[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1862 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 1862
To launch a national strategy to support regenerative medicine through
funding for research and commercial development of regenerative
medicine products and development of a regulatory environment that
enables rapid approval of safe and effective products, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 12, 2011
Mr. Bilbray (for himself, Ms. DeGette, Mr. Dent, Mr. Gerlach, Mr. Holt,
Ms. Fudge, Mr. Butterfield, and Mr. Langevin) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To launch a national strategy to support regenerative medicine through
funding for research and commercial development of regenerative
medicine products and development of a regulatory environment that
enables rapid approval of safe and effective products, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Regenerative
Medicine Promotion Act of 2011''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Report on ongoing Federal programs and activities regarding
regenerative medicine.
Sec. 4. Establishment of regenerative medicine coordinating council.
Sec. 5. Grants for basic or preclinical research into regenerative
medicine.
Sec. 6. Grants for development of drugs, biological products, medical
devices, and biomaterials for use in
regenerative medicine.
Sec. 7. Supporting innovation in regenerative medicine through cures
acceleration network.
Sec. 8. Funding for food and drug administration research.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Regenerative medicine has the potential to treat many
chronic diseases, promote economic growth, and reduce health
care spending in the United States.
(2) Regenerative medicine products have already
successfully treated numerous health conditions, and have the
potential to provide cures, treatments, and diagnostics for a
range of diseases and disabilities including diabetes, spinal
cord injury, heart disease, stroke, and various forms of
cancer.
(3) A United States national strategy on regenerative
medicine is critical to ensure that this technology fulfills
its potential to cure and treat diseases and disabilities,
reduce overall health spending, and promote economic growth.
(4) The Department of Defense has stated that regenerative
medicine has the potential to treat many battlefield injuries
such as burns, that it has the potential to heal wounds without
scarring, and that it has the potential to be used for
traumatic brain injury and other forms of trauma, craniofacial
reconstruction, limb reconstruction, regeneration, and
transplantation.
(5) The Department of Health and Human Services and the
Multi-Agency Tissue Engineering Science Interagency Working
Group have endorsed a national initiative to support research
and product development in regenerative medicine.
(6) The Department of Health and Human Services has said
the potential benefits of regenerative medicine in improved
health care and economic savings are enormous. States that have
invested in regenerative medicine have experienced economic
growth and see future growth potential, including an increase
in biotech employment, payroll increases, and proportional
impacts on tax receipts.
SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND ACTIVITIES REGARDING
REGENERATIVE MEDICINE.
Not later than 180 days after the date of the enactment of this
Act, the Comptroller General of the United States shall provide for the
completion, and submission to the Congress, of a report identifying all
ongoing Federal programs and activities regarding regenerative
medicine.
SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE COORDINATING COUNCIL.
(a) Establishment.--The Secretary of Health and Human Services
shall establish, within six months of the enactment of this Act, in the
Office of the Secretary, a Regenerative Medicine Coordinating Council
(in this section referred to as the ``Council'').
(b) Composition.--The Council shall be composed of the following:
(1) The Secretary of Commerce.
(2) The Secretary of Defense.
(3) The Secretary of Health and Human Services.
(4) The Secretary of the Treasury.
(5) The Secretary of Veterans Affairs.
(6) The Administrator of the Agency for Healthcare Research
and Quality.
(7) The Administrator of the Centers for Medicare &
Medicaid Services.
(8) The Commissioner of Food and Drugs.
(9) The Director of the National Institutes of Health.
(10) The Director of the National Institutes of Standards
and Technology.
(11) The members appointed by the Secretary under
subsection (d).
(c) Chair.--The Secretary of Health and Human Services shall be the
Chair of the Council.
(d) Members Appointed by Secretary.--The Secretary shall appoint at
least 5 persons to serve as members of the Council under subsection
(b)(11). The members of the Council appointed under the preceding
sentence shall include persons with expertise in third-party payment,
regenerative medicine researchers from academic institutions, patient
advocates, persons with expertise in drug discovery, persons with
expertise in drug development, persons with expertise in basic
research, persons with expertise in translational research, persons
with expertise in medical device development, persons with expertise in
biomaterials, clinicians, and persons with expertise in clinical
research.
(e) Functions.--The Council shall--
(1) consult with, and provide information to, the Secretary
of Health and Human Services for purposes of implementing any
recommendations in the report required by section 3;
(2) prepare, and keep up-to-date, a national strategy to
support research into regenerative medicine and the development
of drugs, biological products, medical devices, and
biomaterials for use in regenerative medicine;
(3) prepare a plan specifying priorities for research into
regenerative medicine;
(4) not later than 1 year after the date of the enactment
of this Act, establish priorities for the award of grants under
sections 5 and 6 (relating to grants for basic or preclinical
research into regenerative medicine and for development of
drugs, biological products, medical devices, and biomaterials
for use in regenerative medicine, respectively);
(5) identify sources of funding for research into
regenerative medicine;
(6) identify areas where such funding is inadequate;
(7) make recommendations regarding Federal regulatory,
reimbursement, tax, and other policies that will support
development and marketing of regenerative medicine products;
(8) facilitate development of consensus standards regarding
scientific issues critical to regulatory approval of
regenerative medicine products; and
(9) determine the need for establishing centers of
excellence or consortia to further advance regenerative
medicine.
(f) Transparency; Reporting Requirements.--
(1) Transparency.--The Council shall adopt procedures to
ensure the receipt of public input, such as holding public
stakeholder meetings or creating advisory boards.
