Sec. 608. PEDIATRIC INFORMATION ADDED TO LABELING
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## SEC. 608 PEDIATRIC INFORMATION ADDED TO LABELING Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(o)) is amended— ####
(1)in the subsection heading, by striking “under section 505(j)”; ####
(2)in paragraph (1)— #####
(A)by striking “under section 505(j)” and inserting “under subsection (b)(2) or
(j)of section 505”; and #####
(B)by striking “or by exclusivity under clause
(iii)or
(iv)of section 505(j)(5)(F)” and inserting “, or by exclusivity under clause
(iii)or
(iv)of section 505(j)(5)(F), clause
(iii)or
(iv)of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E”; ####
(3)in paragraph (2), in the matter preceding subparagraph (A)— #####
(A)by inserting “clauses
(iii)and
(iv)of section 505(c)(3)(E), or section 527,” after “section 505(j)(5)(F),”; and #####
(B)by striking “drug approved under section 505(j)” and inserting “drug approved pursuant to an application submitted under subsection (b)(2) or
(j)of section 505”; and ####
(4)by amending paragraph
(3)to read as follows: > > #### “(3) Preservation of pediatric exclusivity and extensions > > This subsection does not affect— > > > ##### “(A) > > the availability or scope of exclusivity under— > > > ###### “(i) > > this section; > > > ###### “(ii) > > section 505 for pediatric formulations; or > > > ###### “(iii) > > section 527; > > > ##### “(B) > > the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E; > > > ##### “(C) > > the question of the eligibility for approval under section 505 of any application described in subsection (b)(2) or
(j)of such section that omits any other aspect of labeling protected by exclusivity under— > > > ###### “(i) > > clause
(iii)or
(iv)of section 505(j)(5)(F); > > > ###### “(ii) > > clause
(iii)or
(iv)of section 505(c)(3)(E); or > > > ###### “(iii) > > section 527(a); or > > > ##### “(D) > > except as expressly provided in paragraphs
(1)and (2), the operation of section 505 or section 527.” > .
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Sec. 608
PEDIATRIC INFORMATION ADDED TO LABELING
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