SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI-
TIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) AUTHORITY REGARDING INVESTIGATION OF 
NOVEL
COMBINATION
DRUGS.—Section 
505B(a)(1)(B) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(1)(B)) is amended, in 
the matter preceding clause (i), by inserting after 
‘‘Public Health Service Act,’’ the following: ‘‘or an 
application under such section 505 or such section 
351 for a drug or biological product that contains a 
novel combination of two or more active ingredients 
(subject to paragraph (3)(B)(iii))’’. 
(2) ADDITIONAL ACTIVE INGREDIENT FOR AP-
PLICATION DRUG; LIMITATION REGARDING NOVEL- 
COMBINATION
APPLICATION
DRUG.—Section 
505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended— 
(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
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‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is (as determined by the Secretary) 
a molecularly targeted pediatric cancer inves-
tigation of— 
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) the active ingredient or ingredi-
ents of such drug or biological product in 
combination with— 
‘‘(I) an active ingredient of a 
drug for which an approved applica-
tion under section 505(j) is in effect 
or an active ingredient of a biological 
product for which an approved appli-
cation under section 351(k) of the 
Public Health Service Act is in effect, 
which drug or biological product is de-
termined by the Secretary to be the 
standard of care for treating a pedi-
atric cancer; 
‘‘(II) an active ingredient of a 
drug for which an approved applica-
tion under section 505(b) is in effect 
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to treat an adult cancer, or an active 
ingredient of a biological product for 
which an approved application under 
section 351(a) of the Public Health 
Service Act is in effect to treat an 
adult cancer, which approved applica-
tion is held by the same person sub-
mitting the application referred to in 
paragraph (1)(B); or 
‘‘(III) an active ingredient of a 
drug or biological product for which 
there is in effect an exemption for in-
vestigational use under section 505(i), 
which drug or biological product is 
under such exemption being studied 
jointly by the person submitting the 
application referred to in paragraph 
(1)(B) and by another person pursu-
ant to an agreement between such 
persons. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
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