Regulatory Focus™ > News Articles > FDA Proposes Electronic Submission System for Antimicrobial Use Reports

FDA Proposes Electronic Submission System for Antimicrobial Use Reports

Posted 25 January 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) wants to make it easier for companies to submit annual reports on the use and characteristics of antimicrobial products, a requirement of the Animal Drug User Fee Act II of 2008.

The law, modeled after the prescription drug and medical device user fee acts (PDUFA/MDUFA), required manufacturers and sponsors of antimicrobial-containing products to annually report to FDA the "amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product."

The section was-and remains-intended to assist regulators in assessing the scope of improper prescribing of antimicrobials, known to be one of the leading causes to antimicrobial-resistant (AMR) strains of bacteria. The problem is of a particular concern in food-producing animals, where antimicrobials are often used as a preventative measure, instead of as a reactive one to active strains.

The reports were mandatory for sponsors and manufacturers of the product as of 31 March 2010, and must contain three things:

  • the amount of each antimicrobial active ingredient by container size, strength, and dosage form
  • quantities distributed domestically and quantities exported
  • a listing of the target animals, indications, and production classes that are specified on the approved label of the product 

An Electronic Submission System

But FDA regulators now say they want to make it easier for companies to submit those forms by allowing them to submit Form FDA 3744 electronically (known as 3744a when it is submitted electronically). Paper forms would still be permitted.

FDA said it is currently "pursuing notice and comment rulemaking to codify these requirements [to allow the submission of 3744a]," and are "currently assessing any additional data requirements." Those wishing to comment on that proposal may do so on FDA's 27 July 2012 Federal Register advanced notice of proposed rulemaking (ANPRM), Antimicrobial Animal Drug Sales and Distribution Reporting.

FDA estimates that the burden of response will be lessened for companies choosing to use the new form. The average burden per response for paper submission is estimated to be 60 hours per response-10 hours more than the estimated 50 hours per response it believes the electronic form will require.

The agency also estimates that companies with the most active products will choose to use the electronic forms, with those companies submitting one more annual report per year than their paper-using counterparts on average.

FDA's explained that its plan now goes to the Office of Management and Budget (OMB), after which it would likely take the form of a notice of proposed rulemaking (NPRM) open for public comment.


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