S.Amdt. 2645

SA 2645. Mrs. BLACKBURN submitted an amendment intended to be
proposed to amendment SA 2499 proposed by Mr. McConnell to the bill S.
178, to condemn gross human rights violations of ethnic Turkic Muslims
in Xinjiang, and calling for an end to arbitrary detention, torture,
and harassment of these communities inside and outside China; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

[[Page S5381]]

SEC. __. NATIONAL CENTER OF EXCELLENCE IN ADVANCED
PHARMACEUTICAL MANUFACTURING.

(a) Short Title.--This section may be cited as the
``Securing America's Medicine Cabinet Act'' or the ``SAM-C
Act''.
(b) Amendment.--Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at
the end the following:

``SEC. 1015. NATIONAL CENTER OF EXCELLENCE IN ADVANCED
PHARMACEUTICAL MANUFACTURING.

``(a) In General.--The Secretary shall designate 5
institutions of higher education as National Centers of
Excellence in Advanced Pharmaceutical Manufacturing,
including continuous pharmaceutical manufacturing.
``(b) Purposes.--The purposes of the program under this
section are to--
``(1) improve the competitiveness of domestic
pharmaceutical manufacturing and increase the production of
pharmaceutical goods manufactured predominantly within the
United States;
``(2) stimulate United States leadership in advanced
pharmaceutical manufacturing research, innovation, and
technology;
``(3) facilitate the transition of innovative technologies
into scalable, cost-effective, and high-performing
manufacturing capabilities;
``(4) accelerate the development of an advanced
pharmaceutical manufacturing workforce;
``(5) facilitate peer exchange of, and the documentation
of, best practices in addressing advanced manufacturing
challenges;
``(6) leverage non-Federal sources of support to promote a
stable and sustainable business model without the need for
long-term Federal funding; and
``(7) create and preserve jobs in the United States.
``(c) Eligibility.--To be eligible for designation under
subsection (a) an entity shall--
``(1) be an institution of higher education;
``(2) demonstrate--
``(A) the physical and technical capacity for research and
development of advanced pharmaceutical manufacturing;
``(B) a record of transferring scientific knowledge to the
marketplace;
``(C) scalable manufacturing knowledge, which may be
through collaborations of other institutions of higher
education, biopharmaceutical manufacturers, or other
entities;
``(D) the ability to train a future workforce for research
on and implementation of advanced pharmaceutical
manufacturing;
``(E) the ability to support Federal agencies with
technical assistance for advanced pharmaceutical
technologies, with an emphasis on creating a secure national
pharmaceutical stockpile and the ability to rapidly address
drug shortages; and
``(F) the potential to--
``(i) improve the competitiveness of domestic
manufacturing;
``(ii) accelerate non-Federal investment in advanced
manufacturing production capacity in the United States; and
``(iii) enable the commercial application of new
technologies or industry-wide manufacturing processes;
``(3) agree to carry out the activities described in
subsection (d) with the active participation of
representatives from multiple industrial entities, research
universities, community colleges, and such other entities as
the Secretary determines appropriate; and
``(4) submit an application to the Secretary at such time,
in such form, and in such manner as the Secretary may
require.
``(d) Activities.--An entity designated under subsection
(a) shall--
``(1) assist pharmaceutical manufacturers in retaining or
expanding industrial production and jobs in the United
States;
``(2) conduct research, development, and demonstration
projects, including proof-of-concept development and
prototyping, to reduce the cost, time, and risk of
commercializing new technologies and improvements in existing
technologies, processes, products, and research and
development of materials to solve precompetitive industrial
problems with economic or national security implications; and
``(3) develop and implement education, training, and
workforce recruitment courses, materials, and programs with
respect to pharmaceutical manufacturing.
``(e) Termination.--The Secretary may terminate the
designation of an entity designated under subsection (a) upon
a determination that the entity no longer meets the
requirements of subsection (c).
``(f) Annual Report.--Not later than 1 year after the date
on which the first designation is made under subsection (a),
and annually thereafter, the Secretary shall submit a report
to Congress on the activities of the entities designated
under such subsection.
``(g) Advanced Manufacturing.--In this section, the term
`advanced manufacturing' means pharmaceutical product
development and manufacturing that incorporates novel
technology or uses an established technique or technology in
a new or innovative way that can improve pharmaceutical
product quality, address shortages of medicines, and speed
time-to-market.
``(h) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $100,000,000
for the period of fiscal year 2021 through 2025.''.
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