{"format":1,"id":"117-hr-7667","congress":117,"number":"H.R. 7667","kind":"bill","group":"bills","title":"Food and Drug Amendments of 2022","title_source":"Short Title(s) as Passed House","official_title":"To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.","titles":[{"type":"Official Title as Introduced","title":"To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes."},{"type":"Display Title","title":"Food and Drug Amendments of 2022"},{"type":"Short Title(s) as Passed House","title":"Food and Drug Amendments of 2022"},{"type":"Short Title(s) as Passed House for portions of this bill","title":"Biosimilar User Fee Amendments of 2022"},{"type":"Short Title(s) as Passed House for portions of this bill","title":"Generic Drug User Fee Amendments of 2022"},{"type":"Short Title(s) as Passed House for portions of this bill","title":"Medical Device User Fee Amendments of 2022"},{"type":"Short Title(s) as Passed House for portions of this bill","title":"Prescription Drug User Fee Amendments of 2022"},{"type":"Short Title(s) as Reported to House","title":"Food and Drug Amendments of 2022"},{"type":"Short Title(s) as Reported to House for portions of this bill","title":"Biosimilar User Fee Amendments of 2022"},{"type":"Short Title(s) as Reported to House for portions of this bill","title":"Generic Drug User Fee Amendments of 2022"},{"type":"Short Title(s) as Reported to House for portions of this bill","title":"Medical Device User Fee Amendments of 2022"},{"type":"Short Title(s) as Reported to House for portions of this bill","title":"Prescription Drug User Fee Amendments of 2022"},{"type":"Short Title(s) as Introduced","title":"Food and Drug Amendments of 2022"},{"type":"Short Title(s) as Introduced for portions of this bill","title":"Biosimilar User Fee Amendments of 2022"},{"type":"Short Title(s) as Introduced for portions of this bill","title":"Generic Drug User Fee Amendments of 2022"},{"type":"Short Title(s) as Introduced for portions of this bill","title":"Medical Device User Fee Amendments of 2022"},{"type":"Short Title(s) as Introduced for portions of this bill","title":"Prescription Drug User Fee Amendments of 2022"}],"outcome":"passed_house","law_number":null,"introduced":"2022-05-06","chambers":{"house":{"status":"roll_call","date":"2022-06-08","vote":{"id":"117-2022-h254","question":"On Motion to Suspend the Rules and Pass, as Amended","title":"Food and Drug Amendments of 2022","result":"Passed","yea":392,"nay":28,"present":0,"not_voting":7,"source":"https://clerk.house.gov/evs/2022/roll254.xml"}},"senate":{"status":"na","date":null,"vote":null}},"president":{"status":"na","date":null},"vice_president_tie_breaker":null,"latest_action":{"text":"Received in the Senate.","date":"2022-06-09"},"nominees":null,"amendments":[],"other_votes":[],"crs_summary":{"date":"2022-06-08","stage":"Passed House","blocks":[{"k":"h","t":"Food and Drug Amendments of 2022"},{"k":"p","t":"This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices."},{"k":"p","t":"Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars."},{"k":"p","t":"The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials."},{"k":"p","t":"In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why)."},{"k":"p","t":"The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications."}],"words":181},"summary":{"main_subject":{"text":"Renews through fiscal year 2027 the Food and Drug Administration's user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products, and makes other changes to the Federal Food, Drug, and Cosmetic Act.","cites":[{"label":"Title I","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H23FFE7ED8BEB4555A3D2BBCF7535D398"},{"label":"Title II","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HBC4374CAFDBB48C5BD8A5D926236B5B1"},{"label":"Title III","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H07168F315A8E423F8D5E36654C3BE49D"},{"label":"Title IV","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H498E466DB88A44EBB4CADC2DDD88E84A"}]},"core_areas":["Prescription drug user fees","Medical device user fees","Generic drug user fees","Biosimilar biological product user fees","Diversity action plans for clinical studies","FDA inspections of drug and device establishments","Accelerated approval of drugs","Medical device cybersecurity"],"what_it_does":[{"text":"Sets the annual base revenue for prescription drug fees for fiscal year 2023 at $1,151,522,958 and sets how fee revenue is adjusted for fiscal years 2023 through 2027.","cite":{"label":"Sec. 103","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H22F47C43F24A40DC83D12057BFB50214"}},{"text":"Sets total medical device fee revenue amounts from $312,606,000 for fiscal year 2023 to $418,343,000 for fiscal year 2027.","cite":{"label":"Sec. 203","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H66CC4050DCA34AEA92F62D41875850E4"}},{"text":"Replaces $493,600,000 with $582,500,000 as the generic drug fee revenue amount for fiscal year 2023 and sets how that amount is adjusted for fiscal years 2024 through 2027.","cite":{"label":"Sec. 302","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H3EA6E88C51F647189E9D84B311D45015"}},{"text":"Sets the annual base revenue for biosimilar biological product fees for fiscal year 2023 at $43,376,922 and sets how fee revenue is adjusted for fiscal years 2023 through 2027.","cite":{"label":"Sec. 403","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HFC569CCB93964C6591BBF0ED93579A82"}},{"text":"Requires sponsors of phase 3 or other pivotal drug studies, and