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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

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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 Web opiates and amphetamines, and reported as positive, due to costs of site as soon as possible after they have specifying the cross-reactivity of the sample preparation and analysis. Based been received: http:// immunoassay to the other analytes(s) on information from non-regulated www.regulations.gov. Follow the search within the group. These proposed workplace drug testing, approximately instructions on that Web site to view Guidelines allow the use of methods 1% of the submitted specimens is public comments. Comments received other than immunoassay for initial expected to be confirmed as positive for before the close of the comment period testing. In addition, these proposed one or more of the following analytes: will also be available for public Guidelines include an alternative for Oxycodone, oxymorphone, inspection as they are received, laboratories to continue to use existing hydrocodone, and/or hydromorphone. generally beginning approximately three FDA-cleared immunoassays which do Therefore, the added cost for weeks after publication of a document, not have the specified cross-reactivity, confirmatory testing will be $0.05 to at the Substance Abuse and Mental by establishing a decision point with the $0.10 per submitted specimen. This Health Services Administration, lowest-reacting analyte. An would indicate that the total cost per immunoassay manufacturer may incur specimen submitted for testing will Division of Workplace Programs, 1 costs if they choose to alter their increase by $0.11–$0.30. These costs for Choke Cherry RD., Rockville, MD, existing product and resubmit the the laboratories or federal agencies 20850, Monday through Friday of each immunoassay for FDA clearance. choosing to use oral fluid in their drug week from 8:30 a.m. to 4:00 p.m. To Costs associated with the addition of testing programs will be incorporated schedule an appointment to view public oral fluid testing and testing for into the overall testing cost for the comments, call (240) 276–2600. oxycodone, oxymorphone, hydrocodone federal agency submitting the specimen Background and hydromorphone will be minimal to the laboratory. Agencies choosing to based on information from some HHS use oral fluid in their drug testing The Department of Health and Human certified laboratories currently testing programs may also incur some costs for Services (HHS) by the authority of non-regulated oral fluid specimens. training of federal employees such as Section 503 of Public Law 100–71, 5 Likewise, there will be minimal costs drug program coordinators. U.S.C. Section 7301, and Executive associated with changing initial testing Based on current figures, Order No. 12564 has established the to include methylenedioxyamphetamine approximately 7% (or 10,500) of the scientific and technical guidelines for (MDA) and 150,000 specimens tested per year for federal workplace drug testing programs methylenedioxyethylamphetamine HHS will be oral fluid, 180,000 oral and established standards for (MDEA) since current immunoassays fluid specimens for DOT, and 14,000 certification of laboratories engaged in can be adapted to test for these analytes. oral fluid specimens for NRC. urine drug testing for federal agencies. Prior to being allowed to test regulated The federal agencies choosing to use As required, HHS originally published oral fluid specimens, laboratories must oral fluid in their drug testing program the Mandatory Guidelines for Federal be certified by the Department through may see many benefits including a Workplace Drug Testing Programs the National Laboratory Certification reduction in time of the collection (Guidelines) in the Federal Register Program (NLCP). Laboratories choosing process; an observed collection method [FR] on April 11, 1988 [53 FR 11979]. to apply for HHS certification will incur leading to reductions in rejected, The Substance Abuse and Mental some administrative costs associated invalid, substituted, and adulterated Health Services Administration with adding the matrix and these specimens; and an effective tool in post- (SAMHSA) subsequently revised the analytes. However, laboratories accident testing identifying the parent Guidelines on June 9, 1994 [59 FR performing urine and oral fluid drug or active drug. Productivity for federal 29908], September 30, 1997 [62 FR testing have trained personnel, drug agencies related to the drug free 51118], November 13, 1998 [63 FR testing methods, and the infrastructure workplace program is expected to 63483], April 13, 2004 [69 FR 19644], (e.g., secured facilities, computer improve. For example, administrative and November 25, 2008 [73 FR 71858] systems, and electronic reporting data indicates it takes, on average, about with an effective date of May 1, 2010 methods) in place. Estimated laboratory 4 hours from the start of the notification (correct effective date published on costs to complete and submit the of the drug test to the actual time a December 10, 2008; [73 FR 75122]). The application are $2,000, and estimated donor reports back to the worksite. effective date of the Guidelines was

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further changed to October 1, 2010 on supplemental information and informal policy concerns about the use of the April 30, 2010 [75 FR 22809]. comments to improve the draft and alternative specimens. As a result of the further SAMHSA’s knowledge base. internal review, the Department issued History and Proposed Changes to the Twenty-eight separate comments were a Final Notice of Revisions to the HHS Mandatory Guidelines for Federal submitted. All comments were Mandatory Guidelines for Federal Workplace Drug Testing Programs summarized, incorporated into the draft Workplace Drug Testing Programs in A focus of the HHS mission is to Guidelines and presented at the next November of 2008 [73 FR 71858] that maintain the integrity and ensure the DTAB meeting held in September 2000. concluded the scientific, technical, and quality of federal drug-free workplace At that DTAB meeting, a second legal information for the testing of programs by a commitment to identify working (revised) draft of the Guidelines alternative specimens (oral fluid, hair, and mandate the use of the most was presented and, again, comments and sweat) was insufficient to include accurate, reliable drug tests and were requested from all interested these specimens in the federal programs methods available. To accomplish that parties. At the December 2000 DTAB at that time. However, the Department goal, the Department has implemented meeting, the public comments committed to monitoring developments an ongoing scientific review and submitted were used to prepare the in alternative specimen testing and has program collaboration with federal third working draft of the Guidelines. continued to do so since 2008. regulators, researchers, the drug testing Concurrently, SAMHSA organized three The complexity of responses to the industry, and public and private sector expert groups [Oral Fluid, Hair, and 2004 notice made it clear that if the employers. As the use of alternative Sweat] that included members from Department were to subsequently specimens (other than urine), analytical science and industry. authorize alternative specimens for the test technologies, and types of To assess laboratory performance and Mandatory Guidelines for Federal commercial workplace drug testing utility of alternative specimen testing Workplace Drug Testing Programs, each products have increased over the past for use in federal workplace programs, specimen matrix would need a separate decade in the private sector, the the Department initiated a voluntary set of guidelines. Additionally, the Department, through SAMHSA’s Drug pilot proficiency testing (PT) program. Department proposed to stagger the Testing Advisory Board (DTAB), has This pilot program provides PT timeline for the review and potential responded by review of these new samples, developed and prepared at incorporation of alternative specimens, products and began a dedicated government expense, to a number of and to begin with oral fluid. The assessment of drug testing using laboratories for testing. Participating decision to begin with oral fluid was alternative specimens, such as oral fluid laboratories used their routine supported by fewer legal and policy (saliva), hair and sweat for possible procedures to test oral fluid, hair and concerns, and current peer-reviewed application in federal agency workplace sweat specimens and shared their PT literature that existed with oral fluid. testing programs. results with SAMHSA. This pilot PT Methods developed since 2004 offer The following OFMG are the result of program was established for two enhanced analytical sensitivity and a directed Departmental assessment that reasons. The first was to determine if it specificity for testing drugs in oral fluid. began in 1997 with a 3-day scientific was possible to prepare stable and The scientific literature base for oral meeting of the DTAB. During that accurate PT samples for the proposed fluid testing and interpretation of results meeting, the DTAB members discussed specimen type that could be used in a has grown substantially. Many non- drug testing using alternative specimens laboratory certification program. regulated private sector organizations and the use of new and developing drug Second, the PT results reported by the have incorporated oral fluid testing into testing technologies that could be laboratories could be used to help their workplace programs. Also, during applicable to workplace drug testing establish criteria for the analysis of this period, SAMHSA funded a review programs. The DTAB meeting was open alternative specimens. of a Medical Review Officer (MRO) to the public. Following the initial Based on data obtained from the pilot database of laboratory-reported results meeting, members of the DTAB PT program, it appeared that valid PT for urine and alternative specimens continued to review and analyze all samples could be prepared but from both regulated and non-regulated available information on alternative refinement was needed. The results in workplaces. The study showed a specimens and testing technologies. the pilot PT program were encouraging, dramatic increase in the use of oral fluid These efforts resulted in identifying and both individual laboratory and testing from 2003 to 2009. specific scientific, administrative, and collective performance improved over At the open session of the January procedural requirements necessary for a time; however, there remained some 2011 DTAB meeting, SAMHSA shared comprehensive federal workplace drug concern about the performance with DTAB and the public the most testing program that included differences among the participating current information on the oral fluid alternative specimens and technologies. laboratories, and the applicability of specimen. During the meeting, experts For more than 15 years, the DTAB has some testing technologies used by the made scientific presentations continued to evaluate the science and laboratories. By 2004, the working concerning oral fluid as a specimen for information submitted by industry groups reached consensus and proposed workplace drug testing, including: representatives on alternative specimens standards for laboratory-based oral Physiological composition of oral fluid, and technologies. The following section fluid, hair, and sweat testing tested drugs and cutoffs, collection presents a chronology of meetings and procedures. devices, and best practices laboratory events leading to these proposed In April 2004, the Department issued methodologies (initial and confirmatory Guidelines for the testing of oral fluid. a Federal Register notice [69 FR 19673] testing). At approximately the same The first working draft of new on the proposed inclusion of oral fluid, time, SAMHSA entered into an guidelines, including the testing of hair, and sweat specimens in federal Interagency Agreement (IAA) with the alternative specimens, was presented at workplace drug testing programs. Public Office of National Drug Control Policy the June 2000 DTAB meeting. These comments and issues raised by federal (ONDCP) and received funding to initial, ‘‘work-in-progress’’ guidelines agencies during the internal review of update and expand the laboratory were placed on the SAMHSA Web site the proposed changes identified standards for federal forensic drug and the public was invited to submit significant scientific, legal, and public testing. The overall goal of this IAA was

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to determine the state of the science for the DTAB recommendations from the What is the mechanism of drug oral fluid collection, testing, and July 2011 meeting. disposition in oral fluid? interpretation, to support the The DTAB recommendations, the Drugs enter oral fluid primarily by development of these proposed results from the SAMHSA-funded PT diffusion from blood and from active Guidelines to include the use of the oral program, and the private sector drug use by oral, transmucosal, smoked, fluid specimen. Additionally, the IAA experience have led the Department to inhaled, and insufflated routes. Oral required researching additional drugs of conclude that oral fluid should be cavity tissues have a rich blood supply. abuse that warranted addition to the included in the federal program as an The movement of drugs from blood existing urine specimen analyte panel. alternative specimen. (plasma) to oral fluid depends upon This included investigation of certain physicochemical properties of prescription drugs with high abuse and Rationale for the Inclusion of Oral the drug. The primary restricting factors impairment potential. Fluid in the Mandatory Guidelines for are drug lipophilicity, degree of Subsequent to the IAA and the Federal Workplace Drug Testing ionization, and the degree of drug January 2011 DTAB meeting, several Programs binding with plasma proteins.34 Lipid- working group meetings were held to soluble molecules pass through cell The scientific basis for use of oral discuss the oral fluid science and membranes more efficiently than those fluid as an alternative specimen for drug develop proposed Guidelines using oral that are more water soluble (e.g., drug testing has been broadly established.1–12 fluid specimens. Working group metabolites). Consequently, parent members included federal partners, Corresponding developments have (unmetabolized) drug is frequently the subject matter experts, industry leaders, proceeded in analytical technologies predominant analyte identified in oral stakeholders, and representatives from that provide the needed sensitivity and fluid. Biological membranes are not the National Laboratory Certification accuracy for testing oral fluid permeable to the drug fraction that is 13–28 Program (NLCP). specimens. bound to plasma proteins or to drug that In June 2011, SAMHSA solicited Oral fluid and urine test results have is in the ionized state; hence only free, comments regarding the science and been shown to be substantially similar, non-protein bound and non-ionized practice of oral fluid testing via a and oral fluid may have some inherent drug in plasma can diffuse into saliva. Request for Information (RFI) [76 FR advantages as a drug test specimen. Oral Consequently, oral fluid drug 34086]. The notice requested written fluid collection will occur under concentrations are closely related to the opinions from the public and industry observation, which should substantially free, unbound drug in blood (plasma). stakeholders regarding a variety of For those drugs that are weak bases (e.g., issues related to oral fluid testing, lessen the risk of specimen substitution cocaine, opioids, amphetamines, and including potential analytes, cutoff and adulteration and, unlike direct phencyclidine), concentrations in oral concentrations, specimen validity, observed urine collections, the collector fluid frequently are higher than plasma specimen collection, collection devices, need not be the same gender as the concentrations as a result of ‘‘ion- testing methods and interpretation of donor. trapping’’ due to oral fluid’s higher analytical results. The RFI was an effort What is oral fluid? acidity relative to plasma. Despite these to give the public and industry restrictions, drug transfer from blood to stakeholders an additional opportunity Oral fluid is the physiological fluid oral fluid is a rapid process as to provide information and comments that can be collected from the oral demonstrated by consistent positive for consideration during the cavity of the mouth. Oral fluid is tests for drug in oral fluid two to five development of the draft Guidelines for comprised primarily of saliva produced minutes following an intravenous oral fluid testing. The Department by the submandibular, sublingual, and injection of heroin 35 or cocaine.36 The received 18 comments from drug testing parotid glands.29 Other sources that correlations of drug concentrations in laboratories, MROs, oral fluid collection contribute to the composition of oral oral fluid to those in plasma vary device manufacturers, drug testing fluid are minor salivary glands, gingival substantially from drug to drug.4 industry associations, and the public crevicular fluid (fluid from between the Deposition of drugs in oral fluid can [available at www.regulation.gov (docket gums and teeth), cellular debris, also occur from external sources. For SAMHSA–2011–0001)]. All submitted bacteria, and food residues.30 The major example, drugs in food sources (e.g., comments were reviewed and were constituent of oral fluid is water. Other morphine in poppy seeds) are a presented to the DTAB members for components include electrolytes such as potential source of contamination.37 consideration during SAMHSA’s potassium, sodium, chloride, Drug residues can initially be deposited continuing assessment of oral fluid as bicarbonates and phosphates, and in high concentration in oral fluid an alternative specimen. organic substances such as enzymes, during active drug administration by At the July 2011 meeting of the DTAB, 31 immunoglobulins, and mucins. The oral, transmucosal, smoked, inhaled, Board members voted unanimously for composition of oral fluid is dynamic and insufflated routes.13536 Generally, the following: and varies with the rate of saliva deposited drug residues disappear fairly (1) Based on review of the science, DTAB production (flow rate). The pH of saliva rapidly because of inherent self- recommends that SAMHSA include oral is generally acidic, but may range from cleansing mechanisms of the oral cavity fluid as an alternative specimen in the 6.0 to 7.8, depending upon the rate of (e.g., saliva production and subsequent Mandatory Guidelines for Federal Workplace saliva flow. As saliva flow increases, Drug Testing Programs; and (2) DTAB swallowing). recommends the inclusion of additional levels of bicarbonate increase, thus Detection times are influenced by Schedule II prescription medications (e.g., increasing pH.32 The volume of saliva many pharmacological and chemical oxycodone, oxymorphone, hydrocodone and produced by individuals varies factors associated with the drug, dose, hydromorphone) in the Mandatory considerably from approximately 500 to route of administration, frequency of Guidelines for Federal Workplace Drug 1500 mL per day. The total volume of drug use, biology of the individual, Testing Programs. oral fluid in the mouth after swallowing specimen type, and the sensitivity of the At the January 2012 DTAB meeting, averages about 0.9 mL for adult males detection system. In general, detection the SAMHSA Administrator received and 0.8 mL for adult females.33 times in oral fluid are somewhat shorter

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than observed for urine. In oral fluid, spectrometric procedures. The authors percent) was for marijuana, with 20 of drugs of abuse are detected for 5 to 48 evaluated two subsets of data related to the 23 discordant specimens negative by hours after use, whereas in urine, the federal workplace drug testing: 263 oral fluid and positive by urine testing. detection time is 1.5 to 4 days or longer comparisons of currently tested drugs Two studies reported almost identical with chronic drug use.11 38 However, as (i.e., morphine, codeine, cannabinoids, rates of recent cocaine and opiate use described below, positivity rates for oral cocaine, amphetamine, and from either type of test, but oral fluid fluid reported for non-regulated methamphetamine) and 491 was less effective in detection of workplace testing are the same as or comparisons that included these drugs marijuana users than urinalysis.43 45 higher than urine positivity rates. These plus hydrocodone and oxycodone. For rates demonstrate the equivalency of the first data set, 92.4 percent of the oral How were analytes and cutoffs selected? these specimen types in identifying fluid and urine specimens had the same drug use, despite differences in drug results (i.e., positive/positive or The selection of analytes for testing detection times. negative/negative). For the second data was based on known drug disposition set (which included hydrocodone and patterns in oral fluid. Some drug How do testing positivity rates compare oxycodone test results), 89.2 percent of disposition patterns in oral fluid are between oral fluid and urine? the specimens had the same results (i.e., similar to urine and others differ in In the absence of paired specimen positive/positive or negative/negative). relative amounts of parent drug versus collections (i.e., urine and oral fluid Statistically, both data sets exhibited metabolite and in type of metabolite. from the same donor) in workplaces, the substantial agreement in results between The mechanisms of drug excretion in positivity rates of urine and oral fluid oral fluid and urine. The overall result oral fluid are somewhat different than in tests can be used to infer the relative discordance for the current drugs was urine. In some cases, direct deposition effectiveness of these two specimen 5.5%, of which 2.5% were positive in of parent drug in oral fluid may occur types. oral fluid and negative in urine, and 3% by oral, snorted (insufflated), The workplace positivity rates for were negative in oral fluid and positive transmucosal, inhaled, and smoked drugs in oral fluid appear to be in urine. For hydrocodone, 9 (7.9%) routes of administration. When this generally comparable to corresponding analyte results were positive in oral occurs, the metabolites generally appear rates reported for urine. The 2013 Drug fluid and negative in urine, while only later in oral fluid. For some drugs (e.g., Testing Index (DTI) by Quest 1 (0.09%) analyte result was negative in cocaine and heroin), it appears that Diagnostics for drugs in the general oral fluid and positive in urine. For 35 36 workforce indicated positivity rates for direct hydrolysis may also occur. oxycodone, 9 (7.9%) analyte results The primary means of entry into oral oral fluid as 0.59 percent amphetamines were positive in oral fluid and negative (combined percentages of amphetamine fluid for most drugs (and metabolites) is in urine, and 14 (12.3%) analyte results by passive diffusion of un-ionized, non- and methamphetamine), 0.31 percent were negative in oral fluid and positive protein bound fraction of drug from cocaine, 4.0 percent marijuana, 0.88 in urine. Differences in time courses of plasma. Diffusion into oral fluid occurs percent opiates, and 0.02 percent PCP drugs and metabolites in these matrices more readily for lipophilic drugs than and, for urine, as 0.87 percent may explain the discordant results. amphetamines, 0.21 percent cocaine, 2.0 Another study compared positivity for water-soluble metabolites. As a percent marijuana, 0.44 percent opiates rates from paired specimens from 45 result of these mechanisms, parent and 0.01 percent PCP.39 The overall subjects (164 paired sets of specimens) (unmetabolized) drug is frequently the drug positivity rate for oral fluid was 5.5 of treatment patients stabilized on either primary analyte present in oral fluid. percent compared to 4.1 percent for methadone or buprenorphine.42 Aside Urinary excretion occurs more readily urine. An earlier study of 77,218 oral from methadone or buprenorphine, 595 for water-soluble metabolites; lipid- fluid specimens reported similar trends (21.1 percent) drug analytes were soluble drugs are frequently re-absorbed in the positive prevalence rates positive and 1948 (69.0 percent) were back into blood during urinary compared to the DTI for urine negative for both specimens for an excretion. specimens collected during the same overall agreement of 90 percent. There The route of administration period.40 In that study, the overall were 82 (2.9 percent) analyte results that influences the time course of both drug combined positivity rate for oral fluid were positive in oral fluid and negative and metabolites in oral fluid.46 Orally was 5.06 percent compared to 4.46 in urine, and 199 (7.0 percent) that were administered drugs generally undergo percent for urine. Both sets of data negative in oral fluid and positive in compared positivity rates in two some degree of metabolism in the urine, for an overall disagreement of 10 gastrointestinal tract and liver prior to separate workplace populations over a percent. Morphine was found more entering the bloodstream, whereas comparable time period. The higher often in urine (n=66) than in oral fluid injected and smoked drugs are absorbed positivity rates for oral fluid are most (n=48), whereas 6-acetylmorphine was primarily intact without metabolite likely due to the fact that oral fluid found more often in oral fluid (n=48) collections are performed under than in urine (n=20). Amphetamine and formation. Once drugs (and metabolites) observation, reducing the ability of methamphetamine were found slightly enter the bloodstream, they rapidly donors to substitute or adulterate the more often in oral fluid than in urine. diffuse into oral fluid by excretion from specimen. Benzodiazepines and cannabis were highly blood-perfused salivary glands. Only limited studies have compared found more frequently in urine. Consequently, oral fluid tests generally positivity rates from ‘‘paired’’ specimen Several studies have been reported are positive for parent drug as soon as collections in the same population. A comparing oral fluid testing to the drug is absorbed into the body. clinical study involving compliance urinalysis for individuals under Additional information on analyte monitoring of pain patients compared criminal justice supervision.43–45 In one selection for each drug is provided test results for oral fluid to urine study, the agreement rates between an below in Subpart C, Oral Fluid specimens collected in ‘‘near oral fluid initial test result and Specimen Tests. In contrast, urine tests simultaneous fashion.’’ 41 The confirmed urine test for 223 that are based solely on detection of a specimens were analyzed for 42 drugs probationers ranged from 90 to 99 metabolite are dependent upon the rate and/or metabolites by mass percent.44 The lowest agreement rate (90 and extent of metabolite formation.

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Will there be specimen validity tests for acceptable and scientifically sound. drugs and/or drug metabolites in the oral fluid? Because OF specimen collections are oral fluid specimen, the Department In regard to specimen validity testing observed and because oral fluid may be recommends that the device collected using a device in which the performance characteristics are such for oral fluid, the Department ≥ considered measuring various oral fluid specimen is diluted by a buffer, a that there is 90 percent recovery (but components (e.g., amylase, albumin, laboratory cannot definitively state that no more than 120 percent) of drug and/ and immunoglobulins such as IgG). a specimen has been substituted. (The or drug metabolite in the undiluted Given that collection of oral fluid collector or MRO may report a refusal to (neat) oral fluid at (or near) the initial specimens will occur under observation, test as described in Section 1.7 of the test cutoff concentration. The OFMG.) As noted in Section 13.5 of the established upper range is to minimize the Department did not find sufficient OFMG, when an OF test is reported as a collection device concentrating the justification for extensive validity Invalid and the donor has no legitimate specimen on the collection pad and/or testing to identify attempts to adulterate explanation for the Invalid result, the the device. Numerous studies of or substitute specimens. However, both MRO directs the agency to collect stability and recovery of drugs from IgG and albumin in oral fluid are another specimen. The agency may commercial oral fluid collection devices currently being used in the industry to decide the type of specimen for the indicate wide variability in performance identify specimen collections in which recollection. characteristics.52–57 The recommended insufficient oral fluid was collected. The limits of ≥90 percent but no more than Department is proposing that all oral How will oral fluid be collected? 120 percent recovery ensure fluid specimens be tested for one of The Department recognizes that concentration accuracy (within these components, but specifically methods for collection of oral fluid experimental limits), prevent potential requests public comment on requiring specimens vary by manufacturers of concentration of drug and/or metabolite these tests. devices and that new, innovative by the device, and ensure consistency in Review of the literature for methods may be developed that offer specimen collections using different concentrations of albumin in oral fluid improvements over existing methods. collection devices. found that healthy subjects were Two basic types of collection devices The Department notes that these characterized by concentrations ranging currently exist: One is designed to collection devices are subject to 47 from 2.6–23.8 mg/dL and in patients collect undiluted (neat) oral fluid by clearance by the FDA. The Department 48 49 with cancer and renal failure, the expectoration; the second type makes requests comments on whether HHS albumin concentrations ranged from use of an absorbent pad that is inserted should publish a list of FDA-cleared 1.0–12.2 mg/dL. These data support into the oral cavity for specimen oral fluid collection devices. using the industry cutoff of 0.6 mg/dL collection and then placed in a tube as a decision point for albumin in oral containing a diluent. The Department is What are the collection procedures? fluid. recommending that all collection The Department is recommending Literature concerning the devices maintain the integrity of the that a split specimen be collected either concentrations of IgG in oral fluid found specimen during collection, storage and (1) as two specimens collected that only predentate babies exhibited transport to the laboratory for testing. simultaneously or serially with two IgG concentrations below 1 mg/L.50 All devices must have an indicator that separate collection devices, or (2) Adults with and without teeth had a demonstrates the adequacy of the collected with a collection device that concentration mean of 19 mg/L. The volume of collected specimen; have a subdivides the specimen into two mean for elderly adults with teeth was sealable, non-leaking container; and separate collection tubes. If collected 24 mg/L and the mean for edentate have components that ensure pre- serially, collection of the second elderly adults was 5.2 mg/L. Young analytical drug and drug metabolite specimen must begin within two healthy adults under various exercise stability; and the device components minutes after the completion of the first routines had IgG concentrations means must not substantially affect the collection. The Department believes this ranging from 5 mg/L to greater than 40 composition of drugs and drug allows sufficient time for the collector to mg/L.51 These data support using the metabolites in the oral fluid specimen. begin the second specimen collection in industry cutoff of 0.5 mg/L as a decision a timely manner, to minimize What are the performance requirements point for IgG in oral fluid. differences in oral fluid collected using for a collection device? To avoid prohibiting other oral fluid two separate collection devices. Oral specimen validity tests that may become The Department proposes that a fluid test results for delta-9- available, the Department is also collection device should collect either a tetrahydrocannabinol (THC) in authorizing additional specimen minimum of 1 mL of undiluted (neat) simultaneously collected specimens validity testing as described in Section oral fluid or, for those collection devices with an absorbent pad have been 3.1.d and Section 3.5. containing a diluent (or other reported to be highly correlated.58 The Department maintains that component, process, or method that In addition, the Omnibus allowing tests for biomarkers other than modifies the volume of the specimen), Transportation Employee Testing Act albumin and IgG can be useful. The that the volume of oral fluid collected (OTETA), which governs the DOT- draft OFMG requirements are analogous should be within 0.1 mL of the target regulated testing programs as well as the to the current urine drug testing volume and the volume of diluent in the Federal Aviation Administration’s requirements in that laboratories must device should be within 0.05 mL of the federal employee testing program, perform specified specimen validity diluent target volume. The Department requires that collected specimens must tests on all specimens and may perform recommends that the device maintain be able to be subdivided, to allow for additional specimen validity tests for stability of drug and/or drug metabolite additional testing upon request of the other measurands. The Department does in the oral fluid specimen allowing ≥90 employee. not want to limit the testing to albumin percent recovery for one week at room Therefore, the Department requests and IgG, because other tests or temperature (18–25 °C). To ensure that comments on whether serial or biomarkers may be identified for use. collection device components do not simultaneous collection using two The tests must be forensically substantially affect the composition of collection devices constitutes a split

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collection, and recommendations for the requirements described in the covered by the Guidelines, who is any other oral fluid collection processes Guidelines. These activities include, but responsible for the development and that enable subdividing the collected are not limited to, reviewing inspection implementation of the Guidelines, how specimen. reports submitted by inspectors, a federal agency requests a change from reviewing PT results submitted by these Guidelines and how these What new drugs are being included? laboratories, preparing inspection and Guidelines are revised. Since the late 1980’s, multiple PT result reports, and making In section 1.5, where terms are recommendations have been made that recommendations to the Department defined, the Department proposes to additional drugs be considered for regarding certification or suspension/ add terms that apply specifically to oral inclusion in workplace drug testing. revocation of laboratories’ certification. fluid (e.g., collection device, oral fluid These recommendations resulted in the It is important to note that, although a specimen). Ecstasy-related drugs— contractor gathers and evaluates Sections 1.6, 1.7, and 1.8 contain the methylenedioxymethamphetamine information provided by the inspectors same policies as described in the (MDMA), methylenedioxyamphetamine or laboratories, all final decisions current UrMG with regard to what an (MDA), and regarding laboratory certification, agency is required to do to protect methylenedioxyethylamphetamine suspension or revocation of certification employee records, the conditions that (MDEA)—being included for testing in are made by the Secretary. constitute refusal to take a federally 2008. The 2012 National Survey on In addition, a contractor has regulated drug test, and the Drug Use and Health (NSDUH) historically collected certain fees from consequences of a refusal to take a indicated that past month illicit drug the laboratories for services related to federally regulated drug test. use of psychotherapeutics was second the certification process, specifically for only to marijuana in prevalence among laboratory application and inspection Subpart B—Oral Fluid Specimen persons aged 12 or older in the United and PT activities for laboratories In section 2.1, the Department States. Prescription psychotherapeutics applying to become HHS-certified, and proposes to expand the drug-testing include pain relievers, tranquilizers, for inspection and PT activities for program for federal agencies to permit stimulants, and sedatives.59 The abuse laboratories maintaining HHS the use of oral fluid specimens. There is of narcotic pain relievers has become a certification. All fees collected by a no requirement for federal agencies to serious and growing public health contractor are applied to its costs under use oral fluid as part of their program. concern. the contract. A federal agency may choose to use Like heroin, many are derived from This same process, used since the urine, oral fluid, or both specimen types opium, but are synthetic analogs. inception of the laboratory certification in their drug testing program. However, Oxycodone and hydrocodone top the program, will also be used by an HHS any agency choosing to use oral fluid is list of narcotic pain relievers causing contractor to collect similar fees from required to follow the OFMG. For visits to hospital emergency laboratories that seek, achieve, and example, an agency program can departments due to non-medical use,60 continue HHS certification to test oral randomly assign individuals to either and are among the top 10 drugs seized fluid. The Department also contributes urine or OF testing, for random or pre- in law enforcement operations and sent funds to this contract for purposes not employment testing. This would not to federal, state, and municipal forensic directly related to laboratory only help reduce subversion, but would laboratories, ranking second and third of certification activities, such as allow comparison of urine and OF prescription drugs on the list.61 Because evaluating technologies and instruments testing outcomes for planning purposes. of the prevalence of their abuse, and providing an assessment of their Section 2.2 describes the hydrocodone and oxycodone have been potential applicability to workplace circumstances under which an oral fluid included in these proposed OFMG. drug testing programs. specimen may be collected. The Hydrocodone is metabolized in the Department has included this section to body to hydromorphone and excreted in Organization of Proposed Guidelines ensure that the circumstances described biological fluids.62 Hydromorphone is This preamble describes the are consistent with the reasons for also available commercially as an differences between the Mandatory collecting a specimen as listed on the analgesic, is more potent than Guidelines for Federal Workplace Drug Federal Custody and Control Form hydrocodone, and exhibits significant Testing Programs using Urine (Federal CCF). The Department will abuse liability. Oxycodone is Specimens (UrMG) and the proposed review comments on the reasons that metabolized in the body to Mandatory Guidelines for Federal are appropriate for oral fluid testing. oxymorphone and excreted in biological Workplace Drug Testing Programs using Section 2.3 describes how each oral fluids.63 Oxymorphone is also available Oral Fluid Specimens (OFMG), and fluid specimen is collected for testing. commercially as an analgesic, is more provides the rationale for the The Department is seeking comment on potent than oxycodone, and exhibits differences. In addition, the Preamble whether the described procedures are significant abuse liability. For these presents a number of the remaining consistent with the established reasons, hydromorphone and issues raised during the development of requirement for all specimens to be oxymorphone are also included in these Guidelines for oral fluid drug testing. collected as a split specimen and proposed OFMG. The issues are organized and presented recommendations for other processes first in summary as they appear in the that enable subdividing the collected Provisions for the Administration of the text of the proposed OFMG and later as specimen. National Laboratory Certification issues of special interest for which the Section 2.4 establishes a known Program (NLCP) Department is seeking specific public volume that must be collected for each In accordance with the current comment. specimen. practice, an HHS contractor will Section 2.5 describes how a split oral perform certain functions on behalf of Subpart A—Applicability fluid specimen is collected. the Department. These functions Sections 1.1, 1.2, 1.3, and 1.4 contain Section 2.6 clarifies that all entities include maintaining laboratory the same policies as described in the and individuals identified in Section 1.1 inspection and PT programs that satisfy current UrMG with regard to who is of these Guidelines are prohibited from

