CHANGE OF IND GUIDELINES FOR CENTERS FOR DIETARY SUPPLEMENT RESEARCH: BOTANICALS Release Date: February 24, 2000 NOTICE: OD-00-025 National Institutes of Health The Office of Dietary Supplements wishes to give notice of a change in guidelines related to INDs for clinical studies of botanicals. The RFA appeared in the December 23, 1999 issue of the NIH Guide for Grants and Contracts and can be accessed at the following URL: http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-00-004.html The RFA states that "Phase I and II studies shall be conducted with an Investigational New Drug (IND) from the FDA." In fact, the NIH does not have the authority to require an IND for botanicals used in clinical studies. Instead, that determination is made by the FDA. Prior to submitting the grant proposal, applicants are advised to contact the FDA for guidance. An FDA contact has been identified, as noted below. Note that, while IND approval by the FDA is not required at the time of submission, applicants must document IRB review of any clinical study proposed as part of the RFA. The NIH will assume that IRB approval is not final until IND issues are resolved. INQUIRIES: Inquiries regarding this notice may be directed to: Christine A. Swanson, Ph.D. Office of Dietary Supplements National Institutes of Health 31 Center Drive, 1B29-2086 Bethesda, MD 20892-2086 Telephone (301) 435-2920 FAX: (301) 480-1845 Email: Swansonc@od.nih.gov FDA contact for IND guidance: Dr. Yuan-yuan Chiu Acting Director Office of New Drug Chemistry Center for Drug Evaluation and Research Food and Drug Administration Rm 13B-31, 5600 Fishers Lane Rockville MD 20857 Telephone: 301 827-5918 Fax: 301 594-0746 Email: Chiu@CDER.FDA.GOV
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