National Health Security Act 2007

If the Director‑General of the CDC receives a report from an entity under section 42, the Director‑General must decide whether or not to register the entity in relation to any or all of the security‑sensitive biological agents and facilities specified in the report.

For the purpose of making a decision under subsection (1), the Director‑General of the CDC may, by written notice to the entity, do either or both of the following:

request the entity to provide such further information as the Director‑General requires within the period specified in the notice, or within such longer period as the Director‑General allows;

request the entity to allow an inspector to inspect a specified facility of the entity at a reasonable time.

A notice requesting the entity to provide further information under paragraph (2)(a) must state that, if the entity does not provide the information within the period allowed under that paragraph, the Director‑General of the CDC may require the entity to dispose of its entire holdings of any or all of the security‑sensitive biological agents specified in the report.

The Director‑General of the CDC must decide to register the entity in relation to a security‑sensitive biological agent and a facility specified in the entity’s report if:

the entity provided all the information required by paragraph 42(3)(b), and any further information requested under paragraph (2)(a) of this section, in relation to that security‑sensitive biological agent and that facility; and

the entity stated in the report that it is complying with the SSBA Standards; and

the Director‑General is satisfied that the purpose stated in the entity’s report for which the entity is handling that security‑sensitive biological agent at that facility is a legitimate purpose.

Section 45 applies if the requirements referred to in paragraphs (4)(a) and (b) of this section are not met.

Section 47 applies if the requirements referred to in paragraphs (4)(a) and (b) of this section are met but the requirement referred to in paragraph (4)(c) of this section is not met.

The Director‑General of the CDC must notify the entity in writing of the Director‑General’s decision under subsection (1). The notice must include the information (if any) prescribed by the regulations.