[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47528-47529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5568]


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.

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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.'' The topics to be 
discussed will include the current status of electronic submissions and 
data standards initiatives to improve the predictability and 
consistency of the electronic submissions process in support of the 
human drug review program. FDA is seeking input from a variety of 
stakeholders--industry, academia, patient advocates, professional 
societies and other interested parties--as it fulfills its commitment 
under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual 
public meetings to seek stakeholder input related to enhancing the 
transparency and accountability of the electronic submission and data 
standards activities. FDA will use the information from the public 
meeting to inform the development of the FDA Information Technology 
(FDA IT) Strategic Plan and electronic submissions gateway target 
timeframes.

DATES: The public meeting will be held March 21, 2018, from 9 a.m. to 4 
p.m. Submit either electronic or written comments regarding this public 
meeting prior to the meeting through April 18, 2018. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the 
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/default.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 18, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of April 18, 2018. 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: 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.
    <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-2017-N-5568 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.
    <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 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 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: 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: Ron Fitzmartin, Center for Drug 
Evaluation

[[Page 47529]]

and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-796-5333, email: 
<a href="/cdn-cgi/l/email-protection#690a0d0c1b0d081d081a1d08070d081b0d1a290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="680b0c0d1a0c091c091b1c09060c091a0c1b280e0c094600001b460f071e">[email protected]</span></a>; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., 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. FDA agreed in the PDUFA VI commitment 
letter 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 2018-2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.

II. Topics for Discussion at the Public Meeting

    FDA strives to achieve a fully automated standards-based IT 
environment that enhances the regulatory review processes for human 
drugs and biologics. The purpose of the March 21, 2018, public meeting 
is to obtain input from industry and other interested stakeholders on 
enhancing the transparency and accountability of the electronic 
submission and data standards activities. To help fulfill its 
commitment, FDA is particularly interested in receiving input on the 
following topics:
    <bullet> Electronic Submissions
    [cir] Electronic submission process, including key electronic 
submission milestones and associated sponsor notifications from the 
completion of the upload of the submission to the Electronic 
Submissions Gateway (ESG) through the time the submission is made 
available to the review team.
    [cir] Electronic submission system past performance, emerging 
industry needs, and technology initiatives.
    [cir] Published and future targets for the ESG and related 
electronic submission systems.
    [cir] Implementation of electronic Common Technical Document (eCTD) 
v4.0.
    <bullet> Data Standards Initiatives
    [cir] International Organization for Standards (ISO) Identification 
of Medicinal Products (IDMP): ISO IDMP standards implementation will 
support a variety of regulatory activities related to development, 
registration, and life cycle management of medicinal products, as well 
as pharmacovigilance and risk management. There are five standards that 
describe the substance (ISO 11238), dosage form and routes of 
administration (ISO 11239), units of measure (ISO 11240), medicinal 
product identifier (ISO 11615), and pharmaceutical product identifier 
(ISO 11616).
    [cir] Individual Case Safety Reports (ICSRs): ICSRs provide a 
consistent approach to the creation and review of drug and biologics 
safety information and pharmacovigilance activities.
    FDA will consider all comments made at this workshop or received 
through the docket (see ADDRESSES).

III. Participating in the Public Meeting

    Registration: To register to attend ``Prescription Drug User Fee 
Act VI; Electronic Submissions and Data Standards; Public Meeting; 
Request for Comments'' please send an email to 
<a href="/cdn-cgi/l/email-protection#a8cbcccddaccc9dcc9dbdcc9c6ccc9daccdbe8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="8cefe8e9fee8edf8edfff8ede2e8edfee8ffcceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a> by February 19, 2018. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by February 19, 2018, midnight 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.
    If you need special accommodations due to a disability, please 
contact Chenoa Conley, 301-796-0035, email <a href="/cdn-cgi/l/email-protection#084b606d666769264b6766646d71486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="67240f02090806492408090b021e27010306490f0f1449000811">[email protected]</span></a> at 
least 7 days before the meeting.
    Request for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session and 
which topic(s) you wish 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 6, 2018. All requests to make oral presentations 
must be received by the close of registration on February 19, 2018, 
midnight Eastern Time. If selected for presentation, any presentation 
materials must be emailed to <a href="/cdn-cgi/l/email-protection#bad9dedfc8dedbcedbc9cedbd4dedbc8dec9fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="f497909186909580958780959a9095869087b4929095da9c9c87da939b82">[email protected]</span></a> no later 
than March 14, 2018. No commercial or promotional material will be 
permitted to be presented or distributed at the public meeting.
    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: October 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21981 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P


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