[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57554-57600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22684]



[[Page 57553]]

Vol. 84

Friday,

No. 207

October 25, 2019

Part II





Department of Health and Human Services





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42 CFR Chapter I





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Mandatory Guidelines for Federal Workplace Drug Testing Programs--Oral/
Fluid; Final Rule

  Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / 
Rules and Regulations  

[[Page 57554]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter I

[SAMHSA--4162-20-P]
RIN 0930-AA24


Mandatory Guidelines for Federal Workplace Drug Testing 
Programs--Oral/Fluid

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

ACTION: Issuance of guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') has established scientific and technical guidelines for 
the inclusion of oral fluid specimens in the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs (Guidelines).

DATES: Effective January 1, 2020.

FOR FURTHER INFORMATION CONTACT: Charles LoDico, M.S., F-ABFT, Division 
of Workplace Programs, Center for Substance Abuse Prevention (CSAP), 
SAMHSA, 5600 Fishers Lane, Room 16N03A, Rockville, MD 20857, telephone 
(240) 276-2600 or email at [email protected].

SUPPLEMENTARY INFORMATION: The Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using Oral Fluid (OFMG) will allow 
federal executive branch agencies to collect and test an oral fluid 
specimen as part of their drug testing programs. In addition, some 
agencies, such as the Department of Transportation, are required to 
follow the Guidelines in developing drug testing programs for their 
regulated industries, whereas others, such as the Nuclear Regulatory 
Commission (NRC), use the Guidelines as part of the regulatory basis 
for their drug testing programs for their regulated industries. The 
OFMG establish standards and technical requirements for oral fluid 
collection devices, initial oral fluid drug test analytes and methods, 
confirmatory oral fluid drug test analytes and methods, processes for 
review by a Medical Review Officer (MRO), and requirements for federal 
agency actions.
    The OFMG provide flexibility for federal agency workplace drug 
testing programs to address testing needs and revise the requirement to 
collect only a urine specimen, which has existed since the Guidelines 
were first published in 1988. Since 1988, several products have 
appeared on the market making it easier for individuals to adulterate 
their urine specimens. The scientific basis for the use of oral fluid 
as an alternative specimen for drug testing has now been broadly 
established and the advances in the use of oral fluid in detecting 
drugs have made it possible for this alternative specimen to be used in 
federal programs with the same level of confidence that has been 
applied to the use of urine. For example, oral fluid collection devices 
and procedures have been developed that protect against biohazards, 
maintain the stability of analytes, and provide sufficient oral fluid 
for testing. Additionally, specimen volume is also much lower, saving 
time in collection and transport cost. Developments in analytical 
technologies have provided efficient and cost-effective methods with 
the analytical sensitivity and accuracy required for testing oral fluid 
specimens.
    Federal agencies, MROs, and regulated industries using the OFMG 
will continue to adhere to all other federal standards established for 
workplace drug testing programs. The OFMG provide the same scientific 
and forensic supportability of drug test results as the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Urine 
(UrMG).

Background

    The Department of Health and Human Services, by authority of 
Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive 
Order No. 12564, establishes the scientific and technical guidelines 
for federal workplace drug testing programs and establishes standards 
for certification of laboratories engaged in drug testing for federal 
agencies. As required, HHS originally published the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in 
the Federal Register [FR] on April 11, 1988 [53 FR 11979]. The 
Substance Abuse and Mental Health Services Administration (SAMHSA) 
subsequently revised the Guidelines on June 9, 1994 [59 FR 29908], 
September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR 63483], 
April 13, 2004 [69 FR 19644], and November 25, 2008 [73 FR 71858]. The 
revised Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Urine (UrMG) were published on January 23, 2017 [82 FR 
7920] with an effective date of October 1, 2017.
    The Department published the proposed Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) in the 
May 15, 2015 Federal Register (80 FR 28054). There was a 60-day public 
comment period, during which 120 commenters submitted comments on the 
OFMG. These commenters were comprised of individuals, organizations, 
and private sector companies. The comments are available for public 
view at http://www.regulations.gov/. All comments were reviewed and 
taken into consideration in the preparation of the Guidelines. The 
issues and concerns raised in the public comments for the OFMG are set 
forth below. Similar comments are considered together in the 
discussion.

Summary of Public Comments and HHS's Response

    The following comments were directed to the information and 
questions in the preamble.

Requirements for Specimen Validity Testing

    The Department requested comments on requirements for federal 
agencies to test all oral fluid specimens for either albumin or 
immunoglobulin G (IgG) to determine specimen validity. Four commenters 
agreed with the proposed requirements. Twelve commenters disagreed with 
the Guidelines as written, suggesting that specimen validity testing is 
not needed because all oral fluid collections are observed, collection 
procedures require visual inspection of the mouth by the collector and 
a 10-minute wait period, collection devices contain a volume indicator, 
and there is a limited volume of oral fluid collected and this volume 
is needed to complete confirmatory drug tests. One commenter expressed 
concern over the consequences of erroneous validity test results in 
relation to inappropriate cutoffs being set. One commenter questioned 
the proposed specimen validity testing analytes and cutoffs, and 
proposed that volume sufficiency be determined upon receipt at the 
laboratory. One commenter disagreed with the proposed IgG cutoff. One 
commenter disagreed that specimen validity testing should be performed 
on all specimens, and recommended performing specimen validity testing 
on a randomly chosen subset. This commenter also stated that specimen 
validity testing must be subjected to oversight by proficiency testing 
and blind sample testing programs. The Department has evaluated the 
comments and has revised the Guidelines to allow, but not require, 
specimen validity testing. The Department agrees that the OFMG 
collection procedures greatly minimize the risks of donor attempts to 
tamper with the specimen, and the volume indicator requirement for oral 
fluid collection devices should prevent collection of insufficient 
volume. To avoid prohibiting use of albumin and

[[Page 57555]]

IgG tests, as well as other scientifically supportable oral fluid 
biomarker or adulterant tests that may become available, the Department 
is authorizing specimen validity testing upon request of the Medical 
Review Officer as described in Sections 3.1 and 3.5. All tests must be 
properly validated and include appropriate quality control samples in 
accordance with these Guidelines. In response to commenters' concerns 
about expending the limited volume of oral fluid collected, it should 
be noted that HHS-certified laboratories currently performing specimen 
validity tests for non-regulated oral fluid testing use low volumes 
(i.e., 25 mcL for albumin tests, 15 mcL for IgG tests) that would not 
be expected to have a significant impact on a laboratory's ability to 
complete testing.

Proposed Cutoff Concentrations

    Nineteen commenters submitted comments on the proposed drug test 
cutoffs. Some were general comments, while others concerned specific 
drug analytes. Cutoffs for marijuana tests are discussed in the 
following section, Testing for Marijuana Use. The comments and the 
Department's responses concerning cutoffs for other drug tests are 
described below.
    Two commenters agreed with all proposed analytes and cutoffs. Two 
deferred setting cutoffs to HHS-certified laboratories. Three disagreed 
with all proposed cutoffs. Two of these commenters recommended 
retaining the cutoffs in the proposed Guidelines of April 13, 2004 (69 
FR 19673). One of these commenters believes that the technology to 
detect analytes at these low levels is questionable and that these 
cutoffs will identify employees on prescribed medications. One 
commenter requested the basis for changing the cutoffs from those 
proposed in 2004. As described in the preamble to the proposed OFMG (80 
FR 28054), the Department based the proposed cutoffs for each drug on 
information in public comments from the April 2004 proposed Guidelines, 
public responses to the June 2011 Request for Information (76 FR 
34086), and the recommendations of a technical workgroup consisting of 
subject matter experts and representatives from various stakeholder 
groups (e.g., collection device and test kit manufacturers, oral fluid 
drug testing laboratories). The Department provided the recommended 
cutoffs with supporting scientific information to the SAMHSA Drug 
Testing Advisory Board (DTAB) for review and discussion and, in the 
preamble to the proposed OFMG of May 15, 2015 (80 FR 28054, pages 
28061-28065), included reasons for the proposed cutoffs for each drug, 
with references to supporting scientific studies. The Department has 
raised the cutoffs for some drug tests to address specific comments as 
described below. The Department concluded that no change is needed for 
other analytes. The cutoffs in Section 3.4 are supported by scientific 
studies, and are consistent with the goals of the federal workplace 
drug testing programs. The National Laboratory Certification Program 
(NLCP) Pilot Performance Testing (PT) Program has documented that 
laboratories are able to meet the Guidelines requirements using the 
cutoffs in Section 3.4.
    One commenter agreed with the proposed initial test cutoff for 
cocaine, and recommended that a slightly lower cutoff be used for the 
confirmatory test. The Department did not find scientific evidence to 
warrant a change to the proposed confirmatory cutoff, which is the same 
as that proposed in 2004.
    Five commenters disagreed with the proposed codeine and morphine 
cutoffs. Two commenters stated that the cutoffs are too low: One 
expressed concern over the technology to detect analytes at the 
proposed low levels and both noted that the change from currently used 
cutoffs will increase the number of initial test positives, thereby 
increasing costs. Two commenters stated that the Department has not 
supported changing from the cutoffs proposed in 2004 (i.e., 40 ng/mL 
for both the initial and confirmatory tests), which are currently used 
by the industry. One commenter indicated that their test data support a 
cutoff of 30 ng/mL for both the initial and confirmatory tests. In the 
preamble to the proposed OFMG of May 15, 2015 (80 FR 28054, page 
28063), the Department included reasons for the selected test cutoffs 
for each drug, with references supporting those cutoffs. The Department 
is retaining the proposed cutoffs (i.e., 30 ng/mL for the initial test 
and 15 ng/mL for the confirmatory test) and is providing further 
explanation below to address the comments.
    Reports in the literature provide information supporting lowering 
the morphine initial test cutoff from 40 to 30 ng/mL. In one dosing 
study with doses of 20 and 10 mg of morphine sulfate, morphine 
concentrations in saliva peaked at 0.5 hours at 37.8 ng/mL and 10.8 ng/
mL, respectively, with detection times of 24 hours using a limit of 
detection (LOD) of 0.6 ng/mL.\1\ In another report, morphine 
concentrations in oral fluid of treatment patients (n=4,575) were 
reported to range from 2 to 3,026 ng/mL with a median concentration of 
49.8 ng/mL.\2\ It was also found that 25% of the specimens contained 
morphine less than 13.5 ng/mL. These reports of short detection times 
and low concentrations of morphine in oral fluid also justify lowering 
the confirmatory cutoff for morphine to 15 ng/mL. The NLCP Pilot PT 
program has demonstrated oral fluid testing laboratories' abilities to 
meet codeine and morphine confirmatory cutoffs of 15 ng/mL using 
current testing technologies.
    One commenter agreed with the proposed initial test cutoffs for 
oxycodone, oxymorphone, hydrocodone, and hydromorphone, but recommended 
that the same cutoffs be used for confirmatory testing. One commenter 
disagreed with all proposed cutoffs for these drugs, stating that the 
cutoffs are too low and will identify legitimate prescription users. 
The Department will retain the cutoffs as proposed. In the preamble to 
the proposed OFMG of May 15, 2015 (80 FR 28054, pages 28064-28065), the 
Department included reasons for the selected test cutoffs for each 
drug, with references supporting those cutoffs. Considerable research 
and discussion were conducted regarding the complex issues surrounding 
the specification of each cutoff concentration. The Department 
solicited input from laboratories, reagent and device manufacturers, 
subject matter experts, and the Food and Drug Administration (FDA). The 
cutoff concentrations are the outcome of the lengthy discussion process 
and represent the best approach currently available. Furthermore, the 
OFMG include the same requirements as the UrMG for Medical Review 
Officers to interview donors to determine whether there is a legitimate 
medical explanation for a positive test result, and to review 
documentation provided by the donor to support a legitimate medical 
explanation.
    One commenter disagreed with the proposed 3 ng/mL initial test 
cutoff for 6-acetylmorphine (6-AM), stating that the proposed cutoff is 
higher than that currently used. As suggested by the commenter, and 
based on current 6-AM test methods and laboratory results from the NLCP 
Pilot PT Program, the Department has raised the proposed 6-AM initial 
test cutoff in Section 3.4 to 4 ng/mL (i.e., the same as proposed in 
2004). The same commenter recommended a higher confirmatory test cutoff 
(3 ng/mL vs. the proposed 2 ng/mL), and noted that their data show that 
using an opiates cutoff of 30 ng/mL and a 6-AM confirmatory cutoff of 3 
ng/mL identifies more positive 6-AM specimens than urine testing. The 
comparison of 6-AM positivity rates in urine and oral fluid does not 
support a

[[Page 57556]]

change to the proposed confirmatory test cutoff. Studies have shown 
that 6-AM is statistically more likely to be detected in oral fluid 
than urine, regardless of the cutoff. 3 4 5 The Department 
has retained the 2 ng/mL 6-AM confirmatory test cutoff proposed in 
2015, primarily for enhanced sensitivity. Studies have shown that 6-AM 
concentrations between 1 and 3 ng/mL are detected in the study 
populations. 2 3 6 7
    One commenter agreed with the proposed test cutoffs for 
phencyclidine (PCP). Three others disagreed, recommending that the 
Department use the 2004 proposed cutoffs (i.e., 10 ng/mL for both the 
initial and confirmatory tests). The Department has evaluated the 
comments and agrees with commenters that there is an insufficient 
scientific basis to warrant changes from the PCP test cutoffs in the 
April 13, 2004 proposed Guidelines (69 FR 19673), which are currently 
used by many test manufacturers and laboratories. Therefore, the 
Department has raised the proposed cutoffs in Section 3.4 as follows: 
PCP cutoffs are 10 ng/mL for both the initial and confirmatory tests.
    Six commenters disagreed with the proposed test cutoffs for 
amphetamines. Two of these commenters recommended that the Department 
use the 2004 proposed cutoffs (i.e., 50 ng/ml for both the initial and 
confirmatory tests). One recommended that the 2004 cutoff be used for 
the initial test; another recommended using the 2004 cutoff for the 
initial test and half of that concentration (25 ng/mL) as the 
confirmatory test cutoff. One commenter suggested cutoffs of 150 ng/mL 
or 120 ng/mL. One suggested setting cutoffs at 120 ng/mL or above to 
reduce the number of unverified positive initial tests. One commenter 
requested the basis for using different initial and confirmatory test 
cutoffs for methylenedioxymethamphetamine (MDMA).
    The Department has evaluated the comments and agrees with 
commenters that, for amphetamines, there is an insufficient scientific 
basis to warrant changes from the initial test cutoffs in the April 13, 
2004 proposed Guidelines (69 FR 19673), which are currently used by 
many test manufacturers and laboratories. Therefore, the Department has 
raised the proposed initial and confirmatory test cutoffs in Section 
3.4 as follows: The initial test cutoff for amphetamines (i.e., 
amphetamine, methamphetamine, MDMA, and MDA) is 50 ng/mL, and the 
confirmatory test cutoff for each amphetamine analyte is 25 ng/mL.

Testing for Marijuana Use

    The Department requested comments on several topics related to 
testing for marijuana use. Public comments and the Department's 
responses are described below. After reviewing the comments, as well as 
the results of scientific studies published after the development of 
the proposed OFMG, the Department has decided to test for one marijuana 
analyte, delta-9-tetrahydrocannabinol (THC). THC is the primary 
psychoactive constituent (or cannabinoid) of the cannabis plant and is 
the primary intoxicant in marijuana. After careful consideration of all 
available evidence for THC in oral fluid, the Department has decided to 
retain the proposed 4 ng/mL initial test cutoff for THC in the final 
OFMG. Details regarding this decision are described below.

The Capability of Laboratories To Test Delta-9-Tetrahydrocannabinol-9-
Carboxylic Acid (THCA) Analyte Using a Cutoff of 50 pg/mL

    One commenter agreed and four commenters disagreed that 
laboratories were currently capable of testing THCA in oral fluid using 
this cutoff. One commenter stated that laboratory instrumentation 
required for the analysis of THCA in oral fluid is widely available and 
can be added to routine laboratory testing. The commenter listed 
examples: Two-dimensional gas chromatography/mass spectrometry (GC/MS), 
GC/MS/MS, and liquid chromatography (LC)/MS/MS. Three commenters 
disagreed, stating that it would require significant investment in more 
sensitive instrumentation. One commenter disagreed, stating they doubt 
the capabilities of the laboratories to consistently test for THCA with 
accuracy, sensitivity and validity. One commenter disagreed, stating 
that the number of laboratories with the experience in testing for THCA 
is limited. The Department has evaluated the comments and agrees that 
there is a limited number of laboratories currently testing for THCA in 
oral fluid. Only one commercial drug testing laboratory participating 
in the Oral Fluid Pilot PT program performed THCA testing. Furthermore, 
due to the concentration differences between THC (i.e., nanogram/
milliliter or ng/mL levels) and THCA (i.e., picogram/milliliter or pg/
mL levels), immunoassays do not have sufficient cross-reactivity to 
enable use of a single assay for both analytes. Initial testing for 
both THC and THCA would require two separate immunoassay kits or use of 
alternative technology. No current immunoassay has been identified that 
is selective for THCA only. Laboratories planning to become HHS-
certified to test federal agency oral fluid specimens may already have 
instrumentation for confirmatory testing that could be used as an 
alternate technology for initial testing, but may incur additional 
costs to develop and validate these new initial drug tests.

The Validity of Whether THCA Can Be Established as an Accurate, 
Sensitive and Valid Marker for Oral Fluid Testing To Detect Marijuana 
Use and Whether THCA Should Be Used To Extend the Window of Detection 
for Marijuana Use

    Four commenters agreed with THCA as a test analyte. These 
commenters believe that analysis of THCA may prevent or minimize the 
risk of positive results due to ``passive exposure'' (i.e., a 
nonsmoker's exposure to secondhand marijuana smoke). One commenter 
stated that if both THC and THCA analytes are required to be present to 
constitute a rule or policy violation, this would also eliminate 
protracted detection of THCA. The commenter suggested that if only one 
of the marijuana analytes is reported, it could be addressed as a 
safety concern. This commenter also opposed MROs requesting THCA 
testing as needed and, as an alternative, suggested requiring 
disclosure from the donor at the time of collection (i.e., the 
collector would ask the donor whether the donor had been exposed to 
marijuana recently and testing for THCA would be performed based on the 
donor's answer). If the donor indicated no recent exposure, the donor 
has waived the right to a passive inhalation defense. One commenter 
recommended an agency or employer should have the option to choose 
either test (THC or THCA), providing flexibility for employers' testing 
goals. One commenter noted that THCA testing, if included in the 
Guidelines, would be in conjunction with THC testing and expressed 
concerns including how to handle two test results (THC and THCA) that 
do not agree, additional costs, longer turnaround time, and handling of 
retests.
    Six commenters disagreed with THCA as a test analyte. One commenter 
disagreed, suggesting solely testing for the active parent drug is one 
of the defining characteristics of oral fluid testing. Two commenters 
disagreed, suggesting THCA is not a reliable metabolite to be an 
appropriate marker for marijuana use. One commenter disagreed, stating 
that THCA is only present in oral fluid at very low levels. One 
commenter disagreed, suggesting that under realistic conditions of 
casual passive exposure and specimen

[[Page 57557]]

collection where the collection occurs outside the exposure area, a 
donor would not test positive for THC at the currently used initial 
test (3 ng/mL) and confirmatory test (1.5 ng/mL) cutoffs. One commenter 
disagreed, stating that more research is needed before adding THCA to 
the Guidelines. One commenter disagreed, indicating that, for the 
majority of the time, no significant THC positives are reported for 
samples containing THCA alone. The commenter also stated that for THCA 
alone (in the absence of THC) to be detected as positive in the 
immunoassay, the level must be at least 1,000 pg/ml, and that specimen 
volume is limited and should not be wasted for unnecessary tests.
    The Department has evaluated the comments and decided to use THC as 
the sole initial and confirmatory test analyte for marijuana, with a 4 
ng/mL initial test cutoff and a 2 ng/mL confirmatory test cutoff. This 
decision is supported by the reasons detailed below.
    First, the Department is not aware of any scientific evidence to 
suggest that individuals would test positive for THC under the 
standards in these Guidelines as the result of incidental exposure to 
secondhand marijuana smoke. The preamble to the proposed OFMG, 
published on May 15, 2015, provided information on THC and THCA results 
from studies of subjects who were passively exposed to marijuana smoke 
under a variety of exposure conditions.8-11 These studies, 
detailed below, were conducted under conditions of extreme marijuana 
smoke exposure for several hours in enclosed spaces (i.e., heavy smoke 
in unventilated and ventilated conditions). The study data indicate 
that transient amounts of THC may be present in nonsmokers' oral fluid 
for a few hours (i.e., one to three), but only under those extreme 
conditions, meaning exposure to smoke from multiple cannabis cigarettes 
in an enclosed space for an extended time period.
    One 2011 study tested nonsmokers in two Dutch coffeehouses where 
marijuana was being smoked.\10\ While some positive tests were obtained 
from the subjects, those samples were taken during a time of ongoing 
exposure to marijuana smoke in the coffeehouses, no subjects tested 
positive after returning for a final collection 12 to 24 hours after 
exposure. It should be noted that at the time of this notice's 
publishing, recreational and/or medical marijuana use is not permitted 
in places of public accommodation under either state or federal law. 
While this study demonstrated the types of THC oral fluid 
concentrations that could be obtained during exposure to secondhand 
marijuana smoke, the study is not directly applicable to Federal drug 
testing because the positive specimens collected in this study were 
collected during ongoing exposure to secondhand marijuana smoke, which 
does not approximate federal drug testing collection conditions.
    A more recent study exposed nonsmokers to extreme levels of 
marijuana smoke under controlled conditions.12 13 The 
extreme exposure in this 2015 study consisted of three different one-
hour sessions in which nonsmokers were enclosed in a sealed room with 
six smokers who smoked cannabis cigarettes almost continually through 
each session. The room was a specially constructed sealed Plexiglas 
chamber (10 ft. by 13 ft. with a 7-ft. ceiling). Nonsmokers and smokers 
were seated around a table in alternating seats and the nonsmokers were 
continually exposed to heavy amounts of marijuana smoke. In two 
sessions, there was no air flow (i.e., air conditioning was turned off) 
and in one session, the air conditioning was turned on. Heavy marijuana 
smoke was present in each session and the smoke caused eye irritation 
in the two non-ventilated sessions. Because of the extreme smoke 
conditions, most participants elected to wear eye goggles to reduce eye 
irritation. In this study, 3 of the 6 nonsmokers were negative directly 
after the exposure concluded (0 hours) and 4 of 6 were negative at 0.5 
hours.
    Some of these subjects (nonsmokers) also reported drug effects that 
were approximately 25% of the smokers' responses (i.e., self-reported 
effects on a visual analog scale). The nonsmokers also exhibited 
detectable levels of performance impairment on some behavioral/
cognitive assessments. Therefore, a reasonable donor in a safety 
sensitive position who is aware that he or she is in an enclosed 
environment with heavy levels of secondhand marijuana smoke should 
understand that he or she is very likely to experience the effects of 
inhaled marijuana smoke if he or she remains in this type of 
environment. Importantly, it is worth noting that exposure to the 
extreme levels of marijuana smoke in all three study sessions (i.e., 
non-ventilated and ventilated) does not represent a real-world 
situation and, therefore, is an unlikely passive exposure situation for 
donors in a federal agency testing program.
    The marijuana studies described above indicate that transient 
amounts of THC may be present in nonsmokers' oral fluid between one to 
three hours after prolonged, extreme exposure. Conversely, however, in 
two similar passive exposure studies from 2001 and 2005, none of the 
nonsmoking subjects tested positive using cutoffs that were lower than 
the OFMG THC cutoffs (i.e., 4 ng/mL for initial tests and 2 ng/mL for 
confirmatory tests).8 9 While the exposure in the 2005 study 
was ``extreme,'' both the 2001 and 2005 studies represent more likely 
``real world'' situations than the 2015 study.
    In the 2005 study of nonsmoking individuals exposed to marijuana 
smoke in an unventilated passenger van, none of the passively exposed 
individuals tested positive using a 3 ng/mL initial test cutoff when 
the oral fluid collection device was protected from exposure to 
contaminated surfaces.\9\ In this two-part study, four non-smoking 
subjects sat beside four active cannabis smokers who each smoked a 
single cannabis cigarette containing either a low dose of THC (Study 1) 
or high dose of THC (Study 2). In Study 1, oral fluid was collected 
inside the THC-contaminated van. Maximum oral fluid THC concentrations 
in non-smoking subjects were 7.5 ng/mL but declined to negative levels 
within 45 minutes of exposure. In Study 2, oral fluid was collected 
outside the van. Even though the dose of THC was more than twice the 
dose in Study 1, the maximum concentration detected in the passively 
exposed subjects was 1.2 ng/mL, which is well below the initial and 
confirmatory THC cutoffs in these Guidelines. When potential 
contamination during collection was eliminated in Study 2, all non-
smoking subjects were negative at both initial and confirmatory cutoff 
concentrations throughout the study.
    In the 2001 study, subjects were administered a single dose of 
marijuana by smoked and oral routes, and their oral fluid and urine THC 
test results were compared.\8\ The study used a 1 ng/mL THC initial 
test cutoff and a 0.5 ng/mL THC confirmatory test cutoff, both lower 
than the THC cutoffs in these Guidelines (i.e., 4 ng/mL initial test 
cutoff and 2 ng/mL confirmatory test cutoff). Two nonsmoking subjects 
were included to simulate passive exposure scenarios (e.g., sitting in 
an unventilated room where marijuana is smoked). These subjects were 
positive by immunoassay using the 1 ng/mL initial test cutoff at 1- and 
4-hours post-exposure but negative by the confirmatory test using a 0.5 
ng/mL cutoff.
    These carefully executed studies on passive exposure are considered 
strong evidence that exposure to secondhand marijuana smoke under 
normal ventilation conditions presents no risk

