[Federal Register Volume 64, Number 250 (Thursday, December 30, 1999)]
[Notices]
[Page 73561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33941]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
Food and Drug Administration
Health Care Financing Administration


CLIA Program; Transfer of Clinical Laboratory Complexity 
Categorization Responsibility

AGENCY: Centers for Disease Control and Prevention, Food and Drug 
Administration, and Health Care Financing Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), the Food 
and Drug Administration (FDA), and the Health Care Financing 
Administration (HFCA) are announcing that CDC is transferring the 
responsibility for the categorization of commercially marketed in vitro 
diagnostic (IVD) tests under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) to FDA. Categorization is the process of 
assigning commercial clinical laboratory tests to one of three CLIA 
regulatory categories (waived, moderate complexity, high complexity). 
An interagency agreement on the scope and nature of the transfer of 
this CLIA function was signed on February 27, 1999.

DATES: The transfer from CDC to FDA of responsibility under CLIA for 
complexity categorization of commercially marketed IVD's is expected to 
be completed by January 31, 2000.

FOR FURTHER INFORMATION CONTACT: Joseph L. Hackett or Clara A. Sliva, 
Center for Devices and Radiological Health (CDRH) (HFZ-440), Food and 
Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-827-
0496.

SUPPLEMENTARY INFORMATION: Under section 353 of the Public Health 
Service Act (42 U.S.C. 263a), as amended by CLIA, and regulations 
implementing CLIA published on February 28, 1992 (57 FR 7002), existing 
and new commercial clinical laboratory tests are categorized into one 
of three regulatory categories. The three test categories are: Waived, 
moderate complexity, and high complexity tests.
    HCFA was originally charged with administering the CLIA program and 
the Public Health Service was enlisted later to provide technical and 
scientific support. Under the regulations issued in 1992, FDA was 
assigned the responsibility of categorizing the complexity of 
commercially marketed laboratory tests. In 1994, this responsibility 
was delegated to CDC because of budgetary considerations.
    CDC, FDA, and HCFA signed an interagency agreement on February 27, 
1999, to transfer the CLIA complexity categorization responsibility for 
commercially marketed tests from CDC to FDA. The transfer was 
contingent upon FDA's receipt of funding for this function. The 
transfer will permit manufacturers of commercially marketed IVD's to 
submit premarket applications for products and requests for complexity 
categorizations of those products to one agency. When the transfer is 
complete, FDA staff in CDRH will evaluate the appropriate complexity 
category as they review premarket submissions for clinical laboratory 
devices. Products seeking a waiver categorization, devices exempt from 
premarket notification, and devices under premarket review by other FDA 
centers also will be processed by these FDA staff. The criteria for 
categorization under CLIA will not change. All other CLIA 
responsibilities currently assigned to CDC, including review of test 
systems, assays, or examinations not commercially marketed as IVD 
products, will remain with CDC.
    FDA and CDC expect the transfer of responsibility to be completed 
by January 31, 2000. Until that time, requests for categorization 
should continue to be submitted to CDC. Both agencies are currently 
participating in training necessary to accomplish the transfer. FDA 
intends to provide guidance on how categorizations will be 
administratively processed before manufacturers begin to send their 
requests to CDRH.
    Dated: December 21, 1999.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention.

Jane E. Henney,
Commissioner of Food and Drugs.

Michael M. Hash,
Deputy Administrator, Health Care Financing Administraion.
[FR Doc. 99-33941 Filed 12-29-99; 8:45 am]
BILLING CODE 4160-01-F