II 

113TH CONGRESS 

1ST SESSION S. 1251 

To establish programs with respect to childhood, adolescent, and young adult 

cancer. 

IN THE SENATE OF THE UNITED STATES 

JUNE 27, 2013 

Mr. REED (for himself, Mrs. FISCHER, Mr. MENENDEZ, Mr. CASEY, Mr. 

FRANKEN, and Ms. KLOBUCHAR) introduced the following bill; which was 

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

and Pensions 

A BILL 

To establish programs with respect to childhood, adolescent, 

and young adult 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 ‘‘Caroline Pryce Walker 

5 Conquer Childhood Cancer Reauthorization Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) Every year, 13,500 children in the United 

9 States are diagnosed with cancer. 


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1 (2) While the cure rates for some childhood 

2 cancers are now over 80 percent, the survival rates 

3 for many types of cancers in children remain ex4 tremely low. 

5 (3) According to the Centers for Disease Con6 trol and Prevention, cancer continues to be the lead7 ing cause of death by disease in children and adoles8 cents under the age of 14. 

9 (4) There are currently more than 360,000 

10 childhood cancer survivors living in the United 

11 States. 

12 (5) As many as two-thirds of childhood cancer 

13 survivors experience at least one long-term health ef14 fect of their cancer treatment, including secondary 

15 malignancies, cardiopulmonary damage, physical and 

16 intellectual developmental impairments, endocrine 

17 disorders, and others. 

18 (6) Collection of biospecimens and clinical and 

19 demographic data on the maximum possible number 

20 of children with cancer in the United States is nec21 essary to improve childhood cancer treatments and 

22 cures. Currently biospecimens and some demo23 graphic data are collected for less than half of chil24 dren with cancer. 


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1 SEC. 3. COMPREHENSIVE CHILDREN’S CANCER BIOREPOSI2 TORIES. 

3 (a) IN GENERAL.—Section 417E of the Public 

4 Health Service Act (42 U.S.C. 285a–11) is amended— 

5 (1) by redesignating subsections (c) and (d) as 

6 subsections (k) and (l), respectively; 

7 (2) by striking subsections (a) and (b) and in8 serting the following: 

9 ‘‘(a) COMPREHENSIVE CHILDREN’S CANCER BIO10 REPOSITORIES.—The Secretary, acting through the Direc11 tor of NIH, may make an award for a duration of at least 

12 5 years to an entity or entities described in subsection (d) 

13 to build upon existing initiatives to collect biospecimens 

14 and clinical and demographic information for at least 90 

15 percent of all children, adolescents, and young adults with 

16 cancer in 1 or more Comprehensive Children’s Cancer Bio17 repositories to achieve a better understanding of the cause 

18 of such cancers and the effects of treatments for such can19 cers. 

20 ‘‘(b) USE OF FUNDS.—Amounts received under the 

21 award under subsection (a) may be used to carry out the 

22 following: 

23 ‘‘(1) Prospectively acquire, preserve, and store 

24 high quality, donated biospecimens and associated 

25 clinical and demographic information on children, 


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1 adolescents, and young adults diagnosed with cancer 

2 in the United States. 

3 ‘‘(2) Maintain a secure searchable database on 

4 stored biospecimens and associated clinical and de5 mographic data from children, adolescents, and 

6 young adults with cancer for the conduct of research 

7 by scientists and qualified health care professionals. 

8 ‘‘(3) Establish procedures for evaluating appli9 cations for access to such biospecimens and clinical 

10 and demographic data from researchers and other 

11 qualified health care professionals. 

12 ‘‘(4) Make available and distribute biospecimens 

13 and clinical and demographic data from children, 

14 adolescents, and young adults with cancer to re15 searchers and qualified health care professionals for 

16 peer-reviewed research at a minimal cost. 

17 ‘‘(c) NO REQUIREMENT.—No child, adolescent, or 

18 young adult with cancer shall be required to contribute 

19 a specimen to a Biorepository or share clinical or demo20 graphic data. 