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releasing specimens collected under the their testing needs above the required and the Food and Drug Administration federal workplace drug testing program minimum. The Department included (FDA). The cutoff concentrations are the to any individual or entity unless requirements for federal agencies to test outcome of the lengthy discussion expressly authorized by these all oral fluid specimens for either process and represent the best approach Guidelines or in accordance with albumin or IgG to determine specimen currently available. The proposed applicable federal law. validity, but specifically requests public analytes follow: Marijuana (Cannabis). While these Guidelines do not comment on requiring these tests. The Department is proposing to test authorize the release of specimens, or The policy in section 3.2 is the same for delta-9-tetrahydrocannabinol (THC) portions thereof, to federal employees, as that for urine testing. Any federal using a 4 ng/mL cutoff concentration for the Guidelines afford employees a agency that wishes to routinely test its the initial test. For the confirmatory test, variety of protections that ensure the specimens for any drug not included in the Department is proposing to test for identity, security and integrity of their the Guidelines must obtain approval THC using a 2 ng/mL cutoff specimens from the time of collection from the Department before expanding concentration. through final disposition of the its program. A specimen may be tested Marijuana (cannabis) continues to be specimen. There are also procedures for any drug listed in Schedule I or II the most prevalent drug of abuse in the that allow federal employees to request of the Controlled Substances Act when U.S. THC is the primary psychoactive the retesting of their specimen (for drugs there is reasonable suspicion/cause to ingredient of marijuana and is rapidly or adulteration) at a different certified believe that a donor may have used a transferred from the lungs to blood laboratory. Furthermore, the Guidelines drug not included in these Guidelines. during smoking.64 THC is distributed by grant federal employees access to a wide When reasonable suspicion/cause exists the blood and absorbed rapidly by body variety of information and records to test for another drug, the federal tissues. Apparently, very little related to the testing of their specimens, agency must document the possibility unchanged THC is excreted in oral fluid including a documentation package that that the use of another drug exists, as demonstrated by investigations with includes, among other items, a copy of attach the documentation to the original intravenously administered THC 65 or the Federal CCF with any attachments, Federal CCF, and ensure that the HHS- orally administered THC (dronabinol).66 internal chain of custody records for the certified laboratory has the capability to The major source of THC in oral fluid specimen, and any memoranda test for the additional drug. The HHS- occurs from deposition in the mouth generated by the laboratory. certified laboratory performing such during smoking or oral use.65 THC Therefore, the Guidelines offer federal additional testing must validate the test appears at its highest concentration in employees and federal agencies methods and meet the quality control oral fluid immediately after smoking transparent and definitive evidence of a requirements as described in the marijuana.58 67 68 69 Initial high specimen’s identity, security, control Guidelines for the other drug analyses. concentrations of THC in oral fluid and chain of custody. However, the Section 3.3 states that specimens must decline rapidly within the first 30 Guidelines do not entitle employees only be tested for drugs and to minutes after use and thereafter decline access to the specimen itself or to a determine their validity in accordance over time in a manner similar to that portion thereof. The reason for this with Subpart C of these Guidelines. observed for THC in plasma 68 and prohibition is that specimens collected Additional explanation is provided serum.70 It has been suggested that the under the Guidelines are uniquely above, in comments for Section 2.6. similarity in oral fluid and plasma designed for the purpose of drug and Section 3.4 lists the proposed analytes concentrations can be attributed to a validity testing only. They are not and cutoff concentrations for undiluted physiological link involving designed for other purposes such as (neat) oral fluid. The table in Section 3.4 transmucosal THC absorption from oral deoxyribonucleic acid (DNA) testing. specifies both initial and confirmatory fluid into blood.1 One study reported Furthermore, conducting additional cutoff concentrations for each drug test significant correlations of oral fluid THC testing outside the parameters of the analyte. Footnote 2 of the table concentrations with subjective Guidelines would not guarantee addresses requirements that differ for intoxication and with heart rate incorporation of the safeguards, quality initial tests using immunoassay-based elevation.71 control protocols, and the exacting technology and those using an Positive prevalence rates for THC in scientific standards developed under ‘‘alternate’’ technology. Over the last 5 oral fluid specimens collected from the Guidelines to ensure the security, years, technological advances have been workplace drug testing programs appear reliability and accuracy of the drug made to techniques (e.g., methods using to be comparable or greater than 11-nor- testing process. spectrometry or spectroscopy) that delta-9-tetrahydrocannabinol-9- enable their use as efficient and cost- carboxylic acid (THCA) rates for urine Subpart C—Oral Fluid Specimen Tests effective alternatives to the drug testing in the general workforce. A Section 3.1 describes the tests to be immunoassay techniques for initial drug 2002 study of 77,218 oral fluid performed on each oral fluid specimen. testing while maintaining the required specimens revealed a positive This is the same policy that is in the degree of sensitivity, specificity, and prevalence of 3.22 percent compared to current UrMG regarding which drug accuracy. The proposed Guidelines a 3.17 percent positivity rate for more tests must be performed on a specimen. allow the use of alternate technologies than 5,200,000 urine specimens A federal agency is required to test all provided that the laboratory validates collected during the same period.40 The specimens for marijuana and cocaine the method in accordance with Section 2012 Drug Testing Index by Quest and is authorized to also test specimens 11 and demonstrates acceptable Diagnostics for marijuana positivity in for opiates, amphetamines, and performance in the PT program. the general workforce for oral fluid was phencyclidine. The Department realizes Considerable research and discussion 4.0 percent and for urine was 2.0 that most federal agencies typically test were conducted regarding the complex percent.39 for all five drug classes authorized by issues surrounding the specification of Once absorbed and distributed to the existing Guidelines, but has not each cutoff concentration. The tissues, THC is ultimately transformed made this a mandatory requirement, and Department solicited input from by oxidative metabolic enzymes to will continue to rely on the individual laboratories, reagent and device THCA. Further metabolism of THCA agencies and departments to determine manufacturers, subject matter experts, leads to formation of a glucuronide

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metabolite (conjugated metabolite). Both for inclusion as a reliable test analyte for marijuana smoke.81 Consequently, the free (unconjugated) THCA 72–74 and detection of marijuana use. presence of THCA provides evidence of conjugated THCA 75 are excreted in oral The proposed initial test cutoff for active use of products containing THC fluid in low concentrations (picograms THC (4 ng/mL) and confirmatory test (e.g., marijuana, dronabinol). However, per milliliter). In a study of one frequent cutoff for THC (2 ng/mL) are the same based on information provided from marijuana smoker,75 concentrations of as those proposed in the 2004 recent studies,82 it does not appear that THC were highest immediately Guidelines. The detection time for THC THCA is reliably present in oral fluid following smoking and declined in oral fluid appears to be shorter than specimens for some marijuana users: a thereafter. In that study, THC the detection time for THCA in marijuana user’s oral fluid specimen concentrations in oral fluid specimens urine;58 67 76 77 78 79 consequently, a lower may be positive for THC and negative collected during three different smoking initial test cutoff concentration would for THCA. occasions ranged from 0 to 93 ng/mL; enhance detection rates of marijuana A number of passive exposure studies free THCA concentrations ranged from use. For this reason, the Department is have been conducted under a variety of 0.027 to 0.085 ng/mL and total interested in receiving comments on exposure conditions.58 67 80 83 Two (conjugated and free) THCA lowering the cutoff concentration for studies reported that false results for concentrations ranged from 0.033 to delta-9-tetrahydrocannabinol (THC) to THC were a problem if oral fluid was 0.314 ng/mL. The ratio of conjugated either 2 or 3 ng/mL for the initial test collected in a contaminated THCA to free THCA ranged from 0.5 to cutoff concentration and to 1 ng/mL for environment.67 80 One passive 3.64. Predominantly, there was the confirmatory cutoff concentration. inhalation study in which oral fluid approximately twice as much Lowering the initial and confirmatory specimens were collected in a clean conjugated THCA as free THCA in oral test cutoff concentrations would environment reported no specimens fluid specimens, indicating the need for lengthen the detection window (i.e., the positive for THC at a confirmatory cutoff hydrolysis prior to confirmatory number of hours after a drug is ingested concentration of 1.5 ng/mL throughout analysis to convert conjugated THCA to by an individual that the concentration an 8-hour monitoring period following 67 80 free THCA, enabling analysis for total of the drug or drug metabolite in oral exposure. A recent study reported THCA. Urine testing programs currently fluid will likely be at or above the cutoff negative results for total THCA at a limit use hydrolysis and test for total THCA, concentration). Lower cutoff of quantification of 0.002 ng/mL, but and the analytical procedures for oral concentrations will increase the number found positive results for THC in oral fluid are similar to those in practice for of specimens that are identified as fluid when specimens were collected urine. containing THC and, thereby, will during three hours of continuous increase the deterrent effect of the passive exposure. Specimens collected In contrast to urine, there is a paucity program and improve identification of 12 to 22 hours after passive exposure of scientific data on the time course of employees using this illicit substance. were negative for total THCA and were excretion or the detection window of The Department had considered predominantly negative for THC; THC, THCA, and conjugated THCA in proposing to test for THCA (i.e., ‘‘total’’ however, two of 10 specimens 1 oral fluid following marijuana use. amount following hydrolysis, as contained detectable amounts of THC This is especially true for occasional described above) using a 0.050 ng/mL (1.0, 1.1 ng/mL) that are well below the users. Studies of daily marijuana cutoff concentration for confirmation to proposed 4 ng/mL cutoff for the initial smokers indicate that THC is detectable extend the window of detection. test and 2 ng/mL cutoff for the for up to two days, but THCA continues However, the Department is concerned confirmatory test. to be excreted in oral fluid during over the utility of confirming for this The Department is not aware of any abstinence for several weeks in daily analyte as well as the ability of studies that demonstrate passive users.76 As noted earlier, the laboratories to reliably implement this exposure causing a positive oral fluid mechanisms of drug excretion in oral test for routine analyses, based on the THC result when the donor would not fluid are somewhat different than in reasons provided below be aware of that exposure. Nor does urine. Because oral fluid tests generally Currently, few laboratories perform there appear to be evidence that are positive for parent drug as soon as confirmatory testing for THCA in oral incidental exposure to marijuana smoke the drug is administered, the fluid testing. Thus, there is limited data can cause an oral fluid specimen to be Department, for oral fluid testing, is on the positivity rates for these analytes reported positive for THC using the considering testing and confirming for in a workplace population. In a study of proposed cutoff levels. Therefore, THC. THC is reliably present in oral 143 specimens positive by passive exposure would not be a fluid immediately after smoked immunoassay using the proposed 4 ng/ reasonable defense for a positive result cannabis administration and remains mL initial test cutoff,74 84 percent were for THC in oral fluid testing. detectable for 24–30 hours or longer, confirmed positive for THC using the The Department recognizes that whereas THCA may or may not be proposed 2 ng/mL confirmatory test THCA testing may be useful, because present. The risks of passive smoke cutoff. Only 51 percent would have THC and THCA may be present singly exposure have been assessed. To date, confirmed positive for THCA using a or in combination in a marijuana user’s studies have indicated that transient 0.010 ng/mL cutoff. oral fluid specimen depending on the amounts of THC may be present in oral Also, testing for THCA requires a length of time between use and fluid for a few hours (1–3), and no larger sample volume than testing for collection. However, Current technology THCA is detected in oral fluid but is THC. This may affect the ability of a for conducting a confirmatory test for detected in blood. The detection of laboratory to perform additional testing THCA at pg/mL concentrations requires traces of THC occurred only under as required. To avoid the risk of positive the use of specialized materials, conditions of extreme tolerated test results from passive exposure, some instrumentation, and methods.72 73 84 In exposure. Unknowing or transient investigators have recommended that addition, a substantial portion of the exposure to marijuana smoke does not THCA be included in confirmatory oral fluid specimen may be consumed appear likely to produce a positive THC testing.74 76 77 78 80 THCA occurs in oral in the analytical process, thus making it test in oral fluid. The Department seeks fluid as a result of passive diffusion difficult for a laboratory to confirm comment on whether THCA is suitable from blood 66 and is not found in multiple initial positive drug tests or

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reanalyze these specimens. Therefore, approximately 24 hours.85 An earlier 6-Acetylmorphine the Department is specifically interested study showed that codeine appeared in in obtaining information on the ability urine within an hour of dosing, and was The Department is proposing to test of laboratories to conduct initial and/or detectable up to four days.86 A for 6-acetylmorphine using a 3 ng/mL confirmatory tests for THCA, as well as metabolite of codeine, norcodeine, was cutoff concentration for the initial test the cost of conducting the confirmatory also detected in oral fluid, but morphine and 2 ng/mL for the confirmatory test test. was not detected. Although there is high cutoff concentration. 6-acetylmorphine, a unique metabolite of heroin, appears Cocaine variability, codeine oral fluid concentrations have been significantly in oral fluid within minutes following The Department is proposing to test correlated with plasma codeine smoked or injected heroin for cocaine/benzoylecgonine using an concentrations.85 87 Codeine undergoes administration.35 A high prevalence of initial cutoff concentration of 15 ng/mL extensive metabolism in the body. Two 6-acetylmorphine in oral fluid and 8 ng/mL for the confirmatory cutoff important, but minor metabolites of specimens following heroin use has concentrations. Cocaine appears in oral codeine are morphine and been reported,93–96 suggesting it may fluid within minutes after use following 88 89 90 hydrocodone. Morphine may be offer advantages over urine in intravenous, nasal and smoked present in oral fluid as a result of administration.36 Cocaine is rapidly workplace testing programs. An initial administration of morphine,91 92 assay for 6-acetylmorphine separate metabolized to benzoylecgonine that heroin,35 or ingestion of poppy seeds.37 also is excreted in oral fluid. At from a general opiates assay is currently A study of morphine levels in urine and used in the UrMG. The 2004 proposed different times after use, cocaine and oral fluid following ingestion of poppy benzoylecgonine may be present singly revisions to the Guidelines did not seeds indicated that morphine was propose a separate initial test for 6- or in combination in oral fluid. The positive for a shorter period of time acetylmorphine. An initial test for 6- current proposed initial test cutoff for (approximately 2 hours) compared to acetylmorphine is proposed because of cocaine/benzoylecgonine (15 ng/mL) is urine (approximately 8 hours).37 A lower than that proposed in the 2004 study of 77,218 oral fluid specimens the recent recognition that 6- proposed revisions to the Guidelines (20 collected under workplace drug testing acetylmorphine may be positive in oral ng/mL). This change is justified because conditions indicated that approximately fluid specimens that would not initially 35 94 of the recognition that different 12.5 percent of specimens positive for test positive for opiates. A study of combinations of cocaine analytes may morphine or codeine were positive in 77,218 oral fluid specimens collected be present at different times after use the concentration range of 30 to 39.9 ng/ under workplace drug testing conditions and for enhanced sensitivity for the mL and would have been reported indicated that 12.5 percent of specimens detection of each analyte. negative using a 40 ng/mL confirmatory positive for 6-acetylmorphine were An immunoassay initial test for cutoff concentration.40 The current positive in the concentration range of 3 cocaine/benzoylecgonine should be proposed initial test cutoff to 3.9 ng/mL and would have been calibrated with one of the two analytes concentration (30 ng/mL) and reported negative at a 4 ng/mL and demonstrate sufficient cross- confirmatory test cutoff concentration confirmatory cutoff concentration.40 reactivity with the other analyte. The (15 ng/mL) for codeine/morphine are Department recommends that the The current proposed confirmatory test lower than those in the 2004 proposed minimum cross-reactivity with either cutoff concentration (2 ng/mL) for 6- revisions to the Guidelines (40 ng/mL analyte be 80 percent or greater. If an acetylmorphine is lower than in the for initial test and confirmatory test), alternate technology initial test is 2004 proposed revisions to the primarily due to the enhanced performed instead of immunoassay, Guidelines (4 ng/mL), primarily for sensitivity especially for the detection of either one or both analytes in the group enhanced sensitivity. morphine. should be used to calibrate, depending Phencyclidine on the technology. The quantitative sum An immunoassay initial test for of the two analytes must be equal to or codeine/morphine should be calibrated The Department is proposing to test with one of the two analytes and greater than 15 ng/mL. The quantitative for phencyclidine using a 3 ng/mL demonstrate sufficient cross-reactivity sum of the two analytes must be based cutoff concentration for the initial test with the other analyte. The Department on quantitative values for each analyte and 2 ng/mL for the confirmatory test proposes that the minimum cross- that are equal to or above the cutoff concentration. Phencyclidine has laboratory’s validated limit of reactivity with either analyte be 80 percent or greater. If an alternate been measured in oral fluid following quantification. different routes of administration. 97 98 A The 8 ng/mL confirmatory test cutoff technology initial test is performed instead of immunoassay, either one or study of 77,218 oral fluid specimens concentration applies equally to cocaine collected under workplace drug testing and benzoylecgonine. A positive test both analytes in the group should be used to calibrate, depending on the conditions indicated that 57.1 percent of would be comprised of either or both specimens positive for phencyclidine analytes with a confirmed concentration technology. The quantitative sum of the were positive in the concentration range equal to or greater than 8 ng/mL. two analytes must be equal to or greater than 30 ng/mL. The quantitative sum of of 1.5 to 9.9 ng/mL and would have Codeine/morphine the two analytes must be based on been reported negative at a 10 ng/mL The Department is proposing to test quantitative values for each analyte that confirmatory cutoff concentration.40 for codeine/morphine using a 30 ng/mL are equal to or above the laboratory’s The current proposed initial test cutoff cutoff concentration for the initial test validated limit of quantification. concentration (3 ng/mL) and and 15 ng/mL for the confirmatory test The 15 ng/mL confirmatory test cutoff confirmatory test cutoff concentration (2 cutoff concentrations. After single oral concentration applies equally to codeine ng/mL) for phencyclidine are lower than use, codeine has been reported to and morphine. A positive test would be those in the 2004 proposed revisions to appear in oral fluid within an hour, comprised of either or both analytes the Guidelines (10 ng/mL for initial test quickly reach maximum concentration with a confirmed concentration equal to and confirmatory test), primarily for and decline over a period of or greater than 15 ng/mL. enhanced sensitivity.

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Amphetamine/methamphetamine The 15 ng/mL confirmatory test cutoff concentration equal to or greater than 15 concentration applies equally to ng/mL. The Department is proposing to test amphetamine and methamphetamine. A Inclusion of Oxycodone, Oxymorphone, for amphetamine/methamphetamine positive test would be comprised of Hydrocodone, Hydromorphone using a 25 ng/mL cutoff concentration either or both analytes with a confirmed for the initial test and 15 ng/mL for the concentration equal to or greater than 15 Misuse and abuse of confirmatory test cutoff concentration. ng/mL. psychotherapeutic prescription drugs, Amphetamine appears rapidly in oral including opoid pain relievers, are fluid following administration 99 and, Methylenedioxymethamphetamine issues of concern for all populations although variable, correlates with blood (MDMA)/Methylenedioxyamphetamine regardless of age, gender, ethnicity, race, concentrations in drivers suspected of (MDA)/ or community. Recent data show that driving under the influence of drugs.100 Methylenedioxyethylamphetamine opoid-related overdose deaths in the Methamphetamine and its metabolite, (MDEA) U.S. now outnumber overdose deaths amphetamine, also appear rapidly in The Department is proposing to test involving all illicit drugs such as heroin oral fluid and plasma following for MDMA/MDA/MDEA using a 25 ng/ and cocaine combined. In addition to administration. 101 102 In one study,102 mL cutoff concentration for the initial overdose deaths, emergency department concentrations of amphetamine relative test and 15 ng/mL for the confirmatory visits, substance abuse treatment to methamphetamine in oral fluid test cutoff concentration. MDMA admissions, and economic costs ranged from 16 percent to 37 percent appears in oral fluid approximately associated with opioid abuse have all following methamphetamine 0.25–1.5 hours following oral increased in recent years. The administration. The positivity rate for administration and demonstrates similar Department is continuing to work with methamphetamine in oral fluid was kinetic patterns as plasma partners at the federal, state, and local highly influenced by the requirement concentrations.103–105 MDMA is levels to implement policies and for detection of amphetamine metabolite programs to reduce prescription drug metabolized by N-demethylation to 107 in the study. When the confirmatory MDA, a compound that exhibits similar abuse and improve public health. The Department proposes the cutoff concentration for psychoactive properties to MDMA. As a inclusion of additional Schedule II methamphetamine was 50 ng/mL and metabolite of MDMA, MDA is excreted prescription medications (i.e., detection of amphetamine at 2.5 ng/mL in oral fluid with concentrations oxycodone, oxymorphone, hydrocodone (limit of detection) was applied to oral representing approximately 4–5 percent and hydromorphone) in the list of fluid specimens, only 1 of 13 of MDMA.104 MDEA also is metabolized individuals tested positive 24 hours authorized drug tests and cutoff by N-dealkylation to MDA as an active concentrations. This action was after a single methamphetamine dose 106 metabolite. MDEA has been reported recommended by the DTAB, reviewed and; only 23 of 130 (18 percent) in oral fluid specimens collected from specimens tested positive within 24 by the Department’s Prescription Drug recreational drug users in Subcommittee of the Behavioral Health hours after dosing. The current concentrations ranging from 25 to 3320 Coordinating Committee, and received proposed initial test cutoff 105 ng/mL. The current recommended by the SAMHSA Administrator in concentration (25 ng/mL) and initial test concentration (25 ng/mL) and January 2012. The inclusion of confirmatory test cutoff concentration confirmatory test cutoff concentration oxycodone, oxymorphone, hydrocodone (15 ng/mL) for amphetamine/ (15 ng/mL) for MDMA/MDA/MDEA are and hydromorphone is supported by methamphetamine are lower than those lower than those in the 2004 proposed various data. According to the 2012 in the 2004 proposed revisions to the revisions to the Guidelines (50 ng/mL National Survey on Drug Use and Guidelines (50 ng/mL for initial test and for initial test and confirmatory test), Health, which provides data on illicit confirmatory test), primarily for primarily for enhanced sensitivity. drug use in the U.S., current (past enhanced sensitivity. There is no An immunoassay initial test for month) nonmedical users aged 12 years proposed reporting requirement for a MDMA/MDA/MDEA should be and older of prescription methamphetamine-positive specimen to calibrated with one of the three analytes psychotherapeutic drugs increased from contain amphetamine as there is in the and demonstrate sufficient cross- 2003 (6.5 million) to 2012 (6.8 UrMG. reactivity with each analyte. The million).59 Psychotherapeutic drugs are An immunoassay initial test for Department recommends that the defined as opioid pain relievers, amphetamine/methamphetamine minimum cross-reactivity with each tranquilizers, sedatives, and stimulants. should be calibrated with one of the two analyte be 80 percent or greater. If an The abuse of psychotherapeutic drugs analytes and demonstrate sufficient alternate technology initial test is non-medically is ranked second behind cross-reactivity with the other analyte. performed instead of immunoassay, marijuana, where pain relievers The Department recommends that the either one or all analytes in the group represent the majority of the group. The minimum cross-reactivity with either should be used to calibrate, depending Drug Abuse Warning Network (DAWN) analyte be 80 percent or greater. If an on the technology. The quantitative sum Report, which provides national alternate technology initial test is of the three analytes must be equal to or estimates of drug-related visits to performed instead of immunoassay, greater than 25 ng/mL. The quantitative hospital emergency departments (ED), either one or both analytes in the group sum of the three analytes must be based showed that of the 1.2 million ED visits should be used to calibrate, depending on quantitative values for each analyte involving nonmedical use of on the technology. The quantitative sum that are equal to or above the pharmaceuticals in 2011, 46.0 percent of of the two analytes must be equal to or laboratory’s validated limit of visits involved nonmedical use of pain greater than 25 ng/mL. The quantitative quantification. relievers, with 29 percent being narcotic sum of the two analytes must be based The 15 ng/mL confirmatory test cutoff pain relievers.60 The most frequently on quantitative values for each analyte concentration applies equally to involved narcotic pain relievers were that are equal to or above the MDMA, MDA and MDEA. A positive oxycodone and hydrocodone. From laboratory’s validated limit of test would be comprised of one or more 2004 to 2011, ED visits involving quantification. of the three analytes with a confirmed nonmedical use of narcotic pain

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relievers increased by 153 percent. ED on the technology. The quantitative sum Services (HHS) for a recommendation visits involving opiates/opioids of the two analytes must be equal to or regarding whether to change the increased by 183 percent during this greater than 30 ng/mL. The quantitative schedule for hydrocodone combination period, with increases of 438 percent for sum of the two analytes must be based drug products, such as Vicodin. The hydromorphone, 263 percent for on quantitative values for each analyte proposed change was from Schedule III oxycodone, and over 100 percent for that are equal to or above the to Schedule II, which would increase hydrocodone, as well as fentanyl and laboratory’s validated limit of the controls on these products. Due to morphine. In addition, the National quantification. the unique history of this issue and the Forensic Laboratory Information System The 15 ng/mL confirmatory test cutoff tremendous amount of public interest, (NFLIS) found that oxycodone and concentration applies equally to in October 2013, the FDA Center for hydrocodone were among the top ten oxycodone and oxymorphone. A Drug Evaluation and Research drugs seized in law enforcement positive test would be comprised of announced the agency’s intent to operations and sent to federal, state, and either or both analytes with a confirmed recommend to HHS that hydrocodone municipal forensic laboratories.61 concentration equal to or greater than 15 combination drug products should be Among prescription drugs, oxycodone ng/mL. reclassified to Schedule II. FDA stated and hydrocodone ranked first and Hydrocodone/hydromorphone that this determination came after a second. Information on over 5 million thorough and careful analysis of drug tests in general workplace drug The Department is proposing to test extensive scientific literature, review of testing shows that the positivity rate for for hydrocodone/hydromorphone using hundreds of public comments on the oxycodone and hydrocodone (0.96%) a 30 ng/mL cutoff concentration for the issue, and several public meetings, was second only to marijuana in 2012.39 initial test and 15 ng/mL for the during which FDA received input from The use of medications, specifically confirmatory test cutoff concentration. a wide range of stakeholders, including Schedule II drugs, without a Hydromorphone appears rapidly in oral patients, health care providers, outside prescription is a growing concern for the fluid following intravenous experts, and other government entities. Department in workplace drug testing, administration and follows a similar In December 2013, FDA, with the and the proposal for their inclusion kinetic profile as that observed in concurrence of the National Institute on offers the opportunity to deter plasma.110 Both hydrocodone and Drug Abuse (NIDA), submitted a formal nonmedical use of these drugs among hydromorphone have been reported to recommendation package to HHS to federal workers. The Department does be readily detectable in oral fluid reclassify hydrocodone combination note that in recognition of the specimens collected from pain drug products into Schedule II. Also in prescription drug abuse issue, the patients.41 108 Hydrocodone is December 2013, the Secretary of HHS Department of Defense issued a metabolized in relatively minor submitted the scientific and medical memorandum on January 30, 2012, amounts to hydromorphone.62 evaluation and scheduling announcing the expansion of their drug Hydromorphone is a potent analgesic recommendation to the DEA for its testing panel to include hydrocodone used for pain relief orally and consideration. On August 22, 2014, DEA and benzodiazepines starting on May 1, parenterally, and is primarily published the Final Rule that moves 2012. Similarly, the Department metabolized by conjugation.111 hydrocodone combination drug proposes that federal agencies include Hydrocodone has been reported to be a products from Schedule III to Schedule the testing of oxycodone, oxymorphone, minor metabolite of codeine 90 and II. hydrocodone, and hydromorphone in hydromorphone has been reported to be Section 3.5 authorizes HHS-certified oral fluid specimens as described below. a minor metabolite of morphine.112 113 laboratories to perform additional tests An immunoassay initial test for to assist the MRO in making a Oxycodone/oxymorphone hydrocodone/hydromorphone should be determination of positive or negative The Department is proposing to test calibrated with one of the two analytes results. The Department believes that for oxycodone/oxymorphone using a 30 and demonstrate sufficient cross additional tests can be requested by the ng/mL cutoff concentration for the reactivity with the other analyte. The MRO to further inform them to initial test and 15 ng/mL for the Department proposes that the minimum determine the veracity of the medical confirmatory test cutoff concentrations. cross-reactivity with either analyte be 80 explanation of the donor. An example of Both oxycodone and oxymorphone have percent or greater. If an alternate an additional test currently requested by been reported to be readily detectable in technology initial test is performed an MRO is when the laboratory reports oral fluid specimens collected from pain instead of immunoassay, either one or a positive methamphetamine result. The patients.41 108 Oxycodone is metabolized both analytes in the group should be MRO may request a d,l-stereoisomer in relatively minor amounts to used to calibrate, depending on the determination for methamphetamine, to oxymorphone.63 Oxymorphone is a technology. The quantitative sum of the determine whether the result could be potent analgesic used for pain relief two analytes must be equal to or greater attributed to use of an over-the-counter orally and parenterally, and is primarily than 30 ng/mL. The quantitative sum of nasal inhaler. Another example of metabolized by conjugation.109 the two analytes must be based on current practice is when the laboratory An immunoassay initial test for quantitative values for each analyte that reports a positive THCA result, and the oxycodone/oxymorphone should be are equal to or above the laboratory’s MRO requests testing for cannabivarin, calibrated with one of the two analytes validated limit of quantification. to distinguish marijuana use from and demonstrate sufficient cross- The confirmatory test cutoff dronabinol (e.g., Marinol®). reactivity with the other analyte. The concentration applies equally to Section 3.6 includes criteria for Department recommends that the hydrocodone and hydromorphone. A reporting an oral fluid specimen as minimum cross-reactivity with either positive test would be comprised of adulterated. While there are no known analyte be 80 percent or greater. If an either or both analytes with a confirmed oral fluid adulterants at this time, the alternate technology initial test is equal to or greater than 15 ng/mL. Department is proposing to establish performed instead of immunoassay, In 2009, the U.S. Drug Enforcement criteria similar to that for urine either one or both analytes in the group Administration (DEA) asked the U.S. specimens, to ensure procedures that should be used to calibrate, depending Department of Health and Human are forensically acceptable and

