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Federal Register/Vol. 80, No. 94/Friday, May 15, 2015/Notices 28054 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices DEPARTMENT OF HEALTH AND the security guard front desk located in standards for certification of laboratories HUMAN SERVICES the main lobby of the building. engaged in urine drug testing for federal Comments erroneously mailed to the agencies. These proposed OFMG Substance Abuse and Mental Health address indicated as appropriate for establish standards for certification of Services Administration hand or courier delivery may be delayed laboratories engaged in oral fluid drug and received after the comment period. testing for federal agencies and the use Mandatory Guidelines for Federal FOR FURTHER INFORMATION CONTACT: of oral fluid testing in federal drug-free Workplace Drug Testing Programs Charles LoDico, M.S., DABFT, Division workplace programs. AGENCY: Substance Abuse and Mental of Workplace Programs, Center for Summary of the Major Provisions of the Health Services Administration Substance Abuse Prevention (CSAP), Proposed OFMG (SAMHSA), HHS. SAMHSA mail to: 1 Choke Cherry Road, Room 7–1045, Rockville, MD 20850, The promulgation of the OFMG ACTION: Notice of the mandatory allows federal agencies to collect and guidelines proposed by the Secretary of telephone (240) 276–2600, fax (240) 276–2610, or email at charles.lodico@ test oral fluid specimens in their Health and Human Services. workplace drug testing programs. The samhsa.hhs.gov. SUMMARY: The Department of Health and collection process for oral fluids SUPPLEMENTARY INFORMATION: Human Services (‘‘HHS’’ or provides that the specimen collection ‘‘Department’’) is proposing to establish Executive Summary will be under observation. The OFMG scientific and technical guidelines for enable split specimen testing by This notice of proposed revisions to requiring two specimens to be obtained the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal the Mandatory Guidelines for Federal from the donor, either concurrently or Workplace Drug Testing Programs serially, using separate collection Workplace Drug Testing Programs (Guidelines) will allow federal (Guidelines). devices or a single collection device that executive branch agencies to collect and can be split into two separate DATES: Submit comments on or before test an oral fluid specimen as part of specimens. Unlike the urine Mandatory July 14, 2015. their drug testing programs. In addition, Guidelines for Federal Workplace Drug ADDRESSES: In commenting, please refer some agencies, such as the Department Testing Programs (UrMG), Instrumented to file code SAMHSA–2015–2. Because of Transportation, are required to follow Initial Test Facilities are not practical of staff and resource limitations, these guidelines in developing drug and will not be allowed due primarily SAMHSA cannot accept comments by testing programs for their regulated to the limited sample volume of oral facsimile (FAX) transmission. industries, whereas others, such as the fluid collected from the donor. With the You may submit comments in one of Nuclear Regulatory Commission (NRC), exception of 6-acetylmorphine, a four ways (please choose only one of the use the guidelines as part of the metabolite of heroin, and ways listed): regulatory basis for their federal drug benzoylecgonine, a metabolite of • Electronically. You may submit testing programs. These proposed cocaine, the analytes detected in oral electronic comments on this regulation Mandatory Guidelines for Federal fluids are primarily parent compounds. to http://www.regulations.gov. Follow Workplace Drug Testing Programs using The OFMG analyte cutoffs are much ‘‘Submit a comment’’ instructions. Oral Fluid (OFMG) establish standards lower than those specified for urine in • By regular mail. You may mail and technical requirements for oral fluid the UrMG because drug analyte written comments to the following collection devices, initial oral fluid drug concentrations in oral fluid are much address ONLY: SAMHSA, Attention test analytes and methods, confirmatory lower than urine concentrations. The Division of Workplace Programs (DWP), oral fluid drug test analytes and Department is proposing that all 1 Choke Cherry Rd., Room 7–1045, methods, processes for review by a specimens be tested for either albumin Rockville, MD 20850. Please allow Medical Review Officer (MRO), and or Immunoglobulin G (IgG) to determine sufficient time for mailed comments to requirements for federal agency actions. whether the specimen is valid. In the be received before the close of the These Guidelines provide flexibility event that an individual is unable to comment period. for federal agency workplace drug provide an oral fluid specimen, the • By express or overnight mail. You testing programs