II 

Calendar No. 521 

112TH CONGRESS 

2D SESSION S. 3566 

To provide for scientific frameworks with respect to recalcitrant cancers. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 19, 2012 

Mr. HARKIN, from the Committee on Health, Education, Labor, and Pensions, 

reported the following original bill; which was read twice and placed on 

the calendar 

A BILL 

To provide for scientific frameworks with respect to 

recalcitrant cancers. 

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 ‘‘Recalcitrant Cancer 

5 Research Act of 2012’’. 


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1 SEC. 2. SCIENTIFIC FRAMEWORK FOR RECALCITRANT CAN2 CERS. 

3 Subpart 1 of part C of title IV of the Public Health 

4 Service Act (42 U.S.C. 285 et seq.) is amended by adding 

5 at the end the following: 

6 ‘‘SEC. 417G. SCIENTIFIC FRAMEWORK FOR RECALCITRANT 

7 CANCERS. 

8 ‘‘(a) DEVELOPMENT OF SCIENTIFIC FRAMEWORK.— 

9 ‘‘(1) IN GENERAL.—For each recalcitrant can10 cer identified under subsection (b), the Director of 

11 the Institute shall develop (in accordance with sub12 section (c)) a scientific framework for the conduct or 

13 support of research on such cancer. 

14 ‘‘(2) CONTENTS.—The scientific framework 

15 with respect to a recalcitrant cancer shall include the 

16 following: 

17 ‘‘(A) CURRENT STATUS.— 

18 ‘‘(i) REVIEW OF LITERATURE.—A 

19 summary of findings from the current lit20 erature in the areas of— 

21 ‘‘(I) the prevention, diagnosis, 

22 and treatment of such cancer; 

23 ‘‘(II) the fundamental biologic 

24 processes that regulate such cancer 

25 (including similarities and differences 

26 of such processes from the biological 


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1 processes that regulate other cancers); 

2 and 

3 ‘‘(III) the epidemiology of such 

4 cancer. 

5 ‘‘(ii) SCIENTIFIC ADVANCES.—The 

6 identification of relevant emerging sci7 entific areas and promising scientific ad8 vances in basic, translational, and clinical 

9 science relating to the areas described in 

10 subclauses (I) and (II) of clause (i). 

11 ‘‘(iii) RESEARCHERS.—A description 

12 of the availability of qualified individuals 

13 to conduct scientific research in the areas 

14 described in clause (i). 

15 ‘‘(iv) COORDINATED RESEARCH INI16 TIATIVES.—The identification of the types 

17 of initiatives and partnerships for the co18 ordination of intramural and extramural 

19 research of the Institute in the areas de20 scribed in clause (i) with research of the 

21 relevant national research institutes, Fed22 eral agencies, and non-Federal public and 

23 private entities in such areas. 

24 ‘‘(v) RESEARCH RESOURCES.—The 

25 identification of public and private reVerDate Mar 15 2010 00:17 Sep 20, 2012 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3566.RS S3566

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1 sources, such as patient registries and tis2 sue banks, that are available to facilitate 

3 research relating to each of the areas de4 scribed in clause (i). 

5 ‘‘(B) IDENTIFICATION OF RESEARCH

6 QUESTIONS.—The identification of research 

7 questions relating to basic, translational, and 

8 clinical science in the areas described in sub9 clauses (I) and (II) of subparagraph (A)(i) that 

10 have not been adequately addressed with re11 spect to such recalcitrant cancer. 

12 ‘‘(C) RECOMMENDATIONS.—Recommenda13 tions for appropriate actions that should be 

14 taken to advance research in the areas de15 scribed in subparagraph (A)(i) and to address 

16 the research questions identified in subpara17 graph (B), as well as for appropriate bench18 marks to measure progress on achieving such 

19 actions, including the following: 

20 ‘‘(i) RESEARCHERS.—Ensuring ade21 quate availability of qualified individuals 

22 described in subparagraph (A)(iii). 

23 ‘‘(ii) COORDINATED RESEARCH INI24 TIATIVES.—Promoting and developing iniVerDate Mar 15 2010 00:17 Sep 20, 2012 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3566.RS S3566

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1 tiatives and partnerships described in sub2 paragraph (A)(iv). 

3 ‘‘(iii) RESEARCH RESOURCES.—Devel4 oping additional public and private re5 sources described in subparagraph (A)(v) 

6 and strengthening existing resources. 