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scientifically sound, while allowing Section 7.3 details the minimum laboratories to become HHS-certified laboratories the flexibility necessary to performance requirements for a and to maintain HHS certification to develop specific testing requirements collection device. Considering the conduct oral fluid testing for a federal for an adulterant. variety of oral fluid collection devices agency, as well as what a laboratory Section 3.7 incorporates criteria from available, the Department considers it must do when certification is not the UrMG that are applicable for necessary to require that any device maintained. reporting an invalid result for an oral used meet minimum standards to Section 9.5 contains specifications for fluid specimen, and includes an ensure the integrity of the specimen and PT samples, Section 9.6 contains PT additional criterion to enable the standardization of the laboratory requirements for an applicant laboratories to perform specimen analysis process. laboratory, and Section 9.7 contains PT requirements for an HHS-certified validity testing using biomarkers other Subpart H—Oral Fluid Specimen than IgG and albumin. laboratory. These sections incorporate Collection Procedure the applicable requirements from the Subpart D—Collectors This subpart addresses the same current UrMG, but exclude UrMG Sections 4.1 through 4.5 contain the topics, in the same order, as the UrMG requirements that are specific for urine same policies as described in the procedures for urine specimen testing and include those specific for current UrMG in regard to who may or collection. oral fluid testing. may not collect a specimen, the Section 8.1 specifies the procedures The remaining Sections 9.8 through requirements to be a collector, the required to provide privacy for the oral 9.17 contain the same policies as the requirements to be a trainer for fluid donor during the collection UrMG. These sections address collectors, and what a federal agency procedure. inspection requirements for applicant must do before a collector is permitted Sections 8.2 through 8.5 describe the and HHS-certified laboratories, to collect a specimen. responsibilities and procedures the inspectors, consequences of an collector must follow before, during, applicant or HHS-certified laboratory Subpart E—Collection Sites and after an oral fluid collection. failing to meet PT or inspection Sections 5.1 through 5.5 address Section 8.6 describes the procedures performance requirements, factors requirements for collection sites, the collector must follow when a donor considered by the Secretary in collection site records, how a collector is unable to provide an oral fluid determining the revocation or ensures the security and integrity of a specimen. suspension of HHS-certification, the Section 8.7 prohibits collection of an specimen at the collection site, and the procedure for notifying a laboratory that alternate specimen when a donor is privacy requirements when collecting a adverse action (e.g., suspension or unable to provide an adequate oral fluid specimen. revocation) is being taken by HHS, and specimen, unless specifically authorized the process for re-application once a Subpart F—Federal Drug Testing by the Mandatory Guidelines for Federal laboratory’s certification has been Custody and Control Form Workplace Drug Testing Programs and revoked by the Department. by the federal agency. Sections 6.1 and 6.2 are the same as Section 9.17 states that a list of Section 8.8 describes how the laboratories certified by HHS to conduct in the current UrMG, requiring an OMB- collector prepares the oral fluid approved Federal CCF be used to forensic drug testing for federal agencies specimens, including the description of will be published monthly in the document custody and control of each the oral fluid split specimen collection. specimen at the collection site, and Federal Register. The list will indicate Section 8.9 specifies how a collector the type of specimen (e.g., oral fluid or specifying what should occur if the is to report a refusal to test. correct OMB-approved CCF is not used. urine) that each laboratory is certified to Section 8.10 is the same as that in the test. Subpart G—Oral Fluid Specimen UrMG in regard to federal agency Subpart J—Blind Samples Submitted by Collection Devices responsibilities for ensuring that each collection site complies with all an Agency Section 7.1 describes the type of provisions of the Mandatory Guidelines. This subpart (Sections 10.1 through collection device that must be used to An example of appropriate action that 10.4) describes the same policies for collect an oral fluid specimen. A single may be taken in response to a reported federal agency blind samples as the use device that has been cleared by the collection site deficiency is self- UrMG, with two exceptions. Oral fluid FDA for the collection of oral fluid must assessment using the Collection Site blind samples that challenge specimen be used. Checklist for the Collection of Oral validity tests are not required, and the Section 7.2 describes specific Fluid Specimens for Federal Agency blind supplier must validate blind requirements for the oral fluid Workplace Drug Testing Programs. This samples in the selected manufacturer’s collection device, to ensure that the document will be available on the collection device. device provides a sufficient volume for SAMHSA Web site http:// Subpart K—Laboratory laboratory analysis and maintains the www.samhsa.gov/workplace/drug- integrity of the specimen. The testing. This subpart addresses the same Department has determined that it is topics, in the same order, as the UrMG essential that the device have a volume Subpart I—HHS-Certification of procedures for laboratories testing urine adequacy indicator showing that a Laboratories specimens. As appropriate, the section minimum volume of 1 mL oral fluid has This subpart addresses the same includes requirements that are specific been collected; that the container be topics for HHS certification of for oral fluid testing. sealable and non-leaking; and that all laboratories to test oral fluid specimens, Sections 11.1 through 11.8 include components of the device ensure drug as are included in the UrMG for HHS the same requirements that are and metabolite stability and do not certification of laboratories to test urine contained in the current UrMG for the substantially affect the composition of specimens. laboratory standard operating procedure drug and/or drug metabolites in the Sections 9.1 through 9.4 contain the (SOP) manual; responsibilities and specimen. same policies as in the current UrMG for scientific qualifications of the

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responsible person (RP); procedures in testing. This section is comparable to increase costs to MROs. Current the event of the RP’s extended absence the same section in the UrMG, differing practices for MRO requirements have from the laboratory; qualifications of the only in that the statistical report equivalent standards but vary among certifying scientists, certifying elements are specific for oral fluid MRO training entities. These technicians, and other HHS-certified testing. requirements will standardize the length laboratory staff; security; and chain of Section 11.21 addresses the laboratory of time each MRO is required to take a custody requirements for specimens and information to be made available to a requalification examination. Currently, aliquots. federal agency and describes the some MRO requalification periods are Sections 11.9 through 11.14 include contents of a standard laboratory longer than five years, while others are the same requirements as in the current documentation package. This is the less than five years. The Department UrMG in regard to initial and same policy as in the UrMG. assumes that the costs to those MROs confirmatory drug test requirements, Section 11.22 addresses the laboratory that have requalification periods over validation, and batch quality control as information to be made available to a five years will be offset by the cost described in each section below. federal employee upon written request savings to MROs that have periods Section 11.9 describes the through the MRO, and clarifies that shorter than five years. Thus, the requirements for the initial drug test specimens are not a part of the Department has not estimated any costs which permit the use of an information package that donors can associated with this provision, but it immunoassay or alternate technology receive from HHS-certified laboratories. welcomes comment on this assumption. (e.g., spectrometry or spectroscopy). The This is the same policy as in the UrMG. The Department anticipates that Department believes that new The remaining section, Section 11.23, MROs will continue to obtain CEUs by technology has advanced in the initial describes the relationships that are virtue of maintaining their medical testing for drugs, and does not want to prohibited between an HHS-certified licensure requirements. In addition, the limit the testing technology to laboratory and an MRO. These are the MRO certification/training entities immunoassay. same as in the UrMG. provide MRO manuals and periodic Sections 11.10 and 11.11 cover newsletters with updates on federal Subpart L—Instrumented Initial Test validation and quality control drug testing program requirements. Facility (IITF) requirements for the initial test. However, the Department is seeking Section 11.12 describes the This subpart emphasizes that federal comments on requiring MRO requirements for a confirmatory drug agencies may choose to use IITFs for requalification CEUs and on the test. The Department proposes to allow urine testing but not for oral fluid optimum number of credits and the analytical procedures using mass testing. Section 12.1 clearly states that appropriate CEU accreditation bodies spectrometry or other equivalent only HHS-certified laboratories are should CEUs be required as part of MRO technologies. Based on ongoing reviews authorized to test oral fluid specimens requalification. of the scientific and forensic literature, for federal agency workplace drug MROs play a key role in the federal and the assessment of a DTAB working testing programs. Instrumented Initial safety program and maintain the balance group that has studied newer Test Facilities are not practical and will between the safety and privacy instruments and technologies, the not be allowed due primarily to the objectives of the program. The MRO’s Department believes that scientifically limited sample volume of oral fluid role in gathering and evaluating the valid confirmatory methods other than collected from the donor. medical evidence and providing due process is imperative. These are duties combined chromatographic and mass Subpart M—Medical Review Officer that must be carried out by the MRO spectrometric methods can be used to (MRO) successfully detect and report the cutoff and cannot be delegated to other concentrations proposed in Subpart C- This subpart addresses the same personnel who are not certified by an Oral Fluid Specimen Drug Tests. topics, in the same order, as the UrMG MRO entity. Sections 11.13 and 11.14 cover procedures for Medical Review Officers The MRO is charged with certain validation and quality control (MROs). important medical and administrative requirements for the confirmatory tests. Section 13.1 describes who may serve duties. The MRO must have detailed Sections 11.15 and 11.16 address as an MRO. With the inclusion of knowledge of the effects of medications specimen validity tests that a laboratory additional Schedule II prescription and other potential alternative medical performs for oral fluid specimens. The medications in the Mandatory explanations for laboratory reported Department included requirements in Guidelines and the ever-changing field drug test results. He or she is the OFMG to test all specimens for of drug testing, medical review of drug responsible for determining whether albumin or IgG and to allow laboratories test results is more complex today than legitimate medical explanations are to perform other specimen validity tests. before. Therefore, the Department available to explain an employee’s drug All specimen validity tests must use proposes to incorporate MRO test result. This medical review process appropriate analytical methods that are requalification training and has become far more complex as a result properly controlled and validated, to reexamination on a regular basis (at of specimen validity testing and the provide scientifically supportable and least every five years). The URMG and myriad of medical explanations for forensic acceptable results to the MRO. OFMG do not include a requirement for adulterated, substituted, and invalid Section 11.17 describes in detail how MROs to obtain continuing education laboratory test results. These a certified laboratory is required to units (CEUs). The Department complexities have made MRO report test results to MRO for oral fluid understands that it would be difficult to knowledge of the effects of drugs and specimens. determine whether CEUs obtained are medications even more important. Sections 11.18 and 11.19 contain the related to federal agency drug testing. In addition, MROs confer with same requirements as the UrMG for The requalification requirement every prescribing physicians in making specimen and record retention. five years will assure agency auditors decisions about prescription changes so Section 11.20 describes the statistical and inspectors and regulated employers that alternative medications can be used summary report that a laboratory must that MROs are appropriately qualified. that will not impact public safety. provide to a federal agency for oral fluid This requirement is not expected to Similarly, the MRO is required to report

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to employers the employees’ sufficient amount of oral fluid for a Section 15.4 describes the prescription and over-the-counter federal agency applicant/pre- discrepancies that may require the MRO medication use (or dangerous employment, follow-up, or return-to- to cancel a test, which are the same as combinations of use) that the MRO duty test. These procedures are the same those in the UrMG. believes will negatively affect duty as in the UrMG. Subpart P—Laboratory Suspension/ performance. In addition, the MRO is The remaining sections, Sections 13.8, Revocation Procedures required to medically assess referral 13.9, and 13.10, are the same as in the physician examinations and evaluations UrMG, addressing who may request a In this subpart, the Department in certain positive and refusal-to-test test of the split (B) specimen, how an proposes the same procedures that are situations. These, too, have become MRO reports a primary (A) specimen described in the UrMG to revoke or more complex over time. result, and the types of relationship that suspend the HHS-certification of Section 13.2 describes how nationally are prohibited between an MRO and an laboratories. recognized entities or subspecialty HHS- certified laboratory. Impact of These Guidelines on boards that certify MROs are approved. Section 13.3 describes the training Subpart N—Split Specimen Tests Government Regulated Industries that is required before a physician may Sections 14.1 and 14.2 include the The Department is aware that these serve as an MRO. The Department has same policies as the UrMG in regard to proposed new Guidelines may impact added a requirement for MRO training when a split (B) specimen may be tested the Department of Transportation (DOT) to include information about how to and the testing requirements for a split and Nuclear Regulatory Commission discuss substance misuse and abuse and specimen when the primary specimen (NRC) regulated industries depending how to access those services. MROs was reported positive for a drug(s). on these agencies’ decisions to performing the review of federal Section 14.3 specifies how the split incorporate the final OFMG into their employee drug test results should be testing laboratory tests a split (B) oral programs under their own authority. aware of prevention and treatment fluid specimen when the primary (A) Topics of Special Interest opportunities for individuals and can specimen was reported as adulterated. The Department requests public provide information to the donor. As noted previously in this Preamble, Section 13.4 describes the comment on all aspects of this notice. the Department is not aware of any responsibilities of an MRO. However, the Department is providing Section 13.5 describes an MRO’s adulterants being used for oral fluid the following list of areas for which actions when reviewing an oral fluid specimens, but has included policies in specific comments are requested. specimen’s test results. This section these Guidelines to allow for the testing Section 3.1 requires federal agencies includes procedures that are specific to and reporting of adulterants in oral to test all oral fluid specimens for either oral fluid specimen results. fluid. albumin or IgG to determine specimen In Section 13.5, item c(2)(ii), the Section 14.4 includes the same policy validity. The Department specifically Department proposes a morphine or as the UrMG, requiring the laboratory to requests public comment on this codeine confirmatory concentration that report the split (B) specimen result to requirement. the MRO verifies as positive without the MRO. Section 3.4 lists the proposed cutoff requiring clinical evidence of illegal In Section 14.5, the Department is concentrations. The Department is drug use, when the donor does not have proposing the actions an MRO must take specifically requesting comments on the a legitimate medical explanation. As in after receiving the split (B) specimen appropriateness of these proposed the UrMG, this section states that the result. This section is analogous to the cutoffs. MRO must not consider consumption of corresponding section in the UrMG, Regarding Section 3.4, the Department food products as a legitimate with differences where applicable for is specifically interested in obtaining explanation for the donor having oral fluid specimen reports. information on the capability of morphine or codeine at or above the Section 14.6 is the same as the UrMG laboratories to test THCA analyte using specified concentration in his or her in regard to how an MRO reports a split a cutoff of 50 pg/mL and the validity of oral fluid. There is limited information (B) specimen result to an agency. whether THCA can be established as an in the scientific literature on the Section 14.7 is the same as the UrMG, accurate, sensitive and valid marker for codeine and/or morphine requiring the HHS-certified laboratory to oral fluid testing to detect marijuana concentrations seen in oral fluid after retain a split oral fluid specimen for the use. Additionally, the Department is consumption of poppy seed food same length of time that the primary interested in obtaining information products. Therefore, the Department is specimen is retained. whether THCA should be used to proposing a conservative concentration Subpart O—Criteria for Rejecting a extend the window of detection of of 150 ng/mL (i.e., 10 times the Specimen for Testing marijuana use. The Department is also confirmatory test cutoff) as the decision interested in receiving comments on point. The Department specifically Sections 15.1 and 15.2 contain the lowering the cutoff concentration for requests public comment on the same policies as the current UrMG for delta-9-tetrahydrocannabinol (THC) to appropriateness of this concentration. discrepancies requiring a laboratory to either 2 or 3 ng/mL for the initial test Section 13.6 describes what an MRO reject a specimen and for discrepancies cutoff concentration and to 1 ng/mL for must do when the collector reports that that require a laboratory to reject a the confirmatory cutoff concentration to a donor did not provide a sufficient specimen unless the discrepancy is extend the window of detection. amount of oral fluid for a drug test. This corrected. In section 7.3, the Department section contains the same procedures as Section 15.3 lists those discrepancies proposes performance requirements for the UrMG, with information specific to that would not affect either testing or a collection device. The Department is oral fluid specimens. reporting of an oral fluid specimen requesting specific comments on these Section 13.7 describes what an MRO result. These are similar to the requirements. must do when a donor has a permanent corresponding section in the UrMG, In Section 13.5, the Department or long-term medical condition that with differences where applicable for proposes a concentration of 150 ng/mL prevents him or her from providing a oral fluid specimens. morphine or codeine be used by the

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MRO to report a positive result in the requirements and allow an activity that substantially lessen the risks of absence of a legitimate medical was otherwise prohibited. The specimen substitution and adulteration explanation (i.e., prescription), without Administrative Procedure Act (APA) that has been associated with urine requiring clinical evidence of illegal delineates an exception to its specimen collections, most of which are opiate use, and to rule out the rulemaking procedures for ‘‘a matter unobserved. All oral fluid specimens possibility of a positive result due to relating to agency management or will be tested for either albumin or consumption of food products. The personnel’’ 5 U.S.C. 553(a)(2). Because immunoglobulin G (IgG) to identify Department is requesting specific the Guidelines issued by the Secretary invalid specimens. comments on this proposed govern federal workplace drug testing Saves Time concentration. programs, HHS has taken the position Oral fluid collection can require less Regulatory Impact and Notices that the Guidelines are a ‘‘matter relating to agency management or time than urine collection, reducing The Department welcomes public personnel’’ and, thus, are not subject to employee time away from the workplace comment on all figures and assumptions the APA’s requirements for notice and and, therefore, reducing costs to the described in this section. comment rulemaking. This position is federal agency employer. Oral fluid collection does not require a facility that Executive Orders 13563 and 12866 consistent with Executive Order 12564 regarding Drug-Free Workplaces, which provides visual privacy during the Executive Order 13563 of January 18, directs the Secretary to promulgate collection. It is expected that many oral 2011 (Improving Regulation and scientific and technical guidelines for fluid collections will occur at or near Regulatory Review) states ‘‘Our executive agency drug testing programs. the workplace, and not at a dedicated regulatory system must protect public collection site, thereby reducing the health, welfare, safety, and our Need for regulation amount of time away from the environment while promoting economic Enhances Flexibility workplace. The collector is allowed to growth, innovation, competitiveness, be in the vicinity of the donor, reducing and job creation.’’ Consistent with this The proposed Mandatory Guidelines the loss of productive time. The option mandate, Executive Order 13563 for Federal Workplace Drug Testing to collect a urine specimen in the event requires agencies to tailor ‘‘regulations Programs using Oral Fluid (OFMG) will that the donor cannot provide an oral to impose the least burden on society, provide flexibility to address workplace fluid specimen (and vice versa) will consistent with obtaining regulatory drug testing needs of federal agencies reduce both the need to reschedule a objectives.’’ Executive Order 13563 also while continuing to promulgate collection and the need for the MRO to requires agencies to ‘‘identify and established standards to ensure the full arrange a medical evaluation of a consider regulatory approaches that reliability and accuracy of drug test donor’s inability to provide a specimen. reduce burdens and maintain flexibility results. Administrative data indicates it takes, and freedom of choice’’ while selecting Enhances Versatility on average, about 4 hours from the start ‘‘those approaches that maximize net of the notification of the drug test to the benefits.’’ This notice proposes a Medical conditions exist that may actual time a donor reports back to the regulatory approach that will reduce prevent a federal employee or applicant worksite. Since oral fluid collection burdens to providers and to consumers from providing sufficient urine or oral does not have the same privacy while continuing to provide adequate fluid for a drug test. When the OFMG concerns as urine collection, onsite protections for public health and are implemented, in the event that an collections are likely, thereby reducing welfare. individual is unable to provide a urine the time a donor is away from the The Secretary has examined the specimen, the federal agency may worksite. The Department estimates the impact of the proposed Guidelines authorize the collection of an oral fluid time savings to be between 1 and 3 under Executive Order 12866, which specimen. In the event a federal agency hours. This range reflects uncertainty directs federal agencies to assess all adopts oral fluid testing and the donor around the location of the collection. costs and benefits of available regulatory is unable to collect an oral fluid The lower bound represents an estimate alternatives and, when regulation is specimen, the federal agency may also of time savings if the collection was necessary, to select regulatory authorize the collection of a urine conducted at an offsite location. The approaches that maximize net benefits specimen. This will reduce both the upper bound estimate represents the (including potential economic, need to reschedule collections and the time savings if the collection was environmental, public health and safety, need for the Medical Review Officer conducted at the employee’s workplace, and other advantages; distributive (MRO) to arrange a medical evaluation and thus incorporates travel time impacts; and equity). In addition, the of a donor’s inability to provide a savings. Using OPM’s estimate for the Department published a Federal specimen. average annual salary of Federal Register notice in June 2011 to solicit Urine collection requires use of a employees converted to an hourly wage, comments regarding the science and specialized collection facility, secured the savings generated for the Federal practice of oral fluid testing via a restrooms, the same gender, and other Government would be roughly $400,000 Request for Information (RFI) [76 FR special requirements. Oral fluid may be to $1.2 million a year, or $38 to $114 per 34086]. collected in various settings. An test. According to Executive Order 12866, acceptable oral fluid collection site must a regulatory action is ‘‘significant’’ if it allow the collector to observe the donor, Versatility in Detection meets any one of a number of specified maintain control of the collection The time course of drugs and conditions, including having an annual device(s) during the process, maintain metabolites differs between oral fluid effect on the economy of $100 million; record storage, and protect donor and urine, resulting in some differences adversely affecting in a material way a privacy. in analytes and detection times. Oral sector of the economy, competition, or fluid tests generally are positive as soon jobs; or if it raises novel legal or policy Decreases Invalid Tests as the drug is absorbed into the body. In issues. The proposed Guidelines do Oral fluid collections will occur contrast, urine tests that are based solely establish additional regulatory under observation, which should on detection of a metabolite are

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dependent upon the rate and extent of or substitute a donor’s urine specimen. testing. In addition, these proposed metabolite formation. Thus, oral fluid Due to individual privacy rights, most Guidelines include an alternative for may permit more interpretative insight urine collections are unobserved, laboratories to continue to use existing into recent drug use drug-induced allowing the opportunity to use such FDA-cleared immunoassays which do effects that may be present shortly products. As the Department has not have the specified cross-reactivity, before or at the time the specimen is established requirements and by establishing a decision point with the collected. A federal agency may select laboratories have developed procedures lowest-reacting analyte. An the specimen type for collection based to control for adulterated and immunoassay manufacturer may incur on the circumstances of the test. For substituted specimens, manufacturers costs if they choose to alter their example, in situations where drug use at have developed new products to avoid existing product and resubmit the the work-site is suspected, the testing of detection. Current research indicates immunoassay for FDA clearance. oral fluid may show the presence of an that some current substitution products Costs associated with the addition of active drug, which may indicate recent are indistinguishable from human urine. administration of the drug and be The use of these products is expected to oral fluid testing and testing for advantageous when assessing whether continue. oxycodone, oxymorphone, hydrocodone the drug contributed to an observed and hydromorphone will be minimal Time Horizon of This Analysis behavior. based on information from some HHS The transition to the testing of oral certified laboratories currently testing Advances in Oral Fluid Drug Testing fluids will be gradual and steady over non-regulated oral fluid specimens. In the past, urine was the only the course of four years, when it should Likewise, there will be minimal costs permitted specimen for forensic plateau. By this time, it is expected that associated with changing initial testing workplace drug testing. However, some oral fluid tests will account for 25–30% to include MDA and MDEA since issues that previously deterred the use of all regulated drug testing. This current immunoassays can be adapted of oral fluid for drug testing have been estimate is based on the non-regulated to test for these analytes. Prior to being resolved. The scientific basis for the use sector’s time course of the testing of oral allowed to test regulated oral fluid of oral fluid as an alternative specimen fluid and urine in the past four years. specimens, laboratories must be for drug testing has now been broadly certified by the Department through the Cost and Benefit established. For example, oral fluid NLCP. Estimated laboratory costs to collection devices and procedures have Using data obtained from the Federal complete and submit the application are been developed that protect against Workplace Drug Testing Programs and $2,000, and estimated costs for the biohazards, maintain the stability of HHS certified laboratories, the Department to process the application analytes, and provide sufficient oral Department estimates the number of are $7,200. These estimates are from fluid for testing. In addition, OFMG specimens tested annually for federal SAMHSA are based on the NLCP fee analyte cutoff concentrations are much agencies to be 150,000. HHS projects schedule and historical costs. The initial lower than those specified for urine in that approximately 7% (or 10,500) of the certification process includes the the Guidelines. Additionally, specimen 150,000 specimens tested per year will requirement to demonstrate that their volume is also much lower, saving time be oral fluid specimens and 93% (or performance meets Guidelines in collection and transport cost. 139,500) will be urine specimens. The requirements by testing three (3) groups Developments in analytical technologies approximate annual numbers of of PT samples. The Department will have allowed their use as efficient and regulated specimens for the Department provide the three groups of PT samples cost-effective methods that provide the of Transportation (DOT) and Nuclear through the NLCP at no cost. Based on needed analytical sensitivity and Regulatory Commission (NRC) are 6 costs charged for urine specimen accuracy for testing oral fluid million and 200,000, respectively. testing, laboratory costs to conduct the specimens. Should DOT and NRC allow oral fluid PT testing would range from $900 to testing in regulated industries’ $1,800 for each applicant laboratory. Current Testing in the Drug Free workplace programs, the estimated Workplace Program Agencies choosing to use oral fluid in annual numbers of specimens for DOT their drug testing programs may also Urine was the original specimen of would be 180,000 oral fluid and incur some costs for training of federal choice for forensic workplace drug 5,820,000 urine, and numbers of employees such as drug program testing, and urine testing is expected to specimens for NRC would be 14,000 coordinators. Based on current training remain an established and reliable oral fluid and 186,000 urine. modules offered to drug program component of federal workplace drug In Section 3.4, the Department is coordinators, and other associated costs testing programs. Urine testing provides proposing criteria for calibrating initial including travel for 90% of drug scientifically accurate and legally tests for grouped analytes such as program coordinators, the estimated defensible results and has proven to be opiates and amphetamines, and total training cost for a one-day training an effective deterrent to drug use in the specifying the cross-reactivity of the session would be between $54,000 and workplace. immunoassay to the other analytes(s) $69,000. This training cost is included A major challenge to urine drug within the group. These proposed in the costs of the revised URMG. testing has been the proliferation of Guidelines allow the use of methods commercial products used to adulterate other than immunoassay for initial Summary of One-Time Costs

Lower bound Upper bound Primary

Cost of Application * ...... $62,000.00 Application Processing * ...... 217,000.00 Performance Testing * ...... 27,900.00 55,800.00 ...... Training * ...... 54,000.00 69,000.00 ......

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Lower bound Upper bound Primary

Total ...... 360,900.00 403,800.00 ...... * Estimated using costs presented above multiplied by the number of laboratories (31).

