[House Report 117-151]
[From the U.S. Government Publishing Office]


117th Congress    }                                    {       Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                    {       117-151

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



 
       NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND CONTINUOUS 
                PHARMACEUTICAL MANUFACTURING ACT OF 2021

                                _______
                                

October 19, 2021.--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. 4369]

    The Committee on Energy and Commerce, to whom was referred 
the bill (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, having 
considered the same, reports favorably thereon with amendments 
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...............................................6
 IV. Committee Consideration..........................................7
  V. Committee Votes..................................................7
 VI. Oversight Findings...............................................7
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures7
VIII.Federal Mandates Statement.......................................8

 IX. Statement of General Performance Goals and Objectives............8
  X. Duplication of Federal Programs..................................8
 XI. Committee Cost Estimate..........................................8
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......8
XIII.Advisory Committee Statement.....................................8

XIV. Applicability to Legislative Branch..............................8
 XV. Section-by-Section Analysis of the Legislation...................8
XVI. Changes in Existing Law Made by the Bill, as Reported...........11

    The amendments are 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 
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.''.

    Amend the title so as to read:
    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 advanced and continuous 
pharmaceutical manufacturing as National Centers of Excellence 
in Advanced and Continuous Pharmaceutical Manufacturing, and 
for other purposes.

                         I. Purpose and Summary

    H.R. 4369, the ``National Centers of Excellence in Advanced 
and Continuous Pharmaceutical Manufacturing Act of 2021,'' 
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 (CM) for 
pharmaceuticals as National Centers of Excellence in Advanced 
and Continuous Pharmaceutical Manufacturing.
    The legislation would promote the development and 
advancement of advanced and continuous manufacturing by 
directing institutions of higher education to study and 
recommend improvements to CM, including a roadmap for 
developing a workforce, collaborating, and sharing data with 
FDA regarding best practices and research generated, and 
partnering with FDA on a report to Congress regarding the role 
of FDA in supporting advanced and continuous manufacturing. The 
report would include a national framework of principles related 
to implementation and regulation and a plan for regulations and 
guidance for how advanced and continuous manufacturing can be 
incorporated into pharmaceutical drug development and FDA's 
regulatory jurisdiction.

                II. Background and Need for Legislation

    Conventionally, pharmaceutical drugs are made using ``batch 
manufacturing.'' Batch manufacturing requires raw materials to 
be loaded into equipment and then undergo a sequence of lengthy 
steps, with quality testing of samples occurring after each 
step in the process.\1\ Conversely, continuous manufacturing 
moves raw materials through a single system that incorporates 
monitoring and quality controls throughout the process.\2\ 
According to FDA, which is responsible for drug development 
regulation, continuous manufacturing ``provides a quicker, more 
reliable way to make pharmaceuticals.''\3\ This is due to 
quicker processing times, real-time product quality assurance, 
and the elimination of manual handling.\4\ These advantages 
allow manufacturers to respond quickly to emergencies, address 
drug shortages, or track and discard defective products.\5\ 
Continuous manufacturing also utilizes smaller manufacturing 
equipment, reducing capital and inventory costs and allowing 
for a reduced footprint.\6\ The ability of continuous 
manufacturing to achieve higher yields and rely on less direct 
labor, compared to traditional manufacturing, can also directly 
impact the cost of drugs.\7\
---------------------------------------------------------------------------
    \1\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).
    \2\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).
    \3\Id.
    \4\U.S. Food and Drug Administration, FDA Perspective on Continuous 
Manufacturing (Jan. 2012) (www.fda.gov/media/85366/download).
    \5\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).
    \6\See note 4.
    \7\See note 5.
---------------------------------------------------------------------------
    Due to these potential benefits, the Committee has 
supported increased federal investment into advanced and 
continuous manufacturing. In the 21st Century Cures Act (P.L. 
114-255), the Committee authorized a grant program through FDA 
to study and make recommendations for improvements to the 
process of continuous manufacturing of drugs and biological 
products, as well as similar innovative monitoring and control 
techniques.\8\ Since enactment, eight grants have been awarded 
to institutions of higher education and non-profits for 
continuous manufacturing.\9\ Yet, as of July 2020, only nine 
pharmaceutical drug applications had been approved by FDA using 
advanced manufacturing capabilities, with eight drugs relying 
on continuous manufacturing, and one utilizing 3D printing.\10\ 
Additional federal support is necessary to speed the pace of 
adoption of advanced and continuous manufacturing.
---------------------------------------------------------------------------
    \8\Pub. L. No. 114-255, Sec. 3016 (2016) (www.congress.gov/114/
plaws/publ255/PLAW-114publ255.pdf).
    \9\See note 2.
    \10\Email from Staff, U.S. Food and Drug Administration, to 
Majority Staff, House Committee on Energy and Commerce (July 27, 2020).
---------------------------------------------------------------------------

                        III. Committee Hearings

    For the purposes of section 3(c) of rule XIII of the Rules 
of the House of Representatives, the following hearing was used 
to develop or consider H.R. 4369:
    The Subcommittee on Health held a legislative hearing in 
the 116th Congress on January 29, 2020, entitled ``Improving 
Safety and Transparency in America's Food and Drugs.'' 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

    Chairman Frank Pallone, Jr. (D-NJ) and Representative Brett 
Guthrie (R-KY) introduced H.R. 4369, the ``National Centers of 
Excellence in Advanced and Continuous Pharmaceutical 
Manufacturing Act of 2021,'' on July 6, 2021, which was 
referred to the Committee on Energy and Commerce. Subsequently, 
on July 7, 2021, H.R. 4369 was referred to the Subcommittee on 
Health.
    On July 15, 2021, the Subcommittee on Health met in a 
hybrid open markup session, pursuant to notice, to consider 
H.R. 4369. During consideration of the bill, an amendment in 
the nature of a substitute (AINS) offered by Chairman Pallone 
was agreed to by a voice vote. Upon conclusion of consideration 
of the bill, the Subcommittee ordered H.R. 4369 reported 
favorably to the full Committee, amended, by a voice vote.
    On July 21, 2021, the full Committee met in open markup 
session, pursuant to notice, to consider H.R. 4369 and 23 other 
bills. During consideration of the bill, an amendment offered 
by Chairman Pallone was agreed to by a voice vote. Upon 
conclusion of consideration of the bill, the full Committee 
agreed to a motion on final passage offered by Chairman Pallone 
to order H.R. 4369 reported favorably to the House, amended, by 
a voice vote.

