81 FR 95145 - Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 248 (December 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 248 (December 27, 2016)
| Page Range | 95145-95146 | |
| FR Document | 2016-31143 |
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)] [Notices] [Pages 95145-95146] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31143] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices 95145
practices regulation (21 CFR 10.115). part 814, subparts B and E, have been Center: http://www.genome.gov/
The guidance represents the current approved under OMB control number 11007522.
thinking of FDA on ‘‘Factors to Consider 0910–0231. The collections of You may submit comments as
Regarding Benefit-Risk in Medical information in 21 CFR part 820, follows:
Device Product Availability, regarding the Quality System regulation, Electronic Submissions
Compliance, and Enforcement have been approved under OMB control
Decisions.’’ It does not establish any number 0910–0073. The collections of Submit electronic comments in the
rights for any person and is not binding information in 21 CFR part 822, following way:
on FDA or the public. You can use an regarding postmarket surveillance of • Federal eRulemaking Portal:
alternative approach if it satisfies the medical devices, have been approved https://www.regulations.gov. Follow the
requirements of the applicable statutes under OMB control number 0910–0449. instructions for submitting comments.
and regulations. Comments submitted electronically,
Dated: December 21, 2016. including attachments, to https://
III. Electronic Access Leslie Kux, www.regulations.gov will be posted to
Persons interested in obtaining a copy Associate Commissioner for Policy. the docket unchanged. Because your
of the guidance may do so by using the [FR Doc. 2016–31145 Filed 12–23–16; 8:45 am] comment will be made public, you are
Internet. A search capability for all BILLING CODE 4164–01–P solely responsible for ensuring that your
CDRH guidance documents is available comment does not include any
at http://www.fda.gov/MedicalDevices/ confidential information that you or a
DeviceRegulationandGuidance/ DEPARTMENT OF HEALTH AND third party may not wish to be posted,
GuidanceDocuments/default.htm. HUMAN SERVICES such as medical information, your or
Guidance documents are also available anyone else’s Social Security number, or
at https://www.regulations.gov. Persons Food and Drug Administration confidential business information, such
unable to download an electronic copy as a manufacturing process. Please note
of ‘‘Factors to Consider Regarding [Docket No. FDA–2016–N–4187] that if you include your name, contact
Benefit-Risk in Medical Device Product information, or other information that
Availability, Compliance, and Coordinated Registry Network for identifies you in the body of your
Enforcement Decisions’’ may send an Devices Used for Acute Ischemic comments, that information will be
email request to CDRH-Guidance@ Stroke Intervention; Public Workshop; posted on https://www.regulations.gov.
fda.hhs.gov to receive an electronic Request for Comments • If you want to submit a comment
copy of the document. Please use the AGENCY: Food and Drug Administration, with confidential information that you
document number 1500065 to identify HHS. do not wish to be made available to the
the guidance you are requesting. public, submit the comment as a
ACTION: Notice of public workshop;
IV. Paperwork Reduction Act of 1995 written/paper submission and in the
request for comments.
manner detailed (see ‘‘Written/Paper
This guidance refers to previously Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
approved collections of information
Administration (FDA) is announcing the Written/Paper Submissions
found in FDA regulations. These
following public workshop entitled
collections of information are subject to In order to permit the widest possible
‘‘Coordinated Registry Network (CRN)
review by the Office of Management and opportunity for public comment, FDA is
for Devices Used for Acute Ischemic
Budget (OMB) under the Paperwork soliciting either electronic or written
Stroke Intervention (DAISI).’’ The
Reduction Act of 1995 (44 U.S.C. 3501– comments on all aspects of the
3520). The collections of information in purpose of the public workshop is to
obtain stakeholders’ input on the workshop topics.
