[House Report 116-513]
[From the U.S. Government Publishing Office]


116th Congress    }                                   {        Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                   {        116-513

======================================================================



 
      NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS PHARMACEUTICAL 
                       MANUFACTURING ACT OF 2020

                                _______
                                

 September 17, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 4866]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4866) 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, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
   I. Purpose and Summary.............................................4
  II. Background and Need for the Legislation.........................5
 III. Committee Hearings..............................................7
  IV. Committee Consideration.........................................8
   V. Committee Votes.................................................8
  VI. Oversight Findings..............................................8
 VII. New Budget Authority, Entitlement Authority, and Tax Expenditure8
VIII. Federal Mandates Statement......................................9
  IX. Statement of General Performance Goals and Objectives...........9
   X. Duplication of Federal Programs.................................9
  XI. Committee Cost Estimate.........................................9
 XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....9
XIII. Advisory Committee Statement....................................9
 XIV. Applicability to Legislative Branch.............................9
  XV. Section-by-Section Analysis of the Legislation.................10
 XVI. Changes in Existing Law Made by the Bill, as Reported..........12

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``National Centers of Excellence in 
Continuous Pharmaceutical Manufacturing Act of 2020''.

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 
        2020, 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 2021 through 2025.
          ``(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.

                         I. Purpose and Summary

    H.R. 4866, the ``National Centers of Excellence in 
Continuous Pharmaceutical Manufacturing Act of 2020'', was 
introduced on October 28, 2019, by Committee Chairman Frank 
Pallone, Jr. (D-NJ) and Representative Brett Guthrie (R-KY) and 
the bill was referred to the Committee on Energy and Commerce. 
H.R. 4866 amends the 21st Century Cures Act to provide the Food 
and Drug Administration (FDA) with the authority to designate 
institutions of higher education that provide research, data, 
and leadership on continuous manufacturing for pharmaceuticals 
as National Centers of Excellence in Continuous Pharmaceutical 
Manufacturing. As defined by the bill, continuous manufacturing 
(CM) is 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 
``consists of an integrated process that consists of a series 
of two or more unit operations.''
    According to testimony before the Committee from Dr. Janet 
Woodcock, Director of the Center for Drug Evaluation and 
Research at FDA, advanced manufacturing, such as CM, ``can be 
used to reduce the Nation's dependence on foreign sources of 
APIs [active pharmaceutical ingredients], increase the 
resilience of our domestic manufacturing base, and reduce 
quality issues that trigger drug shortages or recalls.''\1\ 
Within the last decade, the pharmaceutical industry has begun 
to move towards CM methods because it has been ``shown to 
greatly reduce both the time and the cost of developing and 
manufacturing new medicines, while enabling significant 
improvements in the quality of the final product and the 
reliability of the manufacturing process.''\2\ However, despite 
this potential, CM has not yet been widely adopted by industry.
---------------------------------------------------------------------------
    \1\House Committee on Energy and Commerce, Testimony of Janet 
Woodcock (Oct. 30, 2019) (energycommerce.house.gov/sites/
democrats.energycommerce.house.gov/files/documents/
Testimony-Woodcock-API_103019).
    \2\House Committee on Energy and Commerce, Testimony of Fernando J. 
Muzzio (Jan. 29, 2019) (docs.house.gov/meetings/IF/IF14/20200129/
110423/HHRG-116-IF14-Wstate-MuzzioF-20200129.pdf).
---------------------------------------------------------------------------
    The legislation would support the advancement and 
development of CM by employing institutions of higher education 
to study and recommend improvements to CM, including a roadmap 
for developing a continuous manufacturing workforce, sharing 
data with FDA regarding best practices and research generated, 
and collaborating with FDA on a report to Congress regarding 
the role of FDA in supporting CM. This report should include a 
national framework of principles related to the implementation 
and regulation of CM and a plan for the development of 
regulations and guidance for how CM can be incorporated into 
drug development and FDA's regulatory responsibilities.