                           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. 
4369, including a motion by Mr. Pallone ordering H.R. 4369 
favorably reported to the House, amended.

                         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 Advanced and Continuous 
Pharmaceutical Manufacturing, which will provide research, 
data, and leadership on advanced and continuous manufacturing.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 4369 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. 4369 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 Advanced and Continuous 
Pharmaceutical Manufacturing Act of 2021.''

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

    Section 2 amends section 3016 of the 21st Century Cures Act 
to establish the National Centers of Excellence in Advanced and 
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, or consortia of 
institutions of higher education, to be designated as a 
National Center of Excellence in Advanced and Continuous 
Pharmaceutical Manufacturing (referred to as a `National Center 
of Excellence') to support the advancement, development, and 
implementation of advanced manufacturing and CM. FDA shall 
designate not more than five institutions of higher education 
or consortia that request 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, 
development, implementation, and demonstration of advanced and 
continuous manufacturing; (2) manufacturing knowledge-sharing 
networks with other institutions of higher education, 
manufacturers (large, small, generic, nonprescription, and 
contract), and other relevant entities; (3) proven capacity to 
design and demonstrate new, highly effective technology for use 
in advanced and continuous manufacturing; (4) a track record 
for creating, preserving, and transferring knowledge with 
respect to advanced and continuous manufacturing; (5) the 
proven ability to facilitate training of a future workforce for 
research on and implementation of advanced and continuous 
manufacturing; (6) experience participating in and leading 
advanced and continuous manufacturing technology partnerships 
with other institutions of higher education, manufacturers 
(large, small, generic, nonprescription, and contract), and 
other relevant entities to support companies with 
implementation of advanced and continuous manufacturing in the 
United States; (7) to support federal agencies with technical 
assistance, which may include regulatory and quality metric 
guidance, as applicable, and hands-on training for advanced and 
continuous manufacturing; (8) 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 technology leadership; (9) 
to develop best practices for designing and implementing 
advanced and continuous manufacturing processes; and (10) to 
assess and respond to the national workforce needs for advanced 
and continuous manufacturing, including the development of 
training programs.
    Subsection (d) of the amended section 3016 grants FDA the 
authority to terminate the designation of any National Center 
of Excellence if it is determined that 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 
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, or consortium of institutions, 
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 
an advanced and continuous manufacturing workforce; develop, 
along with industry partners and other designated institutions, 
a roadmap for strengthening existing and new relationships with 
other institutions or consortia of institutions; and to provide 
an annual report to FDA regarding the institution's or 
consortium's activities, including how the institution or 
consortium 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 
advanced and continuous manufacturing, including such 
improvements as may enable the Centers to continue to meet the 
conditions specified in subsection (e); to expand capacity for 
research on, and development of, advanced and continuous 
manufacturing; and to implement research infrastructure in 
advanced and continuous 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. As a condition of 
receipt of funding, a designated institution shall agree to 
consider any input from FDA to ensure such funding helps 
further the advancement of advanced and continuous 
manufacturing through the National Center of Excellence and is 
relevant to the mission of FDA. A rule of construction ensures 
that no element of the amended section 3016 shall be construed 
as restricting a National Center of Excellence from receiving 
funding under another section of the 21st Century Cures Act 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. The report shall also include an accounting of 
Federal administrative expenses incurred. 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 advanced and continuous manufacturing, including a 
national framework of principles related to the implementation 
and regulation of advanced and continuous manufacturing, a plan 
for the development of federal regulations and guidance for how 
advanced and continuous manufacturing 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. 4369 including ``advanced manufacturing,'' 
``continuous manufacturing,'' ``institution of higher 
education,'' and ``Secretary.'' As defined in H.R. 4369, 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 that enhances drug quality or improves 
the manufacturing process. The term ``continuous 
manufacturing,'' as defined in H.R. 4369, 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 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. 4369, means the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs.
    Subsection (i) authorizes $100 million for the period of FY 
2022 through 2026 to be appropriated to carry out the 
activities described in the section, not more than eight 
percent of which can be used for Federal administrative 
expenses, including training, technical assistance, reporting, 
and evaluation.
    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, and includes a clerical amendment to alter the Table 
of Contents in the 21st Century Cures Act.

       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




           *       *       *       *       *       *       *
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``21st Century 
Cures Act''.
  (b) Table of Contents.--The table of contents for this Act is 
as follows:

Sec. 1. Short title; table of contents.
     * * * * * * *

                         TITLE III--DEVELOPMENT

     * * * * * * *

                Subtitle B--Advancing New Drug Therapies

     * * * * * * *
[Sec. 3016. Grants for studying continuous drug manufacturing.]
Sec. 3016. National Centers of Excellence in Advanced and Continuous 
          Pharmaceutical Manufacturing.

           *       *       *       *       *       *       *


DIVISION A--21ST CENTURY CURES

           *       *       *       *       *       *       *


TITLE III--DEVELOPMENT

           *       *       *       *       *       *       *


Subtitle B--Advancing New Drug Therapies

           *       *       *       *       *       *       *


[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 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.

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