
[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Page 30176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12624]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0066] (Formerly Docket No. 2001D-0107)


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outdated and no longer needed to assure the efficient review of these 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.

    Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12624 Filed 5-23-11; 8:45 am]
BILLING CODE 4160-01-P