                II. Background and Need for Legislation

    Traditionally, pharmaceutical drugs are manufactured using 
``batch manufacturing.'' Batch manufacturing requires raw 
materials to be loaded into equipment and then undergo a series 
of lengthy steps, with quality testing of samples occurring 
after each step in the process.\3\ CM, on the other hand, moves 
raw materials through a single system that incorporates 
monitoring and controls throughout the process.\4\ According to 
FDA, which regulates drug development, CM ``provides a quicker, 
more reliable way to make pharmaceuticals.''\5\ This is due to 
shorter processing times, real-time product quality assurance, 
and the removal of manual handling.\6\ Shorter processing times 
with real-time quality assurance allows manufacturers to 
respond quickly to emergencies, address shortages, or defective 
products.\7\
---------------------------------------------------------------------------
    \3\U.S. Food and Drug Administration, Modernizing the Way Drugs Are 
Made: A Transition to Continuous Manufacturing (May 17, 2017) 
(www.fda.gov/drugs/news-events-human-drugs/modernizing-way-drugs-are-
made-transition-continuous-manufacturing).
    \4\ U.S. Food and Drug Administration, Emergency Preparedness and 
Response, Counterterrorism and Emerging Threats, Medical 
Countermeasures Initiative (MCMi), MCM Issues, Advanced Manufacturing 
(www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-
manufacturing).
    \5\Id.
    \6\ U.S. Food and Drug Administration, FDA Perspective on 
Continuous Manufacturing (Jan. 2012) (www.fda.gov/media/85366/
download).
    \7\See note 2.
---------------------------------------------------------------------------
    CM also relies on smaller equipment, which reduces capital 
and inventory costs and allows for a smaller footprint.\8\ 
Because of this, as well as the ability to achieve higher 
yields and rely on less direct labor than traditional 
pharmaceutical manufacturing, CM can directly affect the cost 
of drugs.\9\ As the Committee heard at a hearing in March 2020 
from Dr. Fernando Muzzio, distinguished professor of chemical 
and biochemical engineering and Director of the NSF Engineering 
Research Center on Structured Organic Particulate Systems at 
Rutgers University, because CM products and their manufacturing 
processes can be developed faster than batch manufacturing, 
these products can also reach the market faster, which could 
increase competition in the pharmaceutical industry and 
``contribute to lower drug prices to the U.S. consumer.''\10\ 
Further, in testimony before the Committee, Dr. Woodcock noted 
advanced manufacturing technologies, such as CM, ``could enable 
U.S.-based pharmaceutical manufacturing to regain its 
competitiveness with China and other foreign countries, and 
potentially ensure a stable supply of drugs critical to the 
health of U.S. patients.''\11\
---------------------------------------------------------------------------
    \8\See note 6.
    \9\See note 2.
    \10\Id.
    \11\See note 1.
---------------------------------------------------------------------------
    Because of these potential benefits, the Committee has 
supported increased Federal investment into advanced 
manufacturing and CM. In the 21st Century Cures Act (P.L. 114-
255), the Committee authorized a grant program through the FDA 
to study and make recommendations for improvements to the 
process of CM of drugs and biological products, as well as 
similar innovative monitoring and control techniques.\12\ 
Grants were to be awarded to institutions of higher education 
and non-profits, and since enactment, FDA has made eight such 
awards.\13\ However, as of July 2020, only nine drug 
applications have been approved by FDA using advanced 
manufacturing technologies, with eight drugs relying on CM, and 
one utilizing 3-D printing.\14\ Slow adoption of advanced 
manufacturing and CM is one reason why additional Federal 
support is necessary.
---------------------------------------------------------------------------
    \12\Pub. L. No. 114-255, Sec. 3016 (2016) (www.congress.gov/114/
plaws/publ255/PLAW-114publ255.pdf).
    \13\See note 4.
    \14\Email from Staff, U.S. Food and Drug Administration, to 
Majority Staff, House Committee on Energy and Commerce (July 27, 2020).
---------------------------------------------------------------------------
    H.R. 4866, the ``National Centers of Excellence in 
Continuous Pharmaceutical Manufacturing Act of 2020'', would 
amend the 21st Century Cures Act to establish a program 
designating institutions of higher education as National 
Centers of Excellence in Continuous Pharmaceutical 
Manufacturing. Within one year of enactment of H.R. 4866, the 
FDA shall solicit and receive designation requests from 
institutions of higher education. To request a designation, 
institutions must meet the following criteria at the time of 
designation: (1) physical and technical capacity for research 
and development of CM; (2) manufacturing knowledge-sharing 
networks with other institutions of higher education, 
manufacturers, and other entities; (3) proven capacity to 
design and demonstrate new, highly effective technology for use 
in CM; (4) a track record for creating and transferring 
knowledge with respect to CM; (5) the potential to train a 
future workforce for research on and implementation of advanced 
manufacturing and CM; and (6) experience in participating in 
and leading a CM technology partnership with other institutions 
of higher education, manufacturers (large, small, generic, 
nonprescription, and contract), and other entities to support 
companies with CM in the United States: to support Federal 
agencies with technical assistance, which may include 
regulatory and quality metric guidance, as applicable, for 
advanced manufacturing and CM; with respect to CM, 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 technology leadership; to develop best practices for 
designing CM; and to assess and respond to the workforce needs 
for CM, including the development of training programs if 
needed. FDA is granted authority to terminate the designation 
if it is determined that an institution no longer meets the 
criteria above following written notice to the institution and 
a rationale for such termination.
    As a condition of designation, FDA shall require that an 
institution of higher education enter into an agreement under 
which the institution agrees to collaborate with FDA to publish 
the reports required under H.R. 4866, share data with FDA 
regarding best practices and research generated through funding 
of the Center, develop a roadmap for developing a CM workforce 
and for strengthening existing and new relationships with other 
institutions, and provide an annual report to FDA regarding the 
institution's activities. FDA shall award funding through 
grants, contracts, or cooperative agreements, and is authorized 
$80 million for the period of fiscal years (FY) 2021 through 
2025. As a condition of receipt of funding, a designated 
institution shall agree to input from FDA to ensure such 
funding help furthers the advancement of CM and is relevant to 
the mission of FDA.
    No later than one year after the first designation of a 
Center of Excellence for Continuous Pharmaceutical 
Manufacturing, FDA shall submit to Congress an annual report 
describing the activities, partnerships, collaborations, policy 
recommendations, previous and continued funding, and findings 
of the Centers. Such report shall be made publicly available. 
FDA is also required to periodically review designated Centers 
to ensure that such Centers continue to meet the criteria for 
designation. Within two years of the first designation, the 
Secretary of the Department of Health and Human Services (HHS), 
in consultation with the National Centers of Excellence, shall 
submit to Congress a report on the long-term vision of HHS on 
the role of the FDA in supporting CM, including a national 
framework of principles related to the implementation and 
regulation of CM, a plan for the development of Federal 
regulations and guidance for how advanced manufacturing and CM 
can be incorporated into the development of drugs and 
regulatory responsibilities of FDA, and appropriate public 
feedback.

