[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42361-42362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2006-N-0239]


Index of Legally Marketed Unapproved New Animal Drugs for Minor 
Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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, [email protected].

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

[[Page 42362]]

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 Sec.  
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 Sec.  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

0
1. The authority citation for part 516 continues to read as follows:

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


0
2. In Sec.  516.155, revise paragraphs (a) and (b) to read as follows:


Sec.  516.155  Labeling of indexed drugs.

    (a) The labeling of an indexed drug that is found to be eligible 
for indexing under Sec.  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 Sec.  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.''
* * * * *

    Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10602 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P