The Food and Drug Administration is proposing regulations to implement the "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species" under the 2004 Minor Use and Minor Species Animal Health Act.
The index would make more drugs legally available to veterinarians for the treatment of nonfood minor species. The market for these drugs is so small that insufficient economic incentives exist to motivate sponsors to develop data to support approvals.
The FDA intends the index to be a means by which companies can legally market drugs for nonfood minor species without completing the long and expensive approval process. The index could also include drugs for some early life stages of food animals, such as fish eggs, that present no concerns for human food safety.
The FDA would base inclusion in the index on the findings of expert panels that would evaluate target animal safety and effectiveness of each product. The FDA proposal describes regulations for making determinations regarding the eligibility of animal drug for indexing, regarding the selection of an expert panel, and regarding the findings of the expert panel.
The full proposal appears in the Aug. 22 Federal Register, available at www.gpoaccess.gov/.
Parties may submit comments until Nov. 20 online at www.regulations.gov or www.fda.gov/dockets/ecomments; by fax to (301) 827-6870; or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The heading should include "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species," FDA, Docket Number 2006N-0067.
Information is available from Dr. Andrew Beaulieu, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9090; e-mail, Andrew [dot] Beaulieufda [dot] hhs [dot] gov.