I 

111TH CONGRESS 

2D SESSION H. R. 4756 

To provide for prostate cancer imaging research and education. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 4, 2010 

Mr. CUMMINGS (for himself, Mr. BURTON of Indiana, Mr. MEEKS of New 

York, Mr. FRANK of Massachusetts, Mr. SENSENBRENNER, Mrs. 

CHRISTENSEN, Mr. MCGOVERN, Mr. DOYLE, Mr. EDWARDS of Texas, 

Mrs. DAVIS of California, Mr. MASSA, Mr. MARSHALL, Mr. GRIJALVA, 

and Mr. DEFAZIO) introduced the following bill; which was referred to 

the Committee on Energy and Commerce 

A BILL 

To provide for prostate cancer imaging research and 

education. 

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 Research, Im5 aging, and Men’s Education Act of 2010’’ or the ‘‘PRIME 

6 Act of 2010’’. 

7 SEC. 2. FINDINGS. 

8 Congress makes the following findings: 


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1 (1) Prostate cancer has reached epidemic pro2 portions, particularly among African-American men, 

3 and strikes and kills men in numbers comparable to 

4 the number of women who lose their lives from 

5 breast cancer. 

6 (2) Life-saving breakthroughs in screening, di7 agnosis, and treatment of breast cancer resulted 

8 from the development of advanced imaging tech9 nologies led by the Federal Government. 

10 (3) Men should have accurate and affordable 

11 prostate cancer screening exams and minimally12 invasive treatment tools, similar to what women have 

13 for breast cancer. 

14 (4) While it is important for men to take ad15 vantage of current prostate cancer screening tech16 niques, a recent NCI-funded study demonstrated 

17 that the most common available methods of detect18 ing prostate cancer (PSA blood test and physical 

19 exams) are not foolproof, causing numerous false 

20 alarms and false reassurances. 

21 (5) The absence of advanced imaging tech22 nologies for prostate cancer causes the lack of accu23 rate information critical for clinical decisions, result24 ing in missed cancers and lost lives, as well as unVerDate Nov 24 2008 04:23 Mar 05, 2010 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4756.IH H4756

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1 necessary and costly medical procedures, with re2 lated complications. 

3 (6) With prostate imaging tools, men and their 

4 families would face less physical, psychological, fi5 nancial and emotional trauma and billions of dollars 

6 could be saved in private and public health care sys7 tems. 

8 SEC. 3. RESEARCH AND DEVELOPMENT OF PROSTATE CAN9 CER IMAGING TECHNOLOGIES. 

10 (a) EXPANSION OF RESEARCH.—The Secretary of 

11 Health and Human Services (referred to in this Act as 

12 the ‘‘Secretary’’), acting through the Director of the Na13 tional Institutes of Health and the Administrator of the 

14 Health Resources and Services Administration, and in 

15 consultation with the Secretary of Defense, shall carry out 

16 a program to expand and intensify research to develop in17 novative advanced imaging technologies for prostate can18 cer detection, diagnosis, and treatment comparable to 

19 state-of-the-art mammography technologies. 

20 (b) EARLY STAGE RESEARCH.—In implementing the 

21 program under subsection (a), the Secretary, acting 

22 through the Administrator of the Health Resources and 

23 Services Administration, shall carry out a grant program 

24 to encourage the early stages of research in prostate imag25 ing to develop and implement new ideas, proof of concepts, 


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1 and pilot studies for high-risk technologic innovation in 

2 prostate cancer imaging that would have a high potential 

3 impact for improving patient care, including individualized 

4 care, quality of life, and cost-effectiveness. 

5 (c) LARGE SCALE LATER STAGE RESEARCH.—In im6 plementing the program under subsection (a), the Sec7 retary, acting through the Director of the National Insti8 tutes of Health, shall utilize the National Institute of Bio9 medical Imaging and Bioengineering and the National 

10 Cancer Institute for advanced stages of research in pros11 tate imaging, including technology development and clin12 ical trials for projects determined by the Secretary to have 

13 demonstrated promising preliminary results and proof of 

14 concept. 

15 (d) INTERDISCIPLINARY PRIVATE-PUBLIC PARTNER16 SHIPS.—In developing the program under subsection (a), 

17 the Secretary, through the Administrator of the Health 

18 Resources and Services Administration, shall establish 

19 interdisciplinary private-public partnerships to develop 

20 and implement research strategies for expedited innova21 tion in imaging and image-guided treatment and to con22 duct such research. 

