SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Caroline Pryce Walker Conquer 
Childhood Cancer Reauthorization Act''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Every year, 13,500 children in the United States are 
        diagnosed with cancer.
            (2) While the cure rates for some childhood cancers are now 
        over 80 percent, the survival rates for many types of cancers 
        in children remain extremely low.
            (3) According to the Centers for Disease Control and 
        Prevention, cancer continues to be the leading cause of death 
        by disease in children and adolescents under the age of 14.
            (4) There are currently more than 360,000 childhood cancer 
        survivors living in the United States.
            (5) As many as two-thirds of childhood cancer survivors 
        experience at least one long-term health effect of their cancer 
        treatment, including secondary malignancies, cardiopulmonary 
        damage, physical and intellectual developmental impairments, 
        endocrine disorders, and others.
            (6) Collection of biospecimens and clinical and demographic 
        data on the maximum possible number of children with cancer in 
        the United States is necessary to improve childhood cancer 
        treatments and cures. Currently biospecimens and some 
        demographic data are collected for less than half of children 
        with cancer.

SEC. 3. COMPREHENSIVE CHILDREN'S CANCER BIOREPOSITORIES.

    (a) In General.--Section 417E of the Public Health Service Act (42 
U.S.C. 285a-11) is amended--
            (1) by redesignating subsections (c) and (d) as subsections 
        (k) and (l), respectively;
            (2) by striking subsections (a) and (b) and inserting the 
        following:
    ``(a) Comprehensive Children's Cancer Biorepositories.--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 
subsection (d) 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.
    ``(b) Use of Funds.--Amounts received under the award under 
subsection (a) may be used to carry out the following:
            ``(1) 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.
            ``(2) 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.
            ``(3) Establish procedures for evaluating applications for 
        access to such biospecimens and clinical and demographic data 
        from researchers and other qualified health care professionals.
            ``(4) 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.
    ``(c) No Requirement.--No child, adolescent, or young adult with 
cancer shall be required to contribute a specimen to a Biorepository or 
share clinical or demographic data.
    ``(d) Application; Considerations.--
            ``(1) Application.--To be eligible to receive an award 
        under subsection (a) an entity shall submit an application to 
        the Secretary at such a time, in such a manner, and containing 
        such information as the Secretary may reasonably require.
            ``(2) Considerations.--In evaluating the applications in 
        paragraph (1), 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.
    ``(e) Privacy Protections; Consent.--
            ``(1) In general.--The Secretary may not make an award 
        under subsection (a) to an entity unless the Secretary ensures 
        that such entity--
                    ``(A) 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
                    ``(B) adheres to strict confidentiality to protect 
                the identity and privacy of patients in accordance with 
                Federal and State law.
            ``(2) Consent.--The Secretary shall establish an 
        appropriate process for achieving consent from the patient, 
        parent, or legal guardian.
    ``(f) Single Point of Access; Standard Data; Guidelines and 
Oversight.--
            ``(1) Single point of access.--The Secretary shall ensure 
        that a Biorepository established under subsection (a) 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.
            ``(2) Standard data.--The Secretary shall require all 
        recipients of an award under this section to make available a 
        standard dataset for the purposes of paragraph (1) in a 
        standard electronic format that enables researchers and 
        qualified health care professionals to search.
            ``(3) Guidelines and oversight.--The Secretary shall 
        develop and disseminate appropriate guidelines for the 
        development and maintenance of the biorepositories authorized 
        under this section, including appropriate oversight.
    ``(g) Definitions.--
            ``(1) Award.--The term `award' includes a grant, contract, 
        cooperative agreement, or other mechanism determined by the 
        Secretary.
            ``(2) Biospecimen.--The term `biospecimen' includes--
                    ``(A) solid tumor tissue or bone marrow;
                    ``(B) normal or control tissue;
                    ``(C) blood/plasma;
                    ``(D) DNA and RNA extractions;
                    ``(E) familial DNA; and
                    ``(F) any other sample required by the Secretary.
            ``(3) Clinical and demographic information.--The term 
        `clinical and demographic information' shall include--
                    ``(A) date of diagnosis;
                    ``(B) age at diagnosis;
                    ``(C) patient's gender, race and ethnicity;
                    ``(D) extent of disease at enrollment;
                    ``(E) site of metastases;
                    ``(F) location of primary tumor coded;
                    ``(G) histologic diagnosis;
                    ``(H) tumor marker data when available;
                    ``(I) treatment and outcome data;
                    ``(J) information related to specimen quality; and
                    ``(K) any other information required by the 
                Secretary.
    ``(h) Coordination.--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.
    ``(i) Prohibition on Use of Funds.--Funds made available under this 
section 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.
    ``(j) Report.--Not later than 4 years after the date of enactment 
of the Caroline Pryce Walker Conquer Childhood Cancer Reauthorization 
Act, the Secretary shall submit to Congress a report on--
            ``(1) the number of biospecimens and corresponding clinical 
        demographic data collected through the Comprehensive Children's 
        Cancer Biorepositories established under subsection (a);
            ``(2) the number of biospecimens and corresponding clinical 
        demographic data requested for use by researchers;
            ``(3) any barriers to the collection of biospecimens and 
        corresponding clinical demographic data;
            ``(4) any barriers experienced by researchers or health 
        care professionals in accessing the biospecimens and 
        corresponding clinical demographic data necessary for use in 
        research; and
            ``(5) any recommendations with respect to improving the 
        Comprehensive Children's Cancer Biorepository program under 
        this section.''; and
            (3) in subsection (l), as so redesignated--
                    (A) by striking ``$30,000,000'' and inserting 
                ``$10,000,000''; and
                    (B) by striking ``2013'' and inserting ``2018''.
    (b) Improving Childhood Cancer Surveillance.--Section 399E-1 of the 
Public Health Service Act (42 U.S.C. 280e-3a) is amended--
            (1) by redesignating subsection (b) as subsection (d); and
            (2) by striking subsection (a) and inserting the following:
    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall award grants to 
State cancer registries to enhance and expand infrastructure to track 
the epidemiology of cancer in children, adolescents, and young adults. 
Such registries shall be updated to include each occurrence of such 
cancers within a period of time designated by the Secretary.
    ``(b) Activities.--The grants described in subsection (a) may be 
used for--
            ``(1) identifying, recruiting, and training all potential 
        sources for reporting childhood, adolescent, and young adult 
        cancer cases;
            ``(2) developing procedures to implement early inclusion of 
        childhood, adolescent, and young adult cancer cases on State 
        cancer registries through the use of electronic reporting;
            ``(3) purchasing infrastructure to support the early 
        inclusion of childhood, adolescent, and young adult cancer 
        cases on such registries;
            ``(4) submitting deidentified data to the Centers for 
        Disease Control and Prevention for inclusion in a national 
        database of childhood, adolescent, and young adult cancers; and
            ``(5) tracking the late effects of childhood, adolescent, 
        and young adult cancers.
    ``(c) Coordination.--The Secretary shall ensure that information 
collected through State cancer registries under this section is 
collected in coordination with clinical and demographic information 
collected under section 417E.''.

