[Congressional Record Volume 155, Number 63 (Tuesday, April 28, 2009)]
[Senate]
[Pages S4813-S4817]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER:
  S. 914. A bill to establish an independent Cures Acceleration Network 
agency, to sponsor promising translational research to bridge the gap 
between laboratory discoveries and life-saving therapies, to 
reauthorize the National Institutes of Health, and for other purposes; 
to the Committee on Health, Education, Labor, and Pensions.
  Mr. SPECTER. Mr. President, the bill that I am introducing today 
would authorize the establishment of the Cures Acceleration Network, 
CAN. This new $2 billion agency would provide funds to translate 
research discoveries from the bench to the bedside and would operate as 
an independent agency. It would not be part of the Department of Health 
and Human Services. The CAN would make awards outside of the 
traditional funding stream to accelerate the development of cures and 
treatments including but not limited to drugs, devices, and behavioral 
therapies. The CAN would have a flexible expedited review process to 
get monies into the hands of the grantees as quickly as possible. These 
development

[[Page S4814]]

funds would complement the research dollars provided to the National 
Institutes of Health, NIH, and would not compete or take monies away 
from the NIH.
  The bill also would raise the authorization level of the National 
Institutes of Health to $40 billion in fiscal year 2010, elevate the 
Center for Minority Health and Health Disparities to Institute status, 
and implement a new conflict-of-interest provision.
  While the NIH funds much of the basic biomedical research at 
universities across the country, the CAN would take those findings 
found through basic research and provide funding to fill the gap 
between laboratory discoveries and life-saving medical therapies. This 
funding gap--often referred to as ``the valley of death'' arises after 
Federal basic-science support ends and before investors are willing to 
commit to a promising discovery. Very often finding funds to fill this 
gap is a daunting challenge, especially during a period of economic 
downturn, when investors have fewer resources to invest. This has had a 
severe impact on America's biotechnology industry.
  The need for the CAN is clear: Capital raised by America's 
biotechnology companies fell 55 percent in 2008 compared to 2007. Also 
relative to 2007, 90 percent of small public biotechnology companies 
are now operating with less than 6 months of cash on hand. In the last 
5 months alone, at least 24 U.S. public biotech companies have either 
placed drug development programs on hold or cut programs altogether. 
These companies have postponed clinical trials to treat melanoma, 
cervical cancer, lupus, chemotherapy side effects for breast cancer 
patients, multiple sclerosis, diabetes and atherosclerosis, drug trials 
to treat non-Hodgkin's lymphoma, testing of pandemic flu vaccine, 
trials to treat plaque psoriasis and heart disease, and a treatment for 
mesothelioma.
  In short, without adequate funding--these companies will be unable to 
take these products to the development stage, the basic research done 
by the NIH will be lost, and many patients will die waiting for drugs 
and devices to give them a better quality of life.
  The CAN would fund two types of grant awards, each with an 
authorization of $1 billion in the first year and additional funds in 
succeeding fiscal years.
  The Cures Acceleration Grant Awards will provide grant awards of up 
to $15 million per year per project with out-year funding available. 
These awards would be available to applicants who do not have access to 
private matching funds.
  The Cures Acceleration Partnership Awards also would provide grants 
for up to $15 million per year per project with additional funds 
available in the out-years. However, grant awards would require a match 
of three Federal dollars to one grantee dollar, as a way to partially 
offset development costs.
  For both grant types, the CAN Board may waive the award limitation as 
well as modify the matching requirement.
  Eligible grantees would include public or private entities such as 
institutions of higher education, medical centers, biotechnology 
companies, universities, patient advocacy organizations, pharmaceutical 
companies and academic research institutions.
  To provide for expedited FDA approval, the grantees must also 
establish protocols that comply with FDA standards to meet regulatory 
requirements at all stages of development, manufacturing, review, 
approval and safety surveillance of a medical product.
  The provisions of the Bayh-Dole Act would apply.
  The CAN grant proposals would be evaluated by a 24-member board 