of certain device studies, to submit a diversity action plan stating enrollment goals, the rationale for them, and how the sponsor intends to meet them, unless the Secretary waives the requirement.","cite":{"label":"Sec. 501","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HAFE43CDC848D403E8BC2F0149CA806CD"}},{"text":"Requires the Secretary, on request or during review, to tell a generic drug applicant whether the drug is qualitatively and quantitatively the same as the listed drug, and to identify the ingredients that cause any difference.","cite":{"label":"Sec. 601","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H1A4C7700EC164DED9E863C73A01D46CC"}},{"text":"Authorizes the Secretary to inspect sites and facilities and the records related to studies and submissions supporting marketing authorization of drugs and devices, including clinical and nonclinical studies and postmarket safety activities.","cite":{"label":"Sec. 721","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H5505A0C2A2B74336B97D38556BF1BD3D"}},{"text":"Allows the Secretary to require postapproval studies for drugs approved under accelerated approval, sets expedited procedures for withdrawing such approval, and requires specified labeling statements.","cite":{"label":"Sec. 804","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H101E87F7A14846E3B8257E6858853248"}},{"text":"Requires premarket submissions for cyber devices to include cybersecurity information, and requires manufacturers to have a postmarket vulnerability plan, provide updates and patches, and include a software bill of materials in labeling.","cite":{"label":"Sec. 808","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HE9FB6EDDDFA640B29540B4FCC464487D"}},{"text":"Amends the Social Security Act to replace $0 with $450,000,000 in the Medicaid Improvement Fund provision.","cite":{"label":"Sec. 902","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HB9B7D2191FFE46B68623BF5C097712CA"}}],"unexpected":[{"category":"off_subject","items":[{"cite":{"label":"Sec. 205","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H1FFE92ACE1534B80B2FDC30A1BAF4057"},"heading":"Conformity assessment pilot program","effect":"Rewrites section 514(d) so the Secretary sets up a program in which testing laboratories can be accredited to conduct tests supporting device conformity assessments, with results accepted by the Secretary, and treats the earlier pilot as completed after September 30, 2023.","amount":null,"quote":"testing laboratories meeting criteria specified in guidance by the Secretary may be accredited by accreditation bodies meeting criteria specified in guidance by the Secretary"},{"cite":{"label":"Sec. 206","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HE14677A41FF94BE2B7467C24855E42C2"},"heading":"Reauthorization of third-party review program","effect":"Extends the third-party review program for devices from 2022 to 2027 by changing the year in section 523(c); this is not a user-fee provision.","amount":null,"quote":"Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “2022” and inserting “2027”."},{"cite":{"label":"Sec. 505","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H7D31950FDE9D4478BDDFE886BDF5764A"},"heading":"Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic","effect":"Requires the Secretary to convene a public meeting after the COVID–19 emergency period ends on clinical study recommendations issued during that period, and to publish a report on the topics discussed.","amount":null,"quote":"shall convene a public meeting to discuss the recommendations provided by the Food and Drug Administration during the COVID–19 emergency period to mitigate disruption of clinical studies"},{"cite":{"label":"Sec. 506","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H0234014E21494DCEB14F297111B83907"},"heading":"Decentralized clinical studies","effect":"Requires the Secretary to issue draft and final guidance on decentralized clinical studies, including digital health technology, telehealth, and recruitment and retention of participants.","amount":null,"quote":"issue draft guidance that addresses considerations for decentralized clinical studies, including considerations regarding the engagement, enrollment, and retention"},{"cite":{"label":"Sec. 601","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H1A4C7700EC164DED9E863C73A01D46CC"},"heading":"Increasing transparency in generic drug applications","effect":"Requires the Secretary, on request or during review, to tell a generic applicant whether a new drug is qualitatively and quantitatively the same as the listed drug, to identify the differing ingredients, and limits later changes to that determination.","amount":null,"quote":"the Secretary shall inform the person whether such new drug is qualitatively and quantitatively the same as the listed drug."