June 23, 2021

The U.S. Food and Drug Administration is requesting comments on the agency’s current policy for determining the eligibility of unapproved animal drugs to be added to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index).

The Index is one incentive established by the Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act), which was enacted to encourage the development of animal drugs that are unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) or to major species afflicted with uncommon diseases or conditions (minor use), while still ensuring appropriate safeguards for animal and human health.  

Adding a new animal drug to the Index is a pathway to legal marketing of unapproved new animal drugs for use in minor species that do not enter the food supply. Under current policy, drugs that are intended for use in a food-producing species have generally not been eligible for the Index, even if the individual animal to be treated is not intended for food. For example, because some rabbits are raised for food, the FDA has historically considered all rabbits to be food-producing animals. Therefore, the agency considered drugs intended for use in rabbits to be ineligible for indexing. 

Many stakeholders have provided feedback to the FDA asking the agency to set criteria that would allow indexing of drugs for certain distinct populations of animals from food-producing species when there is reasonable certainty that those animals would not enter the food supply. Changing current indexing policy for eligibility could help promote legal drug availability for underserved populations of animals; however, the FDA is seeking feedback on whether and how this could be accomplished without compromising human or animal health.

The FDA is asking for public comment on three specific questions:

1. What are the reasons we should or should not expand eligibility for indexing to certain discrete subsets of food-producing minor species? 
2. If you support the expansion of indexing, please describe the information we should evaluate when determining which discrete subsets of food-producing minor species should be eligible.  
3. Are there any discrete subsets of food-producing minor species that you believe should be eligible for indexing because they are not intended for consumption by humans or food-producing animals?  

The FDA is accepting public comments 90 days beginning on June 24, 2021. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2017-D-2462 in the search box. For assistance in submitting electronic comments, please see Electronic Method for Specific Electronic Submissions to FDA's Division of Dockets Management Staff.

Dockets Management Staff is receiving USPS mail intermittently (although electronic submissions are preferred). To submit comments to the docket by mail, use the address below. Be sure to include docket number FDA-2017-D-2462 on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments will be accepted at any time but should be submitted no later than September 21, 2021, to ensure that the FDA takes the information into consideration before making further decisions on this issue.

For more information:

• Eligibility for the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Request for Comments
• Regulations.gov: please note that the public comment period opens on June 24, 2021
• Minor Use/Minor Species