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, 20893-20894 [2019-09803]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 92 / Monday, May 13, 2019 / Notices
Authority: 42 U.S.C. 1315.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–09756 Filed 5–10–19; 8:45 am]
BILLING CODE 4184–41–P
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.
Electronic Submissions
Notice of public meeting;
request for comments.
ACTION:
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
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:29 May 10, 2019
Jkt 247001
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.
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.’’
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
20893
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/201523389.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
E:\FR\FM\13MYN1.SGM
13MYN1
jbell on DSK3GLQ082PROD with NOTICES
20894
Federal Register / Vol. 84, No. 92 / Monday, May 13, 2019 / Notices
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
796–5003, Fax: 301–847–8443,
Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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.
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 5year 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.
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).
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
VerDate Sep<11>2014
16:29 May 10, 2019
Jkt 247001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–6549]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GORE VIABAHN VBX
BALLOON EXPANDABLE
ENDOPROSTHESIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for the GORE VIABAHN VBX
BALLOON EXPANDABLE
ENDOPROSTHESIS and is publishing
this notice of that determination as
required by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by July 12, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 12, 2019. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more 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 12, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 12, 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.
DATES:
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,
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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
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
