FDA Issues Proposed Regulations for MUMS Indexing
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004 amended the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration (FDA) to establish new regulatory procedures intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. FDA is issuing proposed regulations to implement Section 572 of the Act entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species” (“the Index”.) These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.
Minor species are all animals other than the major species (cattle, horses, swine, chickens, turkeys, dogs, and cats), for example, sheep, goats, honey bees, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. However, the “Index” is limited to nonfood-producing minor species with a limited exception for some early life stages of food animals, such as fish eggs.
The Index is intended to be a means by which companies can legally market veterinary drugs for minor species with no human food safety concerns without having to go through the long and expensive process of new animal drug approval. Inclusion in the Index will largely be based on the evaluation of the target animal safety and effectiveness of each specific product by a panel of qualified experts who will report their findings to the FDA.
The proposed regulation describes a process whereby the Agency makes determinations regarding the eligibility of a new animal drug for indexing, the selection of a qualified expert panel, and the findings of the qualified expert panel.
The proposed rule was published in the August 22, 2006, Federal Register Written comments on the proposed rule may be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may be faxed to 301-827-6870. Electronic comments may be submitted to the Federal eRulemaking Portal or the FDA web site at http://www.fda.gov/dockets/ecomments. All comments on the draft rules should be submitted by November 20, 2006, and should be identified with the full title of the proposed rule, the Agency name (FDA), and Docket Number 2006N-0067.
Additional information is included in the August 22, 2006, Federal Register. Questions may be directed to Dr. Andrew Beaulieu, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855, 240-276-9090, e-mail Andrew.Beaulieu@fda.hhs.gov