[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61385-61387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25958]


-----------------------------------------------------------------------

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; Announcement of 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 or Agency) is announcing 
the following public meeting entitled ``Prescription Drug User Fee Act 
of 2017; Electronic Submissions and Data Standards.'' FDA is also 
requesting public comments on the subject. The purpose of the 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 initiatives, the FDA Information 
Technology (IT) Strategic Plan, and electronic submissions gateway 
target timeframes.

DATES: The public meeting will be held on April 10, 2019, from 9 a.m. 
to 4 p.m. Submit either electronic or written comments by April 10, 
2019. See the SUPPLEMENTARY INFORMATION section for registration date 
and information.

[[Page 61386]]


ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for 
public meeting participants (non-FDA employees) is through Building 1, 
where routine security check procedures will be performed. For parking 
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 April 10, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of April 10, 2019. 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], 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.

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 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 commitment letter outlines 
FDA's performance goals and procedures under the PDUFA program for the 
years 2018 through 2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.
    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 
register at https://www.eventbrite.com/e/pdufa-vi-public-meeting-on-electronic-submissions-and-data-standards-tickets-49895060469. 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.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting on April 10, 2019, must register by 11:59 p.m. on March 22, 
2019, Eastern Time. Early registration is recommended because seating 
is limited; therefore, FDA may limit the number of participants from 
each organization. Registrants will receive confirmation when they have 
been accepted.
    Request for Oral Presentations: During online registration, you may 
indicate if you wish to present during the public

[[Page 61387]]

comment session and which topic(s) you would like to address. FDA will 
do its best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin 
and will select and notify participants by March 27, 2019. All requests 
to make oral presentations must be received by the close of 
registration at 11:59 on March 22, 2019, Eastern Time. If selected for 
presentation, any presentation materials must be emailed to 
[email protected] no later than April 3, 2019. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public meeting.
    If you need special accommodations due to a disability, please 
contact Chenoa Conley, 301-796-0035, email [email protected], 
no later than April 3, 2019.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will 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: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25958 Filed 11-28-18; 8:45 am]
 BILLING CODE 4164-01-P


