83 FR 42126 - Neurological Devices Panel Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 161 (August 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 161 (August 20, 2018)
| Page Range | 42126-42127 | |
| FR Document | 2018-17867 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Notices] [Pages 42126-42127] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17867] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2946] Neurological Devices Panel Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) announces a forthcoming public Advisory Committee meeting of the Neurological Devices Panel (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 September 27, 2018, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone number is 301- 977-8900 and website is: http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html. 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 [[Page 42127]] Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, Aden.Asefa@fda.hhs.gov, 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 September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT): a multicenter, prospective, non-randomized investigation. The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use. 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 September 20, 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 September 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 September 13, 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 Artair Mallett at Artair.Mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting. 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: August 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17867 Filed 8-17-18; 8:45 am] BILLING CODE 4164-01-P
![42126 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
contact information be made publicly following topics without vote by the (See FOR FURTHER INFORMATION CONTACT)
available, you can provide this committee: at least 7 days in advance of the
information on the cover sheet and not • Overview of the FDA Adverse Event meeting.
in the body of your comments and you Reporting System and lack of efficacy; FDA is committed to the orderly
must identify the information as • Generic drug approval process; and conduct of its advisory committee
‘‘confidential.’’ Any information marked discussion on trade versus generic meetings. Please visit our website at
as ‘‘confidential’’ will not be disclosed drugs; exceptions; https://www.fda.gov/Advisory
except in accordance with 21 CFR 10.20 • Summary of FDA completed review Committees/AboutAdvisoryCommittees/
and other applicable disclosure law. For of pediatric safety issues and updated ucm111462.htm for procedures on
more information about FDA’s posting labeling changes for EXJADE public conduct during advisory
of comments to public dockets, see 80 (deferasirox); committee meetings.
FR 56469, September 18, 2015, or access • Update labeling change for inhaled Notice of this meeting is given under
the information at: https://www.gpo.gov/ corticosteroid long-acting b-2 agonists; the Federal Advisory Committee Act (5
• Safety labeling for gadolinium.
fdsys/pkg/FR-2015-09-18/pdf/2015- FDA intends to make background U.S.C. app. 2).
23389.pdf. material available to the public no later Dated: August 14, 2018.
Docket: For access to the docket to than 2 business days before the meeting. Leslie Kux,
read background documents or the If FDA is unable to post the background Associate Commissioner for Policy.
electronic and written/paper comments material on its website prior to the [FR Doc. 2018–17857 Filed 8–17–18; 8:45 am]
received, go to https:// meeting, the background material will BILLING CODE 4164–01–P
www.regulations.gov and insert the be made publicly available at the
docket number, found in brackets in the location of the advisory committee
heading of this document, into the meeting, and the background material DEPARTMENT OF HEALTH AND
‘‘Search’’ box and follow the prompts will be posted on FDA’s website after HUMAN SERVICES
and/or go to the Dockets Management the meeting. Background material is
Staff, 5630 Fishers Lane, Rm. 1061, available at https://www.fda.gov/ Food and Drug Administration
Rockville, MD 20852. AdvisoryCommittees/Calendar/ [Docket No. FDA–2018–N–2946]
FOR FURTHER INFORMATION CONTACT: default.htm. Scroll down to the
Marieann Brill, Office of the appropriate advisory committee meeting Neurological Devices Panel Advisory
Commissioner, Food and Drug link. Committee; Notice of Meeting
Administration, 10903 New Hampshire Procedure: Interested persons may
Ave., Bldg. 32, Rm. 5154, Silver Spring, present data, information, or views, AGENCY: Food and Drug Administration,
MD 20993, 240–402–3838, email: orally or in writing, on issues pending HHS.
marieann.brill@fda.hhs.gov, or FDA before the committee. Written ACTION: Notice.
