FDA Extends Comment Period on ANPRM related to Collection of Sales and Distribution Data on Antimicrobial Animal Drugs

September 26, 2012

The Food and Drug Administration (FDA) is extending to November 26, 2012, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the July 27, 2012, Federal Register. The ANPRM stated that FDA was soliciting comments from the public on possible enhancements to the existing requirements related to the collection of antimicrobial drug sales/distribution data as well as input on alternative methods for monitoring antimicrobial use in food-producing animals. Collecting data on antimicrobial drugs used in food producing animals assists FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance. Such information is important for supporting FDA’s strategy for promoting the judicious use of medically important antibiotics in food-producing animals. FDA is extending the comment period 60 days from September 25, 2012 to November 26, 2012. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Section 105 of the Animal Drug User Fee Amendments (ADUFA) of 2008 established requirements regarding the collection and reporting of certain data regarding the sales/distribution of approved antimicrobial new animal drugs intended for use in food-producing animals. However, FDA is exploring whether additional information beyond that directed by ADUFA 105 may be needed.

The agency invites comments on all aspects of ADUFA 105, available online at: http://www.gpo.gov/fdsys/pkg/FR-2012-07-27/pdf/2012-18366.pdf. This information may be used to help draft a proposed rule in the near future.