to address testing federal agency may authorize the may send written comments to the needs and remove the requirement to collection of a urine specimen. With the following address ONLY: SAMHSA, collect only a urine specimen, which inclusion of oral fluid testing in federal Attention DWP, 1 Choke Cherry Rd., has existed since the Guidelines were agency workplace programs, medical Room 7–1045, Rockville, MD 20850. first published in 1988. Federal review of drug test results will become • By hand or courier. Alternatively, agencies, MROs, and regulated more complex. The MRO must interpret you may deliver (by hand or courier) industries using these Guidelines will laboratory reported drug test results for your written comments ONLY to the continue to adhere to all other federal both urine and oral fluid specimens. To following address prior to the close of standards established for workplace ensure that MROs remain up-to-date on the comment period: SAMHSA, drug testing programs. These proposed drug testing issues, pharmacological and Attention DWP, 1 Choke Cherry Rd., OFMG provide the same scientific and toxicological information, and federal Room 7–1045, Rockville, MD 20850. If forensic supportability of drug test agency rules and regulations, the OFMG you intend to deliver your comments to results as the Mandatory Guidelines for require MRO requalification training the Rockville address, call telephone Federal Workplace Drug Testing and reexamination on a regular basis number (240) 276–2600 in advance to Programs using Urine (URMG). (i.e., every five years). schedule your arrival with one of our The Department of Health and Human staff members. Because access to the Services, by authority of Section 503 of Costs and Benefits interior of the SAMHSA building is not Public Law 100–71, 5 U.S.C. Section Using data obtained from the Federal readily available to persons without 7301, and Executive Order No. 12564, Workplace Drug Testing Programs and federal government identification, establishes the scientific and technical HHS certified laboratories, the commenters are encouraged to schedule guidelines for federal workplace drug Department estimates the number of their delivery or to leave comments with testing programs and establishes specimens tested annually for federal VerDate Sep<11>2014 19:14 May 14, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\15MYN2.SGM 15MYN2 mstockstill on DSK4VPTVN1PROD with NOTICES2 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices 28055 agencies to be 150,000. HHS projects costs for the Department to process the Since oral fluid collection does not have that approximately 7% (or 10,500) of the application are $7,200. The initial the same privacy concerns as urine 150,000 specimens tested per year will certification process includes the collection, onsite collections are likely, be oral fluid specimens and 93% (or requirement to demonstrate that their thereby reducing the time a donor is 139,500) will be urine specimens. The performance meets Guidelines away from the worksite. The approximate annual numbers of requirements by testing three (3) groups Department estimates the time savings regulated specimens for the Department of PT samples. The Department will to be between 1 and 3 hours. The of Transportation (DOT) and Nuclear provide the three groups of PT samples Department believes the cost reduction Regulatory Commission (NRC) are 6 through the NLCP at no cost. Based on as outlined in this Preamble will benefit million and 200,000, respectively. costs charged for urine specimen the federal agencies and drug free Should DOT and NRC allow oral fluid testing, laboratory costs to conduct the workplace program. testing in regulated industries’ PT testing would range from $900 to Inspection of Public Comments: All workplace programs, the estimated $1,800 for each applicant laboratory. comments received before the close of annual numbers of specimens for DOT The following estimated costs are the comment period are available for would be 180,000 oral fluid and based on current costs for urine testing. viewing by the public. Please note that 5,820,000 urine, and numbers of Once oral fluid testing has been all comments are posted in their entirety specimens for NRC would be 14,000 implemented, the cost per specimen for including personal or confidential oral fluid and 186,000 urine. each initial test will range from $.06 to business information that is included in In Section 3.4, the Department is $0.20, due to reagent costs. Estimated a comment. SAMHSA will post all proposing criteria for calibrating initial costs for each confirmatory test range comments before the close of the tests for grouped analytes such as from $5.00 to $10.00 for each specimen comment period on the following
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