21 ‘‘(d) APPLICATION; CONSIDERATIONS.— 

22 ‘‘(1) APPLICATION.—To be eligible to receive an 

23 award under subsection (a) an entity shall submit an 

24 application to the Secretary at such a time, in such 


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1 a manner, and containing such information as the 

2 Secretary may reasonably require. 

3 ‘‘(2) CONSIDERATIONS.—In evaluating the ap4 plications in paragraph (1), the Secretary shall con5 sider the existing infrastructure of the entity that 

6 would allow for the timely capture of biospecimens 

7 and related clinical and demographic information for 

8 children, adolescents, and young adults with cancer. 

9 ‘‘(e) PRIVACY PROTECTIONS; CONSENT.— 

10 ‘‘(1) IN GENERAL.—The Secretary may not 

11 make an award under subsection (a) to an entity un12 less the Secretary ensures that such entity— 

13 ‘‘(A) collects biospecimens and associated 

14 clinical and demographic information from chil15 dren with appropriate permission from parents 

16 or legal guardians in accordance with Federal 

17 and State law; and 

18 ‘‘(B) adheres to strict confidentiality to 

19 protect the identity and privacy of patients in 

20 accordance with Federal and State law. 

21 ‘‘(2) CONSENT.—The Secretary shall establish 

22 an appropriate process for achieving consent from 

23 the patient, parent, or legal guardian. 

24 ‘‘(f) SINGLE POINT OF ACCESS; STANDARD DATA; 

25 GUIDELINES AND OVERSIGHT.— 


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1 ‘‘(1) SINGLE POINT OF ACCESS.—The Secretary 

2 shall ensure that a Biorepository established under 

3 subsection (a) has electronically searchable data for 

4 use by researchers and other qualified health care 

5 professionals in the manner and to the extent de6 fined by the Secretary. 

7 ‘‘(2) STANDARD DATA.—The Secretary shall re8 quire all recipients of an award under this section to 

9 make available a standard dataset for the purposes 

10 of paragraph (1) in a standard electronic format 

11 that enables researchers and qualified health care 

12 professionals to search. 

13 ‘‘(3) GUIDELINES AND OVERSIGHT.—The Sec14 retary shall develop and disseminate appropriate 

15 guidelines for the development and maintenance of 

16 the biorepositories authorized under this section, in17 cluding appropriate oversight. 

18 ‘‘(g) DEFINITIONS.— 

19 ‘‘(1) AWARD.—The term ‘award’ includes a 

20 grant, contract, cooperative agreement, or other 

21 mechanism determined by the Secretary. 

22 ‘‘(2) BIOSPECIMEN.—The term ‘biospecimen’ 

23 includes— 

24 ‘‘(A) solid tumor tissue or bone marrow; 

25 ‘‘(B) normal or control tissue; 


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1 ‘‘(C) blood/plasma; 

2 ‘‘(D) DNA and RNA extractions; 

3 ‘‘(E) familial DNA; and 

4 ‘‘(F) any other sample required by the Sec5 retary. 

6 ‘‘(3) CLINICAL AND DEMOGRAPHIC INFORMA7 TION.—The term ‘clinical and demographic informa8 tion’ shall include— 

9 ‘‘(A) date of diagnosis; 

10 ‘‘(B) age at diagnosis; 

11 ‘‘(C) patient’s gender, race and ethnicity; 

12 ‘‘(D) extent of disease at enrollment; 

13 ‘‘(E) site of metastases; 

14 ‘‘(F) location of primary tumor coded; 

15 ‘‘(G) histologic diagnosis; 

16 ‘‘(H) tumor marker data when available; 

17 ‘‘(I) treatment and outcome data; 

18 ‘‘(J) information related to specimen qual19 ity; and 

20 ‘‘(K) any other information required by the 

21 Secretary. 

22 ‘‘(h) COORDINATION.—The Secretary shall ensure 

23 that clinical and demographic information collected in ac24 cordance with this section is collected in coordination with 

25 the information collected under section 399E–1. 


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1 ‘‘(i) PROHIBITION ON USE OF FUNDS.—Funds made 

2 available under this section shall not be used to acquire, 

3 preserve, or maintain a biospecimen collected from a pa4 tient if such activity is already covered by funds available 

5 from the National Cancer Institute for such purpose. 