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 4866:
    The Subcommittee on Health held a legislative hearing on 
January 29, 2020, entitled ``Improving Safety and Transparency 
in America's Food and Drugs'' to consider H.R. 4866, the 
``National Centers of Excellence in Continuous Pharmaceutical 
Manufacturing Act of 2019'', among other legislation. The 
Subcommittee received testimony from the following witnesses:
    Panel I:
           Jeff Allen, Ph.D, President and CEO, Friends 
        of Cancer Research;
           Richard Kaeser, Vice President, Global Brand 
        Protection, Johnson & Johnson;
           Fernando Muzzio, Ph.D., Distinguished 
        Professor, Chemical and Biochemical Engineering, 
        Rutgers, the State University of New Jersey; and
           Kao-Ping Chua, M.D., Ph.D., Assistant 
        Professor, Department of Pediatrics University of 
        Michigan Medical School.
    Panel II:
           Melanie Benesh, Legislative Attorney, 
        Environmental Working Group;
           Tom Balmer, Executive Vice President, 
        National Milk Producers Federation;
           J. David Carlin, Senior Vice President of 
        Legislative Affairs and Economic Policy, International 
        Dairy Foods Association;
           Douglas Corey, D.V.M., Past President, 
        American Association of Equine Practitioners;
           Talia Day, Patient Advocate;
           Paul C. DeLeo, Ph.D., Principal, Integral 
        Consulting, Inc.;
           Mardi Mountford, President, Infant Nutrition 
        Council of America;
           Nancy Perry, Senior Vice President, 
        Government Relations, American Society for the 
        Prevention of Cruelty to Animals; and
           Sara Sorscher, Deputy Director of Regulatory 
        Affairs, Center for Science in the Public Interest.

