Page:United States Statutes at Large Volume 111 Part 3.djvu/257

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2345 (c) CONFORMING AMENDMENT.— Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by adding at the end the following: "(y) In the case of a drug, device, or food— "(1) the submission of a report or recommendation by a person accredited under section 523 that is false or misleading in any material respect; "(2) the disclosure by a person accredited under section 523 of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or "(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this Act.". (d) REPORTS ON PROGRAM OF ACCREDITATION.— 21 USC 360m (1) COMPTROLLER GENERAL.— i^ote. (A) IMPLEMENTATION OF PROGRAM.— Not later than 5 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the extent to which the program of accreditation required by the amendment made by subsection (a) has been implemented. (B) EVALUATION OF PROGRAM. —Not later than 6 months prior to the date on which, pursuant to subsection (c) of section 523 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the authority provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the use of accredited persons under such section 523, including an evaluation of the extent to which such use assisted the Secretary in carrying out the duties of the Secretary under such Act with respect to devices, and the extent to which such use promoted actions which are contrary to the purposes of such Act. (2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM. —Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report providing a determination by the Secretary of whether, in the program of accreditation established pursuant to the amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act (relating to class II devices for which clinical data are required in reports under section 510(k)) should be removed. SEC. 211. DEVICE TRACKING. Effective 90 days after the date of the enactment of this Act, section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows: 39-194O-97-9:QL3Part3

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