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U.S. Department of Health and Human Services

For Industry

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Animal Generic Drug User Fee Act Performance Goals and Procedures

The goals and procedures of the Food and Drug Administration (FDA or the Agency) as agreed to under the "Animal Generic Drug User Fee Act of 2008" are summarized as follows:

Five-Year Goals (to be implemented by September 30, 2013)

  1. Review and act on 90 percent of non-administrative original abbreviated new animal drug applications (ANADAs) and reactivations of such applications within 270 days after the submission date.
  2. Review and act on 90 percent of manufacturing supplemental ANADAs and reactivations of such supplemental applications within 270 days after the submission date.
  3. Review and act on 90 percent of generic investigational new animal drug (JINAD) study submissions within 270 days after submission date.
  4. Review and act on 90 percent of JINAD submissions consisting of protocols without substantial data, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an ANADA or supplemental ANADA, within 100 days after the submission date.  
  5. Review and act on 90 percent of administrative ANADAs (ANADAs submitted after all scientific decisions have been made in the JINAD process, i.e., prior to the submission of the ANADA) within 100 days after the submission date.

For the application/submission goals above, 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 (“incomplete letter”). 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, the agency will refuse to file an application containing numbers or types of errors, or flaws in the development plan, 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. The agency will keep a record of the numbers and types of such refusals and include them in its annual performance report.

FDA may request minor amendments to original or supplemental ANADAs and JINAD submissions during its review of the application or submission. At its discretion, the Agency may extend an internal due date (but not a user fee goal) to allow for the complete review of an application or submission for which a minor amendment is requested. If a pending application is amended with significant changes, the amended application may be considered resubmitted, thereby effectively resetting the clock to the date FDA received the amendment. The same policy applies for JINAD submissions.

Sponsors are not required to submit study protocols for review. However, for each voluntarily submitted protocol for a study that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an original or supplemental ANADA, the Agency will issue a complete action letter providing comments resulting from a complete review of the protocol. The complete action letter will be as detailed as possible considering the quality and level of detail of the protocol submission; will include a succinct assessment of the protocol; and will state whether the Agency agrees, disagrees, or lacks sufficient information to reach a decision that the protocol design, execution plans, and data analyses are adequate to achieve the objectives of the study.  If the Agency determines that a protocol is acceptable, this represents an agreement that the data generated by the protocol can be used to support a safety or effectiveness decision regarding the subject new animal drug. The fundamental agreement is that having agreed to the design, execution, or analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspectives on the issues of design, execution, or analyses unless the Agency issues a written order that a substantiated scientific requirement essential to the assessment of the study appeared after the Agency’s protocol assessment, or public or animal health concerns unrecognized at the time of protocol assessment under this process are evident. 

The Agency and the regulated industry agree that the use of both formal meetings (e.g., presubmission conferences) and informal communication by both parties is critical to ensure high submission quality such that performance goals can be achieved.

The term “submission date” is understood to mean the date the FDA Center for Veterinary Medicine (CVM) Document Control Unit (DCU) receives an application or submission.  DCU date stamps an application or submission on the day of receipt. 

Work Queue Review Procedures

The Agency will review all submissions in accordance with procedures for working within a queue. An application/submission that is not reviewed within the applicable Application/Submission Goal time frame (noted below) will be reviewed with the highest possible priority among those pending.

Interim Goals
 


Interim Application/Submission Goals

FY09   90 percent of:

Non-administrative original ANADAs and reactivations of such applications received during FY 2009 are reviewed within 700 days after the submission date.
 

Manufacturing supplemental ANADAs and reactivations of such supplemental applications received during FY 2009 are reviewed within 600 days after the submission date.

JINAD study submissions received during FY 2009 are reviewed within 700 days after the submission date.

JINAD submissions consisting of protocols without substantial data received during FY 2009 are reviewed within 400 days after the submission date.

Administrative ANADAs received during FY 2009 are reviewed within 120 days after the submission date.
 

