115 S292 : Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018
U.S. Senate
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018
or the Childhood Cancer STAR Act
. (b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Maximizing research through discoverySubtitle A—Caroline Pryce Walker Conquer Childhood Cancer Reauthorization ActSec. 101. Children’s cancer biorepositories and biospecimen research.Sec. 102. Improving Childhood Cancer Surveillance.Subtitle B—Pediatric expertise at NIHSec. 111. Inclusion of at least one pediatric oncologist on the National Cancer Advisory Board.Sec. 112. Sense of Congress regarding pediatric expertise at the National Cancer Institute.Subtitle C—NIH reporting on childhood cancer activitiesSec. 121. Reporting on childhood cancer research projects.TITLE II—Maximizing delivery: care, quality of life, survivorship, and caregiver supportSec. 201. Cancer survivorship programs.Sec. 202. Grants to improve care for pediatric cancer survivors.Sec. 203. Best practices for long-term follow-up services for pediatric cancer survivors.Sec. 204. Technical amendment.
<enum>I</enum><header display-inline="yes-display-inline">Maximizing research through discovery</header>
<subtitle commented="no" id="idAFC1E4751EAE47B69D6D4B1246625D89" level-type="subsequent" style="OLC"><enum>A</enum><header display-inline="yes-display-inline">Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act</header>
<section commented="no" display-inline="no-display-inline" id="id32633268-f306-4690-a124-ce95e496946c" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Children’s cancer biorepositories and biospecimen research</header><text display-inline="no-display-inline">Section 417E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/285a-11">42 U.S.C. 285a–11</external-xref>) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id864f84dd-50bd-4ed7-901a-c23dc218b1df"><enum>(1)</enum><text display-inline="yes-display-inline">in the section heading, by striking <quote><header-in-text level="section" style="OLC">research and awareness</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">research, awareness, and survivorship</header-in-text></quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id95CEE75C7E714091B23315B9DF794494"><enum>(2)</enum><text display-inline="yes-display-inline">by striking subsection (a) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id690225e7-7a71-4111-826c-e54c18342bcd" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="idd66a35f2-c0f4-409d-b62b-d36253cfb66d"><enum>(a)</enum><header display-inline="yes-display-inline">Children's cancer biorepositories</header> <paragraph commented="no" display-inline="no-display-inline" id="id2c0641c7-ec9d-4e0c-a4f2-e2e5052dc853"><enum>(1)</enum><header display-inline="yes-display-inline">Award</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id26aa8183-a382-4b33-97be-8614254b8212"><enum>(2)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">Amounts received under an award under paragraph (1) may be used to carry out the following:</text> <subparagraph commented="no" display-inline="no-display-inline" id="idfb009807-011b-4be8-af94-61903f855624"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide134cdba-e45e-434b-ba8c-9d2bb904ef59"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida491f3d6-78dd-488d-a9d1-48e6b532596f"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id668b3942-1ad1-4113-b38c-57ef38d4885a"><enum>(D)</enum><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="idB477F1B392694EAEAE084909C652F929"><enum>(i)</enum><text display-inline="yes-display-inline">consistent with the procedures established pursuant to subparagraph (C);</text> </clause><clause commented="no" display-inline="no-display-inline" id="idB370049BEA0E4E4BA379C3412C568E9B"><enum>(ii)</enum><text display-inline="yes-display-inline">only to the extent permitted by applicable Federal and State law; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCD7F9DBE26ED4B649FDDB89E7FD78C8B"><enum>(iii)</enum><text display-inline="yes-display-inline">in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb69e1f8e-34e0-4fc1-96c2-56fafc7dde31"><enum>(3)</enum><header display-inline="yes-display-inline">No requirement</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idbb6db16f-2f1d-4c76-8da2-65a6d3e247cd"><enum>(4)</enum><header display-inline="yes-display-inline">Application; considerations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id84da36d4-acb2-4827-9c8e-b0bf9b627a9e"><enum>(A)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7bac9958-665e-49b0-93fb-9aecb952d013"><enum>(B)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id92669c02-9883-4bbd-b421-8c9adcc47350"><enum>(5)</enum><header display-inline="yes-display-inline">Privacy protections and informed consent</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id45c833ee-438a-41f0-81d4-3e9a27087027"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may not make an award under paragraph (1) to an entity unless the Secretary ensures that such entity—</text>
