[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4254-4255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-information-technology-goals-and-progress.
    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 https://www.regulations.gov 
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:
     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-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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 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 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: 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: 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, 
[email protected], 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, 
[email protected].

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 
https://www.fda.gov/media/99140/download.
    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: https://www.eventbrite.com/e/pdufa-vi-data-standards-public-meeting-2022-tickets-215684276477?ref=estw. 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 (https://fda.zoomgov.com/j/1606221249).
    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). A link to the transcript will also be available on the 
internet at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.

    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


