H.R. 7667 — what changed
Food and Drug Amendments of 2022
From Reported in House to Engrossed in House. 12 sections amended and 3 added between Reported in House and Engrossed in House.
Sec. 103 Authority to assess and use drug fees
Types of fees—
Human drug application fee— Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended—
in the matter preceding paragraph (1), by striking “fiscal year 2018” and inserting “fiscal year 2023”;
in paragraph (1)(A), by striking “(c)(5)” each place it appears and inserting “(c)(6)”;
in paragraph (1)(C), by inserting “prior to approval” after “or was withdrawn”; and
in paragraph (1), by adding at the end the following:
“(H) Exception for skin-test diagnostic products—A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).”
Prescription drug program fee— Section 736(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is amended—
in subparagraph (A)—
by striking “Except as provided in subparagraphs (B) and (C)” and inserting the following:
“(i) Fee—Except as provided in subparagraphs (B) and (C)”
by striking “subsection (c)(5)” and inserting “subsection (c)(6)”; and
by adding at the end the following:
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“(ii) Special rule—If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 735(3)(A)(iii), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement with respect to such product, supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.”
by amending subparagraph (B) to read as follows:
“(B) Exception for certain prescription drug products—A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—
“(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7);
“(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or
“(iii) a skin-test diagnostic product.”
Fee revenue amounts—
In general— Paragraph (1) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
“(1) In general—For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—
“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
“(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));
“(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));
“(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));
“(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and
“(G) additional dollar amounts for each fiscal year as follows:
“(i) $65,773,693 for fiscal year 2023.
“(ii) $25,097,671 for fiscal year 2024.
“(iii) $14,154,169 for fiscal year 2025.
“(iv) $4,864,860 for fiscal year 2026.
“(v) $1,314,620 for fiscal year 2027.”
Annual base revenue— Paragraph (3) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
“(3) Annual base revenue—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
“(A) for fiscal year 2023, $1,151,522,958; and
“(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).”
Adjustments; annual fee setting—
Inflation adjustment— Section 736(c)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington-Arlington-Alexandria, DC–VA–MD–WV”.
Strategic hiring and retention adjustment— Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended—
by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and
by inserting after paragraph (1) the following:
“(2) Strategic hiring and retention adjustment—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:
“(A) For fiscal year 2023, $9,000,000.
“(B) For each of fiscal years 2024 through 2027, $4,000,000.”
Capacity planning adjustment— Paragraph (3), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
“(3) Capacity planning adjustment
“(A) In general—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.
“(B) Methodology—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled “Prescription Drug User Fee Rates for Fiscal Year 2021” published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are also directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
“(C) Limitation—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).
“(D) Publication in Federal Register—The Secretary shall publish in the Federal Register notice under paragraph (6) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.”
Operating reserve adjustment— Paragraph (4), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended—
by amending subparagraph (A) to read as follows:
“(A) Increase—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:
“(i) For fiscal year 2023, at least 8 weeks of operating reserves.
“(ii) For fiscal year 2024, at least 9 weeks of operating reserves.
“(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.”
in subparagraph (C), by striking “paragraph (5)” and inserting “paragraph (6)”.
Additional direct cost adjustment— Paragraph (5), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
“(5) Additional direct cost adjustment
“(A) Increase—The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—
“(i) for fiscal year 2023, by $44,386,150; and
“(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.
“(B) Applicable amounts—The amounts referred to in subparagraph (A)(ii) are the following:
“(i) For fiscal year 2024, $60,967,993.
“(ii) For fiscal year 2025, $35,799,314.
“(iii) For fiscal year 2026, $35,799, 314.
“(iv) For fiscal year 2027, $35,799,314.”
Annual fee setting— Paragraph (6), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended by striking “September 30, 2017” and inserting “September 30, 2022”.
Crediting and availability of fees— Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”.
Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees— Section 736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as follows:
“(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees—To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—
“(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and
“(2) include in the request any legal authorities under which the request is made.”
