II 

111TH CONGRESS 

2D SESSION S. 3320 

To amend the Public Health Service Act to provide for a Pancreatic Cancer 

Initiative, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 6, 2010 

Mr. WHITEHOUSE introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to provide for 

a Pancreatic Cancer Initiative, and for other purposes. 

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; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Pancreatic Cancer Research and Education Act’’. 

6 (b) FINDINGS.—The Congress finds the following: 

7 (1) Nearly 42,500 Americans were expected to 

8 be diagnosed with pancreatic cancer in 2009 and 

9 nearly 35,250 were expected to die from the disease. 


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1 The incidence among African-Americans is 40 to 50 

2 percent higher than other ethnic groups. 

3 (2) Pancreatic cancer is one of the few cancers 

4 for which survival has not improved substantially 

5 over the past 40 years. As a result, in 2003, pan6 creatic cancer surpassed prostate cancer as the 4th 

7 leading cause of cancer-related death in the United 

8 States. 

9 (3) Seventy-six percent of pancreatic cancer pa10 tients die within the first 12 months of the diag11 nosis. The 5-year survival rate is 5 percent. 

12 (4) Scientific understanding of pancreatic can13 cer—its etiology, pathogenesis, detection, and treat14 ment—lags far behind that of most other forms of 

15 cancer. In fact, pancreatic cancer research is where 

16 breast cancer research was in the 1930s—little un17 derstanding of the causes, no early detection, few ef18 fective treatments, and single-digit survival rates. 

19 (5) In 2001, the National Cancer Institute de20 veloped ‘‘Pancreatic Cancer: An Agenda for Action’’. 

21 Nine years later, only five of the report’s 39 rec22 ommendations have been implemented because of a 

23 lack of funding, focus, and commitment. In the 

24 meantime, pancreatic cancer death rates have con25 tinued to increase. Further, according to the Cancer 


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1 Trends Progress Report—2009/2010 Update, death 

2 rates for pancreatic cancer are increasing while 

3 death rates for all cancers combined, including the 

4 four most common cancers (prostate, breast, lung, 

5 and colorectal), continue to decline. 

6 (6) Pancreatic cancer research constitutes less 

7 than 2 percent of the National Cancer Institute’s 

8 Federal research funding, a figure far too low given 

9 the severity of the disease, its mortality rate, and 

10 how little is known about how to arrest the disease. 

11 (7) Of the more than 5,000 research grants 

12 awarded annually by the Nations Cancer Institute in 

13 2006, only 134 (approximately 3 percent) were cat14 egorized by the Institute as at least 50 percent rel15 evant to pancreatic cancer research. 

16 (8) The future supply of scientists entering this 

17 field of study is in serious jeopardy. Out of the re18 searchers who received National Cancer Institute 

19 funding specifically for pancreatic cancer research in 

20 2008, only 38 received funding totaling $500,000 or 

21 more, a level appropriate for senior scientists. By 

22 comparison, this level of funding was awarded to 

23 273 breast cancer researchers, 129 prostate cancer 

24 researchers, and 121 colorectal cancer researchers. 

25 Further, in the last 3 years, the National Cancer InVerDate Mar 15 2010 03:32 May 07, 2010 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3320.IS S3320

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1 stitute has awarded only 5 grants for training and 

2 supporting new principal investigators in pancreatic 

3 cancer. 

4 (9) In 2007, the Scientific Advisory Board of 

5 the Pancreatic Cancer Action Network reviewed the 

6 current state of the science and the Federal Govern7 ment’s efforts on pancreatic cancer research and 

8 prepared ‘‘The National Plan to Advance Pancreatic 

9 Cancer Research’’ to identify the highest research 

10 priorities, scientific infrastructure needs, and work11 force training requirements that are needed to pro12 vide the answers that pancreatic cancer patients and 

13 their families and loved ones so desperately need. 

14 SEC. 2. PANCREATIC CANCER INITIATIVE. 

15 Part B of title III of the Public Health Service Act 

16 (42 U.S.C. 243 et seq.) is amended by adding at the end 

17 the following: 

18 ‘‘SEC. 320B. PANCREATIC CANCER INITIATIVE. 

19 ‘‘(a) PANCREATIC CANCER INITIATIVE.— 

20 ‘‘(1) ESTABLISHMENT.—The Secretary shall es21 tablish and implement a Pancreatic Cancer Initiative 

22 to assist in coordinating activities to address the 

23 high mortality rate associated with pancreatic can24 cer. Such Initiative shall focus on— 


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1 ‘‘(A) advancing research on the causes, di2 agnosis, and treatment of pancreatic cancer 

3 with the goal of increasing the 5-year survival 

4 rate; 

5 ‘‘(B) promoting a cadre of new investiga6 tors in the field of pancreatic cancer research; 

7 and 

8 ‘‘(C) increasing physician and public 

9 awareness of pancreatic cancer. 