[[Page 57558]]

that an individual will have a passive exposure related positive test 
result under the standards used in these Guidelines.
    Another reason for the Department's decision to test only for THC 
is that THCA cannot be reliably detected in all individuals who use 
marijuana. Two recent studies investigated the presence of THC and THCA 
in oral fluid after various routes of administration.15 16 
One study characterized marijuana analytes including THC and THCA in 
oral fluid of nine occasional and 11 frequent marijuana smokers after 
smoked, vaporized, and oral administration (i.e., ingestion of a 
brownie containing marijuana).\15\ THC was present in oral fluid 
specimens in all individuals from both groups, after all routes of 
administration, immediately after use. THC was detected above the OFMG 
confirmatory cutoff (i.e., 2 ng/mL) for 32 hours with the occasional 
users and 72 hours with the frequent users. Of the nine occasional 
users, all tested positive for THC using the OFMG confirmatory cutoff 
after all administration routes. However, only three occasional users 
tested positive for THCA (i.e., at or above 15 pg/mL) after all 
administration routes. In a second study, drug-free subjects ate 
brownies containing marijuana in three separate dosing sessions, with 
THC concentrations of 10 mg, 25 mg, and 50 mg.\16\ The appearance of 
THCA in oral fluid in this study was highly variable, and THCA was not 
present in all subjects. Within the first eight hours after marijuana 
ingestion, 116 oral fluid specimens were positive for either THC or 
THCA. Of those specimens, 23 specimens were positive for both THC and 
THCA, 75 were positive for THC only, and 18 were positive for THCA 
only. Therefore, THC was detected in approximately 84.5% of the 
positive oral fluid tests, while THCA was only detected in 
approximately 35.3%. These studies support the Department's decision to 
test for THC by showing that THCA cannot be as reliably detected as THC 
in all marijuana users.
    The Department's decision to use THC as the initial and 
confirmatory test analyte is also supported by the differences between 
the detection patterns of the two analytes in occasional smokers versus 
chronic frequent smokers. For example, one study showed that, although 
THCA was detected in frequent cannabis smokers almost 100% of the time 
studied, occasional smokers did not consistently test positive for THCA 
using the previously considered confirmatory test cutoff concentration 
of 0.05 ng/mL.\17\ Some individuals tested negative for THCA after 
smoking cannabis. Consequently, confirmatory testing for THCA without 
performing an initial test for THCA would be biased toward detecting 
chronic frequent cannabis smokers and would be ineffective in detecting 
occasional users. Such an outcome would diminish the reliability of 
marijuana testing using oral fluid. It is also important to note that 
occasional users may exhibit greater acute impairment than chronic 
frequent users due to the lack of tolerance to cannabis effects.\18\ 
This consideration suggests that an oral fluid drug testing system that 
relies upon testing for THCA to detect marijuana use may fail to 
identify occasional users who could pose a safety risk to a federal 
agency's enterprise.
    The Department believes that an immunoassay initial test with the 
appropriate sensitivity for testing for both THCA and THC could allow 
oral fluid marijuana tests to take advantage of THCA's extended 
detection window. The preamble to the proposed OFMG, published on May 
15, 2015, noted the lack of scientific data on the time course of 
excretion or the detection window of THC, THCA, and conjugated THCA in 
oral fluid following marijuana use, especially for occasional users. It 
was noted that studies of daily marijuana smokers indicated that THC is 
detectable for up to two days, but THCA continued to be excreted in 
oral fluid during abstinence for several weeks in daily users.\19\ Two 
other studies evaluated oral fluid results following cannabis smoking 
(i.e., one cannabis cigarette containing 6.8% THC).17 20 In 
a 2013 study, oral fluid was collected from 10 participants using the 
Quantisal\TM\ (Immunalysis) oral fluid collection device over a 22-hour 
period.\17\ The authors used a 0.5 ng/mL cutoff for THC and a 7.5 pg/mL 
cutoff for THCA. The mean time to last concentration and the mean last 
concentration was 12.3 hours and 5.1 ng/mL for THC and 14.6 hours and 
42.3 pg/mL for THCA, thus providing evidence of a longer detection 
window for THCA. A 2012 study evaluated cannabinoid concentrations in 
oral fluid of chronic and occasional smokers.\20\ Oral fluid was 
collected 19 hours before smoking to 30 hours after smoking, using the 
Statsure Saliva Sampler\TM\ (Statsure Diagnostic Systems). The authors 
concluded that: (1) All specimens were THC positive for up to 13.5 
hours post-smoking without significant differences between chronic and 
occasional smokers, (2) THCA provided longer detection times than THC 
in the 13.5 to 30 hour post-smoking period in all chronic smokers, and 
(3) THCA windows of detection for chronic cannabis smokers extended 
beyond 30 hours.
    However, the Department has not identified immunoassay technology 
that is feasible as an initial test for both THC and THCA in a high-
throughput laboratory environment. Such technology is necessary for the 
implementation of THCA testing in the federal drug testing program 
because: (1) THCA-only testing is not a viable option for the federal 
drug testing program (as discussed previously), and (2) even though 
THCA and THC can be tested during the confirmation phase of drug 
testing, the theoretical advantages of THCA's longer detection window 
will not be achieved unless THCA can be detected in the initial test. 
In other words, in the absence of a viable initial test to detect THCA, 
specimens positive for THCA only would not advance to confirmation 
testing. Therefore, until a suitable immunoassay initial test that is 
capable of screening for both THC and THCA is available, the Department 
believes that its decision to test for THC using the cutoffs 
established in these Guidelines provides federal agencies with an 
efficient, cost-effective and reliable means to detect marijuana use.
    As such, it is the conclusion of the Department that a 4 ng/mL 
initial test cutoff for THC is supported by scientific studies and is 
consistent with the Department's objective of detecting the use of 
illicit drugs while, to the extent practicable, eliminating the risk of 
positive test results caused solely by the drug use of others and not 
caused by the drug use of the individual being tested, as directed by 
the SUPPORT for Patients and Communities Act, Public Law 115-271, 
section 8107(b).\14\

Lowering the Initial Test Cutoff Concentration for THC to Either 2 or 3 
ng/mL and Lowering the Confirmation Test Cutoff Concentration for THC 
to 1 ng/mL To Extend the Window of Detection for Marijuana Use

    Three commenters recommended lowering the THC initial test and 
confirmatory cutoffs to extend the window of detection; one commenter 
recommended lowering the initial test cutoff for this reason, but 
keeping the proposed confirmatory cutoff. One commenter recommended a 
slightly lower confirmatory cutoff (i.e., 1.5 ng/mL). Two commenters 
agreed with the proposed THC cutoffs.
    Two other commenters recommended increasing the initial and 
confirmatory THC cutoffs, so claims of positive

[[Page 57559]]

results due to passive exposure will not be justified.
    The Department's decision on initial and confirmatory cutoffs is 
discussed above, but to reiterate, the Department concluded after 
careful review of all available scientific evidence that: (1) Credible 
claims of positive THC tests resulting from second-hand smoke/passive 
exposure are extremely unlikely, and (2) the only scenario in which 
there is a theoretical possibility of testing positive for THC as the 
result of second-hand smoke/passive exposure under these Guidelines 
involves sustained exposure to extreme levels of marijuana smoke. The 
Department is confident that under these Guidelines, only a donor's 
marijuana use would be identified.

Performance Requirements for an Oral Fluid Collection Device

    One commenter agreed and one commenter disagreed with requiring the 
use of only collection devices that have been cleared by the Food and 
Drug Administration (FDA). One commenter suggested the requirements for 
collection devices should be developed by appropriate professionals 
after suitable scientific and stakeholder review, while another 
suggested the requirements be determined by laboratories and 
manufacturers. One commenter disagreed with the Guidelines, and 
suggested that only devices using ``the swab technique'' be required.
    The Department has evaluated these comments, and maintained the 
requirement in Section 7.1 for oral fluid collection devices to be FDA-
cleared.
    Five commenters addressed proposed volume specifications. Three 
commenters suggested that the Department specify oral fluid collection 
and/or diluent volume as a percentage and not a specific volume, due to 
variability in commercially available devices. One commenter encouraged 
increasing the allowed specimen and diluent volume variance to +/- 20%. 
One commenter believes that the proposed 0.05 mL diluent variance is 
too small and not realistic. One commenter suggested that the 
Guidelines not specify a required volume, but emphasize that 
laboratories choose devices that would ensure sufficient volume is 
collected for initial and confirmatory testing. One commenter disagreed 
with the proposed variance in specimen collected and suggested that the 
device must collect a known volume (similar to the ``European 
Guidelines for Workplace in Oral Fluid''). This commenter also 
disagreed with the 1 mL collection requirement, stating that LC/MS/MS 
methods use approximately 200 mcL of oral fluid and that reducing the 
volume will reduce the time required for collection.
    The Department has evaluated these comments, and revised Section 
7.3(b) to specify oral fluid collection and diluent volumes as 
percentages (rather than specific volumes as proposed). The Department 
agreed with commenters that specifying allowable diluent variance as a 
percentage rather than volume would allow different manufacturers to 
produce their oral fluid collection devices with an optimized volume of 
diluent while ensuring reliability across systems. The Department also 
changed the specimen volume variance to a percentage for consistency. 
Section 7.3 specifies variances of 2.5% for diluent volume and 10% for 
specimen volume, based on information obtained from device 
manufacturers. The Department also maintained the requirement to 
collect at least 1 mL of oral fluid. This is a reasonable collection 
volume that will enable sufficient specimen for testing (e.g., when 
repeat testing or confirmatory tests for multiple drugs are required).
    Four commenters addressed the proposed device requirements for 
recovery of >=90% (but no more than 120%) of drug and/or drug 
metabolite at (or near) the initial test cutoff. The commenters 
disagreed with the proposed requirement of >=90%, and suggested 
recovery between 80% and 120%. One commenter noted that 80% to 120% 
recovery is consistent with current FDA-cleared systems. One commenter 
cited adherence of THC to surfaces as a problem in achieving 90% 
recovery, and recommended either requiring >=80% for all drugs or 
requiring >=80% recovery for THC and >=90% recovery for other drugs. 
One commenter agreed with specifying minimum and maximum recovery, and 
recommended additional emphasis on the consistency of recovery 
performance of the device and confirmatory methods.
    The Department has evaluated these comments, and revised Section 
7.3(b) to change the lower limit for drug recovery from >=90% to >=80%.
    Two commenters addressed stability at room temperature. One 
commenter agreed with the requirement for stability at room temperature 
for at least one week, and one commenter disagreed. This commenter 
indicated that in-house studies found cocaine and 6-AM were unstable 
for that length of time and also indicated that specimens are typically 
received at the laboratory one to two days after collection.
    The Department has evaluated these comments, and changed the 
stability requirement in Section 7.3(b) from one week at room 
temperature to five days at room temperature. Because oral fluid is 
collected with either a preservative buffer (i.e., collection device 
with diluent) or preservative dry reagents (i.e., neat oral fluid 
collection), normal transport conditions are not expected to affect 
stability of the drugs and/or drug metabolites. The Department will 
include guidance to collectors concerning proper collection and 
transport of oral fluid specimens in the Oral Fluid Specimen Collection 
Handbook.

Medical Review Officer (MRO) Reporting Procedures for Positive 
Morphine/Codeine Results

    In Section 13.5, the Department proposed a concentration of 150 ng/
mL for codeine and morphine to be used by the MRO to report a positive 
result in the absence of a legitimate medical explanation (i.e., 
prescription), without requiring clinical evidence of illegal use, and 
to rule out the possibility of a positive result due to consumption of 
food products. The Department requested comments on the appropriateness 
of this concentration. One commenter agreed. Six commenters disagreed: 
One commenter recommended 100-120 ng/mL, one commenter recommended 50-
100 ng/mL, one commenter recommended 120 ng/mL, and one commenter 
recommended 40 ng/mL. One commenter suggested that no additional 
decision point is needed because, based on scientific studies including 
in[hyphen]house studies, positive opiate results using a 40 ng/mL 
cutoff are not typical and are difficult to achieve, thus there is no 
justification for an MRO reversal of a codeine or morphine result less 
than 150 ng/mL. One commenter expressed concern that the 150 ng/mL 
decision point would not rule out positive codeine/morphine results due 
to food products and suggested that the Department use a much higher 
decision point or require clinical evidence of illegal drug use before 
an MRO verifies any opiate results as positive. Based on evaluation of 
these comments and examination of the data from scientific studies, the 
Department has concluded that no change is needed.21-24 The 
150 ng/mL concentration is higher than the highest concentration seen 
in study subjects at one hour and later after consumption of raw poppy 
seeds and products containing poppy seeds.

[[Page 57560]]

HHS List of FDA-Cleared Oral Fluid Collection Devices

    The Department requested comments on whether HHS should publish a 
list of FDA-cleared oral fluid collection devices. Seven commenters 
agreed. One commenter disagreed, stating that it is sufficient to 
provide regulation on requirements and noting that the Department does 
not publish a list of FDA-cleared urine specimen containers. After 
further review, the Department has decided not to publish a list. The 
list might not reflect all current FDA-cleared oral fluid collection 
devices, and could be misconstrued as a list of SAMHSA-approved 
devices. Also, FDA clearance does not mean that the collection device 
meets OFMG requirements. The federal agency and/or the HHS-certified 
laboratory must ensure that the FDA-cleared device meets the device 
requirements in Sections 7.2 and 7.3. FDA has a searchable database on 
its website that can be used to identify FDA-cleared oral fluid 
collection devices. The Department will include a link to this database 
on the SAMHSA website http://www.samhsa.gov/workplace.

Medical Review Officer (MRO) Requalification--Continuing Education 
Units (CEUs)

    The Department requested comments on requiring MRO requalification 
continuing education units (CEUs) and on the optimum number of credits 
and the appropriate CEU accreditation bodies should CEUs be required as 
part of MRO requalification. Three commenters agreed with requiring MRO 
recertification, but disagreed with the addition of CEU requirements to 
the Guidelines. Two commenters disagreed with specifying the number of 
CEUs required. Two commenters indicated that certification entities 
already enforce training requirements and recommended that acceptance 
of CEUs be handled by MRO certification boards, not the Department. Two 
commenters recommended a requirement of annual CEUs: One suggested 16 
CEUs and the other recommended three CEUs. One commenter recommended 12 
CEUs prior to initial certification, eight CEUs every five years, and 
also recommended two CEUs related to the new requirements/topics within 
two years of implementation of the revised Guidelines. The Department 
has evaluated the comments and has concluded that requirements for 
continuing education units will remain with the MRO certification 
entities and will not be included in the Guidelines. The Department has 
removed references to MRO training entities in Sections 13.2 and 13.3, 
because training documentation is maintained by MRO certification 
entities. The Department agrees with the comment that MROs should 
receive training on revisions to the Guidelines and has added item 
Section 13.3(b) to require such training prior to the effective date of 
revised Guidelines, to ensure that all MROs are trained in program 
requirements before performing MRO duties for federal agency specimens.

Split Specimen Collection Methods

    All federal agency collections are to be split specimen 
collections. The donor's primary (A) specimen is tested and the split 
(B) specimen is available for testing if the donor requests a retest at 
another HHS-certified laboratory. For urine, one specimen is collected 
from the donor, then the collector pours the collected specimen into 
two bottles that are then labelled as A and B specimens. Most current 
oral fluid collection devices collect a single specimen that cannot be 
divided into A and B specimens. Therefore, the Department requested 
comments on whether serial or simultaneous collection using two 
collection devices constitutes a split oral fluid collection, and 
recommendations for any other oral fluid collection processes that 
enable subdividing the collected specimen. Three commenters agreed with 
the proposed guidelines as written. Two cited problems with collecting 
expectorated oral fluid (i.e., difficult to obtain a sufficient 
specimen, distasteful to donor and collector), and stated that 
collection with a device provides analyte stability, a homogenous 
specimen, and facilitates processing in the laboratory. The commenters 
noted that the split specimen requirement to identify the presence of 
the drug addresses any concentration differences between first and 
second specimens. They also noted that split collections with two 
devices are currently used for non-regulated testing without issue and 
that scientific studies support these methods. Five commenters 
disagreed. Some raised concerns over possible insufficient specimen 
volume and non-homogenous specimens leading to possible discrepant 
primary and split specimen results. One commenter disagreed stating 
that the use of two devices for each collection increases costs. One 
commenter believes that serial collections using two devices may 
increase the likelihood of collection problems (e.g., collector forgets 
to perform the second collection; the donor may leave the collection 
site or be out of collector's line-of-sight between collections; the 
two-minute period may be exceeded). The Department has evaluated the 
comments and has concluded that no change is needed. Either serial or 
simultaneous collection using two collection devices constitutes a 
split oral fluid collection for federal workplace drug testing 
programs. These split collection procedures are described in Section 
8.8. The Department revised the split specimen collection definition in 
Section 1.5 and revised Section 8.8(a) to clarify that the OFMG do not 
prohibit collection of a single specimen and subdividing the collected 
specimen into primary (A) and split (B) specimens. In Section 2.5, the 
Department clarified that the split oral fluid specimen may be 
collected using two devices or using one device and subdividing the 
specimen.

Discussion of Sections

    The Department has not included a discussion in the preamble of any 
sections for which public comments were not submitted or where minor 
typographical or grammatical changes were made.

Subpart A--Applicability

1.5 What do the terms used in these Guidelines mean?

    One commenter requested that ``external service provider'' be 
defined, because this is a new term included in the proposed 
Guidelines. The Department agrees and has added the definition ``An 
independent entity that performs services related to federal workplace 
drug testing on behalf of a federal agency, a collector/collection 
site, an HHS[hyphen]certified laboratory, a Medical Review Officer 
(MRO), or, for urine, an HHS-certified Instrumented Initial Test 
Facility (IITF).''
    Two commenters disagreed with the proposed definition for ``invalid 
result'' which indicated that an invalid result was reported only when 
an HHS-certified laboratory could not complete testing or obtain a 
valid drug test result. The Department agrees and has reinstituted 
wording from the definition in the Guidelines effective October 1, 2010 
(73 FR 71858). The definition in Section 1.5 is ``The result reported 
by an HHS-certified laboratory in accordance with the criteria 
established in Section 3.7 when a positive or negative result cannot be 
established for a specific drug or specimen validity test.''
    To address comments described in this preamble under Section 13.1, 
the Department deleted the definition for ``non-medical use of a 
drug.''
    Two commenters found the definition of ``specimen'' confusing, 
because the term ``sample'' used in the definition

[[Page 57561]]

was also defined as a representative portion of a donor's specimen. The 
Department agrees and has reinstituted some wording for the definition 
of ``specimen'' from the Guidelines effective October 1, 2010 (73 FR 
71858) for clarity. The definition in Section 1.5 is ``Fluid or 
material collected from a donor at the collection site for the purpose 
of a drug test.''
    The Department revised the definition of ``split specimen 
collection (for oral fluid)'' to clarify that the OFMG allow collection 
of a single specimen and subdividing the collected specimen into 
primary (A) and split (B) specimens. This is consistent with the change 
described in this preamble under Section 8.8(a).
    For clarity, the Department added a definition for the term 
``undiluted (neat) oral fluid'' which is used throughout the OFMG. The 
definition in Section 1.5 is ``An oral fluid specimen to which no other 
solid or liquid has been added. For example, see Section 2.4: a 
collection device that uses a diluent (or other component, process, or 
method that modifies the volume of the testable specimen) must collect 
at least 1 mL of undiluted (neat) oral fluid.''

1.6 What is an agency required to do to protect employee records?

    One commenter suggested that the non-applicability of the Health 
Insurance Portability and Accountability Act (HIPAA) and the Health 
Information Technology for Economic and Clinical Health Act (HITECH) 
should be clearly stated in the Guidelines. The Department has 
evaluated the comment and has concluded that the applicability of HIPAA 
and other relevant privacy laws is clearly stated in Section 1.6. 
Accordingly, except for minor rewording for clarity, no further 
revisions are necessary.

1.7 What is a refusal to take a federally regulated drug test?

    The Department proposed within Section 1.7 what is a refusal to 
take a federally regulated drug test. Two commenters noted that this 
section does not include the same requirements as Section 1.7(a)(10) of 
the UrMG defining a refusal to test when a collector finds a device 
intended for the purpose of adulteration or substitution and 
recommended adding similar language to the OFMG. The Department has 
evaluated the comments, and agrees that the collector must report a 
refusal to test when a donor brings materials for adulterating, 
substituting, or diluting the specimen to the collection site, or when 
the collector observes a donor's clear attempt to tamper with a 
specimen. The Department has revised Sections 1.7, 8.3(d), and 8.4(c) 
accordingly. Collectors will inspect the donor's oral cavity to ensure 
it is free of items that may impede or interfere with the drug test as 
described in Section 8.3.
    One commenter recommended that OFMG Section 1.7 include the same 
requirements as UrMG Section 1.7(a)(5) defining a refusal to test when 
the donor failed to provide a sufficient amount of specimen when 
directed, ``and the required medical evaluation did not identify a 
legitimate medical explanation for the failure.'' The Department agrees 
with this comment and has added a new item 4 to Section 1.7(a) 
consistent with the UrMG requirement.
    One commenter recommended clarification that a donor's refusal to 
provide a split specimen will also qualify as a refusal to test. The 
Department has evaluated the comment and has added this as a refusal to 
test in Sections 1.7(a)(7) and Section 8.5(b). If the donor refuses to 
provide a split specimen, the collector will report this as a refusal 
to test.
    Also in regard to Section 1.7, one commenter suggested expanding 
the section to include specific actions that would be classified as a 
refusal to test. The commenter suggested wording under the current 
example ``disrupt the collection process'' describing actions specific 
to OF collections ``(e.g., disrupt the collection process including: 
biting on the collection device, sucking the fluid back out of the 
device, failure to open mouth when directed for inspection, failure to 
rinse mouth when directed, failure to remove foreign object from mouth 
when instructed, failure to permit the observation or monitoring of the 
specimen collection, avoiding swabbing in-between teeth and the gum 
line when instructed, failure to follow the collector's instructions on 
swab location in the mouth, attempting to conceal chemicals or mints in 
the mouth, attempting to use a mouth wash immediately prior to or 
during the collection, attempting to chew ice during the collection, 
behave in a confrontational way that disrupts the collection process, 
fail to wash hands after being directed to do so by the collector, 
possess or wear a prosthetic or other device that could be used to 
interfere with the collection process, other failures to comply with 
the collector's instructions or attempt to defraud the drug test)''.
    The Department has evaluated the comment and has added the failure 
to rinse the mouth when directed by the collector as an example of 
donor actions classified as a refusal to test in Sections 1.7(a)(7) and 
in Section 8.3(d)(2). It should be noted that Section 1.7(a)(7) lists 
some examples. In practice, the trained collector determines whether 
the donor's action is a refusal to test. Many of the commenter's 
described actions would disrupt the collection process and thus 
constitute a refusal to test under Section 1.7(a)(7). The Department 
will consider the commenter's suggestions during preparation of 
guidance which will be provided in the HHS Oral Fluid Specimen 
Collection Handbook.
    One commenter noted that the collector does not report a refusal to 
test when a donor leaves the collection site before the collection 
process begins for a pre-employment test. The commenter recommended 
defining the beginning of the pre-employment collection process as the 
point at which the donor is asked to present photo identification. The 
Department agrees with the suggestion to define the beginning of the 
collection process specifically for this situation. However, the 
Department has designated the beginning as the step described in 
Section 8.4(a), when the collector provides or the donor selects a 
specimen collection device. The Department has revised Sections 
1.7(a)(2) and (3) to include a reference to this section. All 
subsequent items in Section 1.7(a) (i.e., items 4--10) apply once the 
donor has arrived for the pre-employment test collection.