comprised of experienced individuals of distinguished achievement, and 
representative of a broad range of disciplinary interests including: 
venture capitalists and business executives with experience in managing 
scientific enterprises; scientists with expertise in the fields of 
basic research, biopharmaceuticals, drug discovery, drug delivery of 
medical products, bioinformatics, gene therapy or medical 
instrumentation, regulatory review and approval of medical products; 
and representatives of patient advocacy organizations.
  The Chairman and Vice Chairman of the CAN shall be appointed by the 
President with the advice and consent of the Senate. The term of office 
of each member of the Board shall be 2 years. The CAN board also will 
include ex-officio members representing the National Institutes of 
Health, the Food and Drug Administration and the Department of Defense, 
the Department of Veterans Affairs and the National Science Foundation. 
The CAN board will meet four times each calendar year, with 12 board 
members and representatives of the ex-officio members present at each 
meeting. The board will be supported by an executive director and other 
employees that the Board deems necessary to ensure efficient operation 
of the CAN.
  The Chairman of the CAN shall have authority to enter into an 
interagency agreement with the Center for Scientific Review at the 
National Institutes of Health to utilize advisory panels to review 
applications, and to make recommendations to the CAN.
  The increases that have been made in medical research over the past 
20-30 years have dramatically improved the survival rates for many 
diseases--deaths from coronary artery disease declined by 18 percent 
between 1994 and 2004. Stroke deaths also fell by 24.2 percent during 
that same time period. The five-years survival rates for Hodgkin's 
lymphoma have increased from 4 percent in the 1960s to more than 86 
percent today. Survival rates for localized breast cancer have 
increased from 80 percent in the 1950s to 98 percent today. Over the 
past 25 years, survival rates for prostate cancer have increased from 
69 percent to almost 99 percent. So we are seeing real progress. But 
for many other maladies, the statistics are not so good.
  These medical advances do not happen overnight. It takes time and 
money for research institutions to develop scientists skilled in the 
latest research techniques and to develop the costly infrastructure 
where research takes place.
  Regrettably, Federal funding for NIH has steadily declined from the 
$3.8 billion increase provided in 2003--when the 5-year doubling of 
that agency was completed. Had we provided sustained increases of $3.5 
billion per year, plus inflation since 2003, we would have $23 billion 
more in funding for today. The shortfall due to inflationary costs 
alone is $5.2 billion. This flagging investment in medical research, 
many believe, served to discourage bright young investigators from 
entering this field of study.
  The $10 billion for the National Institutes of Health that was 
included in stimulus package provided an immediate infusion of new 
research dollars for medical research. While these funds will only make 
up for a portion of what was lost since 2003, it is a step in the right 
direction. But much remains to be done. Additional dollars must be 
found for the 2010 appropriation and beyond.
  The $40 billion contained in the legislation that I am introducing 
today will help to re-energize our investment in medical research, 
support a new generation of young scientists and invest in the health 
of our Nation.
  The bill also contains a provision which requires the Director of NIH 
to enforce conflict-of-interest policies, requiring primary 
investigators with financial interests to provide a detailed report how 
the grant recipient will manage the investigator's conflict-of-
interest.
  The legislation also elevates the National Center for Minority Health 
and Health Disparities to Institute status, a designation that will 
lead to more resources to address the health status of minority and 
other medically underserved communities.
  While some might argue that at a time when our economy is struggling 
we cannot afford to invest more in medical research. The fact is that 
research offers the only hope of saving lives, allowing our citizens to 
lead longer, more productive lives and saving billions of dollars in 
health care cost. To those critics I would say we cannot afford not to 
invest in medical research. This is not simply good social policy; it 
is good economic policy as well.
  Mr. President, I ask unanimous consent that the text of the bill and 
a list of supporters be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

