Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments, 47528-47529 [2017-21981]
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47528
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
Reports Clearance Officer.
[FR Doc. 2017–21960 Filed 10–11–17; 8:45 am]
BILLING CODE 4184–41–P
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.
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,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
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/WhiteOak
CampusInformation/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:
• 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
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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.
• 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/2015-233
89.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
E:\FR\FM\12OCN1.SGM
12OCN1
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1115, Silver Spring,
MD 20993–0002, 301–796–5333, email:
cderdatastandards@fda.hhs.gov; 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:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
FDA is committed to achieve the longterm 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/for
industry/userfees/prescriptiondrug
userfee/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:
• Electronic Submissions
Æ 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.
Æ Electronic submission system past
performance, emerging industry needs,
and technology initiatives.
Æ Published and future targets for the
ESG and related electronic submission
systems.
Æ Implementation of electronic
Common Technical Document (eCTD)
v4.0.
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
• Data Standards Initiatives
Æ 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).
Æ 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
cderdatastandards@fda.hhs.gov 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
Chenoa.Conley@fda.hhs.gov 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
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
47529
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
cderdatastandards@fda.hhs.gov 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/prescriptiondrug
userfee/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0461]
Format and Content of a Risk
Evaluation and Mitigation Strategy
Document; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Format and Content of a REMS
Document.’’ A Risk Evaluation and
Mitigation Strategy (REMS) document,
which is part of a REMS that is required
by FDA, establishes the goals and
requirements of the REMS. This revised
draft guidance describes a new
recommended format for a REMS
document. The new format was
developed based on extensive
stakeholder feedback. This guidance
revises and supersedes the draft
guidance entitled ‘‘Format and Content
of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS
Assessments, and Proposed REMS
Modifications,’’ that was published by
FDA on October 1, 2009.
DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY:
E:\FR\FM\12OCN1.SGM
12OCN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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-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.
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:
cderdatastandards@fda.hhs.gov; 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:
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.
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
cderdatastandards@fda.hhs.gov 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 Chenoa.Conley@fda.hhs.gov 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 cderdatastandards@fda.hhs.gov 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