[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Pages 29161-29162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1875]


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.

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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, [email protected].

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

[[Page 29162]]

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 [email protected] 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.

    Dated: May 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10131 Filed 5-11-22; 8:45 am]
BILLING CODE 4164-01-P