§ 516.20 - Content and format of a request for MUMS-drug designation.

§ 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 request for designation must constitute a separate submission. A sponsor may request MUMS-drug designation of a previously unapproved drug, or a new intended use or dosage form for an already conditionally approved or approved drug. Only one sponsor may receive MUMS-drug designation of the same drug, in the same dosage form, for the same intended use.

(b) A sponsor must submit two copies of a completed, dated, and signed request for designation that contains the following information:

(1) A request for designation of a new animal drug for a minor use or use in a minor species, which must be specific.

(2) The name and address of the sponsor; the name of the sponsor's primary contact person and/or permanent-resident U.S. agent including title, address, and telephone number; the established name (and proprietary name, if any) of the active pharmaceutical ingredient of the drug; and the name and address of the source of the active pharmaceutical ingredient of the drug.

(3) A description of the proposed intended use for which the drug is being or will be investigated.

(4) A description of the drug and dosage form.

(5) A discussion of the scientific rationale for the intended use of the drug; specific reference, including date(s) of submission, to all data from nonclinical laboratory studies, clinical investigations, copies of pertinent unpublished and published papers, and other relevant data that are available to the sponsor, whether positive, negative, or inconclusive.

(6) A specific description of the product development plan for the drug, its dosage form, and its intended use.

(7) If the drug is intended for a minor use in a major species, documentation in accordance with § 516.21, with appended authoritative references, to demonstrate that such use is a minor use.

(8) A statement that the sponsor submitting the request is the real party in interest of the development and the intended or actual production and sales of the product.

(9) A statement that the sponsor acknowledges that, upon granting a request for MUMS designation, FDA will make information regarding the designation publicly available as specified in § 516.28.

[72 FR 41017, July 26, 2007, as amended at 75 FR 69588, Nov. 15, 2010; 77 FR 18685, Mar. 28, 2012]