Sec. 505. Additional provisions on development of drugs and biological products for pediatric use

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Section 505A(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a(f) ) is amended by adding at the end the following: The Secretary shall provide to the committee referred to in paragraph

(1)any response issued to an applicant or holder with respect to a proposed pediatric study request. . Section 505A(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a(d) ) is amended— by redesignating paragraphs

(3)through

(5)as paragraphs

(4)through (6), respectively; and by inserting after paragraph

(2)the following: The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission. . Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ), as amended by paragraph (1), is further amended by striking subsection (d)(3) each place it appears and inserting (d)(4) . Paragraphs (2), (3), and

(4)of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) are amended by striking section 505A(d)(3) each place it appears and inserting section 505A(d)(4) . The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355d ) shall, not later than one year after the date of enactment of this Act, develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) or section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ). Such plan shall include recommendations to achieve— earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(e)(2)(C) ), as amended by section 503(a); earlier issuance of written requests for a pediatric study under such section 505A, including for investigational new drugs prior to the submission of an application under section 505(b)(1) of such Act ( 21 U.S.C. 355(b)(1) ); and shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m). Section 6(d) of the Best Pharmaceuticals for Children Act ( 21 U.S.C. 393a(d) ) is amended by striking For the 5-year period beginning on the date of enactment of this subsection, at and inserting At . Not later than 2 years after the date of enactment of this Act, the Secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products. Section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(d)(1) ) is amended by adding at the end the following: The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters. . Section 505C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355d ) is amended by inserting or pediatric rare diseases after psychiatry . Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the internet website of the Food and Drug Administration, a report on the lack of information in the labeling of drugs for indications that have received an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) with respect to the use of such drugs pediatric populations. The report described in paragraph

(1)shall include— a list of drugs for which— an indication was granted an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ); an application described under section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a)(1) ) for such indication was submitted to the Secretary of Health and Human Services on or after April 1, 1999; and the labeling for such indication lacks important pediatric information, including information related to safety, dosing, and effectiveness; a description of the lack of information referred to in subparagraph (A)(iii) for each drug for an indication on such list; and Federal policy recommendations to improve the labeling of drugs for indications that have received an orphan designation under such section 526 with respect to the use of such drugs pediatric populations.”

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Sec. 505

Additional provisions on development of drugs and biological products for pediatric use

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