Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, FDA is inviting comments in regard to the Agency exploring the use of statutory changes to modify the current requirement that the use of multiple new animal drugs in a combination drug medicated feed be the subject of an approved new animal drug application (NADA). The Agency also is inviting comment on potential changes to procedures and requirements related to the NADA approval process for such products that can be accomplished under the Agency's existing statutory authority.

DATES:

Although you can comment on this document at any time, to ensure that the Agency considers your comment before finalizing work on the exploration process described in this document, submit either electronic or written comments by September 9, 2015.

ADDRESSES:

Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Linda Wilmot, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E442, Rockville, MD 20855, 240-402-0829, linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA considers the timely review of the safety and effectiveness of new animal drugs to be central to the Agency's mission to protect and promote the public health. Before 2004, the timeliness and predictability of the new animal drug review program was a concern. The Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter referred to as “ADUFA I”), authorized FDA to collect user fees for 5 years—fiscal year (FY) 2004 to FY 2008—that were to be dedicated to expediting the review of new animal drug applications according to certain performance goals and to expand and modernize the new animal drug review program. The Agency agreed to meet a comprehensive set of performance goals established to show significant improvement in the timeliness and predictability of the new animal drug review process. The implementation of ADUFA I provided a significant funding increase that enabled FDA to increase the number of staff dedicated to the new animal drug application review process.

In 2008, before ADUFA I expired, Congress passed the Animal Drug User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to as “ADUFA II”) which included an extension of ADUFA for an additional 5 years—FY 2009 to FY 2013. ADUFA II performance goals were established based on ADUFA I FY 2008 review timeframes. In addition, FDA provided program enhancements to reduce review cycles and improve communications during reviews.

In 2013, before ADUFA II expired, Congress passed ADUFA III (Pub. L. 113-14), which was signed by the President on June 13, 2013. Like its predecessors, ADUFA III includes its own comprehensive set of performance goals. One such goal, as stated in the ADUFA III goals letter, is: Beginning in early FY 2014, the Agency agrees to explore, in concert with affected parties, the feasibility of pursuing statutory revisions, consistent with the Agency's mission to protect and promote the public health, that may modify the current requirement that the use of multiple new animal drugs in the same medicated feed be subject to an approved application and develop recommendations by September 30, 2016.

Currently the use of multiple new animal drugs in the same medicated feed (i.e., a combination drug medicated feed) requires an approved NADA for each new animal drug in the combination and a separate approved NADA for the combination new animal drug itself (21 U.S.C. 360b(d)(4); 21 CFR 514.4(c)). FDA and members of regulated industry jointly agreed to explore, as part of the performance goals outlined in the ADUFA III goals letter, potential changes to the approval process for the use of a combination drug medicated feed. The intent of this exploration is to consider changes intended to allow combination drug medicated feeds to be made available to the end user in the most efficient manner possible while protecting and promoting the public health.

Today, FDA is announcing that it is beginning the exploration process described in the ADUFA III goals letter. With this document, FDA is requesting public comment on potential statutory changes, consistent with its mission to protect and promote the public health, to modify the current requirements related to feed use combination drugs. In addition, although in the ADUFA III performance goals letter FDA only agreed to explore the feasibility of pursuing statutory changes, the Agency also invites comment on potential changes to procedures and requirements related to the approval process for these products that can be accomplished under the Agency's existing statutory authority.

FDA is opening a public docket to receive comments on the issue. FDA will be reviewing the docket and considering comments submitted as it moves forward with this process. The docket will remain open for 365 days following publication of this document in the Federal Register.

II. Comments

Interested persons may submit electronic comments to regarding this document http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.