[[Page S4815]]

                                 S. 914

       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 ``Cures Acceleration Network 
     and National Institutes of Health Reauthorization Act of 
     2009''.

     SEC. 2. CURES ACCELERATION NETWORK.

       (a) Definitions.--In this section--
       (1) the term ``medical product'' means a drug, device, 
     biological product, or product that is a combination of 
     drugs, devices, and biological products;
       (2) the terms ``drug'' and ``device'' have the meanings 
     given such terms in section 201 of the Federal Food, Drug, 
     and Cosmetic Act; and
       (3) the term ``biological product'' has the meaning given 
     such term in section 351 of the Public Health Service Act.
       (b) Establishment of the Cures Acceleration Network.--There 
     is established an independent agency to be known as the Cures 
     Acceleration Network (referred to in this section as 
     ``CAN''), which shall--
       (1) be under the direction 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 
     cures and treatments of diseases, including through the 
     development of medical products and behavioral therapies.
       (c) Functions.--The functions of the CAN are to--
       (1) identify and promote revolutionary advances in basic 
     research, translating scientific discoveries from bench to 
     bedside;
       (2) award grants and contracts to eligible entities;
       (3) provide the resources through grants and contracts 
     necessary for independent investigators, research 
     organizations, biotechnology companies, academic research 
     institutions, and other entities to develop medical products 
     for the treatment and cure of diseases and disorders;
       (4) reduce the barriers between laboratory discoveries and 
     clinical trials for new therapies;
       (5) facilitate priority review in the Food and Drug 
     Administration for the medical products funded by the CAN; 
     and
       (6) accept donations, bequests, and gifts to the CAN.
       (d) CAN Board.--
       (1) Establishment.--There is established a Cures 
     Acceleration Network Review Board (referred to in this 
     section as the ``Board''), which shall direct 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 President and who serve at 
     the pleasure of the President.
       (ii) Chairperson and vice chairperson.--The President, by 
     and with the advice and consent of the Senate, 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 President 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 President 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 President 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 President 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.--The Board shall--
       (A) advise the Chairperson with respect to policies, 
     programs, and procedures for carrying out the Chairperson's 
     duties; and
       (B) review applications for grants and contracts under 
     subsection (e) and make recommendations to the Chairperson.
       (5) Authority of the chairperson.--The Chairperson may--
       (A) prescribe regulations regarding the manner in which the 
     Chairperson's duties shall be carried out, as the Chairperson 
     determines necessary;
       (B) appoint employees, subject to civil service laws, as 
     necessary to carry out the Chairperson's functions;
       (C) define the duties, and supervise and direct the 
     activities, of any employees appointed under subparagraph 
     (B);
       (D) use experts and consultants, including a panel of 
     experts who may be employed as authorized by section 3109 of 
     title 5, United States Code;
       (E) accept and utilize the services of voluntary and 
     uncompensated personnel and reimburse such personnel for 
     travel expenses, as described in paragraph (7)(B);
       (F) make advance, progress, or other payments without 
     regard to section 3324 of title 31, United States Code;
       (G) rent office space in the District of Columbia for use 
     by the CAN;
       (H) enter into agreements with other Federal agencies to 
     carry out oversight of the grant program under subsection 
     (e), which agreements may include provisions for financial 
     reimbursement for the oversight provided by such agencies; 
     and
       (I) make other necessary expenditures.
       (6) 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 (iv).
       (ii) Chairperson or vice chairperson.--Each meeting of the 
     Board shall be attended by either the Chairperson or the Vice 
     Chairperson.
       (iii) Limitation.--No member or ex-officio member of the 
     Board may attend more than 2 meetings of the Board each 
     calendar year with the exceptions of the Chairperson and Vice 
     Chairperson, who may attend all such meetings.
       (iv) 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.
       (7) 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) Grants and contracts.--The Chairperson shall, through 
     the Board of the CAN, award grants and contracts to eligible 
     entities to assist such entities in carrying out projects 
     described in paragraph (3).
       (2) Award process.--The Chairperson of the Board may award 
     a grant or contract under this subsection to an eligible 
     entity only upon the approval of a majority of a quorum of 
     the Board.
       (3) Use of funds.--Funds awarded under this subsection 
     shall be used--
       (A) to accelerate the development of cures and treatments, 
     including through the development of medical products, 
     behavioral therapies, and biomarkers that demonstrate the 
     safety or effectiveness of medical products; or
       (B) to help the award recipient establish protocols that 
     comply with Food and Drug

[[Page S4816]]

     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.
       (4) Eligible entities.--To receive a grant or contract 
     under this subsection, an entity shall--
       (A) be--
       (i) an individual;
       (ii) a group of individuals; or
       (iii) 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 Chairperson 
     may require.
       (5) Study sections of the center for scientific review.--
       (A) In general.--The Chairperson may enter into an 
     interagency agreement with the Center for Scientific Review 
     within the National Institutes of Health to use the study 
     sections of such Center to review applications submitted 
     under paragraphs (4)(B) and additional information submitted 
     under (4)(C) and to make recommendations to the Board. The 
     Chairperson shall promulgate regulations and procedures to--
       (i) ensure that each study section reviewing applications 
     is composed of diverse members, as described in subparagraph 
     (B);
       (ii) require such study sections to create written records 
     summarizing--

       (I) all meetings and discussions of the study section; and
       (II) the recommendations made by such study section to the 
     Board; and

       (iii) make the records described in clause (ii) available 
     to the public in a manner that protects the privacy of 
     applicants and panel members and any proprietary information 
     from applicants.
       (B) Membership.--The Chairperson shall ensure that the 
     study sections of the Center for Scientific Review that 
     review applications submitted under this subsection are 
     selected solely on the basis of established records of 
     distinguished service and include--
       (i) for each of the fields of--

