[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4086-4088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00831]


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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 or Agency) 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

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well as from comments submitted to the docket to provide input into 
data standards initiatives, the FDA Information Technology (IT) 
Strategic Plan, and electronic submissions gateway target timeframes.

DATES: The public meeting will be held on April 7, 2021, 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 7, 2021. 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 7, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of March 7, 2021. 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 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, 240-
402-6511, bryan.spells@fda.hhs.gov, 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, 
stephen.ripley@fda.hhs.gov.

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 IT 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 at 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 to register: https://www.eventbrite.com/e/pdufa-vi-2021-public-meeting-on-electronic-submissions-and-data-standards-tickets-126816546705. 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 
7,

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2021, 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 7, 2021, 11:59 p.m. Eastern Time. We will determine the amount 
of time allotted to each commenter, the approximate time each comment 
is to begin, and will select and notify participants by March 21, 2021. 
No commercial or promotional material will be permitted to be presented 
at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be held via Adobe Connect webcast: https://collaboration.fda.gov/pdufavify21/.
    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 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00831 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P


