Document ID: FDA-2013-N-0502-0091
Agency: fda
Document Type: Notice
Title: Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments
Posted Date: 2017-10-03T04:00Z

[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]

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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.

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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: 
http://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