‘‘(d) DEFINITION.—In this section, the term ‘rare 
disease or condition’ has the meaning given to such term 
in section 526(a)(2).’’. 
(b) APPLICATION.—Section 505G of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), applies only with respect to a drug for which an appli-
cation or supplemental application described in subsection 
(a)(1)(B)(i) of such section 505G is first approved under 
section 505(c) of such Act (21 U.S.C. 355(c)) or section 
351(a) of the Public Health Service Act (42 U.S.C. 
262(a)) on or after the date of the enactment of this Act. 
(c) CONFORMING AMENDMENTS.— 
(1) RELATION TO PEDIATRIC EXCLUSIVITY FOR 
DRUGS.—Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) is amended— 
(A) in subsection (b), by adding at the end 
the following: 
‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG 
APPROVED FOR A NEW INDICATION FOR A RARE DIS-
EASE
OR
CONDITION.—Notwithstanding the ref-
erences in paragraph (1) to the lengths of the exclu-
sivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in para-
graph (1) shall be in addition to any extensions 
under section 505G.’’; and 
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(B) in subsection (c), by adding at the end 
the following: 
‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG 
APPROVED FOR A NEW INDICATION FOR A RARE DIS-
EASE
OR
CONDITION.—Notwithstanding the ref-
erences in paragraph (1) to the lengths of the exclu-
sivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in para-
graph (1) shall be in addition to any extensions 
under section 505G.’’. 
(2) RELATION
TO
EXCLUSIVITY
FOR
NEW 
QUALIFIED
INFECTIOUS
DISEASE
PRODUCTS
THAT 
ARE DRUGS.—Subsection (b) of section 505E of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355f) is amended— 
(A) by amending the subsection heading to 
read as follows: ‘‘RELATION TO PEDIATRIC EX-
CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP-
PROVED FOR A NEW INDICATION FOR A RARE 
DISEASE OR CONDITION.—’’; and 
(B) by striking ‘‘any extension of the pe-
riod under section 505A’’ and inserting ‘‘any 
extension of the periods under sections 505A 
and 505G, as applicable,’’. 
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(3) RELATION TO PEDIATRIC EXCLUSIVITY FOR 
BIOLOGICAL
PRODUCTS.—Section 351(m) of the 
Public Health Service Act (42 U.S.C. 262(m)) is 
amended by adding at the end the following: 
‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO-
LOGICAL PRODUCT APPROVED FOR A NEW INDICA-
TION FOR A RARE DISEASE OR CONDITION.—Not-
withstanding the references in paragraphs (2)(A), 
(2)(B), (3)(A), and (3)(B) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in such 
paragraphs shall be in addition to any extensions 
under section 505G.’’. 
Æ 
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