80 FR 39441 - Acute Ischemic Stroke Medical Devices Trials Workshop; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 131 (July 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 131 (July 9, 2015)
| Page Range | 39441-39442 | |
| FR Document | 2015-16774 |
[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)] [Notices] [Pages 39441-39442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16774] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Acute Ischemic Stroke Medical Devices Trials Workshop; 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 ``Acute Ischemic Stroke Medical Device Trials Workshop''. Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature by mechanical, laser, ultrasound, or a combination of technologies. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions. DATES: The public workshop will be held on October 6, 2015, from 1 p.m. to 5:30 p.m. Registration to attend the meeting must be received by September 25, 2015, at 4 p.m. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the public workshop. Submit either electronic or written comments by November 3, 2015. ADDRESSES: The public workshop will be held at the Bethesda Pooks Hill Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. Please visit the following Web site for parking and security information: http://www.marriott.com/hotels/maps/travel/wasbt-bethesda-marriott/. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 3625, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, [email protected]; or Jamie Waterhouse, Project Manager, Neurointerventional and Neurosurgical Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3063, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature. This may be achieved through a variety of mechanisms, such as mechanical, laser, ultrasound, or a combination of technologies. Acute ischemic stroke medical devices can present both important safety and effectiveness questions as well as study design and data analysis challenges. II. Purpose and Scope of the Public Workshop The workshop seeks to involve industry and academia in addressing scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. By bringing together relevant stakeholders, which include scientists, patient advocates, clinicians, researchers, industry representatives, and regulators, [[Page 39442]] to this workshop, we hope to facilitate the improvement of this rapidly evolving product area. This workshop is aimed to address scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices, including but not limited to, the following topic areas:Considerations for clinical study trial designs, patient populations, and patient selection methods, and Considerations for clinical study endpoints, e.g., clinically relevant outcome measures and related statistical analyses. III. Attendance and Registration Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 25, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 12 p.m. If you need special accommodations due to a disability, please contact Susan Monahan, email: [email protected] or phone: 301- 796-5661 no later than September 25, 2015. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. IV. Comments In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is November 3, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. V. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Dated: July 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16774 Filed 7-8-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices 39441
Information/Guidances/ Use Devices); and 820 (Quality System 5:30 p.m. Registration to attend the
UCM291390.pdf).3 Regulation) have been approved under meeting must be received by September
OMB control numbers 0910–0485, 25, 2015, at 4 p.m. See the
II. Significance of Guidance
0910–0437, 0910–0120, 0910–0078, SUPPLEMENTARY INFORMATION section for
This draft guidance is being issued 0910–0231, 0910–0332, and 0910–0073 instructions on how to register for the
consistent with FDA’s good guidance respectively. public workshop. Submit either
practices regulation (21 CFR 10.115). electronic or written comments by
The draft guidance, when finalized, will V. Comments
November 3, 2015.
represent the current thinking of FDA Interested persons may submit either ADDRESSES: The public workshop will
on labeling and safety testing electronic comments regarding this be held at the Bethesda Pooks Hill
requirements for heparin-containing document to http://www.regulations.gov Marriott, 5151 Pooks Hill Rd., Bethesda,
medical devices and combination or written comments to the Division of MD 20814. Please visit the following
products. It does not establish any rights Dockets Management (see ADDRESSES). It Web site for parking and security
for any person and is not binding on is only necessary to send one set of information: http://www.marriott.com/
FDA or the public. You can use an comments. Identify comments with the hotels/maps/travel/wasbt-bethesda-
alternative approach if it satisfies the docket number found in brackets in the marriott/.
requirements of the applicable statute heading of this document. Received Submit electronic comments to
and regulations. comments may be seen in the Division http://www.regulations.gov. Submit
III. Electronic Access of Dockets Management between 9 a.m. written comments to the Division of
and 4 p.m., Monday through Friday, and Dockets Management (HFA–305), Food
Persons interested in obtaining a copy will be posted to the docket at http://
of the draft guidance may do so by and Drug Administration, 5630 Fishers
www.regulations.gov. Lane, Rm. 1061, Rockville, MD 20852.
downloading an electronic copy from
the Internet. A search capability for all Dated: July 2, 2015. All comments should be identified with
Center for Device and Radiological Leslie Kux, the docket number found in brackets in
Health guidance documents is available Associate Commissioner for Policy. the heading of this document.