Orphan drugs— Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended—
in paragraph (1)(B), by striking “during the previous year” and inserting “as determined under paragraph (2)”; and
by amending paragraph (2) to read as follows:
“(2) Evidence of qualification—An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—
“(A) tax returns submitted to the United States Internal Revenue Service; or
“(B) as necessary, other appropriate financial information.”
Sec. 505 Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic
In general— Not later than 180 days after the date on which the COVID–19 emergency period ends, the Secretary of Health and Human Services 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, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID–19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards”, as updated on August 8, 2021, and by any subsequent updates to such guidance. The Secretary of Health and Human Services shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical studies during the COVID–19 emergency period and organizations representing patients.
Topics— Not later than 90 days after the date on which the public meeting under subsection (a) is convened, the Secretary of Health and Human Services shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such meeting. Such topics shall include discussion of—
the actions drug sponsors took to utilize such recommendations and the frequency at which such recommendations were employed;
the characteristics of the sponsors, studies, and patient populations impacted by such recommendations;
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a consideration of how recommendations intended to mitigate disruption of clinical studies during the COVID–19 emergency period, including any recommendations to consider decentralized clinical studies when appropriate, may have affected access to clinical studies for certain patient populations, especially unrepresented or underrepresented racial and ethnic minorities; and
recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations.
COVID–19 emergency period defined— In this section, the term COVID–19 emergency period has the meaning given the term emergency period in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)).
Sec. 601 Increasing transparency in generic drug applications
In general— Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the following:
“(H)
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“(i) Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application for a new drug under this subsection for which the Secretary has specified in regulation, including under in section 314.94(a)(9), 314.94(a)(9) of title 21, Code of Federal Regulations (or a any successor regulation), regulations), or recommended in applicable guidance, certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of such abbreviated application, the Secretary shall inform the person whether such new drug is qualitatively and quantitatively the same as the listed drug.
“(ii) Notwithstanding section 301(j), if the Secretary determines that such new drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person—
“(I) the ingredient or ingredients that cause the new drug not to be qualitatively or quantitatively the same as the listed drug; and
“(II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.
“(iii) If the Secretary determines that such new drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such new drug under this subsection unless—
“(I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or
“(II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified.
“(iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i).
“(v) The disclosures required by this subparagraph are disclosures authorized by law including for purposes of section 1905 of title 18, United States Code.”
Guidance—
In general— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a new drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters.
Process— In issuing guidance as required by paragraph (1), the Secretary of Health and Human Services shall—
publish draft guidance;
provide a period of at least 60 days for comment on the draft guidance; and
after considering any comments received, and not later than one year after the close of the comment period on the draft guidance, publish final guidance.
Applicability— Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.
Sec. 706 National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
added
In general— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h) is amended to read as follows:
added “3016. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
added “(a) In general—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—
added “(1) shall solicit and, beginning not later than one year after the date of enactment of the Prescription Drug User Fee Amendments of 2022, receive requests from institutions of higher education, or consortia of institutions of higher education, to be designated as a National Center of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a “National Center of Excellence”) to support the advancement, development, and implementation of advanced and continuous pharmaceutical manufacturing; and
added “(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions that—
added “(A) request such designation; and
added “(B) meet the criteria specified in subsection (c).
added “(b) Request for designation—A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require. Any such request shall include a description of how the institution of higher education, or consortium of institutions of higher education, meets or plans to meet each of the criteria specified in subsection (c).
