Overview of AGDUFA

FY 2009 AGDUFA Performance Report Table of Contents

On August 14, 2008, AGDUFA was signed into law. AGDUFA amends the FD&C Act by authorizing the first ever generic animal drug user fee program. AGDUFA provides FDA with additional funds to help enhance the performance of the generic new animal drug review process. The authorization of AGDUFA also helps to enable FDA’s continued assurance that generic new animal drug products are safe and effective and consumers are provided a lower cost alternative to pioneer drugs.

AGDUFA authorizes FDA to collect user fees to support the review of new animal drugs in three categories: applications, products, and sponsors. Under AGDUFA, FDA agreed to meet review performance goals for certain submissions over 5 years (FY 2009 through FY 2013). These review performance goals strive to expedite the review of ANADAs and reactivations, supplemental ANADAs, and JINAD submissions. AGDUFA follows the ADUFA model and is similar to the PDUFA program. The expectation is that AGDUFA will help FDA expedite and improve its review of applications for generic new animal drugs so that safe and effective new products will be more readily available. The guidelines and definitions below apply to FDA’s implementation of AGDUFA.

Review and Act on Applications and Submissions. The term "review and act on" is understood to mean the issuance of a complete    action letter after the complete review of an original ANADA, supplemental ANADA, or JINAD submission which either (1) approves an original or supplemental ANADA or notifies a sponsor that a JINAD submission is complete or (2) sets forth in detail the specific deficiencies in such original or supplemental ANADA or JINAD submission and, where appropriate, the actions necessary to place such an original or supplemental ANADA or JINAD submission in condition for approval.

Refuse to File and Refuse to Review. Within 30 days of submission, FDA shall refuse to file an original or supplemental ANADA, or their reactivation, which is determined to be insufficient on its face or otherwise of unacceptable quality for review upon initial inspection as per 21 CFR 514.110. Thus, FDA will refuse to file an application containing numbers or types of errors, or flaws in the development plan, that are sufficient to cause the quality of the entire submission to be questioned to the extent that it cannot reasonably be reviewed. Within 60 days of submission, FDA will refuse to review a JINAD submission which is determined to be insufficient on its face or otherwise of unacceptable quality upon initial inspection using criteria and procedures similar to those found in 21 CFR 514.110. A decision to refuse to file an application or to refuse to review a submission, as described above, will result in the application or submission not being entered into the cohort upon which the relevant user fee goal is based. FDA records the numbers and types of these exclusions and has included them in this annual performance report.

Withdrawn and Stopped at the Request of the Sponsor. There are occurrences when a review that FDA has begun is ended prior to FDA taking action for reasons that are not determined by FDA. A sponsor may notify FDA that an ANADA that has been previously submitted and accepted for filing by FDA should be withdrawn from the review process. A sponsor can also notify FDA to stop a review of a JINAD submission while the submission is under review. In both instances, FDA will stop the review of the submission. Any resubmission of the product is treated as a new submission, independent of previous work or data.

Refuse to Accept.As stated in Section 741(e) of the Act, an abbreviated application or an investigational submission for a generic new animal drug that is submitted by a person subject to fees is considered to be incomplete and can not be accepted for review until all fees owed by such person have been paid.

AGDUFA requires the Secretary for the Department of Health and Human Services (HHS) to submit two annual reports to Congress for each fiscal year fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report within 120 days of the end of the fiscal year. This report is FDA’s first annual performance report to Congress under AGDUFA. Information about AGDUFA, including the text of the HHS Secretary’s July 30, 2008, commitment letter to Congress, is located in Appendix A. Additional information about AGDUFA is located at: Animal Generic Drug User Fee Act (AGDUFA).

Next page: AGDUFA: Progressively Expediting and Improving Review