A bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer.

Summary: Ovarian Cancer Biomarker Research Act of 2009 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate Ovarian Cancer Biomarker Centers of Excellence to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Permits federal funds to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers, for ovarian cancer; (2) the clinical and laboratory validation of such biomarkers; (3) the development and implementation of clinical and epidemiological research on the utilization of such biomarkers; and (4) the development and implementation of repositories for new tissue, urine, serum, and other biological specimens.

Requires the Director to: (1) make available for research banked serum and tissue specimens from clinical research regarding ovarian cancer that was funded by the Department of Health and Human Services (HHS); and (2) establish an Ovarian Cancer Biomarker Clinical Trial Committee to assist in designing and implementing national clinical trials to determine the utility of using such biomarkers. Requires a national data center to be established in and supported by the Institute to conduct statistical analyses of trial data, and to store such analyses and data. Requires such data and statistical analyses to be used to establish clinical guidelines to provide the medical community with information regarding the use of validated biomarkers.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ovarian Cancer Biomarker Research 
Act of 2009''.

SEC. 2. GRANTS FOR ESTABLISHMENT AND OPERATION OF RESEARCH CENTERS FOR 
              THE STUDY OF OVARIAN CANCER BIOMARKERS.

    Subpart 1 of part C of the Public Health Service Act is amended by 
adding at the end the following new section:

``SEC. 417E. GRANTS FOR ESTABLISHMENT AND OPERATION OF RESEARCH CENTERS 
              FOR THE STUDY OF OVARIAN CANCER BIOMARKERS.

    ``(a) In General.--The Director of the Institute, in consultation 
with the directors of other relevant institutes and centers of the 
National Institutes of Health and the Department of Defense Ovarian 
Cancer Research Program, shall enter into cooperative agreements with, 
or make grants to, public or nonprofit entities to establish and 
operate centers to conduct research on biomarkers for use in risk 
stratification for, and the early detection and screening of, ovarian 
cancer, including fallopian tube cancer or primary peritoneal cancer. 
Each center shall be known as an Ovarian Cancer Biomarker Center of 
Excellence.
    ``(b) Research Funded.--Federal payments made under a cooperative 
agreement or grant under subsection (a) may be used for research on any 
of the following:
            ``(1) The development and characterization of new 
        biomarkers, and the refinement of existing biomarkers, for 
        ovarian cancer.
            ``(2) The clinical and laboratory validation of such 
        biomarkers, including technical development, standardization of 
        assay methods, sample preparation, reagents, reproducibility, 
        portability, and other refinements.
            ``(3) The development and implementation of clinical and 
        epidemiological research on the utilization of biomarkers for 
        the early detection and screening of ovarian cancer.
            ``(4) The development and implementation of repositories 
        for new tissue, urine, serum, and other biological specimens 
        (such as ascites and pleural fluids).
    ``(c) First Agreement or Grant.--Not later than 1 year after the 
date of the enactment of this section, the Director of the Institute 
shall enter into the first cooperative agreement or make the first 
grant under this section.
    ``(d) Availability of Banked Specimens.--The Director of the 
Institute shall make available for research conducted under this 
section banked serum and tissue specimens from clinical research 
regarding ovarian cancer that was funded by the Department of Health 
and Human Services.
    ``(e) Report.--Not later than the end of fiscal year 2010, and 
annually thereafter, the Director of the Institute shall submit a 
report to the Congress on the cooperative agreements entered into and 
the grants made under this section.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $25,000,000 
for each of the fiscal years 2010 through 2013, and such sums as may be 
necessary for each of the fiscal years 2014 through 2020. Such 
authorization of appropriations is in addition to any other 
authorization of appropriations that is available for such purpose.''.

SEC. 3. OVARIAN CANCER BIOMARKER CLINICAL TRIAL COMMITTEE.

    Subpart 1 of part C of the Public Health Service Act, as amended by 
section 2, is further amended by adding at the end the following new 
section:

``SEC. 417F. OVARIAN CANCER BIOMARKER CLINICAL TRIAL COMMITTEE.

    ``(a) Ovarian Cancer Biomarker Research Committee Established.--The 
Director of the Institute shall establish an Ovarian Cancer Biomarker 
Clinical Trial Committee (in this section referred to as the 
`Committee') to assist the Director to design and implement one or more 
national clinical trials, in accordance with this section, to determine 
the utility of using biomarkers validated pursuant to the research 
conducted under section 417E for risk stratification for, and early 
detection and screening of, ovarian cancer. Such Committee shall be 
established and operate in consultation with the Gynecologic Oncology 
Group (as funded by the National Cancer Institute).
    ``(b) Membership.--
            ``(1) In general.--The Committee shall consist of the 
        following types of members, to be appointed by the Director of 
        the Institute, in consultation with appropriate national 
        medical and research societies and patient advocate groups:
                    ``(A) National experts in statistical analysis, 
                clinical trial design, and patient recruitment.
                    ``(B) National experts in ovarian cancer research.
                    ``(C) Patient advocates.
                    ``(D) Representatives of Federal Government 
                agencies that currently fund ovarian cancer research.
                    ``(E) Nonvoting members that the Director of the 
                Institute determines to be appropriate.
            ``(2) Pay.--Members of the Committee shall serve without 
        pay and those members who are full time officers or employees 
        of the United States shall receive no additional pay by reason 
        of their service on the Committee, except that members of the 
        Committee shall receive travel expenses, including per diem in 
        lieu of subsistence, in accordance with applicable provisions 
        under chapter I of chapter 57 of title 5, United States Code.
    ``(c) Meetings.--The Committee shall meet at the call of the 
chairperson or upon the request of the Director of the Institute, but 
at least four times each year.
    ``(d) Clinical Trial Specifications.--In designing and implementing 
the clinical trials under this section, the Director of the Institute 
shall provide for the following:
            ``(1) Participation in trial.--To the greatest extent 
        possible, all academic centers, community cancer centers, and 
        individual physician investigators (as defined in subsection 
        (e)) shall have the opportunity to participate in the trials 
        under this section and to enroll women at risk for ovarian 
        cancer in the trials.
            ``(2) Costs for enrollments.--Subject to the availability 
        of appropriations, all the costs to the centers and offices 
        described in paragraph (1) for enrolling women in the trials 
        under this section shall be reimbursed by the Institute.
            ``(3) National data center.--A national data center shall 
        be established in and supported by the Institute to conduct 
        statistical analyses of the data derived from the trials under 
        this section and to store such analyses and data.
            ``(4) Guidelines for medical community.--Data and 
        statistical analyses of the clinical trials under this section 
        shall be used to establish clinical guidelines to provide the 
        medical community with information regarding the use of 
        biomarkers validated pursuant to the research conducted under 
        section 417E for risk stratification for, and early detection 
        and screening of, ovarian cancer.
    ``(e) Individual Physician Investigator Defined.--For purposes of 
subsection (d)(1), the term `individual physician investigator' means a 
physician--
            ``(1) who is a faculty member at an academic institution or 
        who is in a private medical practice; and
            ``(2) who provides health care services to women at risk 
        for ovarian cancer.
    ``(f) Report.--Not later than the end of fiscal year 2010, and 
annually thereafter, the Director of the Institute shall submit a 
report to the Congress on the activities conducted under this section.
    ``(g) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $5,000,000 
for each of the fiscal years 2010 through 2013, and such sums as may be 
necessary for each of the fiscal years 2014 through 2020. Such 
authorization of appropriations is in addition to any other 
authorization of appropriations that is available for such purpose.''.