[Federal Register Volume 90, Number 169 (Thursday, September 4, 2025)]
[Notices]
[Pages 42746-42748]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16929]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
Intent To Establish Isotope Metallomics Quality Assurance
Consortium
AGENCY: National Institute of Standards and Technology (NIST),
Department of Commerce.
ACTION: Notice of research consortium.
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SUMMARY: The National Institute of Standards and Technology (NIST), an
agency of the United States Department of Commerce, in support of
efforts to develop and evaluate measurement methods and reference
standards, including reference materials, to support measurement
quality and comparability for the isotope metallomics measurement
community, is establishing the Isotope Metallomics Quality Assurance
Program (IMQAP) Consortium (``Consortium''). The Consortium will bring
together stakeholders to identify and address measurement and standards
needs related to isotopic measurements of clinical/biological materials
and products. The Consortium efforts are intended to advance
measurement capabilities, provide measurement quality assurance
strategies, support the development of clinical/biological matrix
reference materials, and collect data to support the development of
best practices and standard methods. Participants will be required to
sign a Cooperative Research and Development Agreement (CRADA). At
NIST's discretion, entities that are legally prohibited or not legally
authorized to enter into a CRADA may be allowed to participate in the
Consortium under an agreement other than a CRADA with terms that may
differ, as necessary, from the CRADA terms.
DATES: The Consortium's activities will commence on September 1, 2025
(``Commencement Date''). NIST will
[[Page 42747]]
accept letters of interest to participate in this Consortium on an
ongoing basis.
ADDRESSES: Completed letters of interest must be submitted via the
letter of interest webform at <a href="https://forms.gle/BFU1DXuAqSxa2XZUA">https://forms.gle/BFU1DXuAqSxa2XZUA</a>, by
email to <a href="/cdn-cgi/l/email-protection#dcb6bdbfada9b9b0b5b2b9f2b1bdb2b29cb2b5afa8f2bbb3aa"><span class="__cf_email__" data-cfemail="5a303b392b2f3f3633343f74373b34341a3433292e743d352c">[email protected]</span></a>, or via hardcopy to the Consortium
Manager, Dr. Jacqueline Mann, Chemical Sciences Division of NIST's
Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8391,
Gaithersburg, Maryland 20899. Organizations whose letters of interest
are accepted in accordance with the process set forth in the
SUPPLEMENTARY INFORMATION section of this notice will be asked to sign
a consortium CRADA with NIST. A consortium CRADA template will be made
available to qualifying applicants.
FOR FURTHER INFORMATION CONTACT: Jaime Maynard, Technology Transfer
Agreements Specialist, Consortia Agreements Specialist, 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 <a href="/cdn-cgi/l/email-protection#dc96bdb5b1b9f291bda5b2bdaeb89cb2b5afa8f2bbb3aa"><span class="__cf_email__" data-cfemail="652f040c08004b28041c0b041701250b0c16114b020a13">[email protected]</span></a> or by phone (301)
975-8408.
SUPPLEMENTARY INFORMATION: The objective of the IMQAP is to develop and
evaluate measurement methods and standards to support quality and
comparability of metal isotope measurements for the isotope metallomics
community with the aim of facilitating the adoption of isotope
analytics by clinical laboratories and practitioners. Naturally
occurring stable metal isotope analytics in the health and medical
sciences (Isotope Metallomics) has demonstrated high potential for
clinical biomarker development, diagnostics and prognostics. Isotopic
biomarkers demonstrate higher sensitivity and specificity for some
pathologies compared to standard biochemical markers as they are less
susceptible to complex biochemical processes than traditional
molecular-based biomarkers. For instance, Copper (Cu) isotope ratios
can detect breast and colorectal cancers several months earlier than
traditional biomarkers and Calcium (Ca) isotopes in blood and urine are
able to detect musculoskeletal diseases such as osteoporosis years
before the standard method of Dual X-ray absorptiometry (DXA). Chronic
diseases like diabetes, cardio-vascular diseases, and cancers are the
leading cause of death worldwide. It is estimated that by 2030 the cost
of these diseases will reach $47 trillion worldwide. The yearly cost of
these diseases to the American medical system is more than $1 trillion
and only growing larger. In response to the ever-rising costs, there is
a clear movement away from the current reactive intervention-based
healthcare model toward predictive, preventive, and personalized
medicine (PPPM) for optimal and cost-effective healthcare. This new
model will demand a new generation of biomarkers that are capable of
early detection and provide for effective monitoring of targeted
therapies. Isotope analytics are emerging as powerful tools for
addressing this need. The focus of this Consortium is to evaluate,
develop, and standardize methods of characterization for metal isotopes
in clinical/biological materials improving the metal isotope
measurement methodologies and capabilities employed by the isotope
metallomics community and the overall measurement comparability within
the community enabling organizations that join the Consortium
(``Consortium Members'') to improve the accuracy and precision of their
measurements and build the quality and confidence needed for adoption
of metal isotopes as a tool in the clinical setting. The IMQAP
Consortium will work together to address the following goals:
<bullet> Evaluate the applicability of current reference materials
to meet the needs of the isotope metallomics community. If needed,
develop new reference materials to support advancement of the isotope
metallomics measurement community.