1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?

    The Department reworded Section 1.8(b) to clarify that the 
requirements in this section apply to donors who fail to appear at the 
collection site in a reasonable time for any test (except a pre-
employment test), as described in Section 1.7(a)(1).

Subpart B--Oral Fluid Specimens

2.1 What type of specimen may be collected?

    Ten commenters agreed with adding oral fluid and three commenters 
disagreed with adding oral fluid and alternate matrices. One commenter 
raised questions regarding the accuracy of oral fluid testing, MRO 
interpretation of detection of the parent compound of a prohibited 
drug, and the cost of oral fluid testing. The Department has evaluated 
the comments, and believes the concerns raised by the commenters are 
not sufficient to remove oral fluid testing from the Guidelines. The 
Department believes that collecting and testing oral fluid specimens 
according to

[[Page 57562]]

the requirements in these Guidelines is an efficient means to detect 
illicit drug use and ensures that the oral fluid test results are 
forensically and scientifically supportable.
    Numerous commenters expressed concern with the Department's urine 
collection policy, stating that 7 to 10% of Americans have a condition 
(``paruresis''), described as a social anxiety disorder which prevents 
a person from producing urine on demand or in the presence of other 
people. These commenters stated that if the government wants to seek 
the largest group of qualified applicants, the Guidelines should 
specify that a diagnosis of paruresis means non-urine (i.e., oral 
fluid) testing will automatically be provided, and that donors should 
not have to attempt to provide a urine specimen first. These comments 
are not relevant to the OFMG. The OFMG establish the standards and 
technical requirements for oral fluid testing in federal workplace drug 
testing programs. Each federal agency will decide whether to collect 
urine, oral fluid, or both specimen types in their workplace testing 
programs.

2.2 Under what circumstances may an oral fluid specimen be collected?

    One commenter recommended that oral fluid be restricted based on 
the reason for the test due to the short window of detection compared 
to urine (and hair), the benefits of observed collection, and the 
ability to identify the parent or active drug that was used. One 
commenter recognized the benefit of oral fluid with respect to fewer 
adulterated, substituted, and/or invalid specimens, but raised concern 
over the shorter window of detection in oral fluid, especially with 
respect to pre-employment testing. Two commenters suggested that oral 
fluid and hair testing be performed for pre-employment and random 
tests. The Department has evaluated the comments and has concluded that 
no change is needed. Each federal agency will decide which of the 
authorized specimen types it will collect and the reasons for 
collecting each type of specimen.

2.3 How is each oral fluid specimen collected?

    One commenter noted that this section does not clearly describe a 
split specimen ``collected either simultaneously or serially.'' The 
Department has evaluated the comment and has revised this section to 
include a reference to Section 8.8, which provides clear descriptions 
of these split specimen collection methods.

2.4 What volume of oral fluid is collected?

2.5 How is the split oral fluid specimen collected?

    Comments on these two sections (i.e., Section 2.4 and Section 2.5) 
are addressed here. One commenter noted that Sections 2.4 and 2.5 
require collection of ``a known volume'' of at least 1 mL undiluted 
oral fluid, and stated that an absorbent pad device will not meet this 
requirement. The commenter recommended that these sections be clarified 
and address all types of oral fluid collection devices. The Department 
has evaluated the comment and has revised Sections 2.4 and 2.5 to 
ensure consistent requirements for collection devices with and without 
a diluent (or other component, process, or method that modifies the 
volume of the testable specimen). The Department revised Section 2.4 to 
require A and B tubes to have a volume marking clearly noting a level 
of 1 mL if the device does not include a diluent (or other component, 
process, or method that modifies the volume of the testable specimen). 
This is consistent with requirements in Section 7.3 for devices that 
modify the volume of the testable specimen to have a volume indicator, 
to ensure that at least 1 mL of oral fluid is collected. In Section 
2.5, in addition to referencing Section 8.8, the Department clarified 
that the split oral fluid specimen may be collected using two devices 
or using one device and subdividing the specimen.

Subpart C--Oral Fluid Specimen Tests

3.1 Which tests are conducted on an oral fluid specimen?

    One commenter suggested changing the term ``opiates'' to 
``opioids'' in the Guidelines. ``Opiates'' is the term used to describe 
naturally occurring substances known as alkaloids derived from the 
opium poppy plant (e.g., codeine; morphine; and heroin, which is 
produced by the acetylation of morphine) that bind to specific 
receptors in the central nervous system. The broadly used term 
``opioids'' includes opiates (e.g., codeine, morphine, and heroin); 
semi-synthetic compounds (e.g., hydrocodone, hydromorphone, methadone, 
oxycodone, and oxymorphone); and synthetic compounds (e.g., fentanyl). 
The Department agrees with the commenter and has changed the term 
``opiates'' to ``opioids'' where appropriate to refer to oxycodone, 
oxymorphone, hydrocodone, and hydromorphone in addition to codeine, 
morphine, and 6-acetylmorphine (6-AM).
    In addition, as described under Requirements for specimen validity 
testing in this preamble, the Department revised Section 3.1 to allow, 
but not require, oral fluid specimen validity testing.

3.2 May a specimen be tested for additional drugs?

    The Department reworded Section 3.2(a) to clarify the additional 
drug tests that may be performed on federal employee specimens.

3.3 May any of the specimens be used for other purposes?

    It should be noted that, consistent with the Urine Mandatory 
Guidelines, Section 3.3 specifically prohibits conducting, among other 
types of testing, deoxyribonucleic acid (DNA) testing, on oral fluid 
specimens unless authorized in accordance with applicable federal law.

3.4 What are the drug test cutoff concentrations for undiluted (neat) 
oral fluid?

    Comments concerning marijuana test cutoffs are addressed under the 
Testing for Marijuana Use section above. Comments on other drug test 
cutoffs are addressed under Proposed cutoff concentrations. To 
summarize, the Department revised Section 3.4 to use higher cutoffs for 
some drugs (i.e., initial test cutoffs for 6-AM, PCP, and amphetamines; 
confirmatory test cutoffs for PCP and amphetamines) than in the 
proposed OFMG. Other comments related to Section 3.4 are addressed 
below.
    Three commenters disagreed with testing for cocaine in oral fluid, 
stating that cocaine is not stable in oral fluid, especially at the pH 
of human oral fluid. The commenters noted that cocaine has a short 
half-life and hydrolyzes to benzoylecgonine, and that benzoylecgonine 
is present longer and at higher levels. Two of these commenters further 
noted that the current industry standard is to test for benzoylecgonine 
only in oral fluid. One stated that their in-house studies found that 
testing cocaine did not increase the positivity rate compared to 
testing only benzoylecgonine. The other commenter refuted the study 
cited in the preamble to the proposed OFMG that supported the inclusion 
of cocaine as a test analyte. The Department based the proposed 
analytes for each drug on the recommendations of a technical workgroup 
consisting of subject matter experts and representatives from various 
stakeholder groups (e.g., collection

[[Page 57563]]

device and test kit manufacturers, oral fluid drug testing 
laboratories). In the preamble to the proposed OFMG of May 15, 2015 (80 
FR 28054, page 28063), the Department included the scientific basis for 
including both analytes. The inclusion of both cocaine and 
benzoylecgonine as test analytes will increase the number of specimens 
that are identified as containing these cocaine analytes and, thereby, 
will increase the deterrent effect of the program and improve 
identification of employees using this drug.
    One commenter disagreed with testing for hydromorphone and 
oxymorphone in oral fluid due to extremely low incidence and 
recommended testing for more prevalent metabolites. The Department has 
evaluated the comment and decided that no change is needed. Information 
provided by initial test manufacturers indicates that the proposed 
analytes (i.e., parent drugs) are present in higher concentrations and 
in the absence of their metabolites.
    One commenter recommended specifying D-isomers as the initial test 
analytes for amphetamines. The Department agrees that an antibody that 
is directed toward D-enantiomers in an immunoassay method should be 
preferred over an antibody that is non[hyphen]stereoselective, but 
concluded that no change is needed. The wording in this section is 
consistent with the UrMG, and the selection of an immunoassay kit or 
methodology will remain the testing laboratory's choice.
    An HHS-certified laboratory may group analytes for initial testing. 
For clarity, the Department has defined the term ``grouped analytes'' 
where used in footnote 1 of the table in Section 3.4: ``(i.e., two or 
more analytes that are in the same drug class and have the same initial 
test cutoff).''
    The Department proposed criteria for calibrating initial tests for 
grouped analytes such as opioids and amphetamines, specifying the 
minimum cross-reactivity to the other analyte(s) within the group. The 
Department also proposed including methylenedioxyamphetamine (MDA) and 
methylenedioxyethylamphetamine (MDEA) as initial test analytes. Four 
commenters stated that 80% cross-reactivity may not be possible with 
current immunoassay technology, so may require independent analyses 
(e.g., hydrocodone and hydromorphone for an opiate assay; MDEA for an 
amphetamines assay). Two of these commenters noted concerns with 
additional oral fluid specimen volume needed for the independent 
assays. Another commenter stated that cross-reactivity specifications 
for hydromorphone are not necessary, based on their non-regulated 
testing results (i.e., confirmatory test concentrations detected after 
using an immunoassay with 60% cross-reactivity for hydromorphone).
    The Department has evaluated these comments and concluded that no 
change is needed for immunoassay cross-reactivity requirements. The 
cross-reactivity requirements in Section 3.4 are necessary to ensure 
consistency in testing among laboratories using different immunoassay 
kits, as well as those using different test methods for initial drug 
testing. Cross-reactivity must be demonstrated and documented by the 
manufacturer (e.g., package insert) and by the HHS-certified laboratory 
(i.e., assay validation studies, reagent lot verification, and batch 
quality control for any analyte that exhibits less than 100% cross-
reactivity).
    One commenter stated that the low prevalence of MDA and MDEA does 
not warrant the burden placed on immunoassay manufacturers and 
laboratories. The Department has evaluated the comment and has removed 
MDEA from the Guidelines (i.e., MDEA is no longer included as an 
authorized drug in Section 3.4). The number of positive MDEA specimens 
reported by HHS-certified urine laboratories (i.e., information 
provided to the Department through the NLCP) does not support testing 
all specimens for MDEA in federal workplace drug testing programs. 
Because MDEA is a Schedule I drug, a federal agency may test specimens 
for MDEA in accordance with Section 3.2 (i.e., on a case-by-case basis 
for reasonable suspicion or post-accident testing, routinely with a 
waiver from the Secretary). The Department understands that some other 
analytes have a low incidence, but believes that continued testing for 
these analytes is warranted in a deterrent program. In particular, 
inclusion of MDA as an initial and confirmatory test analyte is 
warranted because, in addition to being a drug of abuse, it is a 
metabolite of MDEA and MDMA.
    Also in Section 3.4, the Department did not specify the target 
analyte to be used to calibrate an initial test for grouped analytes 
such as amphetamines or opioids. Three commenters noted that when an 
immunoassay is calibrated with a low-reacting drug, other analytes may 
exhibit high cross-reactivity, leading to false initial test positives. 
Two of these commenters also noted that this may result in possibly 
different cross-reactivity profiles for some structurally unrelated and 
concomitantly used prescription and/or over the counter drugs. It was 
not the Department's intent for the laboratory to calibrate an 
immunoassay test using an analyte other than that specified by the 
manufacturer. In the preamble to the proposed OFMG, the Department 
described using a control containing the lowest reacting analyte at its 
cutoff concentration to establish the decision point (i.e., when an 
immunoassay for grouped analytes did not demonstrate at least 80% 
cross-reactivity to each analyte). The Department has determined that 
this approach is not necessary, and will not be permitted. There are 
current immunoassays that meet the requirements of this section for two 
or more analytes in a group (i.e., analytes in the same drug class that 
have the same initial test cutoff). As indicated in Section 3.4, the 
laboratory may use multiple test kits or a single kit to meet the 
requirements.
    However, the Department has revised Section 3.4 regarding the use 
of alternate technology initial tests for THC and 6-AM. To ensure 
consistent treatment of specimens, depending on the technology, the 
confirmatory test cutoff (i.e., 2 ng/mL) must be used for THC and 6-AM. 
For example, because immunoassays cross-react with various marijuana 
constituents and metabolites, a specimen that is positive using a 
cutoff of 4 ng/mL for an immunoassay may not test positive using an 
alternate technology initial test with a 4 ng/mL cutoff for THC. When 
using an alternate technology initial test (e.g., LC/MS/MS) that is 
specific for the target analyte, THC, must be tested using the 
confirmatory test cutoff.

3.5 May an HHS-certified laboratory perform additional drug and/or 
specimen validity tests on a specimen at the request of the Medical 
Review Officer (MRO)?

    One commenter recommended that HHS maintain a list of allowable 
additional tests and reporting criteria (e.g., threshold for reporting 
as positive, adulterated, substituted, and/or invalid, and a limit of 
detection as appropriate), to ensure consistency among laboratories and 
within the testing program. The Department has evaluated the comment 
and has concluded that no change is needed. The Department does not 
want to limit the analytes that may be tested, and will provide 
guidance to laboratories as necessary. It is also noted that the 
section requires all tests to meet appropriate validation and quality 
control requirements. The procedures and specimen records for such 
tests will be reviewed at NLCP inspections. The Department will 
continue to maintain a

[[Page 57564]]

list of HHS-certified laboratories that choose to perform additional 
tests for regulated specimens. The Department has reworded Section 3.5 
in concert with revisions to Section 3.1 removing the requirement for 
albumin or IgG testing, as described under Requirements for specimen 
validity testing in this preamble.
    One commenter asked whether an MRO could submit a blanket request 
to perform additional testing (e.g., additional opioid metabolites) for 
all confirmatory specimens (i.e., would laboratories be permitted to 
monitor the additional compounds in all confirmatory test assays?). The 
Department believes that testing all specimens for additional analytes 
may not be appropriate for some tests, especially hydrocodone, 
hydromorphone, oxycodone and oxymorphone. Recent studies show that 
testing for norhydrocodone and/or noroxycodone is not necessary for the 
interpretation of all results.26 27 Norhydrocodone and 
noroxycodone metabolites may be helpful for the MRO to interpret test 
results only when a donor's prescription does not support the test 
results. The presence of norhydrocodone metabolite would support the 
use of hydrocodone and validate the donor's prescription. The same 
could be said for interpreting test results following an oxycodone 
dose. The presence of noroxycodone metabolite would support the use of 
oxycodone and validate the donor's prescription. The Department will 
provide guidance on these and other additional tests that may provide 
useful information for the MRO in the Medical Review Officer Guidance 
Manual for Federal Workplace Drug Testing Programs. The Department has 
revised Section 3.5 to clarify that HHS-certified laboratories are 
authorized to perform additional tests upon MRO request on a case-by-
case basis, but are not authorized to routinely perform such tests 
without prior authorization from the Secretary or designated HHS 
representative, with the exception of the determination of D,L 
stereoisomers of amphetamine and methamphetamine. The Department will 
continue to allow HHS-certified laboratories to test for D,L 
amphetamine and methamphetamine routinely or upon MRO request. The 
Department will provide guidance on these and other additional tests 
that may provide useful information for the MRO (e.g., 
tetrahydrocannabivarin) in the Medical Review Officer Guidance Manual 
for Federal Workplace Drug Testing Programs.
    Additional drug and specimen validity testing under Section 3.5 
does not include DNA testing.

3.7 What criteria are used to report an invalid result for an oral 
fluid specimen?

    One commenter disagreed and recommended deleting Sections 3.7(a-c) 
and 3.7(g) from the Guidelines due to observed collections by trained 
collectors. As described under Requirements for specimen validity 
testing in this preamble, the Department has revised the Guidelines to 
allow, but not require, specimen validity testing. Section 3.7 has been 
revised accordingly.

Subpart D--Collectors

4.1 Who may collect a specimen?

    One commenter questioned why the Department prohibits supervisors 
or hiring officials from collecting oral fluid specimens (unless no 
other collector is available). The commenter cited fewer privacy 
concerns in collecting oral fluid versus urine, and indicated that 
having supervisors collect specimens would be particularly useful in 
remote locations and/or for post-accident tests. The Department has 
evaluated the comments and has concluded that no change is needed. The 
Department will continue to prohibit routine collections by a 
supervisor, to avoid potential conflicts of interest due to the 
employee-supervisor relationship as much as possible. The Guidelines 
permit collections by a supervisor who has been trained as a collector 
when no other trained collector is available.

4.2 Who may not collect a specimen?

    One commenter expressed concern that this section as written may 
unintentionally prevent the use of valid collection methods (i.e., 
preventing the donor from collecting their own specimen may prohibit 
the donor from holding the collection device). The Department has 
evaluated the comments and has concluded that no change is needed to 
Section 4.2, which includes general language concerning the entire 
collection process. Section 8.4 describes steps the collector takes 
before the donor provides the oral fluid specimen, including reviewing 
with the donor the manufacturer's instructions for oral fluid 
collection using the specimen collection device. Section 8.5 describes 
the collection procedure, including the requirement for the donor to 
position the device for collection, and for the collector and donor to 
complete the collection in accordance with the manufacturer's 
instructions for the collection device. However, the Department has 
revised the wording in Section 8.5(a)(1) to address all types of oral 
fluid collection devices allowed by the OFMG (i.e., including those 
that are not placed in the mouth).

Subpart E--Collection Sites

5.2 What are the requirements for a collection site?

    One commenter suggested that the Department require restricted 
access only to be applicable during a collection period, and allow 
supplies and records to be stored in nearby secured areas. The 
Department has evaluated the comments and has concluded that no change 
is needed. The section clearly describes the requirements and addresses 
the commenter's concerns.

Subpart F--Federal Drug Testing Custody and Control Form (CCF)

6.1 What federal form is used to document custody and control?

6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?

    Comments on these two sections (Sections 6.1 and 6.2) are addressed 
here. Three commenters recommended that the Federal Custody and Control 
Form (CCF) be revised to address oral fluid specimens. The Department 
will revise the Federal CCF when Guidelines allowing oral fluid become 
effective.
    The Department reworded items 6.2(b) and (c) for clarity.

Subpart G--Oral Fluid Specimen Collection Devices

7.3 What are the minimum performance requirements for a collection 
device?

    The Department reworded Section 7.3(a) in reference to oral fluid 
collection volume, as described under Sections 2.4 and 2.5 above, and 
revised Section 7.3(b) in response to public comments, as described 
under Performance requirements for an oral fluid collection device 
above.

Subpart H--Oral Fluid Specimen Collection Procedure

8.2 What must the collector ensure at the collection site before 
starting an oral fluid specimen collection?

    One commenter stated that this section requires the collector to 
deter adulteration or substitution at the collection site, but does not 
provide any information on how this is to be done. The commenter 
recommended that Section 8.2 be deleted or, alternatively, that 
additional information be added to the section. The Department has

[[Page 57565]]

evaluated the comments and has concluded that no change is needed. The 
section provides the general requirement; the Department will provide 
more specific guidance as needed in the HHS Oral Fluid Specimen 
Collection Handbook, which will be issued after these Guidelines become 
effective.

8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?

    In response to comments described under Sections 1.7 and 8.4 in 
this preamble, the Department revised Section 8.3(d) to require the 
collector to report a refusal to test when a donor brings materials for 
adulterating, substituting, or diluting a specimen to the collection 
site.
    One commenter requested that the Guidelines clarify (possibly using 
a flowchart) the different waiting periods in Sections 8.3 and 8.6 
(i.e., if multiple waiting periods are required, do they run 
concurrently or consecutively?). The Department has evaluated the 
comments and has concluded that no change is needed. The Department 
will consider the commenter's suggestion during preparation of the HHS 
Oral Fluid Specimen Collection Handbook.
    Several comments concerned Section 8.3 collection procedures 
regarding rinsing or drinking. One commenter disagreed with the 
requirement to have tobacco users rinse their mouth prior to an oral 
fluid collection, noting it is an inconvenience for the collector to 
provide a place for the donor to spit out the liquid. One commenter 
requested clarification on oral fluid collection procedures for tobacco 
users (e.g., is the collector required to ask, is it a refusal if a 
tobacco user doesn't rinse their mouth, is the donor required to rinse 
with water, what if the donor uses more than 4 oz. of liquid to 
rinse?). The Department removed the reference to tobacco users in 
8.3(d)(2) because there is no need for all tobacco users to rinse their 
mouths. The proposed procedure for tobacco users was due to the dark 
brown color of tobacco juice. The issue is that any discoloration may 
interfere with initial testing (i.e., not just tobacco juice). The 
Department reworded this section to include abnormally colored saliva 
as a reason for the collector to give water to the donor for rinsing 
their mouth.
    One commenter recommended that the Guidelines clarify that if the 
donor drinks water, the water must not be provided by the donor. For 
clarity, the Department revised Section 8.3(d)(2) to require the 
collector to give the donor water (for example, up to 4 oz.) to rinse 
the donor's mouth when the collector's inspection of the oral cavity 
identifies any items that could impede or interfere with the collection 
of an oral fluid specimen. If the donor refuses to rinse, this is a 
refusal to test. Rinsing with more than 4 oz. of water does not 
invalidate the collection, so this amount was given as an example 
rather than a requirement.
    One commenter indicated that some collection devices specifically 
instruct against offering the donor anything to rinse with or drink. 
This commenter suggested modifying Section 8.3 to make offering of 
water conditionally allowed, depending on the collection device 
manufacturer's instructions. The Department has evaluated these 
comments and concluded that no change is needed. The Department 
believes that rinsing the oral cavity with water prior to a 10-minute 
wait period is a reasonable part of the oral fluid collection protocol. 
The wait period is sufficient to comply with the device instructions, 
and will not dilute the collected oral fluid.
    Several comments concerned Section 8.3 collection procedures 
regarding inspection of the donor's mouth. One commenter requested 
clarification on what items need to be removed from a donor's mouth 
prior to an oral fluid collection (tobacco, food, gum, or mints versus 
retainers and piercings). One commenter requested clarification of 
whether ``dental retainer'' refers to a temporary or permanent device 
(or both), should the device be removed and, if so, where the device 
should be placed during the oral fluid collection. The Department has 
evaluated the comments and concluded that only one change is needed: 
Removal of ``dental retainer'' from the examples of items that must be 
removed based on a collector's inspection of the donor's mouth in 
Section 8.3(d). A donor is not required to remove dental appliances 
such as a retainer. The Department will provide additional information 
in the Oral Fluid Specimen Collection Handbook to clarify items that 
may impede or interfere with the collection.
    One commenter recommended that the Guidelines address the situation 
where a donor may have a medical condition that prevents them from 
opening their mouth for the collector to inspect. The Department agrees 
with the commenter and has revised Section 8.3(d) to address this 
situation. The collector will proceed with the same steps as when a 
donor is unable to provide an oral fluid specimen, as described in 
Section 8.6(b)(2), and the MRO will follow the steps in Section 13.6(b) 
requiring a medical evaluation of the donor.

