[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5568 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 5568

   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

                             April 18, 2018

  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 2018''.

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 180 days 
        after the date of enactment of this section, 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 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) scalable manufacturing knowledge-sharing networks 
        with other institutions of higher education, large and small 
        biopharmaceutical 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 continuous manufacturing; and
            ``(6) the potential to participate in and lead a continuous 
        manufacturing technology partnership with other institutions of 
        higher education, large and small biopharmaceutical 
        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 for 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 standardize systems and approaches for 
                designing continuous manufacturing; and
                    ``(E) to develop a plan to establish a continuous 
                manufacturing workforce.
    ``(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 provide an annual report to the Food and Drug 
        Administration regarding the institution's activities under 
        this section; and
            ``(4) to develop, along with industry partners and another 
        institution or institutions designated under this section, if 
        any, a roadmap for developing a continuous manufacturing 
        workforce.
    ``(f) Funding.--
            ``(1) In general.--The Secretary shall award funding 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);
                    ``(B) to submit reports under subsection (e)(3); 
                and
                    ``(C) to expand capacity for research on, and 
                development of, continuing manufacturing.
            ``(2) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $80,000,000 for the period of fiscal years 2019 through 2023.
            ``(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; 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 collaboration 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; and
                    ``(B) a plan for the development of Federal 
                regulations and guidance for how continuous 
                manufacturing can be incorporated into the development, 
                review, and approval process for drugs and biological 
                products.
    ``(h) Definitions.--In this section:
            ``(1) Biological product.--The term `biological product' 
        has the meaning given such term in section 351(i) of the Public 
        Health Service Act (42 U.S.C. 262(i)).
            ``(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) Drug.--The term `drug' has the meaning given such 
        term in section 201 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321).
            ``(4) 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)).
            ``(5) 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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