<clause commented="no" display-inline="no-display-inline" id="ide12d7b3b-0690-428a-ad91-e2f92a62e2df"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id77dc07f8-6b1b-4ee5-86cf-e7830f86e22c"><enum>(ii)</enum><text display-inline="yes-display-inline">protects personal privacy to the extent required by applicable Federal and State law, at minimum.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id33660293-0b22-4337-96a7-bec651b7cb6e"><enum>(B)</enum><header display-inline="yes-display-inline">Informed consent</header><text display-inline="yes-display-inline">The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida6e8e5ba-2781-4fb4-ae1a-080dc2e74052"><enum>(6)</enum><header display-inline="yes-display-inline">Guidelines and oversight</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id82a1cffe-7bf9-47e0-8992-c00cdd7da64f"><enum>(7)</enum><header display-inline="yes-display-inline">Coordination</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida7bbc348-c0c0-4687-8d61-3050028b19d3"><enum>(8)</enum><header display-inline="yes-display-inline">Supplement not supplant</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide6330490-fcc3-414e-98a1-3b649eb6a3d1"><enum>(9)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 4 years after the date of enactment of the <short-title>Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018</short-title>, the Secretary shall submit to Congress a report on—</text> <subparagraph commented="no" display-inline="no-display-inline" id="iddc92c887-5d02-4e00-bd71-0d10ce8f1aa7"><enum>(A)</enum><text display-inline="yes-display-inline">the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph (1);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id80774573-4344-44ab-aa3b-665186b7f6cf"><enum>(B)</enum><text display-inline="yes-display-inline">the number of biospecimens and corresponding clinical demographic data requested for use by researchers;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7f4a4164-8cf1-4bb8-994b-7ca7856957e5"><enum>(C)</enum><text display-inline="yes-display-inline">barriers to the collection of biospecimens and corresponding clinical demographic data;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6471b768-bcde-4b90-aabd-afa38df269ea"><enum>(D)</enum><text display-inline="yes-display-inline">barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7A4EBA48FAE9452FAD7172732D49D88F"><enum>(E)</enum><text display-inline="yes-display-inline">recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb319f2bf-f3e7-449e-94e1-da53f59ec21a"><enum>(10)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this subsection:</text> <subparagraph commented="no" display-inline="no-display-inline" id="idfa9df450-3b39-42b4-957c-85c3183136dd"><enum>(A)</enum><header display-inline="yes-display-inline">Award</header><text display-inline="yes-display-inline">The term <term>award</term> includes a grant, contract, or cooperative agreement determined by the Secretary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb43dbcf7-fa83-4110-90c2-4caa20127b56"><enum>(B)</enum><header display-inline="yes-display-inline">Biospecimen</header><text display-inline="yes-display-inline">The term <term>biospecimen</term> includes—</text> <clause commented="no" display-inline="no-display-inline" id="id41e1b153-4ee9-4742-b1e8-0e68368fb26c"><enum>(i)</enum><text display-inline="yes-display-inline">solid tumor tissue or bone marrow;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ide3cae35b-57a5-4511-8f71-9b439a316696"><enum>(ii)</enum><text display-inline="yes-display-inline">normal or control tissue;</text> </clause><clause commented="no" display-inline="no-display-inline" id="ideaa5edb3-bc6a-410b-9567-0ed24eee3b3c"><enum>(iii)</enum><text display-inline="yes-display-inline">blood and plasma;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idffdced68-46ad-4db4-b830-07e1dcf9bf31"><enum>(iv)</enum><text display-inline="yes-display-inline">DNA and RNA extractions;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id38304e1f-36ff-4644-a9a7-ef079d4dccbb"><enum>(v)</enum><text display-inline="yes-display-inline">familial DNA; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3df01585-095f-4047-837b-2d78af03f305"><enum>(vi)</enum><text display-inline="yes-display-inline">any other sample relevant to cancer research, as required by the Secretary.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id162be56d-3bed-42d1-8f7e-018f55806b47"><enum>(C)</enum><header display-inline="yes-display-inline">Clinical and demographic information</header><text display-inline="yes-display-inline">The term <term>clinical and demographic information</term> includes—</text>
