{"identifier":"/us/usc/t21/s399a","title_num":"21","num":"§ 399a.","heading":"Office of the Chief Scientist","status":null,"guid":"id419288d5-a3d3-11e9-95d4-f3ff9237185e","source_credit":"(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)","seq_in_title":363,"parent_identifier":"/us/usc/t21/ch9/schX","ancestors":[{"identifier":"/us/usc/t21","level":"title","num":"Title 21—","heading":"FOOD AND DRUGS","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9","level":"chapter","num":"CHAPTER 9—","heading":"FEDERAL FOOD, DRUG, AND COSMETIC ACT","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schX","level":"subchapter","num":"SUBCHAPTER X—","heading":"MISCELLANEOUS","status":null,"is_section":false}],"xml":"<section xmlns=\"http://xml.house.gov/schemas/uslm/1.0\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\" xmlns:dc=\"http://purl.org/dc/elements/1.1/\" xmlns:dcterms=\"http://purl.org/dc/terms/\" style=\"-uslm-lc:I80\" id=\"id419288d5-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a\"><num value=\"399a\">§ 399a.</num><heading> Office of the Chief Scientist</heading><subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id419288d6-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/a\"><num value=\"a\" class=\"bold\">(a)</num><heading class=\"bold\"> Establishment; appointment</heading><content><p style=\"-uslm-lc:I11\" class=\"indent0\">The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.</p>\n</content>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id419288d7-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b\"><num value=\"b\" class=\"bold\">(b)</num><heading class=\"bold\"> Duties of the Office</heading><chapeau>The Office of the Chief Scientist shall—</chapeau><paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288d8-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/1\"><num value=\"1\">(1)</num><content> oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288d9-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/2\"><num value=\"2\">(2)</num><content> track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288da-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/3\"><num value=\"3\">(3)</num><content> develop and advocate for a budget to support intramural research;</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288db-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/4\"><num value=\"4\">(4)</num><content> develop a peer review process by which intramural research can be evaluated;</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288dc-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/5\"><num value=\"5\">(5)</num><chapeau> identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—</chapeau><subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id419288dd-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/5/A\"><num value=\"A\">(A)</num><content> representatives of each of the centers and the science-based offices within the Office of the Commissioner; and</content>\n</subparagraph>\n<subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id419288de-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/5/B\"><num value=\"B\">(B)</num><content> experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and</content>\n</subparagraph>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id419288df-a3d3-11e9-95d4-f3ff9237185e\" identifier=\"/us/usc/t21/s399a/b/6\"><num value=\"6\">(6)</num><content> develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.</content>\n</paragraph>\n</subsection>\n<sourceCredit id=\"id419288e0-a3d3-11e9-95d4-f3ff9237185e\">(<ref href=\"/us/act/1938-06-25/ch675/s1010\">June 25, 1938, ch. 675, § 1010</ref>, formerly § 910, as added <ref href=\"/us/pl/110/85/tVI/s602\">Pub. L. 110–85, title VI, § 602</ref>, <date date=\"2007-09-27\">Sept. 27, 2007</date>, <ref href=\"/us/stat/121/898\">121 Stat. 898</ref>; renumbered § 1010, <ref href=\"/us/pl/111/31/dA/tI/s101/b/2\">Pub. L. 111–31, div. A, title I, § 101(b)(2)</ref>, <date date=\"2009-06-22\">June 22, 2009</date>, <ref href=\"/us/stat/123/1784\">123 Stat. 1784</ref>.)</sourceCredit>\n</section>","provision":null,"duplicates":[],"release":{"label":"116-29","currency_date":"2019-07-05","congress":116,"law_num":29,"excluded_laws":[],"update_num":null,"seq":177,"is_partial":false,"caveat":null,"titles_affected":["02","06","07","15","16","19","21","26","34","38","42","43","48","49","50"],"ingested_titles":[]},"served_from":{"label":"116-29","currency_date":"2019-07-05","congress":116,"law_num":29,"excluded_laws":[],"update_num":null,"seq":177,"is_partial":false,"caveat":null,"titles_affected":["02","06","07","15","16","19","21","26","34","38","42","43","48","49","50"],"ingested_titles":[]},"content_first_seen":{"label":"116-29","currency_date":"2019-07-05","congress":116,"law_num":29,"excluded_laws":[],"update_num":null,"seq":177,"is_partial":false,"caveat":null,"titles_affected":["02","06","07","15","16","19","21","26","34","38","42","43","48","49","50"],"ingested_titles":[]},"is_exact":true,"note":null}