I 
114TH CONGRESS 
2D SESSION 
H. R. 5858 
To amend the Federal Food, Drug, and Cosmetic Act to establish a program 
to provide additional incentives for the development of new drugs to 
treat pediatric cancers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 14, 2016 
Mr. MCCAUL (for himself, Mr. BUTTERFIELD, Mr. DUFFY, and Mr. VAN 
HOLLEN) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish a program to provide additional incentives for 
the development of new drugs to treat pediatric cancers, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Research to Accelerate 
Cures and Equity for Children Act’’ or the ‘‘RACE for 
Children Act’’. 
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS
SEC. 2. REQUIRED PEDIATRIC ASSESSMENTS. 
(a) MOLECULAR
TARGETS
REGARDING
CANCER 
DRUGS.—Section 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c) is amended— 
(1) in subsection (a)(1)— 
(A) in subparagraph (A), by striking ‘‘or’’ 
at the end; 
(B) in subparagraph (B), by inserting ‘‘or’’ 
after ‘‘administration,’’; and 
(C) by inserting after subparagraph (B) 
the following: 
‘‘(C) under section 505 of this Act or sec-
tion 351 of the Public Health Service Act, as 
described in subparagraph (A) or (B), that is 
directed at a molecular target present in one or 
more cancers in one or more pediatric popu-
lations,’’; and 
(2) in subsection (b)(1)— 
(A) by amending subparagraph (A)(i) to 
read as follows: 
‘‘(A)(i) the drug or biological product is 
used for a substantial number of pediatric pa-
tients— 
‘‘(I) for the labeled indications; or 
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS
‘‘(II) with respect to one or more spe-
cific molecular targets present in cancers 
in pediatric populations; and’’; 
(B) by amending subparagraph (B) to read 
as follows: 
‘‘(B) there is reason to believe that the 
drug or biological product would represent a 
meaningful therapeutic benefit over existing 
therapies for pediatric patients— 
‘‘(i) for one or more of the claimed in-
dications; or 
‘‘(ii) with respect to one or more spe-
cific molecular targets present in cancers 
in pediatric populations; or’’; and 
(C) by amending paragraph (2) of sub-
section (c) to read as follows: 
‘‘(2) the drug or biological product is in a class 
of products, is for an indication, or is directed at a 
specific molecular target present in cancers in pedi-
atric populations, for which there is need for addi-
tional options.’’. 
(b) EARLY MEETING ON PEDIATRIC STUDY PLAN.— 
(1) 
IN
GENERAL.—Clause 
(i) 
of 
section 
505B(e)(2)(C) of the Federal Food, Drug, and Cos-
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS
metic Act (21 U.S.C. 355c(e)(2)(C)) is amended to 
read as follows: 
‘‘(i) shall meet with the applicant— 
‘‘(I) if requested by the applicant 
with respect to a drug that is directed 
at a molecular target that is present 
in one or more cancers in one or more 
pediatric populations, as described in 
subsection (a)(1)(C), to discuss, not 
later than the end-of-Phase1 meeting 
(as such term is used in section 
312.82(b) of title 21, Code of Federal 
Regulations, or successor regulations), 
preparation of the initial pediatric 
study plan; 
‘‘(II) to discuss the initial pedi-
atric study plan as soon as prac-
ticable, but not later than 90 calendar 
days after the receipt of such plan 
under subparagraph (A); and 
‘‘(III) to discuss any scientific or 
operational challenges that may be the 
basis of a deferral under subsection 
(a)(3) or a full or partial waiver under 
subsection (a)(4);’’. 
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS
(2) CONFORMING CHANGES.—Section 505B(e) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(e)) is amended— 
(A) in the heading of paragraph (2), by 
striking ‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 
(B) in the heading of paragraph (2)(C), by 
striking ‘‘MEETING’’ and inserting ‘‘MEET-
INGS’’; 
(C) in clauses (ii) and (iii) of paragraph 
(2)(C), by striking ‘‘no meeting’’ each place it 
appears and inserting ‘‘no meeting under clause 
(i)(II)’’; and 
(D) in paragraph (3) by striking ‘‘meeting 
under paragraph (2)(C)(i)’’ and inserting 
‘‘meeting under paragraph (2)(C)(i)(II)’’. 
(c) ORPHAN DRUGS.—Section 505B(k) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(k)) 
is amended by inserting ‘‘except in the case of a drug or 
biological product that is the subject of an application de-
scribed in subsection (a)(1)(C),’’ after ‘‘regulation,’’. 
(d) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall issue guidance on the implementa-
tion of this section (including the amendments made by 
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS
this section), including study designs and molecular tar-
gets likely to be present in one or more cancers in pedi-
atric populations that are appropriate for assessment 
under the amendments made by this Act. 
(e) APPLICABILITY.—This Act and the amendments 
made by this Act apply with respect to applications for 
a drug submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 
of the Public Health Service Act (42 U.S.C. 262) on or 
after the date that is 18 months after the date of enact-
ment of this Act. 
(f) REPORT TO CONGRESS.—Not later than July 12, 
2021, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall sub-
mit to Congress a report on the implementation of the 
amendments made by this section, together with any rec-
ommendations of the Secretary regarding such amend-
ments. 
(g) RULE OF CONSTRUCTION.—Nothing in this Act, 
including the amendments made by this Act, shall limit 
the authority of the Secretary of Health and Human Serv-
ices to issue written requests under section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a). 
Æ 
VerDate Sep 11 2014 
19:22 Aug 01, 2016
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H5858.IH
H5858
sradovich on DSK3GMQ082PROD with BILLS