21 CFR part 7, subpart C, have been Submit written/paper submissions as
approved under OMB control number coordination of registries for DAISI.
follows:
0910–0249. The collections of DATES: The public workshop will be • Mail/Hand delivery/Courier (for
information in 21 CFR parts 801 and held on February 2, 2017, 8 a.m. to 5 written/paper submissions): Division of
809, regarding labeling, have been p.m. EST. The deadline for submitting Dockets Management (HFA–305), Food
approved under OMB control number comments regarding this public and Drug Administration, 5630 Fishers
0910–0485. The collections of workshop is March 2, 2017. See the Lane, Rm. 1061, Rockville, MD 20852.
information in 21 CFR part 803, SUPPLEMENTARY INFORMATION section for • For written/paper comments
regarding medical device reporting, registration date and information. submitted to the Division of Dockets
have been approved under OMB control ADDRESSES: The public workshop will Management, FDA will post your
numbers 0910–0291, 0910–0437, and be held at the Ruth L. Kirschstein comment, as well as any attachments,
0910–0471. The collections of Auditorium, Natcher Conference Center, except for information submitted,
information in 21 CFR part 806 have Bldg. 45, National Institutes of Health marked and identified, as confidential,
been approved under OMB control Campus, 9000 Rockville Pike, Bethesda, if submitted as detailed in
number 0910–0359. The collections of MD 20892. Entrance for the public ‘‘Instructions.’’
information in 21 CFR part 807, subpart workshop participants (non-NIH Instructions: All submissions received
E, have been approved under OMB employees) is through the NIH Gateway must include the Docket No. FDA–
control number 0910–0120. The Center located adjacent to the Medical 2016–N–4187 for ‘‘Coordinated Registry
asabaliauskas on DSK3SPTVN1PROD with NOTICES
collections of information in 21 CFR Center Metro, where routine security Network (CRN) for Devices Used for
part 810, regarding medical device check procedures will be performed. Acute Ischemic Stroke Intervention
recall authority, have been approved Please visit the following Web site for (DAISI).’’ Received comments will be
under OMB control number 0910–0432. NIH campus location, parking, security, placed in the docket and, except for
The collections of information in 21 and travel information: http:// those submitted as ‘‘Confidential
CFR part 812 have been approved under www.nih.gov/about/visitor/index.htm. Submissions,’’ publicly viewable at
OMB control number 0910–0078. The Please visit the following Web site for https://www.regulations.gov or at the
collections of information in 21 CFR information on the Natcher Conference Division of Dockets Management
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![95146 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices
between 9 a.m. and 4 p.m., Monday endovascular therapy in combination attending this public workshop must
through Friday. with pharmacotherapy (typically register by January 26, 2017, at 4 p.m.
• Confidential Submissions—To intravenous tissue plasminogen EST. Early registration is recommended
submit a comment with confidential activator (IV t-PA)) for patients with because seating is limited; therefore,
information that you do not wish to be proximal large vessel occlusion stroke FDA may limit the number of
made publicly available, submit your in the anterior circulation (M1 Middle participants from each organization.
comments only as a written/paper Cerebral Artery segment with or without Registrants will receive confirmation
submission. You should submit two concomitant Internal Carotid Artery when they have been accepted. You will
copies total. One copy will include the occlusion) (Refs. 2–6). FDA believes that be notified if you are on a waiting list.
information you claim to be confidential research and development in this field,
with a heading or cover note that states including the collection of data through If you need special accommodations
‘‘THIS DOCUMENT CONTAINS the use of registries, provides a potential due to a disability, please contact Peggy
CONFIDENTIAL INFORMATION.’’ FDA data source for expanding indications Roney, Center for Devices and
will review this copy, including the for already cleared/approved devices. Radiological Health, Office of
claimed confidential information, in its Development and leveraging support for Communication and Education, 301–
consideration of comments. The second data collected within appropriate 796–5671, email: Peggy.Roney@
copy, which will have the claimed registries; with the participation of fda.hhs.gov no later than January 19,
confidential information redacted/ professional medical societies, industry, 2017.
blacked out, will be available for public patient groups, healthcare facilities, and
IV. References
viewing and posted on https:// payers; can further drive innovation in
www.regulations.gov. Submit both this area and aid in the improvement of The following references are on
copies to the Division of Dockets clinical care and patient outcomes. A display in the Division of Dockets
Management. If you do not wish your coordinated registry network may also Management (see ADDRESSES) and are
name and contact information to be collect data reflective of clinical practice available for viewing by interested
made publicly available, you can that is of sufficient quality and breadth persons between 9 a.m. and 4 p.m.,
provide this information on the cover to support scientific, clinical, and Monday through Friday; they are also
sheet and not in the body of your regulatory decision-making and aid in
available electronically at https://
comments and you must identify this the design of future studies and
www.regulations.gov. FDA has verified
information as ‘‘confidential.’’ Any performance testing requirements for
information marked as ‘‘confidential’’ the Web site addresses, as of the date
new or existing devices.