SEC. 4. REPORT TO IMPROVE DEVELOPMENT OF NEW DRUGS AND BIOLOGIC 
              PRODUCTS TO TREAT CHILDHOOD CANCERS.

    (a) In General.--Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States shall report 
to Congress on barriers to studying oncologic therapies in pediatric 
populations under section 505B of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c).
    (b) Content.--The report under subsection (a) shall include--
            (1) an assessment of the feasibility of requiring studies 
        for a pediatric oncologic indication under section 505B of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) if the 
        therapeutic target of a drug or biologic product for an adult 
        oncologic indication is highly relevant to any pediatric cancer 
        to which it could apply;
            (2) recommendations to overcome any barriers identified in 
        the report on how to improve research, development and access 
        to new oncologic therapies for use in pediatric patients; and
            (3) an assessment of the potential impact of altering the 
        exemption under subsection (k) of such section 505B.
    (c) Stakeholder Input.--The report under subsection (a) shall be 
developed with input from relevant stakeholders.
Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act - Amends the Public Health Service Act to reauthorize through FY2018 cancer research programs under the Caroline Pryce Walker Conquer Childhood Cancer Act of 2008.   Replaces the current pediatric cancer research and awareness grant program carried out by the Secretary of Health and Human Services (HHS) with a comprehensive children's cancer biorepositories program. Authorizes the Director of the National Institutes of Health (NIH) to make awards to eligible applicants to build upon existing initiatives to collect biospecimens and clinical and demographic information (including date of diagnosis, age at diagnosis, and patient's gender, race, and ethnicity) for at least 90% of all children, adolescents, and young adults with cancer in Comprehensive Children's Cancer Biorepositories for the purpose of achieving a better understanding of the cause of such cancers and the effects of treatments. Permits award amounts to be used to: (1) 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; (2) maintain a secure searchable database for scientists and qualified health care professionals to research such biospecimens and data; and (3) make available and distribute such biospecimens and data to researchers and professionals for peer-reviewed research.  Revises the national childhood cancer registry grant program to require the Director of the Centers for Disease Control and Prevention (CDC) to award grants to state cancer registries to enhance and expand infrastructure to track the epidemiology of cancer in children, adolescents, and young adults. Requires a Comptroller General (GAO) report regarding the barriers to conducting pediatric studies of oncologic therapies in applications for new drugs or biological products under the Federal Food, Drug, and Cosmetic Act, including recommendations to improve development and access to new therapies as well as assessments of: (1) the feasibility of requiring studies for a pediatric oncologic indication if the therapeutic target of a drug or biologic product for an adult oncologic indication is highly relevant to any pediatric cancer to which it could apply, and (2) the impact of altering the current exemption for orphan drug designations relating to rare diseases or conditions.
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