<clause commented="no" display-inline="no-display-inline" id="id623560bd-77b0-42bc-af1a-08fc3b08df4a"><enum>(i)</enum><text display-inline="yes-display-inline">date of diagnosis;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idcd37c476-885c-495b-852b-4cae2c2515db"><enum>(ii)</enum><text display-inline="yes-display-inline">age at diagnosis;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ida3ea1adb-a6e8-4f6d-81c4-152106a384c6"><enum>(iii)</enum><text display-inline="yes-display-inline">the patient’s sex, race, ethnicity, and environmental exposures;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id0a0efc23-5a04-4e73-9f61-06faee279936"><enum>(iv)</enum><text display-inline="yes-display-inline">extent of disease at enrollment;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id31cdb25b-fccd-40d2-84e8-2f334c8c1b34"><enum>(v)</enum><text display-inline="yes-display-inline">site of metastases;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idb3ba2b9f-ae6a-4c7e-8629-f01f08b968d2"><enum>(vi)</enum><text display-inline="yes-display-inline">location of primary tumor coded;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc0328de3-403a-4074-9a55-06863ec0f558"><enum>(vii)</enum><text display-inline="yes-display-inline">histologic diagnosis;</text> </clause><clause commented="no" display-inline="no-display-inline" id="ida395bfc6-3635-4f78-b1a7-033cb4548562"><enum>(viii)</enum><text display-inline="yes-display-inline">tumor marker data when available;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9d3851c4-0fd1-41d4-be3f-7bcd8dd12c4b"><enum>(ix)</enum><text display-inline="yes-display-inline">treatment and outcome data;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id2c135894-8d1a-47f0-8f4e-2f5a5f80ca80"><enum>(x)</enum><text display-inline="yes-display-inline">information related to specimen quality; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5719d5be-d690-4880-a107-0a28d1e433cf"><enum>(xi)</enum><text display-inline="yes-display-inline">any other applicable information required by the Secretary.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD70F1776EB494C1B9A8F8B729109147A"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c), by striking <quote>(<external-xref legal-doc="usc" parsable-cite="usc/42/202">42 U.S.C. 202</external-xref> note)</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="ida7e2314e-5020-4bcb-b75d-5f3faafda431" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Improving Childhood Cancer Surveillance</header>
<subsection commented="no" display-inline="no-display-inline" id="id06C158C886B34B4EB71F900D1104260E"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 399E–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280e-3a">42 U.S.C. 280e–3a</external-xref>) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="id2db28947-90c3-4efb-93d3-07d5ee8b9812"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idAA20D83FD41442E68A86337DAA58AC6D"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>shall award a grant</quote> and inserting <quote>may make awards to State cancer registries</quote>; and</text> </subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id10F1000B4D2744E7BEE3E6AB10026B5D"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>track the epidemiology of pediatric cancer into a comprehensive nationwide registry of actual occurrences of pediatric cancer</quote> and inserting <quote>collect information to better understand the epidemiology of cancer in children, adolescents, and young adults</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC33B2F9C10A843BFA665C35429875966"><enum>(C)</enum><text display-inline="yes-display-inline">by striking the second sentence and inserting <quote>Such registries may be updated to include each occurrence of such cancers within a period of time designated by the Secretary.</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id409DCA2D465B47CBB357C34FFAC0288F"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subsection (b) as subsection (d);</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5E6244536F5A45D69495BE6613EC0841"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after subsection (a) the following:</text>
<quoted-block display-inline="no-display-inline" id="ida7ae4cd4-9781-4d54-a243-883cca0d8a25" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idc9c3f910-1c8b-4617-9384-ebed1bcfbc75"><enum>(b)</enum><header display-inline="yes-display-inline">Activities</header><text display-inline="yes-display-inline">The grants described in subsection (a) may be used for—</text> <paragraph commented="no" display-inline="no-display-inline" id="ida80e1678-896b-473b-8ef4-4ce6b5930715"><enum>(1)</enum><text display-inline="yes-display-inline">identifying, recruiting, and training potential sources for reporting childhood, adolescent, and young adult cancer cases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9b3ed55a-3933-4a6f-ba3d-d76e713f31f8"><enum>(2)</enum><text display-inline="yes-display-inline">developing practices to ensure early inclusion of childhood, adolescent, and young adult cancer cases in State cancer registries through the use of electronic reporting;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf5aa1cea-1361-4c65-be46-e7eae393e7f6"><enum>(3)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id09b4b551-b2e4-4f44-b016-b31f6c1eb3c6"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id07865dfe-42f0-4e30-b0b4-138de856392d"><enum>(c)</enum><header display-inline="yes-display-inline">Coordination</header><text display-inline="yes-display-inline">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.