[Federal Register Volume 69, Number 2 (Monday, January 5, 2004)]
[Notices]
[Pages 371-372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1990D-0194]


Radioimmunoassay Analysis of Hair to Detect the Presence of Drugs 
of Abuse; Revocation of Compliance Policy Guide 7124.06

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the compliance policy guide (CPG) entitled ``Sec. 370.200 
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse (CPG 
7124.06).'' This CPG no longer reflects current agency policy.

DATES: The revocation is effective January 5, 2004.

ADDRESSES: Submit written requests for single copies of CPG 7124.06 to 
the Division of Compliance Policy (HFC-230), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-827-
0482.
    A copy of the CPG may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD, between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of 
Compliance Policy (HFC-230), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-0411.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the CPG entitled ``Sec. 370.200 RIA Analysis of Hair to 
Detect the Presence of Drugs of Abuse (CPG 7124.06)'' on May 31, 1990. 
The CPG stated that the use of radioimmunoassay (RIA) to analyze hair 
for the presence of drugs of abuse lacked scientific evidence of its 
safety and effectiveness, as defined in 21 CFR 860.7. Accordingly, the 
CPG indicated that approved premarket approval applications (PMAs) were 
necessary before commercially distributing these types of devices.
    Since publication of this CPG, more than 88 scientific articles on 
drugs of abuse testing in hair have been published in the peer-reviewed 
scientific literature. There has been extensive discussion about the 
analytical performance, the clinical parameters, and sources of error 
and testing differences for this technology compared to other 
technologies. FDA has reviewed a number of hair tests and found these 
to be substantially equivalent to predicate devices measuring drugs of 
abuse in other matrices. Given these scientific developments and 
product clearances,

[[Page 372]]

FDA is revoking CPG 7124.06, in its entirety, to eliminate obsolete 
compliance policy.
    Any person who proposes to introduce into commercial distribution 
an in vitro diagnostic device that is intended to test human hair for 
drugs of abuse is required to submit a premarket notification (510(k)) 
to FDA. However, in accordance with Sec.  864.3260 (21 CFR 864.3260), 
over-the-counter test sample collection systems for drugs of abuse 
testing (systems sold for use in nonmedical settings such as insurance, 
workplace, and home) are exempt from the 510(k) submission requirement 
as long as the laboratory test (whether for urine, hair, or other 
matrices) has been cleared or approved by FDA, the laboratory is 
recognized as capable of performing the testing, and the system is 
properly labeled. (See 21 CFR 809.40 and Sec.  864.3260.)

    Dated: December 23, 2003.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-16 Filed 1-2-04; 8:45 am]
BILLING CODE 4160-01-S