},{"cite":{"label":"Sec. 602","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HB313186D4E964516B7C74F44B1F7A839"},"heading":"Enhancing access to affordable medicines","effect":"Replaces the conditions in section 505(j)(10)(A) for approving generic applications while listed drug labeling is being revised, including a condition that the labeling revision not change the Warnings section.","amount":null,"quote":"the labeling revision described under clause (i) does not include a change to the “Warnings” section of the labeling"},{"cite":{"label":"Sec. 701","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H48536F4F27354D158D49E24CD1F77B6D"},"heading":"Animal testing alternatives","effect":"Replaces references to animal tests in section 505 with \"nonclinical tests\" and defines the term to include in vitro, in silico, in chemico, and nonhuman in vivo tests.","amount":null,"quote":"the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test"},{"cite":{"label":"Sec. 702","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HABDEBB580BE5481CA20C63474E5F0F5F"},"heading":"Emerging technology program","effect":"Creates an emerging technology program for innovative drug product design and manufacturing, with grants, guidance and reporting, and authorizes $20,000,000 for each fiscal year 2023 through 2027.","amount":"$20,000,000","quote":"To carry out this section, there is authorized to be appropriated $20,000,000 for each fiscal year 2023 through 2027."},{"cite":{"label":"Sec. 703","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HC6AB367F320841539172F3ABFB97930C"},"heading":"Improving the treatment of rare diseases and conditions","effect":"Requires reports, a contracted study, public meetings and a Government Accountability Office study on drugs for rare diseases or conditions, and amends section 569(a)(2) to allow experts on small population studies.","amount":null,"quote":"The Secretary of Health and Human Services shall enter into a contract with an appropriate entity to conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions"},{"cite":{"label":"Sec. 704","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HCF5450E41A0D4C98AB3D1E75AA0A0E60"},"heading":"Antifungal research and development","effect":"Requires draft and final guidance on approval of antifungal therapies for coccidioidomycosis and a public workshop on preventive vaccines for fungal infections and coccidioidomycosis.","amount":null,"quote":"of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever)"},{"cite":{"label":"Sec. 705","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H9D5FA22CAC434725897A3FBCD0BB7332"},"heading":"Advancing qualified infectious disease product innovation","effect":"Amends the definition of a qualified infectious disease product and adds biological product applications under section 351(a) of the Public Health Service Act to the related incentive provisions and priority review.","amount":null,"quote":"The term qualified infectious disease product means a drug, including an antibacterial or antifungal drug or a biological product, for human use that—"},{"cite":{"label":"Sec. 706","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H4FF7059977D04D46A98CF417B5CB5E10"},"heading":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing","effect":"Rewrites the program for National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, allowing up to 5 designated institutions of higher education, and authorizes $100,000,000 for fiscal years 2023 through 2027.","amount":"$100,000,000","quote":"There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027."},{"cite":{"label":"Sec. 707","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HB4BEEBEB29E0456CB9B805374E1768BD"},"heading":"Advanced manufacturing technologies designation pilot program","effect":"Creates a pilot program under which persons may request designation of a drug manufacturing method as an advanced manufacturing technology, with expedited review of applications that use it.","amount":null,"quote":"the Secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection (b)."},{"cite":{"label":"Sec. 708","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H4260A30515A74B34BC0DB5E4525424F3"},"heading":"Public workshop on cell therapies","effect":"Requires the Secretary to convene a public workshop within 3 years on generating scientific data for stem-cell and other cellular therapies.","amount":null,"quote":"shall convene a public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of certain human cell-, tissue-, and cellular-based medical products"},{"cite":{"label":"Sec. 709","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HBAC5314DB21C4E23B5B63E07230AE986"},"heading":"Reauthorization of best pharmaceuticals for children","effect":"Extends the Best Pharmaceuticals for Children provision in the Public Health Service Act from fiscal years 2018 through 2022 to 2023 through 2027.","amount":null,"quote":"is amended by striking “2018 through 2022” and inserting “2023 through 2027”."},{"cite":{"label":"Sec. 710","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H67BB1E9E17274A09B2F7EC2978C40399"},"heading":"Reauthorization for humanitarian device exemption and demonstration grants for improving pediatric availability","effect":"Extends the humanitarian device exemption provision to 2027 and extends the Pediatric Medical Device Safety and Improvement Act period to fiscal years 2023 through 2027.","amount":null,"quote":"Section 305(e) of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85) is amended by striking “2018 through 2022” and inserting “2023 through 2027”."},{"cite":{"label":"Sec. 711","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H5659AA22A155462EBC91F9631D762074"},"heading":"Reauthorization of provision related to exclusivity of certain drugs containing single enantiomers","effect":"Changes the year in the provision on exclusivity of certain drugs containing single enantiomers from 2022 to 2027.","amount":null,"quote":"Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by striking “2022” and inserting “2027”."