Costs and Benefits effects on competition, employment, programs. The Department of Health Thus, the Department estimates one- productivity, or innovation; or and Human Services, by authority of time, upfront costs of between $360,000 significant effects on the ability of U.S.- Section 503 of Public Law 100–71, 5 and $400,000. While the Department based enterprises to compete with U.S.C. Section 7301, and Executive has only monetized a small portion of foreign-based enterprises in domestic or Order No. 12564, establishes the the benefits (time savings) to a small export markets. This is not a major rule scientific and technical guidelines for subset of the workplace drug testing under the Small Business Regulatory federal workplace drug testing programs programs that could be affected by the Enforcement Fairness Act (SBREFA) of and establishes standards for OFMG (i.e., Federal employee testing 1996. certification of laboratories engaged in urine drug testing for federal agencies. programs and not drug testing programs Unfunded Mandates conducted under NRC and DOT Because the Mandatory Guidelines The Secretary has examined the govern standards applicable to the regulations), the Department is impact of the proposed Guidelines management of federal agency confident that the benefits would under the Unfunded Mandates Reform personnel, there should be little, if any, outweigh the costs. Even if NRC and Act (UMRA) of 1995 (Pub. L. 104–4). direct effect on the states, on the DOT do not implement oral fluid This notice does not trigger the relationship between the national testing, the benefits to Federal requirement for a written statement government and the states, or on the workplace testing programs, estimated under section 202(a) of the UMRA distribution of power and at between $400,000 and $1.2 million, because the proposed Guidelines do not responsibilities among the various would recur on annual basis. impose a mandate that results in an levels of government. Accordingly, the Regulatory Flexibility Analysis expenditure of $100 million (adjusted Secretary has determined that the annually for inflation) or more by either For the reasons outlined above, the Guidelines do not contain policies that state, local, and tribal governments in have federalism implications. Secretary has determined that the the aggregate or by the private sector in proposed Guidelines will not have a any one year. Paperwork Reduction Act of 1995 significant impact upon a substantial The proposed Guidelines contain Environmental Impact number of small entities within the information collection requirements meaning of the Regulatory Flexibility The Secretary has considered the which are subject to review by the Act [5 U.S.C. 605(b)]. The flexibility environmental effects of the OFMG. No Office of Management and Budget added by the OFMG will not require information or comments have been (OMB) under the Paperwork Reduction addition expenditures. Therefore, an received that would affect the agency’s Act of 1995 [the PRA 44 U.S.C. 3507(d)]. initial regulatory flexibility analysis is determination there would be a Information collection and not required for this notice. significant impact on the human recordkeeping requirements which As mentioned in the section on environment and that neither an would be imposed on laboratories Executive Orders 13563 and 12866, the environmental assessment nor an engaged in drug testing for federal Secretary anticipates that there will be environmental impact statement is agencies concern quality assurance and an overall reduction in costs if drug required. quality control documentation, reports, testing is expanded under the OFMG. Executive Order 13132: Federalism performance testing, and inspections as The costs to implement this change to set out in subparts H, I, K, L, M and N. regulation are negligible. The added The Secretary has analyzed the To facilitate ease of use and uniform flexibility will permit federal agencies proposed Guidelines in accordance with reporting, a Federal CCF for each type to select the specimen type best suited Executive Order 13132: Federalism. of specimen collected will be developed for their needs and to authorize Executive Order 13132 requires federal as referenced in section 6.1. The collection of an alternative specimen agencies to carefully examine actions to Department has submitted the type when an employee is unable to determine if they contain policies that information collection and provide the originally authorized have federalism implications or that recordkeeping requirements contained specimen type. Insofar as there are costs preempt state law. As defined in the in the proposed Guidelines to OMB for associated with each drug test, this Order, ‘‘policies that have federalism review and approval. could lead to lower overall testing costs implications’’ refer to regulations, for federal agencies. The added legislative comments or proposed Privacy Act flexibility will also benefit federal legislation, and other policy statements The Secretary has determined that the employees, who should be able to or actions that have substantial direct Guidelines do not contain information provide one of the specimen types, effects on the states, on the relationship collection requirements constituting a thereby facilitating the drug test between the national government and system of records under the Privacy Act. required for their employment. the states, or on the distribution of The Federal Register notice announcing The Secretary has determined that the power and responsibilities among the the proposed Mandatory Guidelines for proposed Guidelines are not a major various levels of government. Federal Workplace Drug Testing rule for the purpose of congressional In this notice, the Secretary is Programs using Oral Fluid is not a review. For the purpose of congressional proposing to establish standards for system of records as noted in the review, a major rule is one which is certification of laboratories engaged in information collection/recordkeeping likely to cause an annual effect on the oral fluid drug testing for federal requirements below. As required, HHS economy of $100 million; a major agencies and the use of oral fluid testing originally published the Mandatory increase in costs or prices; significant in federal drug-free workplace Guidelines for Federal Workplace Drug

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Testing Programs (Guidelines) in the Information Collection/Recordkeeping Description: The Guidelines establish Federal Register on April 11, 1988 [53 Requirements the scientific and technical guidelines FR 11979]. SAMHSA subsequently The information collection for federal drug testing programs and revised the Guidelines on June 9, 1994 requirements (i.e., reporting and establish standards for certification of [59 FR 29908], September 30, 1997 [62 recordkeeping) in the current laboratories engaged in drug testing for FR 51118], November 13, 1998 [63 FR Guidelines, which establish the federal agencies under authority of 63483], April 13, 2004 [69 FR 19644], scientific and technical guidelines for Public Law 100–71, 5 U.S.C. 7301 note, and November 25, 2008 [73 FR 71858] federal workplace drug testing programs and Executive Order No. 12564. Federal with an effective date of May 1, 2010 and establish standards for certification drug testing programs test applicants to (correct effective date published on of laboratories engaged in urine drug sensitive positions, individuals December 10, 2008 [73 FR 75122]). The testing for federal agencies under involved in accidents, individuals for effective date of the Guidelines was authority of 5 U.S.C. 7301 and Executive cause, and random testing of persons in sensitive positions. The program has further changed to October 1, 2010 on Order 12564, are approved by the Office depended on urine specimen testing April 30, 2010 [75 FR 22809]. of Management and Budget (OMB) under control number 0930–0158. The since 1988; the reporting, recordkeeping Executive Order 13175: Consultation Federal Drug Testing Custody and and disclosure requirements associated and Coordination With Indian Tribal Control Form used to document the with urine specimen testing are Governments collection and chain of custody of urine approved under OMB control number specimens at the collection site, for 0930–0158. Since 1988, several Executive Order 13175 (65 FR 67249, laboratories to report results, and for products have appeared on the market November 6, 2000) requires SAMHSA to Medical Review Officers to make a making it easier for individuals to develop an accountable process to determination, the National Laboratory adulterate the urine specimen. Scientific ensure ‘‘meaningful and timely input by Certification Program (NLCP) advances in the use of oral fluid in tribal officials in the development of application, the NLCP Laboratory detecting drugs have made it possible regulatory policies that have tribal Information Checklist, and for this alternative specimen to be used implications.’’ ‘‘Policies that have tribal recordkeeping requirements in the in federal programs with the same level implications’’ as defined in the current Guidelines, as approved under of confidence that has been applied to Executive Order, include regulations control number 0930–0158, will remain the use of urine. The proposed that have ‘‘substantial direct effects on in effect until final Guidelines including Guidelines establish when oral fluid one or more Indian tribes, on the the use of oral fluid specimens are specimens may be collected, the relationship between the federal issued. procedures that must be used in government and the Indian tribes, or on The title, description and respondent collecting an oral fluid specimen, and the distribution of power and description of the information the certification process for approving a laboratory to test oral fluid specimen. responsibilities between the federal collections are shown in the following Description of Respondents: government and Indian tribes.’’ The paragraphs with an estimate of the Individuals or households; businesses; proposed Guidelines do not have tribal annual reporting, disclosure and recordkeeping burden. Included in the or other-for-profit; not-for-profit implications. The Guidelines will not estimate is the time for reviewing institutions. have substantial direct effects on tribal instructions, searching existing data The burden estimates in the tables governments, on the relationship sources, gathering and maintaining the below are based on the following between the federal government and data needed, and completing and number of respondents: 38,000 donors Indian tribes, or on the distribution of reviewing the collection of information. who apply for employment in testing power and responsibilities between the Title: The Mandatory Guidelines for designated positions, 100 collectors, 10 federal government and Indian tribes, as Federal Workplace Drug Testing oral fluid specimen testing laboratories, specified in Executive Order 13175. Programs using Oral Fluid Specimens. and 100 MROs.

ESTIMATE OF ANNUAL REPORTING BURDEN

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

9.2(a)(1) ...... Laboratory required to submit application 10 1 3 30 for certification. 9.10(a)(3) ...... Materials to submit to become an HHS in- 10 1 2 20 spector. 11.3(a) ...... Laboratory submits qualifications of RP to 10 1 2 20 HHS. 11.4(c) ...... Laboratory submits information to HHS on 10 1 2 20 new RP or alternate RP. 11.20 ...... Specifications for laboratory semi-annual 10 5 0 .5 25 statistical report of test results to each federal agency. 13.9 & 14.6 ...... Specifies that MRO must report all verified 100 5 * 0 .05 25 split specimen test results to the federal agency. 16.1(b) & 16.5(a) ...... Specifies content of request for informal 1 1 3 3 review of suspension/proposed revoca- tion of certification.

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ESTIMATE OF ANNUAL REPORTING BURDEN—Continued

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

16.4 ...... Specifies information appellant provides in 1 1 0 .5 0 .5 first written submission when laboratory suspension/revocation is proposed. 16.6 ...... Requires appellant to notify reviewing offi- 1 1 0.5 0.5 cial of resolution status at end of abey- ance period. 16.7(a) ...... Specifies contents of appellant submission 1 1 50 50 for review. 16.9(a) ...... Specifies content of appellant request for 1 1 3 3 expedited review of suspension or pro- posed revocation. 16.9(c) ...... Specifies contents of review file and briefs 1 1 50 50

Total ...... 156 ...... 247 * 3 min.

The following reporting requirements CCF when a sample is a blind sample to report a split specimen result. are also in the proposed Guidelines, but (section 10.3(a)); MRO notifies the SAMHSA has not calculated a separate have not been addressed in the above federal agency and HHS when an error reporting burden for these requirements reporting burden table: Collector must occurs on a blind sample (section because they are included in the burden report any unusual donor behavior or 10.4(c)); section 13.5 describes the hours estimated for collectors to refuse to participate in the collection actions an MRO takes to report a complete Federal CCFs and for MROs to process on the Federal CCF (sections primary specimen result; and section report results to federal agencies. 1.8, 8.9); collector annotates the Federal 14.5 describes the actions an MRO takes

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

Number of Responses/ Hours/ Total Section Purpose respondents respondent response hours

8.3(a) & 8.6(b)(2) ...... Collector must contact federal agency point of 100 1 *0 .05 5 contact. 11.21 & 11.22 ...... Information on drug test that laboratory must 10 10 3 1,500 provide to federal agency upon request or to donor through MRO. 13.8(b) ...... MRO must inform donor of right to request split 100 5 3 1,500 specimen test when a positive or adulterated result is reported.

Total ...... 210 ...... 3,505 * 3 min.

The following disclosure donor and answer any questions collection procedure to the donor and requirements are also included in the (section 8.3(f) and (h), and must review answer any questions is a standard proposed Guidelines, but have not been the procedures for the oral fluid business practice and not a disclosure addressed in the above disclosure specimen collection device used with burden. burden table: The collector must explain the donor (section 8.4(b)). SAMHSA the basic collection procedure to the believes having the collector explain the

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

Number of Responses/ Hours/ Total Section Purpose respondents respondent response hours

8.3, 8.5, & 8.8 ...... Collector completes Federal CCF for specimen 100 380 *0 .07 2,534 collected. 8.8(d) & (f) ...... Donor initials specimen labels/seals and signs 38,000 1 **0 .08 3,167 statement on the Federal CCF. 11.8(a) & 11.17...... Laboratory completes Federal CCF upon re- 10 3,800 ***0 .05 1,900 ceipt of specimen and before reporting result. 13.4(d)(4), 13.9(c), & MRO completes Federal CCF before reporting 100 380 ***0 .05 1,900 14.6(c). the result. 14.1(b) ...... MRO documents donor’s request to have split 300 1 ***0 .05 15 specimen tested.

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ESTIMATE OF ANNUAL RECORDKEEPING BURDEN—Continued

Number of Responses/ Hours/ Total Section Purpose respondents respondent response hours

Total ...... 38,510 ...... 9,516 * 4 min. ** 5 min. *** 3 min.

The proposed Guidelines contain a above tables). This is in addition to the drug testing. J Anal Toxicol, 25, 396–399. number of recordkeeping requirements 1,788,809 hours currently approved by 3. Choo, R.E., Huestis, M.A., 2004. Oral fluid that SAMHSA considers not to be an OMB under control number 0930–0158 as a diagnostic tool. Clin Chem Lab Med, additional recordkeeping burden. In for urine testing under the current 42, 1273–1287. 4. Cone, E.J., Huestis, M.A., 2007. subpart D, a trainer is required to Guidelines. Interpretation of oral fluid tests for drugs document the training of an individual As required by section 3507(d) of the of abuse. Ann N Y Acad Sci, 1098, 51– to be a collector [section 4.3(a)(3)] and PRA, the Secretary has submitted a copy 103. the documentation must be maintained of these proposed Guidelines to OMB 5. Drummer, O.H., 2006. Drug testing in oral in the collector’s training file [section for its review. Comments on the fluid. Clin Biochem Rev, 27, 147–159. 4.3(c)]. SAMHSA believes this training information collection requirements are 6. Kadehjian, L., 2005. Legal issues in oral documentation is common practice and specifically solicited in order to: (1) fluid testing. Forensic Sci Int, 150, 151– is not considered an additional burden. Evaluate whether the proposed 160. In subpart F, if a collector uses an collection of information is necessary 7. Pil, K., Verstraete, A., 2008. Current for the proper performance of HHS’s developments in drug testing in oral incorrect form to collect a federal fluid. Ther Drug Monit, 30, 196–202. agency specimen, the collector is functions, including whether the 8. Samyn, N., De Boeck, G., Verstraete, A.G., required to provide a statement [section information will have practical utility; 2002. The use of oral fluid and sweat 6.2(b)] explaining why an incorrect form (2) evaluate the accuracy of HHS’s wipes for the detection of drugs of abuse was used to document collecting the estimate of the burden of the proposed in drivers. J Forensic Sci, 47, 1380–1387. specimen. SAMHSA believes this is an collection of information, including the 9. Samyn, N., Laloup, M., De Boeck, G., 2007. extremely infrequent occurrence and validity of the methodology and Bioanalytical procedures for assumptions used; (3) enhance the determination of drugs of abuse in oral does not create a significant additional fluid. Anal Bioanal Chem, 388, 1437– recordkeeping burden. Subpart H quality, utility, and clarity of the information to be collected; and (4) 1453. [sections 8.4(d) and 8.5(a)(1)] requires 10. Toennes, S.W., Kauert, G.F., Steinmeyer, collectors to enter any information on minimize the burden of the collection of S., Moeller, M.R., 2005. Driving under the Federal CCF of any unusual findings information on those who are to the influence of drugs—evaluation of during the oral fluid specimen respond, including through the use of analytical data of drugs in oral fluid, collection procedure. These appropriate automated, electronic, serum and urine, and correlation with recordkeeping requirements are an mechanical, or other technological impairment symptoms. Forensic Sci Int, integral part of the collection procedure collection techniques or other forms of 152, 149–155. information technology. 11. Verstraete, A.G., 2004. Detection times of and are essential to documenting the drugs of abuse in blood, urine, and oral chain of custody for the specimens OMB is required to make a decision concerning the collection of information fluid. Ther Drug Monit, 26, 200–205. collected. The burden for these entries 12. Verstraete, A.G., 2005. Oral fluid testing are included in the recordkeeping contained in these proposed Guidelines for driving under the influence of drugs: burden estimated to complete the between 30 and 60 days after history, recent progress and remaining Federal CCF and is, therefore, not publication of this document in the challenges. Forensic Sci Int, 150, 143– considered an additional recordkeeping Federal Register. Therefore, a comment 150. burden. Subparts K describe a number to OMB is best assured of having its full 13. Allen, K.R., Azad, R., Field, H.P., Blake, effect if OMB receives it within 30 days D.K., 2005. Replacement of of recordkeeping requirements for immunoassay by LC tandem mass laboratories associated with their testing of publication. This does not affect the deadline for the public to comment to spectrometry for the routine procedures, maintaining chain of measurement of drugs of abuse in oral custody, and keeping records (i.e., HHS on the proposed Guidelines. fluid. Ann Clin Biochem, 42, 277–284. Organizations and individuals sections 11.1(a) and (d); 11.2(b), (c), and 14. Badawi, N., Simonsen, K.W., Steentoft, desiring to submit comments on the (d); 11.6(b); 11.7(c); 11.8; 11.10(1); A., Bernhoft, I.M., Linnet, K., 2009. information collection requirements 11.13(a); 11.16; 11.17(a), (b), and (c); Simultaneous screening and should direct them to the Office of quantification of 29 drugs of abuse in 11.20; 11.21, and 11.22. These Information and Regulatory Affairs, oral fluid by solid-phase extraction and recordkeeping requirements are OMB, New Executive Office Building, ultraperformance LC–MS/MS. Clin necessary for any laboratory to conduct 725 17th Street NW., Washington, DC Chem, 55, 2004–2018. forensic drug testing and to ensure the 20502, Attn: Desk Officer for SAMHSA. 15. Concheiro, M., de Castro, A., Quintela, scientific supportability of the test O., Cruz, A., Lopez-Rivadulla, M., 2008. Because of delays in receipt of mail, results. Therefore, they are considered Determination of illicit and medicinal comments may also be sent to (202) to be standard business practice and are drugs and their metabolites in oral fluid 395–6974 (fax). not considered a burden for this and preserved oral fluid by liquid analysis. References chromatography-tandem mass Thus the total annual response spectrometry. Anal Bioanal Chem, 391, 1. Bosker, W.M., Huestis, M.A., 2009. Oral 2329–2338. burden associated with the testing of fluid testing for drugs of abuse. Clin 16. Concheiro, M., Gray, T.R., Shakleya, oral fluid specimens by the laboratories Chem, 55, 1910–1931. D.M., Huestis, M.A., 2010. High- is estimated to be 13,268 hours (that is, 2. Caplan, Y.H., Goldberger, B.A., 2001. throughput simultaneous analysis of the sum of the total hours from the Alternative specimens for workplace buprenorphine, methadone, cocaine,

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compared to self reports of recent 90–97. Dated: May 4, 2015. cocaine and heroin use by methadone 106. Freudenmann, R.W., Spitzer, M., 2004. Pamela S. Hyde, maintenance patients. Forensic Sci Int, The Neuropsychopharmacology and Administrator, SAMHSA. 215, 88–91. Toxicology of 3, 4-methylenedioxy-N- Dated: May 7, 2015. 94. Cone, E.J., Clarke, J., Tsanaclis, L., 2007. ethyl-amphetamine (MDEA). CNS Drug Prevalence and disposition of drugs of Sylvia M. Burwell, Rev, 10, 89–116. abuse and opioid treatment drugs in oral Secretary. 107. U.S. Department of Health and Human fluid. J Anal Toxicol, 31, 424–433. For reasons set forth in the preamble, 95. Dams, R., Choo, R.E., Lambert, W.E., Services, Behavioral Health Coordinating Committee, Prescription Drug Abuse the Department proposes to revise the Jones, H., Huestis, M.A., 2007. Oral fluid Mandatory Guidelines for Federal as an alternative matrix to monitor opiate Subcommittee, Addressing Prescription and cocaine use in substance-abuse Drug Abuse in the United States: Current Workplace Drug Testing Programs to treatment patients. Drug Alcohol Activities and Future Opportunities. include Mandatory Guidelines using Depend, 87, 258–267. Department of Health and Human Oral Fluid Specimens to read as follows: 96. Presley, L., Lehrer, M., Seiter, W., Hahn, Services, 2013. http://www.cdc.gov/ Mandatory Guidelines for Federal D., Rowland, B., Smith, M., Kardos, HomeandRecreationalSafety/pdf/HHS_ K.W., Fritch, D., Salamone, S., Niedbala, Workplace Drug Testing Programs Prescription_Drug_Abuse_Report_ R.S., Cone, E.J., 2003. High prevalence of Using Oral Fluid Specimens 09.2013.pdf (accessed 15 September 6-acetylmorphine in morphine-positive Subpart A—Applicability oral fluid specimens. Forensic Sci Int, 2014). 133, 22–25. 108. Heltsley, R., DePriest, A., Black, D.L., 1.1 To whom do these Guidelines apply? 97. Cook, C.E., Brine, D.R., Jeffcoat, A.R., Robert, T., Marshall, L., Meadors, V.M., 1.2 Who is responsible for developing and Hill, J.M., Wall, M.E., Perez-Reyes, M., Caplan, Y.H., Cone, E.J., 2011. Oral fluid implementing these Guidelines? DiGuiseppi, S.R., 1982. Phencyclidine drug testing of chronic pain patients. I. 1.3 How does a federal agency request a disposition after intravenous and oral Positive prevalence rates of licit and change from these Guidelines? 1.4 How are these Guidelines revised? doses. Clin Pharmacol Ther, 31, 625– illicit drugs. J Anal Toxicol,35, 529–540. 634. 1.5 What do the terms used in these 109. Cone, E.J., Darwin, W.D., Buchwald, Guidelines mean? 98. McCarron, M.M., Walberg, C.B., Soares, W.F., Gorodetzky, C.W., 1983. J.R., Gross, S.J., Baselt, R.C., 1984. 1.6 What is an agency required to do to Oxymorphone metabolism and urinary protect employee records? Detection of phencyclidine usage by excretion in human, rat, guinea pig, radioimmunoassay of saliva. J Anal 1.7 What is a refusal to take a federally rabbit, and dog. Drug Metab Dispos, 11, Toxicol, 8, 197–201. regulated drug test? 99. Wan, S.H., Matin, S.B., Azarnoff, D.L., 446–450. 1.8 What are the potential consequences for 1978. Kinetics, salivary excretion of 110. Ritschel, W., Parab, P.V., Denson, D.D., refusing to take a federally regulated amphetamine isomers, and effect of Coyle, D.E., Gregg, R.V., 1987. Absolute drug test? urinary pH. Clin Pharmacol Ther, 23, bioavailability of hydromorphone after Subpart B—Oral Fluid Specimens peroral and rectal administration in 585–590. 2.1 What type of specimen may be 100. Engblom, C., Gunnar, T., Rantanen,A., humans: saliva/plasma ratio and clinical collected? Lillsunde, P., 2007. Driving under the effects. J Clin Pharmacol, 27, 647–653. 2.2 Under what circumstances may an oral influence of drugs—amphetamine 111. Cone, E.J., Phelps, B.A., Gorodetzky, fluid specimen be collected? concentrations in oral fluid and whole C.W., 1977. Urinary excretion of 2.3 How is each oral fluid specimen blood samples. J Anal Toxicol, 31, 276– hydromorphone and metabolites in collected? 280. humans, rats, dogs, guinea pigs, and 2.4 What volume of oral fluid is collected? 101. Huestis, M.A., Cone, E.J., 2007. rabbits. J Pharm Sci, 66, 1709–1713. 2.5 How is the split oral fluid specimen Methamphetamine disposition in oral 112. Cone, E.J., Caplan, Y.H., Moser, F., collected? fluid, plasma, and urine. Ann N Y Acad Robert, T., Black, D., 2008. Evidence that 2.6 When may an entity or individual Sci, 1098, 104–121. release an oral fluid specimen? 102. Schepers, R.J., Oyler, J.M., Joseph, R.E., morphine is metabolized to Jr., Cone, E.J., Moolchan, E.T., Huestis, hydromorphone but not to Subpart C—Oral Fluid Specimen Tests M.A., 2003. Methamphetamine and oxymorphone. J Anal Toxicol, 32, 319– 3.1 Which tests are conducted on an oral amphetamine pharmacokinetics in oral 323. fluid specimen? fluid and plasma after controlled oral 113. Cone, E.J., Heit, H.A., Caplan, Y.H., 3.2 May a specimen be tested for additional methamphetamine administration to Gourlay, D., 2006. Evidence of morphine drugs? human volunteers. Clin Chem, 49, 121– metabolism to hydromorphone in pain 3.3 May any of the specimens be used for 132. patients chronically treated with other purposes? 103. Barnes, A.J., Scheidweiler, K.B., morphine. J Anal Toxicol, 30, 1–5. 3.4 What are the drug test cutoff Kolbrich-Spargo, E.A., Gorelick, D.A., concentrations for undiluted (neat) oral Goodwin, R.S., Huestis, M.A., 2011. The Department believes that the fluid? MDMA and metabolite disposition in benefits of the proposed Mandatory 3.5 May an HHS-certified laboratory expectorated oral fluid after controlled Guidelines using Oral Fluid Specimens perform additional drug and/or oral MDMA administration. Ther Drug outweigh the costs to include this specimen validity tests on a specimen at Monit, 33, 602–608. the request of the Medical Review 104. Navarro, M., Pichini, S., Farre, M., additional specimen type in federal Officer (MRO)? Ortuno, J., Roset, P.N., Segura, J., de.la workplace drug testing programs. There 3.6 What criteria are used to report an oral Torre, R., 2001. Usefulness of saliva for is no requirement for federal agencies to fluid specimen as adulterated? measurement of 3, 4- use oral fluid as part of their drug 3.7 What criteria are used to report an methylenedioxymethamphetamine and testing program. A federal agency may invalid result for an oral fluid specimen? its metabolites: correlation with plasma choose to use urine, oral fluid, or both Subpart D—Collectors drug concentrations and effect of salivary specimen types in their program based pH. Clin Chem, 47, 1788–1795. on the agency’s mission, its employees’ 4.1 Who may collect a specimen? 105. Samyn, N., De Boeck, G., Wood, M., 4.2 Who may not collect a specimen? Lamers, C.T., De Waard, D., Brookhuis, duties, and the danger to the public 4.3 What are the requirements to be a K.A., Verstraete, A.G., Riedel, W.J., 2002. health and safety or to national security collector? Plasma, oral fluid and sweat wipe that could result from an employee’s 4.4 What are the requirements to be a ecstasy concentrations in controlled and failure to carry out the duties of his or trainer for collectors? real life conditions. Forensic Sci Int, 128, her position. 4.5 What must a federal agency do before a

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collector is permitted to collect a 9.6 What are the PT requirements for an drug test? specimen? applicant laboratory? 11.12 What are the requirements for a 9.7 What are the PT requirements for an confirmatory drug test? Subpart E—Collection Sites HHS-certified oral fluid laboratory? 11.13 What must an HHS-certified 5.1 Where can a collection for a drug test 9.8 What are the inspection requirements laboratory do to validate a confirmatory take place? for an applicant laboratory? drug test? 5.2 What are the requirements for a 9.9 What are the maintenance inspection 11.14 What are the batch quality control collection site? requirements for an HHS-certified requirements when conducting a 5.3 Where must collection site records be laboratory? confirmatory drug test? stored? 9.10 Who can inspect an HHS-certified 11.15 What are the analytical and quality 5.4 How long must collection site records laboratory and when may the inspection control requirements for conducting be stored? be conducted? specimen validity tests? 5.5 How does the collector ensure the 9.11 What happens if an applicant 11.16 What must an HHS-certified security and integrity of a specimen at laboratory does not satisfy the minimum laboratory do to validate a specimen the collection site? requirements for either the PT program validity test? 5.6 What are the privacy requirements or the inspection program? 11.17 What are the requirements for an when collecting an oral fluid specimen? 9.12 What happens if an HHS-certified HHS-certified laboratory to report a test result? Subpart F—Federal Drug Testing Custody laboratory does not satisfy the minimum 11.18 How long must an HHS-certified and Control Form requirements for either the PT program or the inspection program? laboratory retain specimens? 6.1 What federal form is used to document 9.13 What factors are considered in 11.19 How long must an HHS-certified custody and control? determining whether revocation of a laboratory retain records? 6.2 What happens if the correct OMB- laboratory’s HHS certification is 11.20 What statistical summary reports approved Federal CCF is not available or necessary? must an HHS-certified laboratory is not used? 9.14 What factors are considered in provide for oral fluid testing? 11.21 What HHS-certified laboratory Subpart G—Oral Fluid Specimen Collection determining whether to suspend a information is available to a federal Devices laboratory’s HHS certification? 9.15 How does the Secretary notify an HHS- agency? 7.1 What is used to collect an oral fluid 11.22 What HHS-certified laboratory specimen? certified laboratory that action is being taken against the laboratory? information is available to a federal 7.2 What are the requirements for an oral employee? fluid collection device? 9.16 May a laboratory that had its HHS certification revoked be recertified to test 11.23 What types of relationships are 7.3 What are the minimum performance prohibited between an HHS-certified requirements for a collection device? federal agency specimens? 9.17 Where is the list of HHS-certified laboratory and an MRO? Subpart H—Oral Fluid Specimen Collection laboratories published? Subpart L—Instrumented Initial Test Procedure Facility (IITF) Subpart J—Blind Samples Submitted by an 8.1 What privacy must the donor be given Agency 12.1 May an IITF test oral fluid specimens when providing an oral fluid specimen? for a federal agency’s workplace drug 10.1 What are the requirements for federal 8.2 What must the collector ensure at the testing program? collection site before starting an oral agencies to submit blind samples to fluid specimen collection? HHS-certified laboratories? Subpart M—Medical Review Officer (MRO) 8.3 What are the preliminary steps in the 10.2 What are the requirements for blind 13.1 Who may serve as an MRO? oral fluid specimen collection samples? 13.2 How are nationally recognized entities procedure? 10.3 How is a blind sample submitted to an or subspecialty boards that certify MROs 8.4 What steps does the collector take in the HHS-certified laboratory? approved? collection procedure before the donor 10.4 What happens if an inconsistent result 13.3 What training is required before a provides an oral fluid specimen? is reported for a blind sample? physician may serve as an MRO? 8.5 What steps does the collector take Subpart K—Laboratory 13.4 What are the responsibilities of an during and after the oral fluid specimen MRO? collection procedure? 11.1 What must be included in the HHS- 13.5 What must an MRO do when 8.6 What procedure is used when the donor certified laboratory’s standard operating reviewing an oral fluid specimen’s test states that he or she is unable to provide procedure manual? results? an oral fluid specimen? 11.2 What are the responsibilities of the 13.6 What action does the MRO take when 8.7 If the donor is unable to provide an oral responsible person (RP)? the collector reports that the donor did fluid specimen, may another specimen 11.3 What scientific qualifications must the not provide a sufficient amount of oral type be collected for testing? RP have? fluid for a drug test? 8.8 How does the collector prepare the oral 11.4 What happens when the RP is absent 13.7 What happens when an individual is fluid specimens? or leaves an HHS-certified laboratory? unable to provide a sufficient amount of 8.9 How does the collector report a donor’s 11.5 What qualifications must an individual oral fluid for a federal agency applicant/ refusal to test? have to certify a result reported by an pre-employment test, a follow-up test, or 8.10 What are a federal agency’s HHS-certified laboratory? a return-to-duty test because of a responsibilities for a collection site? 11.6 What qualifications and training must permanent or long-term medical other personnel of an HHS-certified condition? Subpart I—HHS Certification of Laboratories laboratory have? 13.8 Who may request a test of a split (B) 9.1 Who has the authority to certify 11.7 What security measures must an HHS- specimen? laboratories to test oral fluid specimens certified laboratory maintain? 13.9 How does an MRO report a primary for federal agencies? 11.8 What are the laboratory chain of (A) specimen test result to an agency? 9.2 What is the process for a laboratory to custody requirements for specimens and 13.10 What types of relationships are become HHS-certified? aliquots? prohibited between an MRO and an 9.3 What is the process for a laboratory to 11.9 What are the requirements for an HHS-certified laboratory? maintain HHS certification? initial drug test? 9.4 What is the process when a laboratory 11.10 What must an HHS-certified Subpart N—Split Specimen Tests does not maintain its HHS certification? laboratory do to validate an initial drug 14.1 When may a split (B) specimen be 9.5 What are the qualitative and test? tested? quantitative specifications of 11.11 What are the batch quality control 14.2 How does an HHS-certified laboratory performance testing (PT) samples? requirements when conducting an initial test a split (B) specimen when the

