Allergenic Products Advisory Committee: Difference between revisions
No edit summary |
m (Text replacement - "{{Organization" to "Catergory:Orgs {{Organization") Tag: Reverted |
||
| Line 1: | Line 1: | ||
{{ | [[Catergory:Orgs]] | ||
|OrganizationName=Allergenic Products Advisory Committee | {{<span class="error">Expansion depth limit exceeded</span>|OrganizationName=Allergenic Products Advisory Committee | ||
|OrganizationType=Boards, Commissions, and Committees | |OrganizationType=Boards, Commissions, and Committees | ||
|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. | |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. | ||
| Line 18: | Line 18: | ||
'''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. | '''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. | ||
{{ | {{<span class="error">Expansion depth limit exceeded</span>|url=https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee}} | ||
==Mission== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Parent organization== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Legislation== | ==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 [https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-app-federal.pdf 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.< | 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 [https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-app-federal.pdf 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Partners== | ==Partners== | ||
| Line 36: | Line 36: | ||
The APAC collaborated with: | The APAC collaborated with: | ||
* [[Center for Biologics Evaluation and Research]] for scientific support | * [[Center for Biologics Evaluation and Research]] for scientific support | ||
* Industry and consumer representatives as non-voting members during meetings< | * Industry and consumer representatives as non-voting members during meetings<span class="error">Expansion depth limit exceeded</span> | ||
==Number of employees== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Organization structure== | ==Organization structure== | ||
| Line 50: | Line 50: | ||
===Leader=== | ===Leader=== | ||
The Allergenic Products Advisory Committee was headed by a Chairperson, selected by the FDA Commissioner or designee.< | The Allergenic Products Advisory Committee was headed by a Chairperson, selected by the FDA Commissioner or designee.<span class="error">Expansion depth limit exceeded</span> | ||
===Divisions=== | ===Divisions=== | ||
The APAC had no formal divisions but convened: | The APAC had no formal divisions but convened: | ||
* Ad Hoc Panels for specific product reviews, such as Peanut Allergen Powder in 2019.< | * Ad Hoc Panels for specific product reviews, such as Peanut Allergen Powder in 2019.<span class="error">Expansion depth limit exceeded</span> | ||
==List of programs== | ==List of programs== | ||
The APAC supported: | The APAC supported: | ||
* Product Review Meetings - https://www.fda.gov/advisory-committees/committees-and-meeting-materials/allergenic-products-advisory-committee< | * Product Review Meetings - https://www.fda.gov/advisory-committees/committees-and-meeting-materials/allergenic-products-advisory-committee<span class="error">Expansion depth limit exceeded</span> | ||
==Last total enacted budget== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Staff== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Funding== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Services provided== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==Regulations overseen== | ==Regulations overseen== | ||
The APAC did not oversee regulations but advised under FDA jurisdiction, including 21 CFR Part 14, governing advisory committees, until its termination.< | The APAC did not oversee regulations but advised under FDA jurisdiction, including 21 CFR Part 14, governing advisory committees, until its termination.<span class="error">Expansion depth limit exceeded</span> | ||
==Headquarters address== | ==Headquarters address== | ||
| Line 88: | Line 88: | ||
==History== | ==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.< | 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.<span class="error">Expansion depth limit exceeded</span> | ||
==External links== | ==External links== | ||
| Line 98: | Line 98: | ||
==References== | ==References== | ||
< | <span class="error">Expansion depth limit exceeded</span> | ||
Revision as of 09:20, 2 March 2025
Catergory:Orgs {{Expansion depth limit exceeded|OrganizationName=Allergenic Products Advisory Committee |OrganizationType=Boards, Commissions, and Committees |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. |OrganizationExecutive=Chairperson |Employees=9 |Budget=$336,686 (FY 2024 estimate) |Website=https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee |Services=Safety and efficacy reviews; labeling recommendations; research program evaluations |ParentOrganization=Food and Drug Administration |TopOrganization=Department of Health and Human Services |CreationLegislation= |Regulations= |HeadquartersLocation=39.033750, -76.982750 |HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993, USA }}
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.
{{Expansion depth limit exceeded|url=https://www.fda.gov/advisory-committees/allergenic-products-advisory-committee}}
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
Partners
The APAC collaborated with:
- Center for Biologics Evaluation and Research for scientific support
- Industry and consumer representatives as non-voting members during meetingsExpansion depth limit exceeded
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
Divisions
The APAC had no formal divisions but convened:
- Ad Hoc Panels for specific product reviews, such as Peanut Allergen Powder in 2019.Expansion depth limit exceeded
List of programs
The APAC supported:
- Product Review Meetings - https://www.fda.gov/advisory-committees/committees-and-meeting-materials/allergenic-products-advisory-committeeExpansion depth limit exceeded
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
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.Expansion depth limit exceeded
Regulations overseen
The APAC did not oversee regulations but advised under FDA jurisdiction, including 21 CFR Part 14, governing advisory committees, until its termination.Expansion depth limit exceeded
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.Expansion depth limit exceeded
External links
References
Expansion depth limit exceeded
