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Dietary Supplement Laboratory Method Validation

Solicitation Number: NIHOD2010236
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: Office of Administration
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Sources Sought
Added: Aug 18, 2010 10:17 am
This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not a small business under the applicable NAICS code 541380, Testing Laboratories, should not submit a response to this notice.

The Dietary Supplement Health and Education Act (DSHEA, United States Public Law 103-417) amended the Federal Food, Drug, and Cosmetic (FD&C) Act by defining a dietary supplement (DS) as any product (other than tobacco) that contains a vitamin, mineral, herb or other botanical, or amino acid and is intended as a supplement to the diet. Very limited data to confirm product identity, safety, or integrity is now available for most dietary supplements. Verifiable specifications and related information can only be assured if appropriate, rugged, and reliable analytical methods are available and utilized by stakeholders.

The Office of Dietary Supplements (ODS) was established at the National Institutes of Health (NIH) by the DSHEA in 1994, and began operations in 1995. Through its Analytical Methods/Reference Materials Program (, the ODS has led the Federal effort to identify and develop research tools needed to study dietary supplements. These tools include validated analytical methods for dietary supplement constituents.

When the DSHEA was enacted, the U.S. Congress attempted to address the lack of publicly available, validated analytical methods for dietary supplements. A goal of the ODS is to support the development of research tools for use in the study of dietary supplements. AOAC® Official Methods of AnalysisSM (OMA) are needed in the study of dietary supplements, are recognized in courts of law, are often developed for regulatory purposes, and serve to create consensus standards that promote international trade.

The main objective of a potential future Contract shall be to provide the ODS, NIH, and its stakeholders with accurate, reliable, practical, validated, and published analytical methods for selected dietary supplements. These methods shall be validated using AOAC International guidelines for single-laboratory validation (SLV) and/or the AOAC® OMASM process as directed by ODS. Potential ingredients and finished products may include (but are not limited to): phytochemicals in botanicals botanical extracts; nutrients (including vitamins, minerals, proteins and amino acids, fats and fatty acids); isolates; concentrates; or metabolites; and potentially deleterious substances such as toxic elements, pesticides, and mycotoxins.

The ODS envisions a comprehensive system for the simultaneous development, optimization, and validation of multiple analytical methods coordinated by one laboratory and guided by a stakeholder informed method prioritization process through AOAC International. Each individual method shall constitute a task, and this contract anticipates that the number of tasks will depend on available resources at the Government’s convenience.

The Contractor would be responsible for one or more of the following activities in conformity with the policies, guidelines, and procedures of the AOAC® OMASM Program ( for collaborative studies and guidelines for development, optimization, and conduct of single- and multiple laboratory validation studies for the dietary supplement constituents and matrices prescribed by ODS in each task ( In addition, the Contractor shall publish the results of all studies of the methods in a peer-reviewed journal and, when directed by ODS, submit any completed collaboratively-studied method in the approved AOAC International format to AOAC International for consideration as an OMA.

The NIH anticipates a need for services to be provided for a base period of two years, with three optional years possible. Option years would be exercised at the sole discretion of the Government. Quantities of analytical methods to be validated and published may vary, but by historical comparisons are likely to range from 2-7 methods per year, depending on the nature of the required study (e.g. single laboratory validation, OMA) and availability of funds.

Innovative approaches to satisfying the anticipated requirement to appropriately develop, optimize, and validate quantitative analytical methods for dietary supplement constituents would be encouraged if a solicitation were issued.

If your organization is a small business and has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, web site address, and telephone number. 2) Size and type of ownership for the organization [i.e., small business, small disadvantaged business, 8(a) firm, etc.].

Business experiences consistent with what is described above, sizes, types, and socioeconomic designations shall be included with the capability statements. Capability statements must be received by 2:00 pm (Local Time) on September 3, 2010. Please send/deliver capability statements to the following email A maximum of five (5) pages for the capability statements are required. Only the first five (5) pages of any submission will be reviewed! The font size shall be a minimum of 10 point. All margins shall be at least ¾ inch (1.9 cm).

6011 Executive Blvd
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