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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 917 - Medical Imaging Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameMedical Imaging Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number917
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*13
Current Charter Date5/18/2019Designated Fed Officer Position Title*DFO
Date Of Renewal Charter5/18/2021Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Joyce
Exempt From Renewal*NoDesignated Federal Officer Middle NameY.
Specific Termination AuthorityDesignated Federal Officer Last Name*Yu
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD
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
Exempt From EO 13875 Discretionary CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*joyce.yu@fda.hhs.gov
Committee Type*Continuing
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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are authorities in the fields of nuclear medicine, radiology, epidemiology or statistics, 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 during FY-20.
It is expected that the Committee will meet one to two times during FY-21.
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 made by the agency. 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?The Committee held no closed meetings during FY-20.
Recommendation RemarksAlthough this Committee did not meet in FY-20, considerable time was devoted to appointing 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.

A meeting was planned for April 23, 2020, but was cancelled because the issues for which the FDA was seeking the scientific input of the Committee have been resolved. Please see the following website for more details regarding the cancelled meeting: https://www.fda.gov/advisory-committees/advisory-committee-calendar/cancelled-april-23-2020-meeting-medical-imaging-drugs-advisory-committee-meeting-announcement.

Please note that advisory committees meetings are planned and convened based on the needs of the FDA. Although the current charter states that the Committee will hold meetings approximately 4 times a year, this is only an estimation based on data from previous years and will be revised at the next Charter Renewal, if needed.

Additionally, MIDAC Members David B. Andrews, PhD and Chengjie Xiong, PhD were appointed to the Committee on September 24, 2019 but were not included in the FY-19 ACR. This is being noted here for record keeping purposes.
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 a 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 Medical Imaging 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*4Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 4 recommendations from FY-03 through the FY-20.Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%Access Committee WebsiteYes
% 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, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.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 CommentNA
Agency Feedback Comment*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 Medical Imaging Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology 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*$6,050.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$1,100.00
Payments to Federal Staff*$168,918.00Estimated Payments to Federal Staff*$170,899.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$3,300.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$8,940.00
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*$3,834.00
Other Costs$42,230.00Est. Other Costs Next FY*$45,713.00
Total Costs$211,148.00Est. Total Next FY*$239,836.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksThe Committee did not meet in FY-20.Est Cost RemarksThese estimated FY-21 costs include costs for 1 projected advisory committee meeting.
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Health Care
Safety
Treatment
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-036490Medical Imaging Drugs Advisory Committee2019
 COM-034690Medical Imaging Drugs Advisory Committee2018
 COM-001700Medical Imaging Drugs Advisory Committee2017
 COM-002631Medical Imaging Drugs Advisory Committee2016
 COM-004056Medical Imaging Drugs Advisory Committee2015
 COM-004478Medical Imaging Drugs Advisory Committee2014
 COM-005908Medical Imaging Drugs Advisory Committee2013
 COM-006583Medical Imaging Drugs Advisory Committee2012
 COM-008048Medical Imaging Drugs Advisory Committee2011
 COM-015886Medical Imaging Drugs Advisory Committee2003
 COM-016509Medical Imaging Drugs Advisory Committee2002
 COM-017959Medical Imaging Drugs Advisory Committee2001
 COM-018693Medical Imaging Drugs Advisory Committee2000
 COM-019742Medical Imaging Drugs Advisory Committee1999
 COM-020279Medical Imaging Drugs Advisory Committee1998
 COM-021704Medical Imaging Drugs Advisory Committee1997