8.4 What steps does the collector take in the collection procedure 
before the donor provides an oral fluid specimen?

    Two commenters believe that if the collector finds an adulterant or 
substitution product, this should be a refusal to test. As noted under 
Sections 1.7 and 8.3 in this preamble, the Department agrees that the 
collector must report a refusal to test when a donor brings materials 
for adulterating, substituting, or diluting a specimen to the 
collection site, or when the collector observes a donor's clear attempt 
to tamper with a specimen. The Department has revised Section 8.4(c) 
accordingly.
    The Department deleted Section 8.4(b)(1) for consistency with 
Section 8.6(b). The deleted item stated that the collector may set ``a 
reasonable time for a collection based on the device used, not to 
exceed 15 minutes.'' Section 8.6(b) states that the donor demonstrates 
their inability to provide a specimen when, after 15 minutes of using 
the collection device, there is insufficient volume or no oral fluid 
collected using the device.

8.5 What steps does the collector take during and after the oral fluid 
specimen collection procedure?

    One commenter suggested that the section should state that the 
collector be present and maintain visual contact with the donor and 
collection device during the procedures outlined in this section. The 
Department has evaluated the comment and has concluded that no change 
is needed: Sections 8.4(a) and 8.5(a) clearly require the collector to 
keep the unwrapped collection devices and the donor in view at all 
times during the collection.
    One commenter asked if there was a limit to the number of times a 
collection could be restarted due to collection device failures. The 
Department has evaluated the comment and has reworded Section 8.5 for 
clarity. Section 8.5(a)(1) was revised to indicate that a failure to 
provide a specimen (which may or may not be due to device failure) 
prompts recollection using a new device and that the collector 
documents the failed collection attempt on the Federal CCF. The 
Department also reworded Section 8.5(b) to clarify that a donor's 
refusal to begin the collection process after a failure to collect the 
specimen is a refusal to test. The Department did not set a limit for 
the number of attempts because there may be different reasons for 
failing to collect the specimen from the donor. However, the Department

[[Page 57566]]

revised the section to require the collector to follow the procedure in 
Section 8.6 ``after multiple attempts to collect the specimen.''
    One commenter stated that HHS should clarify that a donor's refusal 
to provide a split specimen will also qualify as a refusal to test. The 
Department agrees with the comment and has revised Section 8.5(b) to 
include the refusal to provide a split oral fluid specimen as a refusal 
to test.
    Additionally, as described under Section 4.2 above, the Department 
revised Section 8.5(a)(1) to address all types of collection devices 
allowed by the OFMG (including those that are not placed in the mouth).

8.6 What procedure is used when the donor states that they are unable 
to provide an oral fluid specimen?

    Three commenters disagreed with the requirement for the collector 
to contact the agency representative for authorization to collect an 
alternate specimen each time a donor is unable to provide a sufficient 
volume. These commenters suggested that the Guidelines allow this to be 
addressed in established standard protocols for the agency. The 
Department agrees with the commenters. Each federal agency may decide 
whether to require notification in each case or whether to provide a 
standard protocol for collectors to follow. Section 8.6 has been 
revised accordingly.
    Also in regard to Section 8.6, one commenter requested additional 
information on donor hydration during an oral fluid specimen collection 
(i.e., asking if there is evidence that hydration improves the ability 
to provide a specimen and whether hydration dilutes the specimen). One 
commenter indicated that the volume of oral fluid collected does not 
appear to be directly related to fluid intake and suggested that, 
because some donors may not be able to provide a sufficient specimen 
even after the one hour wait time, a urine specimen should be collected 
immediately. One commenter disagreed with the one hour period allowed 
for an oral fluid collection, and indicated that there is no evidence 
provided that dry mouth is eliminated by waiting one hour. The 
commenter indicated that this extra time allotted costs the employer 
unnecessary time and money, and maintained that a waiting period of 10 
minutes after consumption of 8 oz. of water is sufficient. The 
Department has evaluated the comments and concluded that no change is 
needed to Section 8.6. The proposed procedure sets a reasonable time 
limit within which most donors would be able to provide an acceptable 
specimen volume (i.e., 10 minutes between attempts to provide the oral 
fluid specimen, up to one hour), and the section clearly states that 
the donor is not required to drink any fluids during the wait time. The 
Guidelines clearly describe the limited circumstances in which the 
collector offers the donor fluids. However, the Department has revised 
Section 8.8(a)(2) to expressly prohibit rinsing or drinking between the 
collection of the primary and split specimens when serially collected.

8.7 If the donor is unable to provide an oral fluid specimen, may 
another specimen type be collected for testing?

    One commenter disagreed with the Guidelines as written and 
suggested that when a donor cannot provide the primary specimen type, 
an alternate specimen should be collected immediately. The commenter 
cited the additional time and cost as well as the fact that the 
collector may not know the agency's policy on alternate specimen types. 
The Department has concluded that no change is needed for Section 8.7 
in response to this comment. The Guidelines will continue to require 
that the donor be allowed reasonable attempts to provide an oral fluid 
specimen as described in Sections 8.5 and 8.6. The Department has 
revised Section 8.6 to allow a federal agency to either require 
notification in each case or provide a standard protocol for collectors 
to follow when the donor is unable to provide an oral fluid specimen. 
The Department has reworded this section to state ``Yes, if. . .'' 
rather than ``No, unless. . .'' in response to a federal agency's 
comment and to enhance clarity. The meaning of this section remains the 
same.

8.8 How does the collector prepare the oral fluid specimens?

    One commenter requested clarification of the ``simultaneous'' oral 
fluid collections. The Department has evaluated the comment and has 
concluded that no change is needed. Section 8.8(a)(1) describes ``Two 
specimens collected simultaneously with two separate collection 
devices.''
    One commenter expressed concern that the requirement for a serial 
collection of a split specimen to begin within two minutes of the first 
collection may be difficult to monitor and may lead to differences 
between the two specimens. This commenter requested clarification on 
how this process will be monitored. One commenter agreed with the two-
minute maximum time between serial collections of a split specimen. The 
Department has evaluated the comments and agrees with the second 
commenter that no change is needed. The proposed procedure in Section 
8.8 sets a reasonable time within which the collector can take the 
first collection device from the donor and record the time on the 
Federal CCF, while the donor positions the second device for the 
collection. Because the collector works with one donor at a time, the 
collector should have no difficulty monitoring the time between primary 
and split collections. Furthermore, the Department believes this timing 
would not affect results of the primary and split oral fluid specimens.
    One commenter disagreed with the proposed two-minute maximum time 
between serial collections of a split specimen and suggested that the 
time be increased to 10 minutes (so as not to rush the collector in 
completing chain of custody forms). This commenter suggested that a 
second specimen should only be collected after an initial test result 
is obtained (which the commenter indicates can usually be done in 10 
minutes). The Department has evaluated the comments and has concluded 
that no change is needed. The collector is not required to complete the 
Federal CCF until both the primary and split specimens have been 
collected. Point of collection testing is not allowed under these 
Guidelines. That is, all testing must be performed at an HHS-certified 
test facility.
    One commenter asked whether hydration would be allowed between 
serial split collections. The Department revised Section 8.8(a)(2) to 
expressly prohibit rinsing or drinking between the collection of the 
primary and split specimens when serially collected. Prohibiting 
rinsing or drinking will better ensure consistency of the primary and 
split specimens.
    The Department added an additional item under Section 8.8(a) to 
clarify that the OFMG allow collection of a single specimen and 
subdividing the collected specimen into primary (A) and split (B) 
specimens. A similar change was made to the definition of ``split 
specimen collection (for oral fluid)'' in Section 1.5.
    The Department also removed the word ``known'' in Section 8.8(b) in 
reference to oral fluid collection volume, as described under Sections 
2.4 and 2.5 above.
    In response to a federal agency comment, the Department deleted a 
sentence in item 8.8(h) that required the collector to send a copy of 
the Federal CCF to the HHS-certified laboratory. The Department agreed 
with the federal

[[Page 57567]]

agency that this instruction is redundant because item 8.8(g) instructs 
the collector to distribute copies of the Federal CCF as required.

Subpart I--HHS-Certification of Laboratories

9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?

    One commenter noted that, because proposed initial test 
requirements allow calibration with a low-reacting analyte, PT schemes 
would likely need to be designed based on the specific implementation 
at each laboratory. The commenter provided an example: When an 
immunoassay is calibrated with a drug/metabolite that exhibits 50% 
cross-reactivity, the intended target analyte (``calibrant'') at the 
cutoff concentration would elicit a response well in excess of the 
cutoff. This could result in inaccurate initial test results (i.e., a 
positive initial test result for a specimen containing the calibrant at 
a concentration below the cutoff). The commenter stated that this 
result could be scored as a ``false positive'' PT result. The 
Department has evaluated the comment and has concluded that no change 
is needed. As noted above regarding Section 3.4, it was not the 
Department's intent for the laboratory to calibrate an immunoassay test 
using an analyte other than that specified by the manufacturer. NLCP PT 
schemes are designed based on known cross-reactivity profiles of the 
initial tests used by HHS-certified laboratories.
    Also in regard to proposed Section 9.5, one commenter suggested 
that the Guidelines use the same wording as in the Guidelines effective 
October 1, 2010 (73 FR 71858) for retest PT sample specifications 
(i.e., ``. . . may be as low as . . .'' rather than the proposed 
wording ``. . . may be less than . . .''). The Department agrees and 
has reinstituted wording from Section 9.3 of the Guidelines effective 
October 1, 2010 (73 FR 71858) into Section 9.5(a)(1)(ii).
    As described under Requirements for specimen validity testing in 
this preamble, the Department has revised the Guidelines to allow, but 
not require, specimen validity testing. Section 9.5 has been revised 
accordingly.

9.6 What are the PT requirements for an applicant laboratory?

9.7 What are the PT requirements for an HHS-certified oral fluid 
laboratory?

    Comments on these two sections (Sections 9.6 and 9.7) are addressed 
here. As described under Requirements for specimen validity testing in 
this preamble, the Department has revised the Guidelines to allow, but 
not require, specimen validity testing. Sections 9.6 and 9.7 have been 
revised accordingly.

Subpart J--Blind Samples Submitted by an Agency

10.1 What are the requirements for federal agencies to submit blind 
samples to HHS-certified laboratories?

    Two commenters disagreed with the proposed limit to the number of 
blind samples required (i.e., a maximum of 400 blind samples per year) 
in Section 10.1(b). The commenters indicated that for a large agency, 
there is a very large difference between 3% and 400 samples and 
suggested keeping only the 3% requirement. Another commenter disagreed 
with the 3% requirement for blind samples and requested that the amount 
to be lowered to 1% to lessen the burden on employers. The Department 
has evaluated the comments and has concluded that no change is needed. 
The 400 sample limit was added to reduce the burden on large agencies 
based on the Department's review of agencies' blind testing programs.
    One commenter suggested that the wording be modified to clarify 
that employers are responsible for ensuring blind samples are sent to 
the laboratories, but that collectors are tasked with submitting the 
blind samples. The Department has evaluated the comment and has 
concluded that no change is needed. The wording in Section 10.1(a) 
clearly describes the responsibilities of the federal agency and the 
role of the collector in blind sample submission; however, the 
Department reworded Section 10.3(a) for clarity as described below.

10.3 How is a blind sample submitted to an HHS-certified laboratory?

    The Department has reworded Section 10.3(a) to clarify that the 
collector sends a blind sample to a laboratory as a split specimen 
(i.e., specimens A and B).

Subpart K--Laboratory

11.9 What are the requirements for an initial drug test?

    One commenter noted that HHS previously required initial and 
confirmatory testing using different techniques, and asked whether this 
requirement had been removed with allowance of technologies other than 
immunoassay for initial testing. The commenter expressed concern that 
an error in the initial drug test could be repeated in the confirmatory 
drug test using the same method. The Department has evaluated the 
comment and has concluded that no change is needed. The Guidelines 
maintain the requirement for initial and confirmatory tests on two 
separate aliquots to report a result other than negative. The NLCP will 
review validation and quality control records, as well as specimen 
records, to ensure that the initial and confirmatory testing methods 
meet Guidelines requirements and provide scientifically and 
forensically supportable results.

11.10 What must an HHS-certified laboratory do to validate an initial 
drug test?

    One commenter noted that Section 11.10 provides general information 
on validation requirements, and asked where detailed requirements can 
be found. The Department has evaluated the comment and has concluded 
that no change is needed. The Department will continue to provide 
details for applicant and certified test facilities through the NLCP.
    One commenter asked whether the requirement in 11.10(c) for 
periodic verification of ``each initial drug test using an alternate 
technology'' applied to immunoassay tests used differently than 
originally cleared by the FDA or other laboratory developed tests. The 
Department has evaluated the comment and has concluded that no change 
is needed. This section clearly distinguishes initial tests using 
immunoassay from those using an alternate technology. Furthermore, 
Section 1.5 includes the definition for ``alternate technology initial 
drug test.''

11.11 What are the batch quality control requirements when conducting 
an initial drug test?

    Seven commenters disagreed with the requirement for an initial test 
control targeted at 25% above the cutoff. The commenters noted that 
drug concentrations are much lower in oral fluid than in urine, and 
stated that assays are unlikely to perform robustly with current 
immunoassay technology. One commenter also noted that oral fluid is 
diluted three- to four-fold. One commenter suggested requiring a 
control targeted at 50% above the cutoff, consistent with current FDA-
cleared assays. The Department has evaluated the comments and has 
concluded that no change is needed. Consistent with the urine program 
requirements, laboratories must have the ability to apply the program 
cutoffs to regulated specimens, and document that ability by analyzing 
a control targeted at 25% above the cutoff in each batch.
    One commenter asked whether the inclusion of ``additional compounds 
as target analytes'' for amphetamine and

[[Page 57568]]

opioid assays affect quality control content requirements. The 
Department has evaluated the comment and has concluded that no change 
is needed. The initial drug test quality control requirements in the 
Guidelines apply to each analyte used to calibrate the test (i.e., 
immunoassay or alternate technology initial drug test). When a single 
immunoassay test is used for two or more analytes in a drug class, the 
HHS-certified laboratory must include a control in accordance with item 
11.11(a)(2) for each analyte that has less than 100% cross-reactivity 
with the assay, to demonstrate that the requirement for at least 80% 
cross-reactivity has been met.

11.14 What are the batch quality control requirements when conducting a 
confirmatory drug test?

    One commenter stated that analyzing quality control samples with 
concentrations of a drug or metabolite targeted at less than 40% of the 
proposed cutoffs would be an analytical challenge for high volume 
laboratories utilizing GC/MS or LC/MS/MS. The Department has evaluated 
the comments and has concluded that no change is needed. The NLCP Pilot 
PT Program has documented the capability of laboratories to meet the 
proposed OFMG requirements.
    Also in regard to the proposed quality control requirements for an 
initial drug test in Section 11.11 and for a confirmatory drug test in 
Section 11.14, one commenter requested clarification for the 
requirement for a drug-free control (i.e., whether the control should 
contain no drug or whether the control should not contain the specific 
analyte for that test). The Department has evaluated the comment and 
has concluded that no change is needed. These Guidelines sections list 
the requirement for ``at least one control certified to contain no drug 
or drug metabolite,'' meaning that the control must contain no 
regulated drug analytes.

11.15 What are the analytical and quality control requirements for 
conducting specimen validity tests?

    The Department has reworded Section 11.15(a) for clarity, to 
correctly reflect requirements.

11.17 What are the requirements for an HHS-certified laboratory to 
report a test result?

    One commenter suggested that the Department remove the requirement 
for an executed CCF as the official report for ``non-negative'' 
specimens and permit the use of an electronic report with the required 
information. The Department has evaluated the comment and has concluded 
that no change is needed. The Federal CCF establishes the chain of 
custody for the specimen from the time of collection until receipt by 
the laboratory and also contains the certification statement signed by 
the certifying scientist. The Federal CCF may be paper or electronic.
    As described under Requirements for specimen validity testing in 
this preamble, the Department has revised the Guidelines to allow, but 
not require, specimen validity testing. Section 11.17 has been revised 
accordingly.

11.21 What HHS-certified laboratory information is available to a 
federal agency?

    As described under Requirements for specimen validity testing in 
this preamble, the Department has revised the Guidelines to allow, but 
not require, specimen validity testing. The list of items provided in a 
standard documentation package for an oral fluid specimen has been 
revised accordingly [i.e., Section 11.21(b)(4)].

11.22 What HHS-certified laboratory information is available to a 
federal employee?

    One commenter asked why the proposed Guidelines include a 
requirement for a copy of the semiannual statistical summary report to 
be sent to the Secretary or designated HHS representative. The 
Department included the requirement to facilitate compilation of 
statistical information for the federal drug-free workplace program. 
This will not place an additional burden on the laboratory other than 
transmission of the report. The Department will continue to evaluate 
the effectiveness of this requirement.

Subpart L--Instrumented Initial Test Facility (IITF)

12.1 May an IITF test oral fluid specimens for a federal agency's 
workplace drug testing program?

    One commenter disagreed with prohibiting IITFs for oral fluid. This 
commenter considers the current HHS-certified urine IITF to be a 
success in Canada and stated that prohibiting oral fluid IITFs would 
result in less enthusiasm for regulated procedures and impact workplace 
safety. At this time, as stated in the preamble to the proposed OFMG, 
IITFs are not practical and will not be allowed due primarily to the 
limited specimen volume of oral fluid collected from the donor. The 
Department will continue to monitor developments in oral fluid drug 
testing after this new specimen type has been implemented in federal 
workplace programs, and may reassess the feasibility of allowing IITFs 
for oral fluid in the future.

Subpart M--Medical Review Officer (MRO)

13.1 Who may serve as an MRO?

    Three commenters disagreed with the term ``nonmedical use of a 
drug'' used in Section 13.1 (and defined in Section 1.5) and indicated 
that the term changes the role of an MRO from review, verify and 
``report a non-negative result'' to review, verify and ``interpret 
before reporting a result as negative or nonmedical use of a drug.'' 
Two commenters disagreed with use of ``interpretation of results'' to 
supplant ``alternative medical explanation.'' One commenter noted that 
this perceived change in the MRO's role represents an unjustified 
shifting of risk to the MRO. One commenter believes the term presents a 
possible legal flaw to Guidelines, stating that this term is legally 
different from ``safety concern'' and places MROs in the position of 
being in conflict with the prescribing physician and subject to 
lawsuits. This commenter stated that even a lack of a finding of 
nonmedical use could be an issue if the donor subsequently had an 
accident after using the drug. The same commenter submitted five 
recommendations related to inclusion of prescription drugs in federal 
workplace drug testing programs, to address the commenter's concerns 
with the proposed Guidelines. These five specific recommendations 
pertain to matters that are outside the scope of these Guidelines, and 
therefore are not addressed in the Department's response below.
    The responsibilities of an MRO to interpret results have largely 
remained the same between the Guidelines effective October 1, 2010 (73 
FR 71858) and these Guidelines. As stated in Section 13.5(c) of these 
Guidelines, ``if the donor provides a legitimate medical explanation 
(e.g., a valid prescription) for the positive result, the MRO reports 
the test result as negative to the agency.'' Accordingly, the intent of 
the Guidelines, in this context, is to confirm whether a positive drug 
test is the result of drug use under a valid prescription. Furthermore, 
the term ``alternate medical explanation'' has never been used in the 
Guidelines, but has been used in the HHS Medical Review Officer Manual 
for Federal Workplace Drug Testing Programs.

[[Page 57569]]

    For the reasons above, the Department believes that the definition 
of ``nonmedical use of a drug'' and the requirement for a physician 
serving as an MRO to have knowledge of this topic do not fundamentally 
change the MRO's responsibilities. However, to address the commenters' 
concerns, the Department has removed this term from the Guidelines 
(i.e., revised Sections 1.5 and 13.1).
    One commenter requested clarification that it is the federal 
agency's burden to ensure that the MRO is certified. One commenter 
asked how the laboratory will be informed that an MRO has met 
requirements for re-qualification. The Department evaluated the 
comments and concluded that no change is needed. The MRO is an employee 
or a contractor of the agency. Therefore, it is the agency's 
responsibility to ensure that the MRO meets the Guidelines 
qualification requirements.
    Two commenters disagreed with the requirement for MRO 
recertification every five years, and recommended that MROs complete 
training every three years. Five commenters stated support for five 
year requalification and examination requirements. The Department has 
evaluated the comments and has concluded that no change is needed. The 
Department will keep the five-year requalification requirement as 
proposed. This is consistent with the MRO requalification requirement 
in the UrMG.

13.2 How are nationally recognized entities or subspecialty boards that 
certify MROs approved?

    One commenter agreed with MRO certification/training entities 
submitting the delivery method and content of the MRO examination as 
applicable along with other required documents. One commenter agreed 
with extending time from one to two years for approved MRO 
certification/training entities' resubmission of qualifications for HHS 
approval. The commenter noted that they would support further extension 
to 3 years.
    One commenter recommended that approval of MRO educational courses 
and content be at the discretion of the MRO certification entities, not 
HHS. Since the certification entities and their examinations are 
subject to HHS oversight and approval, the commenter noted that it may 
be burdensome for HHS to review and approve the courses and content, 
and be a disincentive to development of new courses. One commenter 
recommended that examinations be allowed to be in-person or online with 
appropriate security precautions for each delivery method. The 
Department has evaluated the comments and agrees that the submission of 
training materials to HHS would possibly discourage the development of 
new training courses. Therefore, the review of MRO educational courses 
and content will not be part of the approval process for MRO 
certification entities. As described under Medical Review Officer (MRO) 
requalification--continuing education units (CEUs) in this preamble, 
the Department has removed references to MRO training entities in 
Section 13.2, because training documentation is maintained by MRO 
certification entities. The Department will only require the MRO 
certification entities to submit their examination and any other 
necessary supporting examination materials (e.g., answers, examination 
statistics or background information on questions) that will help in 
the Department's evaluation of the examination. The Department has 
revised Section 13.2 accordingly.
    The Department will review and evaluate the examination delivery 
method (e.g., in-person or online) when reviewing submitted materials 
to ensure that the delivery method employs appropriate security and 
identification procedures.

13.3 What training is required before a physician may serve as an MRO?

    Five commenters disagreed and one commenter agreed with the added 
requirement for MRO training to include information about how to 
discuss substance misuse and abuse and how to access those services. 
The Department has evaluated the comments and has revised Section 13.3 
to remove this requirement. Federal agencies may provide this 
information to employees and applicants to facilitate their access to 
effective treatment and support recovery. The Department provides 
information to the public on help and treatment for substance misuse 
and abuse, and how to access those services, on the SAMHSA website 
http://www.samhsa.gov/.
    One commenter stated that the Department should add a requirement 
for MRO training on what constitutes a refusal to test. One commenter 
suggested that the Department should add a requirement for MRO training 
on when and how to report safety concerns to employers when 
prescription and/or over-the-counter medications may affect 
performance. The Department has evaluated the comments and has 
concluded that no change is needed. Criteria for reporting a refusal to 
test are covered under the topics listed in Section 13.3 such as items 
(a)(4) training on the Guidelines and (a)(5) procedures for 
interpretation, review, and reporting of results. When a donor provides 
a legitimate medical explanation for a positive drug test (e.g., a 
valid prescription), the Guidelines do not require MROs to contact 
federal agency employers for the purpose of reporting a safety concern. 
Accordingly, MRO training related to reporting ``safety concerns'' does 
not relate to a mandatory function under the Guidelines and, therefore, 
is not an essential component of required MRO training. The Department 
will provide additional guidance in the HHS Medical Review Officer 
Guidance Manual for Federal Workplace Drug Testing Programs.
    In addition, the Department revised Section 13.3 as described under 
Medical Review Officer (MRO) requalification--continuing education 
units (CEUs) in this preamble. The Department removed references to MRO 
training entities because training documentation is maintained by MRO 
certification entities, and added item 13.3(b) to require MRO training 
on revised Guidelines prior to their effective date.

