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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 - 2026 - Transmissible Spongiform Encephalopathies Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameTransmissible Spongiform Encephalopathies Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2016Committee Number2026
Original Establishment Date11/28/1990Committee StatusTerminated
Actual Termination Date6/9/2016Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYYesMax Number of Members*16
Current Charter Date6/9/2014Designated Fed Officer Position Title*Center for Biologics Evaluation and Research, FDA
Date Of Renewal Charter6/9/2016Designated Federal Officer PrefixLCDR
Projected Termination Date Designated Federal Officer First Name*Bryan
Exempt From Renewal*NoDesignated Federal Officer Middle NameHatfield
Specific Termination Authority41 CFR Sec. 102-3.30(b)Designated Federal Officer Last Name*Emery
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixB.S.N., MA.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(240) 402-8054
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-595-1307
Exempt From EO 13875 Discretionary Cmte Designated Federal Officer Email*bryan.emery@fda.hhs.gov
Committee Type*Continuing
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 reviewed and evaluated available scientific data concerning the safety of products which may be at risk for the transmission of spongiform encephalopathies (TSE). The committee was terminated on June 9, 2016.
How is membership balanced?*Members were selected from academic and clinical practice settings and included authorities in the areas of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, public health, and other related professions. One member was technically qualified and identified with consumer interests. In addition, the Committee included a non-voting member to represent industry's interests. The committee was terminated on June 9, 2016.
How frequent & relevant are cmte mtgs?*The Committee did not meet during this reporting period. The committee was terminated on June 9, 2016.
Why advice can't be obtained elsewhere?*The committee was terminated on June 9, 2016. During the active period of the committee members of the committee were drawn from academia, research, clinical practice, consumer organizations, product recipients, and healthcare providers. Their advice and input was available to provide credibility to regulatory decisions made and was representative of the knowledge and experience as needed from informed sources. The alternate means of obtaining this advice would have involved the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensation.
Why close or partially close meetings?No meetings were closed during this reporting period.
Recommendation RemarksNo reports were required from this committee. Although this Committee did not meet in FY 2016 and was terminated on June 9, 2016, time was spent in the routine care and maintenance of the Committee; updating the roster and number of vacancies on the FDA website; completing the annual ethics report; reviewing financial disclosures of current members; and providing ethics training.
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 CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Transmissible Spongiform Encephalopathies 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 CommentNA
Number Of Recommendations*25Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made approximately 25 recommendations from FY2003 through FY2016. See 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 Comment*The Agency 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 tabacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Transmissible Spongiform Encephalopathies Advisory Committee supports FDA's mission and strategic action plan by reviewing and evaluating available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health. The Committee supports FDA's mission by using science-based efficient risk management in all of its activities. The Committee recommendations provide the most health promotion and protection at the least cost for the public. This Committee assists the Agency in ensuring timely, high, quality, cost-effective processes for review of new policies and guidelines, effective communication and working relationships with stakeholders to enhance U.S. and global health outcomes, accurately analyzing risks associated with medical products, facilitating the development and availability of medical countermeasures to limit the effects of a terrorist attack on the civilian and military populations, protecting the safety and security of biologics, including products that may be at risk for transmission of spongiform encephalopathies, all key components of FDA's strategic plan objectives. The committee was terminated on June 9, 2016.
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*$132,608.00Estimated 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*$6.00Est. 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$33,152.00Est. Other Costs Next FY*$0.00
Total Costs$165,766.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)*0.80Est. Fed Staff Support Next FY*0.00
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

No interest areas selected for this committee.
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-004008Transmissible Spongiform Encephalopathies Advisory Committee2015
 COM-004433Transmissible Spongiform Encephalopathies Advisory Committee2014
 COM-006124Transmissible Spongiform Encephalopathies Advisory Committee2013
 COM-006876Transmissible Spongiform Encephalopathies Advisory Committee2012
 COM-008278Transmissible Spongiform Encephalopathies Advisory Committee2011
 COM-009046Transmissible Spongiform Encephalopathies Advisory Committee2010
 COM-010088Transmissible Spongiform Encephalopathies Advisory Committee2009
 COM-010980Transmissible Spongiform Encephalopathies Advisory Committee2008
 COM-012204Transmissible Spongiform Encephalopathies Advisory Committee2007
 COM-012498Transmissible Spongiform Encephalopathies Advisory Committee2006
 COM-013952Transmissible Spongiform Encephalopathies Advisory Committee2005
 COM-014561Transmissible Spongiform Encephalopathies Advisory Committee2004
 COM-016018Transmissible Spongiform Encephalopathies Advisory Committee2003
 COM-016601Transmissible Spongiform Encephalopathies Advisory Committee2002
 COM-017653Transmissible Spongiform Encephalopathies Advisory Committee2001
 COM-018419Transmissible Spongiform Encephalopathies Advisory Committee2000
 COM-019805Transmissible Spongiform Encephalopathies Advisory Committee1999
 COM-020270Transmissible Spongiform Encephalopathies Advisory Committee1998
 COM-021740Transmissible Spongiform Encephalopathies Advisory Committee1997