E9-1162. ODS Analytical Methods and Reference Materials Program-Dietary Supplement Element Methodology Workshop; Notice

Notice is hereby given of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) Analytical Methods and Reference Materials Program, Dietary Supplement Element Methodology Workshop to be held Monday, March 23rd and Tuesday, March 24th, 2009 at the Marriott Gaithersburg Washingtonian Center Hotel in Gaithersburg, Maryland, 20878.

Summary: Late in 2001, the U.S. Congress addressed the need for support of analytical methods and reference materials development related to dietary supplements. The Congressional appropriation language supported an increased ODS budget for several topics, including analytical methods and reference materials. The Senate language called for: “ODS to allocate sufficient funds to speed up an ongoing collaborative effort to develop and disseminate validated analytical methods and reference materials for the most commonly used botanicals and other dietary supplements.”

On February 8, 2002, ODS held a public meeting to solicit comments to assist ODS in designing an overall strategy for implementing the Congressional mandate to foster development and validation of analytical methods and reference materials for dietary supplements.

In Fiscal Years 2004 and 2005, Congress again used similar language supporting the Analytical Methods and Reference Materials Program in the ODS appropriations.

On September 10, 2007, ODS held a Stakeholders' Meeting to review the progress that had been made by the Analytical Methods and Reference Materials Program since its inception in 2002 and to receive comments on future programmatic directions.

As a follow-up to the recommendations from the Stakeholders' Meeting, a Vitamin Methodology Workshop was held in July 2008. This workshop sought to evaluate the state of analytical methodology on vitamins suitable for dietary supplements and to identify gaps in the analytical science for the purpose of meeting future methods needs of stakeholders. Results of the Vitamin Methodology Workshop include an executive summary of the outcome of the workshop (in preparation) as well as recognition of a need for a Dietary Supplement Element Methodology Workshop.

The purpose of this upcoming workshop is to evaluate the state of analytical methods for nutrient and non-nutrient minerals (including toxic elements) in dietary supplement products and to identify gaps in methodology, with a view toward designing a research program to fill the unmet methods needs of stakeholders. The desired outcomes of this meeting are to provide an overview of the status of analytical methodology for elements, to discuss analytical method purpose statements, to discuss the definition and evaluation of a method's purpose, as well as its fitness for purpose.

The sponsor of this meeting is the NIH Office of Dietary Supplements.

Registration

Seating at this workshop is very limited. To register please forward your name and complete mailing addresses including phone number via e-mail to Mr. Mike Schultz at [e-mail]. Mr. Schultz will be coordinating the registration for this meeting. If you wish to make an oral presentation during the meeting, you must indicate this when you register and submit the following information: (1) A brief written statement of the general nature of the comments that you wish to present, (2) the names and addresses of the person(s) who will give the presentation, and (3) the approximate length of time that you are requesting for your presentation. Depending on the number of people who register to make presentations, we may have to limit the time allotted for each presentation. If you don't have access to e-mail please call Mr. Schultz at 301-670-0270.

Dated: January 13, 2009.

Paul M. Coates,

Director, Office of Dietary Supplements, National Institutes of Health.