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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePatient Engagement Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number2532
Original Establishment Date10/6/2015Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*9
Current Charter Date10/6/2017Designated Fed Officer Position Title*Program Analyst, Center for Devices and Radiological Health, FDA
Date Of Renewal Charter10/6/2019Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Letise
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Williams
Establishment Authority*Authorized by LawDesignated Federal Officer Suffix
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-8398
Effective Date Of Authority*10/6/2015Designated Federal Officer Fax*(301) 847-8510
Committee Type*ContinuingDesignated Federal Officer Email*letise.williams@fda.hhs.gov
Presidential*No
Committee Function*Non Scientific Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee provides advice to the Commissioner of Food and Drugs 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. The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.
How is membership balanced?*The Patient Engagement Advisory Committee charter specifies that the Committee shall consist of a core of 9 voting members including the Chair. Members and the Chair are selected by the Commissioner 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. The core of voting members may include 1 technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and are recommended by either a consortium of consumer-oriented organizations or other interested persons.
How frequent & relevant are cmte mtgs?*The Patient Engagement Advisory Committee charter specifies that meetings shall be held approximately twice annually. During the meetings the Committee will provide advice to the Commissioner of Food and Drugs on complex issues relating to medical devices, the regulation of devices, and their use by patients. One meeting was held in FY 2018 to discuss clinical trial issues and two meetings are planned for FY 2019.
Why advice can't be obtained elsewhere?*The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. The alternate means of accessing this advice would involve the recruitment of large numbers of specialists on a full-time basis at maximum rates of compensation.
Why close or partially close meetings?Not Applicable
Recommendation RemarksThe committee met once in FY 2018. In addition, considerable time was devoted to maintaining associated records, and streamlining paper processes within FDA. In addition, time was spent in the routine care and maintenance of the committee: the development of a financial report for this website; updating the roster on our website; completing the annual ethics report; reviewing financial disclosures of current members and providing ethics training.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentThe committee will address patient related issues and take appropriate programmatic steps.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Patient Engagement Advisory Committee enables the Agency to obtain required services from experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentNot Applicable
Number Of Recommendations*1Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 1 recommendation since its establishment in FY 2016 through FY 18 - See Meeting Purposes and Dates and question 20a of the annual report or specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*0.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of the committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*100.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentNot Applicable
Agency Feedback CommentThe Agency is developing a guidance document to address the committee's recommendation. The guidance document and other general matters issues will be available publically when implemented.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Patient Engagement Committee supports FDA's strategic priorities by providing advice to the Commissioner of Food and Drugs on complex issues relating to medical devices, the regulation of devices, and their use by patients. Topics to be considered by the Committee include 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. The Committee performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-001638Patient Engagement Advisory Committee2017
 COM-002672Patient Engagement Advisory Committee2016
 COM-034835Patient Engagement Advisory Committee2018