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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameTobacco Products Scientific Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number70466
Original Establishment Date Committee 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 Date8/12/2009Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Janice
Exempt From Renewal*YesDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*O'Connor
Establishment Authority*Statutory (Congress Created)Designated Federal Officer Suffix
Specific Establishment Authority*H.R. 1256 Family Smoking Prevention and Tobacco Control Act; FD&C 21 U.S.C. 387qDesignated Federal Officer Phone*(301) 796-9237
Effective Date Of Authority*6/22/2009Designated Federal Officer Fax*240-276-3655
Committee Type*ContinuingDesignated Federal Officer Email*janice.oconnor@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 safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. One voting member is an officer or employee of a state or local government or of the Federal Government. One voting member is a representative of the general public. In addition to the voting members, the Committee includes 3 non-voting members who are identified with industry interests. These members include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry. This final position can be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Committee.
How frequent & relevant are cmte mtgs?*This committee held two meeting in FY18. One to discuss modified risk tobacco product applications (MRTPAs), submitted by Philip Morris Products S.A. for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks, and one to discussed modified risk tobacco product applications (MRTPAs), submitted by R.J. Reynolds Tobacco Company for six products: MR0000068: Camel Snus Frost, MR0000069: Camel Snus Frost Large, MR0000070: Camel Snus Mellow, MR0000071: Camel Snus Mint, MR0000072: Camel Snus Robust, and MR0000073: Camel Snus Winterchil.
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 and helps those decisions stand up to intense public scrutiny. 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?N/A
Recommendation RemarksNo reports were required of the committee in this fiscal year. The FD&C Act provides for mandatory referral of modified risk tobacco product applications (MRTPA) to the Committee under section 911(f)(1). 21 U.S.C. 387k (f)(1). As such, the committee reviewed MRTP applications submitted by Philip Morris Products S.A. on January 24-25, 2018 and MRTP applications submitted by R.J. Reynolds Tobacco Company on September 13-14, 2018.
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 CommentThe Agency will use the committee's advice in implementing the Family Smoking Prevention and Tobacco Control Act.
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 (insert 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 bases 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*8Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 8 recommendations from FY10 through FY18 - See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*0.00%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, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*0.00%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 Tobacco Products Scientific Advisory Committee supports FDA's strategic priorities by reviewing and evaluating safety, dependence, and health issues relating to tobacco products and making appropriate recommendations to the Commissioner of Food and Drugs.
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-034780Tobacco Products Scientific Advisory Committee2018
 COM-001738Tobacco Products Scientific Advisory Committee2017
 COM-002589Tobacco Products Scientific Advisory Committee2016
 COM-004173Tobacco Products Scientific Advisory Committee2015
 COM-004443Tobacco Products Scientific Advisory Committee2014
 COM-006165Tobacco Products Scientific Advisory Committee2013
 COM-006854Tobacco Products Scientific Advisory Committee2012
 COM-008302Tobacco Products Scientific Advisory Committee2011
 COM-008803Tobacco Products Scientific Advisory Committee2010
 COM-010343Tobacco Products Scientific Advisory Committee2009