[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95145-95146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31143]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4187]
Coordinated Registry Network for Devices Used for Acute Ischemic
Stroke Intervention; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Coordinated Registry Network (CRN)
for Devices Used for Acute Ischemic Stroke Intervention (DAISI).'' The
purpose of the public workshop is to obtain stakeholders' input on the
coordination of registries for DAISI.
DATES: The public workshop will be held on February 2, 2017, 8 a.m. to
5 p.m. EST. The deadline for submitting comments regarding this public
workshop is March 2, 2017. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will be held at the Ruth L. Kirschstein
Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of
Health Campus, 9000 Rockville Pike, Bethesda, MD 20892. Entrance for
the public workshop participants (non-NIH employees) is through the NIH
Gateway Center located adjacent to the Medical Center Metro, where
routine security check procedures will be performed. Please visit the
following Web site for NIH campus location, parking, security, and
travel information: http://www.nih.gov/about/visitor/index.htm. Please
visit the following Web site for information on the Natcher Conference
Center: http://www.genome.gov/11007522.
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
In order to permit the widest possible opportunity for public
comment, FDA is soliciting either electronic or written comments on all
aspects of the workshop topics.
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-4187 for ``Coordinated Registry Network (CRN) for Devices
Used for Acute Ischemic Stroke Intervention (DAISI).'' 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 Division of Dockets Management
[[Page 95146]]
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.'' FDA 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 Division of Dockets Management. 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:
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jamie Waterhouse, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2611, Silver Spring, MD 20993, 301-796-
3063, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Stroke is the fifth leading cause of death in the United States and
the number one preventable cause of disability (Ref. 1). Recent
publication of five prospective randomized trials and revised practice
guidelines in the treatment of stroke has suggested the potential
therapeutic role of endovascular therapy in combination with
pharmacotherapy (typically intravenous tissue plasminogen activator (IV
t-PA)) for patients with proximal large vessel occlusion stroke in the
anterior circulation (M1 Middle Cerebral Artery segment with or without
concomitant Internal Carotid Artery occlusion) (Refs. 2-6). FDA
believes that research and development in this field, including the
collection of data through the use of registries, provides a potential
data source for expanding indications for already cleared/approved
devices. Development and leveraging support for data collected within
appropriate registries; with the participation of professional medical
societies, industry, patient groups, healthcare facilities, and payers;
can further drive innovation in this area and aid in the improvement of
clinical care and patient outcomes. A coordinated registry network may
also collect data reflective of clinical practice that is of sufficient
quality and breadth to support scientific, clinical, and regulatory
decision-making and aid in the design of future studies and performance
testing requirements for new or existing devices.
II. Topics for Discussion at the Public Workshop
This workshop is aimed at addressing scientific, clinical, and
regulatory considerations associated with medical devices used in the
treatment of acute ischemic stroke medical devices and the development
of coordinated registry networks to serve the following topic areas:
Clinical Common Data Elements;
Standardized Definitions and Case Report Forms;
Informatics, Sustainability, and Data Quality; and
Additional scientific, methodological, and clinical
considerations for evaluating information obtained from registries.
III. Participating in the Public Workshop
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences (Medical Devices)
calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Persons interested in attending this
public workshop must register online by January 26, 2017, at 4 p.m.
EST. 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
workshop must register by January 26, 2017, at 4 p.m. EST. 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. You
will be notified if you are on a waiting list.
If you need special accommodations due to a disability, please
contact Peggy Roney, Center for Devices and Radiological Health, Office
of Communication and Education, 301-796-5671, email:
[email protected] no later than January 19, 2017.
IV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. American Stroke Association, ``Impact of Stroke (Stroke
statistics)'' (http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.VvFGChvruUk).
2. Berkhemer, O. A., et al. ``A Randomized Trial of Intraarterial
Treatment for Acute Ischemic Stroke.'' New England Journal of
Medicine. 372, 11-20 (2015).
3. Saver, J. L., et al. ``Stent-Retriever Thrombectomy After
Intravenous t-PA Versus t-PA Alone in Stroke.'' New England Journal
of Medicine. 372, 2285-2295 (2015).
4. Goyal, M., et al. ``Randomized Assessment of Rapid Endovascular
Treatment of Ischemic Stroke.'' New England Journal of Medicine.
372, 1019-1030 (2015).
5. Campbell, B. C., et al. ``Endovascular Therapy for Ischemic
Stroke with Perfusion-Imaging Selection.'' New England Journal of
Medicine. 372, 1009-1018 (2015).
6. Jovin, T. G., et al. ``Thrombectomy Within 8 Hours After Symptom
Onset in Ischemic Stroke.'' New England Journal of Medicine. 372,
2296-2306 (2015).
Dated: December 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31143 Filed 12-23-16; 8:45 am]
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