at http://www.fda.gov/MedicalDevices/ [FR Doc. 2015–16775 Filed 7–8–15; 8:45 am] FOR FURTHER INFORMATION CONTACT:
DeviceRegulationandGuidance/ BILLING CODE 4164–01–P
Hilda Scharen, Center for Devices and
GuidanceDocuments/default.htm. Radiological Health, Food and Drug
Guidance documents are also available Administration, Bldg. 66, Rm. 3625,
at http://www.regulations.gov. Persons DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave., Silver
unable to download an electronic copy HUMAN SERVICES Spring, MD 20993, 301–796–6815,
of ‘‘Heparin-Containing Medical Devices Hilda.Scharen@fda.hhs.gov; or Jamie
and Combination Products: Food and Drug Administration Waterhouse, Project Manager,
Recommendations for Labeling and [Docket No. FDA–2015–N–0001]
Neurointerventional and Neurosurgical
Safety Testing’’ may send an email Devices Branch, Division of
request to CDRH-Guidance@fda.hhs.gov Acute Ischemic Stroke Medical Neurological and Physical Medicine
to receive an electronic copy of the Devices Trials Workshop; Public Devices, Center for Devices and
document. Please use the document Workshop; Request for Comments Radiological Health, Food and Drug
number 1817 to identify the guidance Administration, 10903 New Hampshire
you are requesting. AGENCY: Food and Drug Administration, Ave., Silver Spring, MD 20993, 301–
HHS. 796–3063, Jamie.Waterhouse@
IV. Paperwork Reduction Act of 1995 ACTION: Notice of public workshop; fda.hhs.gov.
This draft guidance refers to currently request for comments. SUPPLEMENTARY INFORMATION:
approved collections of information
found in FDA regulations. These SUMMARY: The Food and Drug I. Background
collections of information are subject to Administration (FDA) is announcing the
Acute ischemic stroke medical
review by the Office of Management and following public workshop entitled
devices are intended to remove blood
Budget (OMB) under the Paperwork ‘‘Acute Ischemic Stroke Medical Device
clots from the cerebral
Reduction Act of 1995 (44 U.S.C. 3501– Trials Workshop’’. Acute ischemic
neurovasculature. This may be achieved
3520). The collections of information in stroke medical devices are intended to
through a variety of mechanisms, such
21 CFR part 211 (Current Good remove blood clots from the cerebral
as mechanical, laser, ultrasound, or a
Manufacturing Practice for Finished neurovasculature by mechanical, laser,
combination of technologies. Acute
Pharmaceuticals) have been approved ultrasound, or a combination of
ischemic stroke medical devices can
under OMB control number 0910–0139. technologies. The purpose of this
present both important safety and
The collections of information in FDA’s workshop is to obtain public input and
effectiveness questions as well as study
medical devices regulations in 21 CFR feedback on scientific, clinical, and
design and data analysis challenges.
parts 801 (Labeling); 803 (Medical regulatory considerations associated
Device Reporting); 807, subpart E with acute ischemic stroke medical II. Purpose and Scope of the Public
(Premarket Notification Procedures); devices. Ideas generated during this Workshop
812 (Investigational Device workshop may facilitate further The workshop seeks to involve
Exemptions); 814, subparts A through E development of guidance regarding the industry and academia in addressing
srobinson on DSK5SPTVN1PROD with NOTICES
(Premarket Approval of Medical content of premarket submissions for scientific, clinical, and regulatory
Devices); 814, subpart H (Humanitarian acute ischemic stroke emerging considerations associated with acute
technologies and help to speed ischemic stroke medical devices. By
3 The Agency updates guidances periodically. To development and approval of future bringing together relevant stakeholders,
make sure you have the most recent version of this submissions. which include scientists, patient
guidance, check the CDER guidance page at http://
www.fda.gov/Drugs/GuidanceCompliance DATES: The public workshop will be advocates, clinicians, researchers,
RegulatoryInformation/Guidances/default.htm. held on October 6, 2015, from 1 p.m. to industry representatives, and regulators,
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![39442 Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices
to this workshop, we hope to facilitate Identify comments with the docket the public during the review and
the improvement of this rapidly number found in brackets in the approval period.
evolving product area. heading of this document. In addition, DATES: Comments on this ICR should be
This workshop is aimed to address when responding to specific questions received no later than August 10, 2015.
scientific, clinical, and regulatory as outlined in section II of this
considerations associated with acute ADDRESSES: Submit your comments,
document, please identify the question
ischemic stroke medical devices, you are addressing. Received comments including the Information Collection
including but not limited to, the may be seen in the Division of Dockets Request Title, to the desk officer for
following topic areas: Management between 9 a.m. and 4 p.m., HRSA, either by email to OIRA_
• Considerations for clinical study Monday through Friday, and will be submission@omb.eop.gov or by fax to
trial designs, patient populations, and posted to the docket at http:// 202–395–5806.
patient selection methods, and www.regulations.gov. FOR FURTHER INFORMATION CONTACT: To
• Considerations for clinical study request a copy of the clearance requests
endpoints, e.g., clinically relevant V. Transcripts submitted to OMB for review, email the
outcome measures and related statistical Please be advised that as soon as a HRSA Information Collection Clearance
analyses. transcript is available, it will be Officer at paperwork@hrsa.gov or call
III. Attendance and Registration accessible at http:// (301) 594–4306.
www.regulations.gov. It may also be SUPPLEMENTARY INFORMATION:
Registration is free and available on a
viewed at the Division of Dockets Information Collection Request Title:
first-come, first-served basis. Persons
Management (see ADDRESSES). A Maternal, Infant, and Early Childhood
interested in attending this public
transcript will be available in either Home Visiting (Home Visiting) Program,
workshop must register online by
hardcopy or on CD–ROM, after Competitive Funding Opportunity
September 25, 2015, at 4 p.m. Early
submission of a Freedom of Information Announcement OMB No. 0915–0351—
registration is recommended because
request. Written requests are to be sent Extension.
