[Federal Register Volume 65, Number 180 (Friday, September 15, 2000)]
[Notices]
[Pages 55981-55982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1394]


Medical Devices; CLIA Waiver Criteria; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to October 
16, 2000, the comment period for the notice of a public workshop that 
appeared in the Federal Register of July 21, 2000 (65 FR 45384). That 
notice announced FDA's intention to review the criteria used to 
determine whether specific laboratory tests are waived from certain 
requirements of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). This extension of the comment period is intended to allow 
interested persons additional time to submit comments on the CLIA 
waiver criteria.

DATES: Submit written comments by October 16, 2000.

[[Page 55982]]


ADDRESSES: Submit written comments on the notice of public workshop to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Extension of Comment Period

    In the Federal Register of July 21, 2000 (65 FR 45384), FDA 
published a notice of a public workshop to review the criteria used to 
determine whether specific laboratory tests are waived from certain 
requirements of the CLIA. FDA is soliciting comments from interested 
persons concerning the review of criteria and the process that the 
agency should use to determine when a particular test is waived. CLIA 
specifies that laboratory requirements be based on the complexity of 
the tests performed and establishes criteria for categorizing a test as 
waived. Responsibility for determining whether a particular test is 
waived was transferred from the Centers for Disease Control and 
Prevention (CDC) to FDA on January 31, 2000.
    FDA received several requests to extend the comment period for an 
additional month to allow adequate time to respond. In response to the 
requests, FDA is extending the comment period until October 16, 2000.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this notice by October 16, 
2000. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: September 12, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23881 Filed 9-13-00; 1:36 pm]
BILLING CODE 4160-01-F