Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium

<NOTICE> DEPARTMENT OF COMMERCE <SUBAGY>National Institute of Standards and Technology</SUBAGY> <SUBJECT>Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> National Institute of Standards and Technology, Department of Commerce. <HD SOURCE="HED">ACTION:</HD> Notice of research consortium. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> 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. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Completed letters of interest must be submitted via the letter of interest webform at <E T="03">https://forms.gle/bCMV9tmc9uRyZxmRA,</E> by email to <E T="03">melissa.phillips@nist.gov,</E> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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 <E T="03">agreements@nist.gov,</E> or by phone (301) 975-8408. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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. <HD SOURCE="HD1">Participation Process</HD> 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 <E T="03">https://forms.gle/bCMV9tmc9uRyZxmRA;</E> alternatively, parties can answer the questions detailed in LETTER OF INTEREST, below, and send via email or hardcopy (for reference, see <E T="02">ADDRESSES</E> 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 T="03">e.g.,</E> 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 T="03">e.g.,</E> 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. <E T="03">Authority:</E> 15 U.S.C. 3710a. <SIG> <NAME>Alicia Chambers,</NAME> NIST Executive Secretariat. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2024-30948 Filed 12-26-24; 8:45 am]</FRDOC> </NOTICE>