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

7 of enactment of the Caroline Pryce Walker Conquer Child8 hood Cancer Reauthorization Act, the Secretary shall sub9 mit to Congress a report on— 

10 ‘‘(1) the number of biospecimens and cor11 responding clinical demographic data collected 

12 through the Comprehensive Children’s Cancer Bio13 repositories established under subsection (a); 

14 ‘‘(2) the number of biospecimens and cor15 responding clinical demographic data requested for 

16 use by researchers; 

17 ‘‘(3) any barriers to the collection of biospeci18 mens and corresponding clinical demographic data; 

19 ‘‘(4) any barriers experienced by researchers or 

20 health care professionals in accessing the biospeci21 mens and corresponding clinical demographic data 

22 necessary for use in research; and 

23 ‘‘(5) any recommendations with respect to im24 proving the Comprehensive Children’s Cancer Bio25 repository program under this section.’’; and 


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1 (3) in subsection (l), as so redesignated, by 

2 striking the first sentence and inserting the fol3 lowing: ‘‘For purposes of carrying out this section 

4 and section 399E–1, there are authorized to be ap5 propriated such sums as may be necessary for each 

6 of fiscal years 2014 through 2018.’’. 

7 (b) IMPROVING CHILDHOOD CANCER SURVEIL8 LANCE.—Section 399E–1 of the Public Health Service Act 

9 (42 U.S.C. 280e–3a) is amended— 

10 (1) by redesignating subsection (b) as sub11 section (d); and 

12 (2) by striking subsection (a) and inserting the 

13 following: 

14 ‘‘(a) IN GENERAL.—The Secretary, acting through 

15 the Director of the Centers for Disease Control and Pre16 vention, shall award grants to State cancer registries to 

17 enhance and expand infrastructure to track the epidemi18 ology of cancer in children, adolescents, and young adults. 

19 Such registries shall be updated to include each occurrence 

20 of such cancers within a period of time designated by the 

21 Secretary. 

22 ‘‘(b) ACTIVITIES.—The grants described in sub23 section (a) may be used for— 


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1 ‘‘(1) identifying, recruiting, and training all po2 tential sources for reporting childhood, adolescent, 

3 and young adult cancer cases; 

4 ‘‘(2) developing procedures to implement early 

5 inclusion of childhood, adolescent, and young adult 

6 cancer cases on State cancer registries through the 

7 use of electronic reporting; 

8 ‘‘(3) purchasing infrastructure to support the 

9 early inclusion of childhood, adolescent, and young 

10 adult cancer cases on such registries; 

11 ‘‘(4) submitting deidentified data to the Centers 

12 for Disease Control and Prevention for inclusion in 

13 a national database of childhood, adolescent, and 

14 young adult cancers; and 

15 ‘‘(5) tracking the late effects of childhood, ado16 lescent, and young adult cancers. 

17 ‘‘(c) COORDINATION.—The Secretary shall ensure 

18 that information collected through State cancer registries 

19 under this section is collected in coordination with clinical 

20 and demographic information collected under section 

21 417E.’’. 


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1 SEC. 4. REPORT TO IMPROVE DEVELOPMENT OF NEW 

2 DRUGS AND BIOLOGIC PRODUCTS TO TREAT 

3 CHILDHOOD CANCERS. 

4 (a) IN GENERAL.—Not later than 2 years after the 

5 date of enactment of this Act, the Comptroller General 

6 of the United States shall report to Congress on barriers 

7 to studying oncologic therapies in pediatric populations 

8 under section 505B of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355c). 

10 (b) CONTENT.—The report under subsection (a) shall 

11 include— 

12 (1) an assessment of the feasibility of requiring 

13 studies for a pediatric oncologic indication under 

14 section 505B of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355c) if the therapeutic target 

16 of a drug or biologic product for an adult oncologic 

17 indication is highly relevant to any pediatric cancer 

18 to which it could apply; 

19 (2) recommendations to overcome any barriers 

20 identified in the report on how to improve research, 

21 development and access to new oncologic therapies 

22 for use in pediatric patients; and 

23 (3) an assessment of the potential impact of al24 tering the exemption under subsection (k) of such 

25 section 505B. 


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1 (c) STAKEHOLDER INPUT.—The report under sub2 section (a) shall be developed with input from relevant 

3 stakeholders. 

Æ 


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