Advisory Committee Information Line, submissions may be made to the contact
1–800–741–8138 (301–443–0572 in the person on or before September 13, 2018. SUMMARY: The Food and Drug
Washington, DC area). A notice in the Oral presentations from the public will Administration (FDA or Agency)
Federal Register about last minute be scheduled between approximately 9 announces a forthcoming public
modifications that impact a previously a.m. and 10 a.m. Those individuals Advisory Committee meeting of the
announced advisory committee meeting interested in making formal oral Neurological Devices Panel
cannot always be published quickly presentations should notify the contact (Committee). The general function of the
enough to provide timely notice. person and submit a brief statement of Committee is to provide advice and
Therefore, you should always check the the general nature of the evidence or recommendations to the Agency on
Agency’s website at https:// arguments they wish to present, the FDA’s regulatory issues. The meeting
www.fda.gov/AdvisoryCommittees/ names and addresses of proposed will be open to the public.
default.htm and scroll down to the participants, and an indication of the DATES: The meeting will be held on
appropriate advisory committee meeting approximate time requested to make September 27, 2018, from 8 a.m. to 5
link, or call the advisory committee their presentation on or before p.m.
information line to learn about possible September 5, 2018. Time allotted for ADDRESSES: Hilton Washington, DC/
modifications before coming to the each presentation may be limited. If the North, Salons A, B, C, and D, 620 Perry
meeting. number of registrants requesting to Pkwy., Gaithersburg, MD 20877. The
speak is greater than can be reasonably hotel’s phone number is 301–977–8900
SUPPLEMENTARY INFORMATION:
accommodated during the scheduled and website is: http://www3.hilton.com/
Agenda: On Thursday, September 20, open public hearing session, FDA may
2018, the PAC will meet to discuss en/hotels/maryland/hilton-washington-
conduct a lottery to determine the dc-north-gaithersburg-GAIGHHF/
pediatric-focused safety reviews, as speakers for the scheduled open public
mandated by the Best Pharmaceuticals index.html. Answers to commonly
hearing session. The contact person will asked questions including information
for Children Act (Pub. L. 107–109) and notify interested persons regarding their
the Pediatric Research Equity Act of regarding special accommodations due
request to speak by September 6, 2018. to a disability, visitor parking, and
2003 (Pub. L. 108–155). Comments Persons attending FDA’s advisory
about the upcoming advisory committee transportation may be accessed at:
committee meetings are advised that
meeting should be submitted to Docket https://www.fda.gov/
FDA is not responsible for providing
daltland on DSKBBV9HB2PROD with NOTICES
No. FDA–2018–N–3000. AdvisoryCommittees/
access to electrical outlets.
The PAC will meet to discuss the FDA welcomes the attendance of the AboutAdvisoryCommittees/
following Center for Drug Evaluation public at its advisory committee ucm408555.htm.
and Research products: INTUNIV and meetings and will make every effort to FOR FURTHER INFORMATION CONTACT:
LEXAPRO. accommodate persons with disabilities. Aden Asefa, Center for Devices and
The FDA will provide general safety If you require accommodations due to a Radiological Health, Food and Drug
updates including updates on the disability, please contact Marieann Brill Administration, 10903 New Hampshire
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![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42127
Ave., Bldg. 66, Rm. G642, Silver Spring, the general nature of the evidence or comment on the proposed collection of
MD 20993–0002, Aden.Asefa@ arguments they wish to present, the certain information by the Agency.
fda.hhs.gov, 301–796–0400, or FDA names and addresses of proposed Under the Paperwork Reduction Act of
Advisory Committee Information Line, participants, and an indication of the 1995 (PRA), Federal Agencies are
1–800–741–8138 (301–443–0572 in the approximate time requested to make required to publish notice in the
Washington, DC area). A notice in the their presentation on or before Federal Register concerning each
Federal Register about last minute September 12, 2018. Time allotted for proposed collection of information,
modifications that impact a previously each presentation may be limited. If the including each proposed extension of an
announced Advisory Committee number of registrants requesting to existing collection of information, and
meeting cannot always be published speak is greater than can be reasonably to allow 60 days for public comment in
quickly enough to provide timely accommodated during the scheduled response to the notice. This notice
notice. Therefore, you should always open public hearing session, FDA may solicits comments on the process for
check the Agency’s website at https:// conduct a lottery to determine the formally resolving scientific and
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public procedural disputes in the Center for
default.htm and scroll down to the hearing session. The contact person will Drug Evaluation and Research (CDER)
appropriate advisory committee meeting notify interested persons regarding their and the Center for Biologics Evaluation
link, or call the advisory committee request to speak by September 13, 2018. and Research (CBER) that cannot be
information line to learn about possible Persons attending FDA’s advisory resolved at the division level.
modifications before coming to the committee meetings are advised that the DATES: Submit either electronic or
meeting. Agency is not responsible for providing written comments on the collection of
SUPPLEMENTARY INFORMATION: access to electrical outlets. information by October 19, 2018.
