2020-28602. Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA)” and an opportunity for public comment. The topics to be discussed are the interim assessment and public stakeholder views of the program to date.

DATES:

The public meeting will be held on January 27, 2021, from 9:30 a.m. to 12:30 p.m. Eastern Time and will take place virtually by Adobe Connect only. Submit either electronic or written comments on this public meeting by March 29, 2021. See the SUPPLEMENTARY INFORMATION section for registration date and information.

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 29, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 29, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2020-N-2252 for “Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA); Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Kimberly Taylor, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1152, Silver Spring, MD 20993, 240-402-5193, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) for a period of 5 years. In 2017, the BsUFA was renewed for 5 more years under the FDA Reauthorization Act of 2017 (FDARA) (BsUFA II) (Pub. L. 115-52, Title IV)). The BsUFA's intent is to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner. BsUFA II was authorized to continue the collection of user fees by FDA to facilitate and expedite the process for the review of biosimilar biological products in the United States.

Under BsUFA II, FDA committed to apply a new review model to original biosimilar biologics license application (BLA) reviews. That review model is identified in section II.B. of the BsUFA II Commitment Letter as the Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs (the Program). The Program provides opportunities for increased communication between FDA and applicants, including mid-cycle and late-cycle meetings. To accommodate the increased interaction during regulatory review, FDA's review clock begins after the 60-day administrative filing review period for applications reviewed under the Program. The goal of the Program is to promote the efficiency and effectiveness of the first-cycle review process and minimize the number of review cycles necessary for approval, ensuring that patients have timely access to safe, effective, and high quality biosimilar and interchangeable biological products.

An independent evaluator is assessing the Program to understand its effect on the review of BsUFA applications. In addition to publishing an interim assessment on FDA's website, a public meeting will be held on January 27, 2021, where the interim assessment will be discussed, and public stakeholders may present their views on the Program to date.

Additional information concerning the BsUFA—including the text of the law, the “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022” (the BsUFA II Commitment Letter), “Biosimilar Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017” (the BsUFA Commitment Letter), key Federal Register documents, BsUFA-related guidances, BsUFA user fee rates, performance reports, and financial reports—may be found at https://www.fda.gov/​industry/​fda-user-fee-programs/​biosimilar-user-fee-amendments.

II. Topics for Discussion at the Public Meeting

FDA and an independent contractor will discuss the findings of the interim assessment, including anonymized and aggregated feedback from biosimilar BLA applicants and FDA review teams resulting from independent contractor interviews. FDA will discuss any issues identified to date, including any proposed plans to improve the likelihood of the Program's success. A panel of external stakeholders will also provide their perspective. To view the interim assessment report, please visit here: https://www.fda.gov/​industry/​biosimilar-user-fee-amendments/​bsufa-ii-assessment-program-enhanced-review-transparency-and-communication-biosimilar-user-fee-act.

III. Participating in the Public Meeting

Registration: To register for the public meeting, please visit the following website to register: https://www.eventbrite.com/​e/​public-meeting-on-the-interim-assessment-of-the-bsufa-ii-program-tickets-127577568943. Please provide complete contact information for each attendee, including name, affiliation, and email.

Persons interested in attending this public meeting must register by January 26, 2021, at 11:59 p.m. Eastern Time. Registrants will receive confirmation once they have been accepted.

Requests for Oral Presentations: Those who register online by January 14, 2021, will receive a notification about an opportunity to participate in the public comment session of the meeting. If you wish to speak during the public comment session, follow the instructions in the notification and identify which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time jointly. All requests to make a public comment during the meeting must be received by January 15, 2021, 11:59 p.m. Eastern Time. We will determine the amount of time allotted to each commenter, the approximate time each comment is to begin, and will select and notify participants by January 20, 2021. No commercial or promotional material will be permitted to be presented at the public meeting.

Streaming Webcast of the Public Meeting: This public meeting will be held via Adobe Connect. The link for this public meeting is https://collaboration.fda.gov/​bsufa012721.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/​common/​help/​en/​support/​meeting_​test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/​go/​connectpro_​overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available at www.regulations.gov in this docket.

Dated: December 21, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.