Page:United States Statutes at Large Volume 124.djvu/3989

 124 STAT. 3963 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(B) RECORDS.—Following any accreditation of a third- party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Sec- retary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. Such report may include documenta- tion that the eligible entity is in compliance with any applicable registration requirements. ‘‘(C) LIMITATION.—The requirement under subpara- graph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third- party auditor, except that the Secretary may access the results of a consultative audit in accordance with section 414. ‘‘(4) REQUIREMENTS OF ACCREDITED THIRD-PARTY AUDITORS AND AUDIT AGENTS OF SUCH AUDITORS.— ‘‘(A) RISKS TO PUBLIC HEALTH.—If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of— ‘‘(i) the identification of the eligible entity subject to the audit; and ‘‘(ii) such condition. ‘‘(B) TYPES OF AUDITS.—An accredited third-party auditor or audit agent of such auditor may perform consult- ative and regulatory audits of eligible entities. ‘‘(C) LIMITATIONS.— ‘‘(i) IN GENERAL.—An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period. ‘‘(ii) WAIVER.—The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third- party auditors in a country or region. ‘‘(5) CONFLICTS OF INTEREST.— ‘‘(A) THIRD-PARTY AUDITORS.—An accredited third- party auditor shall— ‘‘(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor; ‘‘(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and ‘‘(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have main- tained compliance with clauses (i) and (ii) relating to financial conflicts of interest. ‘‘(B) AUDIT AGENTS.—An audit agent shall— ‘‘(i) not own or operate an eligible entity to be audited by such agent; Deadline. Notification.