2015-24524. Biosimilar User Fee Act; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022.

DATES:

The public meeting will be held on December 18, 2015, from 9 a.m. to 2 p.m. Registration to attend the meeting must be received by November 18, 2015. See section III of this document for information on how to register for the meeting. Submit written or electronic comments by January 19, 2016.

ADDRESSES:

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, in section B and C of the Great Room (Rm. 1503), Silver Spring, MD 20993. Participants must enter through Building 1 and undergo security screening. For more information on parking and security procedures, please visit http://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm.

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

Transcripts of the meeting will be available on the FDA Web site approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT:

Sandra Benton, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796-1042, FAX: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction

On July 9, 2012, the Food and Drug Administration Safety and Innovation Act, which included BsUFA (Pub. L. 112-144, title IV), was signed into law by the President. BsUFA authorizes FDA to collect fees for certain activities relating to biosimilar biological product development, for certain types of applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological products are made, and on biosimilar biological products after approval.

BsUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner without compromising review quality. As part of FDA's agreement with industry during the first BsUFA authorization, the Agency agreed to certain performance goals. These goals, which are captured in a Commitment Letter, apply to the process for the review of biosimilar biological product applications, including biosimilar biological product development meetings, review of applications and supplements, and other review activities.

Although BsUFA is similar to the Prescription Drug User Fee Act (PDUFA) program in that it includes fees for marketing applications, manufacturing establishments, and products, there are some differences because of the relatively nascent state of the biosimilar industry in the United States. For example, at the time BsUFA was signed into law, there were no currently marketed biosimilar biological products. Accordingly, BsUFA includes fees for products in the development phase in order to generate fee revenue to support FDA's review work during this phase and enable sponsors to have meetings with FDA early in the development of biosimilar biological product candidates. Additional information concerning BsUFA, including the text of the law, the “Biosimilar Biological Product Authorization Performance Goals And Procedures—Fiscal Years 2013 Through 2017” (the Commitment Letter), key Federal Register documents, BsUFA-related guidances, performance reports, and financial reports may be found on the FDA Web site at http://www.fda.gov/​forindustry/​userfees/​biosimilaruserfeeactbsufa/​default.htm.

II. Purpose of Public Meeting

FDA is announcing a public meeting on BsUFA. The authority for BsUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees to fund the biosimilar biological product review process. Before FDA begins negotiations with the regulated industry on BsUFA reauthorization, the Agency is holding the public meeting announced in this notice, at which members of the public may present their views on reauthorization, including any suggestions for changes to the performance goals referred to in the Commitment Letter. In addition, FDA will provide a period of 30 days after the public meeting to obtain written comments from the public. The purpose of this public meeting is to hear stakeholder views as we consider whether to retain, change, or discontinue the current BsUFA performance goals in the next BsUFA. In addition to any other relevant information the public would like to share, the FDA is interested in responses to the following two general questions:

• What is your assessment of the overall performance of the BsUFA program to date?
• What aspects of BsUFA performance goals should be retained, changed, or discontinued to further strengthen and improve the program?

The meeting will likely include presentations by FDA and a series of panels representing different stakeholder groups. We will also provide an opportunity for other stakeholders to provide public comment at the meeting. FDA policy issues are beyond the scope of these reauthorization discussions. Accordingly, the comments should focus on process enhancements and funding issues, and not on policy issues.

III. Meeting Attendance and Participation

If you wish to attend this meeting, visit https://fdapublicmeeting-bsufa.eventbrite.com. Please register by November 18, 2015. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration must also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once their registrations have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Sandra Benton (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

In addition, any person may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). Comments are to be identified 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. To ensure consideration, all comments must be received by January 19, 2016.

Please be advised that as soon as a transcript is available, it will be accessible at http://www.fda.gov/​ForIndustry/​UserFees/​BiosimilarUserFeeActBsUFA/​UCM461774.htm.

Dated: September 21, 2015.

Leslie Kux,

Associate Commissioner for Policy.