Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims; Withdrawal of Guidance

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 9, 2001.

DATES:

May 24, 2011.

FOR FURTHER INFORMATION CONTACT:

Steven Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of March 9, 2001 (66 FR 14155), FDA announced the availability of a guidance for industry #121 entitled “Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims.”

The guidance predates the enactment of the Animal Drug User Fee Act (ADUFA) of 2003, which was reauthorized by Congress in 2008. ADUFA authorized FDA to collect fees for certain animal drug applications and for the establishments, products, and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drug products. As a result of these increased resources, the efficiencies of our current administrative processes, including the phased review and end review amendment processes, we have significantly reduced our review timeframes and afford sponsors a more efficient pathway to regulatory approval.

At the time the guidance was issued, FDA's review timeframes for new animal drug applications were considerably longer. As noted previously, significant changes have occurred in the Agency's processes and timeframes for reviewing new animal drug applications and the process for expedited review status contained in this guidance is outdated and no longer needed to assure the efficient review of these new animal drug applications.