2015-23523. Request for Nominations of Individuals and Consumer Organizations for the Patient Engagement Advisory Committee

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Patient Engagement Advisory Committee (the Committee) notify FDA in writing. FDA is also requesting nominations for a voting consumer representative to serve on the Committee. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy 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 consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests on the Committee may send a letter or email stating that interest to FDA by October 21, 2015. Concurrently, nomination materials for prospective candidates should be sent to FDA by October 21, 2015.

ADDRESSES:

All statements of interest from consumer organizations interested in participating in the selection process should be sent electronically to Kimberly Hamilton (see FOR FURTHER INFORMATION CONTACT). All Consumer Representative nominations 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: [phone]. Information about becoming a member of 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:

For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-0002, 301-796-6319, [e-mail].

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, [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for a voting consumer representative on 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 Industry 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, 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.

II. Criteria for Members

Persons nominated for membership as a consumer representative on this Committee should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the Committee; serve as a liaison between the Committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the Committees on scientific issues that affect consumers.

III. Selection Procedures

Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests must send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document.

Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing three to five qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee.

IV. Nomination Procedures

Any interested person or organization may nominate one or more qualified individuals to represent consumer interests 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 a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations should also specify the advisory committee for which the nominee is recommended. In addition, 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. Members will be invited to serve for terms up to 4 years.

FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of three to five qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting consumer 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.