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, 31783-31785 [2020-11306]
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Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Notices
Estimated Total Annual Burden
Hours: 11,163.
ACTION:
Request for public comment.
The Office of Refugee
Resettlement (ORR) is requesting a 3year extension of the application and
Withdrawal of Application or
Declination of Placement Form for the
Unaccompanied Refugee Minors (URM)
Program. Proposed revisions to each
instrument are minimal. These forms
were previously approved under OMB
#0970–0498, expiration 7/31/2020. ORR
is currently seeking a new OMB number
specific to these forms, as they were
previously approved as part of another
information collection package for
ORR’s Unaccompanied Alien Children’s
program.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
Authority: Section 426 of the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act, as amended, 42 U.S.C.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–11312 Filed 5–26–20; 8:45 am]
BILLING CODE 4184–PC–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Office of
Refugee Resettlement Unaccompanied
Refugee Minors Program Application
and Withdrawal of Application or
Declination of Placement Form
(Previous OMB #0970–0498)
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
AGENCY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: The URM Program
Application is completed on behalf of
unaccompanied children in the United
States who are applying for entry into
the URM Program. The application
includes biographical data and
information on the child’s needs to
support placement efforts. The
Withdrawal of Application or
Declination of Placement Form is
completed when a child is no longer
interested in entering the URM program.
Respondents: Case managers,
attorneys, or other representatives
working with unaccompanied children
who are eligible for the URM Program.
ADDRESSES:
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Total number
of responses per
respondent
Unaccompanied Refugee Minors Program Application ...
350
3
1.50
1,575
525
Withdrawal of Application or Declination of Placement
Form .............................................................................
30
3
0.20
18
6
Instrument
Estimated Total Annual Burden
Hours: 531.
Authority: 8 U.S.C. 1522(d).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–11307 Filed 5–26–20; 8:45 am]
BILLING CODE 4184–45–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
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is hosting a virtual public meeting
SUMMARY:
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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.
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Average
burden hours
per response
Total burden
hours
Annual burden
hours
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
E:\FR\FM\27MYN1.SGM
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Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
jbell on DSKJLSW7X2PROD with NOTICES
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://
VerDate Sep<11>2014
16:59 May 26, 2020
Jkt 250001
www.govinfo.gov/content/pkg/FR-201509-18/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, Monica.Ellerbe@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The public meeting will include
presentations from FDA on: (1) The 5year 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.
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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 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-transparencyand-efficiency-of-user-fee-programsregistration-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/
E:\FR\FM\27MYN1.SGM
27MYN1
Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1301]
Q3C(R8) Recommendations for the
Permitted Daily Exposures for Three
Solvents—2-Methyltetrahydrofuran,
Cyclopentyl Methyl Ether, and TertButyl Alcohol—According to the
Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of draft
recommendations for new permitted
daily exposures (PDEs) for the residual
solvents 2-methyltetrahydrofuran,
cyclopentyl methyl ether, and tert-butyl
alcohol. The PDEs were developed
according to the methods for
establishing exposure limits included in
the guidance for industry entitled ‘‘Q3C
Impurities: Residual Solvents.’’ The
recommendations were prepared under
the auspices of the International Council
for Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance is
intended to recommend acceptable
amounts for the listed residual solvents
in pharmaceuticals for the safety of
patients.
DATES: Submit either electronic or
written comments on the draft guidance
by July 26, 2024 to ensure that the
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:59 May 26, 2020
Jkt 250001
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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–
2020–D–1301 for ‘‘Q3C(R8)
Recommendations for the Permitted
Daily Exposures for Three Solvents—2Methyltetrahydrofuran, Cyclopentyl
Methyl Ether, and Tert-Butyl Alcohol—
According to the Maintenance
Procedures for the Guidance Q3C
Impurities: Residual Solvents.’’
Received comments 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
PO 00000
Frm 00050
Fmt 4703
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31785
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidance may also be
obtained by mail by calling CBER at 1–
E:\FR\FM\27MYN1.SGM
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]]>Agencies
[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