7 ‘‘(3) TIMING.— 

8 ‘‘(A) INITIAL DEVELOPMENT AND SUBSE9 QUENT UPDATE.—For each recalcitrant cancer 

10 identified under subsection (b)(1), the Director 

11 of the Institute shall— 

12 ‘‘(i) develop a scientific framework 

13 under this subsection not later than 18 

14 months after the date of the enactment of 

15 this section; and 

16 ‘‘(ii) review and update the scientific 

17 framework not later than 5 years after its 

18 initial development. 

19 ‘‘(B) OTHER UPDATES.—The Director of 

20 the Institute may review and update each sci21 entific framework developed under this sub22 section as necessary. 

23 ‘‘(4) PUBLIC NOTICE.—With respect to each 

24 scientific framework developed under subsection (a), 

25 not later than 30 days after the date of completion 


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1 of the framework, the Director of the Institute 

2 shall— 

3 ‘‘(A) submit such framework to the Com4 mittee on Energy and Commerce and Com5 mittee on Appropriations of the House of Rep6 resentatives, and the Committee on Health, 

7 Education, Labor, and Pensions and Committee 

8 on Appropriations of the Senate; and 

9 ‘‘(B) make such framework publically 

10 available on the Internet website of the Depart11 ment of Health and Human Services. 

12 ‘‘(b) IDENTIFICATION OF RECALCITRANT CANCER.— 

13 ‘‘(1) IN GENERAL.—Not later than 6 months 

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

15 Director of the Institute shall identify two or more 

16 recalcitrant cancers that each— 

17 ‘‘(A) have a 5-year relative survival rate of 

18 less than 20 percent; and 

19 ‘‘(B) are estimated to cause the death of at 

20 least 30,000 individuals in the United States 

21 per year. 

22 ‘‘(2) ADDITIONAL CANCERS.—The Director of 

23 the Institute may, at any time, identify other recal24 citrant cancers for purposes of this section. In iden25 tifying a recalcitrant cancer pursuant to the previous 


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1 sentence, the Director may consider additional 

2 metrics of progress (such as incidence and mortality 

3 rates) against such type of cancer. 

4 ‘‘(c) WORKING GROUPS.—For each recalcitrant can5 cer identified under subsection (b), the Director of the In6 stitute shall convene a working group comprised of rep7 resentatives of appropriate Federal agencies and other 

8 non-Federal entities to provide expertise on, and assist in 

9 developing, a scientific framework under subsection (a). 

10 The Director of the Institute (or the Director’s designee) 

11 shall participate in the meetings of each such working 

12 group. 

13 ‘‘(d) REPORTING.— 

14 ‘‘(1) BIENNIAL REPORTS.—The Director of 

15 NIH shall ensure that each biennial report under 

16 section 403 includes information on actions under17 taken to carry out each scientific framework devel18 oped under subsection (a) with respect to a recal19 citrant cancer, including the following: 

20 ‘‘(A) Information on research grants 

21 awarded by the National Institutes of Health 

22 for research relating to such cancer. 

23 ‘‘(B) An assessment of the progress made 

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1 vival rates) for individuals diagnosed with such 

2 cancer. 

3 ‘‘(C) An update on activities pertaining to 

4 such cancer under the authority of section 

5 413(b)(7). 

6 ‘‘(2) ADDITIONAL ONE-TIME REPORT FOR CER7 TAIN FRAMEWORKS.—For each recalcitrant cancer 

8 identified under subsection (b)(1), the Director of 

9 the Institute shall, not later than 6 years after the 

10 initial development of a scientific framework under 

11 subsection (a), submit a report to the Congress on 

12 the effectiveness of the framework (including the up13 date required by subsection (a)(3)(A)(ii)) in improv14 ing the prevention, detection, diagnosis, and treat15 ment of such cancer. 

16 ‘‘(e) RECOMMENDATIONS FOR EXCEPTION FUND17 ING.—The Director of the Institute shall consider each 

18 relevant scientific framework developed under subsection 

19 (a) when making recommendations for exception funding 

20 for grant applications. 

21 ‘‘(f) DEFINITION.—In this section, the term ‘recal22 citrant cancer’ means a cancer for which the five-year rel23 ative survival rate is below 50 percent.’’. 


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Calendar No. 521 

112TH CONGRESS 

2D SESSION S. 3566 

A BILL 

To provide for scientific frameworks with respect to 

S

recalcitrant cancers. 

EPTEMBER 19, 2012 

Read twice and placed on the calendar 


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