Patient Engagement Advisory Committee; Notice of Meeting, 48316-48317 [2018-20640]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 48316 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices expansion of the San Ysidro LPOE in three independent phases to improve overall capacity and operational efficiency at the LPOE. The San Ysidro LPOE is located along Interstate 5 (I–5) at the U.S.-Mexico border in the San Ysidro community of the City of San Diego, California. GSA is proposing the following changes to the Approved Project: A redesign of the proposed pedestrian plaza on the east side of the LPOE. The pedestrian plaza would be expanded to the north to include an additional parcel adjacent to the LPOE. GSA proposes acquisition of the adjacent 0.24-acre parcel to the north that contains two commercial buildings and incorporation of this parcel (Additional Land Area) into the pedestrian plaza. In addition to these proposed changes to the Approved Project, the Revised Project also includes the other components of the Approved Project that have not changed. The changed circumstances associated with the Approved Project include new information regarding the condition of existing structures adjacent to the LPOE that affect the ability of GSA to implement the Approved Project. The Approved Project anticipated that construction of the pedestrian plaza would require demolition of the existing Milo Building within the LPOE. During final design, it was discovered that two existing buildings adjacent to the Milo Building on the Additional Land Area would likely collapse when the Milo Building is removed. The condition of these adjacent buildings was not known at the time the 2009 Final EIS or 2014 Final SEIS were prepared and this changed circumstance has bearing on the ability to implement the Approved Project. Due to the changed circumstances and changes to the Approved Project, GSA made the decision to prepare an SEIS for the Revised Project. The purpose of the Revised Project is the same as the Approved Project that was identified in the 2009 Final EIS and 2014 Final SEIS. The purpose of the Revised Project is to improve operational efficiency, security, and safety for cross-border travelers and federal agencies at the San Ysidro LPOE. The Draft SEIS analyzes two alternatives of the Revised Project, as well as the No Action Alternative. Both of the Action Alternatives include the proposed modifications described above, as well as the other improvements originally proposed as part of the Approved Project. Alternative 1 would include demolition of the two existing buildings within the Additional Land Area that would be added to the LPOE and incorporated VerDate Sep<11>2014 17:40 Sep 21, 2018 Jkt 244001 into the pedestrian plaza. Alternative 2 would involve renovation/adaptive reuse of the existing buildings on the Additional Land Area that would be added to the LPOE and incorporated into the design of the pedestrian plaza and LPOE. Under the No Action Alternative, GSA would continue to implement the Approved Project except that the Milo Building would not be demolished. Public Meeting The public meeting will be conducted in open house format, where project information will be presented and distributed. Comments must be received by November xx, 2018, and emailed to osmahn.kadri@gsa.gov, or sent to the address listed above. Dated: September 12, 2018. Matthew Jear, Director, Portfolio Management Division, Pacific Rim Region, Public Buildings Service. [FR Doc. 2018–20744 Filed 9–21–18; 8:45 am] BILLING CODE 6820–YF–P Dated: September 18, 2018. Emily W. Murphy, Administrator, General Services Administration. GENERAL SERVICES ADMINISTRATION [Notice–CX–2018–01; Docket No. 2018– 0002; Sequence No. 24] Office of Human Resources Management; SES Performance Review Board Office of Human Resources Management (OHRM), General Services Administration (GSA). ACTION: Notice. AGENCY: Notice is hereby given of the appointment of new members to the General Services Administration Senior Executive Service Performance Review Board. The Performance Review Board assures consistency, stability, and objectivity in the performance appraisal process. DATES: These appointments are effective September 24, 2018. FOR FURTHER INFORMATION CONTACT: Ms. Shonna James, Director, Executive Resources Division, Office of Human Resources Management, General Services Administration, 1800 F Street NW, Washington, DC 20405, 202–230– 7005. SUPPLEMENTARY INFORMATION: Section 4314(c)(1) through (5) of title 5 U.S.C requires each agency to establish, in accordance with regulation prescribed by the Office of Personnel Management, one or more SES performance review board(s). The board is responsible for making recommendations to the appointing and awarding authority on SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 the performance appraisal ratings and performance awards for the Senior Executive Service employees. The following have been designated as members of the Performance Review Board of GSA: • Allison Brigati, Deputy Administrator, Office of the Administrator—Chair. • Giancarlo Brizzi, Regional Commissioner, Public Buildings Service, Greater Southwest Region. • Mary Davie, Deputy Commissioner, Federal Acquisition Service. • Michael Gelber, Deputy Commissioner, Public Buildings Service. • Antonia Harris, Chief Human Capital Officer, Office of Human Resources Management. • Tiffany Hixon, Regional Commissioner, Federal Acquisition Service, Northwest, Arctic Region. • Jack St. John, General Counsel. • Alan Thomas, Commissioner, Federal Acquisition Service. [FR Doc. 2018–20704 Filed 9–21–18; 8:45 am] BILLING CODE 6820–FM–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3405] Patient Engagement Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public. DATES: The meeting will be held on November 15, 2018, from 8 a.m. to 5 p.m. SUMMARY: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301–977–8900; additional information available online at: https:// ADDRESSES: E:\FR\FM\24SEN1.SGM 24SEN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices www3.hilton.com/en/hotels/maryland/ hilton-washington-dc-northgaithersburg-GAIGHHF/. 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/AboutAdvisory Committees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993–0002, letise.williams@ fda.hhs.gov, 301–796–8398, 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 November 15, 2018, the Committee will discuss and make recommendations on the topic ‘‘Connected and Empowered Patients: EPlatforms Potentially Expanding the Definition of Scientific Evidence.’’ The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence (https://www.fda.gov/ucm/groups/ fdagov-public/@fdagov-meddev-gen/ documents/document/ucm513027.pdf). This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of VerDate Sep<11>2014 17:40 Sep 21, 2018 Jkt 244001 patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers. 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. Oral presentations from the public will be scheduled between approximately 11:15 a.m. to 12:15 p.m. on November 15, 2018. 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 October 15, 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 October 17, 2018. Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by the Committee may send written submissions to the contact person on or before October 23, 2018. FDA welcomes the attendance of the public at its advisory committee PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 48317 meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at Annmarie.Williams@ fda.hhs.gov, or 301–796–5966 at least 7 days in advance of the meeting. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Please be advised that, for the round table portion of the meeting, FDA will prepare a summary of the discussion in lieu of detailed transcripts. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20640 Filed 9–21–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915–0278—Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than November 23, 2018. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48316-48317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3405]


