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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAntiviral Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2015Committee Number789
Original Establishment Date11/28/1990Committee StatusTerminated
Actual Termination Date2/15/2015Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYYesMax Number of Members*14
Current Charter Date2/15/2013Designated Fed Officer Position Title*DFO
Date Of Renewal Charter2/15/2015Designated Federal Officer Prefix
Projected Termination Date2/15/2015Designated Federal Officer First Name*Jennifer
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Shepherd
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixRPh
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*Terminate
Legislation to Terminate RequiredNo
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investgational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), human immunodeficiency virus related illnesses, and other viral, fungal, and mycobacterial infections and makes appropriate recommendations to the Commissioner of Food and Drugs. 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.
How is membership balanced?*Members are authorities in the fields of clinical pharmacology, internal medicine, infectious diseases, microbiology, virology, psychiatry, statistics, epidemiology, immunology, pediatrics, hematology, and related specialties. The committee includes one technically qualified voting member who is identified with consumer interests. The Committee may include one non-voting member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*The committee did not meet in FY-15.
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 regulatory decisions. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at great expense to the government.
Why close or partially close meetings?There were no closed meetings to report for FY-15.
Recommendation RemarksThe committee is not required to do any reporting for FY-15. Although this committee did not meet in FY-15, considerable time was devoted to the work involved to terminate the committee and members. The committee was terminated on February 15, 2015.
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 new medical products.
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 Anti-Viral Drugs Advisory Committee enabled 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*33Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe commmittee made 33 recommendations from FY03 to FY15 - see question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%Access Committee WebsiteNo
% of Recs Fully 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 GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%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 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 Antiviral 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 acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections, and makes appropriate recommendations to the Commissioner of Food and Drugs. 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*$0.00Est Payments to Non-Fed Members Next FY*$0.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$42,839.00Estimated Payments to Federal Staff*$0.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$10,710.00Est. Other Costs Next FY*$0.00
Total Costs$53,549.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)*0.35Est. Fed Staff Support Next FY*0.00
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-004575Antiviral Drugs Advisory Committee2014
 COM-006079Antiviral Drugs Advisory Committee2013
 COM-006592Antiviral Drugs Advisory Committee2012
 COM-008364Antiviral Drugs Advisory Committee2011
 COM-008711Antiviral Drugs Advisory Committee2010
 COM-010022Antiviral Drugs Advisory Committee2009
 COM-010658Antiviral Drugs Advisory Committee2008
 COM-012165Antiviral Drugs Advisory Committee2007
 COM-012647Antiviral Drugs Advisory Committee2006
 COM-013760Antiviral Drugs Advisory Committee2005
 COM-014485Antiviral Drugs Advisory Committee2004
 COM-015865Antiviral Drugs Advisory Committee2003
 COM-016504Antiviral Drugs Advisory Committee2002
 COM-017578Antiviral Drugs Advisory Committee2001
 COM-018379Antiviral Drugs Advisory Committee2000
 COM-019686Antiviral Drugs Advisory Committee1999
 COM-020403Antiviral Drugs Advisory Committee1998
 COM-021617Antiviral Drugs Advisory Committee1997