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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ovarian Cancer Bio3 marker Research Act of 2009’’. 

4 SEC. 2. GRANTS FOR ESTABLISHMENT AND OPERATION OF 

5 RESEARCH CENTERS FOR THE STUDY OF 

6 OVARIAN CANCER BIOMARKERS. 

7 Subpart 1 of part C of the Public Health Service Act 

8 is amended by adding at the end the following new section: 

9 ‘‘SEC. 417G. GRANTS FOR ESTABLISHMENT AND OPER10 ATION OF RESEARCH CENTERS FOR THE 

11 STUDY OF OVARIAN CANCER BIOMARKERS. 

12 ‘‘(a) IN GENERAL.—The Director of the Institute, in 

13 consultation with the directors of other relevant institutes 

14 and centers of the National Institutes of Health and the 

15 Department of Defense Ovarian Cancer Research Pro16 gram, shall enter into cooperative agreements with, or 

17 make grants to, public or nonprofit entities to establish 

18 and operate centers to conduct research on biomarkers for 

19 use in risk stratification for, and the early detection and 

20 screening of, ovarian cancer, including fallopian tube can21 cer or primary peritoneal cancer. Each center shall be 

22 known as an Ovarian Cancer Biomarker Center of Excel23 lence, and shall focus on translational research of ovarian 

24 cancer biomarkers. 


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1 ‘‘(b) RESEARCH FUNDED.—Federal payments made 

2 under a cooperative agreement or grant under subsection 

3 (a) may be used for research on any of the following: 

4 ‘‘(1) The development and characterization of 

5 new biomarkers, and the refinement of existing bio6 markers, for ovarian cancer. 

7 ‘‘(2) The clinical and laboratory validation of 

8 such biomarkers, including technical development, 

9 standardization of assay methods, sample prepara10 tion, reagents, reproducibility, portability, and other 

11 refinements. 

12 ‘‘(3) The development and implementation of 

13 clinical and epidemiological research on the utiliza14 tion of biomarkers for the early detection and 

15 screening of ovarian cancer. 

16 ‘‘(4) The development and implementation of 

17 repositories for new tissue, urine, serum, and other 

18 biological specimens (such as ascites and pleural 

19 fluids). 

20 ‘‘(5) Genetics, proteomics, and pathways of 

21 ovarian cancer as they relate to the discovery and 

22 development of biomarkers. 

23 ‘‘(c) FIRST AGREEMENT OR GRANT.—Not later than 

24 1 year after the date of the enactment of this section, the 


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1 Director of the Institute shall enter into the first coopera2 tive agreement or make the first grant under this section. 

3 ‘‘(d) AVAILABILITY OF BANKED SPECIMENS.—The 

4 Director of the Institute shall make available for research 

5 conducted under this section banked serum and tissue 

6 specimens from clinical research regarding ovarian cancer 

7 that was funded by the Department of Health and Human 

8 Services. 

9 ‘‘(e) REPORT.—Not later than the end of fiscal year 

10 2010, and annually thereafter, the Director of the Insti11 tute shall submit a report to the Congress on the coopera12 tive agreements entered into and the grants made under 

13 this section. 

14 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

15 purpose of carrying out this section, there are authorized 

16 to be appropriated $25,000,000 for each of the fiscal years 

17 2010 through 2013, and such sums as may be necessary 

18 for each of the fiscal years 2014 through 2020. Such au19 thorization of appropriations is in addition to any other 

20 authorization of appropriations that is available for such 

21 purpose.’’. 


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1 SEC. 3. OVARIAN CANCER BIOMARKER CLINICAL TRIAL 

2 COMMITTEE. 

3 Subpart 1 of part C of the Public Health Service Act, 

4 as amended by section 2, is further amended by adding 

5 at the end the following new section: 

6 ‘‘SEC. 417H. OVARIAN CANCER BIOMARKER CLINICAL 

7 TRIAL COMMITTEE. 

8 ‘‘(a) OVARIAN CANCER BIOMARKER RESEARCH COM9 MITTEE ESTABLISHED.—The Director of the Institute 

10 shall establish an Ovarian Cancer Biomarker Clinical 

11 Trial Committee (in this section referred to as the ‘Com12 mittee’) to assist the Director to design and implement 

13 one or more national clinical trials, in accordance with this 

14 section, to determine the utility of using biomarkers vali15 dated pursuant to the research conducted under section 

16 417E for risk stratification for, and early detection and 

17 screening of, ovarian cancer. 

