Human investigations were performed after institutional review board approval, in accord with an assurance approved by the US Department of Health and Human Services.
This project was approved by the Melbourne Health Human Research Ethics Committee as a quality assurance proposal (approval number QA2012029) and is in compliance with the Helsinki Declaration.
Lance Fors, chief executive of Third Wave, said the antitrust review of the acquisition seemed to be taking longer than expected, with no assurance of approval.
The regulations in this part also apply to any person holding a materials license as defined in this part, a Certificate of Compliance, a sealed source or device registration, a quality assurance program approval, and to a Government agency as defined in this part.
B. Quality assurance program approvals issued under part 71 of this chapter.
§ 171.16 Annual fees: Materials licensees, holders of certificates of compliance, holders of sealed source and device registrations, holders of quality assurance program approvals, and government agencies licensed by the NRC.
6 Standardized spent fuel facilities, 10 CFR parts 71 and 72 Certificates of Compliance and related Quality Assurance program approvals, and special reviews, such as topical reports, are not assessed an annual fee because the generic costs of regulating these activities are primarily attributable to users of the designs, certificates, and topical reports.
The MPA has made project reviews more exacting, improved the data that is gathered about major projects, and strengthened the link between assurance and project approval, according to the NAO.
As this was a quality assurance project, ethics approval was not required.
"I expect them to make the same assurances before any approval of the deal" by national security officials, Mr. Rogers said.
