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FDA creates new NDIN and structure function docket formats

04-Jan-2013
Last updated on 07-Jan-2013 at 17:36 GMT

FDA creates new NDIN and structure function docket formats

The Food and Drug Administration has created new dockets for new dietary ingredient notifications (NDINs) and structure-function claim notification letters.

“In an effort to be more responsive and provide current postings of 30-Day Structure Function Claim Letters Dietary and 75-Day Premarket Notifications for New Dietary Ingredients at www.regulations.gov , and to find better ways to maintain these documents in the FDMS database, we established the new dockets,” explained Dr Daniel Fabricant, director of the Division of Dietary Supplements Program at FDA, in an email.

For NDINs, the new docket number format will be "75-Day Premarket Notifications for New Dietary Ingredients_2008" for filings submitted in 2008, “75-Day Premarket Notifications for New Dietary Ingredients_2009” for 2009 filings, and so on through 2012.

Likewise for structure-function filings, the format is changing to "30-Day Structure Function Claim Notification Letters Dietary_2008” for 2008 filings, through 2012.

75-Day Premarket Notifications for New Dietary Ingredients_2013 and 30-Day Structure Function Claim Notification Letters Dietary_2013 will be created from January 1, 2013 onwards.

“These ‘new’ dockets will be related in the FDMS database to its respective ‘old’ docket (FDA-1995-S-0039 and FDA-1997-S-0039), so searches can still be performed using the ‘old’ docket number,” added Dr Fabricant.