82 FR 61574 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 248 (December 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 248 (December 28, 2017)
| Page Range | 61574-61575 | |
| FR Document | 2017-27974 |
[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)] [Notices] [Pages 61574-61575] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27974] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6888] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on March 1, 2018, from 8 a.m. to 6 p.m. ADDRESSES: Hilton Washington, DC North/Gaithersburg, 620 Perry Pkwy., Salons A, B, C, and D, Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On March 1, 2018, the committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 19, 2018. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 12, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 16, 2018. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at [email protected] or 301-796- 5966 at least 7 days in advance of the meeting. [[Page 61575]] FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27974 Filed 12-27-17; 8:45 am] BILLING CODE 4164-01-P
![61574 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices
dialing 888–946–7207, passcode: DEPARTMENT OF HEALTH AND effectiveness of intracranial aneurysm
5023213. A total of 200 lines will be HUMAN SERVICES treatment devices and factors that can
available. To register for this call, please affect clinical outcomes such as
go to www.cdc.gov/hicpac. Food and Drug Administration aneurysm morphology, size, and
[Docket No. FDA–2017–N–6888] location in the neurovasculature. FDA is
DATES: The meeting will be held on also convening this committee to seek
February 15, 2018, 12:00 p.m. to 2:00 Neurological Devices Panel of the expert opinion on the scientific and
p.m., EST. Medical Devices Advisory Committee; clinical considerations relating to the
ADDRESSES:Teleconference Number: Notice of Meeting clinical trial design that may be relevant
888–946–7207, passcode: 5023213 to the determination of safety and
AGENCY: Food and Drug Administration, effectiveness for these devices.
FOR FURTHER INFORMATION CONTACT: Erin HHS. FDA intends to make background
Stone, M.A., HICPAC, Division of ACTION: Notice. material available to the public no later
Healthcare Quality Promotion, NCEZID, than 2 business days before the meeting.
SUMMARY: The Food and Drug If FDA is unable to post the background
CDC, 1600 Clifton Road NE, Mailstop
Administration (FDA) announces a material on its website prior to the
A–31, Atlanta, Georgia 30333; Email: forthcoming public advisory committee
HICPAC@cdc.gov. meeting, the background material will
meeting of the Neurological Devices be made publicly available at the
SUPPLEMENTARY INFORMATION: Panel of the Medical Devices Advisory location of the advisory committee
Purpose: The Committee is charged Committee. The general function of the meeting, and the background material
committee is to provide advice and will be posted on FDA’s website after
with providing advice and guidance to
recommendations to the Agency on the meeting. Background material is
the Director, Division of Healthcare
FDA’s regulatory issues. The meeting available at https://www.fda.gov/
Quality Promotion (DHQP), the Director, will be open to the public.
National Center for Emerging and AdvisoryCommittees/Calendar/
DATES: The meeting will be held on default.htm. Scroll down to the
Zoonotic Infectious Diseases (NCEZID),
March 1, 2018, from 8 a.m. to 6 p.m. appropriate advisory committee meeting
the Director, CDC, the Secretary, Health
ADDRESSES: Hilton Washington, DC link.
and Human Services regarding (1) the
North/Gaithersburg, 620 Perry Pkwy., Procedure: Interested persons may
practice of healthcare infection present data, information, or views,
Salons A, B, C, and D, Gaithersburg, MD
prevention and control; (2) strategies for 20877. The hotel’s telephone number is orally or in writing, on issues pending
surveillance, prevention, and control of 301–977–8900. Answers to commonly before the committee. Written
infections, antimicrobial resistance, and asked questions including information submissions may be made to the contact
related events in settings where regarding special accommodations due person on or before January 19, 2018.
healthcare is provided; and (3) periodic to a disability, visitor parking, and Oral presentations from the public will
updating of CDC guidelines and other transportation may be accessed at: be scheduled between approximately 1
policy statements regarding prevention https://www.fda.gov/Advisory p.m. and 2 p.m. Those individuals
of healthcare-associated infections and Committees/AboutAdvisoryCommittees/ interested in making formal oral
healthcare-related conditions. ucm408555.htm. presentations should notify the contact
Matters To Be Considered: The agenda person and submit a brief statement of
FOR FURTHER INFORMATION CONTACT:
will include discussions from the the general nature of the evidence or
Aden Asefa, Center for Devices and
arguments they wish to present, the
recommendation categorization update Radiological Health, Food and Drug
names and addresses of proposed
workgroup, the guidelines for infection Administration, 10903 New Hampshire
participants, and an indication of the
prevention in healthcare personnel Ave., Bldg. 66, Rm. G642, Silver Spring,
approximate time requested to make
workgroup, and the guidelines for MD 20993–0002, Aden.Asefa@
their presentation on or before January
infection prevention in patients of fda.hhs.gov, 301–796–0400, or FDA 12, 2018. Time allotted for each
neonatal intensive care units Advisory Committee Information Line, presentation may be limited. If the
workgroup. Agenda items are subject to 1–800–741–8138 (301–443–0572 in the number of registrants requesting to
change as priorities dictate. Washington, DC area). A notice in the speak is greater than can be reasonably
Federal Register about last minute accommodated during the scheduled
The Director, Management Analysis modifications that impact a previously
and Services Office, has been delegated open public hearing session, FDA may
announced advisory committee meeting conduct a lottery to determine the
the authority to sign Federal Register cannot always be published quickly
notices pertaining to announcements of speakers for the scheduled open public
enough to provide timely notice. hearing session. The contact person will
meetings and other committee Therefore, you should always check the
management activities, for both the notify interested persons regarding their
Agency’s website at https:// request to speak by January 16, 2018.
