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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameCardiovascular and Renal Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number817
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*12
Current Charter Date8/27/2018Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter8/27/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Jennifer
Exempt From Renewal*NoDesignated Federal Officer Middle NameA
Specific Termination AuthorityDesignated Federal Officer Last Name*Shepherd
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixR.Ph.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Committee Type*ContinuingDesignated Federal Officer Email*jennifer.shepherd@fda.hhs.gov
Presidential*No
Committee Function*Scientific Technical 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 reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*The committee is balanced with respect to various aspects of cardiology. Committee members have expertise in cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. In addition the committee has one consumer member and may include one non-voting member representing Industry.
How frequent & relevant are cmte mtgs?*The committee did not meet during FY-19. It is expected that the committee will meet one time during FY-20.
Why advice can't be obtained elsewhere?*Members of the committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to FDA regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientist on a full-time basis at a maximum rate of compensation.
Why close or partially close meetings?The committee held no closed meetings during FY-19.
Recommendation RemarksAlthough this committee did not meet in FY 2019, considerable time was devoted to reappointing current members, maintaining associated records for these activities, 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 and number of vacancies on our website; completing the annual ethics report; reviewing financial disclosures of current members and providing ethics training. Since the Committee did not meet, no reporting was required.
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 RegulationsYes
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 CommentFDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Cardiovascular and Renal Drugs Advisory Committee enables the Agency to obtain required and frequently scarce professional services from medical and scientific experts 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 CommentN/A
Number Of Recommendations*53Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee has made 53 recommendations from FY-03 through FY-19.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of the 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 GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of the 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 CommentN/A
Agency Feedback CommentIt usually does. Product approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly 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 Cardiovascular and Renal Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal diseases and making appropriate recommendations to the Commissioner of the Food and Drug Administration. 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

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-034651Cardiovascular and Renal Drugs Advisory Committee2018
 COM-001992Cardiovascular and Renal Drugs Advisory Committee2017
 COM-002270Cardiovascular and Renal Drugs Advisory Committee2016
 COM-003993Cardiovascular and Renal Drugs Advisory Committee2015
 COM-004793Cardiovascular and Renal Drugs Advisory Committee2014
 COM-006136Cardiovascular and Renal Drugs Advisory Committee2013
 COM-006899Cardiovascular and Renal Drugs Advisory Committee2012
 COM-008286Cardiovascular and Renal Drugs Advisory Committee2011
 COM-009012Cardiovascular and Renal Drugs Advisory Committee2010
 COM-010074Cardiovascular and Renal Drugs Advisory Committee2009
 COM-011026Cardiovascular and Renal Drugs Advisory Committee2008
 COM-012151Cardiovascular and Renal Drugs Advisory Committee2007
 COM-012519Cardiovascular and Renal Drugs Advisory Committee2006
 COM-014068Cardiovascular and Renal Drugs Advisory Committee2005
 COM-014450Cardiovascular and Renal Drugs Advisory Committee2004
 COM-016022Cardiovascular and Renal Drugs Advisory Committee2003
 COM-016477Cardiovascular and Renal Drugs Advisory Committee2002
 COM-017971Cardiovascular and Renal Drugs Advisory Committee2001
 COM-018704Cardiovascular and Renal Drugs Advisory Committee2000
 COM-019803Cardiovascular and Renal Drugs Advisory Committee1999
 COM-020411Cardiovascular and Renal Drugs Advisory Committee1998
 COM-021723Cardiovascular and Renal Drugs Advisory Committee1997