PHS/FDA shall no longer regularly inspect clinical trial laboratories or parts thereof that perform hepatitis testing or other laboratory methods for registered blood establishments, if the laboratory is interviewed by the HCFA program and meets the requirements of the HCFA program. If a specific PHS/FDA study is required to demonstrate the existence of suspected significant defects or defects that, if confirmed, would affect the safety or efficacy of the products, or the safety or health of donors, the FDA review will be coordinated with HCFA regional staff. In all cases where PHS/FDA and HCFA find that it is not possible to resolve substantive disputes regarding this agreement, this matter is referred for decision by the Assistant Secretary for Health, the Commissioner of Food and Drugs and the Administrator, HCFA, the Under Secretary of State or the Secretary of State. 2. Authorization and refusal of independent hospitals and laboratories for Medicare purposes. (1) The PHS/FDA is responsible for conducting studies on the technical and scientific aspects of the management and regulation of transfusion services and blood establishments, including studies on the development of standards, improved quality practices and tests, and evaluation methods. . . .