SUPPLEMENTARY INFORMATION:

I. Introduction

FDA is announcing its intention to hold a public meeting on ADUFA. The authority for ADUFA expires September 30, 2013. Without new legislation, FDA will no longer have the authority to collect user fees to fund the new animal drug review process. Prior to beginning negotiations with the regulated industry on ADUFA reauthorization, section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-13) requires FDA to: (1) Publish a notice in the Federal Register requesting public input on the reauthorization; (2) hold a public meeting at which the public may present its views on the reauthorization including specific suggestions for changes to the goals referred to in section 740A(a) of the FD&C Act; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's Web site. FDA is holding a public meeting to gather information on what FDA should consider including in the reauthorization of ADUFA. FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share:

1. What is your assessment of the overall performance of the ADUFA program thus far?

2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program?

The following information is provided to help potential meeting participants better understand the history and evolution of ADUFA, and its current status.

II. What is ADUFA? What does it do?

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 that were to be dedicated to expediting the review of animal drug applications in accordance with certain performance goals. The implementation of ADUFA I provided a significant funding increase for the new animal drug application review process, and enabled FDA to ( printed page 58280) increase the number of staff dedicated to the new animal drug application review process by 30 percent since 2003.

Under ADUFA I, the industry agreed to pay user fees that are available to FDA, in addition to appropriated funds, to spend on the new animal drug application review process. Moreover, FDA's authority to collect user fees is contingent on a certain level of spending from appropriated funds, as adjusted for inflation.

As part of ADUFA I, FDA established review performance goals that have been phased in over a 5-year period. These performance goals set from FY 2004 to FY 2008 were intended to achieve progressive, yearly improvements in the time for review of new animal drug applications. By the 5th and final year of ADUFA ending on September 30, 2008, FDA agreed to review and act on 90 percent of the following submission types within specified times:

• New animal drug applications and reactivations of such applications within 180 days after submission date.
• Nonmanufacturing supplemental new animal drug applications (that is, supplemental new animal drug applications for which safety or effectiveness data are required) and reactivations of such supplemental applications within 180 days after submission date.
• Manufacturing supplemental new animal drug applications and reactivations of such supplemental applications within 120 days after submission date.
• Investigational new animal drug study submissions within 180 days after submission date.
• Investigational new animal drug submissions consisting of protocols, that FDA and the sponsor consider to be an essential part of making the decision to approve or not approve a new animal drug application or supplemental new animal drug application, without substantial data, within 60 days after submission date.
• Administrative new animal drug applications submitted after all scientific decisions have been made in the investigational new animal drug process (that is, prior to submission of the animal drug application) within 60 days after submission date.

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 time frames. In addition, FDA agreed to the following program enhancements to reduce review cycles and improve communications during reviews:

• Incorporating an “end-review amendment” (ERA) process to amend pending submissions to achieve a complete review decision sooner and reduce the number of review cycles.
• Developing an electronic submission tool that allows industry to submit drug applications electronically.
• Participating with industry in public workshops on mutually agreed-upon topics.
• Improving communications by enhancing the timeliness and predictability of foreign pre-approval inspections.

FDA has published a number of reports that provide useful background on ADUFA I and ADUFA II. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports and plans can be found at: http://www.fda.gov/​ForIndustry/​UserFees/​AnimalDrugUserFeeActADUFA/​default.htm.

III. What information should you know about the meeting?

A. When and where will the meeting occur? What format will FDA use?

Throughout this document, FDA has been announcing a public meeting to hear stakeholders' views on what FDA should consider for the ADUFA III program. FDA will conduct the meeting on November 7, 2011, at 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD 20855. (see Comments). In general, the meeting format will include presentations by FDA followed by an open public comment period. Registered speakers for the open public comments will be grouped and invited to speak in the order of their affiliation and time of registration (scientific and academic experts/veterinary professionals, representatives of consumer advocacy groups, and the regulated industry). FDA presentations are planned from 9 a.m. until 10 a.m. The open public comment portion of the meeting for registered speakers is planned to begin at 10 a.m. An opportunity for public comments from meeting attendees will commence following the registered presentations, if time permits.

FDA policy issues are beyond the scope of these reauthorization discussions. Accordingly, the presentations should focus on process enhancements and funding issues, not on policy issues.

The docket will remain open for either electronic or written comments through December 7, 2011.

B. What questions would FDA like the public to consider?

Please consider the following questions for this meeting:

1. What is your assessment of the overall performance of the ADUFA II program thus far?

2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program?

C. How do you register for the meeting or submit comments?

If you wish to attend and/or present at the meeting, please register by email to ADUFAReauthorization@fda.hhs.gov by October 26, 2011. Your e-mail should contain complete contact information for each attendee—name, title, affiliation, address, e-mail, and phone number. Also, please self-identify as a member of one of the following stakeholder categories: Scientific or academic experts; veterinary professionals; patient and consumer advocacy groups; or the regulated industry. Registration is free and will be on a first-come, first-served basis. Early registration is recommended since seating is limited. FDA may limit the number of participants from each organization based on space constraints. Registrants will receive confirmation once their registrations are accepted. Onsite registration on the day of the public meeting will be based on space availability. FDA will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. If you need special accommodations, please contact Patricia Arnwine (see Contact Person) at least 7 days before the meeting.

In addition, interested persons may submit either electronic or written comments to the Division of Dockets Management (see Comments). It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. To ensure consideration before the public meeting, all comments must be received by October 26, 2011.

D. Will meeting transcripts be available?

Please be advised that as soon as the transcript is available, it will be accessible at http://www.fda.gov/​ForIndustry/​UserFees/​ ( printed page 58281) AnimalDrugUserFeeActADUFA/​ucm042891.htm. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be made available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.