Notice2022-01570
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments
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Published
January 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the following virtual public meeting entitled "Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards." The purpose of the virtual public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives.
Full Text
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<title>Federal Register, Volume 87 Issue 18 (Thursday, January 27, 2022)</title>
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[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4254-4255]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01570]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4337]
Prescription Drug User Fee Act of 2017; Electronic Submissions
and Data Standards; 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, Agency, or we) is
announcing the following virtual public meeting entitled ``Prescription
Drug User Fee Act of 2017; Electronic Submissions and Data Standards.''
The purpose of the virtual public meeting and the request for comments
is to fulfill FDA's commitment to seek stakeholder input related to
data standards and the electronic submission system's past performance,
future targets, emerging industry needs, and technology initiatives.
FDA will use the information from the public meeting as well as from
comments submitted to the docket to provide input into data standards
and electronic submissions initiatives.
DATES: The public meeting will be held on April 12, 2022, from 9 a.m.
to 1 p.m. Eastern Time, and will take place virtually, held by webcast
only. Submit either electronic or written comments on this public
meeting by March 22, 2022. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: Registration to attend the meeting and other information can
be found at <a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-information-technology-goals-and-progress">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-information-technology-goals-and-progress</a>.
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 March 22, 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 March 22, 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-2018-N-4337 for ``Prescription Drug User Fee Act of 2017;
Electronic Submissions and Data Standards.'' 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
[[Page 4255]]
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 laws. 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: Bryan Spells, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#fab888839b94d4a98a9f969689ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="20625259414e0e7350454c4c53604644410e4848530e474f56">[email protected]</span></a>, 240-402-6511; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911,
<a href="/cdn-cgi/l/email-protection#5f0c2b3a2f373a31710d362f333a261f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="86d5f2e3f6eee3e8a8d4eff6eae3ffc6e0e2e7a8eeeef5a8e1e9f0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to achieve the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. In the document containing the
performance goals and procedures for the Prescription Drug User Fee Act
(PDUFA) reauthorization for fiscal years 2018 through 2022 (the PDUFA
VI commitment letter), FDA agreed to hold annual public meetings to
seek stakeholder input related to electronic submissions and data
standards to inform the FDA Information Technology Strategic Plan and
published targets. The PDUFA VI commitment letter outlines FDA's
performance goals and procedures under the PDUFA program for the years
2018 through 2022. The PDUFA VI commitment letter can be found at
<a href="https://www.fda.gov/media/99140/download">https://www.fda.gov/media/99140/download</a>.
FDA will consider all comments made at this meeting or received
through the docket (see ADDRESSES).
II. Participating in the Public Meeting
Registration: To register to attend ``Prescription Drug User Fee
Act of 2017; Electronic Submissions and Data Standards,'' please visit
the following website: <a href="https://www.eventbrite.com/e/pdufa-vi-data-standards-public-meeting-2022-tickets-215684276477?ref=estw">https://www.eventbrite.com/e/pdufa-vi-data-standards-public-meeting-2022-tickets-215684276477?ref=estw</a>. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone. A draft agenda will
be posted approximately 1 month prior to the meeting.
Opportunity for Public Comment: Those who register online by March
22, 2022, will receive a notification about an opportunity to
participate in the public comment session of the meeting. If you wish
to speak during the public comment session, follow the instructions in
the notification and identify which topic(s) you wish to address. We
will do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time jointly. All
requests to make a public comment during the meeting must be received
by March 22, 2022, 11:59 p.m. Eastern Time. We will determine the
amount of time allotted to each commenter and the approximate time each
comment is to begin, and we will select and notify participants by
April 1, 2022. No commercial or promotional material will be permitted
to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
be held via Zoom (<a href="https://fda.zoomgov.com/j/1606221249">https://fda.zoomgov.com/j/1606221249</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
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm">https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm</a>.
Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01570 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P
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