[Federal Register Volume 66, Number 41 (Thursday, March 1, 2001)]
[Notices]
[Pages 12939-12940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0044]


Medical Devices Draft Guidance for Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Guidance for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver.'' 
FDA is issuing this draft guidance to propose alternative criteria for 
obtaining CLIA waiver to the criteria proposed by the Health Care 
Financing Administration (HCFA) and the Centers for Disease Control and 
Prevention (CDC). This draft guidance is neither final nor in effect at 
this time.

DATES: Submit written comments on the draft guidance by May 30, 2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Guidance for Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Criteria for Waiver'' to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Joseph L. Hackett, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA assumes primary responsibility for performing the CLIA 
complexity categorization functions that includes requests for waiver. 
Responsibility for determining whether a particular device is waived 
was transferred from the CDC to FDA on January 21, 2000. At the same 
time, HCFA is responsible for financial management operations of the 
CLIA program. In the Federal Register of September 13, 1995 (60 FR 
47534), HCFA and CDC published a notice of proposed rulemaking that 
proposed criteria for obtaining CLIA waiver (the 1995 proposed rule). 
FDA believes, based on its interpretation of the legislative history 
and the changes to the CLIA statute enacted by Congress on November 21, 
1997, as part of the Food and Drug Administration Modernization Act of 
1997 (FDAMA), that alternative criteria to the criteria proposed by 
HCFA and CDC can be used to determine whether a device can be waived. 
HCFA, CDC, and FDA are continuing to discuss whether the criteria 
contained in this guidance appropriately reflect the intent of the 
statute. In an effort to get additional perspective on these criteria, 
this draft guidance will be discussed at the Clinical Laboratory 
Improvement Advisory Committee (CLIAC) meeting to obtain their advice 
and recommendations. FDA is publishing this draft guidance so that it 
can be presented and discussed at the February 7 and 8, 2001, CLIAC 
meeting. FDA remains committed to ensuring an open, consistent, 
reliable process that all parties can understand and comment on as we 
take steps to finalize a rule.
    Because FDA believes the agency will have to repropose a regulation 
to clarify waiver criteria, we think it will be some time before a 
final rule is codified. If this draft guidance is made final, the 
agency would propose alternative waiver criteria that may continue in 
the interim (based on comments received on this draft guidance) until a 
reproposal of the regulation to clarify waiver criteria is published.

II. Significance of Guidance

    FDA bases the recommendations in this draft guidance document on 
our interpretation of the law, our review experience with CLIA 
complexity reviews, and our interactions with stakeholders throughout 
the transition of this program from CDC to FDA. One of the interactions 
with stakeholders was in the form of an open public workshop on August 
14 and 15, 2000. We are still evaluating the comments from this 
workshop. We intend to reevaluate and revise this draft guidance, as 
circumstances warrant, based on these and future comments. The 
recommendations in this draft guidance are different from the 
recommendations made by HCFA and CDC in their 1995 proposed rule. As 
stated in this draft guidance, FDA will continue to review requests for 
waiver that follow the criteria contained in the 1995 proposed rule; 
however, we will also review requests for waiver that follow the 
criteria contained in this draft guidance document. The most 
significant difference between the criteria proposed by CDC and HCFA, 
and the criteria outlined in this draft guidance, is that this draft 
guidance allows studies that compare the performance of the device in 
the hands of untrained users with the performance of the device in the 
hands of laboratory professionals to demonstrate accuracy.
    This draft guidance represents the agency's current thinking on 
criteria for obtaining CLIA waiver. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the applicable statutes and regulations.
    The agency has adopted good guidance practices regulations (GGP's), 
which set forth the agency's policies and procedures for the 
development, issuance, and use of guidance documents (21 CFR 10.115; 65 
FR 56468, September 19, 2000). This draft guidance is issued as a Level 
1 draft guidance consistent with the GGP regulations.

III. Electronic Access

    In order to receive the draft guidance entitled ``Guidance for 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for 
Waiver'' via your fax machine, call the CDRH Facts-On-Demand system at 
800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to 
enter the system. At the second voice prompt press 1 to order a 
document. Enter the document number (1147) followed by the pound sign 
(#). Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes the draft document 
entitled ``Guidance for Clinical Laboratory Improvement Amendments

[[Page 12940]]

of 1988 (CLCIA) Criteria for Waiver,'' device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Guidance for Clinical Laboratory Improvement Amendments of 1988 
(CLIA) Criteria for Waiver'' is available at http://www.fda.gov/cdrh.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by May 
30, 2001. 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. The 
draft guidance and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 14, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-4963 Filed 2-28-01; 8:45 am]
BILLING CODE 4160-01-F