Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments, 46083-46084 [2017-21218]
Download as PDF
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
October 17, 2017, will be provided to
the committees. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 6, 2017. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 10, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require special accommodations
due to a disability, please contact
Kalyani Bhatt at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0502]
Range of Risk Evaluation and
Mitigation Strategies Platform
Standards Initiative: Needs
Assessment; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
seeking public input on the design of
the REMS Platform Standards Initiative,
as well as methods and best practices
for its construction. To facilitate this,
FDA is making available the ‘‘REMS
Platform Standards Initiative: Needs
Assessment’’ (needs assessment), which
summarizes a range of risk evaluation
and mitigation strategies (REMS)
activities that could be standardized and
integrated into the health care system
through the use of electronic data
standards.
SUMMARY:
The comment period will be
open indefinitely.
DATES:
ADDRESSES:
You may submit comments
as follows:
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’’).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
46083
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–
2013–N–0502 for ‘‘REMS Platform
Standards Initiative: Needs Assessment;
Request for Comments.’’ Received
comments 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/201523389.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
E:\FR\FM\03OCN1.SGM
03OCN1
46084
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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:
Adam Kroetsch, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168,
Silver Spring, MD 20993–0002, 301–
796–3842, REMS_Standardization@
fda.hhs.gov; or Aaron Sherman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 240–
402–0493, REMS_Standardization@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
On October 5, 2015, FDA launched
the REMS Platform Standards Initiative
(previously referred to as the ‘‘Common
REMS Platform Initiative’’), with the
goal of developing and leveraging
electronic health data standards,
referred to as ‘‘REMS platform
standards,’’ to further standardize
certain activities associated with REMS
with elements to assure safe use
(ETASU), and integrate them into
existing health care systems.
(Information about the initiative can be
found at: https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM507451.pdf). Since then, FDA has
been working to determine the most
effective methods for carrying out this
initiative, including how best to engage
the public on the project and advance
the development of REMS platform
standards. To achieve these ends, FDA
is publishing the ‘‘REMS Platform
Standards Initiative: Needs
Assessment,’’ which seeks to provide
REMS stakeholders, standards
developers, and health information
technology (IT) systems developers with
specific, detailed information on the
areas in which standards development
is needed and the information that the
data standards would need to
communicate to effectively carry out
REMS activities. FDA seeks comment on
the document as a whole, as well as on
the specific questions that follow.
(1) Does this needs assessment cover
all of the REMS activities for which
standards development would be
beneficial?
(2) Which REMS activities should be
given highest priority for standards
development?
VerDate Sep<11>2014
18:17 Oct 02, 2017
Jkt 244001
(3) What standards already exist that
could be used to address the needs and
facilitate the REMS activities described
in the needs assessment?
(4) Where (if at all) do new standards
need to be developed?
(5) What other opportunities exist to
leverage health IT to facilitate the
completion of REMS activities?
FDA hopes that the needs assessment
will help identify areas where standards
development projects to support REMS
are already underway, as well as areas
that are ripe for standards development,
enabling interested stakeholders to
engage further in this project.
What is the REMS Platform Standards
Initiative?
The goal of the REMS Platform
Standards Initiative is to leverage
electronic health data standards to
standardize certain activities in REMS
with ETASU and integrate them into
health IT systems. Under the initiative,
FDA seeks to work with third-party
standards development organizations to
encourage the development of electronic
data standards that may be used to
facilitate communication between
REMS and their participants. Once the
standards are developed, FDA would
maintain a list of REMS platform
standards, encourage their use in REMS
with ETASU, and encourage the
development of tools that use these
standards to integrate REMS into health
care providers’ existing systems.
Why is FDA launching the REMS
Platform Standards Initiative?
This initiative was launched for a
number of reasons. Stakeholders have
requested a centralized method to enroll
in and interact with REMS with ETASU
and more fundamental standardization
of REMS architecture. There is also a
need for a comprehensive set of
standards for REMS to help minimize
REMS burden on the health care
delivery system and integrate REMS
into health IT systems.
The goal of the REMS Platform
Standards Initiative is to give all
stakeholders—including sponsors, data
vendors, clinical decision support
system developers (such as those for
hospitals, private practices, etc.)—a
‘‘fixed target’’ for standardization and
integration. If successful, this will
clarify how sponsors can develop
standardized REMS that are more easily
integrated into the health care system
and what health care providers must do
to comply with those REMS. Ultimately,
REMS that are more effectively
standardized and integrated into the
health care system should facilitate
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
enhanced compliance and safer use of
drugs that have REMS.
