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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 - 1023 - Science Advisory Board to the National Center for Toxicological Research - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameScience Advisory Board to the National Center for Toxicological ResearchAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number1023
Original Establishment Date6/2/1973Committee 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 Date6/2/2020Designated Fed Officer Position Title*Associate Director for Regulatory Activities, Washington Operations, NCTR
Date Of Renewal Charter6/2/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Donna
Exempt From Renewal*NoDesignated Federal Officer Middle NameL.
Specific Termination AuthorityDesignated Federal Officer Last Name*Mendrick
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPh.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-8892
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8600
Exempt From EO 13875 Discretionary CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*donna.mendrick@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 National Center for Toxicological Research (NCTR) Science Advisory Board (SAB) advises the Director in establishing, implementing and evaluating the research programs that assist the Commissioner of the Food and Drug Administration (FDA) in fulfilling regulatory responsibilities. This external body of recognized scientific experts is a key component of the review and planning process, and helps to ensure that the research programs at NCTR are scientifically sound and pertinent to the FDA.
How is membership balanced?*Members are leading authorities in the fields related to toxicological research. Members represent academia, clinical research, and other scientific disciplines.
How frequent & relevant are cmte mtgs?*It is likely that the Board will hold one site visit and one meeting of the full Board in FY-2021.
Why advice can't be obtained elsewhere?*This function could be performed on an ad hoc basis, however, it would be a much more costly process than what is currently being spent using SGEs. There would be no reduction in alotted Federal staff time, since that time would still be required to support the ad hoc review activity. Moreover, utilizing an ad hoc review approach would not permit the seamless evaluation of the total NCTR research agenda, the inter-relationships of its research components, and the long-range impact on the FDA mission.
Why close or partially close meetings?The Board meets in closed session to permit disucssion where disclosure would constitute a clearly unwarrented invasion of personal privacy (5 U.S.C. 522b(c)(6)). These portions of the meetings are closed to permit discussion of issues related to personnel progress and promotion.
Recommendation RemarksDuring FY20 there were 2 two-day meetings of the full board. On December 3-4, 2019, the Committee met in-person. The NCTR Director provided a Center-wide update on scientific initiatives and accomplishments during the past year. The Science Advisory Board was presented with an overview of the Division of Genetic and Molecular Toxicology Research Program Site Visit Report nd a response to this review. There were updates from the NCTR Research Divisions and a public comment section.
There was a statement given by the FDA Chief Scientist. The Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, and the Center for Tobacco Products. Each Center briefly discussed their center-specific research strategic needs and potential areas of collaboration.
On August 18-19, 2020, the Committee held a virtual-only meeting. On August 18-19, 2020, the Science Advisory Board Chair welcomed the participants, and the NCTR Director provided a center-wide update on scientific initiatives and accomplishments during the past year. The Science Advisory Board was presented with an overview of the Subcommittee Review of the Division of Neurotoxicology Research Program Site Visit Report and a response to that review. The Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, the Center for Tobacco Products and the Office of Regulatory Affairs each briefly discussed their specific research strategic needs and potential areas of collaboration. There were also updates from each of the NCTR Research Divisions.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
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 CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Science Advisory Board to the National Center for Toxicological Research 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 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 CommentNA
Number Of Recommendations*33Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 33 recommendations from FY-03 through 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,and 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*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 Science Advisory Board to the National Center for Toxicological Research supports FDA's strategic priorities by establishing, implementing and evaluating the research programs that assist the Commissioner of Food and Drugs in fulfilling her regulatory responsibilities. The Board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent to the mission of the FDA.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$21,800.00Est Payments to Non-Fed Members Next FY*$12,100.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$202,003.00Estimated Payments to Federal Staff*$203,025.00
Payments to Consultants*$7,650.00Est. Payments to Consultants Next FY*$2,200.00
Travel Reimb. For Non-Federal Members*$9,567.00Est Travel Reimb Non-Fed Members nextFY*$5,083.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$1,965.00Est. Travel Reimb to Fed Staff Next FY*$986.00
Travel Reimb. For Consultants*$2,394.00Est Travel Reimb to Consultants Next FY*$2,406.00
Other Costs$60,518.00Est. Other Costs Next FY*$55,815.00
Total Costs$305,897.00Est. Total Next FY*$281,615.00
Federal Staff Support (FTE)*1.00Est. Fed Staff Support Next FY*1.00
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

Category
Area
Animals
Veterinary Medicine
Food and Drugs
Food and Drugs
Medicine
Health and Health Research
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-036465Science Advisory Board to the National Center for Toxicological Research2019
 COM-034664Science Advisory Board to the National Center for Toxicological Research2018
 COM-001725Science Advisory Board to the National Center for Toxicological Research2017
 COM-002594Science Advisory Board to the National Center for Toxicological Research2016
 COM-004059Science Advisory Board to the National Center for Toxicological Research2015
 COM-004439Science Advisory Board to the National Center for Toxicological Research2014
 COM-005894Science Advisory Board to the National Center for Toxicological Research2013
 COM-006666Science Advisory Board to the National Center for Toxicological Research2012
 COM-008001Science Advisory Board to the National Center for Toxicological Research2011
 COM-008786Science Advisory Board to the National Center for Toxicological Research2010
 COM-010231Science Advisory Board to the National Center for Toxicological Research2009
 COM-010699Science Advisory Board to the National Center for Toxicological Research2008
 COM-011911Science Advisory Board to the National Center for Toxicological Research2007
 COM-012538Science Advisory Board to the National Center for Toxicological Research2006
 COM-014038Science Advisory Board to the National Center for Toxicological Research2005
 COM-014754Science Advisory Board to the National Center for Toxicological Research2004
 COM-015924Science Advisory Board to the National Center for Toxicological Research2003
 COM-016560Science Advisory Board to the National Center for Toxicological Research2002
 COM-017945Science Advisory Board to the National Center for Toxicological Research2001
 COM-018687Science Advisory Board to the National Center for Toxicological Research2000
 COM-019779Science Advisory Board to the National Center for Toxicological Research1999
 COM-020348Science Advisory Board to the National Center for Toxicological Research1998
 COM-021646Science Advisory Board to the National Center for Toxicological Research1997