Centers for Disease Control and www.fda.gov/AdvisoryCommittees/ Persons attending FDA’s advisory
Prevention and the Agency for Toxic default.htm and scroll down to the committee meetings are advised that the
Substances and Disease Registry. appropriate advisory committee meeting Agency is not responsible for providing
link, or call the advisory committee access to electrical outlets.
Claudette Grant,
information line to learn about possible FDA welcomes the attendance of the
Acting Director, Management Analysis and modifications before coming to the public at its advisory committee
sradovich on DSK3GMQ082PROD with NOTICES
Services Office, Centers for Disease Control
meeting. meetings and will make every effort to
and Prevention.
[FR Doc. 2017–28072 Filed 12–27–17; 8:45 am] SUPPLEMENTARY INFORMATION: accommodate persons with disabilities.
Agenda: On March 1, 2018, the If you require accommodations due to a
BILLING CODE 4163–19–P
committee will discuss, make disability, please contact AnnMarie
recommendations, and advise FDA Williams at Annmarie.Williams@
regarding the evaluation of clinical fda.hhs.gov or 301–796–5966 at least 7
study data to support the safety and days in advance of the meeting.
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![Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices 61575
FDA is committed to the orderly instructions for submitting comments. second copy, which will have the
conduct of its advisory committee Comments submitted electronically, claimed confidential information
meetings. Please visit our website at including attachments, to https:// redacted/blacked out, will be available
https://www.fda.gov/Advisory www.regulations.gov will be posted to for public viewing and posted on
Committees/AboutAdvisoryCommittees/ the docket unchanged. Because your https://www.regulations.gov. Submit
ucm111462.htm for procedures on comment will be made public, you are both copies to the Dockets Management
public conduct during advisory solely responsible for ensuring that your Staff. If you do not wish your name and
committee meetings. comment does not include any contact information to be made publicly
Notice of this meeting is given under confidential information that you or a available, you can provide this
the Federal Advisory Committee Act (5 third party may not wish to be posted, information on the cover sheet and not
U.S.C. app. 2). such as medical information, your or in the body of your comments and you
Dated: December 21, 2017. anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux,
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2017–27974 Filed 12–27–17; 8:45 am] information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2017–N–6778] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Fostering Medical Innovation: Case for Submissions’’ and ‘‘Instructions’’). received, go to https://
Quality Voluntary Medical Device www.regulations.gov and insert the
Manufacturing and Product Quality Written/Paper Submissions
docket number, found in brackets in the
Pilot Program Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
HHS. and/or go to the Dockets Management
written/paper submissions): Dockets
ACTION: Notice. Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT:
Lane, Rm. 1061, Rockville, MD 20852.
Administration’s (FDA or Agency or we) • For written/paper comments Francisco Vicenty, Center for Devices
Center for Devices and Radiological submitted to the Dockets Management and Radiological Health, Food and Drug
Health (CDRH or Center) is announcing Staff, FDA will post your comment, as Administration, 10903 New Hampshire
its Case for Quality Voluntary Medical well as any attachments, except for Ave., Bldg. 66, Rm. 3426, Silver Spring,
Device Manufacturing and Product information submitted, marked and MD 20993, 301–796–5577,
Quality Pilot Program (CfQ Pilot identified, as confidential, if submitted Francisco.vicenty@fda.hhs.gov.
Program). The CfQ Pilot Program is as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
voluntary and intends to evaluate Instructions: All submissions received
product and manufacturing quality I. Background
must include the Docket No. FDA–
within the medical device ecosystem. 2017–N–6778 for ‘‘Case for Quality As part of CDRH’s 2016–2017
The CfQ Pilot Program also intends to Voluntary Medical Device strategic priority to ‘‘Promote a Culture
explore the effectiveness of a quality Manufacturing and Product Quality of Quality and Organizational
maturity appraisal, the use of objective Program.’’ Received comments will be Excellence’’ (Ref. 1), CDRH envisions a
metrics, optimization of resources, and placed in the docket and, except for future state where the medical device
impact on quality culture. The pilot those submitted as ‘‘Confidential ecosystem is inherently focused on
program seeks to demonstrate better Submissions,’’ publicly viewable at device features and manufacturing
patient safety and outcomes, a lower https://www.regulations.gov or at the practices that have the greatest impact
regulatory burden on demonstrating Dockets Management Staff between 9 on product quality and patient safety.
quality assurance, and assure safety and a.m. and 4 p.m., Monday through Historically, FDA has evaluated
effectiveness during product Friday. manufacturers’ compliance with
development and manufacturing. • Confidential Submissions—To regulations governing the design and
DATES: The CfQ Pilot Program will run submit a comment with confidential production of devices. Compliance with
from January 2, 2018, to December 28, information that you do not wish to be the Quality System regulation, 21 CFR
2018. See the ‘‘Participation’’ section for made publicly available, submit your part 820, (Ref. 2) is a baseline
instructions on how to submit a request comments only as a written/paper requirement for medical device
to participate. submission. You should submit two manufacturing firms. Focusing on
copies total. One copy will include the elevating manufacturing quality
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit comments
as follows: information you claim to be confidential practices gives greater emphasis to these
with a heading or cover note that states practices, which should correlate to
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS higher quality outcomes. This allows
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The FDA to adjust how we recognize and
following way: Agency will review this copy, including incentivize behaviors and processes
• Federal eRulemaking Portal: the claimed confidential information, in through which the safety and
https://www.regulations.gov. Follow the its consideration of comments. The effectiveness of a medical device is
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Document Created: 2017-12-28 00:43:24
Document Modified: 2017-12-28 00:43:24
| 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. | |
| Dates | The meeting will be held on March 1, 2018, from 8 a.m. to 6 p.m. | |
| Contact | Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 61574 |
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