10 ‘‘(2) CONSULTATION.—In carrying out this sub11 section, the Secretary shall consult with the Director 

12 of the National Institutes of Health, the Director of 

13 the National Cancer Institute, the Director of the 

14 Centers of Disease Control and Prevention, and the 

15 Interdisciplinary Pancreatic Cancer Coordinating 

16 Committee established under subsection (b). 

17 ‘‘(b) INTERDISCIPLINARY PANCREATIC CANCER CO18 ORDINATING COMMITTEE.— 

19 ‘‘(1) ESTABLISHMENT.—Not later than 60 days 

20 after the date of the enactment of this section, the 

21 Secretary, in consultation with the Director of the 

22 National Institutes of Health, shall establish a com23 mittee to be known as the Interdisciplinary Pan24 creatic Cancer Coordinating Committee (in this sub25 section referred to as the ‘Committee’). 


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1 ‘‘(2) MEMBERSHIP.— 

2 ‘‘(A) IN GENERAL.—The members of the 

3 Committee shall be appointed by the Secretary, 

4 in consultation with the Director of the Na5 tional Institutes of Health, and shall consist of 

6 13 individuals as follows: 

7 ‘‘(i) Nine experts in pancreatic cancer 

8 research, who are each a full professor at 

9 a major academic research institution and 

10 who have each received multiple grants 

11 from the National Cancer Institute or 

12 other entities of the National Institutes of 

13 Health with a primary focus on pancreatic 

14 cancer research. 

15 ‘‘(ii) Two young principal investiga16 tors in pancreatic cancer, who are each an 

17 assistant-level professor in a major aca18 demic research institution and who have 

19 each received at least one grant from the 

20 National Cancer Institute or another entity 

21 of the National Institutes of Health with a 

22 primary focus in pancreatic cancer re23 search. 

24 ‘‘(iii) One pancreatic cancer advocate. 


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1 ‘‘(iv) The Director of the National 

2 Cancer Institute (or the Director’s des3 ignee). 

4 ‘‘(B) CHAIR.—The Secretary shall des5 ignate the Chair of the Committee from among 

6 its members. 

7 ‘‘(C) PUBLICATION OF NAMES.—Not later 

8 than 30 days after the establishment of the 

9 Committee, the Secretary shall publish the 

10 names of the Chair and members of the Com11 mittee on the Website of the Department of 

12 Health and Human Services. 

13 ‘‘(D) TERMS.—The members of the Com14 mittee shall each be appointed for a 3-year term 

15 and, at the end of each such term, may be re16 appointed. 

17 ‘‘(E) VACANCIES.—A vacancy on the Com18 mittee shall be filled by the Secretary in the 

19 same manner in which the original appointment 

20 was made. 

21 ‘‘(3) RESPONSIBILITIES.—The Committee 

22 shall— 

23 ‘‘(A) provide advice on overall research ob24 jectives and benchmarks for pancreatic cancer 

25 research; 


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1 ‘‘(B) develop and annually update a stra2 tegic plan in accordance with paragraph (4) for 

3 the conduct and support of pancreatic cancer 

4 research awareness during the upcoming year; 

5 and 

6 ‘‘(C) conduct evaluations and make rec7 ommendations to the Secretary, the Director of 

8 the National Institutes of Health, and the Di9 rector of the National Cancer Institute in ac10 cordance with paragraph (5) regarding the 

11 prioritization and award of National Institutes 

12 of Health research grants relating to pancreatic 

13 cancer. 

14 ‘‘(4) STRATEGIC PLAN.— 

15 ‘‘(A) DEVELOPMENT.—The Committee 

16 shall develop and annually update a strategic 

17 plan for the conduct and support of pancreatic 

18 cancer research and awareness during the up19 coming fiscal year. 

20 ‘‘(B) SUBMISSION.—The Committee 

21 shall— 

22 ‘‘(i) submit to the Secretary each stra23 tegic plan developed under subparagraph 

24 (A) for the upcoming fiscal year; and 


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1 ‘‘(ii) publish each such plan on the 

2 Website of the Department of Health and 

3 Human Services within 30 days after the 

4 earlier of— 

5 ‘‘(I) the date of submission of the 

6 plan to the Secretary under clause (i); 

7 or 

8 ‘‘(II) June 1. 

