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FDA is organized into various offices and centers that carry out the agency\u2019s regulatory responsibilities. The Office of the Commissioner and four other program area offices oversee the core functions of the agency: the Office of Medical Products and Tobacco, the Office of Foods and Veterinary Medicine, the Office of Global Regulatory Operations and Policy, and the Office of Operations. The Office of Medical Products and Tobacco includes the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Tobacco Products (CTP). The Office of Foods and Veterinary Medicine includes the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). The National Center for Toxicological Research (NCTR) is housed within the Office of the Commissioner. \nFDA\u2019s total program level, the amount that FDA can spend, is composed of discretionary appropriations from two different sources: annual appropriations (i.e., discretionary budget authority, or BA) and user fees paid by the regulated industry (e.g., drug manufacturers). In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2016 and FY2020, FDA\u2019s enacted total program level increased from $4.747 billion to $5.921 billion. Over this time period, congressionally appropriated funding increased by 19%, and user fee revenue increased by 33%. The Administration\u2019s FY2021 budget request for a total program level of $6.044 billion would be an increase of $123 million (+2%) over the FY2020-enacted amount ($5.921 billion). This report will be updated with information on FDA funding for FY2021 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R44576", "sha1": "d070350582cb96c5fe8ab553f564f42e7b715778", "filename": "files/20200402_R44576_d070350582cb96c5fe8ab553f564f42e7b715778.html", "images": { "/products/Getimages/?directory=R/html/R44576_files&id=/0.png": "files/20200402_R44576_images_1bd2c728a8b87b01060f17b35d0219b33711fca9.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R44576", "sha1": "dde7c88f5d93ee1d50e8ddbd7f302254b6938ce6", "filename": "files/20200402_R44576_dde7c88f5d93ee1d50e8ddbd7f302254b6938ce6.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" }, { "source": "IBCList", "id": 4920, "name": "Agriculture Appropriations" } ] }, { "source": "EveryCRSReport.com", "id": 597946, "date": "2019-05-08", "retrieved": "2019-05-08T22:04:06.261535", "title": "The Food and Drug Administration (FDA) Budget: Fact Sheet", "summary": "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. FDA is organized into various offices and centers that carry out the agency\u2019s regulatory responsibilities. The Office of the Commissioner and four other program area offices oversee the core functions of the agency: the Office of Medical Products and Tobacco, the Office of Foods and Veterinary Medicine, the Office of Global Regulatory Operations and Policy, and the Office of Operations. The Office of Medical Products and Tobacco includes the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Tobacco Products (CTP), while the Office of Foods and Veterinary Medicine includes the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). The National Center for Toxicological Research (NCTR) is housed within the Office of the Commissioner. \nFDA\u2019s total program level, the amount that FDA can spend, is composed of discretionary appropriations from two different sources: annual appropriations (i.e., discretionary budget authority, or BA) and user fees paid by the regulated industry (e.g., drug manufacturers). In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2015 and FY2019, FDA\u2019s enacted total program level increased from $4.507 billion to $5.725 billion. Over this time period, congressionally appropriated funding increased by 21%, and user fee revenue increased by 35%. The Administration\u2019s FY2020 budget request was for a total program level of $5.981 billion, an increase of $256 million (+4%) over the FY2019-enacted amount ($5.725 billion). This report will be updated with information on FDA funding for FY2020 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R44576", "sha1": "7fb479c5dc5df45adcb3ab9b3d42b5d34c68f2c3", "filename": "files/20190508_R44576_7fb479c5dc5df45adcb3ab9b3d42b5d34c68f2c3.html", "images": { "/products/Getimages/?directory=R/html/R44576_files&id=/0.png": "files/20190508_R44576_images_fa72247e867dd5c049983e4ebb2049ab5eea947f.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R44576", "sha1": "2584438761cef9cafc63c1bdf44ecca14f9b9335", "filename": "files/20190508_R44576_2584438761cef9cafc63c1bdf44ecca14f9b9335.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 585322, "date": "2018-09-12", "retrieved": "2019-04-18T13:46:12.117353", "title": "The Food and Drug Administration (FDA) Budget: Fact Sheet", "summary": "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. FDA is organized into various offices and centers that carry out the agency\u2019s regulatory responsibilities. The Office of the Commissioner and four other program area offices oversee the core functions of the agency: the Office of Medical Products and Tobacco, the Office of Foods and Veterinary Medicine, the Office of Global Regulatory Operations and Policy, and the Office of Operations. The Office of Medical Products and Tobacco includes the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Tobacco Products (CTP), while the Office of Foods and Veterinary Medicine includes the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). The National Center for Toxicological Research (NCTR) is housed within the Office of the Commissioner. \nFDA\u2019s budget has two funding streams: annual appropriations (i.e., discretionary budget authority, or BA) and industry user fees. In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2014 and FY2018, FDA\u2019s enacted total program level increased from $4.387 billion to $5.269 billion. Over this time period, congressionally appropriated funding increased by 12%, and user fee revenue increased by 31%. The Administration\u2019s FY2019 budget request was for a total program level of $5.772 billion, an increase of $503 million (+9%) over the FY2018-enacted amount ($5.269 billion). This report will be updated with information on FDA funding for FY2019 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R44576", "sha1": "d59baa892d887c07fe83dc714bbd32664adf5a2c", "filename": "files/20180912_R44576_d59baa892d887c07fe83dc714bbd32664adf5a2c.html", "images": { "/products/Getimages/?directory=R/html/R44576_files&id=/0.png": "files/20180912_R44576_images_e3e2fd839839a984faa9248a904954e7b2002e1e.