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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameBlood Products Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number224
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*18
Current Charter Date5/13/2018Designated Fed Officer Position Title*Center for Biologics Evaluation and Research, FDA
Date Of Renewal Charter5/13/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Christina
Exempt From Renewal*NoDesignated Federal Officer Middle NameMarie
Specific Termination AuthorityDesignated Federal Officer Last Name*Vert
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixM.S.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*240-402-8054
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-595-1309
Committee Type*ContinuingDesignated Federal Officer Email*christina.vert@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 data on the safety and effectiveness of blood products intended for use in the diagnosis, prevention or treatment of human diseases. On June 22, 2018, the Blood Products Advisory Committee (BPAC) participated in a partially closed meeting in person and in teleconference. In open session, the Committee heard presentations on the research programs in the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and TSE Agents (LBTSE) and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA. After the conclusion of the open session, the meeting was closed to the public from 12:55 p.m. to 1:40 p.m. to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). The recommendations of the advisory committee regarding the progress of the investigator’s research will, along with other information, be used in making decisions regarding pay adjustments of service fellows or promotion and permanent staff regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.
In the afternoon, in open session, under Topic II, the Committee heard presentations on the research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA. After the open session, the meeting was closed to the public from 3:45 p.m. to 4:20 p.m. to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). The recommendations of the advisory committee regarding the progress of the investigator’s research will, along with other information, be used in making decisions regarding pay adjustments of service fellows or promotion and permanent staff regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.
How is membership balanced?*The committee consists of experts in clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biotechnology, and other related specialties. One member is technically qualified and identified with consumer interests and one non-voting member represents the point of view of industry.
How frequent & relevant are cmte mtgs?*The committee held four meetings and conducted two intramural research site visits in FY 2018. With the increasing concern on issues relative to blood and blood safety and the rapid growth of biotechnology products, it is anticipated that the workload of this committee will be demanding. Six meetings and four intramural site reviews are planned for FY 2019.
Why advice can't be obtained elsewhere?*Members of the committee are drawn from academia, research, clinical practice, and consumer interests. Their advice and input lends credibility to regulatory decisions made and has representatives of knowledge and experience needed from informed sources. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensations.
Why close or partially close meetings?FDA is required to close portions of meetings to permit discussion of personal information that constitutes an unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).
Recommendation RemarksNo reports are required from this committee. Waiting for two meeting minutes to be approved by OBRR in order to post on the web and create the minute links for appropriate meetings.
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 Blood Products 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*112Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 112 recommendations from FY2003 through FY2018. See 20a of the Annual Report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%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*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 CommentThe 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 Blood Product Advisory Committee supports FDA's mission and strategic action plan by reviewing and evaluating data on the safety and effectiveness of blood products intended for use in the diagnosis, prevention or treatment of human diseases. The Committee also considers the quality and relevance of FDA's research program which, provides scientific support for the regulation of these products. The Committee supports FDA's mission by using science-based 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 technologies/pre-market submissions, 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 (vaccines, blood, and blood products) all key components of FDA's strategic plan objectives.
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-001614Blood Products Advisory Committee2017
 COM-002604Blood Products Advisory Committee2016
 COM-003858Blood Products Advisory Committee2015
 COM-004545Blood Products Advisory Committee2014
 COM-006090Blood Products Advisory Committee2013
 COM-006546Blood Products Advisory Committee2012
 COM-008407Blood Products Advisory Committee2011
 COM-008764Blood Products Advisory Committee2010
 COM-010019Blood Products Advisory Committee2009
 COM-010706Blood Products Advisory Committee2008
 COM-011985Blood Products Advisory Committee2007
 COM-012687Blood Products Advisory Committee2006
 COM-013802Blood Products Advisory Committee2005
 COM-014500Blood Products Advisory Committee2004
 COM-015942Blood Products Advisory Committee2003
 COM-016554Blood Products Advisory Committee2002
 COM-017916Blood Products Advisory Committee2001
 COM-018726Blood Products Advisory Committee2000
 COM-019774Blood Products Advisory Committee1999
 COM-020377Blood Products Advisory Committee1998
 COM-021428Blood Products Advisory Committee1997
 COM-034727Blood Products Advisory Committee2018