Allergenic Products Advisory Committee

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Allergenic Products Advisory Committee
Type: Boards, Commissions, and Committees
Parent organization: Food and Drug Administration
Top organization: Department of Health and Human Services
Employees: 9
Executive: Chairperson
Budget: $336,686 (FY 2024 estimate)
Address: 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
Website: https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee
Creation Legislation:
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Allergenic Products Advisory Committee
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Mission
The Allergenic Products Advisory Committee advised the FDA on the safety, effectiveness, and labeling of allergenic biological products for human use until its termination in 2024. It evaluated data on products for allergy diagnosis, prevention, and treatment, providing recommendations to the FDA Commissioner to ensure public health standards.
Services

Safety and efficacy reviews; labeling recommendations; research program evaluations

Regulations


Allergenic Products Advisory Committee (APAC) was an advisory body within the Food and Drug Administration (FDA), established on July 9, 1984, to assess allergenic biological products like extracts used for diagnosing and treating allergies, until its termination on July 9, 2024. Comprising nine core voting members with expertise in allergy, immunology, and related fields, APAC reviewed data on safety, efficacy, and labeling, holding infrequent meetings—such as those in 2016, 2019, and 2021—before its duties were absorbed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) due to low utilization.

Official Site

Mission

The Allergenic Products Advisory Committee aimed to assist the FDA in ensuring the safety and effectiveness of allergenic biological products administered to humans for allergy-related purposes, including diagnosis, prevention, and treatment. It provided expert recommendations on product licensing, clinical studies, and FDA research until its termination in 2024, when its responsibilities shifted to VRBPAC to maintain oversight efficiency.[1]

Parent organization

The Allergenic Products Advisory Committee operated under the Food and Drug Administration, specifically within the Center for Biologics Evaluation and Research (CBER). Its top organization was the Department of Health and Human Services, which oversees FDA activities and public health policy.[2]

Legislation

The APAC was established on July 9, 1984, under FDA authority (15 U.S.C. 1451 et seq.; 21 U.S.C. 321 et seq.) and governed by the Federal Advisory Committee Act of 1972, which authorizes advisory bodies to support federal agencies. It was terminated on July 9, 2024, as announced in the Federal Register (89 FR 55827), due to infrequent use.[3]

Partners

The APAC collaborated with:

Number of employees

The APAC had nine core voting members, including the Chairperson, appointed for their expertise; no full-time staff were directly employed, with support provided by FDA CBER personnel.[5]

Organization structure

The APAC was a single-tier advisory body with no sub-organizations:

  • Core Voting Members evaluated allergenic product data and advised the FDA.
  • Temporary Members were added as needed for specific expertise during meetings.

Leader

The Allergenic Products Advisory Committee was headed by a Chairperson, selected by the FDA Commissioner or designee.[6]

Divisions

The APAC had no formal divisions but convened:

  • Ad Hoc Panels for specific product reviews, such as Peanut Allergen Powder in 2019.[7]

List of programs

The APAC supported:

Last total enacted budget

The APAC’s estimated annual cost for FY 2024 was $336,686, covering member compensation ($128,055) and 1.1 person-years of FDA staff support ($208,631), per its final charter before termination.[9]

Staff

The APAC’s nine voting members were appointed experts serving up to four-year terms, supported by a Designated Federal Officer and FDA staff (1.1 person-years); it had no direct employees.[10]

Funding

The APAC was funded through the FDA’s budget within the Department of Health and Human Services, covering member expenses and staff support, with no independent funding sources until its 2024 termination.[11]

Services provided

The APAC reviewed data on allergenic biological products’ safety, effectiveness, and labeling, advised on licensing and clinical studies, and evaluated CBER research programs, such as the Laboratory of Immunobiochemistry in 2021, until its duties transferred to VRBPAC.[12]

Regulations overseen

The APAC did not oversee regulations but advised under FDA jurisdiction, including 21 CFR Part 14, governing advisory committees, until its termination.[13]

Headquarters address

The headquarters address, as listed on Google Maps, was 10903 New Hampshire Ave, Silver Spring, MD 20993, USA, within the FDA White Oak Campus until termination.

History

Established on July 9, 1984, the Allergenic Products Advisory Committee advised the FDA on allergenic biologics for 40 years, with notable reviews like Peanut Allergen Powder (2019) and safety/efficacy endpoints (2016). Terminated on July 9, 2024, due to infrequent meetings (e.g., four since 2016), its responsibilities merged into VRBPAC per Federal Register notice 89 FR 55827, reflecting cost-efficiency measures.[14]

External links

References

  1. ↑ "Allergenic Products Advisory Committee". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee. 
  2. ↑ "About Advisory Committees". Food and Drug Administration. https://www.fda.gov/advisory-committees/about-advisory-committees. 
  3. ↑ "APAC Termination". Federal Register. July 10, 2024. https://www.federalregister.gov/documents/2024/07/10/2024-15136/advisory-committee-allergenic-products-advisory-committee-termination-removal-from-list-of-standing. 
  4. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  5. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  6. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  7. ↑ "2019 Meeting Materials". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/2019-meeting-materials-allergenic-products-advisory-committee. 
  8. ↑ "APAC Meeting Materials". Food and Drug Administration. https://www.fda.gov/advisory-committees/committees-and-meeting-materials/allergenic-products-advisory-committee. 
  9. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  10. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  11. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  12. ↑ "Allergenic Products Advisory Committee". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee. 
  13. ↑ "APAC Charter". Food and Drug Administration. https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-products-advisory-committee. 
  14. ↑ "APAC Termination". Federal Register. July 10, 2024. https://www.federalregister.gov/documents/2024/07/10/2024-15136/advisory-committee-allergenic-products-advisory-committee-termination-removal-from-list-of-standing. 
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