Draft Guidance Issued for Electronic Regulatory Submission

Rockville, MD (July 17)-The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11. The draft guidance establishes a pilot program for the industry to voluntarily submit drug-establishment registration and drug-listing information in an electronic format. The e-format ideally will allow the agency to process, review, and archive information more easily and quickly.

The draft guidance is based on a proposed rule issued in August 2006 to revise 21 CFR Part 207 and on the FDA Amendments Act (FDAAA) of 2007, passed last fall. FDAAA requires electronic submission by domestic and foreign establishments of registration and listing information, unless a waiver is granted. FDA initiated the voluntary pilot program as a transition period to test the submission, receipt, and processing of electronic documents before electronic submissions are required starting in June 2009. The agency intends to issue a final guidance before June 2009.

The standard for electronic submissions will be extensible markup language (XML) in a standard structured-product labeling (SPL) format. The draft guidance explains how companies can transition from paper to an SPL format. The document also discuses how companies can submit additional, useful but not required information that is often included in paper submissions. FDA does not anticipate much new cost associated with electronic submission. According to the draft guidance, free software to create an SPL document will be available and a minor $20.00 electronic-submission-gateway-certificate fee to submit the file will be necessary.

FDA estimates that it may take an additional two hours to prepare an SPL-format submission, according to the draft guidance. The agency also predicts, however, that the burden will decrease over time as companies become familiar with the format. In addition, the new SPL format will allow for multi-establishment and multidrug submissions instead of individual forms currently used with the paper format system.

Comments on the draft guidance, including its adequacy and usefulness, are due Sept. 9, 2008 and can be submitted in writing to the Office of Critical Path Programs (HF-18), Office of the Commissioner, FDA, 5600 Fishers Lane, Rockville, MD 20857 or online at www.regulations.gov.