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R44576", "sha1": "464ee5186cf877ee17d12cb5d3e427a265fecc16", "filename": "files/20180912_R44576_464ee5186cf877ee17d12cb5d3e427a265fecc16.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 462549, "date": "2017-07-10", "retrieved": "2018-05-10T12:59:35.482358", "title": "The Food and Drug Administration (FDA) Budget: Fact Sheet", "summary": "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. Seven centers within FDA represent the broad program areas for which the agency has responsibility: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), and the Center for Tobacco Products (CTP). Several other offices have agency-wide responsibilities. \nFDA\u2019s budget has two funding streams: annual appropriations (i.e., discretionary budget authority, or BA) and industry user fees. In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2012 and FY2017, FDA\u2019s total program level increased from $3.832 billion to $4.745 billion. Although congressionally appropriated funding increased by 11% over that time period, user fee revenue increased more than 47%. The Administration\u2019s FY2018 budget request was for a total program level of $5.112 billion, an increase of $367 million (+8%) over the FY2017 amount ($4.745 billion). This report will be updated with information on FDA funding for FY2018 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44576", "sha1": "9292268db6e84ac25ef41110a57c15d717a7ceee", "filename": "files/20170710_R44576_9292268db6e84ac25ef41110a57c15d717a7ceee.html", "images": { "/products/Getimages/?directory=R/html/R44576_files&id=/0.png": "files/20170710_R44576_images_f6e98d16359cfcb395e54b01879c866c102aa3b8.png" } }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44576", "sha1": "c73952528c8fe2a1db9e87da636cbec37e5936f2", "filename": "files/20170710_R44576_c73952528c8fe2a1db9e87da636cbec37e5936f2.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 456290, "date": "2016-10-05", "retrieved": "2016-11-28T21:27:48.076127", "title": "The Food and Drug Administration (FDA) Budget: Fact Sheet", "summary": "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. Seven centers within FDA represent the broad program areas for which the agency has responsibility: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), and the Center for Tobacco Products (CTP). Several other offices have agency-wide responsibilities. \nFDA\u2019s budget has two funding streams: annual appropriations (i.e., discretionary budget authority, or BA) and industry user fees. In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2012 and FY2016, FDA\u2019s total program level increased from $3.832 billion to $4.745 billion. Although congressionally appropriated funding increased by 9% over that time period, user fee revenue increased more than 50%. The President\u2019s FY2017 budget request was for a total program level of $4.826 billion, an increase of $81 million (+2%) over the FY2016 enacted appropriation of $4.745 billion. Both the House and Senate Appropriations Committees have reported their FY2017 Agriculture appropriations bills (H.R. 5054, S. 2956). This report will be updated with information on FDA funding for FY2017 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44576", "sha1": "9653ec22c1503a63a5cb4bdd5106423457b099d5", "filename": "files/20161005_R44576_9653ec22c1503a63a5cb4bdd5106423457b099d5.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44576", "sha1": "fcce69649fea036b7f5be253d9e61fcc52e6c5a7", "filename": "files/20161005_R44576_fcce69649fea036b7f5be253d9e61fcc52e6c5a7.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 454649, "date": "2016-07-28", "retrieved": "2016-09-09T19:06:23.290376", "title": "The Food and Drug Administration (FDA) Budget: Fact Sheet", "summary": "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. Seven centers within FDA represent the broad program areas for which the agency has responsibility: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), and the Center for Tobacco Products (CTP). Several other offices have agency-wide responsibilities. \nFDA\u2019s budget has two funding streams: annual appropriations (i.e., discretionary budget authority, or BA) and industry user fees. In FDA\u2019s annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. \nBetween FY2012 and FY2016, FDA\u2019s total program level increased from $3.832 billion to $4.745 billion. Although congressionally appropriated funding increased by 9% over that time period, user fee revenue increased more than 50%. The President\u2019s FY2017 budget request was for a total program level of $4.826 billion, an increase of $81 million (+2%) over the FY2016 enacted appropriation of $4.745 billion. Both the House and Senate Appropriations Committees have reported their FY2017 Agriculture appropriations bills (H.R. 5054, S. 2956). This report will be updated with information on FDA funding for FY2017 once legislative action on appropriations for the new fiscal year is completed.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44576", "sha1": "dd73fb99110251572238cf5441277d18d742acf1", "filename": "files/20160728_R44576_dd73fb99110251572238cf5441277d18d742acf1.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44576", "sha1": "26c8d5b9530f9165689cb74add4f736659582db8", "filename": "files/20160728_R44576_26c8d5b9530f9165689cb74add4f736659582db8.pdf", "images": null } ], "topics": [] } ], "topics": [ "Health Policy" ] }