added “(c) Criteria for designation described—The criteria specified in this subsection with respect to an institution of higher education, or consortium of institutions of higher education, are that the institution or consortium has, as of the date of the submission of a request under subsection (a) by such institution or consortium—
added “(1) physical and technical capacity for research, development, implementation, and demonstration of advanced and continuous pharmaceutical manufacturing;
added “(2) manufacturing knowledge-sharing networks with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other relevant entities;
added “(3) proven capacity to design, develop, implement, and demonstrate new, highly effective technologies for use in advanced and continuous pharmaceutical manufacturing;
added “(4) a track record for creating, preserving, and transferring knowledge with respect to advanced and continuous pharmaceutical manufacturing;
added “(5) the proven ability to facilitate training of an adequate future workforce for research on, and implementation of, advanced and continuous pharmaceutical manufacturing; and
added “(6) experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other relevant entities—
added “(A) to support companies seeking to implement advanced and continuous pharmaceutical manufacturing in the United States;
added “(B) to support Federal agencies with technical assistance and employee training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous pharmaceutical manufacturing;
added “(C) with respect to advanced and continuous pharmaceutical manufacturing, to organize and conduct research and development activities needed to create new and more effective technology, develop and share knowledge, create intellectual property, and maintain technological leadership;
added “(D) to develop best practices for designing and implementing advanced and continuous pharmaceutical manufacturing processes; and
added “(E) to assess and respond to the national workforce needs for advanced and continuous pharmaceutical manufacturing, including the development and implementing of training programs.
added “(d) Termination of designation—The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.
added “(e) Conditions for designation—As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees—
added “(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);
added “(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);
added “(3) to develop, along with industry partners (which may include large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or consortium designated under this section, if any, a roadmap for developing an advanced and continuous pharmaceutical manufacturing workforce;
added “(4) to develop, along with industry partners and other institutions or consortia of such institutions designated under this section, a roadmap for strengthening existing, and developing new, relationships with other institutions of higher education or consortia thereof; and
added “(5) to provide an annual report to the Food and Drug Administration regarding the institution’s or consortium’s activities under this section, including a description of how the institution or consortium continues to meet and make progress on the criteria specified in subsection (c).
added “(f) Funding
added “(1) In general—The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the National Centers of Excellence designated under this section for the purpose of studying and recommending improvements to advanced and continuous pharmaceutical manufacturing, including such improvements as may enable the Centers—
added “(A) to continue to meet the conditions specified in subsection (e);
added “(B) to expand capacity for research on, and development of, advanced and continuous pharmaceutical manufacturing; and
added “(C) to implement research infrastructure in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to emerging medical threats, such as emerging drug shortages, quality issues disrupting the supply chain, epidemics and pandemics, and other such situations requiring the rapid development of new products or new manufacturing processes.
added “(2) Consistency with FDA mission—As a condition on receipt of funding under this subsection, a National Center of Excellence shall agree to consider any input from the Secretary regarding the use of funding that would—
added “(A) help to further the advancement of advanced and continuous pharmaceutical manufacturing through the National Center of Excellence; and
added “(B) be relevant to the mission of the Food and Drug Administration.
added “(3) Rule of construction—Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.
added “(g) Annual review and reports
added “(1) Annual report—Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—
added “(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section;
added “(B) include in such report an accounting of the Federal administrative expenses described in subsection (i)(2) over the reporting period; and
added “(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.
added “(2) Review of National Centers of Excellence and potential designees—The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.
added “(3) Report on long-term vision of FDA role—Not later than 2 years after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the long-term vision of the Department of Health and Human Services on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including—
added “(A) a national framework of principles related to the implementation and regulation of advanced and continuous pharmaceutical manufacturing;
added “(B) a plan for the development of Federal regulations and guidance for how advanced and continuous pharmaceutical manufacturing can be incorporated into the development of pharmaceuticals and regulatory responsibilities of the Food and Drug Administration;
added “(C) a plan for development of Federal regulations or guidance for how advanced and continuous pharmaceutical manufacturing will be reviewed by the Food and Drug Administration; and
added “(D) appropriate feedback solicited from the public, which may include other institutions of higher education, large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers.
added “(h) Definitions—In this section:
added “(1) Advanced—The term “advanced”, with respect to pharmaceutical manufacturing, refers to an approach that incorporates novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the performance of a manufacturing process.
added “(2) Continuous—The term continuous, with respect to pharmaceutical manufacturing, refers to a process—
added “(A) where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from the system; and
added “(B) that consists of an integrated process that consists of a series of two or more simultaneous unit operations.
added “(3) Institution of higher education—The term institution of higher education has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)).
added “(4) Secretary—The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.
added “(i) Authorization of appropriations
added “(1) In general—There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.
added “(2) Federal administrative expenses—Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than eight percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.”
added
Transition rule— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section, shall apply with respect to grants awarded under such section before such date of enactment.
