82 FR 46083 - Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46083-46084 | |
| FR Document | 2017-21218 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46083-46084] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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, [email protected]; 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, [email protected]. 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
![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46083
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND Written/Paper Submissions
default.htm. Scroll down to the HUMAN SERVICES Submit written/paper submissions as
appropriate advisory committee meeting follows:
link. Food and Drug Administration • Mail/Hand delivery/Courier (for
Procedure: Interested persons may written/paper submissions): Dockets
present data, information, or views, [Docket No. FDA–2013–N–0502] Management Staff (HFA–305), Food and
orally or in writing, on issues pending Drug Administration, 5630 Fishers
Range of Risk Evaluation and Lane, Rm. 1061, Rockville, MD 20852.
before the committees. All electronic Mitigation Strategies Platform
and written submissions submitted to • For written/paper comments
Standards Initiative: Needs submitted to the Dockets Management
the Docket (see ADDRESSES) on or before Assessment; Request for Comments
October 17, 2017, will be provided to Staff, FDA will post your comment, as
the committees. Oral presentations from AGENCY: Food and Drug Administration, well as any attachments, except for
HHS. information submitted, marked and
the public will be scheduled between
identified, as confidential, if submitted
approximately 1 p.m. and 2 p.m. Those ACTION: Notice; request for comments. as detailed in ‘‘Instructions.’’
individuals interested in making formal Instructions: All submissions received
oral presentations should notify the SUMMARY: The Food and Drug must include the Docket No. FDA–
contact person and submit a brief Administration (FDA or the Agency) is 2013–N–0502 for ‘‘REMS Platform
statement of the general nature of the seeking public input on the design of Standards Initiative: Needs Assessment;
evidence or arguments they wish to the REMS Platform Standards Initiative, Request for Comments.’’ Received
present, the names and addresses of as well as methods and best practices comments will be placed in the docket
proposed participants, and an for its construction. To facilitate this, and, except for those submitted as
indication of the approximate time FDA is making available the ‘‘REMS ‘‘Confidential Submissions,’’ publicly
requested to make their presentation on Platform Standards Initiative: Needs viewable at https://www.regulations.gov
or before October 6, 2017. Time allotted Assessment’’ (needs assessment), which or at the Dockets Management Staff
for each presentation may be limited. If summarizes a range of risk evaluation between 9 a.m. and 4 p.m., Monday
the number of registrants requesting to and mitigation strategies (REMS) through Friday.
speak is greater than can be reasonably activities that could be standardized and • Confidential Submissions—To
accommodated during the scheduled integrated into the health care system submit a comment with confidential
through the use of electronic data information that you do not wish to be
open public hearing session, FDA may
standards. made publicly available, submit your
conduct a lottery to determine the
speakers for the scheduled open public DATES: The comment period will be comments only as a written/paper
hearing session. The contact person will open indefinitely. submission. You should submit two
notify interested persons regarding their copies total. One copy will include the
ADDRESSES: You may submit comments information you claim to be confidential
request to speak by October 10, 2017. as follows: with a heading or cover note that states
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Agency is not responsible for providing Submit electronic comments in the Agency will review this copy, including
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FDA welcomes the attendance of the • Federal eRulemaking Portal: its consideration of comments. The
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identifies you in the body of your of comments to public dockets, see 80
the Federal Advisory Committee Act (5 comments, that information will be
asabaliauskas on DSKBBXCHB2PROD with NOTICES
U.S.C. app. 2). FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Dated: September 27, 2017. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Anna K. Abram, with confidential information that you 23389.pdf.
Deputy Commissioner for Policy, Planning, do not wish to be made available to the Docket: For access to the docket to
Legislation, and Analysis. public, submit the comment as a read background documents or the
[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am] written/paper submission and in the electronic and written/paper comments
BILLING CODE 4164–01–P
manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
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![46084 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
docket number, found in brackets in the (3) What standards already exist that enhanced compliance and safer use of
heading of this document, into the could be used to address the needs and drugs that have REMS.
‘‘Search’’ box and follow the prompts facilitate the REMS activities described
II. Electronic Access
and/or go to the Dockets Management in the needs assessment?
Staff, 5630 Fishers Lane, Rm. 1061, (4) Where (if at all) do new standards Persons with access to the Internet
Rockville, MD 20852. need to be developed? may obtain the needs assessment at
(5) What other opportunities exist to https://www.fda.gov/downloads/
FOR FURTHER INFORMATION CONTACT:
leverage health IT to facilitate the ForIndustry/UserFees/
Adam Kroetsch, Center for Drug
completion of REMS activities? PrescriptionDrugUserFee/
Evaluation and Research, Food and
FDA hopes that the needs assessment UCM565594.pdf.
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168, will help identify areas where standards Dated: September 19, 2017.