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id987EC65ADB1742F1B8EE8956D548C12B"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (d), as so redesignated, by striking <quote>registry established pursuant to subsection (a)</quote> and inserting <quote>activities described in this section</quote>.</text> </paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8DFC541AE083409A8B5AF0E3DD8FAB4B"><enum>(b)</enum><header display-inline="yes-display-inline">Authorization of appropriations</header><text display-inline="yes-display-inline">Section 417E(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/285a-11">42 U.S.C. 285a–11(d)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id19a58f8f2cf64ec093d9f41088149e3b"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>2009 through 2013</quote> and inserting <quote>2019 through 2023</quote>; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1c7110024aae414aa535e43f37191d77"><enum>(2)</enum><text display-inline="yes-display-inline">by striking the second sentence.</text>
</paragraph></subsection></section></subtitle><subtitle commented="no" id="id106F4033A9764C8794EF9BE8D9AD711E" level-type="subsequent" style="OLC"><enum>B</enum><header display-inline="yes-display-inline">Pediatric expertise at NIH</header>
<section commented="no" display-inline="no-display-inline" id="id366edf94-d5f0-4918-9899-7e05d48d0c96" section-type="subsequent-section"><enum>111.</enum><header display-inline="yes-display-inline">Inclusion of at least one pediatric oncologist on the National Cancer Advisory Board</header><text display-inline="no-display-inline">Clause (iii) of section 406(h)(2)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284a">42 U.S.C. 284a(h)(2)(A)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idCDFB686144DA440295BA95F70AE83D11"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>Board not less than five</quote> and inserting “Board—</text> <quoted-block display-inline="no-display-inline" id="idfbe21984-912a-4083-833b-a1c3ab69fce4" style="OLC"> <subclause commented="no" display-inline="no-display-inline" id="id9E6D64DE3365438CA4FF3E876F5C08E8" indent="up2"><enum>(I)</enum><text display-inline="yes-display-inline">not less than 5</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idABB083E1F8A946BD9E8CBC6983C6DDE4"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting <quote>and</quote> after the semicolon; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2C00F7E0B15C48729579A6200548D265"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id335E8ECDC6F94F9A821E298B22D9B210" style="OLC">
<subclause commented="no" display-inline="no-display-inline" id="idD9C5A2AB6A1F4EF6A19945E633400E31" indent="up2"><enum>(II)</enum><text display-inline="yes-display-inline">not less than one member shall be an individual knowledgeable in pediatric oncology;</text></subclause><after-quoted-block>. </after-quoted-block></quoted-block> </paragraph></section><section commented="no" display-inline="no-display-inline" id="id152EAFD2D36348A38847119552BA83D0" section-type="subsequent-section"><enum>112.</enum><header display-inline="yes-display-inline">Sense of Congress regarding pediatric expertise at the National Cancer Institute</header><text display-inline="no-display-inline">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.</text>
</section></subtitle><subtitle commented="no" id="idEE8FA7470F3341E188918797E171F3F8" level-type="subsequent" style="OLC"><enum>C</enum><header display-inline="yes-display-inline">NIH reporting on childhood cancer activities</header>
<section commented="no" display-inline="no-display-inline" id="id2717E41CB984483C9F6F5BE8D67FE9E9" section-type="subsequent-section"><enum>121.</enum><header display-inline="yes-display-inline">Reporting on childhood cancer research projects</header><text display-inline="no-display-inline">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.</text>
</section></subtitle><enum>II</enum><header display-inline="yes-display-inline">Maximizing delivery: care, quality of life, survivorship, and caregiver support</header>
<section commented="no" display-inline="no-display-inline" id="id5799F6857F514227B347065D355ABF66" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Cancer survivorship programs</header>
