Accelerating Biomedical Innovation Act

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1441 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1441

  To establish a Center for Biomedical Innovation and Development in 
  order to accelerate innovation and development of advanced medical 
                        countermeasure products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 4, 2023

 Mr. Cornyn (for himself and Mr. Kaine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To establish a Center for Biomedical Innovation and Development in 
  order to accelerate innovation and development of advanced medical 
                        countermeasure products.

    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 ``Accelerating Biomedical Innovation 
Act''.

SEC. 2. CENTER FOR BIOMEDICAL INNOVATION AND DEVELOPMENT PROGRAM.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by inserting after section 319L-1 the following:

``SEC. 319L-2. CENTER FOR BIOMEDICAL INNOVATION AND DEVELOPMENT 
              PROGRAM.

    ``(a) Establishment of Consortium.--Not later than 1 year after the 
date of enactment of this section, the Secretary shall establish a 
consortium of not fewer than 3 institutions of higher education (as 
defined in section 101 of the Higher Education Act), to accelerate 
innovation and development of advanced medical countermeasure products, 
including biological products and devices, selected by the Biomedical 
Advanced Research and Development Agency (referred to in this section 
as `BARDA'). Such consortium shall be known as the Center for 
Biomedical Innovation and Development (referred to in this section as 
the `Center').
    ``(b) Selection of Participating Institutions.--In selecting 
institutions of higher education to participate in the Center under 
subsection (a), the Secretary shall--
            ``(1) select eligible institutions that have--
                    ``(A) expertise and capabilities in current good 
                manufacturing practices, as defined in part 117 of 
                title 21 Code of Federal Regulations (or successor 
                regulations);
                    ``(B) experience in technology innovation, 
                including advanced manufacturing technologies, that may 
                assist in countermeasure and advanced research and 
                development;
                    ``(C) facilities with flexible and adaptable 
                advanced process development capabilities; and
                    ``(D) other relevant qualifications, as determined 
                by the Secretary;
            ``(2) select at least one institution with the capability 
        to handle secure and classified information, as appropriate; 
        and
            ``(3) prioritize institutions most likely to aid in the 
        advancement and innovation of the medical countermeasure 
        products, the manufacturing processes for such products, and 
        the execution and design of clinical trials.
    ``(c) Center Activities.--The Center established under subsection 
(a) shall assist public and private entities in accelerating 
nonclinical research discoveries with respect to medical 
countermeasures through advanced development and clinical trials. The 
activities of the Center may include--
            ``(1) advanced process development and pilot manufacturing 
        to support clinical trials;
            ``(2) technical assistance;
            ``(3) contract award management;
            ``(4) referral and coordination with potential 
        manufacturing partners;
            ``(5) regulatory assistance;
            ``(6) technology transfer; and
            ``(7) program management.
    ``(d) Eligible Products.--A drug or device (including a combination 
of one or more drugs or devices) is eligible for consideration and 
referral by the Director of BARDA to the Center if such drug or device 
incorporates a novel technology, or uses an established technique or 
technology in a novel way, that will substantially--
            ``(1) further development of a drug or device of interest;
            ``(2) fulfil an unmet need; or
            ``(3) develop the manufacturing process for a drug or 
        device.
    ``(e) International Coordination.--The Director of BARDA, in 
collaboration with the Assistant Secretary for Global Affairs and the 
Center established under subsection (a), shall coordinate, as 
appropriate, with international partners to enhance global health 
security by encouraging other initiatives, similar to the program 
described in subsection (a), under which international advanced 
development networks support an expanded worldwide strategy for 
vaccine, drug, device, and other countermeasure research, development, 
and manufacturing.''.
                                 &lt;all&gt;
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