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primary (A) specimen was reported (3) Any other employing unit or change for which a waiver is sought and positive? authority of the federal government a detailed justification for the change. 14.3 How does an HHS-certified laboratory except the United States Postal Service, Section 1.4 How are these Guidelines test a split (B) oral fluid specimen when the Postal Rate Commission, and the primary (A) specimen was reported revised? employing units or authorities in the adulterated? (a) To ensure the full reliability and 14.4 Who receives the split (B) specimen Judicial and Legislative Branches; and result? (4) The Intelligence Community, as accuracy of specimen tests, the accurate 14.5 What action(s) does an MRO take after defined by Executive Order 12333, is reporting of test results, and the receiving the split (B) oral fluid subject to these Guidelines only to the integrity and efficacy of federal drug specimen result from the second HHS- extent agreed to by the head of the testing programs, the Secretary may certified laboratory? affected agency; make changes to these Guidelines to 14.6 How does an MRO report a split (B) (5) Laboratories that provide drug reflect improvements in the available specimen test result to an agency? testing services to the federal agencies; science and technology. 14.7 How long must an HHS-certified (b) The changes will be published in laboratory retain a split (B) specimen? (6) Collectors who provide specimen collection services to the federal final as a notice in the Federal Register. Subpart O—Criteria for Rejecting a agencies; and Specimen for Testing Section 1.5 What do the terms used in (7) Medical Review Officers (MROs) these Guidelines mean? 15.1 What discrepancies require an HHS- who provide drug testing review and certified laboratory to report a specimen interpretation of results services to the The following definitions are adopted: as rejected for testing? federal agencies. Accessioner. The individual who 15.2 What discrepancies require an HHS- (b) These Guidelines do not apply to signs the Federal Drug Testing Custody certified laboratory to report a specimen and Control Form at the time of as rejected for testing unless the drug testing under authority other than Executive Order 12564, including specimen receipt at the HHS-certified discrepancy is corrected? laboratory or (for urine) the HHS- 15.3 What discrepancies are not sufficient testing of persons in the criminal justice system, such as arrestees, detainees, certified IITF. to require an HHS-certified laboratory to Adulterated Specimen. A specimen reject an oral fluid specimen for testing probationers, incarcerated persons, or that has been altered, as evidenced by or an MRO to cancel a test? parolees.1 15.4 What discrepancies may require an test results showing either a substance MRO to cancel a test? Section 1.2 Who is responsible for that is not a normal constituent for that developing and implementing these type of specimen or showing an Subpart P—Laboratory Suspension/ Guidelines? abnormal concentration of an Revocation Procedures (a) Executive Order 12564 and Public endogenous substance. 16.1 When may the HHS certification of a Aliquot. A portion of a specimen used laboratory be suspended? Law 100–71 require the Department of Health and Human Services (HHS) to for testing. 16.2 What definitions are used for this Alternate Responsible Person. The subpart? establish scientific and technical person who assumes professional, 16.3 Are there any limitations on issues guidelines for federal workplace drug organizational, educational, and subject to review? testing programs. administrative responsibility for the 16.4 Who represents the parties? (b) The Secretary has the day-to-day management of the HHS- 16.5 When must a request for informal responsibility to implement these review be submitted? certified laboratory when the Guidelines. 16.6 What is an abeyance agreement? responsible person is unable to fulfill 16.7 What procedures are used to prepare Section 1.3 How does a federal agency these obligations. the review file and written argument? request a change from these Guidelines? Alternate Technology Initial Drug 16.8 When is there an opportunity for oral Test. An initial drug test using presentation? (a) Each federal agency must ensure 16.9 Are there expedited procedures for that its workplace drug testing program technology other than immunoassay to review of immediate suspension? complies with the provisions of these differentiate negative specimens from 16.10 Are any types of communications Guidelines unless a waiver has been those requiring further testing. prohibited? obtained from the Secretary. Batch. A number of specimens or 16.11 How are communications transmitted (b) To obtain a waiver, a federal aliquots handled concurrently as a by the reviewing official? agency must submit a written request to group. 16.12 What are the authority and Biomarker. An endogenous substance the Secretary that describes the specific responsibilities of the reviewing official? used to validate a biological specimen. 16.13 What administrative records are Blind Sample. A sample submitted to 1 maintained? The NRC-related information in this notice an HHS-certified test facility for quality 16.14 What are the requirements for a pertains to individuals subject to drug testing written decision? conducted pursuant to 10 CFR Part 26, ‘‘Fitness for assurance purposes, with a fictitious 16.15 Is there a review of the final Duty Programs’’ (i.e., employees of certain NRC- identifier, so that the test facility cannot administrative action? regulated entities). distinguish it from a donor specimen. Although HHC has no authority to regulate the Calibrator. A sample of known Subpart A—Applicability transportation industry, the Department of Transportation (DOT) does have such authority. content and analyte concentration Section 1.1 To whom do these DOT is required by law to develop requirements for prepared in the appropriate matrix used Guidelines apply? its regulated industry that ‘‘incorporate the to define expected outcomes of a testing Department of Health and Human Services procedure. The test result of the (a) These Guidelines apply to: scientific and technical guidelines dated April 11, 1988 and any amendments to those guidelines calibrator is verified to be within (1) Executive Agencies as defined in . . .’’ See, e.g., 49 U.S.C. § 20140(c)(2). In carrying established limits prior to use. 5 U.S.C. 105; out its mandate, DOT requires by regulation at 49 Cancelled Test. The result reported by (2) The Uniformed Services, as CFR Part 40 that its federally-regulated employers the MRO to the federal agency when a use only HHS-certified laboratories in the testing of defined in 5 U.S.C. 2101(3) (but employees, 49 CFR § 40.81, and incorporates the specimen has been reported to the MRO excluding the Armed Forces as defined scientific and technical aspects of the HHS as an invalid result (and the donor has in 5 U.S.C. 2101(2)); Mandatory Guidelines. no legitimate explanation) or rejected

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for testing, when a split specimen fails Failed to Reconfirm. The result urine) an HHS-certified IITF to an MRO to reconfirm, or when the MRO reported for a split (B) specimen when when a specimen contains no drug and/ determines that a fatal flaw or a second HHS-certified laboratory is or drug metabolite; or the concentration unrecovered correctable flaw exists in unable to corroborate the result reported of the drug or drug metabolite is less the forensic records (as described in for the primary (A) specimen. than the cutoff for that drug or drug Sections 15.1 and 15.2). Federal Drug Testing Custody and class. Carryover. The effect that occurs Control Form (Federal CCF). The Office Non-Medical Use of a Drug. The use when a sample result (e.g., drug of Management and Budget (OMB) of a prescription drug, whether obtained concentration) is affected by a preceding approved form that is used to document by prescription or otherwise, other than sample during the preparation or the collection and chain of custody of a in the manner or for the time period analysis of a sample. specimen from the time the specimen is prescribed, or by a person for whom the Certifying Scientist (CS). The collected until it is received by the test drug was not prescribed. individual responsible for verifying the facility (i.e., HHS-certified laboratory or, Oral Fluid Specimen. An oral fluid chain of custody and scientific for urine, HHS-certified IITF). It may be specimen is collected from the donor’s reliability of a test result reported by an a paper (hardcopy), electronic, or oral cavity and is a combination of HHS-certified laboratory. combination electronic and paper physiological fluids produced primarily Certifying Technician (CT). The format (hybrid). The form may also be by the salivary glands. individual responsible for verifying the used to report the test result to the Oxidizing Adulterant. A substance chain of custody and scientific Medical Review Officer. that acts alone or in combination with reliability of negative, rejected for HHS. The Department of Health and other substances to oxidize drug or drug testing, and (for urine) negative/dilute Human Services. metabolites to prevent the detection of results reported by an HHS-certified Initial Drug Test. An analysis used to the drugs or drug metabolites, or affects laboratory or (for urine) an HHS- differentiate negative specimens from the reagents in either the initial or certified IITF. those requiring further testing. confirmatory drug test. Chain of Custody (COC) Procedures. Initial Specimen Validity Test. The Performance Testing (PT) Sample. A Procedures that document the integrity first analysis used to determine if a program-generated sample sent to a of each specimen or aliquot from the specimen is invalid, adulterated, or (for laboratory or (for urine) to an IITF to point of collection to final disposition. urine) diluted or substituted. evaluate performance. Instrumented Initial Test Facility Chain of Custody Documents. Forms Positive Result. The result reported by (IITF). A permanent location where (for used to document the control and an HHS-certified laboratory when a urine) initial testing, reporting of security of the specimen and all specimen contains a drug or drug results, and recordkeeping are aliquots. The document may account for metabolite equal to or greater than the performed under the supervision of a an individual specimen, aliquot, or confirmation cutoff concentration. responsible technician. Reconfirmed. The result reported for batch of specimens/aliquots and must Invalid Result. The result reported by a split (B) specimen when the second include the name and signature of each an HHS-certified laboratory when the HHS-certified laboratory corroborates individual who handled the specimen(s) laboratory determines that it cannot the original result reported for the or aliquot(s) and the date and purpose complete testing or obtain a valid drug primary (A) specimen. of the handling. test result. Rejected for Testing. The result Collection Device. A product that is Laboratory. A permanent location reported by an HHS-certified laboratory used to collect an oral fluid specimen where initial and confirmatory drug or (for urine) an HHS-certified IITF and may include a buffer or diluent. testing, reporting of results, and when no tests are performed on a Collection Site. The location where recordkeeping are performed under the specimen because of a fatal flaw or an specimens are collected. supervision of a responsible person. unrecovered correctable error (see Collector. A person trained to instruct Limit of Detection. The lowest Sections 15.1 and 15.2) and assist a donor in providing a concentration at which the analyte (e.g., Responsible Person (RP). The person specimen. drug or drug metabolite) can be who assumes professional, Confirmatory Drug Test. A second identified. organizational, educational, and analytical procedure performed on a Limit of Quantification. For administrative responsibility for the separate aliquot of a specimen to quantitative assays, the lowest day-to-day management of an HHS- identify and quantify a specific drug or concentration at which the identity and certified laboratory. drug metabolite. concentration of the analyte (e.g., drug Sample. A performance testing Confirmatory Specimen Validity Test. or drug metabolite) can be accurately sample, calibrator or control used A second test performed on a separate established. during testing, or a representative aliquot of a specimen to further support Lot. A number of units of an item portion of a donor’s specimen. a specimen validity test result. (e.g., reagents, quality control material, Secretary. The Secretary of the U.S. Control. A sample used to evaluate oral fluid collection device) Department of Health and Human whether an analytical procedure or test manufactured from the same starting Services. is operating within predefined tolerance materials within a specified period of Specimen. A sample collected from a limits. time for which the manufacturer donor at the collection site for the Cutoff. The analytical value (e.g., drug ensures that the items have essentially purpose of a drug test. or drug metabolite concentration) used the same performance characteristics Split Specimen Collection (for Oral as the decision point to determine a and expiration date. Fluid). A collection in which two result (e.g., negative, positive, Medical Review Officer (MRO). A specimens [primary (A) and split (B)] adulterated, invalid, or, for urine, licensed physician who reviews, are collected, concurrently or serially, substituted) or the need for further verifies, and reports a specimen test and independently sealed in the testing. result to the federal agency. presence of the donor. Donor. The individual from whom a Negative Result. The result reported Standard. Reference material of specimen is collected. by an HHS-certified laboratory or (for known purity or a solution containing a

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reference material at a known before the collection process begins for for its workplace drug testing program. concentration. a pre-employment test); Only specimen types authorized by (4) Fail or decline to participate in an Mandatory Guidelines for Federal Section 1.6 What is an agency required alternate specimen collection (e.g., Workplace Drug Testing Programs may to do to protect employee records? urine) as directed by the federal agency be collected. An agency using oral fluid Consistent with 5 U.S.C. 552a and 48 or collector (i.e., as described in Section must follow these Guidelines. CFR 24.101–24.104, all agency contracts 8.6); Section 2.2 Under what circumstances with laboratories, collectors, and MROs (5) Fail to undergo a medical may an oral fluid specimen be must require that they comply with the examination or evaluation, as directed collected? Privacy Act, 5 U.S.C. 552a. In addition, by the MRO as part of the verification the contracts must require compliance process (i.e., Section 13.6) or as directed A federal agency may collect an oral with employee access and by the federal agency. In the case of a fluid specimen for the following confidentiality provisions of Section federal agency applicant/pre- reasons: 503 of Public Law 100–71. Each federal employment drug test, the donor is (a) Federal agency applicant/Pre- agency must establish a Privacy Act deemed to have refused to test on this employment test; System of Records or modify an existing basis only if the federal agency (b) Random test; system or use any applicable applicant/pre-employment test is (c) Reasonable suspicion/cause test; Government-wide system of records to conducted following a contingent offer (d) Post-accident test; cover the records of employee drug test of employment. If there was no (e) Return to duty test; or (f) Follow-up test. results. All contracts and the Privacy contingent offer of employment, the Act System of Records must specifically MRO will cancel the test; Section 2.3 How is each oral fluid require that employee records be (6) Fail to cooperate with any part of specimen collected? maintained and used with the highest the testing process (e.g., disrupt the regard for employee privacy. Each oral fluid specimen is collected collection process); or as a split specimen (i.e., collected either In addition, the Health Insurance (7) Admit to the collector or MRO that Portability and Accountability Act of simultaneously or serially) as described you have adulterated or (for urine) in Section 2.5. 1996 (HIPAA) Privacy Rule (Rule), 45 substituted the specimen. CFR parts 160 and 164, Subparts A and Section 2.4 What volume of oral fluid E, is applicable to certain health care Section 1.8 What are the potential is collected? providers with whom a federal agency consequences for refusing to take a A known volume of at least 1 mL of may contract. If a health care provider federally regulated drug test? undiluted (neat) oral fluid for each oral is a HIPAA covered entity, the provider (a) As a federal agency employee or fluid specimen (designated ‘‘Tube A’’ must protect the individually applicant, a refusal to take a test may and ‘‘Tube B’’) is collected using a identifiable health information it result in the initiation of disciplinary or collection device. maintains in accordance with the adverse action, up to and including requirements of the Rule, which removal from, or non-selection for, Section 2.5 How is the split oral fluid includes not using or disclosing the federal employment. specimen collected? information except as permitted by the (b) When a donor has refused to The collector collects at least 1 mL of Rule and ensuring there are reasonable participate in a part of the collection undiluted (neat) oral fluid in a safeguards in place to protect the process, the collector must terminate collection device designated as ‘‘A’’ privacy of the information. For more that portion of the collection process (primary) and at least 1 mL of undiluted information regarding the HIPAA and take action as described in Section (neat) oral fluid in a collection device Privacy Rule, please visit http:// 8.9: immediately notify the federal designated as ‘‘B’’ (split) either www.hhs.gov/ocr/hipaa. agency’s designated representative by simultaneously or serially (i.e., as Section 1.7 What is a refusal to take a any means (e.g., telephone or secure fax described in Section 8.8.) federally regulated drug test? machine) that ensures that the refusal notification is immediately received, Section 2.6 When may an entity or (a) As a donor for a federally regulated document the refusal on the Federal individual release an oral fluid drug test, you have refused to take a CCF, sign and date the Federal CCF, and specimen? federally regulated drug test if you: send all copies of the Federal CCF to the Entities and individuals subject to (1) Fail to appear for any test (except federal agency’s designated these Guidelines under Section 1.1, may a pre-employment test) within a representative. not release specimens collected reasonable time, as determined by the (c) When documenting a refusal to pursuant to Executive Order 12564, federal agency, consistent with test during the verification process as Public Law 100–71 and these applicable agency regulations, after described in Sections 13.4, 13.5, and Guidelines, to donors or their designees. being directed to do so by the federal 13.6, the MRO must complete the MRO Specimens also may not be released to agency; copy of the Federal CCF to include: (2) Fail to remain at the collection site any other entity or individual unless (1) Checking the refusal to test box; until the collection process is complete expressly authorized by these (2) Providing a reason for the refusal (with the exception of a donor who Guidelines or by applicable federal law. in the remarks line; and leaves the collection site before the This section does not prohibit a donor’s (3) Signing and dating the MRO copy collection process begins for a pre- request to have a split (B) specimen of the Federal CCF. employment test); tested in accordance with Section 13.8. (3) Fail to provide a specimen (e.g., Subpart B—Oral Fluid Specimens Subpart C—Oral Fluid Drug and oral fluid or another authorized Specimen Validity Tests specimen type) for any drug test Section 2.1 What type of specimen required by these Guidelines or federal may be collected? Section 3.1 Which tests are conducted agency regulations (with the exception A federal agency may collect oral on an oral fluid specimen? of a donor who leaves the collection site fluid and/or an alternate specimen type A federal agency:

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(a) Must ensure that each specimen is or post accident testing. A specimen in writing for approval to routinely test tested for marijuana and cocaine as collected from a federal agency for any drug class not listed in Section provided under Section 3.4; employee may be tested by the federal 3.1. Such approval must be limited to (b) Is authorized to test each specimen agency for any drugs listed in Schedule the use of the appropriate science and for opiates, amphetamines, and I or II of the Controlled Substances Act technology and must not otherwise limit phencyclidine, as provided under (other than the drugs listed in Section agency discretion to test for any drug Section 3.4; and 3.1, or when used pursuant to a valid tested under paragraph (a) of this (c) Must ensure that the following prescription or when used as otherwise section. specimen validity tests are conducted authorized by law). The federal agency Section 3.3 May any of the specimens on each oral fluid specimen: must request the HHS-certified (1) Determine the albumin laboratory to test for the additional drug, be used for other purposes? concentration on every specimen; or include a justification to test a specific (a) Specimens collected pursuant to (2) Determine the immunoglobulin G specimen for the drug, and ensure that Executive Order 12564, Public Law (IgG) concentration on every specimen. the HHS-certified laboratory has the 100–71, and these Guidelines must only (d) If a specimen exhibits abnormal capability to test for the drug and has be tested for drugs and to determine characteristics (e.g., unusual odor or established properly validated initial their validity in accordance with color), causes reactions or responses and confirmatory analytical methods. If Subpart C of these Guidelines. Use of characteristic of an adulterant during an initial test procedure is not available specimens by donors, their designees or initial or confirmatory drug tests (e.g., upon request for a suspected Schedule any other entity, for other purposes (e.g., non-recovery of internal standard, I or Schedule II drug, the federal agency deoxyribonucleic acid, DNA, testing) is unusual response), or contains an can request an HHS-certified laboratory prohibited unless authorized in unidentified substance that interferes to test for the drug by analyzing two accordance with applicable federal law. with the confirmatory analysis, then separate aliquots of the specimen in two (b) These Guidelines are not intended additional testing may be performed. separate testing batches using the to prohibit federal agencies, specifically confirmatory analytical method. Section 3.2 May a specimen be tested authorized by law to test a specimen for Additionally, the split (B) specimen will for additional drugs? additional classes of drugs in its be available for testing if the donor workplace drug testing program. (a) On a case-by-case basis, a requests a retest at another HHS- specimen may be tested for additional certified laboratory. Section 3.4 What are the drug test drugs, if a federal agency is conducting (b) A federal agency covered by these cutoff concentrations for undiluted the collection for reasonable suspicion Guidelines must petition the Secretary (neat) oral fluid?

Confirmatory test Initial test analyte Initial test cutoff Confirmatory test analyte cutoff concentration (ng/mL) (ng/mL)

Marijuana (THC) 1 ...... 4 THC ...... 2 Cocaine/Benzoylecgonine ...... 2 15 Cocaine ...... 8 Benzoylecgonine ...... 8 Codeine/Morphine ...... 2 30 Codeine ...... 15 Morphine ...... 15 Hydrocodone/Hydromorphone ...... 2 30 Hydrocodone ...... 15 Hydromorphone ...... 15 Oxycodone/Oxymorphone ...... 2 30 Oxycodone ...... 15 Oxymorphone ...... 15 6-Acetylmorphine ...... 3 6-Acetylmorphine ...... 2 Phencyclidine ...... 3 Phencyclidine ...... 2 Amphetamine/Methamphetamine ...... 2 25 Amphetamine ...... 15 Methamphetamine ...... 15 MDMA 4/MDA 5/MDEA 6 ...... 2 25 3 MDMA ...... 15 4 MDA ...... 15 5 MDEA ...... 15 1 D-9-Tetrahydrocannabinol (THC). 2 Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group. Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff. 3 Methylenedioxymethamphetamine (MDMA). 4 Methylenedioxyamphetamine (MDA). 5 Methylenedioxyethylamphetamine (MDEA).

Section 3.5 May an HHS-certified necessary to provide information that tests must meet appropriate validation laboratory perform additional drug and/ the MRO would use to report a verified and quality control requirements. or specimen validity tests on a specimen drug test result [e.g., d, l-stereoisomers Section 3.6 What criteria are used to at the request of the Medical Review determination for methamphetamine, D- Officer (MRO)? report an oral fluid specimen as 9-tetrahydrocannabinol-9-carboxylic adulterated? An HHS-certified laboratory is acid (THCA), and additional specimen authorized to perform additional drug validity tests including adulterants]. All An HHS-certified laboratory reports and/or specimen validity tests as an oral fluid specimen as adulterated

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when the presence of an adulterant is co-workers in the same testing pool or years that includes the requirements in verified using an initial test on a first who work together with that employee paragraph (a) of this section. aliquot and a different confirmatory test on a daily basis. (c) The collector must maintain the on a second aliquot. (b) A federal agency applicant or documentation of his or her training and employee must not collect his or her provide that documentation to a federal Section 3.7 What criteria are used to own drug testing specimen. agency when requested. report an invalid result for an oral fluid (c) An employee working for an HHS- (d) An individual may not collect specimen? certified laboratory must not act as a specimens for a federal agency until his An HHS-certified laboratory reports a collector if the employee could link the or her training as a collector has been primary (A) oral fluid specimen as an identity of the donor to the donor’s drug properly documented. invalid result when: test result. (a) The albumin concentration is less (d) To avoid a potential conflict of Section 4.4 What are the requirements than 0.6 mg/dL for both the initial (first) interest, a collector must not be related to be a trainer for collectors? test and the second test on two separate to the employee (e.g., spouse, ex-spouse, (a) Individuals are considered aliquots; relative) or a close personal friend (e.g., qualified trainers for collectors for a (b) The IgG concentration is less than fiance´e). specific oral fluid collection device and 0.5 mg/L for both the initial (first) test Section 4.3 What are the requirements may train others to collect oral fluid and the second test on two separate to be a collector? specimens using that collection device aliquots; when they have completed the (a) An individual may serve as a (c) Interference occurs on the initial following: collector if he or she fulfills the drug tests on two separate aliquots (i.e., (1) Qualified as a trained collector and following conditions: valid immunoassay or alternate (1) Is knowledgeable about the regularly conducted oral fluid drug test technology initial drug test results collection procedure described in these collections using that collection device cannot be obtained); Guidelines; for a period of at least one year or (d) Interference with the drug (2) Is knowledgeable about any (2) Completed a ‘‘train the trainer’’ confirmatory assay occurs on two guidance provided by the federal course given by an organization (e.g., separate aliquots of the specimen and agency’s Drug-Free Workplace Program manufacturer, private entity, contractor, the laboratory is unable to identify the and additional information provided by federal agency). interfering substance; the Secretary relating to these (b) A qualified trainer for collectors (e) The physical appearance of the Guidelines; must complete refresher training at least specimen (e.g., viscosity) is such that (3) Is trained and qualified to use the every five years in accordance with the testing the specimen may damage the specific oral fluid collection device. collector requirements in Section 4.3(a). laboratory’s instruments; Training must include the following: (c) A qualified trainer for collectors (f) The specimen has been tested and (i) All steps necessary to complete an must maintain the documentation of his the appearances of the primary (A) and oral fluid collection; or her training and provide that the split (B) specimens (e.g., color) are (ii) Completion and distribution of the documentation to a federal agency when clearly different; or Federal CCF; requested. (g) The concentration of a biomarker (iii) Problem collections; Section 4.5 What must a federal other than albumin or IgG is not (iv) Fatal flaws, correctable flaws, and agency do before a collector is permitted consistent with that established for how to correct problems in collections; to collect a specimen? human oral fluid. and (v) The collector’s responsibility for A federal agency must ensure the Subpart D—Collectors maintaining the integrity of the following: Section 4.1 Who may collect a collection process, ensuring the privacy (a) The collector has satisfied the specimen? of the donor, ensuring the security of requirements described in Section 4.3; the specimen, and avoiding conduct or (b) The collector, who may be self- (a) A collector who has been trained statements that could be viewed as employed, or an organization (e.g., third to collect oral fluid specimens in offensive or inappropriate. party administrator that provides a accordance with these Guidelines and (4) Has demonstrated proficiency in collection service, collector training the manufacturer’s procedures for the collections by completing five company, federal agency that employs collection device. consecutive error-free mock collections. its own collectors) maintains a copy of (b) The immediate supervisor of a (i) The five mock collections must the training record(s); and federal employee donor may only include two uneventful collection (c) The collector has been provided collect that donor’s specimen when no scenarios, one insufficient specimen the name and telephone number of the other collector is available. The quantity scenario, one scenario in which federal agency representative. supervisor must be a trained collector. the donor refuses to sign the Federal (c) The hiring official of a federal CCF, and one scenario in which the Subpart E—Collection Sites agency applicant may only collect that donor refuses to initial the specimen Section 5.1 Where can a collection for federal agency applicant’s specimen collection device tamper-evident seal. a drug test take place? when no other collector is available. (ii) A qualified trainer for collectors The hiring official must be a trained must monitor and evaluate the (a) A collection site may be a collector. individual being trained, in person or by permanent or temporary facility located a means that provides real-time either at the work site or at a remote Section 4.2 Who may not collect a observation and interaction between the site. specimen? trainer and the trainee, and the trainer (b) In the event that an agency- (a) A federal agency employee who is must attest in writing that the mock designated collection site is not in a testing designated position and collections are ‘‘error-free.’’ accessible and there is an immediate subject to the federal agency drug (b) A trained collector must complete requirement to collect an oral fluid testing rules must not be a collector for refresher training at least every five specimen (e.g., an accident

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investigation), another site may be used (7) Ensure that specimens transported Subpart G—Oral Fluid Specimen for the collection, providing the to an HHS-certified laboratory are sealed Collection Devices collection is performed by a trained oral and placed in transport containers Section 7.1 What is used to collect an fluid specimen collector. designed to minimize the possibility of oral fluid specimen? Section 5.2 What are the requirements damage during shipment (e.g., specimen An FDA-cleared single-use collection for a collection site? boxes, padded mailers, or other suitable shipping container), and those device intended to collect an oral fluid The facility used as a collection site containers are securely sealed to specimen must be used. This collection must have the following: eliminate the possibility of undetected device must maintain the integrity of (a) Provisions to ensure donor privacy tampering. such specimens during storage and during the collection (as described in transport so that the specimen Section 8.1); (b) Couriers, express carriers, and contained therein can be tested in an (b) A suitable and clean surface area postal service personnel are not HHS-certified laboratory for the that is not accessible to the donor for required to document chain of custody presence of drugs or their metabolites. handling the specimens and completing since specimens are sealed in packages the required paperwork; that would indicate tampering during Section 7.2 What are the requirements (c) A secure temporary storage area to transit to the HHS-certified laboratory. for an oral fluid collection device? maintain specimens until the specimen An oral fluid specimen collection is transferred to an HHS-certified Section 5.6 What are the privacy device must provide: laboratory; requirements when collecting an oral (a) An indicator that demonstrates the (d) A restricted access area where fluid specimen? adequacy of the volume of oral fluid only authorized personnel may be Collections must be performed at a specimen collected; present during the collection; (b) A sealable, non-leaking container (e) A restricted access area for the site that provides reasonable privacy (as described in Section 8.1). that maintains the integrity of the storage of collection supplies; and specimen during storage and transport (f) The ability to store records Subpart F—Federal Drug Testing so that the specimen contained therein securely. Custody and Control Form can be tested in an HHS-certified laboratory for the presence of drugs or Section 5.3 Where must collection site Section 6.1 What federal form is used records be stored? their metabolites; to document custody and control? (c) Components that ensure pre- Collection site records must be stored analytical drug and drug metabolite at a secure site designated by the The OMB-approved Federal CCF must stability; and collector or the collector’s employer. be used to document custody and control of each specimen at the (d) Components that do not Section 5.4 How long must collection collection site. substantially affect the composition of site records be stored? drugs and/or drug metabolites in the Collection site records (e.g., collector Section 6.2 What happens if the oral fluid specimen. correct OMB-approved Federal CCF is copies of the OMB-approved Federal Section 7.3 What are the minimum not available or is not used for an oral CCF) must be stored securely for a performance requirements for a minimum of 2 years. The collection site fluid specimen? collection device? may convert hardcopy records to (a) The use of a non-federal CCF or an An oral fluid collection device must electronic records for storage and expired Federal CCF is not, by itself, a discard the hardcopy records after 6 meet the following minimum reason for the HHS-certified laboratory months. performance requirements. to automatically reject the specimen for (a) Reliable and reproducible Section 5.5 How does the collector testing or for the MRO to cancel the test. collection of a minimum of 1 mL of ensure the security and integrity of a (b) If the collector uses an incorrect undiluted (neat) oral fluid; specimen at the collection site? form, the collector must document that (b) If the collection device contains a (a) A collector must do the following it is a federal agency specimen diluent (or other component, process, or to maintain the security and integrity of collection and provide the reason that method that modifies the volume of the a specimen: the incorrect form was used. Based on testable specimen): (1) Not allow unauthorized personnel the information provided by the (1) The volume of oral fluid collected should be within 0.1 ml of the target to enter the collection area during the collector, the HHS-certified laboratory volume, and collection procedure; must handle and test the specimen as a (2) The volume of diluent in the (2) Perform only one donor collection federal agency specimen. at a time; device should be within 0.05 ml of the (3) Restrict access to collection (c) If the HHS-certified laboratory or diluent target volume; supplies before, during, and after MRO discovers that an incorrect form (c) Stability (recoverable collection; was used by the collector, the laboratory concentrations ≥90 percent of the (4) Ensure that only the collector and or MRO must obtain a memorandum for concentration at the time of collection) the donor are allowed to handle the the record from the collector describing of the drugs and/or drug metabolites for unsealed specimen; the reason the incorrect form was used. one week at room temperature (18–25 (5) Ensure the chain of custody If a memorandum for the record cannot °C) and under intended shipping and process is maintained and documented be obtained, the HHS-certified storage conditions; and throughout the entire collection, storage, laboratory must wait at least 5 business (d) Recover ≥90 percent (but no more and transport procedures; days before the laboratory reports a than 120 percent) of drug and/or drug (6) Ensure that the Federal CCF is rejected for testing result to the MRO metabolite in the undiluted (neat) oral completed and distributed as required; and the MRO cancels the test. fluid at (or near) the initial test cutoff and (see Section 3.4).

