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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 [www.gpo.gov]
[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 https://forms.gle/bCMV9tmc9uRyZxmRA, by 
email to [email protected], 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 [email protected], 
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:
     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.
     Utilize common materials to collect reproducibility data 
in support of measurement assurance and standards development.
     Propose tests(s) that can be standardized through the AOAC 
International or similar consensus process, using outcomes from 
Consortium efforts as a foundation.
     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 https://forms.gle/bCMV9tmc9uRyZxmRA; 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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