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.

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 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 eugene.hayes@samhsa.hhs.gov.

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?