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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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 5147 - Advisory Committee on Blood and Tissue Safety and Availability - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAdvisory Committee on Blood and Tissue Safety and AvailabilityAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number5147
Original Establishment Date10/9/1996Committee StatusChartered
Actual Termination Date Committee URLhttps://www.hhs.gov/oidp/advisory-committee/blo...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*29
Current Charter Date10/9/2020Designated Fed Officer Position Title*Senior Advisor for Blood and Tissue Policy
Date Of Renewal Charter10/9/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*James
Exempt From Renewal*NoDesignated Federal Officer Middle NameJ.
Specific Termination AuthorityDesignated Federal Officer Last Name*Berger
Establishment Authority*Authorized by LawDesignated Federal Officer Suffix
Specific Establishment Authority*42 USC 217a, Sec 222, Public Health Service ActDesignated Federal Officer Phone*(202) 795-7608
Effective Date Of Authority*10/17/1962Designated Federal Officer Fax*202 691-2102
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*james.berger@hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*National Policy Issue 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 ACBTSA provides recommendations to the Secretary, through the Assistant Secretary for Health, on blood and tissue safety and availability. To accomplish its mission, the Committee collaborates with external and internal stakeholders. Subject to approval of the Secretary or designee, the Committee establishes subcommittees to obtain assistance for carrying out its mission. The established subcommittees provide information on issues for which additional data is needed for the Committee to develop recommendations that are submitted to the Secretary. The subcommittees discuss and pursue objectives in cooperation with other external and internal stakeholders. Recommendations developed by the subcommittees are given to the Committee for discussion and consideration for them to be forwarded to the Secretary.
How is membership balanced?*The Committee consists of 23 voting members appointed by the Secretary and 6 non-voting ex-officio federal members. In appointing members, the Secretary shall ensure that the Committee includes a diverse group of patient advocates, scientific and health professionals. The Committee is composed of 14 public members, including the Chair, who are selected from State and local organizations, patient advocacy groups, provider organizations, academic researchers, ethicists, physicians, surgeons, scientists, risk communication experts, consumer advocates, legal organizations, and from among communities of persons who are frequent recipients of blood or blood products or have received cells, tissues or organs. While there is no prescribed formula for distribution of membership, every attempt is made to ensure that there is equal and diverse representation. In addition, the membership includes 9 individuals who are designated to serve as official representative members of the blood, blood product, cell, tissue and organ professional organizations or business sectors. These members include representatives from the AABB, American Association of Tissue Banks (AATB), the Association of Organ Procurement Organizations(AOPO), one of either the American National Red Cross (ARC) or America’s Blood Centers (ABC) on a rotating basis. The Committee composition can include additional representation from either the plasma protein fraction community or a trade organization; a manufacturer of blood, plasma or other tissue/organ test kits; a manufacturer of blood, plasma, or other tissue/organ equipment; and a major hospital organization or major hospital accreditation organization. Where more than one company produces a specified product or process, representatives from those companies shall rotate on the same schedule as public members. Composition of the Committee membership includes physicians, representatives of the blood and plasma and hospital and medical devices communities, and consumer representatives.
How frequent & relevant are cmte mtgs?*The Committee meets, at a minimum, one time a year. The Committee will hold additional meetings during the year, depending on the availability of funds and public health requirements. At the Committee meetings, the members receive information from various outside sources and then formulate policy recommendations to be given to the Secretary.
Why advice can't be obtained elsewhere?*The Advisory Committee on Blood and Tissue Safety and Availability provides advice to the Secretary, through the Assistant Secretary for Health, on a range of policy issues to include: (1) identification of public health issues that affect safety and availability of blood supply and blood products; (2) broad public health, ethical and legal issues related to transfusion and transplantation safety; (3) the implications of various economic factors affecting product cost and supply on safety and availability; and (4) risk communications related to these products. These public health concerns require actions that are inherently governmental, thus requiring the framework of FACA to gather advice.
Why close or partially close meetings?All meetings of the Committee have been and will continue to be open to the public. Since June 2010, all Committee meetings have been webcast.
Recommendation RemarksThrough its collaborative efforts with external and internal stakeholders, the Committee has found that maintaining an adequate supply of safe blood for transfusion is integral to public health and a national priority; and instability in the blood centers threatens to exacerbate existing spot blood shortages, reduce resilience in the face of public health emergencies through elimination of surge capacity, and reduce ability to provide the most appropriate routine and specialty products and services. These findings and others indicate a clear and present need to address the immediate crisis and to manage a longer term paradigm shift to stabilize blood centers in the U.S. and to ensure that the continued safety and availability of the U.S. blood supply meets the public health needs.
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 PaymentsYes
Outcome Improved Service DeliveryYesAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentThe Committee has worked with HHS operating divisions to realign priorities and provide clarification in some areas for transfusion and transplantation safety.
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 CommentImproved quality care through increased safety and availability of blood, blood products, plasma clotting factors, tissue products and transplantation safety is difficult to measure. Many recommendations are made which influence policy and the prevention of disease.Grants Review CommentNA
Number Of Recommendations*186Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee worked on and submitted three recommendations to the Assistant Secretary for Health in FY22.Access Agency WebsiteYes
% of Recs Fully Implemented*30.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentRecommendations made during previous fiscal years are long-term recommendations requiring coordination and collaboration within HHS.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*20.00%Access PublicationsYes
% of Recs Partially Implemented CommentMany of the recommendations require long-term action which can not be accomplished in a fiscal year.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*Internally the recommendations are provided to the PHS agencies which support the ACBTSA. These recommendations are discussed, if needed, at the Blood, Organ, and Tissue Senior Executive Council (BOTSEC) as described in the internal charter. Feedback is provided to the ACBTSA through direct communication that the DFO has with the Assistant Secretary for Health. The DFO provides this information initially to the Committee Chair and then to the Committee at the next scheduled public meeting. The DFO provides the Committee information on the progress and outcome.Narrative Description*The Secretary is responsible under Sections 301, 351, and 361 of the Public Health Service Act, as amended (42 U.S. Code 241, 262, 264), and various provisions of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), for carrying out research in health fields including diseases involving blood and blood products, and for issuing and enforcing regulations concerning the collection, preparation, and distribution of blood and blood products, and regulations related to the transmission of communicable diseases. The Advisory Committee on Blood and Tissue Safety and Availability advises, assists, consults with, and makes policy recommendations to the Secretary, through the Assistant Secretary for Health, regarding these broad responsibilities. In FY2022, the committee discussed a recommendation to modify the PHS Guidelines pertaining to blood testing requirements for pediatric organ transplantation. Additionally, building off FY21 work, the committee submitted recommendations related to supply chain resiliency, and data collection/infrastructure framework.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$0.00Est Payments to Non-Fed Members Next FY*$0.00
Payments to Federal Members*$2,531.52Est. Payments to Fed Members Next FY*$5,063.04
Payments to Federal Staff*$359,465.88Estimated Payments to Federal Staff*$340,000.00
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$275,000.00Est. Other Costs Next FY*$259,981.00
Total Costs$636,997.40Est. Total Next FY*$605,044.04
Date Cost Last Modified11/8/2022 1:34 PMEst. Fed Staff Support Next FY*2.00
Federal Staff Support (FTE)*2.00Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Health
Health Care
Safety
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 - SUBCOMMITTEES