Patient Engagement Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
forthcoming public advisory committee meeting of the Patient Engagement 
Advisory Committee (the Committee). The general function of the 
Committee is to provide advice to the Commissioner, or designee, on 
complex issues relating to medical devices, the regulation of devices, 
and their use by patients. The meeting will be open to the public.

DATES: The meeting will be held on November 15, 2018, from 8 a.m. to 5 
p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 
Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 
301-977-8900; additional information available online at: https://

[[Page 48317]]

www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-
gaithersburg-GAIGHHF/. 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: Letise Williams, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002, 
[email protected], 301-796-8398, 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 November 15, 2018, the Committee 
will discuss and make recommendations on the topic ``Connected and 
Empowered Patients: E-Platforms Potentially Expanding the Definition of 
Scientific Evidence.'' The recommendations will address how FDA can 
leverage patient-driven platforms, such as social media and registries, 
to better engage patients and consumers as empowered partners in the 
work of protecting public health and promoting responsible innovation. 
Social media and other web platform enablers are facilitating the 
growth of virtual patient communities. Increasingly, patients and 
health care consumers are using these platforms to share their health 
experiences and seek information from other patients and consumers, 
rather than their health care providers alone. Novel approaches and 
methodologies are being used to tap into some of these platforms as 
potentially rich sources of patient-generated health data, which could 
be used as relevant and reliable real-world evidence (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm513027.pdf).
    This meeting will help advance FDA's objective to assure the needs, 
experiences, and perspectives of patients are included as part of FDA's 
deliberations involving the regulation of medical devices and their use 
by patients. For this meeting, FDA is seeking input from the Committee 
and the public on whether and how FDA can harness the emerging 
potential of these patient platforms to better engage patients and 
consumers as empowered partners in the work of protecting public health 
and promoting responsible innovation. In addition, FDA is seeking 
recommendations from the Committee on ways to leverage these platforms 
to disseminate as well as potentially collect and evaluate health 
information to and from patients and consumers.
    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. 
Oral presentations from the public will be scheduled between 
approximately 11:15 a.m. to 12:15 p.m. on November 15, 2018. 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 
October 15, 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 October 17, 
2018. Individuals who do not wish to speak at the open public hearing 
session but would like their comments to be heard by the Committee may 
send written submissions to the contact person on or before October 23, 
2018.
    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.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    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. Please be advised 
that, for the round table portion of the meeting, FDA will prepare a 
summary of the discussion in lieu of detailed transcripts.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20640 Filed 9-21-18; 8:45 am]
 BILLING CODE 4164-01-P

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