80_FR_57185 80 FR 57003 - Request for Nominations for Voting Members for the Patient Engagement Advisory Committee

80 FR 57003 - Request for Nominations for Voting Members for the Patient Engagement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

Page Range57003-57004
FR Document2015-23524

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Patient Engagement Advisory Committee (the Committee), Office of the Center Director, Center for Devices and Radiological Health. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

Federal Register, Volume 80 Issue 182 (Monday, September 21, 2015) 
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57003-57004]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3224]


Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on the Patient Engagement Advisory 
Committee (the Committee), Office of the Center Director, Center for 
Devices and Radiological Health.
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.

DATES: Nominations received by November 20, 2015, will be given first 
consideration for membership on the Committee. Nominations received 
after November 20, 2015, will be considered for nomination to the 
Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Committee Membership Nomination 
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management 
Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.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, 301-796-8398, FAX: 301-847-8510, 
Letise.Williams@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members for the Committee.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
separate documents regarding:
    1. Patient Engagement Advisory Committee; Notice of Establishment.
    2. Request for Nominations of Individuals and Industry 
Organizations for the Patient Engagement Advisory Committee.
    3. Request for Nominations of Individuals and Consumer 
Organizations for the Patient Engagement Advisory Committee.

I. General Description of the Committee's Duties

    The Committee provides advice on complex issues relating to medical 
devices, the regulation of devices, and their use by patients. Agency 
guidance

[[Page 57004]]

and policies, clinical trial or registry design, patient preference 
study design, benefit-risk determinations, device labeling, unmet 
clinical needs, available alternatives, patient reported outcomes and 
device-related quality of life or health status issues are among the 
topics that may be considered by the Committee. Members are 
knowledgeable in areas such as clinical research, primary care patient 
experience, healthcare needs of patient groups in the United States, or 
are experienced in the work of patient and health professional 
organizations, methodologies for eliciting patient preferences, and 
strategies for communicating benefits, risks, and clinical outcomes to 
patients and research subjects.

II. Criteria for Voting Members

    The Committee consists of a core of nine voting members including 
the Chair. Members and the Chair are selected by the Commissioner of 
Food and Drugs or designee from among authorities who are knowledgeable 
in areas such as clinical research, primary care patient experience, 
healthcare needs of patient groups in the United States, or are 
experienced in the work of patient and health professional 
organizations, methodologies for eliciting patient preferences, and 
strategies for communicating benefits, risks, and clinical outcomes to 
patients and research subjects. Members will be invited to serve for 
overlapping terms of up to 4 years. Prospective members should also 
have an understanding of the broad spectrum of patients in a particular 
disease area. Almost all non-Federal members of this Committee serve as 
Special Government Employees.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the Committee. Self-nominations are also 
accepted. Nominations should include a cover letter; a current, 
complete resume or curriculum vitae for each nominee, including a 
current business and/or home address, telephone number, and email 
address if available; and should specify the advisory committee for 
which the nominee is recommended. Nominations should also acknowledge 
that the nominee is aware of the nomination, unless self-nominated. FDA 
will ask potential candidates to provide detailed information 
concerning such matters related to financial holdings, employment, and 
research grants and/or contracts to permit evaluation of possible 
sources of conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23524 Filed 9-18-15; 8:45 am]
BILLING CODE P

Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 57003 United States, or are experienced in the nominations are also accepted. SUMMARY: The Food and Drug work of patient and health professional Nominations should include a cover Administration (FDA) is requesting organizations, methodologies for letter; a current, complete resume or nominations for members to serve on eliciting patient preferences, and curriculum vitae for each nominee, the Patient Engagement Advisory strategies for communicating benefits, including a current business and/or Committee (the Committee), Office of risks, and clinical outcomes to patients home address, telephone number, and the Center Director, Center for Devices and research subjects. email address if available; and a list of and Radiological Health. consumer or community-based FDA seeks to include the views of II. Criteria for Members organizations for which the candidate women and men, members of all racial Persons nominated for membership as can demonstrate active participation. and ethnic groups, and individuals with a consumer representative on this Nominations should also specify the and without disabilities on its advisory Committee should meet the following advisory committee for which the committees and, therefore, encourages criteria: (1) Demonstrate ties to nominee is recommended. In addition, nominations of appropriately qualified consumer and community-based nominations should also acknowledge candidates from these groups. organizations, (2) be able to analyze that the nominee is aware of the DATES: Nominations received by technical data, (3) understand research nomination, unless self-nominated. FDA November 20, 2015, will be given first design, (4) discuss benefits and risks, will ask potential candidates to provide consideration for membership on the and (5) evaluate the safety and efficacy detailed information concerning such Committee. Nominations received after of products under review. The matters related to financial holdings, November 20, 2015, will be considered consumer representative should be able employment, and research grants and/or for nomination to the Committee as later to represent the consumer perspective contracts to permit evaluation of vacancies occur. on issues and actions before the possible sources of conflicts of interest. ADDRESSES: All nominations for Committee; serve as a liaison between Members will be invited to serve for the Committee and interested membership should be sent terms up to 4 years. electronically by logging into the FDA consumers, associations, coalitions, and FDA will review all nominations consumer organizations; and facilitate Advisory Committee Membership received within the specified Nomination Portal: https:// dialogue with the Committees on timeframes and prepare a ballot scientific issues that affect consumers. www.accessdata.fda.gov/scripts/ containing the names of three to five FACTRSPortal/FACTRS/index.cfm, by III. Selection Procedures qualified nominees. Names not selected mail to Advisory Committee Oversight will remain on a list of eligible and Management Staff, Food and Drug Selection of members representing nominees and be reviewed periodically Administration, 10903 New Hampshire consumer interests is conducted by FDA to determine continued interest. Ave., Bldg. 32, Rm. 5103, Silver Spring, through procedures that include the use Upon selecting qualified nominees for MD 20993–0002, or by FAX: 301–847– of organizations representing the public the ballot, FDA will provide those 8640. Information about becoming a interest and public advocacy groups. consumer organizations that are member on an FDA advisory committee These organizations recommend participating in the selection process can also be obtained by visiting FDA’s nominees for the Agency’s selection. with the opportunity to vote on the Web site at http://www.fda.gov/ Representatives from the consumer listed nominees. Only organizations AdvisoryCommittees/default.htm health branches of Federal, State, and vote in the selection process. Persons FOR FURTHER INFORMATION CONTACT: local governments also may participate who nominate themselves to serve as Letise Williams, Center for Devices and in the selection process. Any consumer voting consumer representatives will Radiological Health, Food and Drug organization interested in participating not participate in the selection process. Administration, 10903 New Hampshire in the selection of an appropriate voting This notice is issued under the Ave., Bldg. 66, Rm. 5441, 301–796– member to represent consumer interests Federal Advisory Committee Act (5 8398, FAX: 301–847–8510, must send a letter stating that interest to U.S.C. app. 2) and 21 CFR part 14, Letise.Williams@fda.hhs.gov. FDA (see ADDRESSES) within 30 days of relating to advisory committees. publication of this document. SUPPLEMENTARY INFORMATION: FDA is Within the subsequent 30 days, FDA Dated: September 15, 2015. requesting nominations for voting will compile a list of consumer Jill Hartzler Warner, members for the Committee. organizations that will participate in the Associate Commissioner for Special Medical Elsewhere in this issue of the Federal selection process and will forward to Programs. Register, FDA is publishing separate each such organization a ballot listing [FR Doc. 2015–23523 Filed 9–18–15; 8:45 am] documents regarding: three to five qualified nominees selected BILLING CODE 4164–01–P 1. Patient Engagement Advisory by the Agency based on the nominations Committee; Notice of Establishment. received, together with each nominee’s 2. Request for Nominations of current curriculum vitae or resume. DEPARTMENT OF HEALTH AND Individuals and Industry Organizations Ballots are to be filled out and returned HUMAN SERVICES for the Patient Engagement Advisory to FDA within 30 days. The nominee Committee. receiving the highest number of votes Food and Drug Administration 3. Request for Nominations of ordinarily will be selected to serve as Individuals and Consumer the member representing consumer [Docket No. FDA–2015–N–3224] Organizations for the Patient interests for that particular advisory Engagement Advisory Committee. rmajette on DSK7SPTVN1PROD with NOTICES Request for Nominations for Voting committee. Members for the Patient Engagement I. General Description of the IV. Nomination Procedures Advisory Committee Committee’s Duties Any interested person or organization AGENCY: Food and Drug Administration, The Committee provides advice on may nominate one or more qualified HHS. complex issues relating to medical individuals to represent consumer devices, the regulation of devices, and ACTION: Notice. interests on the Committee. Self- their use by patients. Agency guidance VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

