H.R. 4369 — what changed

changed This Act may be cited as the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021”.

changed “3016. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing

“(a) In general—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—

changed “(1) shall solicit and, beginning not later than one year after the date of enactment of the National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021, receive requests from institutions of higher education 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 advancement, development, and development implementation of advanced and continuous pharmaceutical manufacturing; and

changed “(2) shall so designate any institution not more than 5 institutions of higher education or consortia of such institutions that—

changed “(A) requests request such designation; and

changed “(B) meets meet the criteria specified in subsection (c).

changed “(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 education, or consortium of institutions of higher education, meets or plans to meet each of the criteria specified in subsection (c).

changed “(c) Criteria for designation described—The criteria specified in this subsection with respect to an institution of higher education 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—institution or consortium—

changed “(1) physical and technical capacity for research research, development, implementation, and development demonstration of advanced and continuous pharmaceutical manufacturing;

changed “(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;

changed “(3) proven capacity to design design, develop, implement, and demonstrate new, highly effective technology technologies for use in advanced and continuous pharmaceutical manufacturing;

changed “(4) a track record for creating creating, preserving, and transferring knowledge with respect to advanced and continuous pharmaceutical manufacturing;

changed “(5) the potential proven ability to train a facilitate training of an adequate future workforce for research on on, and implementation of of, advanced manufacturing and continuous pharmaceutical manufacturing; and

changed “(6) experience in participating in and leading a advanced and continuous pharmaceutical manufacturing technology partnership partnerships with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other relevant entities—

changed “(A) to support companies with seeking to implement advanced and continuous pharmaceutical manufacturing in the United States;

changed “(B) to support Federal agencies with technical assistance, assistance and employee training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced manufacturing and continuous pharmaceutical manufacturing;

changed “(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, capture develop and disseminate expertise, share knowledge, create intellectual property, and maintain technological leadership;

changed “(D) to develop best practices for designing and implementing advanced and continuous manufacturing; pharmaceutical manufacturing processes; and

changed “(E) to assess and respond to the national workforce needs for advanced and continuous pharmaceutical manufacturing, including the development and implementing of training programs if needed.programs.

changed “(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 60 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.

changed “(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—

“(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);

“(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);

changed “(3) to develop, along with industry partners (which may include large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers) research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or institutions consortium designated under this section, if any, a roadmap for developing a an advanced and continuous pharmaceutical manufacturing workforce;

changed “(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; institutions of higher education or consortia thereof; and

changed “(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 listed specified in subsection (c).

“(f) Funding

changed “(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—

changed “(A) to continue to meet the conditions specified in subsection (e); and(e);

changed “(B) to expand capacity for research on, and development of, continuing manufacturing.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.

“(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

removed “(A) help to further the advancement of continuous manufacturing through the National Center of Excellence; and

“(B) be relevant to the mission of the Food and Drug Administration.

removed “(3) Authorization of appropriations—There is authorized to be appropriated to carry out this subsection $80,000,000 for the period of fiscal years 2022 through 2026.

changed “(4) “(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.

“(g) Annual review and reports

“(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—

changed “(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; andsection;

changed “(B) make include in such report available to the public in an easily accessible electronic format on the website accounting of the Food and Drug Administration.Federal administrative expenses described in subsection (i)(2) over the reporting period; and

changed “(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 “(C) make such National Centers of Excellence continue report available to meet the criteria for designation under this section.public in an easily accessible electronic format on the website of the Food and Drug Administration.

changed “(3) Report on long-term vision “(2) Review 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 National Centers of Excellence and potential designees—The Secretary shall periodically review the National Centers of Excellence designated under this section, shall submit a report section to the Congress on the long-term vision of the Department of Health and Human Services on the role ensure that such National Centers of Excellence continue to meet the Food and Drug Administration in supporting continuous manufacturing, including—criteria for designation under this section.

changed “(A) a national framework “(3) Report on long-term vision of principles related 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 implementation Congress on the long-term vision of the Department of Health and regulation Human Services on the role of the Food and Drug Administration in supporting advanced and continuous manufacturing;pharmaceutical manufacturing, including—

changed “(B) “(A) a plan for the development national framework of Federal regulations and guidance for how advanced manufacturing and continuous manufacturing can be incorporated into principles related to the development of pharmaceuticals implementation and regulatory responsibilities regulation of the Food advanced and Drug Administration; andcontinuous pharmaceutical manufacturing;

changed “(C) appropriate feedback solicited from “(B) a plan for the public, which may include other institutions, large development of Federal regulations and small biopharmaceutical manufacturers, generic guidance for how advanced and nonprescription manufacturers, continuous pharmaceutical manufacturing can be incorporated into the development of pharmaceuticals and contract manufacturers.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.

“(h) Definitions—In this section:

removed “(1) Advanced manufacturing—The term “advanced manufacturing” means an approach for the manufacturing of pharmaceuticals that incorporates novel technology, or uses an established technique or technology in a new or innovative way (such as continuous manufacturing where the input materials are continuously transformed within the process by two or more unit operations) that enhances drug quality or improves the manufacturing process.

removed “(2) Continuous manufacturing—The term continuous manufacturing—

changed “(A) means “(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 process where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from new or innovative way, that enhances drug quality or improves the system; andperformance of a manufacturing process.

changed “(B) consists of an integrated process that consists of “(2) Continuous—The term continuous, with respect to pharmaceutical manufacturing, refers to a series of two or more unit operations.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.

“(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 2022 through 2026.

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.”

removed “(4) Secretary—The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.”