},{"cite":{"label":"Sec. 712","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H118529241CBE405A893E8DC3DFE20496"},"heading":"Reauthorization of the critical path public-private partnership program","effect":"Changes the critical path public-private partnership authorization from $6,000,000 for each of fiscal years 2018 through 2022 to $10,000,000 for each of fiscal years 2023 through 2027.","amount":"$10,000,000","quote":"striking “$6,000,000 for each of fiscal years 2018 through 2022” and inserting “$10,000,000 for each of fiscal years 2023 through 2027”"},{"cite":{"label":"Sec. 713","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H9801A9CCF4804C04AAD53DD40484EB84"},"heading":"Reauthorization of orphan drug grants","effect":"Adds regulatory science for individualized medical products for rare diseases to the Orphan Drug Act grant purposes and extends the period to fiscal years 2023 through 2027.","amount":null,"quote":"developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions"},{"cite":{"label":"Sec. 714","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HC756AB5BE0D54F85AC347A462AFC54B5"},"heading":"Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs","effect":"Revises pediatric study requirements for molecularly targeted cancer drugs, sets guidance and report deadlines, and applies to applications submitted 3 years after enactment.","amount":null,"quote":"the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of—"},{"cite":{"label":"Sec. 801","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H4B27AEA86B35428AAE0B7F4206BB5FF2"},"heading":"Prompt reports of marketing status by holders of approved applications for biological products","effect":"Extends the marketing status reporting requirements to holders of approved biological product applications and adds a one-time report and list updates for biological products.","amount":null,"quote":"all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A)"},{"cite":{"label":"Sec. 802","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HCE771602A56546439086D23906D63505"},"heading":"Encouraging blood donation","effect":"Exempts voluntary collection of information from blood donors or potential donors, and from patients, from the Paperwork Reduction Act chapter.","amount":null,"quote":"information from blood donors or potential blood donors to support the development of recommendations by the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs concerning blood donation"},{"cite":{"label":"Sec. 803","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H223EF1457F9D4C44935C9F12C9D05C26"},"heading":"Regulation of certain products as drugs","effect":"Provides that any contrast agent, radioactive drug, or OTC monograph drug is deemed a drug and not a device.","amount":null,"quote":"Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 201(g) and not a device under section 201(h)."},{"cite":{"label":"Sec. 805","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H3C019C6FCBFA4374B0A5086E9F34FF6D"},"heading":"Facilitating the use of real world evidence","effect":"Requires guidance on the use of real world data and real world evidence for drug and device regulatory decisions, and a report to Congress after the COVID-19 emergency determination ends.","amount":null,"quote":"shall issue, or revise existing, guidance on considerations for the use of real world data and real world evidence to support regulatory decisionmaking"},{"cite":{"label":"Sec. 806","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HA4CBC0D034474AE5985459A4BE10CE8F"},"heading":"Dual Submission for Certain Devices","effect":"Allows the sponsor of an emergency-use device whose laboratory examination was deemed in a certain category to file a single submission for classification and categorization.","amount":null,"quote":"the sponsor of such device may, when submitting a request for classification under section 513(f)(2), submit a single submission containing—"},{"cite":{"label":"Sec. 807","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H4EDF1A7F169C40EE967DF2FF6BDEBA78"},"heading":"Medical Devices Advisory Committee meetings","effect":"Requires the Secretary to convene Medical Devices Advisory Committee panels at least once a year on devices used in pandemic preparedness and response, ending October 1, 2027.","amount":null,"quote":"shall convene one or more panels of the Medical Devices Advisory Committee not less than once per year"},{"cite":{"label":"Sec. 809","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H5C950D8833E046A982C84F8611FDF206"},"heading":"Public docket on proposed changes to third-party vendors","effect":"Requires a public docket on factors for reviewing requests to change third-party vendors for risk evaluation and mitigation strategies, and a GAO report by December 31, 2026.","amount":null,"quote":"shall open a single public docket to solicit comments on factors that generally should be considered by the Secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies"},{"cite":{"label":"Sec. 810","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H25AC5A680E2E4AF7BBFBB582F895B4A9"},"heading":"Facilitating exchange of product information prior to approval","effect":"Provides that sharing certain product information about investigational drugs or devices with payors and formulary committees does not make a product misbranded, and requires a GAO study.","amount":null,"quote":"no drug or device shall be deemed to be misbranded under such paragraph through the provision of product information to a payor, formulary committee, or other similar entity"},{"cite":{"label":"Sec. 