{"identifier":"/us/usc/t21/s360a","title_num":"21","num":"§ 360a.","heading":"Clinical trial guidance for antibiotic drugs","status":null,"guid":"idc95094ec-f339-11ed-b7d6-eb7e2ad38908","source_credit":"(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)","seq_in_title":186,"parent_identifier":"/us/usc/t21/ch9/schV/ptA","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/schV","level":"subchapter","num":"SUBCHAPTER V—","heading":"DRUGS AND DEVICES","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schV/ptA","level":"part","num":"Part A—","heading":"Drugs and Devices","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=\"id7d0f46cb-81bc-11eb-b838-b6993269d559\" identifier=\"/us/usc/t21/s360a\"><num value=\"360a\">§ 360a.</num><heading> Clinical trial guidance for antibiotic drugs</heading><subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id7d0f46cc-81bc-11eb-b838-b6993269d559\" identifier=\"/us/usc/t21/s360a/a\"><num value=\"a\" class=\"bold\">(a)</num><heading class=\"bold\"> In general</heading><content><p style=\"-uslm-lc:I11\" class=\"indent0\">Not later than 1 year after <date date=\"2007-09-27\">September 27, 2007</date>, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.</p>\n</content>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id7d0f6ddd-81bc-11eb-b838-b6993269d559\" identifier=\"/us/usc/t21/s360a/b\"><num value=\"b\" class=\"bold\">(b)</num><heading class=\"bold\"> Review</heading><content><p style=\"-uslm-lc:I11\" class=\"indent0\">Not later than 5 years after <date date=\"2007-09-27\">September 27, 2007</date>, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.</p>\n</content>\n</subsection>\n<sourceCredit id=\"id7d0f6dde-81bc-11eb-b838-b6993269d559\">(<ref href=\"/us/act/1938-06-25/ch675/s511\">June 25, 1938, ch. 675, § 511</ref>, as added <ref href=\"/us/pl/110/85/tIX/s911\">Pub. L. 110–85, title IX, § 911</ref>, <date date=\"2007-09-27\">Sept. 27, 2007</date>, <ref href=\"/us/stat/121/951\">121 Stat. 951</ref>.)</sourceCredit>\n<notes type=\"uscNote\" id=\"id7d0f6ddf-81bc-11eb-b838-b6993269d559\">\n<note style=\"-uslm-lc:I74\" role=\"crossHeading\" topic=\"editorialNotes\" id=\"id7d0f6de0-81bc-11eb-b838-b6993269d559\"><heading class=\"centered\"><b>Editorial Notes</b></heading></note>\n<note style=\"-uslm-lc:I74\" topic=\"priorProvisions\" id=\"id7d0f6de1-81bc-11eb-b838-b6993269d559\"><heading class=\"centered smallCaps\">Prior Provisions</heading><p style=\"-uslm-lc:I21\" class=\"indent0\">A prior section 360a, <ref href=\"/us/act/1938-06-25/ch675/s511\">act June 25, 1938, ch. 675, § 511</ref>, as added <date date=\"1965-07-15\">July 15, 1965</date>, <ref href=\"/us/pl/89/74/s3/b\">Pub. L. 89–74, § 3(b)</ref>, <ref href=\"/us/stat/79/227\">79 Stat. 227</ref>; amended <date date=\"1968-10-24\">Oct. 24, 1968</date>, <ref href=\"/us/pl/90/639/s2/a\">Pub. L. 90–639, § 2(a)</ref>, <ref href=\"/us/stat/82/1361\">82 Stat. 1361</ref>, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by <ref href=\"/us/pl/91/513/tII\">Pub. L. 91–513, title II</ref>, §§ 701(a), 704, <date date=\"1970-10-27\">Oct. 27, 1970</date>, <ref href=\"/us/stat/84/1281\">84 Stat. 1281</ref>, 1284, effective on the first day of the seventh calendar month that began after <date date=\"1970-10-26\">Oct. 26, 1970</date>.</p>\n</note>\n</notes>\n</section>","provision":null,"duplicates":[],"release":{"label":"118-3","currency_date":"2023-04-10","congress":118,"law_num":3,"excluded_laws":[],"update_num":null,"seq":302,"is_partial":false,"caveat":null,"titles_affected":["01","02","03","05","05a","06","07","08","10","12","15","16","18","19","20","21","22","23","25","26","28","29","30","31","33","34","35","36","37","38","40","41","42","43","44","46","47","48","49","50","51","54"],"ingested_titles":[]},"served_from":{"label":"118-3","currency_date":"2023-04-10","congress":118,"law_num":3,"excluded_laws":[],"update_num":null,"seq":302,"is_partial":false,"caveat":null,"titles_affected":["01","02","03","05","05a","06","07","08","10","12","15","16","18","19","20","21","22","23","25","26","28","29","30","31","33","34","35","36","37","38","40","41","42","43","44","46","47","48","49","50","51","54"],"ingested_titles":[]},"content_first_seen":{"label":"116-314not260not283","currency_date":"2021-01-05","congress":116,"law_num":314,"excluded_laws":[260,283],"update_num":null,"seq":225,"is_partial":true,"caveat":"Current through Public Law 116-314 (01/05/2021), except 116-260, 116-283.","titles_affected":["05","05a","06","15","16","18","21","25","28","31","33","34","42","50","54"],"ingested_titles":[]},"is_exact":true,"note":null}