FY10   90 percent of:

Non-administrative original ANADAs and reactivations of such applications received during FY 2010 are reviewed within 680 days after the submission date.

Manufacturing supplemental ANADAs and reactivations of such supplemental applications received during FY 2010 are reviewed within 570 days after the submission date.

JINAD study submissions received during FY 2010 are reviewed within 680 days after the submission date.

JINAD submissions consisting of protocols without substantial data received during FY 2010 are reviewed within 390 days after the submission date.

Administrative ANADAs received during FY 2010 are reviewed within 115 days after the submission date.
 

FY11   90 percent of:

Non-administrative original ANADAs and reactivations of such applications received during FY 2011 are reviewed within 500 days after the submission date.

Manufacturing supplemental ANADAs and reactivations of such supplemental applications received during FY 2011 are reviewed within 420 days after the submission date.

JINAD study submissions received during FY 2011 are reviewed within 500 days after the submission date.

JINAD submissions consisting of protocols without substantial data received during FY 2011 are reviewed within 290 days after the submission date.

Administrative ANADAs received during FY 2011 are reviewed within 110 days after the submission date.
 

FY12   90 percent of:

Non-administrative original ANADAs and reactivations of such applications received during FY 2012 are reviewed within 380 days after the submission date.

Manufacturing supplemental ANADAs and reactivations of such supplemental applications received during FY 2012 are reviewed within 340 days after the submission date.

JINAD study submissions received during FY 2012 are reviewed within 380 days after the submission date.

JINAD submissions consisting of protocols without substantial data received during FY 2012 are reviewed within 190 days after the submission date.

Administrative ANADAs received during FY 2012 are reviewed within 105 days after the submission date.

FY13   90 percent of:

Non-administrative original ANADAs and reactivations of such applications received during FY 2013 are reviewed within 270 days after the submission date.

Manufacturing supplemental ANADAs and reactivations of such supplemental applications received during FY 2013 are reviewed within 270 days after the submission date.

JINAD study submissions received during FY 2013 are reviewed within 270 days after the submission date.

JINAD submissions consisting of protocols without substantial data received during FY 2013 are reviewed within 100 days after the submission date.

Administrative ANADAs received during FY 2013 are reviewed within 100 days after the submission date.

Amending Similar Applications and Submissions

The Agency and regulated industry agree that applications and submissions to the Agency will be complete and of sufficient quality to allow the Agency’s complete and timely review.  The Agency will refuse to file poor quality and incomplete applications and submissions rather than allowing them to serve as “placeholders” in the review queue that are subsequently amended to add the missing or inadequate portions.  

The Agency recognizes that there are circumstances in which a controlled amendment process can make the review of similar, pending submissions more efficient, without compromising the sponsor’s responsibility for high quality submissions.  Thus, starting no later than FY 2012, if the Agency requests an amendment to a non-administrative original ANADA, manufacturing supplemental ANADA, JINAD study submission, or a JINAD protocol submission (a “CVM-initiated amendment”), or issues an incomplete letter for such an application or submission, a sponsor may request to amend other, similar applications or submissions it has pending with the Agency (“sponsor-initiated amendment(s)”) in accordance with the following criteria:

  1. The amended information for these similar applications or submissions must be the same as in the CVM-requested amendment or incomplete letter; and
  2. The amended information must not significantly change the pending application or submission; and
  3. The amended information for these similar applications or submissions must be submitted no later than:
    1. 120 days after the submission date for a pending non-administrative original ANADA, manufacturing supplemental ANADA, or JINAD study submission; or
    2. 50 days after the submission date for a pending JINAD protocol

If the Agency determines that the above criteria have been met, it will not change the user fee goal for a pending application or submission that has been amended by a sponsor-initiated amendment.  If the above criteria have not been met, the Agency may consider the application or submission resubmitted on the date of the sponsor-initiated amendment, thereby resetting the clock to the date FDA received the amendment.