Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments, 95145-95146 [2016-31143]

Download as PDF Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. asabaliauskas on DSK3SPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500065 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 7, subpart C, have been approved under OMB control number 0910–0249. The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910–0485. The collections of information in 21 CFR part 803, regarding medical device reporting, have been approved under OMB control numbers 0910–0291, 0910–0437, and 0910–0471. The collections of information in 21 CFR part 806 have been approved under OMB control number 0910–0359. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120. The collections of information in 21 CFR part 810, regarding medical device recall authority, have been approved under OMB control number 0910–0432. The collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078. The collections of information in 21 CFR VerDate Sep<11>2014 20:45 Dec 23, 2016 Jkt 241001 part 814, subparts B and E, have been approved under OMB control number 0910–0231. The collections of information in 21 CFR part 820, regarding the Quality System regulation, have been approved under OMB control number 0910–0073. The collections of information in 21 CFR part 822, regarding postmarket surveillance of medical devices, have been approved under OMB control number 0910–0449. Dated: December 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31145 Filed 12–23–16; 8:45 am] BILLING CODE 4164–01–P 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. Notice of public workshop; request for comments. ACTION: 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: https:// www.nih.gov/about/visitor/index.htm. Please visit the following Web site for information on the Natcher Conference SUMMARY: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 95145 Center: https://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 E:\FR\FM\27DEN1.SGM 27DEN1 95146 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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: https://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: Jamie.Waterhouse@fda.hhs.gov. 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 VerDate Sep<11>2014 20:45 Dec 23, 2016 Jkt 241001 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 https://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 PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 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: Peggy.Roney@ fda.hhs.gov 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)’’ (https:// www.strokeassociation.org/ STROKEORG/AboutStroke/Impact-ofStroke-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 E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[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]


-----------------------------------------------------------------------

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: https://www.nih.gov/about/visitor/index.htm. Please 
visit the following Web site for information on the Natcher Conference 
Center: https://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: 
https://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: Jamie.Waterhouse@fda.hhs.gov.

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 https://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: 
Peggy.Roney@fda.hhs.gov 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)'' (https://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

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