PUBLIC LAW 109–462—DEC. 22, 2006
120 STAT. 3473
‘‘(A) results in— ‘‘(i) death; ‘‘(ii) a life-threatening experience; ‘‘(iii) inpatient hospitalization; ‘‘(iv) a persistent or significant disability or incapacity; or ‘‘(v) a congenital anomaly or birth defect; or ‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). ‘‘(3) SERIOUS ADVERSE EVENT REPORT.—The term ‘serious adverse event report’ means a report that is required to be submitted to the Secretary under subsection (b). ‘‘(b) REPORTING REQUIREMENT.— ‘‘(1) IN GENERAL.—The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 403(e)(1)) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the ‘responsible person’) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement. ‘‘(2) RETAILER.—A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in section 403(y). ‘‘(c) SUBMISSION OF REPORTS.— ‘‘(1) TIMING OF REPORTS.—The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 403(y). ‘‘(2) NEW MEDICAL INFORMATION.—The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person. ‘‘(3) CONSOLIDATION OF REPORTS.—The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report. ‘‘(4) EXEMPTION.—The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health. ‘‘(d) CONTENTS OF REPORTS.—Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information. ‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.—
VerDate 14-DEC-2004
12:05 Jul 13, 2007
Jkt 059194
PO 00003
Frm 00276
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL003.109
APPS06
PsN: PUBL003
�
