FACACLASSIC

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 - 784 - Allergenic Products Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Allergenic Products Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2024	Committee Number	784
Original Establishment Date	11/28/1990	Committee Status	Terminated
Actual Termination Date	7/9/2024	Committee URL	https://www.fda.gov/advisory-committees/blood-v...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	10
Terminated This FY	Yes	Designated Fed Officer Position Title*	DFO
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	7/9/2022	Designated Federal Officer First Name*	Valerie
Date Of Renewal Charter	7/9/2024	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Vashio
Exempt From Renewal*	No	Designated Federal Officer Suffix	BPharm
Specific Termination Authority		Designated Federal Officer Phone*	301-796-5106
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	301-595-1307
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	valerie.vashio@fda.hhs.gov
Effective Date Of Authority*	11/28/1990
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Terminate
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	Prior to its termination, the Committee reviewed and evaluated 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. It also made recommendations to the Commissioner of Food and Drugs 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 were selected from academic and clinical practice settings and include authorities in the areas of allergy, immunology, pediatrics, internal medicine, and biochemistry. One member was technically qualified and identified with consumer interests. The Committee also included one non-voting member to represent industry's interests.
How frequent & relevant are cmte mtgs?*	In FY 2024, no Advisory Committee meetings were held.
Why advice can't be obtained elsewhere?*	The committee is no longer needed and has been terminate since July 2024.
Why close or partially close meetings?	There were no open or closed meetings to report for FY24.
Recommendation Remarks	Although this committee did not meet in FY 2024, time was devoted to termination consultation. Since the Committee did not meet, no reporting was required.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve investigational new medical products.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	Prior to its termination, the utilization of the Allergenic Products Advisory Committee enabled 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 Comment	NA
Number Of Recommendations*	21	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 21 recommendations from FY2003 through FY2024.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	16.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	NA
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 management for organizational excellence and accountability. Prior to its termination, the Allergenic Products Advisory Committee supported 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 considered the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products. The Committee supported FDA's mission by using science-based risk management in all of its activities. The Committee's recommendations provided the most health promotion and protection at the least cost for the public. This Committee assisted 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.

COSTS

1. Payments to Non-Federal Members*	$0.00	1. Est Paymnts to Non-Fed Membrs Nxt FY*	$0.00
2. Payments to Federal Members*	$0.00	2. Est. Payments to Fed Members Next FY*	$0.00
3. Payments to Federal Staff*	$317,685.00	3. Estimated Payments to Federal Staff*	$0.00
4. Payments to Consultants*	$0.00	4. Est. Payments to Consultants Next FY*	$0.00
5. Travel Reimb. For Non-Federal Membrs*	$0.00	5. Est Travel Reimb Non-Fed Membr nxtFY*	$0.00
6. Travel Reimb. For Federal Members*	$0.00	6. Est Travel Reimb For Fed Members*	$0.00
7. Travel Reimb. For Federal Staff*	$0.00	7. Est. Travel Reimb to Fed Staf Nxt FY*	$0.00
8. Travel Reimb. For Consultants*	$0.00	8. Est Travel Reimb to Consltnts Nxt FY*	$0.00
10. Other Costs	$79,421.00	10. Est. Other Costs Next FY*	$0.00
11. Total Costs	$397,106.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	9/18/2024 9:58 AM	Est. Fed Staff Support Next FY*	0.00
Federal Staff Support (FTE)*	1.60	Est Cost Remarks	APAC Committee was officially terminated as of 7.2024
Cost Remarks	Costs were Federal staff pertaining to committee management activities

Interest Areas

Category Area Food and Drugs Food and Drugs Health Treatment Medicine Diseases

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