Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 6188 [2018-02766]

Download as PDF 6188 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, Switzer Building, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–02869 Filed 2–12–18; 8:45 am] BILLING CODE 4184–23–P 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; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of December 28, 2017. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes. sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 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, 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) code NE. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 2017, 82 FR 61574, FDA announced that a meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on March 1, 2018, from 8 a.m. to 6 p.m. On page 61574, in the 3rd column, the Procedure portion of the document is changed to read as follows: Procedure: FDA will work with affected industry organizations that have an interest in intracranial aneurysm treatment devices and who wish to make a presentation separate from the general Open Public Hearing; time slots on March 1, 2018, between approximately 9:40 a.m. and 11 a.m. Representatives from industry organizations interested in making formal presentations to the committee should notify the contact person on or before February 16, 2018. 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 February 16, 2018. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. 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 February 9, 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 February 12, 2018. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Dated: February 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02766 Filed 2–12–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0235] Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; 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, the Agency, or we) is announcing the following public workshop entitled ‘‘Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.’’ The purpose of the public workshop is to discuss the development of Orthopaedic SMART Devices. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART Devices. Public input and feedback gained through this workshop may aid in the efficient development of innovative, safe, and effective Orthopaedic SMART Devices for better patient care. DATES: The public workshop will be held on April 30, 2018, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by May 29, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/Working atFDA/BuildingsandFacilities/WhiteOak CampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 29, 2018. The https:// SUMMARY: E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02766]


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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; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Neurological Devices Panel of 
the Medical Devices Advisory Committee. This meeting was announced in 
the Federal Register of December 28, 2017. The amendment is being made 
to reflect a change in the Procedure portion of the document. There are 
no other changes.

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) code NE. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 
2017, 82 FR 61574, FDA announced that a meeting of the Neurological 
Devices Panel of the Medical Devices Advisory Committee would be held 
on March 1, 2018, from 8 a.m. to 6 p.m. On page 61574, in the 3rd 
column, the Procedure portion of the document is changed to read as 
follows:
    Procedure: FDA will work with affected industry organizations that 
have an interest in intracranial aneurysm treatment devices and who 
wish to make a presentation separate from the general Open Public 
Hearing; time slots on March 1, 2018, between approximately 9:40 a.m. 
and 11 a.m. Representatives from industry organizations interested in 
making formal presentations to the committee should notify the contact 
person on or before February 16, 2018.
    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 February 16, 
2018. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. 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 February 9, 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 February 12, 2018.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02766 Filed 2-12-18; 8:45 am]
BILLING CODE 4164-01-P