811","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HE9E71710ED1C480780BD4D7AD1BBC18C"},"heading":"Bans of devices for one or more intended uses","effect":"Allows devices to be banned for one or more intended uses and deems electrical stimulation devices applying a noxious stimulus to the skin to reduce self-injurious or aggressive behavior to be banned devices.","amount":null,"quote":"Electrical stimulation devices that apply a noxious electrical stimulus to a person’s skin intended to reduce or cease self-injurious behavior or aggressive behavior are deemed to be banned devices"},{"cite":{"label":"Sec. 812","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HC309DB3F85BB40C99B89978C6593FC11"},"heading":"Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions","effect":"Changes the scope of exclusive approval for rare disease designated drugs from the same disease or condition to the same approved indication or use, applying to drugs regardless of designation or approval date.","amount":null,"quote":"by striking “same disease or condition” and inserting “same approved indication or use within such rare disease or condition”"},{"cite":{"label":"Sec. 813","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H8D664FD42E954DEB9AD780A9723E340D"},"heading":"GAO report on third-party review","effect":"Requires a GAO report by September 30, 2026 on the device third-party review program, including resources used and an audit of select accredited persons.","amount":null,"quote":"a report on the third-party review program described in section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m)."},{"cite":{"label":"Sec. 814","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H319106646E7E44E492C1056A715C8DF0"},"heading":"Reporting on pending generic drug applications and priority review applications","effect":"Extends the reporting requirement on pending generic drug applications and priority review applications by changing 2022 to 2027.","amount":null,"quote":"is amended, in the matter preceding paragraph (1), by striking “2022” and inserting “2027”."},{"cite":{"label":"Sec. 815","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HCEAFA3D91A6F4B9AA9953D7BCF86BEB9"},"heading":"FDA Workforce Improvements","effect":"Broadens the FDA workforce provision to products regulated by the agency and requires an agency-wide strategic workforce plan and a report to Congress.","amount":null,"quote":"the Commissioner of Food and Drugs shall develop and begin implementation of an agency-wide strategic workforce plan at the Food and Drug Administration"},{"cite":{"label":"Sec. 902","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HB9B7D2191FFE46B68623BF5C097712CA"},"heading":"Medicaid Improvement Fund","effect":"Changes an amount in the Social Security Act provision on the Medicaid Improvement Fund from $0 to $450,000,000.","amount":"$450,000,000","quote":"is amended by striking “$0” and inserting “$450,000,000”."},{"cite":{"label":"Sec. 901","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H22532C7B07C74CCBBF82D27CAE017FE6"},"heading":"Determination of budgetary effects","effect":"Sets the budgetary effects of the Act for Statutory Pay-As-You-Go purposes by reference to a statement printed in the Congressional Record.","amount":null,"quote":"shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act"}]},{"category":"selective_carve_out","items":[{"cite":{"label":"Sec. 102","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H6581F6B0032D4535A48E8243F243B889"},"heading":"Definitions","effect":"Amends the drug fee definitions so that allergenic extract products licensed before October 1, 2022 are left out of the definition of a human drug application, and defines skin-test diagnostic products.","amount":null,"quote":"does not include an application with respect to an allergenic extract product licensed before October 1, 2022"},{"cite":{"label":"Sec. 103","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-H22F47C43F24A40DC83D12057BFB50214"},"heading":"Authority to assess and use drug fees","effect":"Amends the prescription drug fee provisions so that a human drug application for a skin-test diagnostic product is not subject to the application fee, and skin-test diagnostic products are excluded from the program fee.","amount":null,"quote":"A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A)."},{"cite":{"label":"Sec. 808","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh#toc-HE9FB6EDDDFA640B29540B4FCC464487D"},"heading":"Ensuring cybersecurity of medical devices","effect":"Adds cybersecurity requirements for medical devices that include software or can connect to the internet. It also lets the Secretary identify devices or types of devices that are exempt from those requirements and publish a list of them.","amount":null,"quote":"The Secretary may identify devices or types of devices that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section."}]}],"version":{"type":"Engrossed in House","date":"2022-06-08","rule":"passed","href":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text/eh"},"current":true,"model":"claude-sonnet-5-5","approved":"2026-10-15","approved_by":"checks"},"sources":{"congress_gov":"https://www.congress.gov/bill/117th-congress/house-bill/7667","text":"https://www.congress.gov/bill/117th-congress/house-bill/7667/text"},"card":{"image":"card/item/117-hr-7667.png","v":"7c33bae0dffd","alt":"Votes on Record. H.R. 7667, 117th Congress: Food and Drug Amendments of 2022. House: 392 Yea, 28 Nay. Outcome: Passed House, 8 Jun 2022."}}