{"identifier":"/us/usc/t21/s355b","title":21,"num":"\u00a7\u202f355b.","heading":"Adverse-event reporting","text":"\u00a7\u202f355b.\nAdverse-event reporting\n(a)\nToll-free number in labeling\nNot later than one year after\n(1) The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.\n(2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession.\n(3) The rule shall take effect not later than 60 days after the date on which the rule is promulgated.\n(b)\nDrugs with pediatric market exclusivity\n(1)\nIn general\nDuring the one year beginning on the date on which a drug receives a period of market exclusivity under 505A\n1\n1 So in original. Probably should be preceded by \u201csection\u201d.\n21 U.S.C. 355a\nsection 393a of this title\n2\n2 So in original. Probably should be \u201cCommittee\u201d.\n21 U.S.C. 301\n(2)\nRule of construction\nParagraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the one-year period described in such paragraph regarding the drug has expired.","url":"https://projectusc.org/usc/t21/s355b.html","content":[{"t":"sec","id":"/us/usc/t21/s355b","children":[{"t":"num","text":"\u00a7\u202f355b."},{"t":"heading","text":"Adverse-event reporting"},{"t":"subsec","id":"/us/usc/t21/s355b/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"Toll-free number in labeling"},{"t":"chapeau","text":"Not later than one year after ","children":[{"t":"text","text":"January 4, 2002","tail":", the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act ["},{"t":"ref","text":"21 U.S.C. 355","href":"/us/usc/t21/s355","tail":"] (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule:"}]},{"t":"para","id":"/us/usc/t21/s355b/a/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355b/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession.","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355b/a/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" The rule shall take effect not later than 60 days after the date on which the rule is promulgated.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355b/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Drugs with pediatric market exclusivity"},{"t":"para","id":"/us/usc/t21/s355b/b/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A\u202f","children":[{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSo in original. Probably should be preceded by \u201csection\u201d."},{"t":"text","text":"\u202fSo in original. Probably should be preceded by \u201csection\u201d.","tail":" of the Federal Food, Drug, and Cosmetic Act ["},{"t":"ref","text":"21 U.S.C. 355a","href":"/us/usc/t21/s355a","tail":"], any report of an adverse event regarding the drug that the Secretary of Health and Human Services receives shall be referred to the Office of Pediatric Therapeutics established under "},{"t":"ref","text":"section 393a of this title","href":"/us/usc/t21/s393a","tail":". In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee\u202f"},{"t":"ref","text":"2"},{"t":"num","text":"2","tail":"\u202fSo in original. Probably should be \u201cCommittee\u201d."},{"t":"text","text":"\u202fSo in original. Probably should be \u201cCommittee\u201d.","tail":" regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act ["},{"t":"ref","text":"21 U.S.C. 301","href":"/us/usc/t21/s301","tail":" et seq.] in response to the report."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355b/b/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Rule of construction"},{"t":"content","children":[{"t":"p","text":"Paragraph (1) may not be construed as restricting the authority of the Secretary of Health and Human Services to continue carrying out the activities described in such paragraph regarding a drug after the one-year period described in such paragraph regarding the drug has expired.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}