FDA releases proposed rules to collect antimicrobial sales information

FDA releases proposed rules to collect antimicrobial sales information

The U.S. Food and Drug Administration is proposing revisions to its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding about how antimicrobials are sold or distributed for use in major food-producing species and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.

The proposed rule also includes a provision to improve the timeliness of the report by requiring the FDA publish its annual summary report of antimicrobial sales and distribution information by Dec. 31 of the following year.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to the FDA on an annual basis the amount of all antimicrobial drugs they sell or distribute for use in food-producing animals, including those antibiotics not used in human medicine. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public.

Current regulatory authority limits the data collection that FDA can mandate to antimicrobial sales and distribution information. While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance. The FDA is actively engaged with the USDA, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need.

The FDA is accepting public comments on this proposed rule beginning on May 20. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2012-N-0447 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 90 days after it publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final rule.

To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2012-N-0447 on each page of your written comments.

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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