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Clerical amendment— The item relating to section 3016 in the table of contents in section 1(b) of the 21st Century Cures Act (Public Law 114–255) is amended to read as follows:
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Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506J (21 U.S.C. 356j) the following:
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“506K. Advanced manufacturing technologies designation pilot program
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“(a) In general—Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).
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“(b) Designation process—The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug and maintain equivalent or provide superior drug quality, including by—
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“(1) reducing development time for a drug using the designated manufacturing method; or
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“(2) increasing or maintaining the supply of—
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“(A) a drug that is described in section 506C(a) and is intended to treat a serious or life-threatening condition; or
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“(B) a drug that is on the drug shortage list under section 506E.
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“(c) Evaluation and designation of an advanced manufacturing technology
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“(1) Submission—A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—
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“(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and
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“(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.
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“(2) Evaluation and designation—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).
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“(d) Review of advanced manufacturing technologies—If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—
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“(1) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology and could help mitigate or prevent a shortage or substantially improve manufacturing processes for a drug and maintain equivalent or provide superior drug quality, as described in subsection (b); and
removed
“(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.
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“(e) Implementation and evaluation of advanced manufacturing technologies pilot
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“(1) Public meeting—The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss and obtain input and recommendations from relevant stakeholders regarding—
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“(A) the goals and scope of the pilot program, and a suitable framework, procedures, and requirements for such program; and
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“(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.
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“(2) Pilot program guidance
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“(A) In general—The Secretary shall—
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“(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the pilot program under this section; and
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“(ii) not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementation of such program.
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“(B) Content—The guidance described in subparagraph (A) shall address—
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“(i) the process by which a person may request a designation under subsection (b);
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“(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;
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“(iii) the process to expedite the development and review of applications under subsection (d); and
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“(iv) the criteria described in subsection (b) for eligibility for such a designation.
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“(3) Report—Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the pilot program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:
removed
“(A) The number of persons that have requested designations and that have been granted designations.
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“(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.
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“(C) The average number of calendar days for completion of evaluations under subsection (c)(2).
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“(D) An analysis of the factors in data submissions that are relevant to determinations to designate and not to designate after evaluation under subsection (c)(2).
removed
“(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.
removed
“(f) Sunset—The Secretary—
removed
“(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2029; and
removed
“(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (d) prior to such date, if the Secretary determines such activities are in the interest of the public health.”
Sec. 707 Advanced manufacturing technologies designation pilot program
changed
Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner Subchapter A of Food and Drugs, shall convene a public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development chapter V of certain human cell-, tissue-, and cellular-based medical products (and the latest scientific information about such products) that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 351 et seq.) and biological products under is amended by inserting after section 351 of the Public Health Service Act (42 506J (21 U.S.C. 262), namely, stem-cell and other cellular therapies.356j) the following:
added “506K. Advanced manufacturing technologies designation pilot program
added “(a) In general—Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection (b).
added “(b) Designation process—The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug and maintain equivalent or provide superior drug quality, including by—
added “(1) reducing development time for a drug using the designated manufacturing method; or
added “(2) increasing or maintaining the supply of—
added “(A) a drug that is described in section 506C(a) and is intended to treat a serious or life-threatening condition; or
added “(B) a drug that is on the drug shortage list under section 506E.
added “(c) Evaluation and designation of an advanced manufacturing technology
added “(1) Submission—A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by—
added “(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and
added “(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.
added “(2) Evaluation and designation—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).