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Subpart H—Oral Fluid Specimen the specimen collection as described in (a) The collector shall be present and Collection Procedure Section 8.5. maintain visual contact with the donor (2) If the donor’s mouth is not free of during the procedures outlined in this Section 8.1 What privacy must the any items that could impede or interfere section. donor be given when providing an oral with the collection of an oral fluid (1) Under the observation of the fluid specimen? specimen immediately prior to collector, the donor is responsible for The following privacy requirements collection, or the donor claims to be a placing the specimen collection device apply when a donor is providing an oral tobacco user, or claims to have ‘‘dry in his or her mouth. The collector must fluid specimen: mouth,’’ the donor may drink while ensure the collection is performed (a) Only authorized personnel and the rinsing his or her mouth with water (up correctly and that the collection device donor may be present in the restricted to 4 oz.) and wait 10 minutes before is working properly. If the device fails access area where the collection takes beginning the specimen collection. to collect the specimen, the collector place. (e) The collector must provide must begin the process again, beginning (b) The collector is not required to be identification (e.g., employee badge, with Step 8.4(b), using a new specimen the same gender as the donor. employee list) if requested by the donor. collection device (for both A and B specimens) and a new Federal CCF. Section 8.2 What must the collector (f) The collector explains the basic (2) The donor and collector must ensure at the collection site before collection procedure to the donor. complete the collection in accordance starting an oral fluid specimen (g) The collector informs the donor with the manufacturer instructions for collection? that the instructions for completing the Federal Custody and Control Form are the collection device. The collector must deter the (b) If the donor fails to remain present located on the back of the Federal CCF adulteration or substitution of an oral through the completion of the or available upon request. fluid specimen at the collection site. collection, fails to follow the (h) The collector answers any instructions for the collection device, Section 8.3 What are the preliminary reasonable and appropriate questions refuses to provide a second specimen as steps in the oral fluid specimen the donor may have regarding the required in step (a)(1) above, or refuses collection procedure? collection procedure. to provide an alternate specimen as The collector must take the following Section 8.4 What steps does the authorized in Section 8.6, the collector steps before beginning an oral fluid collector take in the collection stops the collection and reports the specimen collection: procedure before the donor provides an refusal to test in accordance with (a) If a donor fails to arrive at the oral fluid specimen? Section 8.9. collection site at the assigned time, the collector must follow the federal agency (a) The collector will provide or the Section 8.6 What procedure is used policy or contact the federal agency donor may select a specimen collection when the donor states that he or she is representative to obtain guidance on device that is clean, unused, and unable to provide an oral fluid action to be taken. wrapped/sealed in original packaging. specimen? (b) When the donor arrives at the The specimen collection device will be (a) If the donor states that he or she collection site, the collector should opened in view of the donor. is unable to provide an oral fluid begin the collection procedure without (1) Both the donor and the collector specimen during the collection process, undue delay. For example, the must keep the unwrapped collection the collector requests that the donor collection should not be delayed devices in view at all times until each follow the collector instructions and because an authorized employer or collection device containing the donor’s attempt to provide an oral fluid employer representative is late in oral fluid specimen has been sealed and specimen. arriving. labeled. (b) The donor demonstrates his or her (c) The collector requests the donor to (b) The collector reviews with the inability to provide a specimen when, present photo identification (e.g., donor the procedures required for a after 15 minutes of using the collection driver’s license; employee badge issued successful oral fluid specimen device, there is insufficient volume or by the employer; an alternative photo collection as stated in the no oral fluid collected using the device. identification issued by a federal, state, manufacturer’s instructions for the (1) If the donor states that he or she or local government agency). If the specimen collection device. could provide a specimen after drinking donor does not have proper photo (1) The collector may set a reasonable some fluids, the collector gives the identification, the collector shall contact time limit for specimen collection donor a drink (up to 8 ounces) and waits the supervisor of the donor or the (based on the device used, not to exceed an additional 10 minutes before federal agency representative who can 15 minutes per device). beginning the specimen collection (a positively identify the donor. If the (c) The collector notes any unusual period of 1 hour must be provided or donor’s identity cannot be established, behavior or appearance of the donor on until the donor has provided a sufficient the collector must not proceed with the the Federal CCF. If the collector detects oral fluid specimen). If the donor simply collection. any conduct that clearly indicates an needs more time before attempting to (d) The collector requests that the attempt to tamper with a specimen, the provide an oral fluid specimen, the donor opens his or her mouth, and the collector must note the conduct on the donor is not required to drink any fluids collector inspects the oral cavity to Federal CCF. during the 1 hour wait time. The ensure that it is free of any items that collector must inform the donor that the Section 8.5 What steps does the could impede or interfere with the donor must remain at the collection site collector take during and after the oral collection of an oral fluid specimen (i.e., in an area designated by the fluid specimen collection procedure? (e.g., candy, gum, food, tobacco, dental collector) during the wait period. retainer). Integrity and Identity of the (2) If the donor states that he or she (1) At this time, the collector starts the Specimen. The collector must take the is unable to provide an oral fluid 10-minute wait period and proceeds following steps during and after the specimen, the collector records the with the steps below before beginning donor provides the oral fluid specimen: reason for not collecting an oral fluid

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specimen on the Federal CCF, notifies (f) The collector asks the donor to for the Collection of Oral Fluid the federal agency’s designated read and sign a statement on the Federal Specimens for Federal Agency representative for authorization of an CCF certifying that the specimens Workplace Drug Testing Programs) or an alternate specimen to be collected, and identified were collected from him or inspection of the collection site. The sends the appropriate copies of the her. If the donor refuses to sign the inspections of these additional Federal CCF to the MRO and to the certification statement, the collector collection sites may be included in the federal agency’s designated notes the refusal on the Federal CCF and 5 percent or maximum of 50 collection representative. If an alternate specimen continues with the collection process. sites inspected annually. (g) The collector signs and prints his is authorized, the collector may begin Subpart I—HHS Certification of or her name on the Federal CCF, the collection procedure for the Laboratories alternate specimen (see Section 8.7) in completes the Federal CCF, and accordance with the Mandatory distributes the copies of the Federal CCF Section 9.1 Who has the authority to Guidelines for Federal Workplace Drug as required. certify laboratories to test oral fluid Testing Programs using the alternative (h) The collector seals the specimens specimens for federal agencies? specimen. (Tube A and Tube B) in a package and, (a) The Secretary has broad discretion within 24 hours or during the next to take appropriate action to ensure the Section 8.7 If the donor is unable to business day, sends them to the HHS- provide an oral fluid specimen, may full reliability and accuracy of drug certified laboratory that will be testing testing and reporting, to resolve another specimen type be collected for the Tube A oral fluid specimen. The testing? problems related to drug testing, and to collector must also send a copy of the enforce all standards set forth in these No, unless the alternate specimen Federal CCF to the HHS-certified Guidelines. The Secretary has the type is authorized by Mandatory laboratory. authority to issue directives to any HHS- Guidelines for Federal Workplace Drug (i) If the specimen and Federal CCF certified laboratory, including Testing Programs and specifically are not immediately transported to an suspending the use of certain analytical authorized by the federal agency. HHS-certified laboratory, they must procedures when necessary to protect remain under direct control of the the integrity of the testing process; Section 8.8 How does the collector collector or be appropriately secured prepare the oral fluid specimens? ordering any HHS-certified laboratory to under proper specimen storage undertake corrective actions to respond (a) All federal agency collections are conditions until transported. to material deficiencies identified by an to be split specimen collections. Section 8.9 How does the collector inspection or through performance An oral fluid split specimen report a donor’s refusal to test? testing; ordering any HHS-certified collection may be: laboratory to send specimens or (1) Two specimens collected If there is a refusal to test as defined specimen aliquots to another HHS- simultaneously with two separate in Section 1.7, the collector stops the certified laboratory for retesting when collection devices; collection, discards any oral fluid necessary to ensure the accuracy of (2) Two specimens collected serially specimen collected and reports the testing under these Guidelines; ordering with two separate collection devices. refusal to test by: the review of results for specimens Collection of the second specimen must (a) Notifying the federal agency by tested under the Guidelines for private begin within two minutes after the means (e.g., telephone, email, or secure sector clients to the extent necessary to completion of the first collection and fax) that ensures that the notification is ensure the full reliability of drug testing recorded on the Federal CCF; or immediately received, for federal agencies; and ordering any (b) Documenting the refusal to test on (3) Two specimens collected other action necessary to address the Federal CCF, and deficiencies in drug testing, analysis, simultaneously using a single collection (c) Sending all copies of the Federal device that directs the oral fluid into specimen collection, chain of custody, CCF to the federal agency’s designated reporting of results, or any other aspect two separate collection tubes. representative. (b) A known volume of at least 1 mL of the certification program. of undiluted (neat) oral fluid is collected Section 8.10 What are a federal (b) A laboratory is prohibited from for the specimen designated as ‘‘Tube agency’s responsibilities for a collection stating or implying that it is certified by A’’ and a known volume of at least 1 mL site? HHS under these Guidelines to test oral of undiluted (neat) oral fluid is collected fluid specimens for federal agencies (a) A federal agency must ensure that unless it holds such certification. for the specimen designated as ‘‘Tube collectors and collection sites satisfy all B’’. requirements in subparts D, E, F, G, and Section 9.2 What is the process for a (c) In the presence of the donor, the H. laboratory to become HHS-certified? collector places a tamper-evident label/ (b) A federal agency (or only one (a) A laboratory seeking HHS seal from the Federal CCF over the cap federal agency when several agencies certification must: of each specimen tube. The collector are using the same collection site) must (1) Submit a completed OMB- records the date of the collection on the inspect 5 percent or up to a maximum approved application form (i.e., the tamper-evident labels/seals. of 50 collection sites each year, selected applicant laboratory provides detailed (d) The collector instructs the donor randomly from those sites used to information on both the administrative to initial the tamper-evident labels/seals collect agency specimens (e.g., virtual, and analytical procedures to be used for on each specimen tube. If the donor onsite, or self-evaluation). federally regulated specimens); refuses to initial the labels/seals, the (c) A federal agency must investigate (2) Have its application reviewed as collector notes the refusal on the reported collection site deficiencies complete and accepted by HHS; Federal CCF and continues with the (e.g., specimens reported ‘‘rejected for (3) Successfully complete the PT collection process. testing’’ by an HHS-certified laboratory) challenges in 3 consecutive sets of (e) The collector must ensure that all and take appropriate action which may initial PT samples; the information required on the Federal include a collection site self-assessment (4) Satisfy all the requirements for an CCF is provided. (i.e., using the Collection Site Checklist initial inspection; and

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(5) Receive notification of certification above the initial test cutoff (7) Correctly identify at least 80 from the Secretary before testing concentration for the drug or drug percent of the total specimen validity specimens for federal agencies. metabolite; testing challenges over the three sets of (ii) The concentration of a drug or PT samples; Section 9.3 What is the process for a metabolite may be less than 40 percent (8) Correctly identify at least 80 laboratory to maintain HHS of the confirmatory test cutoff percent of the challenges for each certification? concentration when the PT sample is individual specimen validity test over (a) To maintain HHS certification, a designated as a retest sample; or the three sets of PT samples; laboratory must: (iii) The concentration of drug or (9) For quantitative specimen validity (1) Successfully participate in both metabolite may differ from 9.5(a)(1)(i) tests, obtain quantitative values for at the maintenance PT and inspection and 9.5(a)(1)(ii) for a special purpose. least 80 percent of the total challenges programs (i.e., successfully test the (2) A PT sample may contain an over the three sets of PT samples that required quarterly sets of maintenance interfering substance or other satisfy the following criteria: PT samples, undergo an inspection 3 substances for special purposes. (i) Albumin concentrations are no months after being certified, and (3) A negative PT sample will not more than ±20 percent or ±2 standard undergo maintenance inspections at a contain a measurable amount of a target deviations from the appropriate minimum of every 6 months thereafter); analyte. reference or peer group mean; and (2) Respond in an appropriate, timely, (b) PT samples used to evaluate (ii) IgG values are no more than ±20 and complete manner to required specimen validity tests shall satisfy, but percent or ±2 standard deviations from corrective action requests if deficiencies are not limited to the following criteria: the appropriate reference or peer group are identified in the maintenance PT (1) The concentration of albumin and/ mean; performance, during the inspections, or IgG will be at least 20 percent below (b) Failure to satisfy these operations, or reporting; and the cutoff; or requirements will result in (2) The concentration of albumin and/ (3) Satisfactorily complete corrective disqualification. remedial actions, and undergo special or IgG may be another concentration for inspection and special PT sets to a special purpose. Section 9.7 What are the PT maintain or restore certification when (c) The laboratory must (to the requirements for an HHS-certified oral material deficiencies occur in either the greatest extent possible) handle, test, fluid laboratory? PT program, inspection program, or in and report a PT sample in a manner (a) A laboratory certified under these identical to that used for a donor operations and reporting. Guidelines must satisfy the following specimen, unless otherwise specified. Section 9.4 What is the process when criteria on the maintenance PT samples: a laboratory does not maintain its HHS Section 9.6 What are the PT (1) Have no false positive results; certification? requirements for an applicant (2) Correctly identify, confirm, and laboratory? report at least 90 percent of the total (a) A laboratory that does not (a) An applicant laboratory that seeks drug challenges over two consecutive maintain its HHS certification must: PT cycles; (1) Stop testing federally regulated certification under these Guidelines must satisfy the following criteria on (3) Correctly identify at least 80 specimens; percent of the drug challenges for each (2) Ensure the security of federally three consecutive sets of PT samples: initial drug test over two consecutive PT regulated specimens and records (1) Have no false positive results; cycles; throughout the required storage period (2) Correctly identify, confirm, and (4) For the confirmatory drug tests, described in Sections 11.18, 11.19, and report at least 90 percent of the total correctly determine that the 14.7; drug challenges over the three sets of PT (3) Ensure access to federally samples; concentrations for at least 80 percent of (3) Correctly identify at least 80 the total drug challenges are no more regulated specimens and records in ± ± accordance with Sections 11.21 and percent of the drug challenges for each than 20 percent or 2 standard 11.22 and Subpart P; and initial drug test over the three sets of PT deviations (whichever is larger) from the (4) Follow the HHS suspension and samples; appropriate reference or peer group revocation procedures when imposed by (4) For the confirmatory drug tests, means over two consecutive PT cycles; the Secretary, follow the HHS correctly determine the concentrations (5) For the confirmatory drug tests, procedures in Subpart P that will be [i.e., no more than ±20 percent or ±2 obtain no more than one drug used for all actions associated with the standard deviations (whichever is concentration on a PT sample that ± suspension and/or revocation of HHS- larger) from the appropriate reference or differs by more than 50 percent from certification. peer group means] for at least 80 percent the appropriate reference or peer group of the total drug challenges over the mean over two consecutive PT cycles; Section 9.5 What are the qualitative three sets of PT samples; (6) For each confirmatory drug test, and quantitative specifications of (5) For the confirmatory drug tests, correctly identify and determine that the performance testing (PT) samples? must not obtain any drug concentration concentrations for at least 50 percent of (a) PT samples used to evaluate drug that differs by more than ±50 percent the drug challenges for an individual tests will be prepared using the from the appropriate reference or peer drug are no more than ±20 percent or ±2 following specifications: group mean; standard deviations (whichever is (1) PT samples may contain one or (6) For each confirmatory drug test, larger) from the appropriate reference or more of the drugs and drug metabolites correctly identify and determine the peer group means over two consecutive in the drug classes listed in Section 3.4 concentrations [i.e., no more than ±20 PT cycles; and may be sent to the laboratory as percent or ±2 standard deviations (7) Correctly identify at least 80 undiluted (neat) oral fluid. The PT (whichever is larger) from the percent of the total specimen validity samples must satisfy one of the appropriate reference or peer group testing challenges over two consecutive following parameters: means] for at least 50 percent of the PT cycles; (i) The concentration of a drug or drug challenges for an individual drug (8) Correctly identify at least 80 metabolite will be at least 20 percent over the three sets of PT samples; percent of the challenges for each

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individual specimen validity test over requirements contained in these (b) The Secretary shall consider the two consecutive PT cycles; Guidelines and in other guidance following factors in determining (9) For quantitative specimen validity consistent with these Guidelines whether revocation is necessary: tests, obtain quantitative values for at provided by the Secretary; (1) Unsatisfactory performance in least 80 percent of the total challenges (3) Submits a resume and analyzing and reporting the results of over two consecutive PT cycles that documentation of qualifications to HHS; drug tests (e.g., an HHS-certified satisfy the following criteria: (4) Attends approved training; and laboratory reporting a false positive (i) Albumin concentrations are no (5) Performs acceptably as an result for an employee’s drug test); more than ±20 percent or ±2 standard inspector on an inspection of an HHS- (2) Unsatisfactory participation in deviations from the appropriate certified laboratory. performance testing or inspections; reference or peer group mean; and (b) The Secretary or a federal agency (3) A material violation of a ± (ii) IgG values are no more than 20 may conduct an inspection at any time. certification standard, contract term, or ± percent or 2 standard deviations from Section 9.11 What happens if an other condition imposed on the HHS- the appropriate reference or peer group applicant laboratory does not satisfy the certified laboratory by a federal agency mean. minimum requirements for either the PT using the laboratory’s services; (b) Failure to participate in all PT program or the inspection program? (4) Conviction for any criminal cycles or to satisfy these requirements offense committed as an incident to If an applicant laboratory fails to may result in suspension or revocation operation of the HHS-certified satisfy the requirements established for of an HHS-certified laboratory’s laboratory; or the initial certification process, the certification. (5) Any other cause that materially laboratory must start the certification affects the ability of the HHS-certified Section 9.8 What are the inspection process from the beginning. requirements for an applicant laboratory to ensure fully reliable and laboratory? Section 9.12 What happens if an HHS- accurate drug test results and reports. certified laboratory does not satisfy the (c) The period and terms of revocation (a) An applicant laboratory is minimum requirements for either the PT shall be determined by the Secretary inspected by a team of two inspectors. program or the inspection program? (b) Each inspector conducts an and shall depend upon the facts and independent review and evaluation of (a) If an HHS-certified laboratory fails circumstances of the revocation and the all aspects of the laboratory’s testing to satisfy the minimum requirements for need to ensure accurate and reliable procedures and facilities using an certification, the laboratory is given a drug testing. inspection checklist. period of time (e.g., 5 or 30 working Section 9.14 What factors are days depending on the nature of the considered in determining whether to Section 9.9 What are the maintenance deficiency) to provide any explanation inspection requirements for an HHS- suspend a laboratory’s HHS for its performance and evidence that all certification? certified laboratory? deficiencies have been corrected. (a) An HHS-certified laboratory must (b) A laboratory’s HHS certification (a) The Secretary may immediately undergo an inspection 3 months after may be revoked, suspended, or no suspend (either partially or fully) a becoming certified and at least every 6 further action taken depending on the laboratory’s HHS certification to months thereafter. seriousness of the deficiencies and conduct drug testing for federal agencies (b) An HHS-certified laboratory is whether there is evidence that the if the Secretary has reason to believe inspected by one or more inspectors. deficiencies have been corrected and that revocation may be required and that The number of inspectors is determined that current performance meets the immediate action is necessary to protect according to the number of specimens requirements for certification. the interests of the United States and its reviewed. Additional information (c) An HHS-certified laboratory may employees. regarding inspections is available from be required to undergo a special (b) The Secretary shall determine the SAMHSA. inspection or to test additional PT period and terms of suspension based (c) Each inspector conducts an samples to address deficiencies. upon the facts and circumstances of the independent evaluation and review of (d) If an HHS-certified laboratory’s suspension and the need to ensure the HHS-certified laboratory’s certification is revoked or suspended in accurate and reliable drug testing. procedures, records, and facilities using accordance with the process described Section 9.15 How does the Secretary guidance provided by the Secretary. in Subpart P, the laboratory is not notify an HHS-certified laboratory that (d) To remain certified, an HHS- permitted to test federally regulated action is being taken against the certified laboratory must continue to specimens until the suspension is lifted laboratory? satisfy the minimum requirements as or the laboratory has successfully stated in these Guidelines. completed the certification (a) When a laboratory’s HHS requirements as a new applicant certification is suspended or the Section 9.10 Who can inspect an HHS- laboratory. Secretary seeks to revoke HHS certified laboratory and when may the certification, the Secretary shall inspection be conducted? Section 9.13 What factors are immediately serve the HHS-certified (a) An individual may be selected as considered in determining whether laboratory with written notice of the an inspector for the Secretary if he or revocation of a laboratory’s HHS suspension or proposed revocation by she satisfies the following criteria: certification is necessary? facsimile, mail, personal service, or (1) Has experience and an educational (a) The Secretary shall revoke registered or certified mail, return background similar to that required for certification of an HHS-certified receipt requested. This notice shall state either an HHS-certified laboratory laboratory in accordance with these the following: responsible person or certifying scientist Guidelines if the Secretary determines (1) The reasons for the suspension or as described in Subpart K; that revocation is necessary to ensure proposed revocation; (2) Has read and thoroughly fully reliable and accurate drug test (2) The terms of the suspension or understands the policies and results and reports. proposed revocation; and

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(3) The period of suspension or Subpart J—Blind Samples Submitted by CCF has been properly completed and proposed revocation. an Agency provides fictitious initials on the specimen label/seal. The collector must (b) The written notice shall state that Section 10.1 What are the indicate that the specimen is a blind the laboratory will be afforded an requirements for federal agencies to opportunity for an informal review of sample on the MRO copy where a donor submit blind samples to HHS-certified would normally provide a signature. the suspension or proposed revocation laboratories? if it so requests in writing within 30 (b) A collector should attempt to days of the date the laboratory received (a) Each federal agency is required to distribute the required number of blind the notice, or if expedited review is submit blind samples for its workplace samples randomly with donor requested, within 3 days of the date the drug testing program. The collector specimens rather than submitting the laboratory received the notice. Subpart must send the blind samples to the full complement of blind samples as a P contains detailed procedures to be HHS-certified laboratory that the single group. collector sends employee specimens. followed for an informal review of the Section 10.4 What happens if an (b) Each federal agency must submit suspension or proposed revocation. inconsistent result is reported for a at least 3 percent blind samples along blind sample? (c) A suspension must be effective with its donor specimens based on the immediately. A proposed revocation projected total number of donor If an HHS-certified laboratory reports must be effective 30 days after written specimens collected per year (up to a a result for a blind sample that is notice is given or, if review is requested, maximum of 400 blind samples). Every inconsistent with the expected result upon the reviewing official’s decision to effort should be made to ensure that (e.g., a laboratory reports a negative uphold the proposed revocation. If the blind samples are submitted quarterly. result for a blind sample that was reviewing official decides not to uphold (c) Approximately 75 percent of the supposed to be positive, a laboratory the suspension or proposed revocation, blind samples submitted each year by reports a positive result for a blind the suspension must terminate an agency must be negative and 25 sample that was supposed to be immediately and any proposed percent must be positive for one or more negative): revocation shall not take effect. drugs. (a) The MRO must contact the (d) The Secretary will publish in the laboratory and attempt to determine if Section 10.2 What are the Federal Register the name, address, and the laboratory made an error during the requirements for blind samples? telephone number of any HHS-certified testing or reporting of the sample; laboratory that has its certification (a) Drug positive blind samples must (b) The MRO must contact the blind revoked or suspended under Section be validated by the supplier in the sample supplier and attempt to 9.13 or Section 9.14, respectively, and selected manufacturer’s collection determine if the supplier made an error the name of any HHS-certified device as to their content using during the preparation or transfer of the laboratory that has its suspension lifted. appropriate initial and confirmatory sample; (c) The MRO must contact the The Secretary shall provide to any tests. collector and determine if the collector member of the public upon request the (1) Drug positive blind samples must made an error when preparing the blind written notice provided to a laboratory be fortified with one or more of the sample for transfer to the HHS-certified that has its HHS certification suspended drugs or metabolites listed in Section laboratory; or revoked, as well as the reviewing 3.4. (2) Drug positive blind samples must (d) If there is no obvious reason for official’s written decision which the inconsistent result, the MRO must upholds or denies the suspension or contain concentrations of drugs between 1.5 and 2 times the initial drug test notify both the federal agency for which proposed revocation under the the blind sample was submitted and the procedures of Subpart P. cutoff concentration. (b) Drug negative blind samples (i.e., Secretary; and Section 9.16 May a laboratory that had certified to contain no drugs) must be (e) The Secretary shall investigate the its HHS certification revoked be validated by the supplier in the selected blind sample error. A report of the recertified to test federal agency manufacturer’s collection device as Secretary’s investigative findings and specimens? negative using appropriate initial and the corrective action taken in response to identified deficiencies must be sent to Following revocation, a laboratory confirmatory tests. (c) The supplier must provide the federal agency. The Secretary shall may apply for recertification. Unless information on the blind samples’ ensure notification of the finding as otherwise provided by the Secretary in content, validation, expected results, appropriate to other federal agencies the notice of revocation under Section and stability to the collection site/ and coordinate any necessary actions to 9.15 or the reviewing official’s decision collector sending the blind samples to prevent the recurrence of the error. under Section 16.9(e) or 16.14(a), a the laboratory or IITF, and must provide laboratory which has had its Subpart K—Laboratory the information upon request to the certification revoked may reapply for MRO, the federal agency for which the Section 11.1 What must be included in HHS certification as an applicant blind sample was submitted, or the the HHS-certified laboratory’s standard laboratory. Secretary. operating procedure manual? Section 9.17 Where is the list of HHS- (a) An HHS-certified laboratory must Section 10.3 How is a blind sample certified laboratories published? have a standard operating procedure submitted to an HHS-certified (SOP) manual that describes, in detail, (a) The list of HHS-certified laboratory? all HHS-certified laboratory operations. laboratories is published monthly in the (a) A blind sample must be submitted When followed, the SOP manual Federal Register. This notice is also in the collection device with the current ensures that all specimens are tested available on the Internet at http:// Federal CCF that the HHS-certified using the same procedures. www.samhsa.gov/workplace. laboratory uses for donor specimens. (b) The SOP manual must include at (b) An applicant laboratory is not The collector provides the required a minimum, but is not limited to, a included on the list. information to ensure that the Federal detailed description of the following:

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(1) Chain of custody procedures; or in analysis of performance testing Secretary’s approval of a new (2) Accessioning; samples; and inspection deficiencies. permanent RP or alternate RP. (3) Security; The RP must ensure that specimen (b) If the RP leaves an HHS-certified (4) Quality control/quality assurance results are not reported until all laboratory: programs; corrective actions have been taken and (1) The HHS-certified laboratory may (5) Analytical methods and that the results provided are accurate maintain certification and continue procedures; and reliable. testing federally regulated specimens (6) Equipment and maintenance under the direction of an alternate RP programs; Section 11.3 What scientific for a period of up to 180 days while (7) Personnel training; qualifications must the RP have? seeking to hire and receive the (8) Reporting procedures; and The RP must have documented Secretary’s approval of the RP’s (9) Computers, software, and scientific qualifications in analytical replacement. laboratory information management toxicology. Minimum qualifications are: (2) The Secretary, in accordance with systems. (a) Certification or licensure as a these Guidelines, will suspend a (c) All procedures in the SOP manual laboratory director by the state in laboratory’s HHS certification for all must be compliant with these forensic or clinical laboratory federally regulated specimens if the Guidelines and all guidance provided toxicology, a Ph.D. in one of the natural laboratory does not have a permanent by the Secretary. sciences, or training and experience RP within 180 days. The suspension (d) A copy of all procedures that have comparable to a Ph.D. in one of the will be lifted upon the Secretary’s been replaced or revised and the dates natural sciences with training and approval of the new permanent RP. on which the procedures were in effect laboratory/research experience in (c) To nominate an individual as an must be maintained for at least 2 years. biology, chemistry, and pharmacology RP or alternate RP, the HHS-certified Section 11.2 What are the or toxicology; laboratory must submit the following responsibilities of the responsible (b) Experience in forensic toxicology documents to the Secretary: the person (RP)? with emphasis on the collection and candidate’s current resume or analysis of biological specimens for curriculum vitae, copies of diplomas (a) Manage the day-to-day operations and licensures, a training plan (not to of the HHS-certified laboratory even if drugs of abuse; (c) Experience in forensic applications exceed 90 days) to transition the another individual has overall candidate into the position, an itemized responsibility for alternate areas of a of analytical toxicology (e.g., publications, court testimony, comparison of the candidate’s multi-specialty laboratory. qualifications to the minimum RP (b) Ensure that there are sufficient conducting research on the pharmacology and toxicology of drugs qualifications described in the personnel with adequate training and Guidelines, and have official academic experience to supervise and conduct the of abuse) or qualify as an expert witness in forensic toxicology; transcript(s) submitted from the work of the HHS-certified laboratory. candidate’s institution(s) of higher The RP must ensure the continued (d) Fulfillment of the RP responsibilities and qualifications, as learning. The candidate must be found competency of laboratory staff by qualified during an on-site inspection of documenting their in-service training, demonstrated by the HHS-certified laboratory’s performance and verified the HHS-certified laboratory. reviewing their work performance, and (d) The HHS-certified laboratory must upon interview by HHS-trained verifying their skills. fulfill additional inspection and PT inspectors during each on-site (c) Maintain a complete and current criteria as required prior to conducting inspection; and SOP manual that is available to all federally regulated testing under a new (e) Qualify as a certifying scientist. personnel of the HHS-certified RP. laboratory and ensure that it is followed. Section 11.4 What happens when the Section 11.5 What qualifications must The SOP manual must be reviewed, RP is absent or leaves an HHS-certified an individual have to certify a result signed, and dated by the RP(s) when laboratory? procedures are first placed into use and reported by an HHS-certified when changed or when a new (a) HHS-certified laboratories must laboratory? individual assumes responsibility for have multiple RPs or one RP and an (a) A certifying scientist must have: the management of the HHS-certified alternate RP. If the RP(s) are (1) At least a bachelor’s degree in the laboratory. The SOP must be reviewed concurrently absent, an alternate RP chemical or biological sciences or and documented by the RP annually. must be present and qualified to fulfill medical technology, or equivalent; (d) Maintain a quality assurance the responsibilities of the RP. (2) Training and experience in the program that ensures the proper (1) If an HHS-certified laboratory is analytical methods and forensic performance and reporting of all test without the RP and alternate RP for 14 procedures used by the HHS-certified results; verify and monitor acceptable calendar days or less (e.g., temporary laboratory relevant to the results that the analytical performance for all controls absence due to vacation, illness, or individual certifies; and and calibrators; monitor quality control business trip), the HHS-certified (3) Training and experience in testing; and document the validity, laboratory may continue operations and reviewing and reporting forensic test reliability, accuracy, precision, and testing of federal agency specimens results and maintaining chain of performance characteristics of each test under the direction of a certifying custody, and an understanding of and test system. scientist. appropriate remedial actions in (e) Initiate and implement all (2) The Secretary, in accordance with response to problems that may arise. remedial actions necessary to maintain these Guidelines, will suspend a (b) A certifying technician must have: satisfactory operation and performance laboratory’s HHS certification for all (1) Training and experience in the of the HHS-certified laboratory in specimens if the laboratory does not analytical methods and forensic response to the following: quality have an RP or alternate RP for a period procedures used by the HHS-certified control systems not within performance of more than 14 calendar days. The laboratory relevant to the results that the specifications; errors in result reporting suspension will be lifted upon the individual certifies; and

