Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee, 57004-57005 [2015-23522]

Download as PDF 57004 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 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. rmajette on DSK7SPTVN1PROD with NOTICES 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 nonFederal 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. Selfnominations 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. VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3173] Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) for the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be selfnominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. 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: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest, must send a letter stating that interest to FDA by October 21, 2015, (see sections I and II of this document for details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 21, 2015. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 All statements of interest from interested industry organizations interested in participating in the selection process should be sent electronically to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing 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 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 https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993– 0002, 301–796–5960, FAX: 301–847– 8510, margaret.ames@fda.hhs.gov. For questions relating to the Committee: 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, 301– 796–8398, letise.williams@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of nonvoting industry representatives for the Committee (this position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by 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 for Voting Members for the Patient Engagement Advisory Committee. 3. Request for Nominations of Individuals and Consumer Organizations for the Patient Engagement Advisory Committee. ADDRESSES: 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 and policies, clinical trial or registry design, patient preference study design, E:\FR\FM\21SEN1.SGM 21SEN1 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices business and/or home address, telephone number, and email address if available. Nominations should specify the advisory committee for which the nominee is recommended within 30 days of publication of this document (see DATES). In addition, nominations should also acknowledge that the nominee is aware of the nomination, unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the Committee. Only interested industry organizations participate in the selection process. Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process. 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. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest must send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate or candidates (to serve in a pool of individuals, with varying areas of expertise), to represent industry interest for the Committee, within 60 days after the receipt of the FDA letter. The interested organizations are not bound by the list of nominees in selecting a candidate or candidates. However, if no individual is selected within 60 days, the Commissioner will select temporary nonvoting members (or pool of individuals) to represent industry interests. rmajette on DSK7SPTVN1PROD with NOTICES 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, health care 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. The Commissioner of Food and Drugs (the Commissioner), or designee, shall have the authority to select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with industry interests. The number of temporary members selected for a particular meeting will depend on the meeting topic(s). [FR Doc. 2015–23522 Filed 9–18–15; 8:45 am] III. Nomination Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a temporary nonvoting industry representative. Nominations should include a cover letter and a current, complete resume or curriculum vitae for each nominee, including a current VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 Dated: September 15, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 13, 2015, from 8:45 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993–0002. For those unable to attend in person, the meeting will also be Webcast and will be available at the following link https://collaboration.fda.gov/ vrbpac1115/. Answers to commonly PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 57005 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. Contact Person: Sujata Vijh or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, 240–402–7107 or 240– 402–8158, 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 Web site 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. Agenda: On November 13, 2015, the committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant. 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 Web site 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 Web site 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 October 29, 2015. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:45 a.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 E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57004-57005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3173]


Request for Nominations of Individuals and Industry Organizations 
for the Patient Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting industry 
organizations interested in participating in the selection of a pool of 
nonvoting industry representatives to serve as temporary nonvoting 
members on the Patient Engagement Advisory Committee (the Committee) 
for the Center for Devices and Radiological Health notify FDA in 
writing. FDA is also requesting nominations for temporary nonvoting 
industry representatives to be included in a pool of individuals to 
serve on the Committee. Nominees recommended to serve as a temporary 
nonvoting industry representative may either be self-nominated or 
nominated by an industry organization. This position may be filled by 
representatives of different medical device areas based on areas of 
expertise relevant to the topics being considered by the Committee. 
Nominations will be accepted for current vacancies effective with this 
notice.
    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: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest, must send a letter stating that interest to FDA by October 
21, 2015, (see sections I and II of this document for details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 21, 2015.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process 
should be sent electronically to Margaret Ames (see FOR FURTHER 
INFORMATION CONTACT). All nominations for nonvoting industry 
representatives may be submitted electronically by accessing 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 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to 
participation in the selection process: Margaret Ames, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993-0002, 
301-796-5960, FAX: 301-847-8510, margaret.ames@fda.hhs.gov.
    For questions relating to the Committee: 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, 301-796-8398, letise.williams@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of 
nonvoting industry representatives for the Committee (this position may 
be filled by representatives of different medical device areas based on 
areas of expertise relevant to the topics being considered by 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 for Voting Members 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 and policies, clinical trial or registry design, patient 
preference study design,

[[Page 57005]]

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, health care 
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. The Commissioner of Food and Drugs (the Commissioner), or 
designee, shall have the authority to select from a group of 
individuals nominated by industry to serve temporarily as nonvoting 
members who are identified with industry interests. The number of 
temporary members selected for a particular meeting will depend on the 
meeting topic(s).

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest must send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations; and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate or candidates (to serve in a pool of 
individuals, with varying areas of expertise), to represent industry 
interest for the Committee, within 60 days after the receipt of the FDA 
letter. The interested organizations are not bound by the list of 
nominees in selecting a candidate or candidates. However, if no 
individual is selected within 60 days, the Commissioner will select 
temporary nonvoting members (or pool of individuals) to represent 
industry interests.

III. Nomination Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a temporary nonvoting industry 
representative. Nominations should include a cover letter and 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. Nominations should specify the advisory 
committee for which the nominee is recommended within 30 days of 
publication of this document (see DATES). In addition, nominations 
should also acknowledge that the nominee is aware of the nomination, 
unless self-nominated. FDA will forward all nominations to the 
organizations expressing interest in participating in the selection 
process for the Committee. Only interested industry organizations 
participate in the selection process. Persons who nominate themselves 
as nonvoting industry representatives will not participate in the 
selection process.
    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. 2015-23522 Filed 9-18-15; 8:45 am]
BILLING CODE 4164-01-P
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