Sec. 101. Comprehensive children’s cancer biorepositories

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

(a)and inserting the following: The Secretary, acting through the Director of NIH, may make an award for a duration of at least 5 years to an entity or entities described in paragraph

(4)to build upon existing initiatives to collect biospecimens and clinical and demographic information for at least 90 percent of all children, adolescents, and young adults with cancer in 1 or more Comprehensive Children's Cancer Biorepositories to achieve a better understanding of the cause of such cancers and the effects of treatments for such cancers. Amounts received under the award under paragraph

(1)may be used to carry out the following: Prospectively acquire, preserve, 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. Maintain a secure searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the conduct of research by scientists and qualified health care professionals. Establish procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals. Make available and distribute 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 at a minimal cost. 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. 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. In evaluating the applications in 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. The Secretary may not make an award under paragraph

(1)to an entity unless the Secretary ensures that such entity— collects biospecimens and associated clinical and demographic information from children with appropriate permission from parents or legal guardians in accordance with Federal and State law; and adheres to strict confidentiality to protect the identity and privacy of patients in accordance with Federal and State law. The Secretary shall establish an appropriate process for achieving consent from the patient, parent, or legal guardian. The Secretary shall ensure that each Biorepository supported under paragraph

(1)has electronically searchable data for use by researchers and other qualified health care professionals in the manner and to the extent defined by the Secretary. The Secretary shall require all recipients of an award under this section to make available a standard dataset for the purposes of subparagraph

(A)in a standard electronic format that enables researchers and qualified health care professionals to search. The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this section, including appropriate oversight. The Secretary shall ensure that clinical and demographic information collected in accordance with this section is collected in coordination with the information collected under section 399E–1. Funds made available to carry out this subsection shall not be used to acquire, preserve, or maintain a biospecimen collected from a patient if such activity is already covered by funds available from the National Cancer Institute for such purpose. Not later than 4 years after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2015 , the Secretary shall submit to Congress a report on— the number of biospecimens and corresponding clinical demographic data collected through the Comprehensive Children’s Cancer Biorepositories supported under paragraph (1); the number of biospecimens and corresponding clinical demographic data requested for use by researchers; any barriers to the collection of biospecimens and corresponding clinical demographic data; any barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and any recommendations with respect to improving the Comprehensive Children’s Cancer Biorepository program under this subsection. For purposes of this subsection: The term award includes a grant, contract, cooperative agreement, or other mechanism determined by the Secretary. The term biospecimen includes— solid tumor tissue or bone marrow; normal or control tissue; blood and plasma; DNA and RNA extractions; familial DNA; and any other sample required by the Secretary. The term clinical and demographic information includes— date of diagnosis; age at diagnosis; patient’s gender, race, and ethnicity; extent of disease at enrollment; site of metastases; location of primary tumor coded; histologic diagnosis; tumor marker data when available; treatment and outcome data; information related to specimen quality; and any other information required by the Secretary. ; and in subsection (d)— by striking and section 399E–1 and inserting and sections 317U, 399E–1, 417H, and 417H–1 ; by striking 2009 through 2013 and inserting 2016 through 2020 ; and by striking such purpose and inserting such purposes .

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42 USC 285a–11

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Sec. 101

Comprehensive children’s cancer biorepositories

Cite42 USC 285a–11

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