13.4 What are the responsibilities of an MRO?

    One commenter suggested creating a subset of medical professionals 
trained specifically to determine fitness for duty since an MRO cannot 
determine fitness for duty over the telephone. The Department has 
evaluated the comment and has concluded that no change is needed. 
Fitness for duty evaluations fall outside the purview of the 
Guidelines.

13.5 What must an MRO do when reviewing an oral fluid specimen's test 
results?

    The Department has revised Section 13.5(c)(1) to include ``a valid 
prescription'' as an example of documentation to support a medical 
explanation for a positive drug test result.
    As described under Testing for Marijuana Use in this preamble, the 
Department has revised Section 13.5(c)(1) to reflect the Department's 
policy that passive exposure to a drug (e.g., exposure to secondhand 
marijuana smoke) and ingestion of food products containing marijuana 
are not legitimate medical explanations for a positive drug test 
result.
    In Section 13.5(c)(2)(i), the Department clarified that the 
requirement for ``clinical evidence of illegal use'' does not apply if 
the laboratory confirms the presence of 6-

[[Page 57570]]

acetylmorphine (i.e., the presence of this metabolite is proof of 
heroin use).

13.6 What action does the MRO take when the collector reports that the 
donor did not provide a sufficient amount of oral fluid for a drug 
test?

    One commenter requested definition of ``appropriate expertise'' in 
medical issues raised by a donor's failure to provide a specimen. The 
same commenter requested medical referral information on the employer's 
actions when a donor could not provide a urine specimen and then could 
not provide an oral fluid specimen. The Department has evaluated the 
comments and has concluded that no change is needed. A physician who is 
a trained MRO will have the knowledge necessary to identify another 
physician with appropriate expertise for the medical evaluation. The 
Department will provide additional guidance in the HHS Medical Review 
Officer Guidance Manual for Federal Workplace Drug Testing Programs as 
appropriate when oral fluid is allowed in federal workplace drug 
testing programs.
    The Department clarified the definition of ``permanent or long-term 
medical conditions'' in Section 13.6(b)(1) based on a federal agency 
comment.

Subpart O--Criteria for Rejecting a Specimen for Testing

15.1 What discrepancies require an HHS-certified laboratory to report a 
specimen as rejected for testing?

    The Department revised wording in items a and b of this section, 
and included three additional fatal flaws as items f-h, to reflect 
fatal flaws for regulated donor specimens that have been identified by 
HHS-certified laboratories. These fatal flaws were addressed in NLCP 
guidance sent to all HHS-certified and applicant laboratories and IITFs 
on August 9, 2016. In addition, the Department revised this section to 
include an additional item i to allow a laboratory to reject a specimen 
when they identify a flaw that prevents testing or affects the forensic 
defensibility of the drug test, and cannot be corrected. This general 
item enables laboratories to reject specimens with fatal flaws that may 
be rare, but do occur. It is not possible to list all such flaws in the 
Guidelines.

15.3 What discrepancies are not sufficient to require an HHS-certified 
laboratory to reject an oral fluid specimen for testing or an MRO to 
cancel a test?

    Two commenters indicated that inclusion of some items as 
insignificant discrepancies contradicts guidance provided to HHS-
certified laboratories and IITFs in NLCP Notices, which required 
laboratories to attempt to recover missing information. One of these 
commenters suggested that if these items are important, they should be 
removed from the ``insignificant'' list. Two commenters disagreed with 
the Guidelines designating the listed omissions and discrepancies as 
``insignificant only when they occur no more than once per month.'' The 
Department has evaluated the comments. The listed discrepancies would 
not result in rejection or cancellation. NLCP Notices requiring 
laboratory action are consistent with this section. However, the 
Department has reworded section 15.3 to not classify these errors as 
insignificant. While these types of errors do not warrant laboratory 
rejection of a specimen or MRO cancellation of a test, as noted in 
section 15.3(c), corrective action must be initiated when they occur 
more than once a month.
    The commenters indicated that this section implies that the MRO 
must keep a log of insignificant errors by laboratory and by collection 
site in order to track frequency. The commenters noted that this is an 
unenforceable policy, that this should be a duty of inspectors of 
laboratories and collection sites, and that requiring MROs to keep 
these types of logs would create significant extra costs. One commenter 
suggested that item 15.3(c) be modified for the MRO to advise the 
collector or laboratory to retrain staff on relevant procedures to 
ensure that collections are completed correctly (rather than directing 
them to immediately take corrective action). The Department has 
evaluated the comments and has concluded that no change is needed. This 
section is the same as in the Guidelines effective October 1, 2010 (73 
FR 71858).
    One commenter suggested modifying 15.3(a)(5) to read ``donor 
identification number'' which would include a social security number or 
an employee identification number since many employers no longer use 
social security numbers for employee identification. The Department 
agrees and has revised Section 15.3(a)(5) to include ``employee 
identification number'' in addition to ``Social Security Number.''

15.4 What discrepancies may require an MRO to cancel a test?

    One commenter suggested adding the scenario where the donor did not 
sign the CCF because the collector forgot to ask the donor to sign, 
rather than the donor's refusal to sign. The Department has evaluated 
the comment and has concluded that no change is needed. As stated in 
Section 15.4, the MRO contacts the collector ``to obtain a statement to 
verify that the donor refused to sign the MRO copy.''

Regulatory Impact and Notices

Executive Order 12866

    The Secretary has examined the impact of the Guidelines under 
Executive Order 12866, which directs federal agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). In addition, the Department published a Federal Register 
notice in June 2011 to solicit comments regarding the science and 
practice of oral fluid testing via a Request for Information (RFI) [76 
FR 34086].
    According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. The 
Guidelines do establish additional regulatory requirements and allow an 
activity that was otherwise prohibited. The Administrative Procedure 
Act (APA) delineates an exception to its rulemaking procedures for ``a 
matter relating to agency management or personnel'' 5 U.S.C. 553(a)(2). 
Because the Guidelines issued by the Secretary govern federal workplace 
drug testing programs, HHS has taken the position that the Guidelines 
are a ``matter relating to agency management or personnel'' and, thus, 
are not subject to the APA's requirements for notice and comment 
rulemaking. This position is consistent with Executive Order 12564 
regarding Drug-Free Workplaces, which directs the Secretary to 
promulgate scientific and technical guidelines for executive agency 
drug testing programs.
    The Department included a Regulatory Impact and Notices section 
with cost and benefits analysis and burden estimates in the May 15, 
2015

[[Page 57571]]

Federal Register Notice for the proposed OFMG (80 FR 28054), and 
requested public comment on all estimates and assumptions.
    One commenter disagreed with the Department's projected numbers of 
oral fluid and urine drug tests by federal agencies and industries 
regulated by the Department of Transportation (DOT) and the Nuclear 
Regulatory Commission (NRC). This commenter predicted that there will 
be a large shift from urine to oral fluid testing when oral fluid is 
allowed in regulated testing, stating that the oral fluid collection is 
a more efficient and direct process for the collector, oral fluid is 
much less likely to be adulterated than urine, oral collections are 
quicker than most urine collections, and oral fluid is looked upon 
favorably from a hygienic perspective by donors and collectors. The 
commenter did not provide any substantive evidence or data to support 
these comments. One commenter disagreed with inclusion of cost 
estimates within the Guidelines due to the difficulty in comparing 
urine and oral fluid costs. The Department has evaluated the comments 
and has concluded that no change is needed. The Department's 
projections were developed using information from current HHS-certified 
urine testing laboratories, with input from DOT and NRC, and cost 
analysis was based on information provided by multiple oral fluid 
testing laboratories and MROs. Each federal agency will decide whether 
to collect urine, oral fluid, or both specimen types in their workplace 
testing programs, and DOT and NRC will decide whether to allow oral 
fluid testing in workplace drug testing regulations for their regulated 
industries. Costs are expected to vary among individual laboratories 
and MROs, depending on their processes and testing populations. 
Additional information on the estimated costs associated is below.
Need for Regulation
Enhances Flexibility
    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Oral Fluid (OFMG) revise the requirement to collect only 
a urine specimen, which has existed since the Guidelines were first 
published in 1988, while continuing to promulgate established standards 
to ensure the full reliability and accuracy of drug test results. Urine 
testing is subject to issues related to a donor's inability to produce 
a urine specimen due to a legitimate medical condition. In such 
situations, the test may produce an invalid result or create delays 
accruing from the need to reschedule the test or medically assess the 
donor's inability to provide a urine sample. When the OFMG are 
implemented by an agency, such agency will be authorized to collect an 
oral fluid specimen from an individual who is unable to provide a urine 
specimen. This added flexibility will reduce both the need to 
reschedule collections and the need for the Medical Review Officer 
(MRO) to arrange a medical evaluation of a donor's inability to provide 
a specimen. Therefore, the OFMG provide flexibility to address 
workplace drug testing needs of federal agencies by permitting the 
selection of the specimen type best suited for their needs and 
authorizing collection of an alternative specimen type when a donor is 
unable to provide a specimen. The added flexibility will also benefit 
donors, who should be able to provide one of the specimen types, 
thereby facilitating the drug test required for their employment.
Enhances Versatility
    Urine collection requires use of a specialized collection facility, 
secured restrooms, the same gender, and other special requirements. 
Oral fluid may be collected in various settings. An acceptable oral 
fluid collection site must allow the collector to observe the donor, 
maintain control of the collection device(s) during the process, 
maintain record storage, and protect donor privacy.
Decreases Invalid Tests
    All unobserved specimen collections are at risk for substitution 
and adulteration. Studies conducted by the drug testing industry 
indicate that 0.05 to 3% of urine specimens collected for drug use 
detection are determined to be substituted or 
adulterated.5 27 28 Oral fluid collections will occur under 
observation, which should substantially lessen the risks of specimen 
substitution and adulteration that has been associated with urine 
specimen collections, most of which are unobserved. Specimen validity 
testing of oral fluid specimens will be allowed to identify invalid 
specimens (e.g., testing for a biomarker such as albumin or 
immunoglobulin G, IgG).
Saves Time
    Oral fluid collection can require less time than urine collection, 
reducing employee time away from the workplace and, therefore, reducing 
costs to the federal agency employer. Oral fluid collection does not 
require a facility that provides visual privacy during the collection. 
Unlike urine specimen collections, it is expected that many oral fluid 
collections will occur at or near the workplace, and not at a dedicated 
collection site, thereby reducing the amount of time away from the 
workplace. The collector is allowed to be in the vicinity of the donor, 
reducing the loss of productive time. The option to collect a urine 
specimen in the event that the donor cannot provide an oral fluid 
specimen (and vice versa) will reduce both the need to reschedule a 
collection and the need for the MRO to arrange a medical evaluation of 
a donor's inability to provide a specimen. Administrative data for 
urine collections indicates it takes, on average, about 4 hours from 
the start of the notification of the drug test to the actual time a 
donor reports back to the worksite. Since oral fluid collection does 
not have the same privacy concerns as urine collection, onsite 
collections are likely, thereby reducing the time a donor is away from 
the worksite. The Department estimates the time savings to be more than 
2 hours. This estimate takes into account the time savings if the oral 
fluid collection was conducted at the employee's workplace, and thus 
incorporates travel time savings. Using OPM's estimate for the average 
annual salary of Federal employees converted to an hourly wage, the 
savings generated for the Federal Government would be roughly $400,000 
to $1.2 million a year, or $38 to $114 per test.
Versatility in Detection
    The time course of drugs and metabolites differs between oral fluid 
and urine, resulting in some differences in analytes and detection 
times. Oral fluid tests generally are positive as soon as the drug is 
absorbed into the body. In contrast, urine tests that are based solely 
on detection of a metabolite are dependent upon the rate and extent of 
metabolite formation. Thus, oral fluid may permit more interpretative 
insight into recent drug use drug-induced effects that may be present 
shortly before or at the time the specimen is collected. A federal 
agency may select the specimen type for collection based on the 
circumstances of the test. For example, in situations where drug use at 
the work-site is suspected, the testing of oral fluid may show the 
presence of an active drug, which may indicate recent administration of 
the drug and be advantageous when assessing whether the drug 
contributed to an observed behavior.
Current Testing in the Drug Free Workplace Program
    Urine was the original specimen of choice for forensic workplace 
drug

[[Page 57572]]

testing, and urine testing is expected to remain an established and 
reliable component of federal workplace drug testing programs. Urine 
testing provides scientifically accurate and legally defensible results 
and has proven to be an effective deterrent to drug use in the 
workplace.
    A major challenge to urine drug testing has been the proliferation 
of commercial products used to adulterate or substitute a donor's urine 
specimen. Due to individual privacy rights, most urine collections are 
unobserved, allowing the opportunity to use such products. As the 
Department has established requirements and laboratories have developed 
procedures to control for adulterated and substituted specimens, 
manufacturers have developed new products to avoid detection. The use 
of these products is expected to continue.
Cost and Benefit
    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS-certified laboratories, the Department estimates the 
number of specimens tested annually for federal agencies to be 150,000. 
The Department projects that approximately 7% (or 10,500) of the 
150,000 specimens tested per year will be oral fluid specimens and 93% 
(or 139,500) will be urine specimens. The subsequent transition to oral 
fluid testing is expected to be gradual and steady over the course of 
four years, when it should plateau to account for 25 to 30% of federal 
agency drug testing (i.e., 37,500 to 45,000 specimens). This transition 
estimate is based on the non-regulated sector's time course of the 
testing of oral fluid and urine in the four years preceding the final 
OFMG.
    The approximate annual numbers of regulated specimens collected 
from applicants and employees under the Department of Transportation 
(DOT) and Nuclear Regulatory Commission (NRC) drug testing regulations 
are 6 million and 155,000, respectively. Should DOT and NRC allow oral 
fluid testing in regulated industries' workplace programs, the 
estimated annual numbers of specimens for DOT would be 180,000 oral 
fluid and 5,820,000 urine, and numbers of specimens for NRC would be 
10,850 oral fluid and 144,150 urine. Assuming the same four-year 
transition time for DOT- and NRC-regulated industries, the numbers of 
oral fluid specimens are expected to be 1,500,000 to 1,800,000 
specimens under DOT regulations and 38,750 to 46,500 specimens under 
NRC regulations.
    In Section 3.4, the Department included criteria for calibrating 
initial tests for grouped analytes such as opiates and amphetamines, 
and specified the cross-reactivity of the immunoassay to the other 
analytes(s) within the group. These Guidelines allow the use of methods 
other than immunoassay for initial testing. An immunoassay manufacturer 
may incur costs if they choose to alter their existing product and 
resubmit the immunoassay for FDA clearance.
    Costs associated with the addition of oral fluid testing and 
testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will 
be minimal based on information from some HHS-certified laboratories 
currently testing private sector oral fluid specimens. Prior to being 
allowed to test regulated oral fluid specimens, laboratories must be 
certified by the Department through the NLCP. Estimated laboratory 
costs to complete and submit the application are $3,000, and estimated 
costs for the Department to process the application are $7,200. These 
estimates are from SAMHSA and are based on the NLCP fee schedule and 
historical costs. The initial certification process includes the 
requirement to demonstrate that the applicant laboratory's performance 
meets Guidelines requirements by testing three (3) groups of PT 
samples. The Department will provide the three groups of PT samples 
through the NLCP at no cost. Based on costs charged for urine specimen 
testing, laboratory costs to conduct the PT testing would range from 
$900 to $1,800 for each applicant laboratory.
    Agencies choosing to use oral fluid in their drug testing programs 
may also incur some costs for training of federal employees such as 
drug program coordinators. Based on current training modules offered to 
drug program coordinators, and other associated costs including travel 
for 90% of drug program coordinators, the estimated total training cost 
for a one-day training session would be between $108,000 and $138,000 
(i.e., assuming 8 hours of time multiplied by a GS 12/13 wage including 
benefits and overhead adjustments). This training cost is included in 
the costs of the revised URMG. The Department will offer the choice of 
online or in-person training. This will eliminate travel costs for 
those federal agencies who choose to use online training.

                                            Summary of One-Time Costs
----------------------------------------------------------------------------------------------------------------
                                                                    Lower bound     Upper bound       Primary
----------------------------------------------------------------------------------------------------------------
Cost of Application *...........................................  ..............  ..............      $93,000.00
Application Processing *........................................  ..............  ..............      217,000.00
Performance Testing *...........................................      $27,900.00      $55,800.00  ..............
Training *......................................................      108,000.00      138,000.00  ..............
                                                                 -----------------------------------------------
    Total.......................................................      445,900.00      503,800.00  ..............
----------------------------------------------------------------------------------------------------------------
* Estimated using costs presented above multiplied by the number of Laboratories (31).

Costs and Benefits
    Thus, the Department estimates one-time, upfront costs of between 
$446,000 and $504,000. While the Department has only monetized a small 
portion of the benefits (time savings) to a small subset of the 
workplace drug testing programs that could be affected by the OFMG 
(i.e., federal employee testing programs and not drug testing programs 
conducted under NRC and DOT regulations), the Department is confident 
that the benefits would outweigh the costs. Even if NRC and DOT do not 
implement oral fluid testing for their regulated industries' drug 
testing programs, the benefits to Federal workplace testing programs, 
estimated at between $400,000 and $1.2 million, would recur on an 
annual basis.

Executive Order 13771: Reducing Regulation and Controlling Regulatory 
Costs

    This set of Guidelines is considered an E.O. 13771 deregulatory 
action. The net cost savings, annualized over a perpetual time horizon 
using a 7% discount rate and expressed in 2016 dollars, is estimated to 
be $87.34 million.

[[Page 57573]]

Regulatory Flexibility Analysis

    For the reasons outlined above, the Secretary has determined that 
the Guidelines will not have a significant impact upon a substantial 
number of small entities within the meaning of the Regulatory 
Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by the OFMG 
will not require additional expenditures. Therefore, a final regulatory 
flexibility analysis is not required for this notice.
    As mentioned in the section on Executive Order 12866, the Secretary 
anticipates that there will be an overall reduction in costs if drug 
testing is expanded under the OFMG. The costs to implement this change 
to regulation are negligible. The added flexibility will permit federal 
agencies to select the specimen type best suited for their needs and to 
authorize collection of an alternative specimen type when an employee 
is unable to provide the originally authorized specimen type. Insofar 
as there are costs associated with each drug test, this could lead to 
lower overall testing costs for federal agencies. The added flexibility 
will also benefit federal employees, who should be able to provide one 
of the specimen types, thereby facilitating the drug test required for 
their employment.
    The Secretary has determined that the Guidelines are not a major 
rule for the purpose of congressional review. For the purpose of 
congressional review, a major rule is one which is likely to cause an 
annual effect on the economy of $100 million; a major increase in costs 
or prices; significant effects on competition, employment, 
productivity, or innovation; or significant effects on the ability of 
U.S.-based enterprises to compete with foreign-based enterprises in 
domestic or export markets. This is not a major rule under the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.

Unfunded Mandates

    The Secretary has examined the impact of the Guidelines under the 
Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This 
notice does not trigger the requirement for a written statement under 
section 202(a) of the UMRA because the Guidelines do not impose a 
mandate that results in an expenditure of $100 million (adjusted 
annually for inflation) or more by either state, local, and tribal 
governments in the aggregate or by the private sector in any one year.

Environmental Impact

    The Secretary has considered the environmental effects of the OFMG. 
No information or comments have been received that would affect the 
agency's determination there would be a significant impact on the human 
environment and that neither an environmental assessment nor an 
environmental impact statement is required.

Executive Order 13132: Federalism

    The Secretary has analyzed the Guidelines in accordance with 
Executive Order 13132: Federalism. Executive Order 13132 requires 
federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
state law. As defined in the Order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.
    In this notice, the Secretary establishes standards for 
certification of laboratories engaged in oral fluid drug testing for 
federal agencies and the use of oral fluid testing in federal drug-free 
workplace programs. The Department of Health and Human Services, by 
authority of Section 503 of Public Law 100-71, 5 U.S.C. 7301, and 
Executive Order No. 12564, establishes the scientific and technical 
guidelines for federal workplace drug testing programs and establishes 
standards for certification of laboratories engaged in urine drug 
testing for federal agencies. Because the Mandatory Guidelines govern 
standards applicable to the management of federal agency personnel, 
there should be little, if any, direct effect on the states, on the 
relationship between the national government and the states, or on the 
distribution of power and responsibilities among the various levels of 
government. Accordingly, the Secretary has determined that the 
Guidelines do not contain policies that have federalism implications.

Privacy Act

    The Secretary has determined that the Guidelines do not contain 
information collection requirements constituting a system of records 
under the Privacy Act. The Federal Register notice announcing the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Oral Fluid is not a system of records as noted in the information 
collection/recordkeeping requirements below. As required, HHS 
originally published the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs (Guidelines) in the Federal Register on April 11, 
1988 [53 FR 11979]. SAMHSA subsequently revised the Guidelines on June 
9, 1994 [59 FR 29908], September 30, 1997 [62 FR 51118], November 13, 
1998 [63 FR 63483], April 13, 2004 [69 FR 19644], and November 25, 2008 
[73 FR 71858] with an effective date of May 1, 2010 (correct effective 
date published on December 10, 2008 [73 FR 75122]). The effective date 
of the Guidelines was further changed to October 1, 2010 on April 30, 
2010 [75 FR 22809]. The revised Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using Urine (UrMG) were published on 
January 23, 2017 [82 FR 7920] with an effective date of October 1, 
2017.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 6, 2000) requires 
SAMHSA to develop an accountable process to ensure ``meaningful and 
timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' as defined in the Executive Order, include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
federal government and Indian tribes.'' The Guidelines do not have 
tribal implications. The Guidelines will not have substantial direct 
effects on tribal governments, on the relationship between the federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the federal government and Indian tribes, as 
specified in Executive Order 13175.

