[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2589 Introduced in Senate (IS)]
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117th CONGRESS
1st Session
S. 2589
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 manufacturing as National Centers
of Excellence in Continuous Pharmaceutical Manufacturing, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 3, 2021
Mrs. Blackburn (for herself and Mr. Menendez) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
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 manufacturing as National Centers
of Excellence in Continuous Pharmaceutical Manufacturing, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Securing America's Medicine Cabinet
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 Securing America's Medicine
Cabinet 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 enters 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) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $80,000,000 for
the period of fiscal years 2022 through 2026.
``(4) Rule of construction.--Nothing in this section shall
be construed as precluding a National Center for Excellence
designated under this section from receiving funds under any
other provision of this Act or any other Federal law.
``(g) Annual Review and Reports.--
``(1) Annual report.--Beginning not later than one year
after the date on which the first designation is made under
subsection (a), and annually thereafter, the Secretary shall--
``(A) submit to Congress a report describing the
activities, partnerships and collaborations, Federal
policy recommendations, previous and continuing
funding, and findings of, and any other applicable
information from, the National Centers of Excellence
designated under this section; and
``(B) make such report available to the public in
an easily accessible electronic format on the website
of the Food and Drug Administration.
``(2) Review of national centers of excellence and
potential designees.--The Secretary shall periodically review
the National Centers of Excellence designated under this
section to ensure that such National Centers of Excellence
continue to meet the criteria for designation under this
section.
``(3) Report on long-term vision of fda role.--Not later
than 2 years after the date on which the first designation is
made under subsection (a), the Secretary, in consultation with
the National Centers of Excellence designated under this
section, shall submit a report to 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.''.
(b) Transition Rule.--Section 3016 of the 21st Century Cures Act
(21 U.S.C. 399h), as in effect on the day before the date of the
enactment of this section, shall apply with respect to grants awarded
under such section before such date of enactment.
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