1.Short title; table of
contents
(a)This Act may be cited
as the Regenerative Medicine Promotion Act of
2010
.
(b)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.
2.Congress finds the following:
(1)Regenerative medicine has the potential to
treat many chronic diseases and promote economic growth in the United
States.
(2)Regenerative
medicine has 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)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 craniofacial
reconstruction, limb reconstruction, regeneration, and transplantation.
(4)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.
(5)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.
3.Report on ongoing
Federal programs and activities regarding regenerative medicineNot later than 90 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall provide
for the completion, and submission to the Congress, of a report identifying all
ongoing Federal programs and activities regarding regenerative medicine.
4.Establishment of
Regenerative Medicine Coordinating Council
(a)The Secretary of Health and Human Services
shall establish, in the Office of the Secretary, a Regenerative Medicine
Coordinating Council (in this section referred to as the
Council
).
(b)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)Such other
members as may be appointed by the Secretary.
(c)The Secretary of Health and Human Services
shall be the Chair of the Council.
(d)Members
appointed by SecretaryThe
members of the Council appointed by the Secretary under subsection (b)(11)
shall include insurers, persons 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, and person with expertise
in clinical research.
(e)The
Council shall—
(1)consult with and
provide information to the Secretary of Health and Human Services for purposes
of preparing the report required by section 3;
(2)prepare, and keep up-to-date, a national
strategy for the promotion of 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 120 days 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, and other policies that will support development and
marketing of regenerative medicine products;
(8)develop 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)The
Council shall adopt procedures to ensure the receipt of public input, such as
holding public stakeholder meetings or creating advisory boards.
(2)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)identify
regenerative medicine products currently on the market and those in
development;
(C)identify
regenerative medicine research and technological advances and discoveries that
occurred in the previous year; and
(D)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; and
(iii)increases in tax
revenues.
5.Grants for basic
or preclinical research into regenerative medicine
(a)Grants for basic
or preclinical researchThe
Secretary may make grants to eligible entities for the purpose of funding basic
or preclinical research into regenerative medicine.
(b)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)A grant under this section may be made on such terms
and conditions as the Secretary determines appropriate.
(d)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)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.
(f)Authorization of
appropriationsTo carry out
this section, there is authorized to be appropriated $100,000,000 for the
period of fiscal years 2011 though 2016.
6.Grants for
development of drugs, biological products, medical devices, and biomaterials
for use in regenerative medicine
(a)Grants for drug
developmentThe 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)A grant under this section may be made on such terms
and conditions as the Secretary determines appropriate.
(c)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)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.
(e)Authorization of
appropriationsTo carry out
this section, there is authorized to be appropriated $100,000,000 for the
period of fiscal years 2011 though 2016.
7.Supporting innovation
in regenerative medicine through Cures Acceleration NetworkSection 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)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.
;
(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 medicineThe
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.
;
and
(3)in subsection
(g)—
(A)in paragraph (2),
by striking paragraph (1)
and inserting paragraph (1) or
(2)
;
(B)by redesignating
paragraph (2) as paragraph (3); and
(C)by inserting after
paragraph (1) the following:
(2)For providing
assistance under subsection (e)(1) with respect to medical products and
behavioral therapies for use in regenerative medicine, in addition to amounts
authorized to be appropriated by paragraph (1), there are authorized to be
appropriated $100,000,000 for each of fiscal years 2011 through
2015.
.
8.Funding for Food
and Drug Administration Research
(a)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)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.
(c)Authorization of
appropriationsTo carry out
this section, there are authorized to be appropriated $25,000,000 for fiscal
year 2011 and $125,000,000 for the period of fiscal years 2012 though
2016.