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GUIDANCE DOCUMENT

CVM GFI #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species April 2018

Final
Docket Number:
FDA-2017-D- 2462
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (Pub. L. No. 108-282) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide animal drug companies with incentives to develop new animal drugs for minor species and minor uses in major species, while still ensuring appropriate safeguards for animal and human health.

Congress recognized that the markets for new animal drugs for minor species and for minor uses in major species are so small that there often is insufficient economic incentive to motivate sponsors to pursue FDA approval of such products.

The MUMS Act encourages the development of animal drugs to treat minor species (species other than major species) or for minor uses (uncommon diseases or conditions) in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats).

One of the incentives established by the MUMS Act is the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, also commonly referred to as “the Index.” The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of section 572 of the FD&C Act. We refer to the process of adding a new animal drug to the Index as “indexing.” Indexing represents a new pathway for legally marketing unapproved new animal drugs.

In the Federal Register of December 6, 2007, FDA published final regulations establishing administrative procedures and criteria for listing a new animal drug for use in a minor species in the Index (72 FR 69108). These regulations, which are codified at 21 CFR part 516, subpart C, are administered by the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) within FDA’s Center for Veterinary Medicine (CVM). That office also maintains the Index, which is available to the public through FDA’s website.

This guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index is available for new animal drugs intended for use in minor species; the Index is not available for drugs intended for minor use in major species.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D- 2462.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002