Information Collection/Record Keeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines (82 FR 7920), which establish 
the scientific and technical guidelines for federal workplace drug 
testing programs and establish standards for certification of 
laboratories engaged in urine drug testing for federal agencies under 
authority of 5 U.S.C. 7301 and Executive Order 12564, are approved by 
the Office of Management and Budget (OMB) under control number 0930-
0158. The Federal Drug Testing Custody and Control Form used to 
document the collection and chain of custody of urine

[[Page 57574]]

specimens at the collection site, for laboratories to report results, 
and for Medical Review Officers to make a determination, the National 
Laboratory Certification Program (NLCP) application, the NLCP 
Laboratory Information Checklist, and recordkeeping requirements in the 
current Guidelines, as approved under control number 0930-0158, will 
remain in effect for regulated urine drug testing under the UrMG. The 
same documents specifically for regulated oral fluid drug testing under 
the OFMG will be submitted for OMB approval under a new control number.
    The title, description, and respondent description of the 
information collections are shown in the following paragraphs with an 
estimate of the annual reporting, disclosure and recordkeeping burden. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information.
    Title: The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Oral Fluid Specimens
    Description: The Guidelines establish the scientific and technical 
guidelines for federal drug testing programs and establish standards 
for certification of laboratories engaged in drug testing for federal 
agencies under authority of Public Law 100-71, 5 U.S.C. 7301 note, and 
Executive Order No. 12564. Federal drug testing programs test 
applicants to sensitive positions, individuals involved in accidents, 
individuals for cause, and random testing of persons in sensitive 
positions. The program has depended on urine specimen testing since 
1988; the reporting, recordkeeping and disclosure requirements 
associated with urine specimen testing are approved under OMB control 
number 0930-0158. These Guidelines establish when oral fluid specimens 
may be collected, the procedures that must be used in collecting an 
oral fluid specimen, and the certification process for approving a 
laboratory to test oral fluid specimen.
    Description of Respondents: Individuals or households; businesses; 
or other-for-profit; not-for-profit institutions.
    The annual burden estimates in the tables below are based on the 
following number of respondents: 10,500 donors who apply for employment 
or are employed in testing designated positions, 100 collectors, 10 
oral fluid specimen testing laboratories, 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                        10               1               3              30
                                                  application for certification.
9.10(a)(3).....................................  Materials to submit to become an HHS                 10               1               2              20
                                                  inspector.
11.3(a)........................................  Laboratory submits qualifications of RP              10               1               2              20
                                                  to HHS.
11.4(c)........................................  Laboratory submits information to HHS                10               1               2              20
                                                  on new RP or alternate RP.
11.20..........................................  Specifications for laboratory semi-                  10               5             0.5              25
                                                  annual statistical report of test
                                                  results to each federal agency.
13.9 & 14.6....................................  Specifies that MRO must report all                  100              14          * 0.05              70
                                                  verified primary and split specimen
                                                  test results to the federal agency.
16.1(b) & 16.5(a)..............................  Specifies content of request for                      1               1               3               3
                                                  informal review of suspension/proposed
                                                  revocation of certification.
16.4...........................................  Specifies information appellant                       1               1             0.5             0.5
                                                  provides in first written submission
                                                  when laboratory suspension/revocation
                                                  is proposed.
16.6...........................................  Requires appellant to notify reviewing                1               1             0.5             0.5
                                                  official of resolution status at end
                                                  of abeyance period.
16.7(a)........................................  Specifies contents of appellant                       1               1              50              50
                                                  submission for review.
16.9(a)........................................  Specifies content of appellant request                1               1               3               3
                                                  for expedited review of suspension or
                                                  proposed revocation.
16.9(c)........................................  Specifies contents of review file and                 1               1              50              50
                                                  briefs.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             156  ..............  ..............             292
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (3 min).

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

[[Page 57575]]



                                                          Estimate of Annual Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              No. of        Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a) & 8.6(b)(2).............................  Collector must contact federal agency               100               1          * 0.05               5
                                                  point of contact.
11.21 & 11.22..................................  Information on drug test that                        50              10               3           1,500
                                                  laboratory must provide to federal
                                                  agency upon request or to donor
                                                  through MRO.
13.8 (b).......................................  MRO must inform donor of right to                   100              14               3           4,200
                                                  request split specimen test when a
                                                  positive or adulterated result is
                                                  reported.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             210  ..............  ..............           5,705
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (3 min).

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

                                                         Estimate of Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               No. of        Responses/
                 Section                              Purpose                respondents     respondent           Hours/ response           Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.5, & 8.8.........................  Collector completes Federal CCF             100             380  0.07 (4 min).................           2,534
                                           for specimen collected.
8.8(d) & (f)............................  Donor initials specimen labels/          10,500               1  0.08 (5 min).................             875
                                           seals and signs statement on
                                           the Federal CCF.
11.8(a) & 11.17.........................  Laboratory completes Federal                 10           3,800  0.05 (3 min).................           1,900
                                           CCF upon receipt of specimen
                                           and before reporting result.
13.4(d) (4), 13.9 (c), & 14.6(c)........  MRO completes Federal CCF                   100             380  0.05 (3 min).................           1,900
                                           before reporting the result.
14.1(b).................................  MRO documents donor's request               300               1  0.05 (3 min).................              15
                                           to have split specimen tested.
                                                                          ------------------------------------------------------------------------------
    Total...............................  ...............................          11,010  ..............  .............................           7,224
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Guidelines contain a number of recordkeeping requirements that 
SAMHSA considers not to be an additional recordkeeping burden. In 
subpart D, a trainer is required to document the training of an 
individual to be a collector [section 4.3(a)(3)] and the documentation 
must be maintained in the collector's training file [section 4.3(c)]. 
Because this is required by the current Guidelines using urine 
specimens as well as these Guidelines using oral fluid specimens and is 
consistent with general forensic requirements, SAMHSA believes this 
training documentation is common practice and is not considered an 
additional burden. In subpart F, if a collector uses an incorrect form 
to collect a federal agency specimen, the collector is required to 
provide a statement [section 6.2(b)] explaining why an incorrect form 
was used to document collecting the specimen. SAMHSA believes this is 
an extremely infrequent occurrence and does not create a significant 
additional recordkeeping burden. Subpart H [sections 8.4(d) and 
8.5(a)(1)] requires collectors to enter any information on the Federal 
CCF of any unusual findings during the oral fluid specimen collection 
procedure. These recordkeeping requirements are an integral part of the 
collection procedure and are essential to documenting the chain of 
custody for the specimens collected. The burden for these entries is 
included in the recordkeeping burden estimated to complete the Federal 
CCF and is, therefore, not considered an additional recordkeeping 
burden. Subparts K describe a number of recordkeeping requirements for 
laboratories associated with their testing procedures, maintaining 
chain of custody, and keeping records (i.e., sections 11.1(a) and (d); 
11.2(b), (c), and (d); 11.6(b); 11.7(c); 11.8; 11.10(1); 11.13(a); 
11.16; 11.17(a), (b), and (c); 11.20; 11.21, and 11.22. These 
recordkeeping requirements are necessary for any laboratory to conduct 
forensic drug testing and to ensure the scientific supportability of 
the test results. Therefore, they are considered to be standard 
business practice and are not considered a burden for this analysis.
    Thus, the total annual response burden associated with the testing 
of oral fluid specimens by the laboratories is estimated to be 13,221 
hours (that is, the sum of the total hours from the above tables). 
Because of the expected transition from urine to oral fluid testing, 
this number will replace some of the 1,788,809 hours currently approved 
by OMB under control number 0930-0158 for urine testing under the 
current Guidelines.
    As required by section 3507(d) of the PRA, the Secretary submitted 
a copy of the proposed Guidelines to OMB for its review. Comments on 
the information collection requirements were specifically solicited in 
order to: (1) Evaluate whether the proposed collection of information 
is necessary for the proper performance of HHS's functions, including 
whether the information will have practical utility; (2) evaluate the 
accuracy of HHS's estimate of the burden of the proposed

[[Page 57576]]

collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and (4) minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology.

References

1. Cone, E.J., 1990. Testing human hair for drugs of abuse. I. 
Individual dose and time profiles of morphine and codeine in plasma, 
saliva, urine, and beard compared to drug-induced effects on pupils 
and behavior. J Anal Toxicol, 14, 1-7.
2. Cone, E.J., Clarke, J., Tsanaclis, L., 2007. Prevalence and 
disposition of drugs of abuse and opioid treatment drugs in oral 
fluid. J Anal Toxicol, 31, 424-433.
3. Petrides, A.K., Melanson, SEF., Kantartjis, M., Le, R.D., 
Demetriou, C.A., Flood, J.G., 2018. Monitoring opioid and 
benzodiazepine use and abuse: Is oral fluid or urine the preferred 
specimen type? Clin Chim Acta, 481, 75-82.
4. Vindenes, V., Yttredal, B., [Oslash]iestad, E.L., Waal, H., 
Bernard, J.P., M[oslash]rland, J.G., Christophersen, A.S., 2011. 
Oral fluid is a viable alternative for monitoring drug abuse: 
Detection of drugs in oral fluid by liquid chromatography-tandem 
mass spectrometry and comparison to the results from urine samples 
from patients treated with Methadone or Buprenorphine. J Anal 
Toxicol, 35, 32-39.
5. Quest Diagnostics, 2018. Workforce drug positivity at highest 
rate in a decade, finds analysis of more than 10 million drug test 
results. https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf Accessed October 19, 
2018.
6. Dams, R., Choo, R.E., Lambert, W.E., Jones, H., Huestis, M.A., 
2007. Oral fluid as an alternative matrix to monitor opiate and 
cocaine use in substance-abuse treatment patients. Drug Alcohol 
Depend, 87, 258-267.
7. Cone, E.J., 2012. Oral fluid results compared to self reports of 
recent cocaine and heroin use by methadone maintenance patients. 
Forensic Sci Int, 215, 88-91.
8. Niedbala, R.S., Kardos, K.W., Fritch, D.F., Kardos, S., Fries, 
T., Waga, J., Robb, J., Cone, E.J., 2001. Detection of marijuana use 
by oral fluid and urine analysis following single-dose 
administration of smoked and oral marijuana. J Anal Toxicol, 25, 
289-303.
9. Niedbala, R.S., Kardos, K.W., Fritch, D.F., Kunsman, K.P., Blum, 
K.A., Newland, G.A., Waga, J., Kurtz, L., Bronsgeest, M., Cone, 
E.J., 2005. Passive cannabis smoke exposure and oral fluid testing. 
II. Two studies of extreme cannabis smoke exposure in a motor 
vehicle. J Anal Toxicol, 29, 607-615.
10. Moore, C., Coulter, C., Uges, D., Tuyay, J., van der Linde, S., 
van Leeuwen, A., Garnier, M., Orbita, J. Jr., 2011. Cannabinoids in 
oral fluid following passive exposure to marijuana smoke. Forensic 
Sci Int, 212, 227-230.
11. Niedbala, S., Kardos, K., Salamone, S., Fritch, D., Bronsgeest, 
M., Cone, E.J., 2004. Passive cannabis smoke exposure and oral fluid 
testing. J Anal Toxicol, 28, 546-552.
12. Herrmann, E.S., Cone, E.J., Mitchell, J.M., Bigelow, G.E., 
LoDico, C., Flegel, R., Vandrey, R., 2015. Non-smoker exposure to 
secondhand cannabis smoke. II. Effect of room ventilation on the 
physiological, subjective, and behavioral/cognitive effects. Drug 
Alcohol Depend, 151, 194-202.
13. Cone, E.J., Bigelow, G.E., Herrmann, E.S., Mitchell, J.M., 
LoDico, C., Flegel, R., Vandrey, R., 2015. Nonsmoker exposure to 
secondhand cannabis smoke. III. Oral fluid and blood drug 
concentrations and corresponding subjective effects. J Anal Toxicol, 
39, 497-509.
14. SUPPORT for Patients and Communities Act, H.R. 6, 115th Cong. 
(2018). https://www.congress.gov/bill/115th-congress/house-bill/6.
15. Swortwood, M.J., Newmeyer, M.N., Andersson, M., Abulseoud, O.A., 
Scheidweiler, K.B., Huestis, M.A., 2017. Cannabinoid disposition in 
oral fluid after controlled smoked, vaporized, and oral cannabis 
administration. Drug Test Anal, 9, 905-915.
16. Vandrey, R., Herrmann, E.S., Mitchell, J.M., Bigelow, G.E., 
Flegel, R., LoDico, C., Cone, E.J., 2017. Pharmacokinetic profile of 
oral cannabis in humans: blood and oral fluid disposition and 
relation to pharmacodynamic outcomes. J Anal Toxicol, 41, 83-89.
17. Anizan, S., Milman, G., Desrosiers, N., Barnes, A.J., Gorelick, 
D.A., Huestis, M.A., 2013. Oral fluid cannabinoid concentrations 
following controlled smoked cannabis in chronic frequent and 
occasional smokers. Anal Bioanal Chem, 405, 8451-8461.
18. Desrosiers, N.A., Ramaekers, J.G., Chauchard, E., Gorelick, 
D.A., Huestis, M.A., 2015. Smoked cannabis' psychomotor and 
neurocognitive effects in occasional and frequent smokers. J Anal 
Toxicol, 39, 251-261.
19. Lee, D., Milman, G., Barnes, A.J., Goodwin, R.S., Hirvonen, J., 
Huestis, M.A., 2011. Oral fluid cannabinoids in chronic, daily 
cannabis smokers during sustained, monitored abstinence. Clin Chem, 
57, 1127-1136.
20. Lee, D., Schwope, D.M., Milman, G., Barnes, A.J., Gorelick, 
D.A., Huestis, M.A., 2012. Cannabinoid disposition in oral fluid 
after controlled smoked cannabis. Clin Chem, 58, 748-756.
21. Rohrig, T.P., Moore, C., 2003. The determination of morphine in 
urine and oral fluid following ingestion of poppy seeds. J Anal 
Toxicol, 27, 449-452.
22. Samano, K.L., Clouette, R.E., Rowland, B.J., Sample, R.H.B., 
2015. Concentrations of morphine and codeine in paired oral fluid 
and urine specimens following ingestion of a poppy seed roll and raw 
poppy seeds. J Anal Toxicol, 39, 655-661.
23. Newmeyer, M.N., Concheiro, M., da Costa, J.L., LoDico, C., 
Gorelick, D.A., Huestis, M.A., 2015. Simultaneous plasma and oral 
fluid morphine and codeine concentrations after controlled 
administration of poppy seeds with known opiate content. Forensic 
Toxicol, 33, 235-243.
24. Concheiro, M., Newmeyer, M.N., da Costa, J.L., Flegel, R., 
Gorelick, D.A., Huestis, M.A., 2015. Morphine and codeine in oral 
fluid after controlled poppy seed administration. Drug Test Anal, 7, 
586-591.
25. Cone, E.J., DePriest, A.Z., Heltsley, R., Black, D.L., Mitchell, 
J.M., LoDico, C., Flegel, R., 2015. Prescription opioids. III. 
Disposition of oxycodone in oral fluid and blood following 
controlled single dose administration. J Anal Toxicol, 39, 192-202.
26. Cone, E.J., DePriest, A.Z., Heltsley, R., Black, D.L., Mitchell, 
J.M., LoDico, C., Flegel, R., 2015. Prescription opioids. IV. 
Disposition of hydrocodone in oral fluid and blood following single 
dose administration. J Anal Toxicol, 39: 510-518.
27. Goggin, M.M., Tann, C., Miller, A., Nguyen, A., Janis, G.C., 
2017. Catching fakes: New markers of urine sample validity and 
invalidity. J Anal Toxicol, 41, 121-126.
28. Kluge, J., Rentzsch, L., Remane, D., Peters, F.T., Wissenbach, 
D.K., 2018. Systematic investigations of novel validity parameters 
in urine drug testing and prevalence of urine adulteration in a 
two[hyphen]year cohort. Drug Test Anal, 10,1536-1542.

    Dated: October 7, 2019.
Elinore F. McCance-Katz,
Assistant Secretary for Mental Health and Substance Use.
    Dated: October 7, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

    The Mandatory Guidelines using Oral Fluid Specimens are hereby 
adopted in accordance with section 503 of Public Law 100-71 and 
Executive Order 12564.

Mandatory Guidelines For Federal Workplace Drug Testing Programs Using 
Oral Fluid Specimens

Subpart A--Applicability

1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these 
Guidelines?
1.3 How does a federal agency request a change from these 
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect employee records?
1.7 What is a refusal to take a federally regulated drug test?

[[Page 57577]]

1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?

Subpart B--Oral Fluid Specimens

2.1 What type of specimen may be collected?
2.2 Under what circumstances may an oral fluid specimen be 
collected?
2.3 How is each oral fluid specimen collected?
2.4 What volume of oral fluid is collected?
2.5 How is the split oral fluid specimen collected?
2.6 When may an entity or individual release an oral fluid specimen?

Subpart C--Oral Fluid Specimen Tests

3.1 Which tests are conducted on an oral fluid specimen?
3.2 May a specimen be tested for additional drugs?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug test cutoff concentrations for undiluted 
(neat) oral fluid?
3.5 May an HHS-certified laboratory perform additional drug and/or 
specimen validity tests on a specimen at the request of the Medical 
Review Officer (MRO)?
3.6 What criteria are used to report an oral fluid specimen as 
adulterated?
3.7 What criteria are used to report an invalid result for an oral 
fluid specimen?

Subpart D--Collectors

4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be a trainer for collectors?
4.5 What must a federal agency do before a collector is permitted to 
collect a specimen?

Subpart E--Collection Sites

5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a 
specimen at the collection site?
5.6 What are the privacy requirements when collecting an oral fluid 
specimen?

Subpart F--Federal Drug Testing Custody and Control Form

6.1 What federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?

Subpart G--Oral Fluid Specimen Collection Devices

7.1 What is used to collect an oral fluid specimen?
7.2 What are the requirements for an oral fluid collection device?
7.3 What are the minimum performance requirements for a collection 
device?

Subpart H--Oral Fluid Specimen Collection Procedure

8.1 What privacy must the donor be given when providing an oral 
fluid specimen?
8.2 What must the collector ensure at the collection site before 
starting an oral fluid specimen collection?
8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?
8.4 What steps does the collector take in the collection procedure 
before the donor provides an oral fluid specimen?
8.5 What steps does the collector take during and after the oral 
fluid specimen collection procedure?
8.6 What procedure is used when the donor states that they are 
unable to provide an oral fluid specimen?
8.7 If the donor is unable to provide an oral fluid specimen, may 
another specimen type be collected for testing?
8.8 How does the collector prepare the oral fluid specimens?
8.9 How does the collector report a donor's refusal to test?
8.10 What are a federal agency's responsibilities for a collection 
site?

Subpart I--HHS Certification of Laboratories

9.1 Who has the authority to certify laboratories to test oral fluid 
specimens for federal agencies?
9.2 What is the process for a laboratory to become HHS-certified?
9.3 What is the process for a laboratory to maintain HHS 
certification?
9.4 What is the process when a laboratory does not maintain its HHS 
certification?
9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory?
9.7 What are the PT requirements for an HHS-certified oral fluid 
laboratory?
9.8 What are the inspection requirements for an applicant 
laboratory?
9.9 What are the maintenance inspection requirements for an HHS-
certified laboratory?
9.10 Who can inspect an HHS-certified laboratory and when may the 
inspection be conducted?
9.11 What happens if an applicant laboratory does not satisfy the 
minimum requirements for either the PT program or the inspection 
program?
9.12 What happens if an HHS-certified laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?
9.13 What factors are considered in determining whether revocation 
of a laboratory's HHS certification is necessary?
9.14 What factors are considered in determining whether to suspend a 
laboratory's HHS certification?
9.15 How does the Secretary notify an HHS-certified laboratory that 
action is being taken against the laboratory?
9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?
9.17 Where is the list of HHS-certified laboratories published?

Subpart J--Blind Samples Submitted by an Agency

10.1 What are the requirements for federal agencies to submit blind 
samples to HHS-certified laboratories?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory?
10.4 What happens if an inconsistent result is reported for a blind 
sample?

Subpart K--Laboratory

11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified 
laboratory?
11.5 What qualifications must an individual have to certify a result 
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an 
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory 
maintain?
11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?
11.9 What are the requirements for an initial drug test?
11.10 What must an HHS-certified laboratory do to validate an 
initial drug test?
11.11 What are the batch quality control requirements when 
conducting an initial drug test?
11.12 What are the requirements for a confirmatory drug test?
11.13 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
11.14 What are the batch quality control requirements when 
conducting a confirmatory drug test?
11.15 What are the analytical and quality control requirements for 
conducting specimen validity tests?
11.16 What must an HHS-certified laboratory do to validate a 
specimen validity test?
11.17 What are the requirements for an HHS-certified laboratory to 
report a test result?
11.18 How long must an HHS-certified laboratory retain specimens?
11.19 How long must an HHS-certified laboratory retain records?
11.20 What statistical summary reports must an HHS-certified 
laboratory provide for oral fluid testing?
11.21 What HHS-certified laboratory information is available to a 
federal agency?
11.22 What HHS-certified laboratory information is available to a 
federal employee?

[[Page 57578]]

11.23 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?

Subpart L--Instrumented Initial Test Facility (IITF)

12.1 May an IITF test oral fluid specimens for a federal agency's 
workplace drug testing program?

Subpart M--Medical Review Officer (MRO)

13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards 
that certify MROs approved?
13.3 What training is required before a physician may serve as an 
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing an oral fluid specimen's 
test results?
13.6 What action does the MRO take when the collector reports that 
the donor did not provide a sufficient amount of oral fluid for a 
drug test?
13.7 What happens when an individual is unable to provide a 
sufficient amount of oral fluid for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because 
of a permanent or long-term medical condition?
13.8 Who may request a test of a split (B) specimen?
13.9 How does an MRO report a primary (A) specimen test result to an 
agency?
13.10 What types of relationships are prohibited between an MRO and 
an HHS-certified laboratory?

Subpart N--Split Specimen Tests

14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen 
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported 
adulterated?
14.4 Who receives the split (B) specimen result?
14.5 What action(s) does an MRO take after receiving the split (B) 
oral fluid specimen result from the second HHS-certified laboratory?
14.6 How does an MRO report a split (B) specimen test result to an 
agency?
14.7 How long must an HHS-certified laboratory retain a split (B) 
specimen?

Subpart O--Criteria for Rejecting a Specimen for Testing

15.1 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing?
15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject an oral fluid specimen for testing or 
an MRO to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?

Subpart P--Laboratory Suspension/Revocation Procedures

16.1 When may the HHS certification of a laboratory be suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written 
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate 
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing 
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?

Subpart A--Applicability

Section 1.1 To whom do these Guidelines apply?

    (a) These Guidelines apply to:
    (1) Executive Agencies as defined in 5 U.S.C. 105;
    (2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but 
excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
    (3) Any other employing unit or authority of the federal government 
except the United States Postal Service, the Postal Rate Commission, 
and employing units or authorities in the Judicial and Legislative 
Branches; and
    (4) The Intelligence Community, as defined by Executive Order 
12333, is subject to these Guidelines only to the extent agreed to by 
the head of the affected agency;
    (5) Laboratories that provide drug testing services to the federal 
agencies;
    (6) Collectors who provide specimen collection services to the 
federal agencies; and
    (7) Medical Review Officers (MROs) who provide drug testing review 
and interpretation of results services to the federal agencies.
    (b) These Guidelines do not apply to drug testing under authority 
other than Executive Order 12564, including testing of persons in the 
criminal justice system, such as arrestees, detainees, probationers, 
incarcerated persons, or parolees.\1\
---------------------------------------------------------------------------

    \1\ The NRC-related information in this notice pertains to 
individuals subject to drug testing conducted pursuant to 10 CFR 
Part 26, ``Fitness for Duty Programs'' (i.e., employees of certain 
NRC-regulated entities).
    Although HHS has no authority to regulate the transportation 
industry, the Department of Transportation (DOT) does have such 
authority. DOT is required by law to develop requirements for its 
regulated industry that ``incorporate the Department of Health and 
Human Services scientific and technical guidelines dated April 11, 
1988 and any amendments to those guidelines . . .'' See, e.g., 49 
U.S.C. Sec. 20140(c)(2). In carrying out its mandate, DOT requires 
by regulation at 49 CFR Part 40 that its federally-regulated 
employers use only HHS-certified laboratories in the testing of 
employees, 49 CFR Sec. 40.81, and incorporates the scientific and 
technical aspects of the HHS Mandatory Guidelines.
---------------------------------------------------------------------------

Section 1.2 Who is responsible for developing and implementing these 
Guidelines?

    (a) Executive Order 12564 and Public Law 100-71 require the 
Department of Health and Human Services (HHS) to establish scientific 
and technical guidelines for federal workplace drug testing programs.
    (b) The Secretary has the responsibility to implement these 
Guidelines.

Section 1.3 How does a federal agency request a change from these 
Guidelines?

    (a) Each federal agency must ensure that its workplace drug testing 
program complies with the provisions of these Guidelines unless a 
waiver has been obtained from the Secretary.
    (b) To obtain a waiver, a federal agency must submit a written 
request to the Secretary that describes the specific change for which a 
waiver is sought and a detailed justification for the change.

Section 1.4 How are these Guidelines revised?

