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FDA Reviewing Information Collections on Recalls of Foods, Drugs, Medical Devices, Etc.

Wednesday, February 11, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting written comments through March 13 on the proposed extension of the following information collections associated with its regulations on recalls of FDA-regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco).

- providing FDA with complete details of the recall, including reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, the firm's recall strategy, a copy of any recall communication(s), and a contact official

- notifying direct accounts of the recall

- providing guidance regarding further distribution

- giving instructions as to what to do with the product

- providing recipients with a ready means of reporting to the recalling firm

- submitting periodic status reports so that FDA may assess the progress of the recall (status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks and product returns)

- providing the opportunity for a firm to request in writing that FDA terminate the recall

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