2011-24083. Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Generic Drug User Fee Act (AGDUFA). FDA invites public comment on the AGDUFA program and suggestions regarding the features FDA should propose for the next AGDUFA program.

Date and Time: The meeting will be held on November 7, 2011, from 1 p.m. to 4 p.m.

Location: The meeting will be held at the Food and Drug Administration, 7519 Standish Pl., 3d floor, rm. A, Rockville, MD 20855. If you require special accommodations, please contact Patricia Arnwine (see Contact Person) at least 7 days before the meeting.

Contact Person: Donal Parks, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240-276-8688, FAX: [phone], [e-mail]; or Patricia Arnwine, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240-276-9724, FAX: [phone], [e-mail].

Comments: Regardless of attendance at the meeting, interested persons may submit either electronic or written comments regarding this document. 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. Identify comments with the docket number found in brackets in the heading of this document. Comments received by October 26, 2011, will be taken into consideration before the public meeting.

Transcripts: Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at http://www.fda.gov/​ForIndustry/​UserFees/​AnimalGenericDrugUserFeeActAGDUFA/​ucm270232.htm approximately 30 days after the meeting.

SUPPLEMENTARY INFORMATION:

I. Introduction

FDA is announcing its intention to hold a public meeting on AGDUFA. The authority for AGDUFA expires September 30, 2013. Without new legislation, FDA will no longer have the authority to collect user fees to fund the generic animal drug review process. Prior to beginning negotiations with the regulated industry on AGDUFA reauthorization, section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-13(d)(2)) 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 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 AGDUFA. 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 AGDUFA program thus far?

2. What aspects of AGDUFA 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 AGDUFA, and its current status.

II. What is AGDUFA? What does it do?

The Animal Generic Drug User Fee Act enacted in 2008 (Public Law 110-316; hereinafter referred to as “AGDUFA I”) amended the FD&C Act to authorize the FDA's first-ever generic animal drug user fee program. AGDUFA provides FDA with additional funds to enhance the performance of the generic animal drug review process. Furthermore, the authorization of AGDUFA enables FDA's continued assurance that generic animal drug products are safe and effective, and enables FDA's continued support for lower-cost alternatives to brand drugs for consumers. Under AGDUFA, FDA agreed to meet review performance goals for certain submissions over 5 years from fiscal year (FY) 2009 through FY 2013. These review performance goals strive to expedite the review of abbreviated new animal drug applications (ANADAs) and reactivations, supplemental ANADAs, and generic investigational new animal drug (JINAD) submissions.

Under AGDUFA, the industry agreed to pay user fees that are available to FDA, in addition to appropriated funds, to spend on the generic animal drug 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.

AGDUFA established increasingly-stringent review performance goals over a 5-year period from FY 2009 through FY 2013. By the final year of AGDUFA, FDA agreed to review and act on 90 percent of the following submission types within the specified time frames:

• Original ANADAs and reactivations within 270 days of the submission date.
• Administrative ANADAs (ANADAs submitted after all scientific decisions have been made during the JINAD process, i.e., prior to the submission of the original ANADAs) within 100 days after the submission date.
• Manufacturing supplemental ANADAs and reactivations within 270 days after the submission date.
• JINAD study submissions within 270 days after the submission date.
• JINAD protocol submissions within 100 days after submission date. JINAD protocol submissions consist of protocols without substantial data that FDA 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.

The additional resources provided under AGDUFA I enabled FDA to completely eliminate the backlog of ANADA and JINAD submissions by August 2010.

FDA has published a number of reports that provide useful background on AGDUFA. AGDUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports and plans can be found at: http://www.fda.gov/​ForIndustry/​UserFees/​AnimalGenericDrugUserFeeActAGDUFA/​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 AGDUFA II program. 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 1 p.m. until 2 p.m. The open public comment portion of the meeting for registered speakers is planned to begin at 2 p.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 AGDUFA program thus far?

2. What aspects of AGDUFA 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 e-mail to [e-mail] 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 viewed 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/​AnimalGenericDrugUserFeeActAGDUFA/​ucm270232.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.

Dated: September 13, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.