Proposed Changes to Antibiotic Regulation Given More Time for Public Comment

Posted 24 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has extended the amount of time the public and members of industry may comment on an advanced notice of public rulemaking concerning proposed changes to the way the agency collects and tracks information about antibiotics.

The regulation regards authority given to the agency under the Animal Drug User Fee Amendments Act of 2008 (AGDUFA), which allows FDA to require sponsors to submit annual reports detailing sales, distribution, and active ingredient data to the agency for analysis.

FDA's 27 July advanced notice of public rulemaking indicates the agency is interested in making changes to its interpretation of requirements under the law, and calls for comments regarding whether it is necessary to collect additional information on sales and distribution date, whether it can present the data more effectively, and whether the agency can collect the information using alternate methods.

(For additional information, please see Regulatory Focus' 27 July 2012 story, "FDA Wants More Data on Antibiotics.")

The original deadline for the submission of comments was 25 September 2012. The new deadline for comments is now 26 November 2012.

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