    (a) To ensure the full reliability and accuracy of specimen tests, 
the accurate reporting of test results, and the integrity and efficacy 
of federal drug testing programs, the Secretary may make changes to 
these Guidelines to reflect improvements in the available science and 
technology.
    (b) The changes will be published in final as a notice in the 
Federal Register.

Section 1.5 What do the terms used in these Guidelines mean?

    The following definitions are adopted:
    Accessioner. The individual who signs the Federal Drug Testing 
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.

[[Page 57579]]

    Adulterated Specimen. A specimen that has been altered, as 
evidenced by test results showing either a substance that is not a 
normal constituent for that type of specimen or showing an abnormal 
concentration of an endogenous substance.
    Aliquot. A portion of a specimen used for testing.
    Alternate Responsible Person. The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified laboratory when the 
responsible person is unable to fulfill these obligations.
    Alternate Technology Initial Drug Test. An initial drug test using 
technology other than immunoassay to differentiate negative specimens 
from those requiring further testing.
    Batch. A number of specimens or aliquots handled concurrently as a 
group.
    Biomarker. An endogenous substance used to validate a biological 
specimen.
    Blind Sample. A sample submitted to an HHS-certified test facility 
for quality assurance purposes, with a fictitious identifier, so that 
the test facility cannot distinguish it from a donor specimen.
    Calibrator. A sample of known content and analyte concentration 
prepared in the appropriate matrix used to define expected outcomes of 
a testing procedure. The test result of the calibrator is verified to 
be within established limits prior to use.
    Cancelled Test. The result reported by the MRO to the federal 
agency when a specimen has been reported to the MRO as an invalid 
result (and the donor has no legitimate explanation) or rejected for 
testing, when a split specimen fails to reconfirm, or when the MRO 
determines that a fatal flaw or unrecovered correctable flaw exists in 
the forensic records (as described in Sections 15.1 and 15.2).
    Carryover. The effect that occurs when a sample result (e.g., drug 
concentration) is affected by a preceding sample during the preparation 
or analysis of a sample.
    Certifying Scientist (CS). The individual responsible for verifying 
the chain of custody and scientific reliability of a test result 
reported by an HHS-certified laboratory.
    Certifying Technician (CT). The individual responsible for 
verifying the chain of custody and scientific reliability of negative, 
rejected for testing, and (for urine) negative/dilute results reported 
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
    Chain of Custody (COC) Procedures. Procedures that document the 
integrity of each specimen or aliquot from the point of collection to 
final disposition.
    Chain of Custody Documents. Forms used to document the control and 
security of the specimen and all aliquots. The document may account for 
an individual specimen, aliquot, or batch of specimens/aliquots and 
must include the name and signature of each individual who handled the 
specimen(s) or aliquot(s) and the date and purpose of the handling.
    Collection Device. A product that is used to collect an oral fluid 
specimen and may include a buffer or diluent.
    Collection Site. The location where specimens are collected.
    Collector. A person trained to instruct and assist a donor in 
providing a specimen.
    Confirmatory Drug Test. A second analytical procedure performed on 
a separate aliquot of a specimen to identify and quantify a specific 
drug or drug metabolite.
    Confirmatory Specimen Validity Test. A second test performed on a 
separate aliquot of a specimen to further support a specimen validity 
test result.
    Control. A sample used to evaluate whether an analytical procedure 
or test is operating within predefined tolerance limits.
    Cutoff. The analytical value (e.g., drug or drug metabolite 
concentration) used as the decision point to determine a result (e.g., 
negative, positive, adulterated, invalid, or, for urine, substituted) 
or the need for further testing.
    Donor. The individual from whom a specimen is collected.
    External Service Provider. An independent entity that performs 
services related to federal workplace drug testing on behalf of a 
federal agency, a collector/collection site, an HHS-certified 
laboratory, a Medical Review Officer (MRO), or, for urine, an HHS-
certified Instrumented Initial Test Facility (IITF).
    Failed to Reconfirm. The result reported for a split (B) specimen 
when a second HHS-certified laboratory is unable to corroborate the 
result reported for the primary (A) specimen.
    Federal Drug Testing Custody and Control Form (Federal CCF). The 
Office of Management and Budget (OMB) approved form that is used to 
document the collection and chain of custody of a specimen from the 
time the specimen is collected until it is received by the test 
facility (i.e., HHS-certified laboratory or, for urine, HHS-certified 
IITF). It may be a paper (hardcopy), electronic, or combination 
electronic and paper format (hybrid). The form may also be used to 
report the test result to the Medical Review Officer.
    HHS. The Department of Health and Human Services.
    Initial Drug Test. An analysis used to differentiate negative 
specimens from those requiring further testing.
    Initial Specimen Validity Test. The first analysis used to 
determine if a specimen is invalid, adulterated, or (for urine) diluted 
or substituted.
    Instrumented Initial Test Facility (IITF). A permanent location 
where (for urine) initial testing, reporting of results, and 
recordkeeping are performed under the supervision of a responsible 
technician.
    Invalid Result. The result reported by an HHS-certified laboratory 
in accordance with the criteria established in Section 3.7 when a 
positive or negative result cannot be established for a specific drug 
or specimen validity test.
    Laboratory. A permanent location where initial and confirmatory 
drug testing, reporting of results, and recordkeeping are performed 
under the supervision of a responsible person.
    Limit of Detection. The lowest concentration at which the analyte 
(e.g., drug or drug metabolite) can be identified.
    Limit of Quantification. For quantitative assays, the lowest 
concentration at which the identity and concentration of the analyte 
(e.g., drug or drug metabolite) can be accurately established.
    Lot. A number of units of an item (e.g., reagents, quality control 
material, oral fluid collection device) manufactured from the same 
starting materials within a specified period of time for which the 
manufacturer ensures that the items have essentially the same 
performance characteristics and expiration date.
    Medical Review Officer (MRO). A licensed physician who reviews, 
verifies, and reports a specimen test result to the federal agency.
    Negative Result. The result reported by an HHS-certified laboratory 
or (for urine) an HHS-certified IITF to an MRO when a specimen contains 
no drug and/or drug metabolite; or the concentration of the drug or 
drug metabolite is less than the cutoff for that drug or drug class.
    Oral Fluid Specimen. An oral fluid specimen is collected from the 
donor's oral cavity and is a combination of physiological fluids 
produced primarily by the salivary glands.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drug or drug metabolites to prevent 
the detection of

[[Page 57580]]

the drugs or drug metabolites, or affects the reagents in either the 
initial or confirmatory drug test.
    Performance Testing (PT) Sample. A program-generated sample sent to 
a laboratory or (for urine) to an IITF to evaluate performance.
    Positive Result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the confirmation cutoff concentration.
    Reconfirmed. The result reported for a split (B) specimen when the 
second HHS-certified laboratory corroborates the original result 
reported for the primary (A) specimen.
    Rejected for Testing. The result reported by an HHS-certified 
laboratory or (for urine) an HHS-certified IITF when no tests are 
performed on a specimen because of a fatal flaw or an unrecovered 
correctable error (see Sections 15.1 and 15.2)
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of an HHS-certified laboratory.
    Sample. A performance testing sample, calibrator or control used 
during testing, or a representative portion of a donor's specimen.
    Secretary. The Secretary of the U.S. Department of Health and Human 
Services.
    Specimen. Fluid or material collected from a donor at the 
collection site for the purpose of a drug test.
    Split Specimen Collection (for Oral Fluid). A collection in which 
two specimens [primary (A) and split (B)] are collected, concurrently 
or serially, and independently sealed in the presence of the donor; or 
a collection in which a single specimen is collected using a single 
collection device and is subdivided into a primary (A) specimen and a 
split (B) specimen, which are independently sealed in the presence of 
the donor.
    Standard. Reference material of known purity or a solution 
containing a reference material at a known concentration.
    Undiluted (neat) oral fluid. An oral fluid specimen to which no 
other solid or liquid has been added. For example, see Section 2.4: A 
collection device that uses a diluent (or other component, process, or 
method that modifies the volume of the testable specimen) must collect 
at least 1 mL of undiluted (neat) oral fluid.

Section 1.6 What is an agency required to do to protect employee 
records?

    Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency 
contracts with laboratories, collectors, and MROs must require that 
they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the 
contracts must require compliance with employee access and 
confidentiality provisions of Section 503 of Public Law 100-71. Each 
federal agency must establish a Privacy Act System of Records or modify 
an existing system or use any applicable Government-wide system of 
records to cover the records of employee drug test results. All 
contracts and the Privacy Act System of Records must specifically 
require that employee records be maintained and used with the highest 
regard for employee privacy.
    The Health Insurance Portability and Accountability Act of 1996 
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, Subparts A and 
E, may be applicable to certain health care providers with whom a 
federal agency may contract. If a health care provider is a HIPAA 
covered entity, the provider must protect the individually identifiable 
health information it maintains in accordance with the requirements of 
the Rule, which includes not using or disclosing the information except 
as permitted by the Rule and ensuring there are reasonable safeguards 
in place to protect the privacy of the information. For more 
information regarding the HIPAA Privacy Rule, please visit http://www.hhs.gov/ocr/hipaa.

Section 1.7 What is a refusal to take a federally regulated drug test?

    (a) As a donor for a federally regulated drug test, you have 
refused to take a federally regulated drug test if you:
    (1) Fail to appear for any test (except a pre-employment test) 
within a reasonable time, as determined by the federal agency, 
consistent with applicable agency regulations, after being directed to 
do so by the federal agency;
    (2) Fail to remain at the collection site until the collection 
process is complete with the exception of a donor who leaves the 
collection site before the collection process begins for a pre-
employment test as described in section 8.4(a);
    (3) Fail to provide a specimen (e.g., oral fluid or another 
authorized specimen type) for any drug test required by these 
Guidelines or federal agency regulations with the exception of a donor 
who leaves the collection site before the collection process begins for 
a pre-employment test as described in section 8.4(a);
    (4) Fail to provide a sufficient amount of oral fluid when 
directed, and it has been determined, through a required medical 
evaluation, that there was no legitimate medical explanation for the 
failure as determined by the process described in Section 13.6;
    (5) Fail or decline to participate in an alternate specimen 
collection (e.g., urine) as directed by the federal agency or collector 
(i.e., as described in Section 8.6);
    (6) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification process (i.e., Section 
13.6) or as directed by the federal agency. In the case of a federal 
agency applicant/pre-employment drug test, the donor is deemed to have 
refused to test on this basis only if the federal agency applicant/pre-
employment test is conducted following a contingent offer of 
employment. If there was no contingent offer of employment, the MRO 
will cancel the test;
    (7) Fail to cooperate with any part of the testing process (e.g., 
disrupt the collection process; fail to rinse the mouth after being 
directed to do so by the collector; refuse to provide a split 
specimen);
    (8) Bring materials to the collection site for the purpose of 
adulterating, substituting, or diluting the specimen;
    (9) Attempt to adulterate, substitute, or dilute the specimen; or
    (10) Admit to the collector or MRO that you have adulterated or 
substituted the specimen.

Section 1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?

    (a) As a federal agency employee or applicant, a refusal to take a 
test may result in the initiation of disciplinary or adverse action, up 
to and including removal from, or non-selection for, federal 
employment.
    (b) When a donor has refused to participate in a part of the 
collection process, including failing to appear in a reasonable time 
for any test except a pre-employment test as described in Section 
1.7(a)(1), the collector must terminate the collection process and take 
action as described in Section 8.9. Required action includes 
immediately notifying the federal agency's designated representative by 
any means (e.g., telephone or secure fax machine) that ensures that the 
refusal notification is immediately received and, if a Federal CCF has 
been initiated, documenting the refusal on the Federal CCF, signing and 
dating the Federal

[[Page 57581]]

CCF, and sending all copies of the Federal CCF to the federal agency's 
designated representative.
    (c) When documenting a refusal to test during the verification 
process as described in Sections 13.4, 13.5, and 13.6, the MRO must 
complete the MRO copy of the Federal CCF to include:
    (1) Checking the refusal to test box;
    (2) Providing a reason for the refusal in the remarks line; and
    (3) Signing and dating the MRO copy of the Federal CCF.

Subpart B--Oral Fluid Specimens

Section 2.1 What type of specimen may be collected?

    A federal agency may collect oral fluid and/or an alternate 
specimen type for its workplace drug testing program. Only specimen 
types authorized by Mandatory Guidelines for Federal Workplace Drug 
Testing Programs may be collected. An agency using oral fluid must 
follow these Guidelines.

Section 2.2 Under what circumstances may an oral fluid specimen be 
collected?

    A federal agency may collect an oral fluid specimen for the 
following reasons:
    (a) Federal agency applicant/Pre-employment test;
    (b) Random test;
    (c) Reasonable suspicion/cause test;
    (d) Post accident test;
    (e) Return to duty test; or
    (f) Follow-up test.

Section 2.3 How is each oral fluid specimen collected?

    Each oral fluid specimen is collected as a split specimen (i.e., 
collected either simultaneously or serially) as described in Sections 
2.5 and 8.8.

Section 2.4 What volume of oral fluid is collected?

    A volume of at least 1 mL of undiluted (neat) oral fluid for each 
oral fluid specimen (designated ``Tube A'' and ``Tube B'') is collected 
using a collection device. If the device does not include a diluent (or 
other component, process, or method that modifies the volume of the 
testable specimen), the A and B tubes must have a volume marking 
clearly noting a level of 1 mL.

Section 2.5 How is the split oral fluid specimen collected?

    The collector collects at least 1 mL of undiluted (neat) oral fluid 
in a collection device designated as ``A'' (primary) and at least 1 mL 
of undiluted (neat) oral fluid in a collection device designated as 
``B'' (split) either simultaneously or serially (i.e., using two 
devices or using one device and subdividing the specimen), as described 
in Section 8.8.

Section 2.6 When may an entity or individual release an oral fluid 
specimen?

    Entities and individuals subject to these Guidelines under Section 
1.1, may not release specimens collected pursuant to Executive Order 
12564, Public Law 100-71 and these Guidelines, to donors or their 
designees. Specimens also may not be released to any other entity or 
individual unless expressly authorized by these Guidelines or by 
applicable federal law. This section does not prohibit a donor's 
request to have a split (B) specimen tested in accordance with Section 
13.8.

Subpart C--Oral Fluid Drug and Specimen Validity Tests

Section 3.1 Which tests are conducted on an oral fluid specimen?

    A federal agency:
    (a) Must ensure that each specimen is tested for marijuana and 
cocaine as provided under Section 3.4;
    (b) Is authorized to test each specimen for opioids, amphetamines, 
and phencyclidine, as provided under Section 3.4; and
    (c) Is authorized upon a Medical Review Officer's request to test 
an oral fluid specimen to determine specimen validity using, for 
example, a test for a biomarker such as albumin or immunoglobulin G 
(IgG) or a test for a specific adulterant.
    (d) If a specimen exhibits abnormal characteristics (e.g., unusual 
odor or color), causes reactions or responses characteristic of an 
adulterant during initial or confirmatory drug tests (e.g., non-
recovery of internal standard, unusual response), or contains an 
unidentified substance that interferes with the confirmatory analysis, 
then additional testing may be performed.

Section 3.2 May a specimen be tested for additional drugs?

    (a) On a case-by-case basis, a specimen may be tested for 
additional drugs, if a federal agency is conducting the collection for 
reasonable suspicion or post accident testing. A specimen collected 
from a federal agency employee may be tested by the federal agency for 
any drugs listed in Schedule I or II of the Controlled Substances Act. 
The federal agency must request the HHS-certified laboratory to test 
for the additional drug, include a justification to test a specific 
specimen for the drug, and ensure that the HHS-certified laboratory has 
the capability to test for the drug and has established properly 
validated initial and confirmatory analytical methods. If an initial 
test procedure is not available upon request for a suspected Schedule I 
or Schedule II drug, the federal agency can request an HHS-certified 
laboratory to test for the drug by analyzing two separate aliquots of 
the specimen in two separate testing batches using the confirmatory 
analytical method. Additionally, the split (B) specimen will be 
available for testing if the donor requests a retest at another HHS-
certified laboratory.
    (b) A federal agency covered by these Guidelines must petition the 
Secretary in writing for approval to routinely test for any drug class 
not listed in Section 3.1. Such approval must be limited to the use of 
the appropriate science and technology and must not otherwise limit 
agency discretion to test for any drug tested under paragraph (a) of 
this section.

Section 3.3 May any of the specimens be used for other purposes?

    (a) Specimens collected pursuant to Executive Order 12564, Public 
Law 100-71, and these Guidelines must only be tested for drugs and to 
determine their validity in accordance with Subpart C of these 
Guidelines. Use of specimens by donors, their designees or any other 
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing) 
is prohibited unless authorized in accordance with applicable federal 
law.
    (b) These Guidelines are not intended to prohibit federal agencies 
specifically authorized by law to test a specimen for additional 
classes of drugs in its workplace drug testing program.

Section 3.4 What are the drug test cutoff concentrations for undiluted 
(neat) oral fluid?

[[Page 57582]]



----------------------------------------------------------------------------------------------------------------
                                                                                                   Confirmatory
                                                 Initial test                                       test cutoff
             Initial test analyte               cutoff \1\ (ng/     Confirmatory test analyte      concentration
                                                      mL)                                             (ng/mL)
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\...........................           \3\ 4  THC.............................               2
Cocaine/Benzoylecgonine.......................              15  Cocaine.........................               8
                                                                Benzoylecgonine.................               8
Codeine/Morphine..............................              30  Codeine.........................              15
                                                                Morphine........................              15
Hydrocodone/Hydromorphone.....................              30  Hydrocodone.....................              15
                                                                Hydromorphone...................              15
Oxycodone/Oxymorphone.........................              30  Oxycodone.......................              15
                                                                Oxymorphone.....................              15
6-Acetylmorphine..............................           \3\ 4  6-Acetylmorphine................               2
Phencyclidine.................................              10  Phencyclidine...................              10
Amphetamine/Methamphetamine...................              50  Amphetamine.....................              25
                                                                Methamphetamine.................              25
MDMA \4\/MDA \5\..............................              50  MDMA............................              25
                                                                MDA.............................              25
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
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.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol (THC).
\3\ Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology
  initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

Section 3.5 May an HHS-certified laboratory perform additional drug 
and/or specimen validity tests on a specimen at the request of the 
Medical Review Officer (MRO)?

    An HHS-certified laboratory is authorized to perform additional 
drug and/or specimen validity tests on a case-by-case basis as 
necessary to provide information that the MRO would use to report a 
verified drug test result (e.g., specimen validity tests including 
biomarker and/or adulterant tests, tetrahydrocannabivarin). An HHS-
certified laboratory is not authorized to routinely perform additional 
drug and/or specimen validity tests at the request of an MRO without 
prior authorization from the Secretary or designated HHS 
representative, with the exception of the determination of D,L 
stereoisomers of amphetamine and methamphetamine. All tests must meet 
appropriate validation and quality control requirements in accordance 
with these Guidelines.

Section 3.6 What criteria are used to report an oral fluid specimen as 
adulterated?

    An HHS-certified laboratory reports an oral fluid specimen as 
adulterated when the presence of an adulterant is verified using an 
initial test on the first aliquot and a different confirmatory test on 
the second aliquot.

Section 3.7 What criteria are used to report an invalid result for an 
oral fluid specimen?

    An HHS-certified laboratory reports a primary (A) oral fluid 
specimen as an invalid result when:
    (a) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid immunoassay or alternate technology initial drug 
test results cannot be obtained);
    (b) Interference with the drug confirmatory assay occurs on two 
separate aliquots of the specimen and the laboratory is unable to 
identify the interfering substance;
    (c) The physical appearance of the specimen (e.g., viscosity) is 
such that testing the specimen may damage the laboratory's instruments;
    (d) The specimen has been tested and the appearances of the primary 
(A) and the split (B) specimens (e.g., color) are clearly different; or
    (e) The concentration of a biomarker (e.g., albumin or IgG) is not 
consistent with that established for human oral fluid for both the 
initial (first) test and the second test on two separate aliquots.

Subpart D--Collectors

Section 4.1 Who may collect a specimen?

    (a) A collector who has been trained to collect oral fluid 
specimens in accordance with these Guidelines and the manufacturer's 
procedures for the collection device.
    (b) The immediate supervisor of a federal employee donor may only 
collect that donor's specimen when no other collector is available. The 
supervisor must be a trained collector.
    (c) The hiring official of a federal agency applicant may only 
collect that federal agency applicant's specimen when no other 
collector is available. The hiring official must be a trained 
collector.

Section 4.2 Who may not collect a specimen?

    (a) A federal agency employee who is in a testing designated 
position and subject to the federal agency drug testing rules must not 
be a collector for co-workers in the same testing pool or who work 
together with that employee on a daily basis.
    (b) A federal agency applicant or employee must not collect their 
own drug testing specimen.
    (c) An employee working for an HHS-certified laboratory must not 
act as a collector if the employee could link the identity of the donor 
to the donor's drug test result.
    (d) To avoid a potential conflict of interest, a collector must not 
be related to the employee (e.g., spouse, ex-spouse, relative) or a 
close personal friend (e.g., fianc[eacute]e).

[[Page 57583]]

Section 4.3 What are the requirements to be a collector?

    (a) An individual may serve as a collector if they fulfill the 
following conditions:
    (1) Is knowledgeable about the collection procedure described in 
these Guidelines;
    (2) Is knowledgeable about any guidance provided by the federal 
agency's Drug-Free Workplace Program and additional information 
provided by the Secretary relating to these Guidelines;
    (3) Is trained and qualified to use the specific oral fluid 
collection device. Training must include the following:
    (i) All steps necessary to complete an oral fluid collection;
    (ii) Completion and distribution of the Federal CCF;
    (iii) Problem collections;
    (iv) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (v) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of the donor, ensuring the 
security of the specimen, and avoiding conduct or statements that could 
be viewed as offensive or inappropriate.
    (4) Has demonstrated proficiency in collections by completing five 
consecutive error-free mock collections.
    (i) The five mock collections must include two uneventful 
collection scenarios, one insufficient specimen quantity scenario, one 
scenario in which the donor refuses to sign the Federal CCF, and one 
scenario in which the donor refuses to initial the specimen tube 
tamper-evident seal.
    (ii) A qualified trainer for collectors must monitor and evaluate 
the individual being trained, in person or by a means that provides 
real-time observation and interaction between the trainer and the 
trainee, and the trainer must attest in writing that the mock 
collections are error-free.
    (b) A trained collector must complete refresher training at least 
every five years that includes the requirements in paragraph (a) of 
this section.
    (c) The collector must maintain the documentation of their training 
and provide that documentation to a federal agency when requested.
    (d) An individual may not collect specimens for a federal agency 
until the individual's training as a collector has been properly 
documented.

Section 4.4 What are the requirements to be a trainer for collectors?

    (a) Individuals are considered qualified trainers for collectors 
for a specific oral fluid collection device and may train others to 
collect oral fluid specimens using that collection device when they 
have completed the following:
    (1) Qualified as a trained collector and regularly conducted oral 
fluid drug test collections using that collection device for a period 
of at least one year or
    (2) Completed a ``train the trainer'' course given by an 
organization (e.g., manufacturer, private entity, contractor, federal 
agency).
    (b) A qualified trainer for collectors must complete refresher 
training at least every five years in accordance with the collector 
requirements in Section 4.3(a).
    (c) A qualified trainer for collectors must maintain the 
documentation of the trainer's training and provide that documentation 
to a federal agency when requested.

Section 4.5 What must a federal agency do before a collector is 
permitted to collect a specimen?

    A federal agency must ensure the following:
    (a) The collector has satisfied the requirements described in 
Section 4.3;
    (b) The collector, who may be self-employed, or an organization 
(e.g., third party administrator that provides a collection service, 
collector training company, federal agency that employs its own 
collectors) maintains a copy of the training record(s); and
    (c) The collector has been provided the name and telephone number 
of the federal agency representative.

Subpart E--Collection Sites

Section 5.1 Where can a collection for a drug test take place?

