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Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices
meeting by December 2, 2021. See SUPPLEMENTARY INFORMATION for registration date and information.
ADDRESSES: Registration to attend the meeting and other information can be found at https bsufaiiifinalpublicmeeting.eventbrite.com.
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 December 2, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 2, 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 elses 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 HFA305, 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
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identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include the Docket No. FDA
2015N3326 for Reauthorization of the Biosimilar User Fee Act; 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Emily Ewing, Center for Drug Evaluation and Research, Food and Drug Administration, 2404020196, Emily.Ewing@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Introduction FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of BsUFA, the legislation that authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current authorization of the program BsUFA II
expires in September 2022. Without new legislation, FDA will no longer be able to collect user fees for future FYs to fund the process for the review of biosimilar biological product applications. Section 744If2 of the FD&C Act 21 U.S.C. 379j53f2
requires the Agency perform the following actions after holding negotiations with regulated industry members: 1 Present recommendations to the relevant Congressional committees; 2 publish recommendations in the Federal Register, 3 provide a period of 30 days for the public to provide written comments on the recommendations; 4
hold a meeting at which the public may present its views; and 5 after consideration of public views and comments, revise the recommendations as necessary.
This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. After the public meeting, we will revise the recommendations as necessary and present our proposed recommendations to the Congressional committees.
The purpose of the meeting is to hear the publics views on the proposed recommendations for the reauthorized program BsUFA III. The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and the status of the proposed BsUFA III recommendations.
II. What is BsUFA and what does it do?
BsUFA is a law that authorizes FDA
to assess and collect fees from drug companies that submit marketing applications for certain biosimilar biological products. BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act FDASIA, Pub. L. 112
144 for a period of 5 years. In 2017, BsUFA was renewed for 5 more years under the FDA Reauthorization Act of 2017 FDARA, Pub. L. 11552.
BsUFA is intended to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar
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