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. 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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
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