23 (e) RACIAL DISPARITIES.—In developing the pro24 gram under subsection (a), the Secretary shall recognize 

25 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 care and participa5 tion in clinical trials that are specific to racial mi6 norities. 

7 (f) AUTHORIZATION OF APPROPRIATIONS.— 

8 (1) IN GENERAL.—Subject to paragraph (2), 

9 there is authorized to be appropriated to carry out 

10 this section, $100,000,000 for each of the fiscal 

11 years 2012 through 2016. 

12 (2) SPECIFIC ALLOCATIONS.—Of the amount 

13 authorized to be appropriated under paragraph (1) 

14 for each of the fiscal years described in such para15 graph— 

16 (A) no less than 10 percent may be appro17 priated to carry out the grant program under 

18 subsection (b); and 

19 (B) no more than 1 percent may be appro20 priated to carry out subsection (d). 

21 SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 

22 (a) NATIONAL CAMPAIGN.—The Secretary shall carry 

23 out a national campaign to increase the awareness and 

24 knowledge of Americans with respect to the need for prosVerDate Nov 24 2008 04:23 Mar 05, 2010 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4756.IH H4756

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1 tate cancer screening and for improved detection tech2 nologies. 

3 (b) REQUIREMENTS.—The national campaign con4 ducted under subsection (a) shall include— 

5 (1) roles for the Health Resources Services Ad6 ministration, the Office on Minority Health of the 

7 Department of Health and Human Services, the 

8 Centers for Disease Control and Prevention, and the 

9 Office of Minority Health of the Centers for Disease 

10 Control and Prevention; and 

11 (2) the development and distribution of written 

12 educational materials, and the development and 

13 placing of public service announcements, that are in14 tended to encourage men to seek prostate cancer 

15 screening and to create awareness of the need for 

16 improved imaging technologies for prostate cancer 

17 screening and diagnosis, including in vitro blood 

18 testing and imaging technologies. 

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

20 campaign under subsection (a), the Secretary shall recog21 nize and address— 

22 (1) the racial disparities in the incidences of 

23 prostate cancer and mortality rates with respect to 

24 such disease; and 


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1 (2) any barriers in access to care and participa2 tion in clinical trials that are specific to racial mi3 norities. 

4 (d) GRANTS.—The Secretary shall establish a pro5 gram to award grants to nonprofit private entities to en6 able such entities to test alternative outreach and edu7 cation strategies to increase the awareness and knowledge 

8 of Americans with respect to the need for prostate cancer 

9 screening and improved imaging technologies. 

10 (e) AUTHORIZATION OF APPROPRIATIONS.—There is 

11 authorized to be appropriated to carry out this section, 

12 $10,000,000 for each of the fiscal years 2012 through 

13 2016. 

14 SEC. 5. IMPROVING PROSTATE CANCER SCREENING BLOOD 

15 TESTS. 

16 (a) IN GENERAL.—The Secretary, in coordination 

17 with the Secretary of Defense, shall carry out research to 

18 develop an improved prostate cancer screening blood test 

19 using in-vitro detection. 

20 (b) AUTHORIZATION OF APPROPRIATIONS.—There is 

21 authorized to be appropriated to carry out this section, 

22 $20,000,000 for each of fiscal years 2012 through 2016. 

23 SEC. 6. REPORTING AND COMPLIANCE. 

24 (a) REPORT AND STRATEGY.—Not later than 12 

25 months after the date of the enactment of this Act, the 


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1 Secretary shall submit to Congress a report that details 

2 the strategy of the Secretary for implementing the require3 ments of this Act and the status of such efforts. 

4 (b) FULL COMPLIANCE.—Not later than 36 months 

5 after the date of the enactment of this Act, and annually 

6 thereafter, the Secretary shall submit to Congress a report 

7 that— 

8 (1) describes the research and development and 

9 public awareness and education campaigns funded 

10 under this Act; 

11 (2) provides evidence that projects involving 

12 high-risk, high impact technologic innovation, proof 

13 of concept, and pilot studies are prioritized; 

14 (3) provides evidence that the Secretary recog15 nizes and addresses any barriers in access to care 

16 and participation in clinical trials that are specific to 

17 racial minorities in the implementation of this Act; 

18 (4) contains assurances that the all other provi19 sions of this Act are fully implemented; and 

20 (5) certifies compliance with the provisions of 

21 this Act, or in the case of a Federal agency that has 

22 not complied with any of such provisions, an expla23 nation as to such failure to comply. 

Æ 


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