Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; 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 “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

DATES:

The public meeting will be held on June 7, 2022, from 9:30 a.m. to 10:50 a.m. via ZoomGov. Submit either electronic or written comments on this public meeting by July 7, 2022. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The public meeting will be held virtually due to extenuating circumstances.

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 July 7, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 7, 2022. 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-2019-N-1875 for “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; 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:

Monica Ellerbe, Office of Finance, Budget, Acquisition, and Planning, 4041 Powder Mill Rd., Rm. 72044, Beltsville, MD 20750, 301-796-5276, Monica.Ellerbe@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The meeting will include presentations from FDA on topics related to the financial management of certain user fee programs, including presentations on the following: (1) The 5-year financial plan for the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II and (2) the Agency's progress in implementing resource capacity planning and modernized time reporting. This meeting is intended to satisfy FDA's commitment to host an annual public meeting in the third quarter of each fiscal year beginning in FY 2019 and can be found in the Commitment Letters listed below (sections II.B.3 of PDUFA VI (p. 38), IV.B.3 of BsUFA II (p. 29), and VI.B.4 of GDUFA II (p.22)).

This public meeting is intended to meet performance commitments included in the respective Commitment Letters for PDUFA VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017. The complete set of performance goals for each program are available at:

• PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf

• BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf

• GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf

Each of these user fee programs' Commitment Letters included a set of commitments related to financial management. These included commitments to publish a 5-year financial plan and update that plan annually, develop resource capacity planning capability and modernize time reporting practices, and have a third-party evaluation of resource management practices for these user fee programs. In addition, each user fee program includes a commitment to host a public meeting in the third quarter of each fiscal year, beginning in FY 2019, to discuss specific topics.

II. Topics for Discussion at the Public Meeting

This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VI, BsUFA II, and GDUFA II. These topics include the 5-year financial plans for each of these programs and FDA's progress towards implementing resource capacity planning and modernizing its time reporting approach.

III. Participating in the Public Meeting

Registration: To register for the public meeting, please visit the following website: https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA . Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Persons interested in attending this public meeting must register by June 2, 2022, at 11:59 p.m. Eastern Time. We will let registrants know if registration closes before the day of the public meeting.

If you need special accommodations due to a disability, please contact Monica Ellerbe at Monica.Ellerbe@fda.hhs.gov by June 2, 2022, at 11:59 p.m. Eastern Time.

Streaming Webcast of the Public Meeting: This public meeting will be a webcast. To register for the public meeting and obtain the webcast information, please visit the following website: https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA .

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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.