                      IV. Committee Consideration

    Representatives Pallone (D-NJ) and Guthrie (R-KY) 
introduced H.R. 4866, the ``National Centers of Excellence in 
Continuous Pharmaceutical Manufacturing Act of 2019'', on 
October 28, 2019, and the bill was referred to the Committee on 
Energy and Commerce. Subsequently, H.R. 4866 was referred to 
the Subcommittee on Health on October 29, 2019. A legislative 
hearing was held on the bill on January 29, 2020.
    On March 11, 2020, the Subcommittee on Health met in open 
markup session, pursuant to notice, to consider H.R. 4866. 
During consideration of the bill, a manager's amendment offered 
by Mr. Pallone was agreed to by a voice vote. Subsequently, the 
Subcommittee on Health agreed by a voice vote to a motion by 
Ms. Eshoo, Chairwoman of the subcommittee, to forward favorably 
H.R. 4866, amended, to the full Committee on Energy and 
Commerce.
    On July 15, 2020, the full Committee met in virtual open 
markup session, pursuant to notice, to consider a committee 
print of the bill H.R. 4866, as amended by the Subcommittee on 
Health on March 11, 2020. There were no amendments offered to 
the committee print of H.R. 4866. Upon conclusion of 
consideration of the bill, the full Committee agreed to a 
motion on final passage by Mr. Pallone, Chairman of the 
committee, to order H.R. 4866 reported favorably to the House, 
as amended, by a voice vote, a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
4866, including the motion for final passage of the bill.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to support 
the advancement and development of continuous manufacturing 
through the designation of institutions of higher education as 
National Centers of Excellence in Pharmaceutical Manufacturing, 
which will provide research, data, and leadership on continuous 
manufacturing.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 4866 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 4866 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section by Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title may be cited as 
the ``National Centers of Excellence in Continuous 
Pharmaceutical Manufacturing Act of 2020''.

Sec. 2. National Centers of Excellence in Continuous Pharmaceutical 
        Manufacturing

