Page:United States Statutes at Large Volume 118.djvu/607

 118 STAT. 577 PUBLIC LAW 108–214—APR. 1, 2004 (II) in clause (ii), by striking ‘‘subsection (a)(1)(A)(i)’’ and inserting ‘‘subsection (a)(2)(A)(i)’’; and (iv) in subsection (j), by striking ‘‘subsection (a)(1)(D),’’ and inserting ‘‘subsection (a)(2)(D),’’. (C) ADDITIONAL CONFORMING AMENDMENT.—Section 102(b)(1) of Public Law 107–250 (116 Stat. 1600) is amended, in the matter preceding subparagraph (A), by striking ‘‘section 738(a)(1)(A)(ii)’’ and inserting ‘‘section 738(a)(2)(A)(ii)’’. (3) PUBLIC LAW 107–250.—Public Law 107–250 is amended— (A) in section 102(a) (116 Stat. 1589), by striking ‘‘(21 U.S.C. 379F et seq.)’’ and inserting ‘‘(21 U.S.C. 379f et seq.)’’; (B) in section 102(b) (116 Stat. 1600)— (i) by striking paragraph (2); (ii) in paragraph (1), by redesignating subpara graphs (A) and (B) as paragraphs (1) and (2), respec tively; and (iii) by striking: ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE MARKET REPORTS.— ‘‘(1) IN GENERAL.—A person submitting a premarket report’’ and inserting: ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE MARKET REPORTS.—A person submitting a premarket report’’; and (C) in section 212(b)(2) (116 Stat. 1614), by striking ‘‘, such as phase IV trials,’’. SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR CHILDREN. Not later than 180 days after the date of 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 a report on the barriers to the availability of devices intended for the treatment or diagnosis of diseases and conditions that affect children. The report shall include any rec ommendations of the Secretary of Health and Human Services for changes to existing statutory authority, regulations, or agency Deadline. 21 USC 360l note. 21 USC 379i, 379j. 21 USC 379j note.

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