       (I) basic research;
       (II) medicine;
       (III) biopharmaceuticals;
       (IV) discovery and delivery of medical products;
       (V) bioinformatics and gene therapy; and
       (VI) medical instrumentation,

     at least 2 individuals with expertise in such fields;
       (ii) at least 3 representatives of professional venture 
     capital or private equity organizations with demonstrated 
     experience in private equity investing; and
       (iii) at least 3 representatives of disease advocacy 
     organizations.
       (C) Financial compensation.--Any agreement under 
     subparagraph (A) shall include an arrangement whereby the 
     Chairperson reimburses the Center for Scientific Review for 
     the services provided under such subparagraph.
       (6) 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, except that the 
     Chairperson of the Board may increase the award amount for an 
     eligible entity if the Board so determines by a majority 
     vote.
       (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 (4). The Chairperson 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) if the Board so determines by majority vote.
       (iii) Matching funds.--As a condition for receiving a grant 
     or contract under this subparagraph, 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 Chairperson may waive or modify such matching 
     requirement by a majority vote of the Board.
       (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, except that the 
     Chairperson of the Board may increase the award amount for an 
     eligible entity if the Board so determines by a majority 
     vote.
       (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 (4). The Chairperson 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) if the Board so determines by majority vote.
       (7) Suspension of awards for defaults, noncompliance with 
     provisions and plans, and diversion of funds; repayment of 
     funds.--The Chairperson may suspend the award to any entity 
     upon noncompliance by such entity with provisions and plans 
     under this section or diversion of funds.
       (8) Audits.--The Chairperson may enter into agreements with 
     other entities to conduct periodic audits of the projects 
     funded by grants or contracts awarded under this subsection.
       (9) 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).
       (f) Staff.--The CAN may employ such officers and employees 
     (including experts and consultants), appointed by the 
     Chairperson, as may be necessary to enable the CAN to carry 
     out its functions under this section, and may employ and fix 
     the compensation of such officers and employees.
       (g) Gifts, Bequests, and Devises.--
       (1) In general.--The CAN may accept donations, bequests, 
     and devises, with or without conditions, and transfers for 
     tax purposes, for the purpose of aiding or facilitating the 
     work of the CAN subject to the following:
       (A) In any case in which money or other property is 
     donated, bequeathed, or devised to the CAN without 
     designation for the benefit of which such property is 
     intended, and without condition or restriction other than 
     that such property be used for the purposes of the CAN, such 
     property shall be deemed to have been donated, bequeathed, or 
     devised to the CAN and the Chairperson shall have authority 
     to receive such property.
       (B) In any case in which any money or other property is 
     donated, bequeathed, or devised to the CAN with a condition 
     or restriction, such property shall be deemed to have been 
     donated, bequeathed, or devised to the CAN whose function it 
     is to carry out the purpose or purposes described, or 
     referred to, by the terms of such condition or restriction, 
     and the Chairperson shall have authority to receive such 
     property.
       (C) For the purposes of subparagraph (B), if one or more of 
     the purposes of such a condition or restriction is covered by 
     the functions of the CAN, or if some of the purposes of such 
     a condition or restriction are covered by the CAN, the Board 
     shall determine an equitable manner for distribution by the 
     CAN of the property so donated, bequeathed, or devised.
       (D) For the purpose of Federal income tax, gift tax, and 
     estate tax laws, any money or other property donated, 
     bequeathed, or devised to the Chairperson pursuant to 
     authority derived under this subsection shall be deemed to 
     have been donated, bequeathed, or devised to, or for the use 
     of, the United States.
       (h) Conflicts of Interest.--
       (1) In general.--The Chairperson shall develop and enforce 
     conflict of interest policies for the CAN and shall respond 
     in a timely manner when such policies have been violated by a 
     recipient of funds provided under a grant or contract awarded 
     under this section.
       (2) Information.--
       (A) In general.--In the case in which the principal 
     investigator for a recipient described under subparagraph (B) 
     has a conflict of interest, the Chairperson shall require the 
     recipient to provide to the Chairperson the following 
     information:
       (i) The degree of the primary investigator's financial 
     interest, estimated to the nearest $1,000.
       (ii) A detailed report explaining how the recipient will 
     manage the primary investigator's conflict of interest.
       (B) Recipient.--A recipient described in this subparagraph 
     is a recipient--
       (i) of a grant or contract awarded under subsection (e); 
     and
       (ii) that receives more than $250,000 under such grant or 
     contract.
       (i) Authorization of Appropriations.--For purposes of 
     carrying out this section, there are authorized to be 
     appropriated--
       (1) for fiscal year 2010, $1,000,000,000 for awards 
     described under subsection (e)(6)(A), including associated 
     administrative costs;
       (2) for fiscal year 2010, $1,000,000,000 for awards 
     described under subsection (e)(6)(B), including associated 
     administrative costs; and
       (3) such sums as may be necessary for subsequent fiscal 
     years.