<subsection commented="no" display-inline="no-display-inline" id="id813374b6-a648-44d1-b05c-5179cfcfb950"><enum>(a)</enum><header display-inline="yes-display-inline">Pilot programs To explore model systems of care for pediatric cancer survivors</header>
<paragraph commented="no" display-inline="no-display-inline" id="id38dbc4fb-6fa7-4d13-8ead-f9fce054b2e2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) may make awards to eligible entities to establish pilot programs to develop, study, or evaluate model systems for monitoring and caring for childhood cancer survivors throughout their lifespan, including evaluation of models for transition to adult care and care coordination.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1166f959-3d0c-47bb-87a9-076c74a0ce95"><enum>(2)</enum><header display-inline="yes-display-inline">Awards</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idFCE9D227997E4812A6CF1F563556FF03"><enum>(A)</enum><header display-inline="yes-display-inline">Types of entities</header><text display-inline="yes-display-inline">In making awards under this subsection, the Secretary shall, to the extent practicable, include—</text> <clause commented="no" display-inline="no-display-inline" id="id0b845942f6fb45b0b92f9cc530be7884"><enum>(i)</enum><text display-inline="yes-display-inline">small, medium, and large-sized eligible entities; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ide9dd7cd7e4504d89b748d87abf517ea5"><enum>(ii)</enum><text display-inline="yes-display-inline">sites located in different geographic areas, including rural and urban areas.</text> </clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6E09EF3A3F7D45D590FC84A96B1EFCF2"><enum>(B)</enum><header display-inline="yes-display-inline">Eligible entities</header><text display-inline="yes-display-inline">In this subsection, the term <term>eligible entity</term> means—</text>
<clause commented="no" display-inline="no-display-inline" id="idcef35acd-44ec-4369-bcc3-4672d1ddc5b6"><enum>(i)</enum><text display-inline="yes-display-inline">a medical school;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id26e19ba0-9b70-4255-8224-c0dd282ecca2"><enum>(ii)</enum><text display-inline="yes-display-inline">a children’s hospital;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8949cb41-8613-43f9-be34-2f27d1bd9ef9"><enum>(iii)</enum><text display-inline="yes-display-inline">a cancer center;</text> </clause><clause commented="no" display-inline="no-display-inline" id="id2c2dc828-9829-44a3-896e-2f00c0e6ec97"><enum>(iv)</enum><text display-inline="yes-display-inline">a community-based medical facility; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id84676069-311d-4cb6-8570-341b703378bb"><enum>(v)</enum><text display-inline="yes-display-inline">any other entity with significant experience and expertise in treating survivors of childhood cancers.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0924c6b0-ab10-416a-bca2-0c7afe2e39cb"><enum>(3)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">Funds awarded under this subsection may be used—</text> <subparagraph commented="no" display-inline="no-display-inline" id="id5b039582-9ef7-453f-8bca-9c3b86a2ef18"><enum>(A)</enum><text display-inline="yes-display-inline">to develop, study, or evaluate one or more models for monitoring and caring for cancer survivors; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id79aff5c4-7fd8-43e1-ac14-c3ab4aa05a84"><enum>(B)</enum><text display-inline="yes-display-inline">in developing, studying, and evaluating such models, to give special emphasis to—</text> <clause commented="no" display-inline="no-display-inline" id="idf8e57465-9d0f-43b3-af6e-6fefa231d0b2"><enum>(i)</enum><text display-inline="yes-display-inline">design of models of follow-up care, monitoring, and other survivorship programs (including peer support and mentoring programs);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id01f7b44b-66c7-4b95-a1bb-5919f31fc0c7"><enum>(ii)</enum><text display-inline="yes-display-inline">development of models for providing multidisciplinary care;</text> </clause><clause commented="no" display-inline="no-display-inline" id="idede4679c-60ef-44b4-8bea-460b9775a72e"><enum>(iii)</enum><text display-inline="yes-display-inline">dissemination of information to health care providers about culturally and linguistically appropriate follow-up care for cancer survivors and their families, as appropriate and practicable;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ide1c596a1-cb85-423c-96fa-888e9a5aa643"><enum>(iv)</enum><text display-inline="yes-display-inline">development of psychosocial and support programs to improve the quality of life of cancer survivors and their families, which may include peer support and mentoring programs;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9bec7344-61ac-4454-9adb-c4f8a254926d"><enum>(v)</enum><text display-inline="yes-display-inline">design of systems for the effective transfer of treatment information and care summaries from cancer care providers to other health care providers (including risk factors and a plan for recommended follow-up care);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id605b82da-3350-47be-9c00-70bf4ec3feb8"><enum>(vi)</enum><text display-inline="yes-display-inline">dissemination of the information and programs described in clauses (i) through (v) to other health care providers (including primary care physicians and internists) and to cancer survivors and their families, where appropriate and in accordance with Federal and State law; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ida0eed56e-2797-4620-8477-9b34195538c9"><enum>(vii)</enum><text display-inline="yes-display-inline">development of initiatives that promote the coordination and effective transition of care between cancer care providers, primary care physicians, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id97ea1264-7a38-47df-bbba-2435888f052d"><enum>(b)</enum><header display-inline="yes-display-inline">Workforce development for health care providers on medical and psychosocial care for childhood
cancer survivors</header>
<paragraph commented="no" display-inline="no-display-inline" id="id0cbc8764-6058-4dd8-9c07-852f91aba2ac"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall, not later than 1 year after the date of enactment of this Act, conduct a review of the activities of the Department of Health and Human Services related to workforce development for health care providers who treat pediatric cancer patients and survivors. Such review shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id70D7016B2FB4485BA0926379A6B73195"><enum>(A)</enum><text display-inline="yes-display-inline">an assessment of the effectiveness of supportive psychosocial care services for pediatric cancer patients and survivors, including pediatric cancer survivorship care patient navigators and peer support programs;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE9F4DCA6934743C1AFE2CC939A602C9B"><enum>(B)</enum><text display-inline="yes-display-inline">identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers, and programs related to training for health professionals who provide such services to individuals surviving pediatric cancers; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4371E07B9D564A659E7A1B49A59B89C4"><enum>(C)</enum><text display-inline="yes-display-inline">recommendations for improving the provision of psychosocial care for pediatric cancer survivors and patients.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8df5d501-6e94-444a-b7f7-924fc40150f3"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives, a report concerning the findings and recommendations from the review conducted under paragraph (1).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="ideedf5cbf-f650-4e59-af2a-521bf0a5bcb2" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Grants to improve care for pediatric cancer survivors</header>
<subsection commented="no" display-inline="no-display-inline" id="iddf77cc8d-e917-4a45-9f16-1f57e0bd29d9"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 417E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/285a-11">42 U.S.C. 285a–11</external-xref>), as amended by section 101, is further amended by striking subsection (b) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id4e8096a4-6e4b-4769-aa0a-cc11b87d6713" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ide4e91032-7608-4ab7-b1a3-2a0dc423e49f"><enum>(b)</enum><header display-inline="yes-display-inline">Improving care for pediatric cancer survivors</header>
<paragraph commented="no" display-inline="no-display-inline" id="idec1a8b50-5ddf-4ef2-bd30-bce23b45de01"><enum>(1)</enum><header display-inline="yes-display-inline">Research on pediatric cancer survivorship</header><text display-inline="yes-display-inline">The Director of NIH, in coordination with ongoing research activities, may continue to conduct or support pediatric cancer survivorship research including in any of the following areas:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id861e5458-fd88-4b88-8c85-7cba1ac50dd1"><enum>(A)</enum><text display-inline="yes-display-inline">Outcomes of pediatric cancer survivors, including within minority or other medically underserved populations and with respect to health disparities of such outcomes.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0146dae8-093d-45af-9642-d49ea0ad43b5"><enum>(B)</enum><text display-inline="yes-display-inline">Barriers to follow-up care for pediatric cancer survivors, including within minority or other medically underserved populations.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id34a17aed-b906-449b-a2e0-de1c48f098b4"><enum>(C)</enum><text display-inline="yes-display-inline">The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on treatment outcomes and survivorship.