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(2) Training and experience in specimen or aliquot is handled or concentration 75 percent of the cutoff; reviewing and reporting forensic test transferred, and every individual in the and results and maintaining chain of chain must be identified. (4) At least one control that appears custody, and an understanding of (e) The date and purpose must be as a donor specimen to the analysts. appropriate remedial actions in recorded on an appropriate chain of (b) Calibrators and controls must total response to problems that may arise. custody form each time a specimen or at least 10 percent of the aliquots aliquot is handled or transferred. Section 11.6 What qualifications and analyzed in each batch. training must other personnel of an Section 11.9 What are the Section 11.12 What are the HHS-certified laboratory have? requirements for an initial drug test? requirements for a confirmatory drug (a) All HHS-certified laboratory staff (a) An initial drug test may be: test? (e.g., technicians, administrative staff) (1) An immunoassay or (a) The analytical method must use must have the appropriate training and (2) An alternate technology (e.g., mass spectrometric identification [e.g., skills for the tasks they perform. spectrometry, spectroscopy). gas chromatography/mass spectrometry (b) Each individual working in an (b) An HHS-certified laboratory must (GC/MS), liquid chromatography/mass HHS-certified laboratory must be validate an initial drug test before spectrometry (LC/MS), GC/MS/MS, LC/ properly trained (i.e., receive training in testing specimens. MS/MS] or equivalent. each area of work that the individual (c) Initial drug tests must be accurate (b) A confirmatory drug test must be will be performing, including training in and reliable for the testing of specimens validated before it can be used to test forensic procedures related to their job when identifying drugs or their federally regulated specimens. duties) before he or she is permitted to metabolites. (c) Confirmatory drug tests must be work independently with federally (d) An HHS-certified laboratory may accurate and reliable for the testing of regulated specimens. All training must conduct a second initial drug test using an oral fluid specimen when identifying be documented. a method with different specificity, to and quantifying drugs or their rule out cross-reacting compounds. This metabolites. Section 11.7 What security measures second initial drug test must satisfy the must an HHS-certified laboratory batch quality control requirements Section 11.13 What must an HHS- maintain? specified in Section 11.11. certified laboratory do to validate a (a) An HHS-certified laboratory must confirmatory drug test? Section 11.10 What must an HHS- control access to the drug testing (a) An HHS-certified laboratory must facility, specimens, aliquots, and certified laboratory do to validate an initial drug test? demonstrate and document the records. following for each confirmatory drug (b) Authorized visitors must be (a) An HHS-certified laboratory must test: escorted at all times, except for demonstrate and document the (1) The linear range of the analysis; individuals conducting inspections (i.e., following for each initial drug test: (2) The limit of detection; for the Department, a federal agency, a (1) The ability to differentiate negative (3) The limit of quantification; state, or other accrediting agency) or specimens from those requiring further (4) The accuracy and precision at the emergency personnel (e.g., firefighters testing; cutoff concentration; and medical rescue teams). (2) The performance of the test around (c) An HHS-certified laboratory must the cutoff concentration, using samples (5) The accuracy (bias) and precision maintain records documenting the at several concentrations between 0 and at 40 percent of the cutoff concentration; identity of the visitor and escort, date, 150 percent of the cutoff concentration; (6) The potential for interfering time of entry and exit, and purpose for (3) The effective concentration range substances; access to the secured area. of the test (linearity); (7) The potential for carryover; and (4) The potential for carryover; (8) The potential matrix effects if Section 11.8 What are the laboratory (5) The potential for interfering using liquid chromatography coupled chain of custody requirements for substances; and with mass spectrometry. specimens and aliquots? (6) The potential matrix effects if (b) Each new lot of reagent must be (a) HHS-certified laboratories must using an alternate technology. verified prior to being placed into use chain of custody procedures (b) Each new lot of reagent must be service. (internal and external) to maintain verified prior to being placed into (c) HHS-certified laboratories must re- control and accountability of specimens service. verify each confirmatory drug test from the time of receipt at the laboratory (c) Each initial drug test using an method periodically or at least annually. through completion of testing, reporting alternate technology must be re-verified Section 11.14 What are the batch of results, during storage, and periodically or at least annually. quality control requirements when continuing until final disposition of the Section 11.11 What are the batch conducting a confirmatory drug test? specimens. (b) HHS-certified laboratories must quality control requirements when (a) At a minimum, each batch of use chain of custody procedures to conducting an initial drug test? specimens must contain the following document the handling and transfer of (a) Each batch of specimens must calibrators and controls: aliquots throughout the testing process contain the following controls: (1) A calibrator at the cutoff until final disposal. (1) At least one control certified to concentration; (c) The chain of custody must be contain no drug or drug metabolite; (2) At least one control certified to documented using either paper copy or (2) At least one positive control with contain no drug or drug metabolite; electronic procedures. the drug or drug metabolite targeted at (3) At least one positive control with (d) Each individual who handles a a concentration 25 percent above the the drug or drug metabolite targeted at specimen or aliquot must sign and cutoff; 25 percent above the cutoff; and complete the appropriate entries on the (3) At least one control with the drug (4) At least one control targeted at or chain of custody form when the or drug metabolite targeted at a less than 40 percent of the cutoff.

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(b) Calibrators and controls must total (e) A primary (A) oral fluid specimen and multiplying the result by the at least 10 percent of the aliquots is reported as an invalid result when: appropriate dilution factor. analyzed in each batch. (1) Interference occurs on the initial (k) HHS-certified laboratories may drug tests on two separate aliquots (i.e., transmit test results to the MRO by Section 11.15 What are the analytical valid initial drug test results cannot be various electronic means (e.g., and quality control requirements for obtained); teleprinter, facsimile, or computer). conducting specimen validity tests? (2) Interference with the confirmatory Transmissions of the reports must (a) Each specimen validity test result drug test occurs on at least two separate ensure confidentiality and the results must be based on performing an initial aliquots of the specimen and the HHS- may not be reported verbally by specimen validity test on one aliquot certified laboratory is unable to identify telephone. Laboratories and external and a second or confirmatory test on a the interfering substance; service providers must ensure the second aliquot; (3) The physical appearance of the confidentiality, integrity, and (b) The HHS-certified laboratory must specimen is such that testing the availability of the data and limit access establish acceptance criteria and specimen may damage the laboratory’s to any data transmission, storage, and analyze calibrators and controls as instruments; retrieval system. appropriate to verify and document the (4) The physical appearances of Tubes (l) HHS-certified laboratories must validity of the test results; and A and B are clearly different (note: A is facsimile, courier, mail, or electronically (c) Controls must be analyzed tested); transmit a legible image or copy of the (5) The albumin concentration is less concurrently with specimens. completed Federal CCF and/or forward than 0.6 mg/dL for both the initial (first) a computer-generated electronic report. Section 11.16 What must an HHS- test and the second test on two separate The computer-generated report must certified laboratory do to validate a aliquots; contain sufficient information to ensure specimen validity test? (6) The IgG concentration is less than that the test results can accurately 0.5 mg/L for both the initial (first) test An HHS-certified laboratory must represent the content of the custody and and the second test on two separate demonstrate and document for each control form that the MRO received aliquots; or specimen validity test the appropriate from the collector. (7) The concentration of a biomarker (m) For positive, adulterated, invalid, performance characteristics of the test, other than albumin or IgG is not and must re-verify the test periodically, and rejected specimens, laboratories consistent with that established for must facsimile, courier, mail, or or at least annually. Each new lot of human oral fluid. reagent must be verified prior to being electronically transmit a legible image (f) An HHS-certified laboratory shall or copy of the completed Federal CCF. placed into service. reject a primary (A) oral fluid specimen Section 11.17 What are the for testing when a fatal flaw occurs as Section 11.18 How long must an HHS- requirements for an HHS-certified described in Section 15.1 or when a certified laboratory retain specimens? laboratory to report a test result? correctable flaw as described in Section (a) An HHS-certified laboratory must 15.2 is not recovered. The HHS-certified retain specimens that were reported as (a) Laboratories must report a test laboratory will indicate on the Federal positive, adulterated, or as an invalid result to the agency’s MRO within an CCF that the specimen was rejected for result for a minimum of 1 year. average of 5 working days after receipt testing and provide the reason for (b) Retained specimens must be kept of the specimen. Reports must use the reporting the rejected for testing result. in secured frozen storage (¥20 °C or Federal CCF and/or an electronic report. (g) An HHS-certified laboratory must less) to ensure their availability for Before any test result can be reported, it report all positive, adulterated, and retesting during an administrative or must be certified by a certifying scientist invalid test results for an oral fluid judicial proceeding. or a certifying technician (as specimen. For example, a specimen can (c) Federal agencies may request that appropriate). be positive for a specific drug and the HHS-certified laboratory retain a (b) A primary (A) specimen is adulterated. specimen for an additional specified reported negative when each initial drug (h) An HHS-certified laboratory must period of time and must make that test is negative or if the specimen is report the confirmatory concentration of request within the 1-year period. negative upon confirmatory drug each drug or drug metabolite reported testing, and the specimen does not meet for a positive result. Section 11.19 How long must an HHS- invalid criteria as described in items (i) An HHS-certified laboratory must certified laboratory retain records? (e)(1) through (e)(4) below. report numerical values of the specimen (a) An HHS-certified laboratory must (c) A primary (A) specimen is validity test results that support a retain all records generated to support reported positive for a specific drug or specimen that is reported adulterated or test results for at least 2 years. The drug metabolite when both the initial invalid (as appropriate). laboratory may convert hardcopy drug test is positive and the (j) When the concentration of a drug records to electronic records for storage confirmatory drug test is positive in or drug metabolite exceeds the validated and then discard the hardcopy records accordance with Section 3.4. linear range of the confirmatory test, after 6 months. (d) For a specimen that has an invalid HHS-certified laboratories may report to (b) A federal agency may request the result for one of the reasons stated in the MRO that the quantitative value HHS-certified laboratory to maintain a items (e)(1) through (e)(4) below, the exceeds the linear range of the test or documentation package (as described in HHS-certified laboratory shall contact that the quantitative value is greater Section 11.21) that supports the chain of the MRO and both will decide if testing than ‘‘insert the actual value for the custody, testing, and reporting of a by another HHS-certified laboratory upper limit of the linear range,’’ or donor’s specimen that is under legal would be useful in being able to report laboratories may report a quantitative challenge by a donor. The federal a positive or adulterated result. If no value above the upper limit of the linear agency’s request to the laboratory must further testing is necessary, the HHS- range that was obtained by diluting an be in writing and must specify the certified laboratory then reports the aliquot of the specimen to achieve a period of time to maintain the invalid result to the MRO. result within the method’s linear range documentation package.

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(c) An HHS-certified laboratory may results or a documentation package or interest or derive any financial benefit retain records other than those included any relevant certification, review, or by having a federal agency use a specific in the documentation package beyond revocation of certification records. MRO. the normal 2-year period of time. (b) Standard documentation packages This means an MRO may be an provided by an HHS-certified laboratory employee of the agency or a contractor Section 11.20 What statistical must contain the following items: for the agency; however, an MRO shall summary reports must an HHS-certified (1) A cover sheet providing a brief not be an employee or agent of or have laboratory provide for oral fluid testing? description of the procedures and tests any financial interest in the HHS- (a) HHS-certified laboratories must performed on the donor’s specimen; certified laboratory for which the MRO provide to each federal agency for (2) A table of contents that lists all is reviewing drug testing results. which they perform testing a documents and materials in the package Additionally, an MRO shall not derive semiannual statistical summary report by page number; any financial benefit by having an that must be submitted by mail, (3) A copy of the Federal CCF with agency use a specific HHS-certified facsimile, or email within 14 working any attachments, internal chain of laboratory or have any agreement with days after the end of the semiannual custody records for the specimen, an HHS-certified laboratory that may be period. The summary report must not memoranda (if any) generated by the construed as a potential conflict of include any personal identifying HHS-certified laboratory, and a copy of interest. information. A copy of the semiannual the electronic report (if any) generated statistical summary report will also be by the HHS-certified laboratory; Subpart L—Instrumented Initial Test sent to the Secretary or designated HHS (4) A brief description of the HHS- Facility (IITF) representative. The semiannual certified laboratory’s initial drug and Section 12.1 May an IITF test oral statistical report contains the following specimen validity testing procedures, fluid specimens for a federal agency’s information: instrumentation, and batch quality workplace drug testing program? (1) Reporting period (inclusive dates); control requirements; No, only HHS-certified laboratories (2) HHS-certified laboratory name and (5) Copies of the initial test data for are authorized to test oral fluid address; the donor’s specimen with all specimens for federal agency workplace (3) Federal agency name; calibrators and controls and copies of all (4) Number of specimen results internal chain of custody documents drug testing programs in accordance reported; related to the initial tests; with these Guidelines. (5) Number of specimens collected by (6) A brief description of the HHS- Subpart M—Medical Review Officer reason for test; certified laboratory’s confirmatory drug (MRO) (6) Number of specimens reported (and specimen validity, if applicable) negative; testing procedures, instrumentation, and Section 13.1 Who may serve as an (7) Number of specimens rejected for batch quality control requirements; MRO? testing because of a fatal flaw; (7) Copies of the confirmatory test (a) A currently licensed physician (8) Number of specimens rejected for data for the donor’s specimen with all who has: testing because of an uncorrected flaw; calibrators and controls and copies of all (1) A Doctor of Medicine (M.D.) or (9) Number of specimens tested internal chain of custody documents Doctor of Osteopathy (D.O.) degree; positive by each initial drug test; related to the confirmatory tests; and (2) Knowledge regarding the (10) Number of specimens reported (8) Copies of the re´sume´ or pharmacology and toxicology of illicit positive; curriculum vitae for the RP(s) and the drugs and nonmedical use of (11) Number of specimens reported certifying technician or certifying prescription drugs; positive for each drug and drug scientist of record. (3) The training necessary to serve as metabolite; an MRO as set out in Section 13.3; (12) Number of specimens reported Section 11.22 What HHS-certified (4) Satisfactorily passed an initial adulterated; and laboratory information is available to a examination administered by a (13) Number of specimens reported as federal employee? nationally recognized entity or invalid result. A federal employee who is the subject subspecialty board that has been (b) An HHS-certified laboratory must of a workplace drug test may submit a approved by the Secretary to certify make copies of an agency’s test results written request through the MRO and MROs; and available when requested to do so by the the federal agency requesting copies of (5) At least every five years, Secretary or by the federal agency for any records relating to his or her drug completed requalification training on which the laboratory is performing test results or a documentation package the topics in Section 13.3 and drug-testing services. as described in Section 11.21(b) and any satisfactorily passed a requalification (c) An HHS-certified laboratory must relevant certification, review, or examination administered by a ensure that a qualified individual is revocation of certification records. nationally recognized entity or a available to testify in a proceeding Federal employees, or their designees, subspecialty board that has been against a federal employee when the are not permitted access to their approved by the Secretary to certify proceeding is based on a test result specimens collected pursuant to MROs. reported by the laboratory. Executive Order 12564, Public Law Section 13.2 How are nationally 100–71, and these Guidelines. Section 11.21 What HHS-certified recognized entities or subspecialty laboratory information is available to a Section 11.23 What types of boards that certify MROs approved? federal agency? relationships are prohibited between an All nationally recognized entities or (a) Following a federal agency’s HHS-certified laboratory and an MRO? subspecialty boards which seek receipt of a positive or adulterated drug An HHS-certified laboratory must not approval by the Secretary to certify and/ test report, the federal agency may enter into any relationship with a or train physicians as MROs for federal submit a written request for copies of federal agency’s MRO that may be workplace drug testing programs must the records relating to the drug test construed as a potential conflict of submit their qualifications and, if

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applicable, a sample examination. designated representative. The MRO donor to determine if there is any Approval will be based on an objective must review at least 5 percent of all legitimate medical explanation for the review of qualifications that include a negative results reported by the MRO positive result. copy of the MRO applicant application staff to ensure that the MRO staff are (1) If the donor provides a legitimate form, the course syllabus and materials, properly performing the review process. medical explanation for the positive documentation that the continuing (c) The MRO must discuss potential result, the MRO reports the test result as education courses are accredited by a invalid results with the HHS-certified negative to the agency. professional organization, and, if laboratory, as addressed in Section (2) If the donor is unable to provide applicable, the delivery method and 11.17(d) to determine whether testing at a legitimate medical explanation, the content of the examination. Each another HHS-certified laboratory may be MRO reports a positive result to the approved MRO training/certification warranted. agency for all drugs except codeine and/ entity must resubmit their qualifications (d) After receiving a report from an or morphine as follows: for approval every two years. The HHS-certified laboratory or (for urine) (i) For codeine and/or morphine less Secretary shall publish at least every HHS-certified IITF, the MRO must: than 150 ng/mL and no legitimate two years a notice in the Federal (1) Review the information on the medical explanation: the MRO must Register listing those entities and MRO copy of the Federal CCF that was determine if there is clinical evidence of subspecialty boards that have been received from the collector and the illegal use (in addition to the drug test approved. This notice is also available report received from the HHS-certified result) to report a positive result to the on the Internet at http:// laboratory or HHS-certified IITF; agency. If there is no clinical evidence www.samhsa.gov/workplace/drug- (2) Interview the donor when of illegal use, the MRO reports a testing. required; negative result to the agency. (3) Make a determination regarding (ii) For codeine and/or morphine at or Section 13.3 What training is required the test result; and above 150 ng/mL and no legitimate before a physician may serve as an (4) Report the verified result to the medical explanation: the MRO reports a MRO? federal agency. positive result to the agency. (a) A physician must receive training (e) The MRO must maintain records Consumption of food products must not that includes a thorough review of the for a minimum of 2 years while be considered a legitimate medical following: maintaining the confidentiality of the explanation for the donor having (1) The collection procedures used to information. The MRO may convert morphine or codeine at or above this collect federal agency specimens; hardcopy records to electronic records concentration. (2) How to interpret test results for storage and discard the hardcopy (d) When the HHS-certified laboratory reported by HHS-certified laboratories records after 6 months. reports an adulterated result for the (e.g., negative, negative/dilute, positive, (f) The MRO must conduct a medical primary (A) oral fluid specimen, the adulterated, substituted, rejected for examination or a review of the MRO contacts the donor to determine if testing, and invalid); examining physician’s findings and the donor has a legitimate medical (3) Chain of custody, reporting, and make a determination of refusal to test explanation for the adulterated result. recordkeeping requirements for federal or cancelled test when a collector (1) If the donor provides a legitimate agency specimens; reports that the donor was unable to medical explanation, the MRO reports a (4) The HHS Mandatory Guidelines provide a specimen, as addressed in negative result to the federal agency. for Federal Workplace Drug Testing Section 8.6. (2) If the donor is unable to provide a legitimate medical explanation, the Programs for all authorized specimen Section 13.5 What must an MRO do MRO reports a refusal to test to the types; when reviewing an oral fluid specimen’s (5) Procedures for interpretation, federal agency because the oral fluid test results? review (e.g., donor interview for specimen was adulterated. legitimate medical explanations), and (a) When the HHS-certified laboratory (e) When the HHS-certified laboratory reporting of results specified by any reports a negative result for the primary reports an invalid result for the primary federal agency for which the individual (A) specimen, the MRO reports a (A) oral fluid specimen, the MRO must may serve as an MRO; and negative result to the agency. contact the donor to determine if there (6) Training in Substance Abuse (b) When the HHS-certified laboratory is a legitimate explanation for the including information about how to reports multiple results for the primary invalid result. discuss substance misuse and abuse, (A) specimen, as the MRO, you must (1) If the donor provides a legitimate and how individuals that test positive follow the verification procedures explanation (e.g., a prescription can access services. described in 13.5(c) through (f) and: medication), the MRO reports a test (b) Nationally recognized entities or (1) Report all verified positive and/or cancelled result with the reason for the subspecialty boards that train or certify refusal to test results to the federal invalid result and informs the federal physicians as MROs should make the agency. agency that a recollection is not MROs aware of prevention and (2) If an invalid result was reported in required because there is a legitimate treatment opportunities for individuals conjunction with a positive or explanation for the invalid result. after testing positive. adulterated result, do not report the (2) If the donor is unable to provide verified invalid result to the federal a legitimate explanation, the MRO Section 13.4 What are the agency at this time. The MRO reports reports a test cancelled result and responsibilities of an MRO? the verified invalid result(s) for the directs the agency to collect another (a) The MRO must review all positive, primary (A) specimen only if the split specimen from the donor. adulterated, rejected for testing, invalid, specimen is tested and reported as a (i) If the second specimen collected and (for urine) substituted test results. failure to reconfirm as described in provides a valid result, the MRO follows (b) Staff under the direct, personal Section 14.5(c). the procedures in Section 13.5(a) supervision of the MRO may review and (c) When the HHS-certified laboratory through (d). report negative and (for urine) negative/ reports a positive result for the primary (ii) If the second specimen collected dilute test results to the agency’s (A) specimen, the MRO must contact the provides an invalid result, the MRO

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reports this specimen as test cancelled condition beyond what is necessary to Section 13.7 What happens when an and recommends that the agency collect explain the referral physician’s individual is unable to provide a another authorized specimen type (e.g., conclusion. sufficient amount of oral fluid for a urine). (3) As the MRO, if another physician federal agency applicant/pre- (f) When the HHS-certified laboratory performed the evaluation, you must employment test, a follow-up test, or a reports a rejected for testing result on return-to-duty test because of a consider and assess the referral the primary (A) specimen, the MRO permanent or long-term medical physician’s recommendations in making reports a test cancelled result to the condition? agency and recommends that the agency your determination. You must make one (a) This section concerns a situation collect another specimen from the of the following determinations and in which the donor has a medical donor. report it to the federal agency in writing: condition that precludes him or her Section 13.6 What action does the (i) A medical condition as defined in from providing a sufficient specimen for MRO take when the collector reports paragraph (b)(1) of this section has, or a federal agency applicant/pre- that the donor did not provide a with a high degree of probability could employment test, a follow-up test, or a sufficient amount of oral fluid for a drug have, precluded the employee from return-to-duty test and the condition test? providing a sufficient amount of oral involves a permanent or long-term fluid, but is not a permanent or long- (a) When another specimen type (e.g., disability and the federal agency does term disability. As the MRO, you must urine) was collected as authorized by not authorize collection of an alternative the federal agency, the MRO reviews report a test cancelled result to the specimen. As the MRO in this situation, and reports the test result in accordance federal agency. you must do the following: with the Mandatory Guidelines for (ii) A permanent or long-term medical (1) You must determine if there is Federal Workplace Drug Testing condition as defined in paragraph (b)(1) clinical evidence that the individual is Programs using the alternative of this section has, or with a high degree an illicit drug user. You must make this specimen. of probability could have, precluded the determination by personally (b) When the federal agency did not employee from providing a sufficient conducting, or causing to be conducted, a medical evaluation and through authorize the collection of an alternative amount of oral fluid and is highly likely consultation with the donor’s physician specimen, the MRO consults with the to prevent the employee from providing and/or the physician who conducted the federal agency. The federal agency a sufficient amount of oral fluid for a immediately directs the donor to obtain, evaluation under Section 13.6. very long or indefinite period of time. (2) If you do not personally conduct within five days, an evaluation from a As the MRO, you must follow the licensed physician, acceptable to the the medical evaluation, you must ensure requirements of Section 13.7, as that one is conducted by a licensed MRO, who has expertise in the medical appropriate. If Section 13.7 is not issues raised by the donor’s failure to physician acceptable to you. applicable, you report a test cancelled provide a specimen. The MRO may (b) If the medical evaluation reveals result to the federal agency and perform this evaluation if the MRO has no clinical evidence of drug use, as the appropriate expertise. recommend that the agency authorize MRO, you must report the result to the (1) For purposes of this section, a collection of an alternative specimen federal agency as a negative test with medical condition includes an type (e.g., urine) for any subsequent written notations regarding results of ascertainable physiological condition. drug tests for the donor. both the evaluation conducted under Permanent or long-term medical (iii) There is not an adequate basis for Section 13.6 and any further medical conditions are those physiological, determining that a medical condition examination. This report must state the anatomic, or psychological has or, with a high degree of probability, basis for the determination that a permanent or long-term medical abnormalities documented as being could have precluded the employee condition exists, making provision of a present prior to the attempted from providing a sufficient amount of collection, and considered not amenable sufficient oral fluid specimen oral fluid. As the MRO, you must report impossible, and for the determination to correction or cure for an extended a refusal to test to the federal agency. period of time, if ever. that no signs and symptoms of drug use (2) As the MRO, if another physician (4) When a federal agency receives a exist. The MRO recommends that the will perform the evaluation, you must report from the MRO indicating that a agency authorize collection of an provide the other physician with the test is cancelled as provided in alternate specimen type (e.g., urine) for following information and instructions: paragraph (b)(3)(i) of this section, the any subsequent collections. (i) That the donor was required to take agency takes no further action with (c) If the medical evaluation reveals a federally regulated drug test, but was respect to the donor. When a test is clinical evidence of drug use, as the unable to provide a sufficient amount of canceled as provided in paragraph MRO, you must report the result to the oral fluid to complete the test; (b)(3)(ii) of this section, the agency takes federal agency as a cancelled test with (ii) The consequences of the no further action with respect to the written notations regarding results of appropriate federal agency regulation donor other than designating collection both the evaluation conducted under for refusing to take the required drug of an alternate specimen type (i.e., Section 13.6 and any further medical test; authorized by the Mandatory Guidelines examination. This report must state that (iii) That, after completing the for Federal Workplace Drug Testing a permanent or long-term medical evaluation, the referral physician must condition [as defined in Section Programs) for any subsequent agree to provide a written statement to 13.6(b)(1)] exists, making provision of a collections, in accordance with the the MRO with a recommendation for sufficient oral fluid specimen one of the determinations described in federal agency plan. The donor remains impossible, and state the reason for the paragraph (b)(3) of this section and the in the random testing pool. determination that signs and symptoms basis for the recommendation. The of drug use exist. Because this is a statement must not include detailed cancelled test, it does not serve the information on the employee’s medical purposes of a negative test (e.g., the

