II 

112TH CONGRESS 

2D SESSION S. 3345 

To provide for research and education to improve screening, detection and 

diagnosis of prostate cancer. 

IN THE SENATE OF THE UNITED STATES 

JUNE 27, 2012 

Mrs. BOXER (for herself and Mr. KERRY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To provide for research and education to improve screening, 

detection and diagnosis of prostate cancer. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prostate Cancer Detec5 tion Research and Education Act’’. 

6 SEC. 2. PLAN TO DEVELOP AND VALIDATE A TEST OR 

7 TESTS FOR PROSTATE CANCER. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this Act as the ‘‘Sec10 retary’’), acting through the Director of the National InVerDate Mar 15 2010 16:54 Jun 28, 2012 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3345.IS S3345

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1 stitutes of Health, shall establish an advisory council on 

2 prostate cancer (referred to in this Act as the ‘‘advisory 

3 council’’) to draft a plan for the development and valida4 tion of an accurate test or tests, such as biomarkers or 

5 imaging, to detect and diagnose prostate cancer. 

6 (b) ADVISORY COUNCIL.— 

7 (1) MEMBERSHIP.— 

8 (A) FEDERAL MEMBERS.—The advisory 

9 council shall be comprised of the following ex10 perts: 

11 (i) A designee of the Centers for Dis12 ease Control and Prevention. 

13 (ii) A designee of the Centers for 

14 Medicare & Medicaid Services. 

15 (iii) A designee of the Office of the 

16 Director of the National Cancer Institute. 

17 (iv) A designee of the Director of the 

18 Department of Defense Congressionally 

19 Directed Medical Research Program. 

20 (v) A designee of the Director of the 

21 National Institute of Biomedical Imaging 

22 and Bioengineering. 

23 (vi) A designee of the Director of the 

24 National Institute of General Medical 

25 Sciences. 


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1 (vii) A designee of the Director of the 

2 National Institute on Minority Health and 

3 Health Disparities. 

4 (viii) A designee of the Office of the 

5 Director of the National Institutes of 

6 Health. 

7 (ix) A designee of the Food and Drug 

8 Administration. 

9 (x) A designee of the Agency for 

10 Healthcare Research and Quality. 

11 (xi) A designee of the Director of the 

12 Telemedicine and Advanced Technology 

13 Research Center of the Department of De14 fense. 

15 (B) NON-FEDERAL MEMBERS.—In addi16 tion to the members described in subparagraph 

17 (A), the advisory council shall include 8 expert 

18 members from outside the Federal Government 

19 to be appointed by the Secretary, which shall 

20 include— 

21 (i) 2 prostate cancer patient advo22 cates; 

23 (ii) 2 health care providers with a 

24 range of expertise and experience in pros25 tate cancer; and 


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1 (iii) 4 leading researchers with pros2 tate cancer-related expertise in a range of 

3 clinical disciplines. 

4 (2) MEETINGS.—The advisory council shall 

5 meet quarterly and such meetings shall be open to 

6 the public. 

7 (3) ADVICE.—The advisory council shall advise 

8 the Secretary, or the Secretary’s designee. 

9 (4) ANNUAL REPORT.—Not later than 1 year 

10 after the date of enactment of this Act, the advisory 

11 council shall provide to the Secretary, or the Sec12 retary’s designee and Congress— 

13 (A) an initial evaluation of all Federally 

14 funded efforts in prostate cancer research relat15 ing to the development and validation of an ac16 curate test or tests to detect and diagnose pros17 tate cancer; 

18 (B) a plan for the development and valida19 tion of a reliable test or tests for the detection 

20 and accurate diagnosis of prostate cancer; and 

21 (C) a set of standards for prostate cancer 

22 screening, developed in coordination with the 

23 United States Preventive Services Task Force, 

24 to ensure that any tools for screening, detec25 tion, and diagnosis developed in accordance 


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1 with the plan under subparagraph (B) will meet 

2 the requirements of the Task Force for rec3 ommendation as a proven preventive or diag4 nostic service. 

5 (5) TERMINATION.—The advisory council shall 

6 terminate on December 31, 2016. 

7 (c) FUNDING.—The Secretary may make available 

8 $1,000,000 from amounts appropriated to the National 

9 Institutes of Health for each of fiscal years 2013 through 

10 2017 to carry out this section. 

11 SEC. 3. COORDINATION AND INTENSIFICATION OF PROS12 TATE CANCER RESEARCH. 

13 (a) IN GENERAL.—The Director of the National In14 stitutes of Health, in consultation with the Secretary of 

15 Defense, shall coordinate and intensify research in accord16 ance with the plan developed under section 2(b)(4)(B), 

17 with particular attention provided to leveraging existing 

18 research to develop and validate a test or tests, such as 

19 biomarkers or imaging, to detect and accurately diagnose 

20 prostate cancer in order to improve quality of life for mil21 lions of Americans, and decrease health care system costs. 

22 (b) FUNDING.—The Secretary may make available 

23 $30,000,000 from amounts appropriated to the National 

24 Institutes of Health for each of fiscal years 2014 through 

25 2018 to carry out this section. 


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1 SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 

2 (a) NATIONAL CAMPAIGN.—The Secretary, in coordi3 nation with the Director of the National Institutes of 

4 Health and the Director of the Centers for Disease Con5 trol and Prevention, shall carry out a national campaign 

6 to increase the awareness and knowledge of prostate can7 cer. 

8 (b) REQUIREMENTS.—The national campaign con9 ducted under subsection (a) shall include— 

10 (1) roles for the National Cancer Institute, the 

11 National Institute on Minority Health and Health 

12 Disparities, the Office on Minority Health of the De13 partment of Health and Human Services, and the 

14 Office of Minority Health of the Centers for Disease 

15 Control and Prevention; and 

16 (2) the development and distribution of written 

17 educational materials, and the development and 

18 placing of public service announcements, that are in19 tended to encourage men to seek prostate cancer 

20 screening when symptoms are present, when they 

21 have a family history of prostate cancer, or if they 

22 belong to a high-risk population. 

23 (c) RACIAL DISPARITIES.—In developing the national 

24 campaign under subsection (a), the Secretary shall recog25 nize and address— 


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1 (1) the racial disparities in the incidences of 

2 prostate cancer and mortality rates with respect to 

3 such disease; and 

4 (2) any barriers in access to patient care and 

5 participation in clinical trials that are specific to ra6 cial minorities. 

7 (d) GRANTS.—The Secretary shall establish a pro8 gram to award grants to nonprofit private entities to en9 able such entities to test alternative outreach and edu10 cation strategies to increase the awareness and knowledge 

11 of Americans with respect to prostate cancer. 

12 (e) AUTHORIZATION OF APPROPRIATIONS.—There is 

13 authorized to be appropriated to carry out this section, 

14 $5,000,000 for each of fiscal years 2013 through 2017. 

Æ 


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