Rule2024-10602
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 15, 2024
Effective
May 15, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 95 (Wednesday, May 15, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#91fde4f2e8bffdf4f4d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="abc7dec8d285c7ceceebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>.
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
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