2024-10602. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive.

DATES:

This rule is effective May 15, 2024.

FOR FURTHER INFORMATION CONTACT:

Lucy Lee, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0563, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act of 2004) (Pub. L. 108-282) amended the FD&C Act to establish regulatory procedures that provide incentives 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.

In 2007, FDA issued final regulations (72 FR 69108, December 6, 2007) to implement section 572 of the MUMS Act entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” These regulations establish administrative procedures and criteria for index listing a new animal drug that provide a basis for legally marketing an unapproved new animal drug for use in a minor species.

The MUMS Act and the 2007 regulations derived from it required indexed products to state their unapproved status on labeling. Subsequently, section 302 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (User Fee Amendments of 2018; Pub. L. 115-234) amended the required labeling statement found in section 572(h)(1) of the FD&C Act (21 U.S.C. 360ccc-1(h)(1)) to reinforce that indexed products are legally marketed.

The User Fee Amendments of 2018 also amended the required label statements found in section 572(h)(2) of the FD&C Act regarding, except for use in a non-food early life stage, the prohibition of indexed drugs for use in food-producing animals.

At this time, we are revising the animal drug regulations at § 516.155 (21 CFR 516.155) for labeling of indexed drugs to reflect the amendments made by the User Fee Amendments of 2018 to section 572(h) of the FD&C Act.

II. Paperwork Reduction Act

The labeling statements required under section 572(h) of the FD&C Act, as reflected in § 516.155, are public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2)); therefore, they are exempt from the Office of Management and Budget review and approval under the Paperwork Reduction Act.

III. Legal Authority

This final rule sets forth a technical amendment to the regulations to improve the accuracy and completeness of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801 through 808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

List of Subjects in 21 CFR Part 516

• Administrative practice and procedure
• Animal drugs
• Confidential business information
• Reporting and recordkeeping requirements

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 516 is amended as follows:

PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

1. The authority citation for part 516 continues to read as follows:

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

2. In § 516.155, revise paragraphs (a) and (b) to read as follows:

§ 516.155

Labeling of indexed drugs.

(a) The labeling of an indexed drug that is found to be eligible for indexing under § 516.129(c)(7)(i) shall state, prominently and conspicuously: “LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF # (followed by the applicable minor species index file number and a period).” “Extra-label use is prohibited.” “This product is not to be used in animals intended for use as food for humans or food-producing animals.”

(b) The labeling of an indexed drug that is found to be eligible for indexing for use in an early, non-food life stage of a food-producing minor species animal, under § 516.129(c)(7)(ii), shall state, prominently and conspicuously: “LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF # (followed by the applicable minor species index file number and a period).” “Extra-label use is prohibited.”

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Dated: May 9, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.