Guideline 170
III. Types of Fees
A. Animal Drug Application and Supplement Fee
ADUFA requires FDA to collect fees from each person who submits certain animal drug applications or supplements on or after
All animal drug applications submitted under section 512(b)(1) of the FD&C Act are subject to fees. Section 740(a)(1)(A)(i) of the FD&C Act. Animal drug applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act, and supplemental animal drug application that requests a change for which safety or effectiveness data are required, whether the change is to an application that had been approved under section 512(c)(1) or 512(c)(2) of the FD&C Act. Sections 739(2) and 740(a)(1)(A)(ii) of the FD&C Act, are subject to fees. Supplemental animal drug applications for which safety and effectiveness data are not required and abbreviated new animal drug applications, which are submitted under section 512(b)(2) of the FD&C Act, are not subject to application fees, under ADUFA.
If you have paid the fee for an application or supplement, which was accepted for filing, but was either not approved or was withdrawn without a waiver or refund, then if you or your licensee, assignee, or successor submit an application or supplement for the same product (i.e., a reactivation), it will not be subject to an application fee. Section 740(a)(1)(C) of the FD&C Act.
An applicant may submit an amendment to an application or supplement. If you amend a pending application or supplement, the unamended application may be considered as withdrawn and the amended application considered resubmitted. 21 CFR 514.6. FDA intends to accept minor changes without considering the amended application as resubmitted.
B. Animal Drug Product Fee
Under specified circumstances, ADUFA requires FDA to collect an annual product fee for each drug product which has been submitted for listing under section 510 of the FD&C Act. Section 740(a)(2) of the FD&C Act. FDA believes that this requirement applies to approved animal drug products that have been listed or submitted for listing. ADUFA defines the term “animal drug product” to mean “each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved.” Section 739(3) of the FD&C Act. The product fee is assessed to the person named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product that has been submitted for listing and who, after September 1, 2003, had pending with FDA an animal drug application or supplemental animal drug application. Section 740(a)(2) of the FD&C Act.
C. Animal Drug Establishment Fee
ADUFA requires FDA to collect an annual establishment fee from each person who 1) owns or operates, directly or through an affiliate, an animal drug establishment; 2) is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 510 of the FD&C Act; and 3) after September 1, 2003, had pending with FDA an animal drug application or supplemental animal drug application. Section 740(a)(3) of the FD&C Act. The person is assessed an establishment fee for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures that animal drug product. Section 740(a)(3) of the FD&C Act. If an animal drug establishment listed in an application does not engage in the manufacture of the animal drug product during a particular fiscal year, an annual establishment fee will not be assessed for that fiscal year on the basis of that product. Section 740(a)(3) of the FD&C Act.
If a single establishment manufactures both animal drug products and human prescription drug products as defined in section 735(3) of the FD&C Act, such establishment shall be assessed both the animal drug establishment fee (under ADUFA) and the prescription drug establishment fee (under PDUFA). Section 740(a)(3) of the FD&C Act.
D. Animal Drug Sponsor Fee
ADUFA requires FDA to collect animal drug sponsor fees. An animal drug sponsor is defined in section 739(6) of the FD&C Act as either an applicant named in an animal drug application, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Agency. A person who meets this definition within a fiscal year is assessed a fee in that fiscal year if, after September 1, 2003, the person had pending with FDA an animal drug application, a supplemental animal drug application, or an investigational animal drug submission. Section 740(a)(4) of the FD&C Act. Each sponsor will pay only one such fee each fiscal year. Section 740(a)(4) of the FD&C Act.
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