S.Amdt. 2866

SA 2866. Mr. SPECTER submitted an amendment intended to be proposed
to amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr.
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal
Revenue Code of 1986 to modify the first-time homebuyers credit in the
case of members of the Armed Forces and certain other Federal
employees, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of subtitle D of title IV, insert the following:

SEC. 4307. CURES ACCELERATION NETWORK.

(a) Short Title.--This section may be cited as the ``Cures
Acceleration Network Act of 2009''.
(b) Requirement for the Director of NIH to Establish a
Cures Acceleration Network.--Section 402(b) of the Public
Health Service Act (42 U.S.C. 282(b)) is amended--
(1) in paragraph (22), by striking ``and'' at the end;
(2) in paragraph (23), by striking the period and inserting
``; and''; and
(3) by inserting after paragraph (23), the following:
``(24) implement the Cures Acceleration Network described
in section 402C.''.
(c) Accepting Gifts to Support the Cures Acceleration
Network.--Section 499(c)(1) of the Public Health Service Act
(42 U.S.C. 290b(c)(1)) is amended by adding at the end the
following:
``(E) The Cures Acceleration Network described in section
402C.''.
(d) Establishment of the Cures Acceleration Network.--Part
A of title IV of the Public Health Service Act is amended by
inserting after section 402B (42 U.S.C. 282b) the following:

``SEC. 402C. CURES ACCELERATION NETWORK.

``(a) Definitions.--In this section:
``(1) Biological product.--The term `biological product'
has the meaning given such term in section 351 of the Public
Health Service Act.
``(2) Drug; device.--The terms `drug' and `device' have the
meanings given such terms in section 201 of the Federal Food,
Drug, and Cosmetic Act.
``(3) High need cure.--The term `high need cure' means a
drug (as that term is defined by section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act, biological product (as
that term is defined by section 262(i)), or device (as that
term is defined by section 201(h) of the Federal Food, Drug,
and Cosmetic Act) that, in the determination of the Director
of NIH--
``(A) is a priority to diagnose, mitigate, prevent, or
treat harm from any disease or condition; and
``(B) for which the incentives of the commercial market are
unlikely to result in its adequate or timely development.
``(4) Medical product.--The term `medical product' means a
drug, device, biological product, or product that is a
combination of drugs, devices, and biological products.
``(b) Establishment of the Cures Acceleration Network.--
Subject to the appropriation of funds as described in
subsection (g), there is established within the Office of the
Director of NIH a program to be known as the Cures
Acceleration Network (referred to in this section as `CAN'),
which shall--
``(1) be under the direction of the Director of NIH, taking
into account the recommendations of a CAN Review Board
(referred to in this section as the `Board'), described in
subsection (d); and
``(2) award grants and contracts to eligible entities, as
described in subsection (e), to accelerate the development of
high need cures, including through the development of medical
products and behavioral therapies.
``(c) Functions.--The functions of the CAN are to--
``(1) conduct and support revolutionary advances in basic
research, translating scientific discoveries from bench to
bedside;
``(2) award grants and contracts to eligible entities to
accelerate the development of high need cures;
``(3) provide the resources necessary for government
agencies, independent investigators, research organizations,
biotechnology companies, academic research institutions, and
other entities to develop high need cures;
``(4) reduce the barriers between laboratory discoveries
and clinical trials for new therapies; and
``(5) facilitate review in the Food and Drug Administration
for the high need cures funded by the CAN, through activities
that may include--
``(A) the facilitation of regular and ongoing communication
with the Food and Drug Administration regarding the status of
activities conducted under this section;
``(B) ensuring that such activities are coordinated with
the approval requirements of the Food and Drug
Administration, with the goal of expediting the development
and approval of countermeasures and products; and
``(C) connecting interested persons with additional
technical assistance made available under section 565 of the
Federal Food, Drug, and Cosmetic Act.
``(d) CAN Board.--
``(1) Establishment.--There is established a Cures
Acceleration Network Review Board (referred to in this
section as the `Board'), which shall advise the Director of
NIH on the conduct of the activities of the Cures
Acceleration Network.
``(2) Membership.--
``(A) In general.--
``(i) Appointment.--The Board shall be comprised of 24
members who are appointed by the Secretary and who serve at
the pleasure of the Secretary.
``(ii) Chairperson and vice chairperson.--The Secretary
shall designate, from among the 24 members appointed under
clause (i), one Chairperson of the Board (referred to in this
section as the `Chairperson') and one Vice Chairperson.
``(B) Terms.--
``(i) In general.--Each member shall be appointed to serve
a 4-year term, except that any member appointed to fill a
vacancy occurring prior to the expiration of the term for
which the member's predecessor was appointed shall be
appointed for the remainder of such term.
``(ii) Consecutive appointments; maximum terms.--A member
may be appointed to serve not more than 3 terms on the Board,
and may not serve more than 2 such terms consecutively.
``(C) Qualifications.--
``(i) In general.--The Secretary shall appoint individuals
to the Board based solely upon the individual's established
record of distinguished service in one of the areas of
expertise described in clause (ii). Each individual appointed
to the Board shall be of distinguished achievement and have a
broad range of disciplinary interests.
``(ii) Expertise.--The Secretary shall select individuals
based upon the following requirements:

