[Federal Register Volume 84, Number 92 (Monday, May 13, 2019)]
[Notices]
[Pages 20893-20894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09803]


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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 
purpose of the public meeting is to meet performance commitments 
included in the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar 
User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) 
II. The public meeting will include presentations from FDA on the 5-
year plans for the PDUFA VI, BsUFA II, and GDUFA II; the Agency's 
progress in implementing resource capacity planning and modernized time 
reporting; and the results of the fiscal year (FY) 2018 evaluation of 
PDUFA, BsUFA, and GDUFA resource management. The Agency will also 
address the impact of the modernized fee structure changes on the PDUFA 
and BsUFA programs and report on the contribution of the BsUFA spending 
trigger to the BsUFA program.

DATES: The public meeting will be held on June 7, 2019, from 9 a.m. to 
12 p.m. Submit either electronic or written comments on this public 
meeting by July 8, 2019. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 8, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of July 8, 2019. 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 20894]]

Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This public 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 (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)). These user fee programs were 
reauthorized as part of the Food and Drug Administration 
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 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 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 discuss the vision 
for the resource capacity planning capability, as well as update 
participants on the progress towards implementing resource capacity 
planning and modernizing its time reporting approach. FDA will also 
address the impact of the fee structure changes on PDUFA VI and BsUFA 
II, as well as the contribution of the BsUFA spending trigger to the 
BsUFA program. Finally, the meeting will include a presentation from 
representatives of the MITRE Corporation or Grant Thornton on their 
evaluation of PDUFA, BsUFA, and GDUFA resource management during FY 
2018 and FDA's response to this evaluation.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://fdafinancemeeting.eventbrite.com. If you are 
unable to attend the meeting in person, you can register to view a live 
webcast of the meeting. You will be asked to indicate in your 
registration if you plan to attend in person or via webcast. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by June 3, 2019, at 11:59 p.m. Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation once they have been 
accepted. If time and space permit, onsite registration on the day of 
the public meeting will be provided beginning at 8 a.m. 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 Graham Thompson no later than June 3, 2019, 11:59 p.m. Eastern 
Time.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the webcast by visiting https://fdafinancemeeting.eventbrite.com.
    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).

    Dated: May 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09803 Filed 5-10-19; 8:45 am]
BILLING CODE 4164-01-P