(2) Annual reports.--The Council shall submit an annual
report on its activities to the Congress, the Director of the
National Institutes of Health, and the Commissioner of Food and
Drugs. Each such report shall--
(A) provide details on progress in meeting goals
identified by the Council for regenerative medicine;
(B) make recommendations regarding funding,
regulatory, or other policies to achieve regenerative
medicine goals identified by the Council;
(C) identify all regenerative medicine products
currently on the market and those in development;
(D) identify regenerative medicine research and
technological advances and discoveries that occurred in
the previous year; and
(E) assess the impact of regenerative medicine on
the Nation's economy, including with respect to--
(i) the number of people employed in
companies or research institutions working in
regenerative medicine;
(ii) the number of companies pursuing
regenerative medicine products;
(iii) increases in tax revenues; and
(iv) the impact on national health
spending.
SEC. 5. GRANTS FOR BASIC OR PRECLINICAL RESEARCH INTO REGENERATIVE
MEDICINE.
(a) Grants for Basic or Preclinical Research.--The Secretary may
make grants to eligible entities for the purpose of funding basic or
preclinical research into regenerative medicine.
(b) Conditions.--The Secretary may make a grant under this section
for research only if--
(1) the research is carried out directly by the grant
recipient;
(2) the research is partly funded by one or more private
entities; and
(3) the amount of the grant does not exceed the total
amount provided for the research by private entities (other
than the grant recipient itself).
(c) Terms and Conditions.--A grant under this section may be made
on such terms and conditions as the Secretary determines appropriate.
(d) Priority.--In awarding grants under this section, the Secretary
shall take into consideration the priorities established by the
Regenerative Medicine Coordinating Council under section 4(e).
(e) Definitions.--In this section:
(1) The term ``eligible entity'' means a nonprofit entity
or an institution of higher education.
(2) The term ``institution of higher education'' has the
meaning given that term in section 101 of the Higher Education
Act of 1965 (20 U.S.C. 1001).
(3) The term ``nonprofit entity'' means an entity that--
(A) is described in section 501(c)(3) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3));
and
(B) is exempt from tax under section 501(a) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
(4) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Director of the National
Institutes of Health.
SEC. 6. GRANTS FOR DEVELOPMENT OF DRUGS, BIOLOGICAL PRODUCTS, MEDICAL
DEVICES, AND BIOMATERIALS FOR USE IN REGENERATIVE
MEDICINE.
(a) Grants for Drug Development.--The Secretary may make grants to
eligible entities for the purpose of funding projects that have as
their aim--
(1) the research and development of drugs, biological
products, medical devices, and biomaterials for use in
regenerative medicine; and
(2) the making of an investigational new drug application
with respect to such drugs or biological products, or the
making of an investigational device exemption application with
respect to such devices, by not later than the end of the 4-
year period beginning on the date on which such grant is made.
(b) Terms and Conditions.--A grant under this section may be made
on such terms and conditions as the Secretary determines appropriate.
(c) Priority.--In awarding grants under this section, the Secretary
shall take into consideration the priorities established by the
Regenerative Medicine Coordinating Council under section 4(e).
(d) Definitions.--In this section:
(1) The term ``biological product'' has the meaning given
the term in section 351(i) of the Public Health Service Act (42
U.S.C. 262(i)).
(2) The terms ``drug'' and ``medical device'' have the
meanings given to the terms ``drug'' and ``device'',
respectively, in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).
(3) The term ``eligible entity'' means a collaborative
partnership including--
(A) a qualified nonprofit entity or an institution
of higher education; and
(B) a for-profit entity.
(4) The term ``institution of higher education'' has the
meaning given that term in section 101 of the Higher Education
Act of 1965 (20 U.S.C. 1001).
(5) The term ``investigational new drug application'' means
an investigational new drug application that is made to the
Food and Drug Administration under section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 505(i)).
(6) The term ``investigational device exemption
application'' means an application for an investigational
device exemption that is made to the Food and Drug
Administration under section 520(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(g)).
(7) The term ``qualified nonprofit entity'' means an entity
that--
(A) is described in section 501(c)(3) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3));
and
(B) is exempt from tax under section 501(a) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
(8) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Director of the National
Institutes of Health.
SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MEDICINE THROUGH CURES
ACCELERATION NETWORK.
Section 402C of the Public Health Service Act (42 U.S.C. 282d) is
amended--
(1) in subsection (d), by adding at the end the following:
``(7) Collaboration.--With respect to activities of the
Board relating to medical products and behavioral therapies for
use in regenerative medicine, the Board shall collaborate with
the Regenerative Medicine Coordinating Council.''; and
(2) in subsection (e)(3), by adding at the end the
following:
``(D) The cures acceleration awards with respect to
products and therapies for use in regenerative
medicine.--The Director of NIH may, without regard to
subparagraphs (A), (B), and (C), provide assistance
under paragraph (1) with respect to medical products
and behavioral therapies for use in regenerative
medicine, including assistance--
``(i) to perform clinical trials under a
protocol approved by the Commissioner of Food
and Drugs or studies which use good
manufacturing practice or good laboratory
practice procedures and the data from which are
intended for inclusion in an investigational
new drug application or an investigational
device exemption application; or
``(ii) to perform basic research or
preclinical studies in regenerative medicine
the data from which are not intended for
inclusion in an investigational new drug
application or an investigational device
exemption application.''.
SEC. 8. FUNDING FOR FOOD AND DRUG ADMINISTRATION RESEARCH.
(a) Grants.--The Secretary may--
(1) conduct, support, or collaborate in regulatory research
for the purpose of assisting the Food and Drug Administration
to perform its functions with respect to regenerative medicine;
or
(2) make grants to fund regulatory research for such
purpose.
(b) Definitions.--In this section:
(1) The term ``regulatory research'' means research
regarding development, evaluation, and availability of new or
improved tools, methods, standards, and applied science that
support a better understanding and improved evaluation of
product safety, quality, effectiveness, and manufacturing
throughout the product life cycle.
(2) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food and
Drugs.
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