Sec. 509. TECHNICAL AMENDMENTS

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## SEC. 509 TECHNICAL AMENDMENTS ###

(a)Pediatric Studies of Drugs in FFDCA Section 505A (21 U.S.C. 355a) is amended— ####

(1)in subsection (k)(2), by striking “subsection (f)(3)(F)” and inserting “subsection (f)(6)(F)”; ####

(2)in subsection (l)— #####

(A)in paragraph (1)— ######

(i)in the paragraph heading, by striking “year one” and inserting “first 18-month period”; and ######

(ii)by striking “one-year” and inserting “18-month”; #####

(B)in paragraph (2)— ######

(i)in the paragraph heading, by striking “years” and inserting “periods”; and ######

(ii)by striking “one-year period” and inserting “18-month period”; #####

(C)by redesignating paragraph

(3)as paragraph (4); and #####

(D)by inserting after paragraph

(2)the following: > > #### “(3) Preservation of authority > > Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population.” > ; ####

(3)in subsection (n)— #####

(A)in the subsection heading, by striking “completed” and inserting “submitted”; and #####

(B)in paragraph (1)— ######

(i)in the matter preceding subparagraph (A), by striking “have not been completed” and inserting “have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request”; ######

(ii)in subparagraph (A)— ######

(I)in the first sentence, by inserting “, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 351 of the Public Health Service Act has not ended” after “expired”; and ######

(II)by striking “Prior to” and all that follows through the period at the end; and ######

(iii)in subparagraph (B), by striking “no listed patents or has 1 or more listed patents that have expired,” and inserting “no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 351 of the Public Health Service Act apply,”; and ####

(4)in subsection (o)(2), by amending subparagraph

(B)to read as follows: > > ##### “(B) > > a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.” > . ###

(b)Research Into Pediatric Uses for Drugs and Biological Projects in FFDCA Section 505B (21 U.S.C. 355c) is amended— ####

(1)in subsection (a)— #####

(A)in paragraph (1), in the matter before subparagraph (A), by inserting “for a drug” after “(or supplement to an application)”; and #####

(B)in paragraph (4)(C)— ######

(i)in the first sentence, by inserting “partial” before “waiver is granted”; and ######

(ii)in the second sentence, by striking “either a full or” and inserting “such a”; ####

(2)in subsection (b)(1), in the matter preceding subparagraph (A), by striking “After providing notice” and all that follows through “studies), the” and inserting “The”; ####

(3)in subsection (g)— #####

(A)in paragraph (1)(A), by inserting “that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review” after “after the date of the submission of the application or supplement”; and #####

(B)in paragraph (2), by striking “the label of such product” and inserting “the labeling of such product”; ####

(4)in subsection (h)(1)— #####

(A)by inserting “an application (or supplement to an application) that contains” after “date of submission of”; and #####

(B)by inserting “if the application (or supplement) receives a priority review, or not later than 330 days after the date of submission of an application (or supplement to an application) that contains a pediatric assessment under this section, if the application (or supplement) receives a standard review,” after “under this section,”; and ####

(5)in subsection (i)— #####

(A)in paragraph (1)— ######

(i)in the paragraph heading, by striking “year one” and inserting “first 18-month period”; and ######

(ii)by striking “one-year” and inserting “18-month”; #####

(B)in paragraph (2)— ######

(i)in the paragraph heading, by striking “years” and inserting “periods”; and ######

(ii)by striking “one-year period” and inserting “18-month period”; #####

(C)by redesignating paragraph

(3)as paragraph (4); and #####

(D)by inserting after paragraph

(c)Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral Extensions, and Waivers Section 505C (21 U.S.C. 355d) is amended— ####

(1)in the section heading, by inserting “deferral extensions,” after “deferrals,”; and ####

(2)by inserting “neonatology,” after “pediatric ethics,”. ###

(d)Program for Pediatric Studies of Drugs Section 409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) is amended— ####

(1)in paragraph (1)— #####

(A)in the matter preceding subparagraph (A), by inserting “or section 351(m) of this Act,” after “Cosmetic Act,”; #####

(B)in subparagraph (A)(i), by inserting “or section 351(k) of this Act” after “Cosmetic Act”; and #####

(C)by amending subparagraph

(B)to read as follows: > > ##### “(B) > > there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act, or applicable twelve-year period referred to in section 351(k)(7) of this Act, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act has ended for at least one form of the drug; and” > ; and ####

(2)in paragraph (2)— #####

(A)in the paragraph heading, by striking “for drugs lacking exclusivity”; #####

(B)by striking “under section 505 of the Federal Food, Drug, and Cosmetic Act”; and #####

(C)by striking “505A of such Act” and inserting “505A of the Federal Food, Drug, and Cosmetic Act or section 351(m) of this Act”. ###

(e)Pediatric Subcommittee of the Oncologic Advisory Committee Section 15(a) of the Best Pharmaceuticals for Children Act (Public Law 107-109), as amended by section 502(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85), is amended in paragraph (1)(D), by striking “section 505B(f)” and inserting “section 505C”. ###

(f)Foundation of National Institutes of Health Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking “for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act”. ###

(g)Application; Transition Rule **[**[21 U.S.C. 355a note](/us/usc/t21/s355a)**]** ####

(1)Application Notwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provision applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 or the date of the enactment of the Pediatric Research Equity Act of 2007, any amendment made by this Act to such a provision applies beginning on the date of the enactment of this Act. ####

(2)Transitional rule for adverse event reporting With respect to a drug for which a labeling change described under section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or made, respectively, during the one-year period that ends on the day before the date of enactment of this Act, the Secretary shall apply section 505A(l) and section 505B(i), as applicable, to such drug, as such sections were in effect on such day.

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