{"identifier":"/us/usc/t21/s360bbb\u20131","title":21,"num":"\u00a7\u202f360bbb\u20131.","heading":"Dispute resolution","text":"\u00a7\u202f360bbb\u20131.\nDispute resolution\nIf, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [\n42 U.S.C. 262\nsection 355(n) of this title\nsection 360e(g)(2)(B) of this title\nNovember 21, 1997","url":"https://projectusc.org/usc/t21/s360bbb\u20131.html","content":[{"t":"sec","id":"/us/usc/t21/s360bbb\u20131","children":[{"t":"num","text":"\u00a7\u202f360bbb\u20131."},{"t":"heading","text":"Dispute resolution"},{"t":"content","text":"\n","children":[{"t":"p","text":"If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [","children":[{"t":"ref","text":"42 U.S.C. 262","href":"/us/usc/t42/s262","tail":"], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in "},{"t":"ref","text":"section 355(n) of this title","href":"/us/usc/t21/s355/n","tail":" or an advisory committee described in "},{"t":"ref","text":"section 360e(g)(2)(B) of this title","href":"/us/usc/t21/s360e/g/2/B","tail":". Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after "},{"t":"text","text":"November 21, 1997","tail":"."}],"tail":"\n"}]},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}