[Congressional Record Volume 167, Number 183 (Tuesday, October 19, 2021)]
[House]
[Pages H5645-H5647]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




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

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 4369

       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 ``National Centers of 
     Excellence in Advanced and Continuous Pharmaceutical 
     Manufacturing Act of 2021''.

[[Page H5646]]

  


     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.

[[Page H5647]]

       ``(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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 4369.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, my colleagues and I on the Energy and Commerce 
Committee have been working on legislation to invest in and support 
American pharmaceutical manufacturing to reduce our dependence on items 
produced abroad, such as active ingredients and raw materials. As the 
COVID-19 pandemic has made clear, domestic pharmaceutical manufacturing 
is critical to our Nation's public health and global economic 
competitiveness.
  The bill before us now, H.R. 4369, would leverage the expertise and 
ingenuity of academic institutions in the United States to help support 
and develop advanced manufacturing technologies right here at home. The 
legislation will improve the quality of our pharmaceuticals, reduce 
drug shortages, and help to produce more nimble and efficient 
manufacturing processes that could be replicated throughout the Nation.
  Specifically, H.R. 4369 would direct the Food and Drug Administration 
to designate a number of American academic institutions as national 
centers of excellence. It then provides funding to these centers to 
develop advanced and continuous manufacturing.
  Now, continuous manufacturing is an emerging technology whereby a 
finished product is produced in a continuous stream, making it more 
efficient than the current so-called batch model that can be slow and 
may be subject to the risk of defects or errors during the 
manufacturing process.
  The centers would be required to work closely with the FDA and 
industry to support regulatory guidance and expertise, catalyze 
research and development in advanced and continuous manufacturing 
technologies, and cultivate an advanced pharmaceutical manufacturing 
workforce here in the United States.
  The legislation requires that the majority of the $100 million in 
funding be awarded directly to the designated centers of excellence, 
while also providing resources for FDA technical assistance, guidance, 
or training.
  H.R. 4369 sets us on the right track for advanced manufacturing here 
at home.
  This legislation passed the House last Congress but was not taken up 
in the Senate. If we are to meet the goal and demand for uninterrupted 
access and supply of critical drugs and active pharmaceutical 
ingredients, the time to act is now.
  I want to thank our Health Subcommittee Ranking Member Guthrie for 
working with me on this legislation, as well as full committee Ranking 
Member Rodgers and Health Subcommittee Chairwoman Anna Eshoo.
  I urge my colleagues to support H.R. 4369, and I hope the Senate will 
follow suit so that we can finally expand advanced and continuous 
manufacturing technology here in the United States.
  Madam Speaker, I reserve the balance of my time.
  Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today in support of H.R. 4369, the National 
Centers of Excellence in Advanced and Continuous Pharmaceutical 
Manufacturing Act, a bill I introduced with my colleague, Energy and 
Commerce Committee Chairman Frank Pallone. I enjoyed working with him 
on this bill.
  In 2016, I was proud to work with my fellow committee members on the 
21st Century Cures Act, which included legislation to issue grants for 
institutions of higher education to study the process of continuous 
pharmaceutical manufacturing.
  H.R. 4369, which we are considering today, builds on this partnership 
established in the Cures Act. Advanced and continuous manufacturing for 
pharmaceuticals is a new technology that allows for drugs to be 
produced in a continuous stream, helping drugs get into the market 
faster.
  This is something that has become increasingly important during the 
COVID-19 pandemic. We need to ensure that our drug supply chain does 
not depend too heavily on other countries, such as China.
  I urge my colleagues to support H.R. 4369, and I reserve the balance 
of my time.
  Mr. PALLONE. Madam Speaker, I have no additional speakers. I am 
prepared to close, and I reserve the balance of my time.
  Mr. GUTHRIE. Madam Speaker, this is an important bill. We have all 
seen what happened with COVID-19, our dependence on the global supply 
chain, particularly in pharmaceuticals. It is a national security issue 
that we have our own production here.
  As we saw, we have had shortages during the height of the pandemic, 
and we are still experiencing other supply chain issues. As we know, 
those will work themselves out.
  Having access to our own pharmaceuticals is not a luxury that we have 
time for them to work out themselves. We are hopeful that we will get 
things moving again in a normal supply chain, but we absolutely must 
take the action necessary to make sure that we make it in America, and 
we don't depend on countries such as China.
  Madam Speaker, I urge the passage of this bill. I yield back the 
balance of my time.
  Mr. PALLONE. Madam Speaker, I, too, would say this is an important 
bill, both from the point of view of moving toward more domestic 
manufacturing and addressing the supply chain shortages that we saw 
during COVID-19 for drugs.
  Madam Speaker, I ask for Members to support this bill, and I yield 
back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 4369, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PALLONE. Madam Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

                          ____________________