[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49582-49583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20464]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1401]


Draft Guidance for Industry on Administrative Procedures for CLIA 
Categorization; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry entitled ``Guidance for 
Administrative Procedures for CLIA Categorization.'' The Center for 
Devices and Radiological Health is issuing this draft guidance document 
to provide information to manufacturers on how to submit requests for 
complexity categorization under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) and how FDA will notify the manufacturer of 
the complexity categorization.

DATES: Submit written comments on the draft guidance document by 
November 13, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5diskette 
of the draft guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' 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written comments concerning this draft guidance document to the Dockets 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access to the draft guidance document.

[[Page 49583]]


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. Background

    On January 31, 2000, the responsibility for categorization of 
commercially marketed products under CLIA was transferred from the 
Centers for Disease Control and Prevention (CDC) to FDA. This allows 
manufacturers to submit premarket applications for products and 
requests for complexity categorization of these products under CLIA to 
one agency. This draft guidance document contains information on the 
administrative procedures that the manufacturers of in vitro diagnostic 
products will use to receive a complexity categorization under CLIA 
from FDA.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the administrative procedures for CLIA categorization of 
commercially marketed in vitro diagnostic products. 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 statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as Level 1 guidance consistent 
with GGP's.

III. Electronic Access

    In order to receive the draft guidance document entitled ``Guidance 
for the Administrative Procedures for CLIA Categorization'' via your 
fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to access DSMA Facts, at second voice prompt press 2, and then 
enter the document number (1143) followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance 
document may also do so using the Internet. The Center for Devices and 
Radiological Health (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 access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Guidance for 
Administrative Procedures for CLIA Categorization,'' 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. The draft guidance document entitled 
``Guidance on the Administrative Procedures for CLIA Categorization'' 
will be available at http://www.fda.gov/cdrh//ode/guidance/1143.pdf

IV. Comments

    Interested persons may, on or before November 13, 2000, submit to 
Dockets Management Branch (address above) written comments regarding 
this draft guidance document. 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 document and received comments may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: August 1, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20464 Filed 8-11-00; 8:45 am]
BILLING CODE 4160-01-F