[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4369 Engrossed in House (EH)]

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117th CONGRESS
  1st Session
                                H. R. 4369

_______________________________________________________________________

                                 AN ACT


 
   To amend the 21st Century Cures Act to provide for designation of 
   institutions of higher education that provide research, data, and 
 leadership on advanced and continuous pharmaceutical manufacturing as 
       National Centers of Excellence in Advanced and Continuous 
         Pharmaceutical Manufacturing, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Centers of Excellence in 
Advanced and Continuous Pharmaceutical Manufacturing Act of 2021''.

SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND CONTINUOUS 
              PHARMACEUTICAL MANUFACTURING.

    (a) In General.--Section 3016 of the 21st Century Cures Act (21 
U.S.C. 399h) is amended to read as follows:

``SEC. 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--
            ``(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, 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
            ``(2) shall so designate not more than 5 institutions of 
        higher education or consortia of such institutions that--
                    ``(A) request such designation; and
                    ``(B) meet the criteria specified in subsection 
                (c).
    ``(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).
    ``(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--
            ``(1) physical and technical capacity for research, 
        development, implementation, and demonstration of advanced and 
        continuous pharmaceutical manufacturing;
            ``(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;
            ``(3) proven capacity to design, develop, implement, and 
        demonstrate new, highly effective technologies for use in 
        advanced and continuous pharmaceutical manufacturing;
            ``(4) a track record for creating, preserving, and 
        transferring knowledge with respect to advanced and continuous 
        pharmaceutical manufacturing;
            ``(5) the proven ability to facilitate training of an 
        adequate future workforce for research on, and implementation 
        of, advanced and continuous pharmaceutical manufacturing; and
            ``(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--
                    ``(A) to support companies seeking to implement 
                advanced and continuous pharmaceutical manufacturing in 
                the United States;
                    ``(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;
                    ``(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;
                    ``(D) to develop best practices for designing and 
                implementing advanced and continuous pharmaceutical 
                manufacturing processes; and
                    ``(E) to assess and respond to the national 
                workforce needs for advanced and continuous 
                pharmaceutical manufacturing, including the development 
                and implementing of training programs.
    ``(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.
    ``(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);
            ``(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;
            ``(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
            ``(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).
    ``(f) Funding.--
            ``(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--
                    ``(A) to continue to meet the conditions specified 
                in subsection (e);
                    ``(B) to expand capacity for research on, and 
                development of, advanced and continuous pharmaceutical 
                manufacturing; and
                    ``(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--
                    ``(A) help to further the advancement of advanced 
                and continuous pharmaceutical manufacturing through the 
                National Center of Excellence; and
                    ``(B) be relevant to the mission of the Food and 
                Drug Administration.
            ``(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--
                    ``(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;
                    ``(B) include in such report an accounting of the 
                Federal administrative expenses described in subsection 
                (i)(2) over the reporting period; and
                    ``(C) make such report available to the public in 
                an easily accessible electronic format on the website 
                of the Food and Drug Administration.
            ``(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.
            ``(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--
                    ``(A) a national framework of principles related to 
                the implementation and regulation of advanced and 
                continuous pharmaceutical manufacturing;
                    ``(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;
                    ``(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
                    ``(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:
            ``(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.
            ``(2) Continuous.--The term `continuous', with respect to 
        pharmaceutical manufacturing, refers to a process--
                    ``(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
                    ``(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)).
            ``(4) Secretary.--The term `Secretary' means the Secretary 
        of Health and Human Services, acting through the Commissioner 
        of Food and Drugs.
    ``(i) Authorization of Appropriations.--
            ``(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.
            ``(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.''.
    (b) 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.
    (c) 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:

``Sec. 3016. National Centers of Excellence in Advanced and Continuous 
                            Pharmaceutical Manufacturing.''.

            Passed the House of Representatives October 19, 2021.

            Attest:

                                                                 Clerk.
117th CONGRESS

  1st Session

                               H. R. 4369

_______________________________________________________________________

                                 AN ACT

   To amend the 21st Century Cures Act to provide for designation of 
   institutions of higher education that provide research, data, and 
 leadership on advanced and continuous pharmaceutical manufacturing as 
       National Centers of Excellence in Advanced and Continuous 
         Pharmaceutical Manufacturing, and for other purposes.