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idacb94d19-03bb-45cc-aec3-faca93d3e4a8"><enum>(D)</enum><text display-inline="yes-display-inline">The development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddc6ee148-bce5-44dd-a56f-e1e698d77d35"><enum>(E)</enum><text display-inline="yes-display-inline">The identification of, as applicable—</text> <clause commented="no" display-inline="no-display-inline" id="idA16F1058C25C4296916E1431CDDCBD47"><enum>(i)</enum><text display-inline="yes-display-inline">risk factors associated with the late effects of cancer treatment;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5B0AA6187A9041BFA038B8097A76291A"><enum>(ii)</enum><text display-inline="yes-display-inline">predictors of adverse neurocognitive and psychosocial outcomes; and</text> </clause><clause commented="no" display-inline="no-display-inline" id="id5DBDDE478BEC4AE1BF8E00E999D61B4C"><enum>(iii)</enum><text display-inline="yes-display-inline">the molecular basis of long-term complications.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2d9809a9-8138-458a-9636-60b4a2a14df0"><enum>(F)</enum><text display-inline="yes-display-inline">The development of targeted interventions to reduce the burden of morbidity borne by cancer survivors in order to protect such cancer survivors from the late effects of cancer.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBF615108F8394ED8B9FC75E1D4176B64"><enum>(2)</enum><header display-inline="yes-display-inline">Balanced approach</header><text display-inline="yes-display-inline">In conducting or supporting research under paragraph (1)(A)(i) on pediatric cancer survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such research addresses both the physical and the psychological needs of such survivors, as appropriate.</text></paragraph></subsection><after-quoted-block>. </after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id6a31cb05-9188-4ec9-8f5b-ddde193f3ee8" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Best practices for long-term follow-up services for pediatric cancer survivors</header><text display-inline="no-display-inline">The Secretary of Health and Human Services may facilitate the identification of best practices for childhood and adolescent cancer survivorship care, and, as appropriate, may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="iddea387bc-b247-4f6b-a429-95284fa0f942"><enum>(1)</enum><text display-inline="yes-display-inline">oncologists, which may include pediatric oncologists;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="idbbe4a250-10fa-4166-aec6-70dc58945328"><enum>(2)</enum><text display-inline="yes-display-inline">primary care providers engaged in survivorship care;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfeed901c-6483-4171-960a-654c14a6df02"><enum>(3)</enum><text display-inline="yes-display-inline">survivors of childhood and adolescent cancer;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id406185e1-bc80-4dcb-a22b-e008961bb72a"><enum>(4)</enum><text display-inline="yes-display-inline">parents of children and adolescents who have been diagnosed with and treated for cancer and parents of long-term survivors;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id11f216a4-bedb-45e8-95ff-f9bd5af4a2f9"><enum>(5)</enum><text display-inline="yes-display-inline">nurses and social workers;</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id684dd1cb-39e4-470a-b2cd-42914b959562"><enum>(6)</enum><text display-inline="yes-display-inline">mental health professionals;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9c71a7ef-de2e-4949-8bc2-78aa0ce11e2d"><enum>(7)</enum><text display-inline="yes-display-inline">allied health professionals, including physical therapists and occupational therapists; and</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="id13298ddc-4e5f-4aed-aa42-c712f2245e4a"><enum>(8)</enum><text display-inline="yes-display-inline">others, as the Secretary determines appropriate.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id0DE52E61FA944F1AB5B92FE1C53E4507" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Technical amendment</header>
<subsection commented="no" display-inline="no-display-inline" id="idFF406EEBDE154BF288B38C87A31B4A97"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 3 of the Hematological Cancer Research Investment and Education Act of 2002 (<external-xref legal-doc="public-law" parsable-cite="pl/107/172">Public Law 107–172</external-xref>; 116 Stat. 541) is amended by striking <quote>section 419C</quote> and inserting <quote>section 417C</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id9188000378A548D7A8188728F89CD6FA"><enum>(b)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendment made by subsection (a) shall take effect as if included in section 3 of the Hematological Cancer Research Investment and Education Act of 2002 (<external-xref legal-doc="public-law" parsable-cite="pl/107/172">Public Law 107–172</external-xref>; 116 Stat. 541).</text></subsection></section>Passed the Senate March 22, 2018.Julie E. Adams,Secretary