<bullet> Evaluate the suitability of current measurement approaches
(e.g., repeatability and comparability) to measure the suite of
relevant metal isotopes using interlaboratory exercises based on
candidate reference materials and/or commercial products.
<bullet> Utilize common clinical/biological materials to collect
reproducibility data in support of measurement assurance and standards
development.
<bullet> Propose tests(s) that can be standardized through the
clinical lab standards organization or similar consensus process, using
outcomes from Consortium efforts as a foundation.
<bullet> No proprietary information will be shared as part of the
Consortium. Contributions of materials to be used as interlaboratory
study samples, such as chemical/biological materials, are highly
encouraged.
Participation Process
NIST is soliciting responses from all sources, including other
Federal Government agencies, foreign government agencies, industrial
organizations (including corporations, partnerships, and limited
partnerships, and industrial development organizations), public and
private foundations, and nonprofit organizations (including
universities). Eligibility to participate in the Consortium will be
determined by NIST based on the information provided by prospective
participants in response to this notice. Prospective participants can
submit a letter of interest by completing the letter of interest
webform at <a href="https://forms.gle/BFU1DXuAqSxa2XZUA">https://forms.gle/BFU1DXuAqSxa2XZUA</a> alternatively, parties
can answer the questions detailed in LETTER OF INTEREST, below, and
send via email or hardcopy (for reference, see ADDRESSES section
above). NIST will contact interested parties if there are questions
regarding the responsiveness of the letters of interest to the project
objective or requirements identified below.
Each responding organization's letter of interest should include
the address, point of contact, and following information:
(1) The contribution(s) the organization will make to the
Consortium efforts. All Consortium members must contribute one or more
of the following:
a. Analytical Testing: Narrative of interest and experience in the
measurement of stable metal isotopes of biological materials and
description of the services and/or technical capabilities (e.g.,
available instrumentation, published methods, relevant accreditations)
they will contribute to Consortium activities.
b. Materials: Narrative of interest and description of the
biological materials and products they will contribute to Consortium
activities.
c. Unique Industry or Community Perspective: Narrative of interest
and description of other relevant expertise (e.g., standards
development, measurement methods development) they will contribute to
Consortium activities.
(2) List of interested party's anticipated participants.
Letters of interest must not include proprietary information,
including proprietary business information. NIST will not treat any
information provided in response to this notice as proprietary
information. NIST will notify each organization of its eligibility to
join the Consortium. In order to participate in this Consortium, each
eligible organization must sign a CRADA. Entities that are legally
prohibited or not legally authorized to enter into a CRADA may be
allowed to participate in the Consortium, at NIST's discretion, under
an agreement other than a CRADA with terms that may differ, as
necessary, from the Consortium CRADA terms. Foreign governmental
entities
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may, at NIST's discretion, be permitted to participate in the
Consortium under an appropriate international agreement. NIST does not
guarantee participation in the Consortium to any organization
submitting a letter of interest.
(Authority: 15 U.S.C. 3710a)
Alicia Chambers,
NIST Executive Secretariat.
[FR Doc. 2025-16929 Filed 9-3-25; 8:45 am]
BILLING CODE 3510-13-P
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