03-28435. Delegation of Authority

Notice is hereby given that I have delegated to the Commissioner of Food and Drugs the authority, vested in the Secretary of the Department of Health and Human Services, under section 353 of the Public Health Service Act (42 U.S.C. 263a), as amended, to implement CLIA's complexity categorization provisions, which includes, but is not limited to the following:

(a) Interpreting the CLIA provisions related to complexity categorization;

(b) Holding public workshops and meetings on CLIA complexity categorization; and,

(c) Developing and issuing implementing rules and guidance for CLIA complexity categorization.

The existing delegation of authority to the Administrator, Centers for Medicare & Medicaid, concerning CLIA is unaffected.

This delegation is effective upon date of signature. In addition, I ratify and affirm any actions taken by the Commissioner of Food and Drugs or his subordinates which involved the exercise of the authorities delegated herein prior to the effective date of this delegation.

Dated: October 31, 2003.

Tommy G. Thompson,

Secretary.