for such drug pursuant to subsection (a)(1)(C)(iii), 
except that, if a court from which no appeal (other 
than a writ of certiorari) has been or could be taken 
rules a listed patent invalid or not infringed, then 
such patent shall no longer be considered for pur-
poses of this paragraph. 
‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED IN-
FECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any exten-
sion under subsection (b) of a period shall be in addition 
to any extension of the periods under sections 505A and 
505E of this Act and section 351(m) of the Public Health 
Service Act, as applicable, with respect to the drug. 
‘‘(d) LIMITATIONS.—The extension described in sub-
section (b) shall not apply if the drug designated under 
subsection (a)(1) has previously received an extension by 
operation of subsection (b). 
‘‘(e) REGULATIONS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this section, the Sec-
retary shall adopt final regulations implementing 
this section. 
‘‘(2) PROCEDURE.—In promulgating a regula-
tion implementing this section, the Secretary shall— 
‘‘(A) issue a notice of proposed rulemaking 
that includes the proposed regulation; 
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‘‘(B) provide a period of not less than 60 
days for comments on the proposed regulation; 
and 
‘‘(C) publish the final regulation not less 
than 30 days before the effective date of the 
regulation. 
‘‘(3) 
RESTRICTIONS.—Notwithstanding 
any 
other provision of law, the Secretary shall promul-
gate regulations implementing this section only as 
described in paragraph (2), except that the Sec-
retary may issue interim guidance for sponsors seek-
ing to submit an application or supplemental appli-
cation described in subsection (a) prior to the pro-
mulgation of such regulations. 
‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 
The Secretary shall designate drugs under sub-
section (a) prior to the promulgation of regulations 
under this subsection, if such drugs meet the criteria 
described in subsection (a). 
‘‘(f) DEFINITION.—In this section: 
‘‘(1) The terms ‘biological product’, ‘biosimilar’, 
and ‘reference product’ have the meanings given to 
such terms in section 351(i) of the Public Health 
Service Act. 
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‘‘(2) The term ‘rare disease or condition’ has 
the meaning given to such term in section 
526(a)(2).’’. 
(b) APPLICATION.—Section 505F 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 subpara-
graphs (B) and (C) of subsection (a)(1) of such section 
505F 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 subsection (b)(1) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in sub-
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section (b)(1) shall be in addition to any extensions 
under section 505F.’’; and 
(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 subsection (c)(1) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in sub-
section (c)(1) shall be in addition to any extensions 
under section 505F.’’. 
(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 
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extension of the periods under sections 505A or 
505F’’. 
(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 505F.’’. 
Æ 
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