Sec. 402. Establishment of no-fault reporting system
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Title III of the Public Health Service Act is amended by inserting after section 351A ( 42 U.S.C. 262a ) the following: In this section: The term listed agents and toxins has the meaning given the term in section 351A(l). The term reporting system means the reporting system established under subsection (b)(1). Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act , the Secretary shall establish a confidential, anonymous, voluntary, no-fault reporting system related to accidents, near-accidents, or other safety incidents involving biological agents and toxins, in order to support continuous improvement and sharing of lessons learned related to such incidents.
The ability to submit reports on a voluntary basis to the reporting system shall be made available to individuals affiliated with laboratories located in the United States, or at federally-funded entities outside the United States, that conduct research involving biological agents and toxins. Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act , the Secretary shall publish a notice in the Federal Register on plans for the reporting system, including— data elements that will be included in the submission of reports; procedures and processes for the submission of reports; criteria for incidents that may be reported to such system; and procedures for privacy and anonymization.
The Secretary shall test and prototype the reporting system for not less than 1 year before finalizing the reporting system. The Secretary shall seek feedback on development of the reporting system from external stakeholders, including prior to publication of the information under paragraph
(3)and prior to introduction of prototypes and finalization of such system under paragraph (4). Information submitted to, or derived from, the reporting system shall be exempt from disclosure under section 552 of title 5, United States Code. For purposes of paragraph (1), this section shall be considered a statute described in section 552(b)(3)(B) of title 5, United States Code. Information submitted to, or derived from, the reporting system shall not be used in any Federal or State enforcement action or criminal prosecution. An individual or entity that submits information to the reporting system under subsection
(b)shall not be required to provide their name. The voluntary reporting system established under this section shall supplement, and not supplant, any other requirements to submit reports under any other reporting system. .
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Sec. 402
Establishment of no-fault reporting system
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