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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