[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34086-34087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14092]


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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; 
Request for Information Regarding Specific Issues Related to the Use of 
the Oral Fluid Specimen for Drug Testing

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

ACTION: Request for Information.

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SUMMARY: This document is a request for information regarding specific 
aspects of the regulatory policies and standards that may be applied to 
the Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(oral fluid specimen).

DATES: Comment Close Date: To be assured consideration, comments must 
be received at one of the addresses provided below on or before August 
9, 2011.

ADDRESSES: Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
     Electronically. You may submit electronic comments to 
http://www.regulations.gov. Follow ``Submit a comment'' instructions.
     By regular mail. You may mail written comments to the 
following address only: Substance Abuse and Mental Health Services 
Administration, Attention: Division of Workplace Programs, 1 Choke 
Cherry Road, Room 2-1049, Rockville, MD 20857. Please allow sufficient 
time for mailed comments to be received before the close of the comment 
period.
     By express or overnight mail. You may send written 
comments to the following address only: Substance Abuse and Mental 
Health Services Administration, Attention: Division of Workplace 
Programs, 1 Choke Cherry

[[Page 34087]]

Road, Room 2-1049, Rockville, MD 20850.
     By hand or courier. Alternatively, you may deliver (by 
hand or courier) your written comments only to the following address 
prior to the close of the comment period:
     For delivery in Rockville, MD: Substance Abuse and Mental 
Health Services Administration, Attention: Division of Workplace 
Programs, 1 Choke Cherry Road, Room 2-1049, Rockville, MD 20850. To 
deliver your comments to the Rockville address, call telephone number 
(240) 276-2600 in advance to schedule your delivery with one of our 
staff members. Because access to the interior of the Substance Abuse 
and Mental Health Services Administration Building is not readily 
available to persons without Federal government identification, 
commenters are encouraged to either schedule your drop off or leave 
your comments with the security guard in the main lobby of the 
building.

FOR FURTHER INFORMATION CONTACT: LT Eugene Hayes, Division of Workplace 
Programs, CSAP, SAMHSA, 1 Choke Cherry Road, Room 2-1033, Rockville, 
Maryland 20857, (240) 276-1459 (phone), (240) 276-2610 (Fax), or e-mail 
at [email protected].

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments. Comments received by the 
deadline will also be available for public inspection at the Substance 
Abuse and Mental Health Services Administration, Division of Workplace 
Programs, 1 Choke Cherry Road, Rockville, MD 20850, Monday through 
Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment 
to view public comments, phone (240) 276-1459.
    I. Background: The Department of Health and Human Services (HHS) 
establishes the standards for Federal workplace drug testing programs 
under the authority of Section 503 of Public Law 100-71, 5 U.S.C. 
Section 7301, and Executive Order No. 12564. As required, HHS published 
the Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(Guidelines) in the Federal Register on April 11, 1988 [53 FR 11979]. 
SAMHSA subsequently revised the Guidelines on June 9, 1994 [59 FR 
29908], September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR 
63483], April 13, 2004 [69 FR 19644], and on November 25, 2008 [73 FR 
71858]. If there is an adequate scientific basis, HHS anticipates 
issuing further revisions to the Mandatory Guidelines to address the 
use of oral fluid specimen.
    Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note, 
required the Department to establish scientific and technical 
guidelines and amendments in accordance with Executive Order 12564 and 
to publish Mandatory Guidelines which establish comprehensive standards 
for all aspects of laboratory drug testing and procedures, including 
standards that require the use of the best available technology for 
ensuring the full reliability and accuracy of drug tests and strict 
procedures governing the chain of custody of specimens collected for 
drug testing. These revisions to the Mandatory Guidelines promote and 
establish standards that use the best available technology for ensuring 
the full reliability and accuracy of urine drug tests, while reflecting 
the ongoing process of review and evaluation of legal, scientific, and 
societal concerns.
    SAMHSA's chartered CSAP Drug Testing Advisory Board (DTAB) will be 
the vehicle to provide recommendations for including alternative 
specimens (oral fluid) in the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs. The overall intent of this effort will 
be publication of the proposed revisions to the Mandatory Guidelines in 
the Federal Register for public comment and the development of the 
Final Notice.
    To assist the DTAB, we are soliciting written comments and 
statements from the general public and industry stakeholders regarding 
a variety of issues related to oral fluid specimen drug testing, 
including analytes, cutoffs, specimen validity, collection, collection 
devices, and testing.
    II. Solicitation of Comments: As we develop our initial outline for 
the Mandatory Guidelines, we are seeking additional information that is 
current, scientific, and peer reviewed in reference to oral fluid 
specimen drug testing, specifically on the following questions:
     Analytes/Cutoffs: What analytes should be measured in oral 
fluid for the initial and confirmatory tests? What initial and 
confirmation cutoffs should be used for the oral fluid drug tests? 
Should the oral fluid drug testing panel be expanded to include 
schedule II prescription medications?
     Specimen Validity: Are bio-markers needed to validate the 
oral fluid specimen? Are there appropriate bio-markers or tests for the 
oral fluid specimen that would reveal adulteration, substitution, and/
or dilution?
     Collection: How should an oral fluid specimen be 
collected? For an oral fluid split specimen collection, how should the 
collection of the two specimens be performed? As a donor, would you 
prefer to provide an oral fluid or a urine specimen?
     Collection Devices: What should be the technical 
requirements for an oral fluid specimen collection device?
     Testing: What technologies are available to perform 
initial and confirmatory testing on oral fluid specimens?

    Dated: June 6, 2011.
Elaine Parry,
Director, Office of Management, Technology and Operations.
[FR Doc. 2011-14092 Filed 6-9-11; 8:45 am]
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