SUBCOMMITTEES

Committee

Subcommittees

ActionCommittee System IDSubcommittee NameFiscal Year
 COM-039629Meeting Topic and Agenda2022
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-040393Advisory Committee on Blood and Tissue Safety and Availability2021
 COM-038671Advisory Committee on Blood and Tissue Safety and Availability2020
 COM-036541Advisory Committee on Blood and Tissue Safety and Availability2019
 COM-034753Advisory Committee on Blood and Tissue Safety and Availability2018
 COM-001878Advisory Committee on Blood and Tissue Safety and Availability2017
 COM-002235Advisory Committee on Blood and Tissue Safety and Availability2016
 COM-003790Advisory Committee on Blood and Tissue Safety and Availability2015
 COM-004717Advisory Committee on Blood and Tissue Safety and Availability2014
 COM-006273Advisory Committee on Blood and Tissue Safety and Availability2013
 COM-006547Advisory Committee on Blood Safety and Availability2012
 COM-008273Advisory Committee on Blood Safety and Availability2011
 COM-008732Advisory Committee on Blood Safety and Availability2010
 COM-010333Advisory Committee on Blood Safety and Availability2009
 COM-010729Advisory Committee on Blood Safety and Availability2008
 COM-011869Advisory Committee on Blood Safety and Availability2007
 COM-012815Advisory Committee on Blood Safety and Availability2006
 COM-013961Advisory Committee on Blood Safety and Availability2005
 COM-014610Advisory Committee on Blood Safety and Availability2004
 COM-015950Advisory Committee on Blood Safety and Availability2003
 COM-016376Advisory Committee on Blood Safety and Availability2002
 COM-017585Advisory Committee on Blood Safety and Availability2001
 COM-018429Advisory Committee on Blood Safety and Availability2000
 COM-019648Advisory Committee on Blood Safety and Availability1999
 COM-020624Advisory Committee on Blood Safety and Availability1998
 COM-021445Advisory Committee on Blood Safety and Availability1997