WHEREAS, Article V, Section 1, of the Constitution of the State of Michigan of 1963 vests the executive power in the Governor; and

WHEREAS, Article V, Section 2, of the Constitution of the State of Michigan of 1963 empowers the Governor to make changes in the organization of the Executive Branch or in the assignment of functions among its units which he considers necessary for efficient administration; and

WHEREAS, Executive Order 1995-25 created the Michigan Biologic Products Institute and the Michigan Biologic Products Commission, both as temporary agencies under Article V, Section 4, of the Constitution of the State of Michigan of 1963; and

WHEREAS, certain functions supporting the manufacture of biologic products at the Michigan Biologic Products Institute are currently provided by the Michigan Department of Community Health and the Michigan Department of Management and Budget; and

WHEREAS, federal regulations concerning biologic manufacturing enterprises, being 21 CFR 600.10, require that the management of such enterprises exercise control in all matters impacting manufacturing at the establishment; and

WHEREAS, recent regulatory actions by the United States Food and Drug Administration have created a need for management of the Michigan Biologic Products Institute to take immediate control of certain functions in order to comply with federal regulations.

NOW, THEREFORE, I, John Engler, Governor of the State of Michigan, pursuant to the powers vested in me by the Constitution of the State of Michigan of 1963 and the laws of the State of Michigan, do hereby order the following:

1. The portion of the Stockroom operation for the North Complex of the Michigan Department of Community Health supporting the Michigan Biologic Products Institute and the portion of the North Complex Security service supporting the Michigan Biologic Products Institute of the Michigan Department of Management and Budget are hereby transferred to the Michigan Biologic Products Institute by a Type II transfer, as defined by Section 3 of Public Act No. 380 of the Public Acts of 1965, being Section 16.103 of the Michigan Compiled Laws. The Michigan Biologic Products Institute shall assume all functions, duties, contractual obligations, responsibilities, inventory, tangible and intangible property, and employees for the portion of the Stockroom operation for the North Complex of the Michigan Department of Community Health supporting the Michigan Biologic Products Institute and the portion of the North Complex Security service of the Michigan Department of Management and Budget supporting the Michigan Biologic Products Institute.

2. The Director of the Michigan Biologic Products Institute shall provide executive direction and supervision for the implementation of the transfers. The Director of the Michigan Biologic Products Institute shall make internal organizational changes as may be administratively necessary to complete the realignment of responsibilities prescribed by this order.

3. All records, personnel, property, and unexpended balances of appropriations, allocations and other funds used, held, employed, available or to be made available to the portion of the Stockroom operation for the North Complex of the Michigan Department of Community Health supporting the Michigan Biologic Products Institute are hereby transferred to the Michigan Biologic Products Institute.

4. All records, personnel, property and unexpended balances of appropriations, allocations and other funds used, held, employed, available or to be made available to the portion of the North Complex Security service of the Michigan Department of Management and Budget supporting the Michigan Biologic Products Institute are hereby transferred to the Michigan Biologic Products Institute.

5. The Michigan Department of Community Health and the Michigan Department of Management and Budget shall make internal organizational changes as may be administratively necessary to complete the realignment of responsibilities prescribed by this order.

6. The Director of the Michigan Department of Community Health, the Director of the Michigan Department of Management and Budget, and the Director of the Michigan Biologic Products Institute shall immediately initiate coordination to facilitate the transfer and develop a memorandum of record identifying any pending settlements, issues of compliance with applicable federal and state laws and regulations, or obligations to be resolved by the Michigan Biologic Products Institute.

7. The Department of Management and Budget shall determine and authorize the most efficient manner possible for handling financial transactions and records in the state's financial management system for the remainder of the fiscal year.

8. All rules, orders, contracts and agreements relating to the assigned functions lawfully adopted prior to the effective date of this order shall continue to be effective until revised, amended, or repealed.

9. Any suit, action, or other proceeding lawfully commenced by, against, or before any entity affected by this order shall not abate by reason of the taking effect of this order. Any suit, action, or other proceeding may be maintained by, against, or before the appropriate successor of any entity affected by this order.

History: 1997, E.R.O. No. 1997-8, Eff. June 25, 1997