FDA creates new dockets for NDI notifications

FDA creates new dockets for NDI notifications

FDA restructures documents in FDMS database to provide more responsive information regarding Structure Function Claim Letters and Premarket Notifications for NDIs.

 

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 listed below:

 

Original Docket 1997-S-0039 (legacy 1997S-0162) and all subsequent Dockets will be related to FDA-1997-S-0039

FDA-2008-S-0663 - 30-Day Structure Function Claim Notification Letters Dietary_2008

FDA-2009-S-0607 - 30-Day Structure Function Claim Notification Letters Dietary_2009

FDA-2010-S-0664 - 30-Day Structure Function Claim Notification Letters Dietary_2010

FDA-2011-S-0932 - 30-Day Structure Function Claim Notification Letters Dietary_2011

FDA-2012-S-1144 - 30-Day Structure Function Claim Notification Letters Dietary_2012

30-Day Structure Function Claim Notification Letters Dietary_2013 will be created on or about January 1, 2013 and every year forward a new docket created for that year.

 

Original Docket 1995-S-0039 (legacy 1995S-0316) and all subsequent Dockets will be related to FDA-1995-S-0039

FDA-2008-S-0664 - 75-Day Premarket Notifications for New Dietary Ingredients_2008

FDA-2009-S-0608 - 75-Day Premarket Notifications for New Dietary Ingredients_2009

FDA-2010-S-0665 - 75-Day Premarket Notifications for New Dietary Ingredients_2010

FDA-2011-S-0933 - 75-Day Premarket Notifications for New Dietary Ingredients_2011

FDA-2012-S-1178 - 75-Day Premarket Notifications for New Dietary Ingredients_2012

75-Day Premarket Notifications for New Dietary Ingredients_2013 will be created on or about January 1, 2013 and every year forward a new docket created for that year.

As we move forward into the coming months, 2009, 2010, 2011, and 2012 documents received will become available significantly faster. You may have noticed more of these documents are becoming available already.

Please know that 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. All documents received prior to January 2008 will remain directly associated to the original dockets, and there will be a small amount of documents received after January 2008 that will remain in the FDA-1995-S-0039 and FDA-1997-S-0039 Dockets because they were posted prior to establishing new Docket IDs.

 

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