[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]
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