added “(d) Review of advanced manufacturing technologies—If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—
added “(1) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology and could help mitigate or prevent a shortage or substantially improve manufacturing processes for a drug and maintain equivalent or provide superior drug quality, as described in subsection (b); and
added “(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.
added “(e) Implementation and evaluation of advanced manufacturing technologies pilot
added “(1) Public meeting—The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss and obtain input and recommendations from relevant stakeholders regarding—
added “(A) the goals and scope of the pilot program, and a suitable framework, procedures, and requirements for such program; and
added “(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.
added “(2) Pilot program guidance
added “(A) In general—The Secretary shall—
added “(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the pilot program under this section; and
added “(ii) not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementation of such program.
added “(B) Content—The guidance described in subparagraph (A) shall address—
added “(i) the process by which a person may request a designation under subsection (b);
added “(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions;
added “(iii) the process to expedite the development and review of applications under subsection (d); and
added “(iv) the criteria described in subsection (b) for eligibility for such a designation.
added “(3) Report—Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the pilot program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:
added “(A) The number of persons that have requested designations and that have been granted designations.
added “(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.
added “(C) The average number of calendar days for completion of evaluations under subsection (c)(2).
added “(D) An analysis of the factors in data submissions that are relevant to determinations to designate and not to designate after evaluation under subsection (c)(2).
added “(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.
added “(f) Sunset—The Secretary—
added “(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2029; and
added “(2) may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (d) prior to such date, if the Secretary determines such activities are in the interest of the public health.”
Sec. 708 Public workshop on cell therapies
changed
Section 409I(d)(1) Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, 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 (and the latest scientific information about such products) that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “2018 through 2022” 262), namely, stem-cell and inserting “2023 through 2027”.other cellular therapies.
Sec. 709 Reauthorization of best pharmaceuticals for children
added Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “2018 through 2022” and inserting “2023 through 2027”.
removed
Humanitarian device exemption— Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “2022” and inserting “2027”.
removed
Pediatric Medical Device Safety and Improvement Act— 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”.
Sec. 710 Reauthorization for humanitarian device exemption and demonstration grants for improving pediatric availability
added
Humanitarian device exemption— Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “2022” and inserting “2027”.
added
Pediatric Medical Device Safety and Improvement Act— 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”.
removed
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”.
Sec. 711 Reauthorization of provision related to exclusivity of certain drugs containing single enantiomers
changed
Section 566(f) 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) 355(u)(4)) is amended by striking “$6,000,000 for each of fiscal years 2018 through 2022” “2022” and inserting “$10,000,000 for each of fiscal years 2023 through 2027”.“2027”.
Sec. 712 Reauthorization of the critical path public-private partnership program
changed
Section 5 566(f) of the Orphan Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee) 360bbb–5(f)) is amended—amended by 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”.
removed
in subsection (a)—
removed
by striking “and (3)” and inserting “(3)”; and
removed
by inserting before the period at the end the following: “, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions”; and
removed
in subsection (c), by striking “2018 through 2022” and inserting “2023 through 2027”.
Sec. 713 Reauthorization of orphan drug grants
added Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended—
removed
In general—
removed
Additional active ingredient for application drug; limitation regarding novel-combination application drug— Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)) is amended—
removed
by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and
removed
by striking subparagraph (A) and inserting the following:
removed
“(A) In general—For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of—
removed
“(i) the drug or biological product for which the application referred to in such paragraph is submitted; or
removed
“(ii) such drug or biological product in combination with—
removed
“(I) an active ingredient of a drug or biological product—
removed
“(aa) for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and
removed
“(bb) that is determined by the Secretary to be the standard of care for treating a pediatric cancer; or
removed
“(II) an active ingredient of a drug or biological product—
removed
“(aa) for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and
removed
“(bb) that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
removed
“(B) Additional requirements
removed
“(i) Design of investigation—A molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.
removed
“(ii) Limitation—An investigation described in subparagraph (A)(ii) may be required only if the drug or biological product for which the application referred to in paragraph (1)(B) contains either—
removed
“(I) a single new active ingredient; or
removed
“(II) more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer.
