The Food and Drug Administration wants to know what the public and industry officials think about the reporting requirements for recalls. The agency also seeks suggestions about how to streamline the process.
The FDA database showed 9,303 total recalls for 2008-2010, according to the agency’s request for comments in the June 29 Federal Register. That total includes all FDA regulated products, including fresh produce, medicine and medical products.
Based on the number of recalls in those three years, the agency estimates that fulfilling the reporting requirements for a single recall takes between 50 and 60 hours. However, the agency noted in the Federal Register that the amount of time required can vary greatly depending on the type of product.
Comments, due by Aug. 29, may be submitted online or sent to: Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments must include the docket number FDA-2011-N-0439.
FDA wants comments specifically about:
Whether the proposed collection of information is necessary and whether it will have practical use;
Whether its estimate of the burden of the information collection is accurate;
Ways to enhance the “quality, utility and clarity” of the information collected; and
- How to minimize the burden of the information collection.