; and (2) by inserting after paragraph (2) the following: (3) Action on submissions The Secretary shall review and act upon a submission of a proposed pediatric study request or a sponsor's proposed amendment to a written request for pediatric studies within 120 days of the submission. . (c) Study 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 ). Such plan shall include recommendations to achieve— (1) earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, 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 2; (2) 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 the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(1) ); and (3) shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A. 4. Neonatology expertise 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 .