Agenda: On September 27, 2018, the FDA welcomes the attendance of the ADDRESSES: You may submit comments
Committee will discuss, make public at its advisory committee as follows. Please note that late,
recommendations, and vote on the meetings and will make every effort to untimely filed comments will not be
premarket approval application accommodate persons with disabilities. considered. Electronic comments must
sponsored by Sequent Medical, Inc. for If you require accommodations due to a be submitted on or before October 19,
the Woven Endobridge (WEB) disability, please contact Artair Mallett 2018. The https://www.regulations.gov
Aneurysm Embolization System, which at Artair.Mallett@fda.hhs.gov or 301– electronic filing system will accept
is intended to treat wide-neck 796–9638 at least 7 days in advance of comments until midnight Eastern Time
intracranial aneurysms arising or the meeting. at the end of October 19, 2018.
located at a vessel bifurcation. The WEB FDA is committed to the orderly Comments received by mail/hand
device is being evaluated in the WEB conduct of its advisory committee delivery/courier (for written/paper
Intrasaccular Therapy Study (WEB–IT): meetings. Please visit our website at submissions) will be considered timely
a multicenter, prospective, non- https://www.fda.gov/Advisory if they are postmarked or the delivery
randomized investigation. The Committees/AboutAdvisoryCommittees/ service acceptance receipt is on or
Committee will be asked to review the ucm111462.htm for procedures on before that date.
clinical data from the WEB–IT study to public conduct during advisory
help the Agency assess the safety and committee meetings. Electronic Submissions
effectiveness of the device for the Notice of this meeting is given under Submit electronic comments in the
proposed indications for use. the Federal Advisory Committee Act (5 following way:
FDA intends to make background U.S.C. app. 2). • Federal eRulemaking Portal:
material available to the public no later Dated: August 14, 2018. https://www.regulations.gov. Follow the
than 2 business days before the meeting. Leslie Kux, instructions for submitting comments.
If FDA is unable to post the background Associate Commissioner for Policy. Comments submitted electronically,
material on its website prior to the [FR Doc. 2018–17867 Filed 8–17–18; 8:45 am]
including attachments, to https://
meeting, the background material will www.regulations.gov will be posted to
BILLING CODE 4164–01–P
be made publicly available at the the docket unchanged. Because your
location of the advisory committee comment will be made public, you are
meeting, and the background material DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
will be posted on FDA’s website after HUMAN SERVICES comment does not include any
the meeting. Background material is confidential information that you or a
available at https://www.fda.gov/ Food and Drug Administration third party may not wish to be posted,
AdvisoryCommittees/Calendar/ such as medical information, your or
default.htm. Scroll down to the [Docket No. FDA–2012–N–0248] anyone else’s Social Security number, or
appropriate Advisory Committee confidential business information, such
Agency Information Collection
meeting link. as a manufacturing process. Please note
Activities; Proposed Collection;
Procedure: Interested persons may that if you include your name, contact
Comment Request; Guidance for
present data, information, or views, information, or other information that
Industry on Formal Dispute
orally or in writing, on issues pending identifies you in the body of your
Resolution; Appeals Above the
before the committee. Written comments, that information will be
Division Level
submissions may be made to the contact posted on https://www.regulations.gov.
daltland on DSKBBV9HB2PROD with NOTICES
person on or before September 20, 2018. AGENCY: Food and Drug Administration, • If you want to submit a comment
Oral presentations from the public will HHS. with confidential information that you
be scheduled between approximately 1 ACTION: Notice. do not wish to be made available to the
p.m. and 2 p.m. Those individuals public, submit the comment as a
interested in making formal oral SUMMARY: The Food and Drug written/paper submission and in the
presentations should notify the contact Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper
person and submit a brief statement of announcing an opportunity for public Submissions’’ and ‘‘Instructions’’).
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Document Created: 2018-08-18 01:28:27
Document Modified: 2018-08-18 01:28:27
| 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 September 27, 2018, from 8 a.m. to 5 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 | 83 FR 42126 |
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