[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\
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\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.
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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.
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\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).
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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.
* * * * * * *
[all]