9 ‘‘(C) CONTENTS.—Each strategic plan de10 veloped under subparagraph (A) shall include— 

11 ‘‘(i) recommended budgetary require12 ments for pancreatic cancer research, in13 cluding research grants awarded through 

14 the National Cancer Institute, funding for 

15 Specialized Programs of Research Excel16 lence (SPORE) that are focused on pan17 creatic cancer, and funding for the portion 

18 of the cancer research incubator pilot 

19 project established by section 409J(a) that 

20 is focused on pancreatic cancer; 

21 ‘‘(ii) recommendations on the coordi22 nation of extramural and intramural pan23 creatic cancer research initiatives and pos24 sibilities for partnerships among the na25 tional research institutes, including the 


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1 National Cancer Institute, the National In2 stitute of Diabetes and Digestive and Kid3 ney Diseases, the National Institute of En4 vironmental Health Sciences, the National 

5 Center for Complementary and Alternative 

6 Medicine, and the National Center on Mi7 nority Health and Health Disparities; 

8 ‘‘(iii) recommendations for improving 

9 physician and public education about pan10 creatic cancer; 

11 ‘‘(iv) recommendations for increasing 

12 the number of scientists with doctorate de13 grees and clinician-scientists specializing in 

14 pancreatic cancer research; and 

15 ‘‘(v) guidelines for information gath16 ered by pancreatic cancer patient registries 

17 and tissue banks to ensure uniformity and 

18 accessibility to the research community. 

19 ‘‘(5) PRIORITIZATION AND AWARD OF NIH RE20 SEARCH GRANTS.— 

21 ‘‘(A) IN GENERAL.—The Committee shall 

22 conduct evaluations and make recommendations 

23 to the Secretary, the Director of the National 

24 Institutes of Health, and the Director of the 

25 National Cancer Institute regarding the 


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1 prioritization and award of National Institutes 

2 of Health research grants relating to pancreatic 

3 cancer. 

4 ‘‘(B) PEER REVIEW COMMITTEE.—In car5 rying out subparagraph (A), the Committee 

6 may appoint a peer review committee to assist 

7 in the evaluation of pancreatic cancer grant ap8 plications to ensure that such applications are 

9 reviewed by individuals with the appropriate ex10 pertise. 

11 ‘‘(C) EVALUATION.—In evaluating pan12 creatic cancer grant applications under sub13 paragraph (A), the Committee shall emphasize 

14 grants that achieve at least one of the following 

15 goals: 

16 ‘‘(i) The grant is determined to be at 

17 least 75 percent relevant to pancreatic can18 cer research and has a primary focus on at 

19 least one of the following areas: 

20 ‘‘(I) Basic research to advance 

21 the understanding of the biology of 

22 pancreatic cancer, its natural history, 

23 and the genetic and environmental 

24 factors that contribute to its develop25 ment. 


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1 ‘‘(II) Research on more precise 

2 diagnostic methods and screening to 

3 detect pancreatic cancer in earlier 

4 stages. 

5 ‘‘(III) Advanced innovative clin6 ical trials testing targeted thera7 peutics and novel agents that will ex8 tend the survival of pancreatic cancer 

9 patients and improve their quality of 

10 life. 

11 ‘‘(ii) The grant will increase the num12 ber of young pancreatic cancer investiga13 tors. 

14 ‘‘(iii) The grant will meet identified 

15 needs, criteria, or specific research goals 

16 set forth in the strategic plan developed 

17 under paragraph (3)(B). 

18 ‘‘(D) RECOMMENDATIONS.—The Com19 mittee shall make recommendations for excep20 tion funding for grant applications that— 

21 ‘‘(i) have 75 percent or greater rel22 evance to pancreatic cancer; and 

23 ‘‘(ii) score within 10 points of the 

24 payline. 

25 ‘‘(c) PHYSICIAN AWARENESS.— 


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1 ‘‘(1) PROGRAM.—The Secretary, in consultation 

2 with the Director of the National Institutes of 

3 Health, the Director of the Centers for Disease Con4 trol and Prevention, and relevant patient advocate 

5 and physician organizations, shall develop a primary 

6 care provider education program on pancreatic can7 cer. The Secretary may include in such program ac8 credited continuing medical education and such 

9 other activities as the Secretary determines appro10 priate. 

11 ‘‘(2) DEFINITION.—The term ‘relevant patient 

12 advocate and physician organization’ means a na13 tionwide organization that— 

14 ‘‘(A) provides evidence-based disease infor15 mation to the public in a case management 

16 style; 

17 ‘‘(B) directly funds research in an unbi18 ased manner by working collaboratively with 

19 health professionals at a variety of institutions 

20 and using a peer-reviewed grant mechanism; 

21 ‘‘(C) advocates public policy outcomes that 

22 reflect the needs of patients; and 

23 ‘‘(D) provides information to patients, 

24 families, and health professionals at the com25 munity level. 


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1 ‘‘(d) COMMUNICATION TOOL KIT.—The Director of 

2 the National Institutes of Health and the Director of the 

3 Centers for Disease Control and Prevention, working col4 laboratively with patient advocate organizations, shall de5 velop a communication tool kit for patients and their fami6 lies that focuses on specific pancreatic cancer issues re7 lated to patient choices and patient care. 

