; and (2) not later than 12 months after closing the comment period on such draft guidance, finalize such guidance. (c) Applicability The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) and any application under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262 ), that is submitted on or after the date that is 3 years after the date of enactment of this Act. (d) Reports to Congress (1) Secretary of Health and Human Services Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s efforts, in coordination with industry, to ensure implementation of the amendments made by subsection (a). (2) GAO study and report (A) Study Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.355c), as amended by subsection (a), in the development of drugs and biological products for pediatric cancer indications. (B) Findings Not later than 7 years after the date of enactment of this Act, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under subparagraph (A).