    Section 2 amends section 3016 of the 21st Century Cures Act 
to establish the National Centers of Excellence in Continuous 
Pharmaceutical Manufacturing program. Subsection (a) of the 
amended section 3016 requires within one year of enactment that 
the Secretary of HHS, acting through the Commissioner of Food 
and Drugs, solicit and receive requests from institutions of 
higher education to be designated as a National Center of 
Excellence in Continuous Pharmaceutical Manufacturing (referred 
to as a `National Center of Excellence') to support the 
advancement and development of continuous manufacturing (CM). 
FDA shall designate any institution of higher education that 
requests such designation and meets the criteria identified.
    Subsection (b) of the amended section 3016 requires 
designation requests to be made at such time, in such manner, 
and containing such information as FDA may require. Any request 
shall include a description of how the institution of higher 
education meets or plans to meet each of the criteria 
identified.
    Subsection (c) of the amended section 3016 describes the 
criteria that an institution of higher education should have at 
the date of submission of a designation request. This shall 
include: (1) physical and technical capacity for research and 
development of CM; (2) manufacturing knowledge-sharing networks 
with other institutions of higher education, manufacturers 
(large, small, generic, nonprescription, and contract), and 
other entities; (3) proven capacity to design and demonstrate 
new, highly effective technology for use in CM; (4) a track 
record for creating and transferring knowledge with respect to 
CM; (5) the potential to train a future workforce for research 
on and implementation of advanced manufacturing and CM; and (6) 
experience in participating in and leading a CM technology 
partnership with other institutions of higher education, 
manufacturers (large, small, generic, nonprescription, and 
contract), and other entities to support companies with CM in 
the United States: to support Federal agencies with technical 
assistance, which may include regulatory and quality metric 
guidance, as applicable, for advanced manufacturing and CM; 
with respect to CM, 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 technology leadership; to 
develop best practices for designing CM; and to assess and 
respond to the workforce needs for CM, including the 
development of training programs if needed.
    Subsection (d) of the amended section 3016 grants FDA the 
authority to terminate the designation of any National Center 
of Excellence designated if it is determined that 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 termination, FDA shall provide written notice to 
the institution and a rationale for such termination.
    Subsection (e) of the amended section 3016 specifies that 
as a condition of designation, FDA shall require that an 
institution of higher education enter into an agreement under 
which the institution agrees to collaborate with FDA to publish 
the reports required under subsection (g), share data with FDA 
regarding best practices and research generated through funding 
under subsection (f), develop a roadmap, along with industry 
partners (which may include large and small biopharmaceutical 
manufacturers, generic and nonprescription manufacturers, and 
contract manufacturers) and other designated institutions for 
developing a CM workforce, to develop, along with industry 
partners and other designated institutions, a roadmap for 
strengthening existing and new relationships with other 
institutions, and to provide an annual report to FDA regarding 
the institution's activities, including how the institution 
continues to meet and make progress on the criteria listed in 
subsection (c).
    Subsection (f) of the amended section 3016 requires FDA to 
award funding through grants, contracts, or cooperative 
agreements, to the National Centers of Excellence designated 
for the purpose of studying and recommending improvements to 
CM, including such improvements as may enable the Centers to 
continue to meet the conditions specified in subsection (e) and 
to expand capacity for research on, and development of, CM. As 
a condition of receipt of funding, a designated institution 
shall agree to consider any input from FDA to ensure such 
funding help further the advancement of CM through the National 
Center of Excellence and is relevant to the mission of FDA. 
There is authorized to be appropriated to carry out the 
activities $80 million for the period of fiscal years 2021 
through 2025. Nothing in this section shall be construed as 
precluding a designated National Center of Excellence from 
receiving funds under any other provision of H.R. 4866 or any 
other Federal law.
    Subsection (g) of the amended section 3016 requires that 
not later than one year after the first designation of a 
National Center of Excellence, FDA shall submit to Congress an 
annual report describing the activities, partnerships, 
collaborations, Federal policy recommendations, previous and 
continued funding, and findings of, and any other applicable 
information from, the designated National Centers of 
Excellence. Such report shall be made publicly available on the 
website of the FDA. FDA is also required to periodically review 
designated National Centers of Excellence to ensure that such 
centers continue to meet the criteria for designation. Within 
two years of the first designation, the Secretary of HHS, in 
consultation with the National Centers of Excellence, shall 
submit to Congress a report on the long-term vision of HHS on 
the role of the FDA in supporting CM, including a national 
framework of principles related to the implementation and 
regulation of CM, a plan for the development of Federal 
regulations and guidance for how advanced manufacturing and CM 
can be incorporated into the development of drugs and 
regulatory responsibilities of FDA, and appropriate feedback 
solicited from the public, which may include other institutions 
and manufacturers (large, small, generic, nonprescription, and 
contract).
    Subsection (h) of the amended section 3016 defines relevant 
terms in H.R. 4866 including ``advanced manufacturing'', 
``continuous manufacturing'', ``institution of higher 
education'', and ``Secretary''. As defined in H.R. 4866, 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. The term 
``continuous manufacturing'', as defined in H.R. 4866, 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 
consists of an integrated process that consists of a series of 
two or more unit operations. 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)). The 
term ``Secretary'', as defined in H.R. 4866, means the 
Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs.
    Section 2 also clarifies that section 3016 of the 21st 
Century Cures Act, as in effect on the day before the date of 
the enactment of this section, shall apply with respect to 
grants awarded under this section before such date of 
enactment.

       XVI. Changes in Existing Law Made by the Bill, as Reported

    In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                         21ST CENTURY CURES ACT



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DIVISION A--21ST CENTURY CURES

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TITLE III--DEVELOPMENT

           *       *       *       *       *       *       *


Subtitle B--Advancing New Drug Therapies

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[SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING.

  [(a) In general.--The Secretary of Health and Human Services 
may award grants to institutions of higher education and 
nonprofit organizations for the purpose of studying and 
recommending improvements to the process of continuous 
manufacturing of drugs and biological products and similar 
innovative monitoring and control techniques.
  [(b) Definitions.--In this section--
          [(1) 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);
          [(2) 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)); and
          [(3) 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)).]

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 2019, 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 
        2021 through 2025.
          (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.

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