removed
“(iii) Results of already-completed preclinical studies of application drug—The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) include the results of all preclinical studies on which the decision to conduct such investigation was based.
removed
“(iv) Rule of construction regarding inactive ingredients—With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination.”
removed
Determination of applicable requirements— Section 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is amended by adding at the end the following: “The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).”.
removed
Clarifying applicability— Section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is amended by adding at the end the following:
removed
“(C) Rule of construction—No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).”
removed
Conforming amendments— Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended—
removed
in paragraph (3)(C), as redesignated by paragraph (1)(A) of this subsection, by striking “investigations described in this paragraph” and inserting “investigations referred to in subparagraph (A)”; and
removed
in paragraph (3)(D), as redesignated by paragraph (1)(A) of this subsection, by striking “the assessments under paragraph (2)(B)” and inserting “the assessments required under paragraph (1)(A)”.
changed
Guidance— The Secretary shall—in subsection (a)—
added
by striking “and (3)” and inserting “(3)”; and
changed
not later than 6 months after by inserting before the date of enactment of this Act, issue draft guidance on period at the implementation of end the requirements in subsection (a); following: “, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions”; and
removed
not later than 12 months after closing the comment period on such draft guidance, finalize such guidance.
changed
Applicability— The amendments made in subsection (c), by this section apply with respect to any application under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) striking “2018 through 2022” and any application under section 351(a) of the Public Health Service Act (42 U.S.C. 262), that is submitted on or after the date that is 3 years after the date of enactment of this Act.inserting “2023 through 2027”.
removed
Reports to Congress—
removed
Secretary of Health and Human Services— Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s efforts, in coordination with industry, to ensure implementation of the amendments made by subsection (a).
removed
GAO study and report—
removed
Study— Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.355c), as amended by subsection (a), in the development of drugs and biological products for pediatric cancer indications.
removed
Findings— Not later than 4 years after the date of enactment of this Act, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under subparagraph (A).
Sec. 714 Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs
added
added
In general—
added
Additional active ingredient for application drug; limitation regarding novel-combination application drug— Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)) is amended—
added
by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and
added
by striking subparagraph (A) and inserting the following:
added “(A) In general—For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of—
added “(i) the drug or biological product for which the application referred to in such paragraph is submitted; or
added “(ii) such drug or biological product in combination with—
added “(I) an active ingredient of a drug or biological product—
added “(aa) for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and
added “(bb) that is determined by the Secretary to be the standard of care for treating a pediatric cancer; or
added “(II) an active ingredient of a drug or biological product—
added “(aa) for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and
added “(bb) that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
added “(B) Additional requirements
added “(i) Design of investigation—A molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.
added “(ii) Limitation—An investigation described in subparagraph (A)(ii) may be required only if the drug or biological product for which the application referred to in paragraph (1)(B) contains either—
added “(I) a single new active ingredient; or
added “(II) more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer.
added “(iii) Results of already-completed preclinical studies of application drug—The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) include the results of all preclinical studies on which the decision to conduct such investigation was based.
added “(iv) Rule of construction regarding inactive ingredients—With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination.”
added
Determination of applicable requirements— Section 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is amended by adding at the end the following: “The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).”.
added
Clarifying applicability— Section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is amended by adding at the end the following:
added “(C) Rule of construction—No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).”
added
Conforming amendments— Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended—
added
in paragraph (3)(C), as redesignated by paragraph (1)(A) of this subsection, by striking “investigations described in this paragraph” and inserting “investigations referred to in subparagraph (A)”; and
added
in paragraph (3)(D), as redesignated by paragraph (1)(A) of this subsection, by striking “the assessments under paragraph (2)(B)” and inserting “the assessments required under paragraph (1)(A)”.
added
Guidance— The Secretary shall—
added
not later than 12 months after the date of enactment of this Act, issue draft guidance on the implementation of the requirements in subsection (a); and
added
not later than 12 months after closing the comment period on such draft guidance, finalize such guidance.
added
Applicability— The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under section 351(a) of the Public Health Service Act (42 U.S.C. 262), that is submitted on or after the date that is 3 years after the date of enactment of this Act.
added
Reports to Congress—
added
Secretary of Health and Human Services— Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s efforts, in coordination with industry, to ensure implementation of the amendments made by subsection (a).
added
GAO study and report—
added
Study— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.355c), as amended by subsection (a), in the development of drugs and biological products for pediatric cancer indications.
added
Findings— Not later than 7 years after the date of enactment of this Act, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under subparagraph (A).
