[Federal Register Volume 63, Number 219 (Friday, November 13, 1998)]
[Notices]
[Pages 63483-63484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Revisions to the Mandatory Guidelines.

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SUMMARY: On September 30, 1997, the Department of Health and Human 
Services (HHS) published a notice in the Federal Register, 62 FR 51118, 
revising the testing cutoff levels for opiates that were in Mandatory 
Guidelines for Federal Workplace Drug Testing Programs, 59 FR 29916 
(June 9, 1994). The Federal Register notice indicated that May 1, 1998, 
was the effective date for implementing the new opiate testing cutoff 
levels. Subsequent to the publication of that notice, it became clear 
that not all manufacturers of immunoassay test kits would be able to 
provide a sufficient supply of the modified opiate reagents by that 
date, that it would take more time for the certified drug testing 
laboratories to validate the new immunoassay test kits and confirmatory 
test procedures for opiates, and that it would take more time to verify 
the performance of each laboratory using external performance testing 
samples. For these reasons, on February 4, 1998, the Division of 
Workplace Programs sent a letter to all Federal agencies, HHS certified 
and applicant drug testing laboratories, and immunoassay test kit 
manufacturers informing them that the effective date would be delayed 4 
to 6 months beyond the May 1, 1998, effective date published in the 
September 30, 1997, Federal Register notice. This notice establishes a 
new effective date.

EFFECTIVE DATE: December 1, 1998.

FOR FURTHER INFORMATION CONTACT:
Dr. Donna M. Bush, Drug Testing Team Leader, Division of Workplace 
Programs, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, 
Maryland 20857, tel. (301) 443-6014.

SUPPLEMENTARY INFORMATION: The Division of Workplace Programs is 
satisfied that the manufacturers of test kits can provide an adequate 
supply of the modified opiate test kits to the certified laboratories 
by the December 1, 1998, effective date. During June 1998, the 
certified laboratories received a special set of performance testing 
samples from the National Laboratory Certification Program (NLCP) 
contractor to evaluate each laboratory's ability to conduct the initial 
and confirmatory tests at the revised testing levels for opiates. The 
results for this set of samples indicate that all the laboratories were 
able to conduct the initial test using the modified opiate test kits 
provided by the immunoassay test kit manufacturers. Based on this 
information, all the manufacturers were contacted and informed that a 
December 1, 1998, effective date has been selected. There was unanimous 
agreement among the manufacturers that each would be able to provide a 
sufficient number of kits to the laboratories before that date. A 
second set of special performance testing samples will be sent to the 
laboratories in September 1998 to further ensure that all laboratories 
are prepared to test specimens for opiates using the revised testing 
levels.
    The September 30, 1997, Federal Register notice discusses the 
background and summary of public comments regarding the changes to the 
testing cutoff levels of opiates. The Department's responses to those 
comments and the proposed policy have

[[Page 63484]]

not changed. However, to ensure that there is no misunderstanding, the 
changes to the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs published on June 9, 1994 (59 FR 29916) are restated in this 
notice.
    Information Collection Requirements: There are no new paperwork 
requirements subject to the Office of management and Budget approval 
under the Paperwork Reduction Act of 1980.

    Dated: September 21, 1998.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services 
Administration.

    Dated: October 31, 1998.
Donna E. Shalala,
Secretary.

    The following amendments are made to the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs published on June 9, 1994 (59 
FR 29916):

Subpart B

    1. Section 2.4(e)(1), the initial test level for opiate metabolites 
appearing in the table, is amended by changing the value of ``300'' to 
``2,000'' and deleting the footnote that had specified a 25 ng/mL 
testing level if the immunoassay test was specific for free morphine.
    2. Section 2.4(f)(1), the confirmatory test level for morphine 
appearing in the table, is amended by changing the value of ``300'' to 
``2,000.''
    3. Section 2.4(f)(1), the confirmatory test level for codeine 
appearing in the table, is amended by changing the value of ``300'' to 
``2,000.''
    4. Section 2.4(f)(1), the table of confirmatory test levels, is 
amended by adding a new line under opiates to read as follows:

6-Acetylmorphine\4\  10 ng/mL

    \4\ Test for 6-AM when the morphine concentration exceeds 2,000 
ng/mL.

    5. Section 2.4(f)(1), the table of confirmatory test levels, is 
amended by adding a new footnote under the table to read as follows:
[FR Doc. 98-30403 Filed 11-12-98; 8:45 am]
BILLING CODE 4160-20-M