Oak Ridge Associated Universities
Research on Dietary Ingredients Program
Dietary Ingredients Program
Project # FDA CFSAN 2007-13
A project is available in the Research Participation Program at the Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration (FDA). The appointee will be assigned to the Office of Nutritional Products, Labeling, and Dietary Supplements in College Park, Maryland.
Description of Project:
The Division of Dietary Supplement Programs reviews scientific submissions of data received from firms interested in marketing new dietary ingredients as dietary supplements. These activities are conducted pursuant to the Dietary Supplement Health and Education Act of 1994 which mandates that FDA review safety of proposed new dietary ingredients.
The fellow will be assigned to the regulations and review team and performs tasks that include resolving a broad range of issues of concerning the application of any of FDA’s enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government. Assignments are often complicated by the need to research complex or controversial scientific-regulatory issues of wide public interest and prepare documents based on the findings.
The fellow will be trained in the evaluation of scientific, toxicological, and/or chemical data relevant to the safety of dietary ingredients. The fellow will gain an understanding of how such data, when coupled with a review of the chemical and toxicological data, determine to a large extent whether a new dietary ingredient notification will be objected to or not. The fellow also evaluates adverse information on products already approved by the agency. The fellow will learn how these evaluations provide guidance in determining whether administrative actions are necessary. The fellow will collaborate with FDA staff on his/her findings.
The training involves FDA’s regulatory mission and the safety of the nation’s dietary supplement supply. The fellow:
-Assists Division in systems to manage workflow, including use of computer programming to ensure consistent and timely processing and completion of assignments.
-Studies complex and high priority scientific matters affecting the regulation of dietary supplements with particular interest in food safety and regulatory compliance issues. Drafts documents regarding findings.
-Collaborates on matters related to chemistry, clinical nutrition, and/or scientific issues and related regulatory actions.
-Drafts or review reports based on her findings related to dietary supplements.
-Prepares replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have abroad health implications.
A doctoral degree received within the past five years is required as is US citizenship or lawful permanent resident status. The fellow must have pursued studies leading to their doctoral degree in the area of chemistry, toxicology, and/or other appropriate biological science(s). Additionally, excellent writing and oral communication skills are required since the appointee will be required to provide written reports for the Center’s records and will also be responsible for oral communication with colleagues in meetings, seminars, etc., and with visiting stakeholders in formal pre-submission meetings.
The appointment is for up to one year and may be renewed for another year upon recommendation of CFSAN and subject to availability of funds. The participant will receive an annual stipend of up to $79,400 depending on background and experience. Limited inbound travel/moving expenses will be reimbursed. Funds are also available for travel to scientific meetings. The participant must show proof of health and medical insurance. The appointment is full time at CFSAN in College Park, Maryland. Participants do not become employees of CFSAN, FDA, or the program administrator and there are no fringe benefits paid.
The Research Participation Program at CFSAN is administered by the Oak Ridge Institute for Science and Education (ORISE). To be considered for this project, send a current résumé via e-mail to Melissa.Goodman@orau.org or via fax to (865) 241-5219. Please reference Project # 2007-13 on all correspondence and on the subject line of your e-mail. For additional information, contact Ms. Goodman at (865) 241-1294.
Oak Ridge Associated Universities
P.O. Box 117, MS-36
Oak Ridge, TN 37831
Phone: (865) 576-1089
Fax: (865) 241-5219
Employer's Web Site: http://www.orau.org