Sec. 721 Factory inspection
In general— Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking “restricted devices” each place it appears and inserting “devices”.
Records or other information—
renumbered
was (3)(2)
Establishments— Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended—
renumbered
was (3)(2)(3)
by striking “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and inserting “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or that is subject to inspection under paragraph (5)(C),”; and
renumbered
was (3)(2)(4)
by inserting after “a sufficient description of the records requested” the following: “and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection”.
added
Guidance—
removed
Guidance—
renumbered
was (3)(3)(2)
In general— The Secretary of Health and Human Services shall issue or update guidance describing—
renumbered
was (3)(3)(2)(3)
circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, as amended by paragraph (1);
renumbered
was (3)(3)(2)(4)
processes for responding to such requests electronically or in physical form; and
renumbered
was (3)(3)(2)(5)
factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
renumbered
was (3)(3)(3)
Timing— The Secretary of Health and Human Services shall—
renumbered
was (3)(3)(3)(3)
not later than 1 year after the date of enactment of this Act, issue draft guidance under subparagraph (A); and
renumbered
was (3)(3)(3)(4)
not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A).
Bioresearch monitoring inspections—
renumbered
was (4)(2)
In general— Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the end the following:
“(5) Bioresearch monitoring inspections
“(A) In general—The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.
“(B) Information subject to inspection—An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.
“(C) Sites and facilities subject to inspection
“(i) Sites and facilities described—The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—
“(I) developing an application or other submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);
“(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or
“(III) holding any records or other information described in subparagraph (B).
“(ii) Persons described—A person described in this clause is—
“(I) the sponsor of an application or submission specified in subparagraph (E);
“(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;
“(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or
“(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).
“(D) Conditions of inspection
“(i) Access to information subject to inspection—Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—
“(I) permitting the Secretary to record or copy such information for purposes of this paragraph;
“(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and
“(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.
“(ii) No effect on applicability of provisions for protection of proprietary information or trade secrets—Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.
“(iii) Reasonableness of inspections—An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.
“(E) Studies and submissions described—The studies and submissions described in this subparagraph are each of the following:
“(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described in paragraph (1).
“(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act.
“(iii) Any other clinical investigation of—
“(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or
“(II) a device subject to section 520(g).
“(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.
“(F) Clarification—This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.”
added
Review of processes and practices; guidance for industry—
removed
Review of processes and practices; guidance for industry—
renumbered
was (4)(3)(2)
In general— The Secretary of Health and Human Services shall—
renumbered
was (4)(3)(2)(3)
review processes and practices in effect as of the date of enactment of this Act applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1); and
renumbered
was (4)(3)(2)(4)
evaluate whether any updates are needed to facilitate the consistency of such processes and practices.
added
Guidance—
removed
Guidance—
renumbered
was (4)(3)(3)(2)
In general— The Secretary of Health and Human Services shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.
renumbered
was (4)(3)(3)(3)
Timing— The Secretary of Health and Human Services shall—
renumbered
was (4)(3)(3)(3)(3)
not later than 18 months after the date of enactment of this Act, issue draft guidance under clause (i); and
renumbered
was (4)(3)(3)(3)(4)
not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under clause (i).
Sec. 901 Determination of budgetary effects
addedadded The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.
Sec. 902 Medicaid Improvement Fund
addedadded Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w–1(b)(3)(A)) is amended by striking “$0” and inserting “$450,000,000”.