57004 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices and policies, clinical trial or registry This notice is issued under the ADDRESSES: All statements of interest design, patient preference study design, Federal Advisory Committee Act (5 from interested industry organizations benefit-risk determinations, device U.S.C. app. 2) and 21 CFR part 14, interested in participating in the labeling, unmet clinical needs, available relating to advisory committees. selection process should be sent alternatives, patient reported outcomes Dated: September 15, 2015. electronically to Margaret Ames (see FOR and device-related quality of life or Jill Hartzler Warner, FURTHER INFORMATION CONTACT). All health status issues are among the topics nominations for nonvoting industry Associate Commissioner for Special Medical that may be considered by the Programs. representatives may be submitted Committee. Members are knowledgeable electronically by accessing the FDA [FR Doc. 2015–23524 Filed 9–18–15; 8:45 am] in areas such as clinical research, Advisory Committee Membership BILLING CODE P primary care patient experience, Nomination Portal: https:// healthcare needs of patient groups in www.accessdata.fda.gov/scripts/ the United States, or are experienced in DEPARTMENT OF HEALTH AND FACTRSPortal/FACTRS/index.cfm, by the work of patient and health HUMAN SERVICES mail to Advisory Committee Oversight professional organizations, and Management Staff, Food and Drug methodologies for eliciting patient Food and Drug Administration Administration, 10903 New Hampshire preferences, and strategies for Ave., Bldg. 32, Rm. 5103, Silver Spring, communicating benefits, risks, and [Docket No. FDA–2015–N–3173] MD 20993–0002, or FAX: 301–847– clinical outcomes to patients and 8640. Information about becoming a Request for Nominations of Individuals research subjects. member on an FDA advisory committee and Industry Organizations for the II. Criteria for Voting Members Patient Engagement Advisory can also be obtained by visiting FDA’s Committee Web site at http://www.fda.gov/ The Committee consists of a core of AdvisoryCommittees/default.htm. nine voting members including the AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: For Chair. Members and the Chair are HHS. selected by the Commissioner of Food questions relating to participation in the ACTION: Notice. selection process: Margaret Ames, and Drugs or designee from among authorities who are knowledgeable in SUMMARY: The Food and Drug Center for Devices and Radiological areas such as clinical research, primary Administration (FDA) is requesting Health, Food and Drug Administration, care patient experience, healthcare industry organizations interested in 10903 New Hampshire Ave., Bldg. 66, needs of patient groups in the United participating in the selection of a pool Rm. 5234, Silver Spring, MD 20993– States, or are experienced in the work of of nonvoting industry representatives to 0002, 301–796–5960, FAX: 301–847– patient and health professional serve as temporary nonvoting members 8510, margaret.ames@fda.hhs.gov. organizations, methodologies for on the Patient Engagement Advisory For questions relating to the eliciting patient preferences, and Committee (the Committee) for the Committee: Letise Williams, Center for strategies for communicating benefits, Center for Devices and Radiological Devices and Radiological Health, Food risks, and clinical outcomes to patients Health notify FDA in writing. FDA is and Drug Administration, 10903 New and research subjects. Members will be also requesting nominations for Hampshire Ave., Bldg. 66, Rm. 5441, invited to serve for overlapping terms of temporary nonvoting industry Silver Spring, MD 20993–0002, 301– up to 4 years. Prospective members representatives to be included in a pool 796–8398, letise.williams@fda.hhs.gov. should also have an understanding of of individuals to serve on the SUPPLEMENTARY INFORMATION: FDA is the broad spectrum of patients in a Committee. Nominees recommended to requesting nominations for a pool of particular disease area. Almost all non- serve as a temporary nonvoting industry nonvoting industry representatives for Federal members of this Committee representative may either be self- the Committee (this position may be serve as Special Government nominated or nominated by an industry filled by representatives of different Employees. organization. This position may be filled medical device areas based on areas of by representatives of different medical expertise relevant to the topics being III. Nomination Procedures device areas based on areas of expertise considered by the Committee). Any interested person may nominate relevant to the topics being considered Elsewhere in this issue of the Federal one or more qualified individuals for by the Committee. Nominations will be Register, FDA is publishing separate membership on the Committee. Self- accepted for current vacancies effective documents regarding: nominations are also accepted. with this notice. 1. Patient Engagement Advisory Nominations should include a cover FDA seeks to include the views of Committee; Notice of Establishment. letter; a current, complete resume or women and men, members of all racial 2. Request for Nominations for Voting curriculum vitae for each nominee, and ethnic groups, and individuals with Members for the Patient Engagement including a current business and/or and without disabilities on its advisory Advisory Committee. home address, telephone number, and committees and, therefore encourages 3. Request for Nominations of email address if available; and should nominations of appropriately qualified Individuals and Consumer specify the advisory committee for candidates from these groups. Organizations for the Patient which the nominee is recommended. DATES: Any industry organization Engagement Advisory Committee. Nominations should also acknowledge interested in participating in the that the nominee is aware of the selection of an appropriate nonvoting I. General Description of the rmajette on DSK7SPTVN1PROD with NOTICES nomination, unless self-nominated. FDA member to represent industry interest, Committee’s Duties will ask potential candidates to provide must send a letter stating that interest to The Committee provides advice on detailed information concerning such FDA by October 21, 2015, (see sections complex issues relating to medical matters related to financial holdings, I and II of this document for details). devices, the regulation of devices, and employment, and research grants and/or Concurrently, nomination materials for their use by patients. Agency guidance contracts to permit evaluation of prospective candidates should be sent to and policies, clinical trial or registry possible sources of conflicts of interest. FDA by October 21, 2015. design, patient preference study design, VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2015-12-15 09:38:37
Document Modified: 2015-12-15 09:38:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesNominations received by November 20, 2015, will be given first consideration for membership on the Committee. Nominations received after November 20, 2015, will be considered for nomination to the Committee as later vacancies occur.
ContactLetise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510, [email protected]
FR Citation80 FR 57003 
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