HR 3381 RDS
‘‘(A) IN
GENERAL.—The Secretary may 
not make an award under paragraph (1) to an 
entity unless the Secretary ensures that such 
entity— 
‘‘(i) collects biospecimens and associ-
ated clinical and demographic information 
from children and adolescents with appro-
priate permission from parents or legal 
guardians in accordance with Federal and 
State law; and 
‘‘(ii) adheres to strict confidentiality 
to protect the identity and privacy of pa-
tients in accordance with Federal and 
State law. 
‘‘(B) CONSENT.—The Secretary shall es-
tablish an appropriate process for achieving 
consent from the patient, parent, or legal 
guardian. 
‘‘(6) SINGLE
POINT
OF
ACCESS; STANDARD 
DATA; GUIDELINES AND OVERSIGHT.— 
‘‘(A) SINGLE POINT OF ACCESS.—The Sec-
retary shall ensure that each biorepository sup-
ported under paragraph (1) has electronically 
searchable data for use by researchers and 
other qualified health care professionals in the 
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manner and to the extent defined by the Sec-
retary. 
‘‘(B) STANDARD
DATA.—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 re-
searchers and qualified health care professionals 
to search. 
‘‘(C) GUIDELINES AND OVERSIGHT.—The 
Secretary shall develop and disseminate appro-
priate guidelines for the development and main-
tenance of the biorepositories supported under 
this section, including appropriate oversight. 
‘‘(7) COORDINATION.—The Secretary shall en-
sure that clinical and demographic information col-
lected in accordance with this section is collected in 
coordination with the information collected under 
section 399E–1. 
‘‘(8) PROHIBITION ON USE OF FUNDS.—Funds 
made available to carry out this subsection shall not 
be used to acquire, preserve, or maintain a biospeci-
men collected from a patient if such activity is al-
ready covered by funds available from the National 
Cancer Institute for such purpose. 
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‘‘(9) REPORT.—Not later than 4 years after the 
date of enactment of the Childhood Cancer Survivor-
ship, Treatment, Access, and Research Act of 2016, 
the Secretary shall submit to Congress a report on— 
‘‘(A) the number of biospecimens and cor-
responding clinical demographic data collected 
through the biospecimen research efforts sup-
ported under paragraph (1); 
‘‘(B) the number of biospecimens and cor-
responding clinical demographic data requested 
for use by researchers; 
‘‘(C) any barriers to the collection of bio-
specimens and corresponding clinical demo-
graphic data; 
‘‘(D) any barriers experienced by research-
ers or health care professionals in accessing the 
biospecimens and corresponding clinical demo-
graphic data necessary for use in research; and 
‘‘(E) any recommendations with respect to 
improving the biospecimen and biorepository re-
search efforts under this subsection. 
‘‘(10) DEFINITIONS.—For purposes of this sub-
section: 
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‘‘(A) AWARD.—The term ‘award’ includes 
a grant, contract, cooperative agreement, or 
other transaction determined by the Secretary. 
‘‘(B) BIOSPECIMEN.—The term ‘biospeci-
men’ includes— 
‘‘(i) solid tumor tissue or bone mar-
row; 
‘‘(ii) normal or control tissue; 
‘‘(iii) blood and plasma; 
‘‘(iv) DNA and RNA extractions; 
‘‘(v) familial DNA; and 
‘‘(vi) any other sample required by the 
Secretary. 
‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR-
MATION.—The term ‘clinical and demographic 
information’ includes— 
‘‘(i) date of diagnosis; 
‘‘(ii) age at diagnosis; 
‘‘(iii) the patient’s gender, race, eth-
nicity, and environmental exposures; 
‘‘(iv) extent of disease at enrollment; 
‘‘(v) site of metastases; 
‘‘(vi) location of primary tumor coded; 
‘‘(vii) histologic diagnosis; 
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‘‘(viii) tumor marker data when avail-
able; 
‘‘(ix) treatment and outcome data; 
‘‘(x) information related to specimen 
quality; and 
‘‘(xi) any other information required 
by the Secretary.’’; and 
(2) in subsection (d)— 
(A) by striking ‘‘and section 399E–1’’ and 
inserting ‘‘and sections 317U, 399E–1, 417H, 
and 417H–1’’; 
(B) by striking ‘‘2009 through 2013’’ and 
inserting ‘‘2017 through 2021’’; and 
(C) by striking ‘‘such purpose’’ and insert-
ing ‘‘such purposes’’. 
SEC. 102. 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-
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vention, may make awards to State cancer registries to 
enhance and expand infrastructure to track the epidemi-
ology of cancer in children, adolescents, and young adults. 
Such registries may 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; 
‘‘(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. 
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