[Federal Register Volume 69, Number 81 (Tuesday, April 27, 2004)]
[Notices]
[Page 22849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Delegation of Authority

    Notice is hereby given that I have delegated to Commissioner 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 as they apply to commercially 
available tests to the Commissioner of Food and Drugs (FDA). This 
authority 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 Administrator of the Centers for Medicare & Medicaid Services 
(CMS) will provide funding to implement CLIA's complexity 
categorization provisions as set forth in the Agency Agreement between 
FDA and CMS (CMS IA-04-01, FDA 224-04-6052), as amended.
    Except as provided above, the existing delegation of authority to 
the Administrator of CMS concerning CLIA is unaffected.
    This delegation supersedes the delegation of authority memorandum 
dated October 31, 2003, from the Secretary to the Commissioner of Food 
and Drugs, titled ``Delegation of Authority for the Clinical Laboratory 
Improvements Amendments of 1988 (CLIA), Section 353 of the Public 
Health Service Act, as amended.''
    This delegation shall be exercised under the Department's existing 
delegation and policy on regulations. In addition, I ratified and 
reaffirmed any actions taken by you or your subordinates which involved 
the exercise of this authorities prior to the effective date of this 
delegation.
    This delegation was effective upon date of signature.

Tommy G. Thompson,
Secretary, Department of Health and Human Services
[FR Doc. 04-9527 Filed 4-26-04; 8:45 am]
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