Notice2022-10131
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 92 (Thursday, May 12, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Notices]
[Pages 29161-29162]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10131]
-----------------------------------------------------------------------
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
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#b5f8dadbdcd6d49bf0d9d9d0c7d7d0f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="29644647404a48076c45454c5b4b4c694f4d480741415a074e465f">[email protected]</span></a>.
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:
<bullet> PDUFA VI program: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf</a>
<bullet> BsUFA II program: <a href="https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf">https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf</a>
<bullet> GDUFA II program: <a href="https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf">https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf</a>
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: <a href="https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA">https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA</a>. 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 <a href="/cdn-cgi/l/email-protection#c588aaabaca6a4eb80a9a9a0b7a7a085a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="3d705253545e5c13785151584f5f587d5b595c1355554e135a524b">[email protected]</span></a> 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: <a href="https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA">https://fda.zoomgov.com/webinar/register/WN_C5cXHj38R6WeNg1ZuqbKaA</a>.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 12, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.