8 ‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 

9 after the date of the enactment of this section, and annu10 ally thereafter, the Secretary shall submit a report to the 

11 Congress identifying the steps taken to implement the 

12 Pancreatic Cancer Initiative under subsection (a). The re13 port shall include— 

14 ‘‘(1) an assessment of the progress in improv15 ing outcomes and reducing mortality rates for those 

16 diagnosed with pancreatic cancer; 

17 ‘‘(2) an explanation of how recommendations of 

18 the Interdisciplinary Pancreatic Cancer Coordinating 

19 Committee in the strategic plan developed under 

20 subsection (b)(3)(B) for the preceding year have 

21 been implemented; 

22 ‘‘(3) a summary of the recommendations that 

23 were made by the Interdisciplinary Pancreatic Can24 cer Coordinating Committee for grant funding, in25 cluding exception funding, the number of such recVerDate Mar 15 2010 03:32 May 07, 2010 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S3320.IS S3320

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1 ommendations that were met, and the reasons why 

2 any recommendations were not met; 

3 ‘‘(4) a breakdown of research grant award 

4 amounts by the National Institutes of Health during 

5 the past year that are deemed relevant to pancreatic 

6 cancer research along with a quantifiable measure as 

7 to the relevancy of the grants to pancreatic cancer; 

8 ‘‘(5) the number of such grants awarded to 

9 young principal investigators in pancreatic cancer 

10 described in subsection (b)(2)(A)(ii); and 

11 ‘‘(6) a summary of progress and deficiencies 

12 that were made in pancreatic cancer research during 

13 the preceding year. 

14 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated— 

16 ‘‘(1) to carry out subsection (a), $140,000,000 

17 for fiscal year 2011 and such sums as may be nec18 essary for fiscal years 2012 through 2015; 

19 ‘‘(2) to carry out subsection (c), $2,000,000 for 

20 fiscal year 2011 and such sums as may be necessary 

21 for fiscal years 2012 through 2015; and 

22 ‘‘(3) to carry out subsection (d), $2,000,000 for 

23 fiscal year 2011 and such sums as may be necessary 

24 for fiscal years 2012 through 2015.’’. 


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1 SEC. 3. NATIONAL INSTITUTES OF HEALTH RESEARCH. 

2 Part B of title IV of the Public Health Service Act 

3 (42 U.S.C. 284 et seq.) is amended by adding at the end 

4 the following: 

5 ‘‘SEC. 409J. CANCER RESEARCH. 

6 ‘‘(a) CANCER RESEARCH INCUBATOR PILOT

7 PROJECT.— 

8 ‘‘(1) GRANTS.— 

9 ‘‘(A) IN GENERAL.—The Secretary may 

10 award grants to research institutions for use in 

11 developing innovative compounds or tech12 nologies for the prevention, early detection, or 

13 treatment of those cancers with 5-year survival 

14 rates of less than 50 percent. 

15 ‘‘(B) RELATION TO OTHER NIH GRANTS.— 

16 Subject to subparagraph (A), the Secretary 

17 shall encourage each recipient of a grant under 

18 this section to use the grant for research activi19 ties that may serve as a springboard for the re20 ceipt of other grants, including Specialized Pro21 grams of Research Excellence (SPORE) grants, 

22 from the National Institutes of Health and its 

23 national research institutes. 

24 ‘‘(2) GRANT PERIOD.—The period of a grant 

25 under this section shall be 5 years. 


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1 ‘‘(3) FOCUS.—During the initial 5 fiscal years 

2 of carrying out this section, the Secretary shall focus 

3 on awarding grants for use in developing innovative 

4 compounds or technologies for the prevention, early 

5 detection, or treatment of pancreatic cancer. 

6 ‘‘(4) REPORT.—Not later than 5 years after the 

7 date of the enactment of this section, the Secretary 

8 shall submit a report to the Congress evaluating the 

9 program under this section and making rec10 ommendations for expansion of the program to other 

11 cancers. 

12 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

13 To carry out this subsection, there are authorized to 

14 be appropriated $5,000,000 for fiscal year 2011 and 

15 such sums as may be necessary for fiscal years 2012 

16 through 2015. 

17 ‘‘(b) CENTERS OF EXCELLENCE.— 

18 ‘‘(1) DESIGNATION.—The Secretary may des19 ignate two additional Specialized Programs of Re20 search Excellence (SPOREs) focusing solely on pan21 creatic cancer research. In carrying out this para22 graph, the Secretary may choose to designate one or 

23 more satellite centers that augment the work of a 

24 previously designated Specialized Program of Re25 search Excellence. 


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1 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

2 To carry out this subsection, there are authorized to 

3 be appropriated $20,000,000 for fiscal year 2011 

4 and such sums as may be necessary for fiscal years 

5 2012 through 2015.’’. 

Æ 


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