     SEC. 3. ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.

       (a) Redesignation of Center on Minority Health and Health 
     Disparities.--Title IV of the Public Health Service Act (42 
     U.S.C. 281 et seq.) is amended--
       (1) by redesignating subpart 6 of part E as subpart 20;

[[Page S4817]]

       (2) by transferring subpart 20, as so redesignated, to part 
     C of such title IV;
       (3) by inserting subpart 20, as so redesignated, after 
     subpart 19 of such part C; and
       (4) in subpart 20, as so redesignated--
       (A) by redesignating sections 485E through 485H as sections 
     464z-3 through 464z-6, respectively;
       (B) by striking ``National Center on Minority Health and 
     Health Disparities'' each place such term appears and 
     inserting ``National Institute on Minority Health and Health 
     Disparities''; and
       (C) by striking ``Center'' each place such term appears and 
     inserting ``Institute''.
       (b) Purpose of Institute.--Subsection (h) of section 464z-3 
     of the Public Health Service Act, as so redesignated, is 
     amended--
       (1) in paragraph (1), by striking ``research endowments at 
     centers of excellence under section 736.'' and inserting the 
     following: ``research endowments--
       ``(1) at centers of excellence under section 736; and
       ``(2) at centers of excellence under section 464z-4.''; and
       (2) in paragraph (2)(A), by striking ``average'' and 
     inserting ``median''.
       (c) Technical Amendment.--Section 401(b)(24) of the Public 
     Health Service Act (42 U.S.C. 281(b)(24)) is amended by 
     striking ``Center'' and inserting ``Institute''.
       (d) Conforming Amendment.--Subsection (d)(1) of section 903 
     of the Public Health Service Act (42 U.S.C. 299a-1(d)(1)) is 
     amended by striking ``section 485E'' and inserting ``section 
     464z-3''.

     SEC. 4. CONFLICTS OF INTEREST.

       Section 402 of the Public Health Service Act (42 U.S.C. 
     282) is amended by adding at the end the following:
       ``(m) Enforcement of Conflict of Interest Policies.--
       ``(1) In general.--The Director shall develop and enforce 
     the conflict of interest policies for the National Institutes 
     of Health and shall respond in a timely manner when such 
     policies have been violated by a recipient of funds provided 
     under a grant or contract awarded under this title.
       ``(2) Information.--
       ``(A) In general.--In the case in which the principal 
     investigator for a recipient described under subparagraph (B) 
     has a conflict of interest, the Director shall require the 
     recipient to provide to the Director the following 
     information:
       ``(i) The degree of the primary investigator's financial 
     interest, estimated to the nearest $1,000.
       ``(ii) A detailed report explaining how the recipient will 
     manage the primary investigator's conflict of interest.
       ``(B) Recipient.--A recipient described in this 
     subparagraph is a recipient--
       ``(i) of a grant or contract awarded under this title; and
       ``(ii) that receives more than $250,000 under such grant or 
     contract.''.

     SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

       (a) Authorization of Appropriations.--Section 402A of the 
     Public Health Service Act (42 U.S.C. 282a) is amended by 
     striking paragraphs (1) through (3) of subsection (a) and 
     inserting the following:
       ``(1) $40,000,000,000 for fiscal year 2010; and
       ``(2) such sums as may be necessary for each of fiscal 
     years 2011 and 2012.''.
       (b) Office of the Director.--Subparagraph (b) of section 
     402A of the Public Health Service Act (42 U.S.C. 282a(b)) is 
     amended by striking ``2007 through 2009'' and inserting 
     ``2010 through 2012''.

                               Supporters

       Autism Speaks, Association of Minority Health Professions 
     Schools, Morehouse School of Medicine, Meharry Medical 
     College, Charles Drew University of Medicine and Science, 
     Cure Alzheimer's Fund, American Thoracic Society, Scleroderma 
     Foundation, NephCure Foundation, National Marfan Foundation, 
     Crohn's and Colitis Foundation of America, Pulmonary 
     Hypertension Association, Biotechnology Industry 
     Organization, Melanoma Research Foundation, Alzheimer's 
     Association, Medical Library Association, Association of 
     Academic Health Sciences Libraries, American Lung 
     Association, Lupus Research Institute, S.L.E. Lupus 
     Foundation, Friends of Cancer Research, College on Problems 
     of Drug Dependence, Parkinson's Action Network.
                                 ______