facilities are limited and, therefore, FDA
to the Division of Freedom of Abstract: The Home Visiting Program,
may limit the number of participants
Information (ELEM–1029), Food and administered by the Health Resources
from each organization. If time and
Drug Administration, 12420 Parklawn and Services Administration (HRSA) in
space permits, onsite registration on the
Dr., Element Bldg., Rockville, MD close partnership with the
day of the public workshop will be
20857. A link to the transcripts will be Administration for Children and
provided beginning at 12 p.m.
If you need special accommodations available approximately 45 days after Families (ACF), supports voluntary,
due to a disability, please contact Susan the public workshop on the Internet at evidence-based home visiting services
Monahan, email: susan.monahan@ http://www.fda.gov/MedicalDevices/ during pregnancy and to parents with
fda.hhs.gov or phone: 301–796–5661 no NewsEvents/WorkshopsConferences/ young children up to kindergarten
later than September 25, 2015. default.htm. (Select this public entry. The 50 states, District of
To register for the public workshop, workshop from the posted events list). Columbia, and 5 territories and eligible
please visit FDA’s Medical Devices Dated: July 2, 2015. nonprofit organizations are eligible for
News & Events—Workshops & Leslie Kux, Home Visiting Competitive Funding.
Conferences calendar at http:// Associate Commissioner for Policy. Need and Proposed Use of the
www.fda.gov/MedicalDevices/ [FR Doc. 2015–16774 Filed 7–8–15; 8:45 am] Information: The purpose of this
NewsEvents/WorkshopsConferences/ BILLING CODE 4164–01–P announcement is to solicit Fiscal Year
default.htm. (Select this meeting/public 2016 (FY16) applications for the Home
workshop from the posted events list.) Visiting Competitive Grant program.
Please provide complete contact DEPARTMENT OF HEALTH AND Competitive Grants provide funds to
information for each attendee, including HUMAN SERVICES eligible entities that are states and
name, title, affiliation, email, and certain territories that continue to make
telephone number. Those without Health Resources and Services significant progress toward
Internet access should contact Susan Administration implementing a high-quality home
Monahan to register. Registrants will visiting program as part of a
receive confirmation after they have Agency Information Collection comprehensive, high-quality early
been accepted. You will be notified if Activities: Submission to OMB for childhood system and are ready and
you are on a waiting list. Review and Approval; Public Comment able to take effective programs to scale
Request to address unmet need. This
IV. Comments
information collection is needed for
In order to permit the widest possible AGENCY:Health Resources and Services
eligible entities to apply for competitive
opportunity to obtain public comment, Administration, HHS.
funding opportunities under the
FDA is soliciting either electronic or ACTION: Notice. MIECHV. As noted above, this program
written comments on all aspects of the is authorized under the Social Security
public workshop topics. The deadline SUMMARY: In compliance with Section Act, Title V, Section 511 (42 U.S.C.
for submitting comments related to this 3507(a)(1)(D) of the Paperwork 701), as amended by Section 2951 of the
public workshop is November 3, 2015. Reduction Act of 1995, the Health Patient Protection and Affordable Care
Regardless of attendance at the public Resources and Services Administration
srobinson on DSK5SPTVN1PROD with NOTICES
Act of 2010 (Pub. L. 111–148). A portion
workshop, interested persons may (HRSA) has submitted an Information of funding under this program is
submit either electronic comments Collection Request (ICR) to the Office of awarded to participating states and
regarding this document to http:// Management and Budget (OMB) for eligible jurisdictions 1 by formula.
www.regulations.gov or written review and approval. Comments
comments to the Division of Dockets submitted during the first public review 1 The 50 states, the U.S. Virgin Islands, Puerto
Management (see ADDRESSES). It is only of this ICR will be provided to OMB. Rico, American Samoa, the Northern Marianas,
necessary to send one set of comments. OMB will accept further comments from District of Columbia, and Guam.
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Document Created: 2018-02-23 09:14:23
Document Modified: 2018-02-23 09:14:23
| 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 October 6, 2015, from 1 p.m. to 5:30 p.m. Registration to attend the meeting must be received by September 25, 2015, at 4 p.m. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the public workshop. Submit either electronic or written comments by November 3, 2015. | |
| Contact | Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 3625, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, [email protected]; or Jamie Waterhouse, Project Manager, Neurointerventional and Neurosurgical Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3063, [email protected] | |
| FR Citation | 80 FR 39441 |
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