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.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2607 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2607
To establish programs with respect to childhood, adolescent, and young
adult cancer.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 28, 2013
Mr. Van Hollen (for himself, Mr. McCaul, Mr. Upton, Ms. Speier, Mr.
Reichert, Ms. Castor of Florida, Mr. King of New York, Mr. Waxman, and
Mr. Harper) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To establish programs with respect to childhood, adolescent, and young
adult cancer.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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