Title I — Maximizing Research Through Discovery

115th Congress · Approved Jun 5, 2018 · 132 Stat. 1382

TITLE I Maximizing Research Through Discovery

Subtitle A Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act

SEC. 101. Children’s Cancer Biorepositories and Biospecimen Research.

Section 417E of the Public Health Service Act (42 U.S.C. 285a–11) is amended—

(1)

in the section heading, by striking “ research and awareness” and inserting “ research, awareness, and survivorship”;

(2)

by striking subsection (a) and inserting the following:

“(a) Children’s Cancer Biorepositories.—

“(1) Award.—The Secretary, acting through the Director of NIH, may make awards to an entity or entities described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.

“(2) Use of funds.—Amounts received under an award under paragraph (1) may be used to carry out the following:

“(A) Collect and store high-quality, donated biospecimens and associated clinical and demographic information on children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children, adolescents, and young adults with cancer enrolled in clinical trials for whom current treatments are least effective. Activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the National Cancer Institute.

“(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.

“(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.

“(D) Provide access to biospecimens and clinical and demographic data from children, adolescents, and young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—

“(i) consistent with the procedures established pursuant to subparagraph (C);

“(ii) only to the extent permitted by applicable Federal and State law; and

“(iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.

“(3) No requirement.—No child, adolescent, or young adult with cancer shall be required under this subsection to contribute a specimen to a biorepository or share clinical or demographic data.

“(4) Application; considerations.—

“(A) Application.—To be eligible to receive an award under paragraph (1) an entity shall submit an application to the Secretary at such a time, in such manner, and containing such information as the Secretary may reasonably require.

“(B) Considerations.—In evaluating applications submitted under subparagraph (A), the Secretary shall consider the existing infrastructure of the entity that would allow for the timely capture of biospecimens and related clinical and demographic information for children, adolescents, and young adults with cancer for whom current treatments are least effective.

“(5) Privacy protections and informed consent.—

“(A) In general.—The Secretary may not make an award under paragraph (1) to an entity unless the Secretary ensures that such entity—

“(i) collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with Federal and State law; and

“(ii) protects personal privacy to the extent required by applicable Federal and State law, at minimum.

“(B) Informed consent.—The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).

“(6) Guidelines and oversight.—The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight, to facilitate further research on select cancer subtypes (and their recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).

“(7) Coordination.—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection, the Secretary shall ensure the appropriate coordination of programs supported under this section with existing federally supported cancer registry programs and the activities under section 399E–1, as appropriate.

“(8) Supplement not supplant.—Funds provided under this subsection shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.

“(9) Report.—Not later than 4 years after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018, the Secretary shall submit to Congress a report on—

“(A) the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph (1);

“(B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;

“(C) barriers to the collection of biospecimens and corresponding clinical demographic data;

“(D) barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and

“(E) recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.

“(10) Definitions.—For purposes of this subsection:

“(A) Award.—The term ‘award’ includes a grant, contract, or cooperative agreement determined by the Secretary.

“(B) Biospecimen.—The term ‘biospecimen’ includes—

“(i) solid tumor tissue or bone marrow;

“(ii) normal or control tissue;

“(iii) blood and plasma;

“(iv) DNA and RNA extractions;

“(v) familial DNA; and

“(vi) any other sample relevant to cancer research, as required by the Secretary.

“(C) Clinical and demographic information.—The term ‘clinical and demographic information’ includes—

“(i) date of diagnosis;

“(ii) age at diagnosis;

“(iii) the patient’s sex, race, ethnicity, and environmental exposures;

“(iv) extent of disease at enrollment;

“(v) site of metastases;

“(vi) location of primary tumor coded;

“(vii) histologic diagnosis;

“(viii) tumor marker data when available;

“(ix) treatment and outcome data;

“(x) information related to specimen quality; and

“(xi) any other applicable information required by the Secretary.”

; and

(3)

in subsection (c), by striking “ (42 U.S.C. 202 note)”.

SEC. 102. Improving Childhood Cancer Surveillance.

(a)

In General.— Section 399E–1 of the Public Health Service Act (42 U.S.C. 280e–3a) is amended—

(1)

in subsection (a)—

(A)

by striking “ shall award a grant” and inserting “ may make awards to State cancer registries”; and

(B)

by striking “ track the epidemiology of pediatric cancer into a comprehensive nationwide registry of actual occurrences of pediatric cancer” and inserting “ collect information to better understand the epidemiology of cancer in children, adolescents, and young adults”; and

(C)

by striking the second sentence and inserting “ Such registries may be updated to include each occurrence of such cancers within a period of time designated by the Secretary.”;

(2)

by redesignating subsection (b) as subsection (d);

(3)

by inserting after subsection (a) the following:

“(b) Activities.—The grants described in subsection (a) may be used for—

“(1) identifying, recruiting, and training potential sources for reporting childhood, adolescent, and young adult cancer cases;

“(2) developing practices to ensure early inclusion of childhood, adolescent, and young adult cancer cases in State cancer registries through the use of electronic reporting;

“(3) collecting and submitting deidentified data to the Centers for Disease Control and Prevention for inclusion in a national database that includes information on childhood, adolescent, and young adult cancers; and

“(4) improving State cancer registries and the database described in paragraph (3), as appropriate, including to support the early inclusion of childhood, adolescent, and young adult cancer cases.

“(c) Coordination.—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this section, the Secretary shall ensure the appropriate coordination of programs supported under this section with other federally supported cancer registry programs and the activities under section 417E(a), as appropriate.”

; and

(4)

in subsection (d), as so redesignated, by striking “ registry established pursuant to subsection (a)” and inserting “ activities described in this section”.

(b)

Authorization of Appropriations.— Section 417E(d) of the Public Health Service Act (42 U.S.C. 285a–11(d)) is amended—

(1)

by striking “ 2009 through 2013” and inserting “ 2019 through 2023”; and

(2)

by striking the second sentence.

Subtitle B Pediatric Expertise at NIH

SEC. 111. Inclusion of at Least One Pediatric Oncologist on the National Cancer Advisory Board.

Clause (iii) of section 406(h)(2)(A) of the Public Health Service Act (42 U.S.C. 284a(h)(2)(A)) is amended—

(1)

by striking “ Board not less than five” and inserting

“(I) not less than 5”

(2)

by inserting “ and” after the semicolon; and

(3)

by adding at the end the following:

“(II) not less than one member shall be an individual knowledgeable in pediatric oncology;”

SEC. 112. Sense of Congress Regarding Pediatric Expertise at the National Cancer Institute.

It is the sense of Congress that the Director of the National Cancer Institute should ensure that all applicable study sections, committees, advisory groups, and panels at the National Cancer Institute include one or more qualified pediatric oncologists, as appropriate.

Subtitle C NIH Reporting on Childhood Cancer Activities

SEC. 121. Reporting on Childhood Cancer Research Projects.

The Director of the National Institutes of Health shall ensure that childhood cancer research projects conducted or supported by the National Institutes of Health are included in appropriate reports to Congress, which may include the Pediatric Research Initiative report.

Title I — Maximizing Research Through Discovery