I 
111TH CONGRESS 
1ST SESSION H. R. 1816 
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. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 31, 2009 
Mr. BERMAN (for himself, Mr. HALL of Texas, Ms. BORDALLO, Ms. LEE of 
California, Mr. VAN HOLLEN, Mr. MCGOVERN, Mr. MCDERMOTT, Mr. 
BOUCHER, Mr. KING of New York, Mr. GENE GREEN of Texas, Mr. 
WOLF, Ms. KILROY, Mr. BURTON of Indiana, Mr. ISRAEL, Mr. HINCHEY, 
Mr. SESTAK, Ms. DELAURO, Ms. SHEA-PORTER, Mrs. MALONEY, Mr. 
MCMAHON, Ms. WASSERMAN SCHULTZ, Mrs. CAPPS, Mr. SERRANO, Mr. 
FARR, and Ms. EDWARDS of Maryland) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ovarian Cancer Bio-
marker 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. 417G. GRANTS FOR ESTABLISHMENT AND OPER-
ATION 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 Pro-
gram, 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 can-
cer or primary peritoneal cancer. Each center shall be 
known as an Ovarian Cancer Biomarker Center of Excel-
lence, and shall focus on translational research of ovarian 
cancer biomarkers. 
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‘‘(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 bio-
markers, for ovarian cancer. 
‘‘(2) The clinical and laboratory validation of 
such biomarkers, including technical development, 
standardization of assay methods, sample prepara-
tion, reagents, reproducibility, portability, and other 
refinements. 
‘‘(3) The development and implementation of 
clinical and epidemiological research on the utiliza-
tion 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). 
‘‘(5) Genetics, proteomics, and pathways of 
ovarian cancer as they relate to the discovery and 
development of biomarkers. 
‘‘(c) FIRST AGREEMENT OR GRANT.—Not later than 
1 year after the date of the enactment of this section, the 
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Director of the Institute shall enter into the first coopera-
tive 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 Insti-
tute shall submit a report to the Congress on the coopera-
tive 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 au-
thorization of appropriations is in addition to any other 
authorization of appropriations that is available for such 
purpose.’’. 
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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. 417H. OVARIAN CANCER BIOMARKER CLINICAL 
TRIAL COMMITTEE. 
‘‘(a) OVARIAN CANCER BIOMARKER RESEARCH COM-
MITTEE ESTABLISHED.—The Director of the Institute 
shall establish an Ovarian Cancer Biomarker Clinical 
Trial Committee (in this section referred to as the ‘Com-
mittee’) 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 vali-
dated pursuant to the research conducted under section 
417E for risk stratification for, and early detection and 
screening of, ovarian cancer. 
‘‘(b) MEMBERSHIP.— 
‘‘(1) NUMBER.—The Committee shall consist of 
11 voting members and such number of nonvoting 
members as the Director of the Institute determines 
appropriate. 
‘‘(2) APPOINTMENT.—The members of the 
Committee shall be appointed by the Director of the 
Institute, in consultation with appropriate national 
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medical societies, research societies, and patient ad-
vocate organizations, as follows: 
‘‘(A) 
VOTING
MEMBERS.—The 
voting 
members of the Committee shall be appointed 
by the Director of the Institute as follows: 
‘‘(i) Two patient advocates. 
‘‘(ii) Two national experts in statis-
tical analysis, clinical trial design, and pa-
tient recruitment. 
‘‘(iii) Two representatives from the 
Gynecologic Oncology Group. 
‘‘(iv) One representative from the De-
partment of Defense Ovarian Cancer Re-
search Program. 
‘‘(v) Four ovarian cancer researchers. 
‘‘(B) NONVOTING
MEMBERS.—The non-
voting members of the Committee shall include 
such individuals as the Director of the Institute 
determines to be appropriate. 
‘‘(3) 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 Com-
mittee shall receive travel expenses, including per 
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diem in lieu of subsistence, in accordance with appli-
cable provisions under chapter I of chapter 57 of 
title 5, United States Code. 
‘‘(c) CHAIRPERSON.—The voting members of the 
Committee appointed under subsection (b)(2) shall select 
a chairperson from among such members. 
‘‘(d) 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. 
‘‘(e) CLINICAL TRIAL SPECIFICATIONS.—In design-
ing and implementing the clinical trials under this section, 
the Director of the Institute shall provide for the fol-
lowing: 
‘‘(1) PARTICIPATION IN TRIAL.—To the great-
est extent possible, all academic centers, community 
cancer centers, and individual physician investigators 
(as defined in subsection (f)) shall have the oppor-
tunity 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. 
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‘‘(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 in-
formation 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. 
‘‘(f) INDIVIDUAL
PHYSICIAN
INVESTIGATOR
DE-
FINED.—For purposes of subsection (e)(1), the term ‘indi-
vidual 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. 
‘‘(g) REPORT.—Not later than the end of fiscal year 
2010, and annually thereafter, the Director of the Insti-
tute shall submit a report to the Congress on the activities 
conducted under this section. 
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‘‘(h) 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 au-
thorization of appropriations is in addition to any other 
authorization of appropriations that is available for such 
purpose.’’. 
Æ 
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