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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 - 784 - Allergenic Products Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAllergenic Products Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number784
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*10
Current Charter Date7/9/2020Designated Fed Officer Position Title*DFO
Date Of Renewal Charter7/9/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Kathleen
Exempt From Renewal*NoDesignated Federal Officer Middle NameElizabeth
Specific Termination AuthorityDesignated Federal Officer Last Name*Hayes
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixM.P.H.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-7864
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-595-1307
Exempt From EO 13875 Discretionary CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*kathleen.hayes@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 Committee reviews and evaluates data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA's research programs which provide the scientific support for regulating these agents.
How is membership balanced?*Members are selected from academic and clinical practice settings and include authorities in the areas of allergy, immunology, pediatrics, internal medicine, and biochemistry. One member is technically qualified and identified with consumer interests. The Committee may also include one non-voting member to represent industry's interests.
How frequent & relevant are cmte mtgs?*In FY 2020, the Committee did not have any meetings. The anticipated and scheduled May, 2020 meeting was cancelled.
Per the charter this Committee is approved to meet approximately two times a year. It is anticipated that the Committee will meet at least once in FY 2021.
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 involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensations.
Why close or partially close meetings?There were no closed meetings to report for FY20.
Recommendation RemarksNo reports are required for this committee.
AC Member Kelly Stone was removed from the roster; member resigned in June of 2019 from initial FY2020 appointment.
AC Member Ray Stokes Peebles was removed from the roster; member resigned prior to fulfilling FY 2020 appointment.
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 an investigational 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 Allergenic 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*20Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 20 recommendations from FY2003 through FY2020.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.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*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 management for organizational excellence and accountability. The Allergenic Products Advisory Committee supports FDA's mission and strategic action plan by reviewing and evaluating available data relating to the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention or treatment of allergies and allergic disease. 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 are all key components of FDA's strategic plan objectives.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$0.00Est Payments to Non-Fed Members Next FY*$6,600.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$550.00
Payments to Federal Staff*$201,494.00Estimated Payments to Federal Staff*$172,183.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$7,700.00
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$50,373.00Est. Other Costs Next FY*$43,046.00
Total Costs$251,867.00Est. Total Next FY*$230,079.00
Federal Staff Support (FTE)*1.25Est. Fed Staff Support Next FY*1.10
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Treatment
Medicine
Diseases
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-036512Allergenic Products Advisory Committee2019
 COM-034720Allergenic Products Advisory Committee2018
 COM-001922Allergenic Products Advisory Committee2017
 COM-002372Allergenic Products Advisory Committee2016
 COM-004061Allergenic Products Advisory Committee2015
 COM-004503Allergenic Products Advisory Committee2014
 COM-006214Allergenic Products Advisory Committee2013
 COM-006901Allergenic Products Advisory Committee2012
 COM-008276Allergenic Products Advisory Committee2011
 COM-009078Allergenic Products Advisory Committee2010
 COM-010080Allergenic Products Advisory Committee2009
 COM-011000Allergenic Products Advisory Committee2008
 COM-012252Allergenic Products Advisory Committee2007
 COM-012634Allergenic Products Advisory Committee2006
 COM-014065Allergenic Products Advisory Committee2005
 COM-014535Allergenic Products Advisory Committee2004
 COM-015941Allergenic Products Advisory Committee2003
 COM-016576Allergenic Products Advisory Committee2002
 COM-017999Allergenic Products Advisory Committee2001
 COM-018729Allergenic Products Advisory Committee2000
 COM-019718Allergenic Products Advisory Committee1999
 COM-020368Allergenic Products Advisory Committee1998
 COM-021407Allergenic Products Advisory Committee1997