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

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117th CONGRESS
  1st Session
                                H. R. 4369

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              July 6, 2021

  Mr. Pallone (for himself and Mr. Guthrie) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the 21st Century Cures Act to provide for designation of 
   institutions of higher education that provide research, data, and 
     leadership on continuous manufacturing as National Centers of 
 Excellence in 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 
Continuous Pharmaceutical Manufacturing Act of 2021''.

SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN 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 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 Continuous Pharmaceutical Manufacturing Act of 
        2021, receive requests from institutions of higher education to 
        be designated as a National Center of Excellence in Continuous 
        Pharmaceutical Manufacturing (in this section referred to as a 
        `National Center of Excellence') to support the advancement and 
        development of continuous manufacturing; and
            ``(2) shall so designate any institution of higher 
        education that--
                    ``(A) requests such designation; and
                    ``(B) meets 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 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 
are that the institution has, as of the date of the submission of a 
request under subsection (a) by such institution--
            ``(1) physical and technical capacity for research and 
        development of continuous 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 entities;
            ``(3) proven capacity to design and demonstrate new, highly 
        effective technology for use in continuous manufacturing;
            ``(4) a track record for creating and transferring 
        knowledge with respect to continuous manufacturing;
            ``(5) the potential to train a future workforce for 
        research on and implementation of advanced manufacturing and 
        continuous manufacturing; and
            ``(6) experience in participating in and leading a 
        continuous manufacturing technology partnership with other 
        institutions of higher education, large and small 
        pharmaceutical manufacturers, generic and nonprescription 
        manufacturers, contract manufacturers, and other entities--
                    ``(A) to support companies with continuous 
                manufacturing in the United States;
                    ``(B) to support Federal agencies with technical 
                assistance, which may include regulatory and quality 
                metric guidance as applicable, for advanced 
                manufacturing and continuous manufacturing;
                    ``(C) with respect to continuous manufacturing, to 
                organize and conduct research and development 
                activities needed to create new and more effective 
                technology, capture and disseminate expertise, create 
                intellectual property, and maintain technological 
                leadership;
                    ``(D) to develop best practices for designing 
                continuous manufacturing; and
                    ``(E) to assess and respond to the workforce needs 
                for continuous manufacturing, including the development 
                of training programs if needed.
    ``(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 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 enter into an agreement 
with the Secretary under which the institution 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 
        manufacturers) and another institution or institutions 
        designated under this section, if any, a roadmap for developing 
        a continuous manufacturing workforce;
            ``(4) to develop, along with industry partners and other 
        institutions designated under this section, a roadmap for 
        strengthening existing, and developing new, relationships with 
        other institutions; and
            ``(5) to provide an annual report to the Food and Drug 
        Administration regarding the institution's activities under 
        this section, including a description of how the institution 
        continues to meet and make progress on the criteria listed 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 
        continuous manufacturing, including such improvements as may 
        enable the Centers--
                    ``(A) to continue to meet the conditions specified 
                in subsection (e); and
                    ``(B) to expand capacity for research on, and 
                development of, continuing manufacturing.
            ``(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 continuous 
                manufacturing through the National Center of 
                Excellence; and
                    ``(B) be relevant to the mission of the Food and 
                Drug Administration.
            ``(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.
            ``(4) 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; and
                    ``(B) 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 
        continuous manufacturing, including--
                    ``(A) a national framework of principles related to 
                the implementation and regulation of continuous 
                manufacturing;
                    ``(B) a plan for the development of Federal 
                regulations and guidance for how advanced manufacturing 
                and continuous manufacturing can be incorporated into 
                the development of pharmaceuticals and regulatory 
                responsibilities of the Food and Drug Administration; 
                and
                    ``(C) appropriate feedback solicited from the 
                public, which may include other institutions, large and 
                small biopharmaceutical manufacturers, generic and 
                nonprescription manufacturers, and contract 
                manufacturers.
    ``(h) Definitions.--In this section:
            ``(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.
            ``(2) Continuous manufacturing.--The term `continuous 
        manufacturing'--
                    ``(A) means a process 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) consists of an integrated process that 
                consists of a series of two or more 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.''.
    (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.
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