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federal agency is not authorized to allow the HHS-certified laboratory that may be confirmatory specimen validity test(s) the donor to begin or resume performing construed as a potential conflict of needed to reconfirm the adulterated official functions because a negative test interest. result reported by the first HHS-certified is needed for that purpose). laboratory. Subpart N—Split Specimen Tests Section 14.4 Who receives the split (B) Section 13.8 Who may request a test of Section 14.1 When may a split (B) specimen result? a split (B) specimen? specimen be tested? The second HHS-certified laboratory (a) For a positive or adulterated result (a) The donor may verbally request reported on a primary (A) specimen, a through the MRO that the split (B) must report the result to the MRO. donor may request through the MRO specimen be tested at a different (i.e., Section 14.5 What action(s) does an that the split (B) specimen be tested by second) HHS-certified oral fluid MRO take after receiving the split (B) a second HHS-certified laboratory to laboratory when the primary (A) oral fluid specimen result from the verify the result reported by the first specimen was determined by the MRO second HHS-certified laboratory? HHS-certified laboratory. to be positive, adulterated, or (for urine) (b) The donor has 72 hours (from the The MRO takes the following actions substituted. when the second HHS-certified time the MRO notified the donor that (b) A donor has 72 hours to initiate laboratory reports the result for the split his or her specimen was reported the verbal request after being informed oral fluid specimen as: positive, adulterated, or (for urine) of the result by the MRO. The MRO substituted to request a test of the split (a) Reconfirmed the drug(s) or must document in his or her records the adulteration result. The MRO reports (B) specimen. The MRO must inform the verbal request from the donor to have donor that he or she has the opportunity reconfirmed to the agency. the split (B) specimen tested. (b) Failed to reconfirm a single or all to request a test of the split (B) specimen (c) If a split (B) oral fluid specimen drug positive results and adulterated. If when the MRO informs the donor that cannot be tested by a second HHS- the donor provides a legitimate medical a positive, adulterated, or (for urine) certified laboratory (e.g., insufficient explanation for the adulteration result, substituted result is being reported to specimen, lost in transit, split not the MRO reports a failed to reconfirm the federal agency on the primary (A) available, no second HHS-certified [specify drug(s)] and cancels both tests. specimen. laboratory available to perform the test), If there is no legitimate medical the MRO reports to the federal agency Section 13.9 How does an MRO report explanation, the MRO reports a failed to that the test must be cancelled and the a primary (A) specimen test result to an reconfirm [specify drug(s)] and a refusal agency? reason for the cancellation. The MRO directs the federal agency to ensure the to test to the agency and indicates the (a) The MRO must report all verified immediate recollection of another oral adulterant that is present in the results to an agency using the completed fluid specimen from the donor, with no specimen. The MRO gives the donor 72 MRO copy of the Federal CCF or a notice given to the donor of this hours to request that Laboratory A retest separate report using a letter/ collection requirement until the primary (A) specimen for the memorandum format. The MRO may immediately before the collection. adulterant. If Laboratory A reconfirms use various electronic means for (d) If a donor chooses not to have the the adulterant, the MRO reports refusal reporting (e.g., teleprinter, facsimile, or split (B) specimen tested by a second to test and indicates the adulterant computer). Transmissions of the reports HHS-certified oral fluid laboratory, a present. If Laboratory A fails to must ensure confidentiality. The MRO federal agency may have a split (B) reconfirm the adulterant, the MRO and external service providers must specimen retested as part of a legal or cancels both tests and directs the agency ensure the confidentiality, integrity, and administrative proceeding to defend an to immediately collect another availability of the data and limit access original positive, adulterated, or (for specimen. The MRO shall notify the to any data transmission, storage, and urine) substituted result. appropriate regulatory office about the retrieval system. failed to reconfirm and cancelled test. (b) A verified result may not be Section 14.2 How does an HHS- (c) Failed to reconfirm a single or all reported to the agency until the MRO certified laboratory test a split (B) drug positive results and not has completed the review process. specimen when the primary (A) adulterated. The MRO reports to the (c) The MRO must send a copy of specimen was reported positive? agency a failed to reconfirm result either the completed MRO copy of the (a) The testing of a split (B) specimen specify drug(s)], cancels both tests, and Federal CCF or the separate letter/ for a drug or metabolite is not subject to notifies the HHS office responsible for memorandum report for all positive, the testing cutoff concentrations coordination of the drug-free workplace adulterated, and (for urine) substituted established. program. results. (b) The HHS-certified laboratory is (d) Failed to reconfirm a single or all (d) The MRO must not disclose only required to confirm the presence of drug positive results and invalid result. numerical values of drug test results to the drug or metabolite that was reported The MRO reports to the agency a failed the agency. positive in the primary (A) specimen. to reconfirm result [specify drug(s) and gives the reason for the invalid result], Section 13.10 What types of Section 14.3 How does an HHS- cancels both tests, directs the agency to relationships are prohibited between an certified laboratory test a split (B) oral immediately collect another specimen MRO and an HHS-certified laboratory? fluid specimen when the primary (A) and notifies the HHS office responsible An MRO must not be an employee, specimen was reported adulterated? for coordination of the drug-free agent of, or have any financial interest (a) The HHS-certified laboratory must workplace program. in an HHS-certified laboratory for which use its confirmatory specimen validity (e) Failed to reconfirm one or more the MRO is reviewing drug test results. test at an established limit of drugs, reconfirmed one or more drugs, This means an MRO must not derive quantification (LOQ) to reconfirm the and adulterated. The MRO reports to any financial benefit by having an presence of the adulterant. the agency a reconfirmed result [specify agency use a specific HHS-certified (b) The second HHS-certified drug(s)] and a failed to reconfirm result laboratory or have any agreement with laboratory may only conduct the [specify drug(s)]. The MRO tells the

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agency that it may take action based on adulterant] and a failed to reconfirm Subpart O—Criteria for Rejecting a the reconfirmed drug(s) although result [specify drug(s)]. The MRO tells Specimen for Testing Laboratory B failed to reconfirm one or the agency that it may take action based Section 15.1 What discrepancies more drugs and found that the specimen on the reconfirmed drug(s) and the require an HHS-certified laboratory to was adulterated. The MRO shall notify reconfirmed adulterant although the HHS office official responsible for report a specimen as rejected for Laboratory B failed to reconfirm one or testing? coordination of the drug-free workplace more drugs. program regarding the test results for the The following discrepancies are specimen. (l) Failed to reconfirm at least one considered to be fatal flaws. The HHS- (f) Failed to reconfirm one or more drug and failed to reconfirm the certified laboratory must stop the testing drugs, reconfirmed one or more drugs, adulterant. The MRO reports to the process, reject the specimen for testing, and not adulterated. The MRO reports agency a reconfirmed result [specify and indicate the reason for rejecting the a reconfirmed result [specify drug(s)] drug(s)] and a failed to reconfirm result specimen on the Federal CCF when: and a failed to reconfirm result [specify [specify drug(s) and adulterant]. The (a) The specimen ID number on the drug(s)]. The MRO tells the agency that MRO tells the agency that it may take specimen label/seal does not match the it may take action based on the action based on the reconfirmed drug(s) ID number on the Federal CCF, or the reconfirmed drug(s) although Laboratory although Laboratory B failed to ID number is missing either on the B failed to reconfirm one or more drugs. reconfirm one or more drugs and failed Federal CCF or on either specimen The MRO shall notify the HHS office to reconfirm the adulterant. label/seal; responsible for coordination of the drug- (b) The primary (A) specimen label/ free workplace program regarding the Section 14.6 How does an MRO report seal is broken or shows evidence of test results for the specimen. a split (B) specimen test result to an tampering and the split (B) specimen (g) Failed to reconfirm one or more agency? cannot be re-designated as the primary drugs, reconfirmed one or more drugs, (A) specimen; and invalid result. The MRO reports to (a) The MRO must report all verified (c) The collector’s printed name and the agency a reconfirmed result [specify results to an agency using the completed signature are omitted on the Federal drug(s)] and a failed to reconfirm result MRO copy of the Federal CCF or a CCF; [specify drug(s)]. The MRO tells the separate report using a letter/ (d) There is an insufficient amount of agency that it may take action based on memorandum format. The MRO may specimen for analysis in the primary (A) the reconfirmed drug(s) although use various electronic means for specimen unless the split (B) specimen Laboratory B failed to reconfirm one or reporting (e.g., teleprinter, facsimile, or can be re-designated as the primary (A) more drugs and reported an invalid computer). Transmissions of the reports specimen; or result. The MRO shall notify the HHS must ensure confidentiality. The MRO (e) The accessioner failed to office responsible for coordination of and external service providers must document the primary (A) specimen the Drug-free Workplace Program ensure the confidentiality, integrity, and seal condition on the Federal CCF at the regarding the test results for the availability of the data and limit access time of accessioning, and the split (B) specimen. to any data transmission, storage, and specimen cannot be re-designated as the (h) Failed to reconfirm adulteration. retrieval system. primary (A) specimen. The MRO reports to the agency a failed to reconfirm result (specify adulterant) (b) A verified result may not be Section 15.2 What discrepancies and cancels both tests. The MRO shall reported to the agency until the MRO require an HHS-certified laboratory to notify the HHS office responsible for has completed the review process. report a specimen as rejected for testing unless the discrepancy is corrected? coordination of the drug-free workplace (c) The MRO must send a copy of program regarding the test results for the either the completed MRO copy of the The following discrepancies are specimen. Federal CCF or the separate letter/ considered to be correctable: (i) Failed to reconfirm a single or all memorandum report for all split (a) If a collector failed to sign the Federal CCF, the HHS-certified drug positive results and reconfirmed an specimen results. adulterant. The MRO reports to the laboratory must attempt to recover the agency a reconfirmed result (specify (d) The MRO must not disclose the collector’s signature before reporting the adulterant) and a failed to reconfirm numerical values of the drug test results test result. If the collector can provide result [specify drug(s)]. The MRO tells to the agency. a memorandum for record recovering the signature, the HHS-certified the agency that it may take action based Section 14.7 How long must an HHS- laboratory may report the test result for on the reconfirmed result (adulterated) certified laboratory retain a split (B) although Laboratory B failed to the specimen. If, after holding the specimen? reconfirm the drug(s) result. specimen for at least 5 business days, (j) Failed to reconfirm a single or all A split (B) specimen is retained for the HHS-certified laboratory cannot drug positive results and failed to the same period of time that a primary recover the collector’s signature, the reconfirm the adulterant. The MRO (A) specimen is retained and under the laboratory must report a rejected for reports to the agency a failed to same storage conditions. This applies testing result and indicate the reason for reconfirm result [specify drug(s) and even for those cases when the split (B) the rejected for testing result on the adulterant] and cancels both tests. The Federal CCF. specimen is tested by a second HHS- MRO shall notify the HHS office (b) If a specimen is submitted using a certified laboratory and the second responsible for coordination of the drug- non-federal form or an expired Federal HHS-certified laboratory does not free workplace program regarding the CCF, the HHS-certified laboratory must test results for the specimen. confirm the original result reported by test the specimen and also attempt to (k) Failed to reconfirm at least one the first HHS-certified laboratory for the obtain a memorandum for record drug and reconfirmed the adulterant. primary (A) specimen. explaining why a non-federal form or an The MRO reports to the agency a expired Federal CCF was used and reconfirmed result [specify drug(s) and ensure that the form used contains all

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the required information. If, after are considered insignificant and should statement from the certifying scientist, holding the specimen for at least 5 not cause an MRO to cancel a test: the MRO must cancel the test. business days, the HHS-certified (1) The testing laboratory fails to (d) If error (a)(3) occurs, the MRO laboratory cannot obtain a indicate the correct name and address in must contact the HHS-certified memorandum for record from the the results section when a different laboratory. If, after at least 5 business collector, the laboratory must report a laboratory name and address is printed days, the laboratory does not retransmit rejected for testing result and indicate at the top of the Federal CCF; a corrected electronic report, the MRO the reason for the rejected for testing (2) The accessioner fails to print his must cancel the test. or her name; result on the report to the MRO. Subpart P—Laboratory Suspension/ (3) The certifying scientist or Revocation Procedures Section 15.3 What discrepancies are certifying technician fails to print his or not sufficient to require an HHS- her name; Section 16.1 When may the HHS certified laboratory to reject an oral (4) The certifying scientist or certification of a laboratory be fluid specimen for testing or an MRO to certifying technician accidentally suspended? cancel a test? initials the Federal CCF rather than These procedures apply when: (a) The following omissions and signing for a specimen reported as (a) The Secretary has notified an HHS- discrepancies on the Federal CCF that rejected for testing; certified laboratory in writing that its are received by the HHS-certified (c) The above omissions and certification to perform drug testing laboratory are considered insignificant discrepancies are considered under these Guidelines has been and should not cause an HHS-certified insignificant only when they occur no suspended or that the Secretary laboratory to reject an oral fluid more than once a month. The proposes to revoke such certification. specimen or cause an MRO to cancel a expectation is that each trained collector (b) The HHS-certified laboratory has, test: and HHS-certified laboratory will make within 30 days of the date of such (1) An incorrect laboratory name and every effort to ensure that the Federal notification or within 3 days of the date address appearing at the top of the form; CCF is properly completed and that all of such notification when seeking an (2) Incomplete/incorrect/unreadable the information is correct. When an expedited review of a suspension, employer name or address; error occurs more than once a month, requested in writing an opportunity for (3) MRO name is missing; the MRO must direct the collector or an informal review of the suspension or (4) Incomplete/incorrect MRO HHS-certified laboratory (whichever is proposed revocation. address; responsible for the error) to immediately (5) A transposition of numbers in the take corrective action to prevent the Section 16.2 What definitions are used donor’s SSN; recurrence of the error. for this subpart? (6) A telephone number is missing/ Section 15.4 What discrepancies may Appellant. Means the HHS-certified incorrect; require an MRO to cancel a test? laboratory which has been notified of its (7) A fax number is missing/incorrect; suspension or proposed revocation of its (8) A ‘‘reason for test’’ box is not (a) An MRO must attempt to correct certification to perform testing and has marked; the following errors: requested an informal review thereof. (9) A ‘‘drug tests to be performed’’ box (1) The donor’s signature is missing Respondent. Means the person or is not marked; on the MRO copy of the Federal CCF persons designated by the Secretary in (10) A ‘‘specimen collection’’ box is and the collector failed to provide a implementing these Guidelines. not marked; comment that the donor refused to sign Reviewing Official. Means the person (11) The lot number of the collection the form; or persons designated by the Secretary device used for the collection is (2) The certifying scientist failed to who will review the suspension or missing; sign the Federal CCF for a specimen proposed revocation. The reviewing (12) The collection site address is being reported drug positive, official may be assisted by one or more missing; adulterated, invalid, or (for urine) of his or her employees or consultants (13) The collector’s printed name is substituted; or in assessing and weighing the scientific missing but the collector’s signature is (3) The electronic report provided by and technical evidence and other properly recorded; the HHS-certified oral fluid laboratory information submitted by the appellant (14) The time of collection is not does not contain all the data elements and respondent on the reasons for the indicated; required for the HHS standard suspension and proposed revocation. (15) The date of collection is not laboratory electronic report for a indicated; specimen being reported drug positive, Section 16.3 Are there any limitations (16) Incorrect name of delivery adulterated, invalid result, or (for urine) on issues subject to review? service; substituted. The scope of review shall be limited (17) The collector has changed or (b) If error (a)(1) occurs, the MRO to the facts relevant to any suspension corrected information by crossing out must contact the collector to obtain a or proposed revocation, the necessary the original information on either the statement to verify that the donor interpretations of those facts, the Federal CCF or specimen label/seal refused to sign the MRO copy. If, after relevant Mandatory Guidelines for without dating and initialing the at least 5 business days, the collector Federal Workplace Drug Testing change; or cannot provide such a statement, the Programs, and other relevant law. The (18) The donor’s name inadvertently MRO must cancel the test. legal validity of these Guidelines shall appears on the HHS-certified laboratory (c) If error (a)(2) occurs, the MRO not be subject to review under these copy of the Federal CCF or on the must obtain a statement from the procedures. tamper-evident labels used to seal the certifying scientist that he or she specimens. inadvertently forgot to sign the Federal Section 16.4 Who represents the (b) The following omissions and CCF, but did, in fact, properly conduct parties? discrepancies on the Federal CCF that the certification review. If, after at least The appellant’s request for review are made at the HHS-certified laboratory 5 business days, the MRO cannot get a shall specify the name, address, and

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telephone number of the appellant’s (a) Appellant’s Documents and Brief. presentation at the official’s own representative. In its first written Within 15 days after receiving the initiative or at the request of the submission to the reviewing official, the acknowledgment of the request for respondent. respondent shall specify the name, review, the appellant shall submit to the (b) Presiding Official. The reviewing address, and telephone number of the reviewing official the following (with a official or designee will be the presiding respondent’s representative. copy to the respondent): official responsible for conducting the (1) A review file containing the oral presentation. Section 16.5 When must a request for documents supporting appellant’s (c) Preliminary Conference. The informal review be submitted? argument, tabbed and organized presiding official may hold a prehearing (a) Within 30 days of the date of the chronologically, and accompanied by an conference (usually a telephone notice of the suspension or proposed index identifying each document. Only conference call) to consider any of the revocation, the appellant must submit a essential documents should be following: simplifying and clarifying written request to the reviewing official submitted to the reviewing official. issues, stipulations and admissions, seeking review, unless some other time (2) A written statement, not to exceed limitations on evidence and witnesses period is agreed to by the parties. A 20 double-spaced pages, explaining why that will be presented at the hearing, copy must also be sent to the respondent’s decision to suspend or time allotted for each witness and the respondent. The request for review must propose revocation of appellant’s hearing altogether, scheduling the include a copy of the notice of certification is wrong (appellant’s brief). hearing, and any other matter that will suspension or proposed revocation, a (b) Respondent’s Documents and assist in the review process. Normally, brief statement of why the decision to Brief. Within 15 days after receiving a this conference will be conducted suspend or propose revocation is wrong, copy of the acknowledgment of the informally and off the record; however, and the appellant’s request for an oral request for review, the respondent shall the presiding official may, at his or her presentation, if desired. submit to the reviewing official the discretion, produce a written document (b) Within 5 days after receiving the following (with a copy to the appellant): summarizing the conference or request for review, the reviewing official (1) A review file containing transcribe the conference, either of will send an acknowledgment and documents supporting respondent’s which will be made a part of the record. advise the appellant of the next steps. decision to suspend or revoke (d) Time and Place of the Oral The reviewing official will also send a appellant’s certification to perform drug Presentation. The presiding official will copy of the acknowledgment to the testing, which is tabbed and organized attempt to schedule the oral respondent. chronologically, and accompanied by an presentation within 30 days of the date index identifying each document. Only the appellant’s request for review is Section 16.6 What is an abeyance received or within 10 days of agreement? essential documents should be submitted to the reviewing official. submission of the last reply brief, Upon mutual agreement of the parties (2) A written statement, not exceeding whichever is later. The oral presentation to hold these procedures in abeyance, 20 double-spaced pages in length, will be held at a time and place the reviewing official will stay these explaining the basis for suspension or determined by the presiding official procedures for a reasonable time while proposed revocation (respondent’s following consultation with the parties. the laboratory attempts to regain brief). (e) Conduct of the Oral Presentation. compliance with the Guidelines or the (c) Reply Briefs. Within 5 days after (1) General. The presiding official is parties otherwise attempt to settle the receiving the opposing party’s responsible for conducting the oral dispute. As part of an abeyance submission, or 20 days after receiving presentation. The presiding official may agreement, the parties can agree to acknowledgment of the request for be assisted by one or more of his or her extend the time period for requesting review, whichever is later, each party employees or consultants in conducting review of the suspension or proposed may submit a short reply not to exceed the oral presentation and reviewing the revocation. If abeyance begins after a 10 double-spaced pages. evidence. While the oral presentation request for review has been filed, the (d) Cooperative Efforts. Whenever will be kept as informal as possible, the appellant shall notify the reviewing feasible, the parties should attempt to presiding official may take all necessary official at the end of the abeyance develop a joint review file. steps to ensure an orderly proceeding. period, advising whether the dispute (e) Excessive Documentation. The (2) Burden of Proof/Standard of Proof. has been resolved. If the dispute has reviewing official may take any In all cases, the respondent bears the been resolved, the request for review appropriate step to reduce excessive burden of proving by a preponderance will be dismissed. If the dispute has not documentation, including the return of of the evidence that its decision to been resolved, the review procedures or refusal to consider documentation suspend or propose revocation is will begin at the point at which they found to be irrelevant, redundant, or appropriate. The appellant, however, were interrupted by the abeyance unnecessary. has a responsibility to respond to the agreement with such modifications to respondent’s allegations with evidence Section 16.8 When is there an the procedures as the reviewing official and argument to show that the opportunity for oral presentation? deems appropriate. respondent is wrong. (a) Electing Oral Presentation. If an (3) Admission of Evidence. The Section 16.7 What procedures are used opportunity for an oral presentation is Federal Rules of Evidence do not apply to prepare the review file and written desired, the appellant shall request it at and the presiding official will generally argument? the time it submits its written request admit all testimonial evidence unless it The appellant and the respondent for review to the reviewing official. The is clearly irrelevant, immaterial, or each participate in developing the file reviewing official will grant the request unduly repetitious. Each party may for the reviewing official and in if the official determines that the make an opening and closing statement, submitting written arguments. The decision-making process will be may present witnesses as agreed upon procedures for development of the substantially aided by oral presentations in the prehearing conference or review file and submission of written and arguments. The reviewing official otherwise, and may question the argument are: may also provide for an oral opposing party’s witnesses. Since the

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parties have ample opportunity to of the request for review must also be Section 16.11 How are prepare the review file, a party may sent to the respondent. communications transmitted by the introduce additional documentation (b) Reviewing Official’s Response. As reviewing official? during the oral presentation only with soon as practicable after the request for (a) Because of the importance of a the permission of the presiding official. review is received, the reviewing official timely review, the reviewing official The presiding official may question will send an acknowledgment with a should normally transmit written witnesses directly and take such other copy to the respondent. communications to either party by steps necessary to ensure an effective facsimile, secured electronic (c) Review File and Briefs. Within 7 and efficient consideration of the transmissions, or overnight mail in days of the date the request for review evidence, including setting time which case the date of transmission or limitations on direct and cross- is received, but no later than 2 days day following mailing will be examinations. before an oral presentation, each party considered the date of receipt. In the (4) Motions. The presiding official shall submit to the reviewing official the case of communications sent by regular may rule on motions including, for following: mail, the date of receipt will be example, motions to exclude or strike (1) A review file containing essential considered 3 days after the date of redundant or immaterial evidence, documents relevant to the review, mailing. motions to dismiss the case for which is tabbed, indexed, and organized (b) In counting days, include insufficient evidence, or motions for chronologically; and Saturdays, Sundays, and federal summary judgment. Except for those holidays. However, if a due date falls on (2) A written statement, not to exceed made during the hearing, all motions a Saturday, Sunday, or federal holiday, 20 double-spaced pages, explaining the and opposition to motions, including then the due date is the next federal party’s position concerning the argument, must be in writing and be no working day. suspension and any proposed more than 10 double-spaced pages in revocation. No reply brief is permitted. Section 16.12 What are the authority length. The presiding official will set a (d) Oral Presentation. If an oral and responsibilities of the reviewing reasonable time for the party opposing official? the motion to reply. presentation is requested by the (5) Transcripts. The presiding official appellant or otherwise granted by the In addition to any other authority shall have the oral presentation reviewing official, the presiding official specified in these procedures, the transcribed and the transcript shall be will attempt to schedule the oral reviewing official and the presiding made a part of the record. Either party presentation within 7–10 days of the official, with respect to those authorities may request a copy of the transcript and date of appellant’s request for review at involving the oral presentation, shall the requesting party shall be responsible a time and place determined by the have the authority to issue orders; for paying for its copy of the transcript. presiding official following consultation examine witnesses; take all steps (f) Obstruction of Justice or Making of with the parties. The presiding official necessary for the conduct of an orderly False Statements. Obstruction of justice may hold a prehearing conference in hearing; rule on requests and motions; grant extensions of time for good or the making of false statements by a accordance with Section 16.8(c) and reasons; dismiss for failure to meet witness or any other person may be the will conduct the oral presentation in deadlines or other requirements; order basis for a criminal prosecution under accordance with the procedures of the parties to submit relevant 18 U.S.C. 1505 or 1001. Sections 16.8(e), (f), and (g). information or witnesses; remand a case (g) Post-hearing Procedures. At his or (e) Written Decision. The reviewing for further action by the respondent; her discretion, the presiding official official shall issue a written decision waive or modify these procedures in a may require or permit the parties to upholding or denying the suspension or specific case, usually with notice to the submit post-hearing briefs or proposed proposed revocation and will attempt to parties; reconsider a decision of the findings and conclusions. Each party issue the decision within 7–10 days of reviewing official where a party may submit comments on any major the date of the oral presentation or promptly alleges a clear error of fact or prejudicial errors in the transcript. within 3 days of the date on which the law; and to take any other action Section 16.9 Are there expedited transcript is received or the date of the necessary to resolve disputes in procedures for review of immediate last submission by either party, accordance with the objectives of these suspension? whichever is later. All other provisions procedures. set forth in Section 16.14 will apply. (a) Applicability. When the Secretary Section 16.13 What administrative notifies an HHS-certified laboratory in (f) Transmission of Written records are maintained? Communications. Because of the writing that its certification to perform The administrative record of review drug testing has been immediately importance of timeliness for these expedited procedures, all written consists of the review file; other suspended, the appellant may request submissions by the parties; transcripts an expedited review of the suspension communications between the parties and between either party and the or other records of any meetings, and any proposed revocation. The conference calls, or oral presentation; appellant must submit this request in reviewing official shall be by facsimile, secured electronic transmissions, or evidence submitted at the oral writing to the reviewing official within presentation; and orders and other overnight mail. 3 days of the date the HHS-certified documents issued by the reviewing and laboratory received notice of the Section 16.10 Are any types of presiding officials. suspension. The request for review must communications prohibited? include a copy of the suspension and Section 16.14 What are the any proposed revocation, a brief Except for routine administrative and requirements for a written decision? statement of why the decision to procedural matters, a party shall not (a) Issuance of Decision. The suspend and propose revocation is communicate with the reviewing or reviewing official shall issue a written wrong, and the appellant’s request for presiding official without notice to the decision upholding or denying the an oral presentation, if desired. A copy other party. suspension or proposed revocation. The

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decision will set forth the reasons for Workplace Drug Testing Programs Executive Summary the decision and describe the basis (Guidelines), 73 FR 71858 (November This notice of proposed revisions to therefore in the record. Furthermore, the 25, 2008) for urine testing. the Mandatory Guidelines for Federal reviewing official may remand the DATES: Submit comments on or before Workplace Drug Testing Programs matter to the respondent for such July 14, 2015. (Guidelines) will revise the initial and further action as the reviewing official confirmatory drug test analytes and ADDRESSES: In commenting, please refer deems appropriate. methods for urine testing, revise the (b) Date of Decision. The reviewing to file code SAMHSA–2015–0002. cutoff for reporting a specimen as official will attempt to issue his or her Because of staff and resource adulterated based on low pH, revise the decision within 15 days of the date of limitations, SAMHSA cannot accept requalification requirements for the oral presentation, the date on which comments by facsimile (FAX) individuals serving as Medical Review the transcript is received, or the date of transmission. Officers (MROs) and, where appropriate, the last submission by either party, You may submit comments in one of include references to the use of an whichever is later. If there is no oral four ways (please choose only one of the presentation, the decision will normally alternate specimen in federal workplace ways listed): drug testing programs. References to an be issued within 15 days of the date of • receipt of the last reply brief. Once Electronically. You may submit alternate specimen are not applicable issued, the reviewing official will electronic comments on this regulation until final Guidelines are implemented immediately communicate the decision to http://www.regulations.gov. Follow for the use of the alternative specimen to each party. ‘‘Submit a comment’’ instructions. matrix. The Department is issuing a (c) Public Notice. If the suspension • By regular mail. You may mail separate Notice in the Federal Register and proposed revocation are upheld, the written comments to the following proposing Mandatory Guidelines for revocation will become effective address ONLY: SAMHSA, Attention Federal Workplace Drug Testing immediately and the public will be Division of Workplace Programs (DWP), Programs using Oral Fluid (OFMG) to notified by publication of a notice in the 1 Choke Cherry RD., Rm. #7–1045, allow federal agencies to collect and test Federal Register. If the suspension and Rockville, MD 20857. Please allow oral fluid specimens in their workplace proposed revocation are denied, the sufficient time for mailed comments to drug testing programs. revocation will not take effect and the be received before the close of the In particular, these revised Mandatory suspension will be lifted immediately. comment period. Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) Public notice will be given by • By express or overnight mail. You publication in the Federal Register. allow federal executive branch agencies may send written comments to the to test for additional Schedule II of the Section 16.15 Is there a review of the following address ONLY: SAMHSA, Controlled Substances Act prescription final administrative action? Attention DWP, 1 Choke Cherry RD., medications (i.e., oxycodone, Rm. #7–1045, Rockville, MD 20850. Before any legal action is filed in oxymorphone, hydrocodone and court challenging the suspension or • By hand or courier. Alternatively, hydromorphone) in federal drug-free proposed revocation, respondent shall you may deliver (by hand or courier) workplace programs, add exhaust administrative remedies your written comments ONLY to the methylenedioxyamphetamine (MDA) provided under this subpart, unless following address prior to the close of and methylenedioxyethylamphetamine otherwise provided by Federal Law. The the comment period: SAMHSA, (MDEA) as initial test analytes, raise the reviewing official’s decision, under Attention DWP, 1 Choke Cherry RD., lower pH cutoff from 3 to 4 for Section 16.9(e) or 16.14(a) constitutes Rm. #7–1045, Rockville, MD 20850. If identifying specimens as adulterated, final agency action and is ripe for you intend to deliver your comments to require MRO requalification training judicial review as of the date of the the Rockville address, call telephone and re-examination at least every five decision. number (240) 276–2600 in advance to years after initial MRO certification, and [FR Doc. 2015–11523 Filed 5–13–15; 4:15 pm] schedule your arrival with one of our allow federal agencies to authorize staff members. Because access to the BILLING CODE 4162–20–P collection of an alternate specimen (e.g., interior of the SAMHSA Building is not oral fluid) when a donor in their readily available to persons without program is unable to provide a sufficient DEPARTMENT OF HEALTH AND federal government identification, amount of urine specimen at the HUMAN SERVICES commenters are encouraged to schedule collection site. Many of the proposed their delivery or to leave comments with wording changes and reorganization of Substance Abuse and Mental Health the security guard front desk located in the UrMG were made for clarity, to use Services Administration the main lobby of the building. current scientific terminology or Comments erroneously mailed to the preferred grammar, and for consistency Mandatory Guidelines for Federal address indicated as appropriate for with the proposed OFMG. Workplace Drug Testing Programs hand or courier delivery may be delayed Costs and Benefits AGENCY: Substance Abuse and Mental and received after the comment period. Health Services Administration FOR FURTHER INFORMATION CONTACT: Using data obtained from the Federal (SAMHSA), HHS. Charles LoDico, M.S., DABFT, Division Workplace Drug Testing Programs and ACTION: Notice of proposed revisions to of Workplace Programs, Center for HHS certified laboratories, the the mandatory guidelines by the Substance Abuse Prevention (CSAP), Department estimates the number of Secretary of Health and Human SAMHSA mail to: 1 Choke Cherry Road, specimens tested annually for federal Services. Room 7–1045, Rockville, MD 20857, agencies to be 150,000. HHS projects telephone (240) 276–2600, fax (240) that approximately 7% (or 10,500) of the SUMMARY: The Department of Health and 276–2610, or email at charles.lodico@ 150,000 specimens tested per year will Human Services (‘‘HHS’’ or samhsa.hhs.gov. be oral fluid specimens and 93% (or ‘‘Department’’) is proposing to revise the 139,500) will be urine specimens once Mandatory Guidelines for Federal SUPPLEMENTARY INFORMATION: the proposed OFMG have been

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