``(I) For each of the fields of--

``(aa) basic research;
``(bb) medicine;
``(cc) biopharmaceuticals;
``(dd) discovery and delivery of medical products;
``(ee) bioinformatics and gene therapy;
``(ff) medical instrumentation; and
``(gg) regulatory review and approval of medical products,

the Secretary shall select at least 1 individual who is
eminent in such fields.
``(II) At least 4 individuals shall be recognized leaders
in professional venture capital or private equity
organizations and have demonstrated experience in private
equity investing.
``(III) At least 8 individuals shall represent disease
advocacy organizations.

``(3) Ex-officio members.--
``(A) Appointment.--In addition to the 24 Board members
described in paragraph (2), the Secretary shall appoint as
ex-officio members of the Board--
``(i) a representative of the National Institutes of
Health, recommended by the Secretary of the Department of
Health and Human Services;
``(ii) a representative of the Office of the Assistant
Secretary of Defense for Health Affairs, recommended by the
Secretary of Defense;
``(iii) a representative of the Office of the Under
Secretary for Health for the Veterans Health Administration,
recommended by the Secretary of Veterans Affairs;
``(iv) a representative of the National Science Foundation,
recommended by the Chair of the National Science Board; and
``(v) a representative of the Food and Drug Administration,
recommended by the Commissioner of Food and Drugs.
``(B) Terms.--Each ex-officio member shall serve a 3-year
term on the Board, except that the Chairperson may adjust the
terms of the initial ex-officio members in order to provide
for a staggered term of appointment for all such members.
``(4) Responsibilities of the board and the director of
nih.--
``(A) Responsibilities of the board.--
``(i) In general.--The Board shall advise, and provide
recommendations to, the Director of NIH with respect to--

``(I) policies, programs, and procedures for carrying out
the duties of the Director of NIH under this section; and
``(II) significant barriers to successful translation of
basic science into clinical application (including issues
under the purview of other agencies and departments).

``(ii) Report.--In the case that the Board identifies a
significant barrier, as described in clause (i)(II), the
Board shall submit to the Secretary a report regarding such
barrier.
``(B) Responsibilities of the director of nih.--With
respect to each recommendation

[[Page S12342]]

provided by the Board under subparagraph (A)(i), the Director
of NIH shall respond in writing to the Board, indicating
whether such Director will implement such recommendation. In
the case that the Director of NIH indicates a recommendation
of the Board will not be implemented, such Director shall
provide an explanation of the reasons for not implementing
such recommendation.
``(5) Meetings.--
``(A) In general.--The Board shall meet 4 times per
calendar year, at the call of the Chairperson.
``(B) Quorum; requirements; limitations.--
``(i) Quorum.--A quorum shall consist of a total of 13
members of the Board, excluding ex-officio members, with
diverse representation as described in clause (iii).
``(ii) Chairperson or vice chairperson.--Each meeting of
the Board shall be attended by either the Chairperson or the
Vice Chairperson.
``(iii) Diverse representation.--At each meeting of the
Board, there shall be not less than one scientist, one
representative of a disease advocacy organization, and one
representative of a professional venture capital or private
equity organization.
``(6) Compensation and travel expenses.--
``(A) Compensation.--Members shall receive compensation at
a rate to be fixed by the Chairperson but not to exceed a
rate equal to the daily equivalent of the annual rate of
basic pay prescribed for level IV of the Executive Schedule
under section 5315 of title 5, United States Code, for each
day (including travel time) during which the member is
engaged in the performance of the duties of the Board. All
members of the Board who are officers or employees of the
Untied States shall serve without compensation in addition to
that received for their services as officers or employees of
the United States.
``(B) Travel expenses.--Members of the Board shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for persons employed
intermittently by the Federal Government under section
5703(b) of title 5, United States Code, while away from their
homes or regular places of business in the performance of
services for the Board.
``(e) Grant Program.--
``(1) Supporting innovation.--To carry out the purposes
described in this section, the Director of NIH shall award
contracts, grants, or cooperative agreements to the entities
described in paragraph (2), to--
``(A) promote innovation in technologies supporting the
advanced research and development and production of high need
cures, including through the development of medical products
and behavioral therapies;
``(B) accelerate the development of high need cures,
including through the development of medical products,
behavioral therapies, and biomarkers that demonstrate the
safety or effectiveness of medical products; or
``(C) help the award recipient establish protocols that
comply with Food and Drug Administration standards and
otherwise permit the recipient to meet regulatory
requirements at all stages of development, manufacturing,
review, approval, and safety surveillance of a medical
product.
``(2) Eligible entities.--To receive assistance under
paragraph (1), an entity shall--
``(A) be a public or private entity, which may include a
private or public research institution, an institution of
higher education, a medical center, a biotechnology company,
a pharmaceutical company, a disease advocacy organization, a
patient advocacy organization, or an academic research
institution;
``(B) submit an application containing--
``(i) a detailed description of the project for which the
entity seeks such grant or contract;
``(ii) a timetable for such project;
``(iii) an assurance that the entity will submit--

