[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Notices]
[Pages 31783-31785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11306]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a virtual public meeting entitled ``Financial Transparency and 
Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee 
Act, and Generic Drug User Fee Amendments,'' and an opportunity for 
public comment. This public meeting will take place virtually due to 
extenuating circumstances and will be held by webcast only.

DATES: The public meeting will take place remotely on June 22, 2020, 
from 9 a.m. to 11 a.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: 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 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 22, 2020. 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

[[Page 31784]]

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 
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, 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.
     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 and Acquisitions, 4041 Powder Mill Rd., Rm. 72044, Beltsville, 
MD 20750, 301-796-5276, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The public meeting will include presentations from FDA on: (1) The 
5-year plans for the Prescription Drug User Fee Act (PDUFA) VI, 
Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee 
Amendments (GDUFA) II; (2) the Agency's progress in implementing 
resource capacity planning and modernized time reporting; and (3) the 
Agency's progress in addressing the findings from the independent third 
party evaluation of the resource management associated with PDUFA, 
BsUFA, and GDUFA that concluded and was published in fiscal year (FY) 
2019. 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 (II.B.3 of PDUFA VI (p. 38), IV.B.3 of BsUFA II (p. 28), and 
VI.B.4 of GDUFA II (p.22)).
    This public meeting is intended to meet performance commitments 
included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs 
were reauthorized as part of the FDA Reauthorization Act of 2017 
(FDARA) (Pub. L. 115-52) 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; and
     GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf.
    Each of these user fee programs included a set of commitments 
related to financial management. These included commitments to publish 
a 5-year financial plan that should be updated annually, develop 
resource capacity planning capability and to 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 public 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. FDA will present the 5-
year financial plans for each of these programs and update participants 
on the progress towards implementing resource capacity planning and 
modernizing its time reporting approach. In addition, FDA will provide 
an update on the Agency's progress in addressing the findings from the 
independent third party evaluation of the resource management 
associated with PDUFA, BsUFA, and GDUFA that concluded and was 
published in FY 2019. To view the evaluation assessment report, please 
visit here: https://www.fda.gov/media/127605/download.

III. Attending the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://www.eventbrite.com/e/public-meeting-financial-transparency-and-efficiency-of-user-fee-programs-registration-101672491158. 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 19, 2020, at 11:59 p.m. Eastern Time. Registrants will receive 
confirmation once they have been accepted. 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 no later than June 15, 2020, 11:59 p.m. Eastern 
Time.
    Streaming Webcast of the Public Meeting: The webcast for this 
public meeting is https://collaboration.fda.gov/fdafinancial062220/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/

[[Page 31785]]

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

    Dated: May 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11306 Filed 5-26-20; 8:45 am]
BILLING CODE 4164-01-P