Animal & Veterinary
Deadline Extended for Submitting Data for Poultry Fluoroquinolone NOOH
January 5, 2001
The Center for Veterinary Medicine (CVM) has extended the deadline for Bayer Corporation, Agriculture Division, to submit data and information in response to CVM’s proposal to withdraw approval of the company’s fluoroquinolone product for use in poultry.
The extension was granted because some of the data cited in the October 31, 2000, Notice of Opportunity for Hearing (NOOH) were found to be incorrect. The data used in the NOOH were taken from reference number 2 of the NOOH, the risk assessment entitled "The Human Health Impact of Fluoroquinolone Resistant Campylobacter Attributed to the Consumption of Chicken." CVM discovered that corrections were needed to two cell references in the risk assessment model. Since CVM needs to make these corrections to the risk assessment, it also intends to incorporate the final FoodNet data for 1999. The NOOH stated that in 1999, a mean estimate of 11,477 persons were infected with fluoroquinolone-resistant Campylobacter from chicken and subsequently prescribed a fluoroquinolone. As a result of the correction of the two cell references in the risk assessment model and the incorporation of the final FoodNet data for 1999, that number will be revised to 9,261 persons. The numbers given for the 5th and 95th percentiles in the NOOH – 6,412 and 18,978 persons – will also be revised to 5,227 and 15,326 persons.
CVM does not believe that the revisions alter the premise of the NOOH. In the NOOH, CVM has proposed to withdraw the approval of the new animal drug application for use of enrofloxacin in poultry on the grounds that new evidence shows that the product has not been shown to be safe as provided for in the Federal Food, Drug, and Cosmetic Act, the statute that covers the use of new animal drugs in the U.S.
A notice to revise the data in the NOOH and the Campylobacter risk assessment will be published in the Federal Register. Publication of this notice is expected later in January. Bayer will have 30 days following the publication to submit data and information supporting the company’s request for a hearing. Other interested persons may also submit comments on the NOOH during the additional 30-day time period.
Bayer’s original deadline for submitting data and information was January 2, 2001. However, the company was informed that the deadline would be extended and, therefore, did not submit any data or information by the original deadline. Except for data and information prohibited from public disclosure, e.g., trade secret information, any information that is submitted may be seen in FDA’s Dockets Management Branch.
CVM continues to encourage public review of the NOOH and information connected to it. The Center has made the risk assessment and the program to run the calculations publicly available through its Website.