18 ‘‘(b) MEMBERSHIP.— 

19 ‘‘(1) NUMBER.—The Committee shall consist of 

20 11 voting members and such number of nonvoting 

21 members as the Director of the Institute determines 

22 appropriate. 

23 ‘‘(2) APPOINTMENT.—The members of the 

24 Committee shall be appointed by the Director of the 

25 Institute, in consultation with appropriate national 


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1 medical societies, research societies, and patient ad2 vocate organizations, as follows: 

3 ‘‘(A) VOTING MEMBERS.—The voting 

4 members of the Committee shall be appointed 

5 by the Director of the Institute as follows: 

6 ‘‘(i) Two patient advocates. 

7 ‘‘(ii) Two national experts in statis8 tical analysis, clinical trial design, and pa9 tient recruitment. 

10 ‘‘(iii) Two representatives from the 

11 Gynecologic Oncology Group. 

12 ‘‘(iv) One representative from the De13 partment of Defense Ovarian Cancer Re14 search Program. 

15 ‘‘(v) Four ovarian cancer researchers. 

16 ‘‘(B) NONVOTING MEMBERS.—The non17 voting members of the Committee shall include 

18 such individuals as the Director of the Institute 

19 determines to be appropriate. 

20 ‘‘(3) PAY.—Members of the Committee shall 

21 serve without pay and those members who are full 

22 time officers or employees of the United States shall 

23 receive no additional pay by reason of their service 

24 on the Committee, except that members of the Com25 mittee shall receive travel expenses, including per 


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1 diem in lieu of subsistence, in accordance with appli2 cable provisions under chapter I of chapter 57 of 

3 title 5, United States Code. 

4 ‘‘(c) CHAIRPERSON.—The voting members of the 

5 Committee appointed under subsection (b)(2) shall select 

6 a chairperson from among such members. 

7 ‘‘(d) MEETINGS.—The Committee shall meet at the 

8 call of the chairperson or upon the request of the Director 

9 of the Institute, but at least four times each year. 

10 ‘‘(e) CLINICAL TRIAL SPECIFICATIONS.—In design11 ing and implementing the clinical trials under this section, 

12 the Director of the Institute shall provide for the fol13 lowing: 

14 ‘‘(1) PARTICIPATION IN TRIAL.—To the great15 est extent possible, all academic centers, community 

16 cancer centers, and individual physician investigators 

17 (as defined in subsection (f)) shall have the oppor18 tunity to participate in the trials under this section 

19 and to enroll women at risk for ovarian cancer in the 

20 trials. 

21 ‘‘(2) COSTS FOR ENROLLMENTS.—Subject to 

22 the availability of appropriations, all the costs to the 

23 centers and offices described in paragraph (1) for 

24 enrolling women in the trials under this section shall 

25 be reimbursed by the Institute. 


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1 ‘‘(3) NATIONAL DATA CENTER.—A national 

2 data center shall be established in and supported by 

3 the Institute to conduct statistical analyses of the 

4 data derived from the trials under this section and 

5 to store such analyses and data. 

6 ‘‘(4) GUIDELINES FOR MEDICAL COMMUNITY.— 

7 Data and statistical analyses of the clinical trials 

8 under this section shall be used to establish clinical 

9 guidelines to provide the medical community with in10 formation regarding the use of biomarkers validated 

11 pursuant to the research conducted under section 

12 417E for risk stratification for, and early detection 

13 and screening of, ovarian cancer. 

14 ‘‘(f) INDIVIDUAL PHYSICIAN INVESTIGATOR DE15 FINED.—For purposes of subsection (e)(1), the term ‘indi16 vidual physician investigator’ means a physician— 

17 ‘‘(1) who is a faculty member at an academic 

18 institution or who is in a private medical practice; 

19 and 

20 ‘‘(2) who provides health care services to 

21 women at risk for ovarian cancer. 

22 ‘‘(g) REPORT.—Not later than the end of fiscal year 

23 2010, and annually thereafter, the Director of the Insti24 tute shall submit a report to the Congress on the activities 

25 conducted under this section. 


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1 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 

2 purpose of carrying out this section, there are authorized 

3 to be appropriated $5,000,000 for each of the fiscal years 

4 2010 through 2013, and such sums as may be necessary 

5 for each of the fiscal years 2014 through 2020. Such au6 thorization of appropriations is in addition to any other 

7 authorization of appropriations that is available for such 

8 purpose.’’. 

Æ 


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