will not be disclosed except in this document publishes in the Federal
II. Topics for Discussion at the Public Register, but Web sites are subject to
accordance with 21 CFR 10.20 and other
Workshop change over time.
applicable disclosure law. For more
information about FDA’s posting of This workshop is aimed at addressing 1. American Stroke Association, ‘‘Impact of
comments to public dockets, see 80 FR scientific, clinical, and regulatory Stroke (Stroke statistics)’’ (http://
56469, September 18, 2015, or access considerations associated with medical www.strokeassociation.org/
the information at: http://www.fda.gov/ devices used in the treatment of acute STROKEORG/AboutStroke/Impact-of-
regulatoryinformation/dockets/ ischemic stroke medical devices and the Stroke-Stroke-statistics_UCM_310728_
default.htm. development of coordinated registry Article.jsp#.VvFGChvruUk).
Docket: For access to the docket to networks to serve the following topic 2. Berkhemer, O. A., et al. ‘‘A Randomized
read background documents or the areas: Trial of Intraarterial Treatment for Acute
electronic and written/paper comments • Clinical Common Data Elements; Ischemic Stroke.’’ New England Journal
received, go to https:// • Standardized Definitions and Case of Medicine. 372, 11–20 (2015).
www.regulations.gov and insert the Report Forms; 3. Saver, J. L., et al. ‘‘Stent-Retriever
docket number, found in brackets in the • Informatics, Sustainability, and Thrombectomy After Intravenous t-PA
heading of this document, into the Data Quality; and Versus t-PA Alone in Stroke.’’ New
• Additional scientific, England Journal of Medicine. 372, 2285–
‘‘Search’’ box and follow the prompts
methodological, and clinical 2295 (2015).
and/or go to the Division of Dockets
considerations for evaluating 4. Goyal, M., et al. ‘‘Randomized Assessment
Management, 5630 Fishers Lane, Rm.
information obtained from registries. of Rapid Endovascular Treatment of
1061, Rockville, MD 20852.
III. Participating in the Public Ischemic Stroke.’’ New England Journal
FOR FURTHER INFORMATION CONTACT:
Workshop of Medicine. 372, 1019–1030 (2015).
Jamie Waterhouse, Center for Devices
5. Campbell, B. C., et al. ‘‘Endovascular
and Radiological Health, Food and Drug To register for the public workshop, Therapy for Ischemic Stroke with
Administration, 10903 New Hampshire please visit FDA’s Medical Devices Perfusion-Imaging Selection.’’ New
Ave., Bldg. 66, Rm. 2611, Silver Spring, News & Events—Workshops & England Journal of Medicine. 372, 1009–
MD 20993, 301–796–3063, email: Conferences (Medical Devices) calendar 1018 (2015).
Jamie.Waterhouse@fda.hhs.gov. at http://www.fda.gov/MedicalDevices/ 6. Jovin, T. G., et al. ‘‘Thrombectomy Within
SUPPLEMENTARY INFORMATION: NewsEvents/WorkshopsConferences/ 8 Hours After Symptom Onset in
default.htm. Persons interested in Ischemic Stroke.’’ New England Journal
I. Background
attending this public workshop must
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of Medicine. 372, 2296–2306 (2015).
Stroke is the fifth leading cause of register online by January 26, 2017, at 4
death in the United States and the p.m. EST. Please provide complete Dated: December 20, 2016.
number one preventable cause of contact information for each attendee, Leslie Kux,
disability (Ref. 1). Recent publication of including name, title, affiliation, Associate Commissioner for Policy.
five prospective randomized trials and address, email, and telephone. [FR Doc. 2016–31143 Filed 12–23–16; 8:45 am]
revised practice guidelines in the Registration is free and based on BILLING CODE 4164–01–P
treatment of stroke has suggested the space availability, with priority given to
potential therapeutic role of early registrants. Persons interested in
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Document Created: 2018-02-14 09:13:16
Document Modified: 2018-02-14 09:13:16
| 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 of public workshop; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 81 FR 95145 |
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