Silver Spring, MD 20993–0002, 301– development projects to support REMS Leslie Kux,
796–3842, REMS_Standardization@ are already underway, as well as areas Associate Commissioner for Policy.
fda.hhs.gov; or Aaron Sherman, Center that are ripe for standards development, [FR Doc. 2017–21218 Filed 10–2–17; 8:45 am]
for Drug Evaluation and Research, Food enabling interested stakeholders to BILLING CODE 4164–01–P
and Drug Administration, 10903 New engage further in this project.
Hampshire Ave., Bldg. 51, Rm. 6366, What is the REMS Platform Standards
Silver Spring, MD 20993–0002, 240– Initiative? DEPARTMENT OF HEALTH AND
402–0493, REMS_Standardization@ HUMAN SERVICES
fda.hhs.gov. The goal of the REMS Platform
Standards Initiative is to leverage National Institutes of Health
SUPPLEMENTARY INFORMATION: electronic health data standards to
standardize certain activities in REMS Eunice Kennedy Shriver National
I. Background
with ETASU and integrate them into Institute of Child Health & Human
On October 5, 2015, FDA launched health IT systems. Under the initiative, Development; Notice of Closed
the REMS Platform Standards Initiative FDA seeks to work with third-party Meetings
(previously referred to as the ‘‘Common standards development organizations to Pursuant to section 10(d) of the
REMS Platform Initiative’’), with the encourage the development of electronic Federal Advisory Committee Act, as
goal of developing and leveraging data standards that may be used to amended, notice is hereby given of the
electronic health data standards, facilitate communication between following meetings.
referred to as ‘‘REMS platform REMS and their participants. Once the The meetings will be closed to the
standards,’’ to further standardize standards are developed, FDA would public in accordance with the
certain activities associated with REMS maintain a list of REMS platform provisions set forth in sections
with elements to assure safe use standards, encourage their use in REMS 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(ETASU), and integrate them into with ETASU, and encourage the as amended. The grant applications and
existing health care systems. development of tools that use these the discussions could disclose
(Information about the initiative can be standards to integrate REMS into health confidential trade secrets or commercial
found at: http://www.fda.gov/ care providers’ existing systems. property such as patentable material,
downloads/ForIndustry/UserFees/ and personal information concerning
PrescriptionDrugUserFee/ Why is FDA launching the REMS
Platform Standards Initiative? individuals associated with the grant
UCM507451.pdf). Since then, FDA has applications, the disclosure of which
been working to determine the most This initiative was launched for a would constitute a clearly unwarranted
effective methods for carrying out this number of reasons. Stakeholders have invasion of personal privacy.
initiative, including how best to engage requested a centralized method to enroll
the public on the project and advance Name of Committee: National Institute of
in and interact with REMS with ETASU Child Health and Human Development
the development of REMS platform and more fundamental standardization Special Emphasis Panel NICHD Education
standards. To achieve these ends, FDA of REMS architecture. There is also a Grants.
is publishing the ‘‘REMS Platform need for a comprehensive set of Date: November 6, 2017.
Standards Initiative: Needs standards for REMS to help minimize Time: 3:00 p.m. to 5:00 p.m.
Assessment,’’ which seeks to provide REMS burden on the health care Agenda: To review and evaluate grant
REMS stakeholders, standards delivery system and integrate REMS applications.
developers, and health information into health IT systems. Place: National Institutes of Health, 6710 B
technology (IT) systems developers with Rockledge Drive, Bethesda, MD 20892,
The goal of the REMS Platform (Telephone Conference Call).
specific, detailed information on the Standards Initiative is to give all Contact Person: Joanna Kubler-Kielb,
areas in which standards development stakeholders—including sponsors, data Scientific Review Officer, Scientific Review
is needed and the information that the vendors, clinical decision support Branch, Eunice Kennedy Shriver National
data standards would need to system developers (such as those for Institute of Child Health and Human
communicate to effectively carry out hospitals, private practices, etc.)—a Development, 6100 Executive Boulevard,
REMS activities. FDA seeks comment on ‘‘fixed target’’ for standardization and Room 5B01, Bethesda, MD 20892–7510, 301–
the document as a whole, as well as on 435–6916, kielbj@mail.nih.gov.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
integration. If successful, this will
the specific questions that follow. clarify how sponsors can develop Name of Committee: National Institute of
(1) Does this needs assessment cover standardized REMS that are more easily Child Health and Human Development
all of the REMS activities for which integrated into the health care system Special Emphasis Panel, SPROUTS:
standards development would be Development of eating behaviors in early
and what health care providers must do childhood.
beneficial? to comply with those REMS. Ultimately, Date: November 13, 2017.
(2) Which REMS activities should be REMS that are more effectively Time: 1:00 p.m. to 4:00 p.m.
given highest priority for standards standardized and integrated into the Agenda: To review and evaluate contract
development? health care system should facilitate proposals.
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Document Created: 2017-10-03 01:01:05
Document Modified: 2017-10-03 01:01:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for comments. | |
| Dates | The comment period will be open indefinitely. | |
| 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, [email protected]; 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, [email protected] | |
| FR Citation | 82 FR 46083 |
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