adolescents, and young adults diagnosed with cancer 
in the United States. 
‘‘(2) Maintain a secure searchable database on 
stored biospecimens and associated clinical and de-
mographic 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 appli-
cations 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 re-
searchers 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 demo-
graphic 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 
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a manner, and containing such information as the 
Secretary may reasonably require. 
‘‘(2) CONSIDERATIONS.—In evaluating the ap-
plications in paragraph (1), the Secretary shall con-
sider 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 un-
less the Secretary ensures that such entity— 
‘‘(A) collects biospecimens and associated 
clinical and demographic information from chil-
dren 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.— 
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‘‘(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 de-
fined by the Secretary. 
‘‘(2) STANDARD DATA.—The Secretary shall re-
quire 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 Sec-
retary shall develop and disseminate appropriate 
guidelines for the development and maintenance of 
the biorepositories authorized under this section, in-
cluding 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; 
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‘‘(C) blood/plasma; 
‘‘(D) DNA and RNA extractions; 
‘‘(E) familial DNA; and 
‘‘(F) any other sample required by the Sec-
retary. 
‘‘(3) CLINICAL
AND
DEMOGRAPHIC
INFORMA-
TION.—The term ‘clinical and demographic informa-
tion’ 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 qual-
ity; and 
‘‘(K) any other information required by the 
Secretary. 
‘‘(h) COORDINATION.—The Secretary shall ensure 
that clinical and demographic information collected in ac-
cordance with this section is collected in coordination with 
the information collected under section 399E–1. 
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‘‘(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 pa-
tient 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 Child-
hood Cancer Reauthorization Act, the Secretary shall sub-
mit to Congress a report on— 
‘‘(1) the number of biospecimens and cor-
responding clinical demographic data collected 
through the Comprehensive Children’s Cancer Bio-
repositories established under subsection (a); 
‘‘(2) the number of biospecimens and cor-
responding clinical demographic data requested for 
use by researchers; 
‘‘(3) any barriers to the collection of biospeci-
mens and corresponding clinical demographic data; 
‘‘(4) any barriers experienced by researchers or 
health care professionals in accessing the biospeci-
mens and corresponding clinical demographic data 
necessary for use in research; and 
‘‘(5) any recommendations with respect to im-
proving the Comprehensive Children’s Cancer Bio-
repository program under this section.’’; and 
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(3) in subsection (l), as so redesignated— 
(A) by striking ‘‘$30,000,000’’ and insert-
ing ‘‘$10,000,000’’; and 
(B) by striking ‘‘2013’’ and inserting 
‘‘2018’’. 
(b) IMPROVING
CHILDHOOD
CANCER
SURVEIL-
LANCE.—Section 399E–1 of the Public Health Service Act 
(42 U.S.C. 280e–3a) is amended— 
(1) by redesignating subsection (b) as sub-
section (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 Pre-
vention, shall award grants to State cancer registries to 
enhance and expand infrastructure to track the epidemi-
ology 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 sub-
section (a) may be used for— 
‘‘(1) identifying, recruiting, and training all po-
tential sources for reporting childhood, adolescent, 
and young adult cancer cases; 
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‘‘(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, ado-
lescent, 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 
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under section 505B of the Federal Food, Drug, and Cos-
metic 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 Cos-
metic 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 al-
tering the exemption under subsection (k) of such 
section 505B. 
(c) STAKEHOLDER INPUT.—The report under sub-
section (a) shall be developed with input from relevant 
stakeholders. 
Æ 
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