II. Electronic Access
Persons with access to the Internet
may obtain the needs assessment at
https://www.fda.gov/downloads/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM565594.pdf.
Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–21218 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel NICHD Education
Grants.
Date: November 6, 2017.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6710 B
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Joanna Kubler-Kielb,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–7510, 301–
435–6916, kielbj@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, SPROUTS:
Development of eating behaviors in early
childhood.
Date: November 13, 2017.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46083-46084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0502]
Range of Risk Evaluation and Mitigation Strategies Platform
Standards Initiative: Needs Assessment; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
seeking public input on the design of the REMS Platform Standards
Initiative, as well as methods and best practices for its construction.
To facilitate this, FDA is making available the ``REMS Platform
Standards Initiative: Needs Assessment'' (needs assessment), which
summarizes a range of risk evaluation and mitigation strategies (REMS)
activities that could be standardized and integrated into the health
care system through the use of electronic data standards.
DATES: The comment period will be open indefinitely.
ADDRESSES: You may submit comments as follows:
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-2013-N-0502 for ``REMS Platform Standards Initiative: Needs
Assessment; Request for Comments.'' Received comments 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
[[Page 46084]]
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: Adam Kroetsch, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-
796-3842, REMS_Standardization@fda.hhs.gov; or Aaron Sherman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002,
240-402-0493, REMS_Standardization@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On October 5, 2015, FDA launched the REMS Platform Standards
Initiative (previously referred to as the ``Common REMS Platform
Initiative''), with the goal of developing and leveraging electronic
health data standards, referred to as ``REMS platform standards,'' to
further standardize certain activities associated with REMS with
elements to assure safe use (ETASU), and integrate them into existing
health care systems. (Information about the initiative can be found at:
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM507451.pdf). Since then, FDA has been
working to determine the most effective methods for carrying out this
initiative, including how best to engage the public on the project and
advance the development of REMS platform standards. To achieve these
ends, FDA is publishing the ``REMS Platform Standards Initiative: Needs
Assessment,'' which seeks to provide REMS stakeholders, standards
developers, and health information technology (IT) systems developers
with specific, detailed information on the areas in which standards
development is needed and the information that the data standards would
need to communicate to effectively carry out REMS activities. FDA seeks
comment on the document as a whole, as well as on the specific
questions that follow.
(1) Does this needs assessment cover all of the REMS activities for
which standards development would be beneficial?
(2) Which REMS activities should be given highest priority for
standards development?
(3) What standards already exist that could be used to address the
needs and facilitate the REMS activities described in the needs
assessment?
(4) Where (if at all) do new standards need to be developed?
(5) What other opportunities exist to leverage health IT to
facilitate the completion of REMS activities?
FDA hopes that the needs assessment will help identify areas where
standards development projects to support REMS are already underway, as
well as areas that are ripe for standards development, enabling
interested stakeholders to engage further in this project.
What is the REMS Platform Standards Initiative?
The goal of the REMS Platform Standards Initiative is to leverage
electronic health data standards to standardize certain activities in
REMS with ETASU and integrate them into health IT systems. Under the
initiative, FDA seeks to work with third-party standards development
organizations to encourage the development of electronic data standards
that may be used to facilitate communication between REMS and their
participants. Once the standards are developed, FDA would maintain a
list of REMS platform standards, encourage their use in REMS with
ETASU, and encourage the development of tools that use these standards
to integrate REMS into health care providers' existing systems.
Why is FDA launching the REMS Platform Standards Initiative?
This initiative was launched for a number of reasons. Stakeholders
have requested a centralized method to enroll in and interact with REMS
with ETASU and more fundamental standardization of REMS architecture.
There is also a need for a comprehensive set of standards for REMS to
help minimize REMS burden on the health care delivery system and
integrate REMS into health IT systems.
The goal of the REMS Platform Standards Initiative is to give all
stakeholders--including sponsors, data vendors, clinical decision
support system developers (such as those for hospitals, private
practices, etc.)--a ``fixed target'' for standardization and
integration. If successful, this will clarify how sponsors can develop
standardized REMS that are more easily integrated into the health care
system and what health care providers must do to comply with those
REMS. Ultimately, REMS that are more effectively standardized and
integrated into the health care system should facilitate enhanced
compliance and safer use of drugs that have REMS.
II. Electronic Access
Persons with access to the Internet may obtain the needs assessment
at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM565594.pdf.
Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21218 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P