Notice2024-30948
Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2024
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 standards, including reference materials, to support quality and safety for the dietary supplement testing community, is establishing the Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium ("Consortium"). The Consortium will bring together stakeholders to identify and address measurement and standards needs related to analytical testing of dietary supplement ingredients and products. The Consortium efforts are intended to advance measurement capabilities, provide measurement quality assurance strategies, support the development of dietary supplement 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 not permitted to enter into CRADAs pursuant to law or other governmental constraint may be allowed to participate in the Consortium pursuant to a separate non-CRADA agreement.
Full Text
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<title>Federal Register, Volume 89 Issue 248 (Friday, December 27, 2024)</title>
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[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Notices]
[Pages 105535-105536]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30948]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
Dietary Supplement Laboratory Quality Assurance Program (DSQAP)
Consortium
AGENCY: National Institute of Standards and Technology, 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 standards,
including reference materials, to support quality and safety for the
dietary supplement testing community, is establishing the Dietary
Supplement Laboratory Quality Assurance Program (DSQAP) Consortium
(``Consortium''). The Consortium will bring together stakeholders to
identify and address measurement and standards needs related to
analytical testing of dietary supplement ingredients and products. The
Consortium efforts are intended to advance measurement capabilities,
provide measurement quality assurance strategies, support the
development of dietary supplement 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
not permitted to enter into CRADAs pursuant to law or other
governmental
[[Page 105536]]
constraint may be allowed to participate in the Consortium pursuant to
a separate non-CRADA agreement.
DATES: The Consortium's activities will commence on May 1, 2025
(``Commencement Date''). NIST will 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/bCMV9tmc9uRyZxmRA">https://forms.gle/bCMV9tmc9uRyZxmRA</a>, by
email to <a href="/cdn-cgi/l/email-protection#a8c5cdc4c1dbdbc986d8c0c1c4c4c1d8dbe8c6c1dbdc86cfc7de"><span class="__cf_email__" data-cfemail="600d050c091313014e1008090c0c091013200e0913144e070f16">[email protected]</span></a>, or via hardcopy to the Consortium
Manager, Dr. Melissa Phillips, Chemical Sciences Division of NIST's
Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8390,
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: J'aime Maynard, Consortia Agreements
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 <a href="/cdn-cgi/l/email-protection#0d6c6a7f6868606863797e4d63647e79236a627b"><span class="__cf_email__" data-cfemail="6c0d0b1e0909010902181f2c02051f18420b031a">[email protected]</span></a>,
or by phone (301) 975-8408.
SUPPLEMENTARY INFORMATION: The objective of the DSQAP is to develop and
evaluate measurement methods and standards to support quality and
safety for the dietary supplement testing community. Approximately 75%
of the U.S. population takes dietary supplements, including vitamins
and mineral supplements, representing an annual expenditure of more
than $20 billion USD. Regulations, driven by reported cases of
inaccurate labeling, adulteration, contamination (with pesticides,
heavy metals, or toxic botanicals), and drug interactions, are now in
place that require manufacturers to evaluate the identity, purity, and
composition of their ingredients and finished products. The plethora of
unique products on the market has led to an uptick in published methods
but limited outlets for external method evaluation and validation.
The focus of this Consortium is to evaluate and standardize methods
to characterize and quantify nutrients, marker compounds, and/or
contaminants in dietary supplement ingredients and finished products,
improving overall comparability within the community and enabling
organizations that join the Consortium (``Consortium Members'') to
improve the accuracy and precision of their own, internal measurements.
The Consortium will organize at least two interlaboratory exercises
annually based on candidate reference materials and/or commercial
products with the following goals:
<bullet> Evaluate the suitability of current published methods,
including standard methods, to measure nutrients, marker compounds,
and/or contaminants in dietary supplement ingredients and finished
products.
<bullet> Utilize common materials to collect reproducibility data
in support of measurement assurance and standards development.
<bullet> Propose tests(s) that can be standardized through the AOAC
International or similar consensus process, using outcomes from
Consortium efforts as a foundation.
<bullet> Evaluate the applicability of current reference materials
for dietary supplement ingredient and finished product testing. If
needed, develop new reference materials to support advancement of the
dietary supplement testing industry.
No proprietary information will be shared as part of the
Consortium. Contributions of materials to be used as interlaboratory
study samples, such as dietary supplement ingredients or products, are
highly encouraged.
Participation Process
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/bCMV9tmc9uRyZxmRA">https://forms.gle/bCMV9tmc9uRyZxmRA</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
analytical testing of dietary supplement ingredients and products and
description of the services and/or technical capabilities (e.g.,
available instrumentation, relevant accreditations, published methods)
they will contribute to Consortium activities.
b. Materials: Narrative of interest and description of the dietary
supplement ingredients 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., trade associations,
regulatory oversight, standards development) they will contribute to
Consortium activities.
(2) List of anticipated participating individuals.
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 not
permitted to enter into CRADAs pursuant to law or other governmental
constraint may be allowed to participate in the Consortium, at NIST's
discretion, pursuant to separate non-CRADA agreements with terms that
may differ, as necessary from the Consortium CRADA terms. 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. 2024-30948 Filed 12-26-24; 8:45 am]
BILLING CODE 3510-13-P
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