``(I) interim reports describing the entity's--

``(aa) progress in carrying out the project; and
``(bb) compliance with all provisions of this section and
conditions of receipt of such grant or contract; and

``(II) a final report at the conclusion of the grant
period, describing the outcomes of the project; and

``(iv) a description of the protocols the entity will
follow to comply with Food and Drug Administration standards
and regulatory requirements at all stages of development,
manufacturing, review, approval, and safety surveillance of a
medical product; and
``(C) provide such additional information as the Director
of NIH may require.
``(3) Awards.--
``(A) The cures acceleration partnership awards.--
``(i) Initial award amount.--Each award under this
subparagraph shall be not more than $15,000,000 per project
for the first fiscal year for which the project is funded,
which shall be payable in one payment.
``(ii) Funding in subsequent fiscal years.--An eligible
entity receiving an award under clause (i) may apply for
additional funding for such project by submitting to the
Director of NIH the information required under subparagraphs
(B) and (C) of paragraph (2). The Director may fund a project
of such eligible entity in an amount not to exceed
$15,000,000 for a fiscal year subsequent to the initial award
under clause (i).
``(iii) Matching funds.--As a condition for receiving an
award under this subsection, an eligible entity shall
contribute to the project non-Federal funds in the amount of
$1 for every $3 awarded under clauses (i) and (ii), except
that the Director of NIH may waive or modify such matching
requirement in any case where the Director determines that
the goals and objectives of this section cannot adequately be
carried out unless such requirement is waived.
``(B) The cures acceleration grant awards.--
``(i) Initial award amount.--Each award under this
subparagraph shall be not more than $15,000,000 per project
for the first fiscal year for which the project is funded,
which shall be payable in one payment.
``(ii) Funding in subsequent fiscal years.--An eligible
entity receiving an award under clause (i) may apply for
additional funding for such project by submitting to the
Board the information required under subparagraphs (B) and
(C) of paragraph (2). The Director of NIH may fund a project
of such eligible entity in an amount not to exceed
$15,000,000 for a fiscal year subsequent to the initial award
under clause (i).
``(C) The cures acceleration flexible research awards.--If
the Director of NIH determines that the goals and objectives
of this section cannot adequately be carried out through a
contract, grant, or cooperative agreement, the Director of
NIH shall have flexible research authority to use other
transactions to fund projects in accordance with the terms
and conditions of this section. Awards made under such
flexible research authority for a fiscal year shall not
exceed 20 percent of the total funds appropriated under
subsection (g)(1) for such fiscal year.
``(4) Suspension of awards for defaults, noncompliance with
provisions and plans, and diversion of funds; repayment of
funds.--The Director of NIH may suspend the award to any
entity upon noncompliance by such entity with provisions and
plans under this section or diversion of funds.
``(5) Audits.--The Director of NIH may enter into
agreements with other entities to conduct periodic audits of
the projects funded by grants or contracts awarded under this
subsection.
``(6) Closeout procedures.--At the end of a grant or
contract period, a recipient shall follow the closeout
procedures under section 74.71 of title 45, Code of Federal
Regulations (or any successor regulation).
``(7) Review.--A determination by the Director of NIH as to
whether a drug, device, or biological product is a high need
cure (for purposes of subsection (a)(3)) shall not be subject
to judicial review.
``(f) Competitive Basis of Awards.--Any grant, cooperative
agreement, or contract awarded under this section shall be
awarded on a competitive basis.
``(g) Authorization of Appropriations.--
``(1) In general.--For purposes of carrying out this
section, there are authorized to be appropriated $500,000,000
for fiscal year 2010, and such sums as may be necessary for
subsequent fiscal years. Funds appropriated under this
section shall be available until expended.
``(2) Limitation on use of funds otherwise appropriated.--
No funds appropriated under this Act, other than funds
appropriated under paragraph (1), may be allocated to the
Cures Acceleration Network.''.
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