Sec. 501. BEST PHARMACEUTICALS FOR CHILDREN
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## SEC. 501 BEST PHARMACEUTICALS FOR CHILDREN Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended— ####
(1)in subsection (a)(2)(A)(ii), by inserting “and identification of biomarkers for such diseases, disorders, or conditions,” after “biologics,”; ####
(2)in subsection (c)— #####
(A)in paragraph (6)— ######
(i)by amending subparagraph
(B)to read as follows: > > ##### “(B) Availability of reports > > > ###### “(i) In general > > Each report submitted under subparagraph
(A)shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after submission of such report, shall be— > > > ###### “(I) > > posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of— > > > ###### “(aa) > > human research participants, including with respect to privacy, security, informed consent, and protected health information; and > > > ###### “(bb) > > proprietary interests, confidential commercial information, and intellectual property rights; and > > > ###### “(II) > > assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments. > > > ###### “(ii) Submission of comments > > An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.” > ; and ######
(ii)in subparagraph (C), by striking “appropriate action” and all that follows through the period and inserting “action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).”; and #####
(B)in paragraph (7)— ######
(i)in the matter preceding subparagraph (A), by striking “During” and inserting “Within”; ######
(ii)in subparagraph (C)(i), by striking “place” and all that follows through “and of” and inserting “include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of”; and ######
(iii)in clause (ii), by striking “in the Federal Register and”; ####
(3)by striking subsection (d); ####
(4)by redesignating subsection
(e)as subsection (d); and ####
(5)in paragraph
(1)of subsection (d), as so redesignated, by striking “2013 through 2017” and inserting “2018 through 2022”.
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Sec. 501
BEST PHARMACEUTICALS FOR CHILDREN
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