Description
The Minor Use and Minor Species Animal Health Act of 2004 (commonly referred to as the “MUMS” Act) amended the FD&C Act to provide incentives to sponsors to develop “MUMS drugs,” that is, new animal drugs for use in minor species or for use in major species afflicted with uncommon diseases or conditions (minor uses), while ensuring appropriate safeguards for animal and human health.
Scope & Applicability
Product Classes
10Products subject to clinical investigation guidance.
animal whose genome contains an intentionally modified nucleotide sequence
MUMS drug granted Designation status by OMUMS
presumes that the MUMS product is not a different formulation
special considerations for target animal safety
Veterinary use products that may use other standards
indications for terrestrial minor species
indications for minor species
used to manufacture medicated feed; A concentrated form of a drug used to manufacture medicated feed.; Concentrated drug form used to manufacture medicated feed; single ingredient component for medicated feed; Medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.; Concentrated drug form for manufacturing medicated feed; Concentrated form of animal drug used to manufacture medicated feed; Type A medicated articles fo
The category of products covered by this guidance.
Stakeholders
7Assists FDA in communications with foreign establishments
outreach to a wide variety of stakeholders interested in MUMS issues
Addition to the Index is largely based on the report of a qualified expert panel
Entity that may sign the BE study protocol
Public or private entities collaborating with sponsors
Entity responsible for submitting applications under section 524B
ONADE project managers serve as a central point of contact for drug sponsors
Regulatory Context
Attributes
10Intended use in a major species for a disease that occurs infrequently
Refers to a labeling statement that allows entry of edible tissues into the food chain without regard to the time of last drug administration.
drug shown to provide a significant therapeutic or physiologic advantage
daily intake without adverse effects or harm to the health of the consumer
required for drugs used in lactating animals
time required before slaughter for food safety; interval between last administration and safe slaughter
The intended marketed product that should be used in safety and effectiveness studies.
Specifications that are directly associated with the intended use of the device.
Criteria to distinguish from the same drug
Standard required for full NADA approval
Related CFR Sections (20)
- 21CFR516.115§ 516.115 Definitions.
(a) The following definitions of terms apply only in the context of subpart C of this part :Read full regulation →
- 21CFR514.4§ 514.4 Substantial evidence.
(a) Definition of substantial evidence. Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairlyRead full regulation →
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 21CFR516.3§ 516.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 321 ) apply to those terms when used in this part.Read full regulation →
- 21CFR514.117§ 514.117 Adequate and well-controlled studies.
(a) Purpose. The primary purpose of conducting adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal drug from other influences, such as spontaneous change in the course of the disease, normal animal production performance, or biased observation. OnRead full regulation →
- 21CFR514.3§ 514.3 Definitions.
The definition and interpretation of terms contained in this section apply to those terms as used throughout subchapter E.Read full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.33§ 25.33 Animal drugs.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR556.3§ 556.3 Definitions.
As used in this part:Read full regulation →
- 21CFR516.26§ 516.26 Amendment to MUMS-drug designation.
(a) At any time prior to conditional approval or approval of an application for a MUMS-designated drug, the sponsor may apply for an amendment to the designated intended use if the proposed change is due to new and unexpected findings in research on the drug, information arising from FDA recommendatRead full regulation →
- 21CFR514.11§ 514.11 Confidentiality of data and information in a new animal drug application file.
(a) For purposes of this section the NADA file includes all data and information submitted with or incorporated by reference in the NADA, INAD's incorporated into the NADA, supplemental NADA's, reports under §§ 514.80 and 510.301 of this chapter , master files, and other related submissions. The avaRead full regulation →
- 21CFR516.20§ 516.20 Content and format of a request for MUMS-drug designation.
(a) A sponsor that submits a request for designation of a new animal drug intended for a minor use or minor species must submit each request in the form and containing the information required in paragraph (b) of this section. While a request for designation may involve multiple intended uses, each Read full regulation →
- 21CFR516.31§ 516.31 Scope of MUMS-drug exclusive marketing rights.
(a) After conditional approval or approval of an application for a MUMS-designated drug in the dosage form and for the intended use for which MUMS-drug designation has been granted, FDA will not conditionally approve or approve another application or abbreviated application for the same drug in the Read full regulation →
- 21CFR516.34§ 516.34 FDA recognition of exclusive marketing rights.
(a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable) timely written notice recognizing exclusive marketing rights when an application for a MUMS-designated drug has been conditionally approved or approved. The written notice will inform the sponsor of the requirements Read full regulation →
- 21CFR516.30§ 516.30 Annual reports for a MUMS-designated drug.
Within 14 months after the date on which a MUMS drug is granted designation and annually thereafter until approval, the sponsor of a MUMS-designated drug shall submit a brief progress report on the drug to the investigational new animal drug file addressed to the Director of the Office of Minor Use Read full regulation →
- 21CFR516.29§ 516.29 Termination of MUMS-drug designation.
(a) The sponsor of a MUMS-designated drug must notify FDA of any decision to discontinue active pursuit of conditional approval or approval of such MUMS drug. FDA must terminate the designation upon such notification.Read full regulation →
- 21CFR516.25§ 516.25 Refusal to grant MUMS-drug designation.
(a) FDA will refuse to grant a request for MUMS-drug designation if any of the following reasons apply:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs (Status: Final)
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals (Status: Final)
- CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) (Status: Final)
- CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions (Status: Final)
- CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species (Status: Final)
- CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (Status: Final)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach (Status: Final)