Changes in NIDA’s Program Announcement PA-06-424: Complementary and Alternative Medicine for Substance and Alcohol Related Disorders

Notice Number: NOT-DA-06-017

Key Dates
Release Date: July 11, 2006

Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

Purpose

The purpose of this Notice is to announce that this Program Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-06-424.html) will no longer follow the procedures outlined by NCCAM regarding approval for the testing of certain products. The original Program Announcement cited the NCCAM website for guidance on NIH policy regarding the quality of natural products and the dosing of CAM therapeutics for clinical trials. Changes in the NCCAM procedures make the following paragraph, originally citing the NCCAM websites, no longer valid:

Certain CAM therapies may require INDs and FDA approval. With biologicals and natural products quality certificates will be required. For information and guidance on NIH policy on the quality of natural products, please refer to NCCAM instructions. (http://nccam.nih.gov/research/policies/naturalproducts.htm) For guidance on designing clinical trials of NCCAM therapies determining dose ranges, please refer to the NCAM site. (http://nccam.nih.gov/research/policies/guideonct.htm).

Instead, investigators are referred to the FDA website for guidance. The previous paragraph is being replaced by the following:

Certain CAM therapies may require INDs and FDA approval. With biologicals and natural products quality certificates will be required. For information and guidance on FDA requirements, please refer to the following FDA website: http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm.

Inquiries

Inquiries associated with this Notice should be directed to:

Melissa W. Racioppo. Ph.D.
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4230, MSC 9593
Bethesda, MD 20892-9593
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2261
FAX: (301) 443-6814
Email: mraciopp@nida.nih.gov