The agency estimates it will receive 55 annual notifications, with each notification requiring 20 hours of the agency’s time to address.
FDA will be seeking public comment on the process for submitting a new dietary ingredient (NDI) notification to the agency. Specifically, based on the number of notifications it has received so far, the agency estimates it will receive 55 annual notifications, with each notification requiring 20 hours of the agency’s time to address.
The agency is now seeking comment on its estimates and whether how it collects NDI notification is “practical.” It says it is looking for “ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.”
Notably, FDA stated, “The Agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the Agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the FD&C Act.”
FDA says it received 77 notifications in 2008, 39 in 2009, and 48 in 2010-the average of which is 55, which is how the agency estimated the number of submissions it expects to receive yearly.
Nutritional Outlook thanks Ullman, Shapiro & Ullman LLP for the tip.