    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) In the event that an agency-designated collection site is not 
accessible and there is an immediate requirement to collect an oral 
fluid specimen (e.g., an accident investigation), another site may be 
used for the collection, providing the collection is performed by a 
collector who has been trained to collect oral fluid specimens in 
accordance with these Guidelines and the manufacturer's procedures for 
the collection device.

Section 5.2 What are the requirements for a collection site?

    The facility used as a collection site must have the following:
    (a) Provisions to ensure donor privacy during the collection (as 
described in Section 8.1);
    (b) A suitable and clean surface area that is not accessible to the 
donor for handling the specimens and completing the required paperwork;
    (c) A secure temporary storage area to maintain specimens until the 
specimen is transferred to an HHS-certified laboratory;
    (d) A restricted access area where only authorized personnel may be 
present during the collection;
    (e) A restricted access area for the storage of collection 
supplies; and
    (f) The ability to store records securely.

Section 5.3 Where must collection site records be stored?

    Collection site records must be stored at a secure site designated 
by the collector or the collector's employer.

Section 5.4 How long must collection site records be stored?

    Collection site records (e.g., collector copies of the OMB-approved 
Federal CCF) must be stored securely for a minimum of 2 years. The 
collection site may convert hardcopy records to electronic records for 
storage and discard the hardcopy records after 6 months.

Section 5.5 How does the collector ensure the security and integrity of 
a specimen at the collection site?

    (a) A collector must do the following to maintain the security and 
integrity of a specimen:
    (1) Not allow unauthorized personnel to enter the collection area 
during the collection procedure;
    (2) Perform only one donor collection at a time;
    (3) Restrict access to collection supplies before, during, and 
after collection;
    (4) Ensure that only the collector and the donor are allowed to 
handle the unsealed specimen;
    (5) Ensure the chain of custody process is maintained and 
documented throughout the entire collection, storage, and transport 
procedures;
    (6) Ensure that the Federal CCF is completed and distributed as 
required; and
    (7) Ensure that specimens transported to an HHS-certified 
laboratory are sealed and placed in transport containers designed to 
minimize the possibility of damage during shipment (e.g., specimen 
boxes, padded mailers, or other suitable shipping container), and those 
containers are securely sealed to eliminate the possibility of 
undetected tampering.
    (b) Couriers, express carriers, and postal service personnel are 
not

[[Page 57584]]

required to document chain of custody since specimens are sealed in 
packages that would indicate tampering during transit to the HHS-
certified laboratory.

Section 5.6 What are the privacy requirements when collecting an oral 
fluid specimen?

    Collections must be performed at a site that provides reasonable 
privacy (as described in Section 8.1).

Subpart F--Federal Drug Testing Custody and Control Form

Section 6.1 What federal form is used to document custody and control?

    The OMB-approved Federal CCF must be used to document custody and 
control of each specimen at the collection site.

Section 6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?

    (a) The use of a non-federal CCF or an expired Federal CCF is not, 
by itself, a reason for the HHS-certified laboratory to automatically 
reject the specimen for testing or for the MRO to cancel the test.
    (b) If the collector does not use the correct OMB-approved Federal 
CCF, the collector must document that it is a federal agency specimen 
collection and provide the reason that the incorrect form was used. 
Based on the documentation provided by the collector, the HHS-certified 
laboratory must handle and test the specimen as a federal agency 
specimen.
    (c) If the HHS-certified laboratory or MRO discovers that the 
collector used an incorrect form, the laboratory or MRO must obtain a 
memorandum for the record from the collector describing the reason the 
incorrect form was used. If a memorandum for the record cannot be 
obtained, the laboratory reports a rejected for testing result to the 
MRO and the MRO cancels the test. The HHS-certified laboratory must 
wait at least 5 business days while attempting to obtain the memorandum 
before reporting a rejected for testing result to the MRO.

Subpart G--Oral Fluid Specimen Collection Devices

Section 7.1 What is used to collect an oral fluid specimen?

    An FDA-cleared single-use collection device intended to collect an 
oral fluid specimen must be used. This collection device must maintain 
the integrity of such specimens during storage and transport so that 
the specimen contained therein can be tested in an HHS-certified 
laboratory for the presence of drugs or their metabolites.

Section 7.2 What are the requirements for an oral fluid collection 
device?

    An oral fluid specimen collection device must provide:
    (a) An indicator that demonstrates the adequacy of the volume of 
oral fluid specimen collected;
    (b) A sealable, non-leaking container that maintains the integrity 
of the specimen during storage and transport so that the specimen 
contained therein can be tested in an HHS-certified laboratory for the 
presence of drugs or their metabolites;
    (c) Components that ensure pre-analytical drug and drug metabolite 
stability; and
    (d) Components that do not substantially affect the composition of 
drugs and/or drug metabolites in the oral fluid specimen.

Section 7.3 What are the minimum performance requirements for a 
collection device?

    An oral fluid collection device must meet the following minimum 
performance requirements.
    (a) Reliable collection of a minimum of 1 mL of undiluted (neat) 
oral fluid;
    (b) If the collection device contains a diluent (or other 
component, process, or method that modifies the volume of the testable 
specimen):
    (1) The volume of oral fluid collected should be at least 1.0 mL 
10 percent, and
    (2) The volume of diluent in the device should be within 2.5 percent of the diluent target volume;
    (c) Stability (recoverable concentrations >=80 percent of the 
concentration at the time of collection) of the drugs and/or drug 
metabolites for five days at room temperature (64-77 [deg]F/18-25 
[deg]C) and under the manufacturer's intended shipping and storage 
conditions; and
    (d) Recover >=80 percent (but no more than 120 percent) of drug 
and/or drug metabolite in the undiluted (neat) oral fluid at (or near) 
the initial test cutoff (see Section 3.4).

Subpart H--Oral Fluid Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing an oral 
fluid specimen?

    The following privacy requirements apply when a donor is providing 
an oral fluid specimen:
    (a) Only authorized personnel and the donor may be present in the 
restricted access area where the collection takes place.
    (b) The collector is not required to be the same gender as the 
donor.

Section 8.2 What must the collector ensure at the collection site 
before starting an oral fluid specimen collection?

    The collector must deter the adulteration or substitution of an 
oral fluid specimen at the collection site.

Section 8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?

    The collector must take the following steps before beginning an 
oral fluid specimen collection:
    (a) If a donor fails to arrive at the collection site at the 
assigned time, the collector must follow the federal agency policy or 
contact the federal agency representative to obtain guidance on action 
to be taken.
    (b) When the donor arrives at the collection site, the collector 
should begin the collection procedure without undue delay. For example, 
the collection should not be delayed because an authorized employer or 
employer representative is late in arriving.
    (c) The collector requests the donor to present photo 
identification (e.g., driver's license; employee badge issued by the 
employer; an alternative photo identification issued by a federal, 
state, or local government agency). If the donor does not have proper 
photo identification, the collector shall contact the supervisor of the 
donor or the federal agency representative who can positively identify 
the donor. If the donor's identity cannot be established, the collector 
must not proceed with the collection.
    (d) The collector requests that the donor open the donor's mouth, 
and the collector inspects the oral cavity to ensure that it is free of 
any items that could impede or interfere with the collection of an oral 
fluid specimen (e.g., candy, gum, food, tobacco) or could be used to 
adulterate, substitute, or dilute the specimen. If an item is present 
that appears to have been brought to the collection site with the 
intent to adulterate, substitute, or dilute the specimen, this is 
considered a refusal to test. The collector must stop the collection 
and report the refusal to test as described in Section 8.9.
    (1) At this time, the collector starts the 10-minute wait period 
and proceeds with the steps below before beginning the specimen 
collection as described in Section 8.5.
    (2) If the collector's inspection of the donor's oral cavity 
reveals any items that could impede or interfere with the collection of 
an oral fluid specimen (including abnormally colored saliva),

[[Page 57585]]

or the donor claims to have ``dry mouth,'' the collector gives the 
donor water (e.g., up to 4 oz.) to rinse their mouth. The donor may 
drink the water. The collector must then wait 10 minutes before 
beginning the specimen collection. If the donor refuses to remove the 
item or refuses to rinse, this is a refusal to test.
    (3) If the donor claims that they have a medical condition that 
prevents opening their mouth for inspection, the collector follows the 
procedure in Section 8.6(b)(2).
    (e) The collector must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (f) The collector explains the basic collection procedure to the 
donor.
    (g) The collector informs the donor that the instructions for 
completing the Federal Custody and Control Form are located on the back 
of the Federal CCF or available upon request.
    (h) The collector answers any reasonable and appropriate questions 
the donor may have regarding the collection procedure.

Section 8.4 What steps does the collector take in the collection 
procedure before the donor provides an oral fluid specimen?

    (a) The collector will provide or the donor may select a specimen 
collection device that is clean, unused, and wrapped/sealed in original 
packaging. The specimen collection device will be opened in view of the 
donor.
    (1) Both the donor and the collector must keep the unwrapped 
collection devices in view at all times until each collection device 
containing the donor's oral fluid specimen has been sealed and labeled.
    (b) The collector reviews with the donor the procedures required 
for a successful oral fluid specimen collection as stated in the 
manufacturer's instructions for the specimen collection device.
    (c) The collector notes any unusual behavior or appearance of the 
donor on the Federal CCF. If the collector detects any conduct that 
clearly indicates an attempt to tamper with a specimen (e.g., an 
attempt to bring into the collection site an adulterant or oral fluid 
substitute), the collector must report a refusal to test in accordance 
with Section 8.9.

Section 8.5 What steps does the collector take during and after the 
oral fluid specimen collection procedure?

    Integrity and Identity of the Specimen. The collector must take the 
following steps during and after the donor provides the oral fluid 
specimen:
    (a) The collector shall be present and maintain visual contact with 
the donor during the procedures outlined in this section.
    (1) Under the observation of the collector, the donor is 
responsible for positioning the specimen collection device for 
collection. The collector must ensure the collection is performed 
correctly and that the collection device is working properly. If there 
is a failure to collect the specimen, the collector must begin the 
process again, beginning with Step 8.4(b), using a new specimen 
collection device (for both A and B specimens) and notes the failed 
collection attempt on the Federal CCF. If the donor states that they 
are unable to provide an oral fluid specimen during the collection 
process or after multiple failures to collect the specimen, the 
collector follows the procedure in Section 8.6.
    (2) The donor and collector must complete the collection in 
accordance with the manufacturer instructions for the collection 
device.
    (b) If the donor fails to remain present through the completion of 
the collection, fails to follow the instructions for the collection 
device, refuses to begin the collection process after a failure to 
collect the specimen as required in step (a)(1) above, refuses to 
provide a split specimen as instructed by the collector, or refuses to 
provide an alternate specimen as authorized in Section 8.6, the 
collector stops the collection and reports the refusal to test in 
accordance with Section 8.9.

Section 8.6 What procedure is used when the donor states that they are 
unable to provide an oral fluid specimen?

    (a) If the donor states that they are unable to provide an oral 
fluid specimen during the collection process, the collector requests 
that the donor follow the collector instructions and attempt to provide 
an oral fluid specimen.
    (b) The donor demonstrates their inability to provide a specimen 
when, after 15 minutes of using the collection device, there is 
insufficient volume or no oral fluid collected using the device.
    (1) If the donor states that they could provide a specimen after 
drinking some fluids, the collector gives the donor a drink (up to 8 
ounces) and waits an additional 10 minutes before beginning the 
specimen collection (a period of 1 hour must be provided or until the 
donor has provided a sufficient oral fluid specimen). If the donor 
simply needs more time before attempting to provide an oral fluid 
specimen, the donor is not required to drink any fluids during the 1 
hour wait time. The collector must inform the donor that the donor must 
remain at the collection site (i.e., in an area designated by the 
collector) during the wait period.
    (2) If the donor states that they are unable to provide an oral 
fluid specimen, the collector records the reason for not collecting an 
oral fluid specimen on the Federal CCF, notifies the federal agency's 
designated representative for authorization of an alternate specimen to 
be collected, and sends the appropriate copies of the Federal CCF to 
the MRO and to the federal agency's designated representative. The 
federal agency may choose to provide the collection site with a 
standard protocol to follow in lieu of requiring the collector to 
notify the agency's designated representative for authorization in each 
case. If an alternate specimen is authorized, the collector may begin 
the collection procedure for the alternate specimen (see Section 8.7) 
in accordance with the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using the alternative specimen.

Section 8.7 If the donor is unable to provide an oral fluid specimen, 
may another specimen type be collected for testing?

    Yes, if the alternate specimen type is authorized by Mandatory 
Guidelines for Federal Workplace Drug Testing Programs and specifically 
authorized by the federal agency.

Section 8.8 How does the collector prepare the oral fluid specimens?

    (a) All federal agency collections are to be split specimen 
collections.
    An oral fluid split specimen collection may be:
    (1) Two specimens collected simultaneously with two separate 
collection devices;
    (2) Two specimens collected serially with two separate collection 
devices. The donor is not allowed to drink or rinse their mouth between 
the two collections. Collection of the second specimen must begin 
within two minutes after the completion of the first collection and 
recorded on the Federal CCF;
    (3) Two specimens collected simultaneously using a single 
collection device that directs the oral fluid into two separate 
collection tubes; or
    (4) A single specimen collected using a single collection device, 
that is subsequently subdivided into two specimens.
    (b) A volume of at least 1 mL of undiluted (neat) oral fluid is 
collected for the specimen designated as ``Tube

[[Page 57586]]

A'' and a volume of at least 1 mL of undiluted (neat) oral fluid is 
collected for the specimen designated as ``Tube B''.
    (c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over the cap of each specimen 
tube. The collector records the date of the collection on the tamper-
evident labels/seals.
    (d) The collector instructs the donor to initial the tamper-evident 
labels/seals on each specimen tube. If the donor refuses to initial the 
labels/seals, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (e) The collector must ensure that all the information required on 
the Federal CCF is provided.
    (f) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the specimens identified were collected 
from the donor. If the donor refuses to sign the certification 
statement, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (g) The collector signs and prints their name on the Federal CCF, 
completes the Federal CCF, and distributes the copies of the Federal 
CCF as required.
    (h) The collector seals the specimens (Tube A and Tube B) in a 
package and, within 24 hours or during the next business day, sends 
them to the HHS-certified laboratory that will be testing the Tube A 
oral fluid specimen.
    (i) If the specimen and Federal CCF are not immediately transported 
to an HHS-certified laboratory, they must remain under direct control 
of the collector or be appropriately secured under proper specimen 
storage conditions until transported.

Section 8.9 How does the collector report a donor's refusal to test?

    If there is a refusal to test as defined in Section 1.7, the 
collector stops the collection, discards any oral fluid specimen 
collected and reports the refusal to test by:
    (a) Notifying the federal agency by means (e.g., telephone, email, 
or secure fax) that ensures that the notification is immediately 
received,
    (b) Documenting the refusal to test on the Federal CCF, and
    (c) Sending all copies of the Federal CCF to the federal agency's 
designated representative.

Section 8.10 What are a federal agency's responsibilities for a 
collection site?

    (a) A federal agency must ensure that collectors and collection 
sites satisfy all requirements in subparts D, E, F, G, and H.
    (b) A federal agency (or only one federal agency when several 
agencies are using the same collection site) must inspect 5 percent or 
up to a maximum of 50 collection sites each year, selected randomly 
from those sites used to collect agency specimens (e.g., virtual, 
onsite, or self-evaluation).
    (c) A federal agency must investigate reported collection site 
deficiencies (e.g., specimens reported ``rejected for testing'' by an 
HHS-certified laboratory) and take appropriate action which may include 
a collection site self-assessment (i.e., using the Collection Site 
Checklist for the Collection of Oral Fluid Specimens for Federal Agency 
Workplace Drug Testing Programs) or an inspection of the collection 
site. The inspections of these additional collection sites may be 
included in the 5 percent or maximum of 50 collection sites inspected 
annually.

Subpart I--HHS Certification of Laboratories

Section 9.1 Who has the authority to certify laboratories to test oral 
fluid specimens for federal agencies?

    (a) The Secretary has broad discretion to take appropriate action 
to ensure the full reliability and accuracy of drug testing and 
reporting, to resolve problems related to drug testing, and to enforce 
all standards set forth in these Guidelines. The Secretary has the 
authority to issue directives to any HHS-certified laboratory, 
including suspending the use of certain analytical procedures when 
necessary to protect the integrity of the testing process; ordering any 
HHS-certified laboratory to undertake corrective actions to respond to 
material deficiencies identified by an inspection or through 
performance testing; ordering any HHS-certified laboratory to send 
specimens or specimen aliquots to another HHS-certified laboratory for 
retesting when necessary to ensure the accuracy of testing under these 
Guidelines; ordering the review of results for specimens tested under 
the Guidelines for private sector clients to the extent necessary to 
ensure the full reliability of drug testing for federal agencies; and 
ordering any other action necessary to address deficiencies in drug 
testing, analysis, specimen collection, chain of custody, reporting of 
results, or any other aspect of the certification program.
    (b) A laboratory is prohibited from stating or implying that it is 
certified by HHS under these Guidelines to test oral fluid specimens 
for federal agencies unless it holds such certification.

Section 9.2 What is the process for a laboratory to become HHS-
certified?

    (a) A laboratory seeking HHS certification must:
    (1) Submit a completed OMB-approved application form (i.e., the 
applicant laboratory provides detailed information on both the 
administrative and analytical procedures to be used for federally 
regulated specimens);
    (2) Have its application reviewed as complete and accepted by HHS;
    (3) Successfully complete the PT challenges in 3 consecutive sets 
of initial PT samples;
    (4) Satisfy all the requirements for an initial inspection; and
    (5) Receive notification of certification from the Secretary before 
testing specimens for federal agencies.

Section 9.3 What is the process for a laboratory to maintain HHS 
certification?

    (a) To maintain HHS certification, a laboratory must:
    (1) Successfully participate in both the maintenance PT and 
inspection programs (i.e., successfully test the required quarterly 
sets of maintenance PT samples, undergo an inspection 3 months after 
being certified, and undergo maintenance inspections at a minimum of 
every 6 months thereafter);
    (2) Respond in an appropriate, timely, and complete manner to 
required corrective action requests if deficiencies are identified in 
the maintenance PT performance, during the inspections, operations, or 
reporting; and
    (3) Satisfactorily complete corrective remedial actions, and 
undergo special inspection and special PT sets to maintain or restore 
certification when material deficiencies occur in either the PT 
program, inspection program, or in operations and reporting.

Section 9.4 What is the process when a laboratory does not maintain its 
HHS certification?

    (a) A laboratory that does not maintain its HHS certification must:
    (1) Stop testing federally regulated specimens;
    (2) Ensure the security of federally regulated specimens and 
records throughout the required storage period described in Sections 
11.18, 11.19, and 14.7;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.21 and 11.22 and Subpart P; and
    (4) Follow the HHS suspension and revocation procedures when 
imposed by the Secretary, follow the HHS procedures in Subpart P that 
will be

[[Page 57587]]

used for all actions associated with the suspension and/or revocation 
of HHS-certification.

Section 9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?

    (a) PT samples used to evaluate drug tests will be prepared using 
the following specifications:
    (1) PT samples may contain one or more of the drugs and drug 
metabolites in the drug classes listed in Section 3.4 and may be sent 
to the laboratory as undiluted (neat) oral fluid. The PT samples must 
satisfy one of the following parameters:
    (i) The concentration of a drug or metabolite will be at least 20 
percent above the initial test cutoff concentration for the drug or 
drug metabolite;
    (ii) The concentration of a drug or metabolite may be as low as 40 
percent of the confirmatory test cutoff concentration when the PT 
sample is designated as a retest sample; or
    (iii) The concentration of drug or metabolite may differ from 
9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
    (2) A PT sample may contain an interfering substance or other 
substances for special purposes.
    (3) A negative PT sample will not contain a measurable amount of a 
target analyte.
    (b) The laboratory must (to the greatest extent possible) handle, 
test, and report a PT sample in a manner identical to that used for a 
donor specimen, unless otherwise specified.

Section 9.6 What are the PT requirements for an applicant laboratory?

    (a) An applicant laboratory that seeks certification under these 
Guidelines must satisfy the following criteria on three consecutive 
sets of PT samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over the three sets of PT samples;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over the three sets of PT samples;
    (4) For the confirmatory drug tests, correctly determine the 
concentrations [i.e., no more than 20 percent or 2 standard deviations (whichever is larger) from the appropriate 
reference or peer group means] for at least 80 percent of the total 
drug challenges over the three sets of PT samples;
    (5) For the confirmatory drug tests, must not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group mean;
    (6) For each confirmatory drug test, correctly identify and 
determine the concentrations [i.e., no more than 20 percent 
or 2 standard deviations (whichever is larger) from the 
appropriate reference or peer group means] for at least 50 percent of 
the drug challenges for an individual drug over the three sets of PT 
samples;
    (b) Failure to satisfy these requirements will result in 
disqualification.

Section 9.7 What are the PT requirements for an HHS-certified oral 
fluid laboratory?

    (a) A laboratory certified under these Guidelines must satisfy the 
following criteria on the maintenance PT samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over two consecutive PT cycles;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over two consecutive PT cycles;
    (4) For the confirmatory drug tests, correctly determine that the 
concentrations for at least 80 percent of the total drug challenges are 
no more than 20 percent or 2 standard 
deviations (whichever is larger) from the appropriate reference or peer 
group means over two consecutive PT cycles;
    (5) For the confirmatory drug tests, obtain no more than one drug 
concentration on a PT sample that differs by more than 50 
percent from the appropriate reference or peer group mean over two 
consecutive PT cycles;
    (6) For each confirmatory drug test, correctly identify and 
determine that the concentrations for at least 50 percent of the drug 
challenges for an individual drug are no more than 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group means over two consecutive PT 
cycles;
    (b) Failure to participate in all PT cycles or to satisfy these 
requirements may result in suspension or revocation of an HHS-certified 
laboratory's certification.

Section 9.8 What are the inspection requirements for an applicant 
laboratory?

    (a) An applicant laboratory is inspected by a team of two 
inspectors.
    (b) Each inspector conducts an independent review and evaluation of 
all aspects of the laboratory's testing procedures and facilities using 
an inspection checklist.

Section 9.9 What are the maintenance inspection requirements for an 
HHS-certified laboratory?

    (a) An HHS-certified laboratory must undergo an inspection 3 months 
after becoming certified and at least every 6 months thereafter.
    (b) An HHS-certified laboratory is inspected by one or more 
inspectors. The number of inspectors is determined according to the 
number of specimens reviewed. Additional information regarding 
inspections is available from SAMHSA.
    (c) Each inspector conducts an independent evaluation and review of 
the HHS-certified laboratory's procedures, records, and facilities 
using guidance provided by the Secretary.
    (d) To remain certified, an HHS-certified laboratory must continue 
to satisfy the minimum requirements as stated in these Guidelines.

Section 9.10 Who can inspect an HHS-certified laboratory and when may 
the inspection be conducted?

    (a) An individual may be selected as an inspector for the Secretary 
if they satisfy the following criteria:
    (1) Has experience and an educational background similar to that 
required for either a responsible person or a certifying scientist for 
an HHS-certified laboratory as described in Subpart K;
    (2) Has read and thoroughly understands the policies and 
requirements contained in these Guidelines and in other guidance 
consistent with these Guidelines provided by the Secretary;
    (3) Submits a resume and documentation of qualifications to HHS;
    (4) Attends approved training; and
    (5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory.
    (b) The Secretary or a federal agency may conduct an inspection at 
any time.

Section 9.11 What happens if an applicant laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?

    If an applicant laboratory fails to satisfy the requirements 
established for the initial certification process, the laboratory must 
start the certification process from the beginning.

Section 9.12 What happens if an HHS-certified laboratory does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?

    (a) If an HHS-certified laboratory fails to satisfy the minimum 
requirements for certification, the laboratory is given a period of 
time (e.g., 5 or 30 working days depending on the nature of the

[[Page 57588]]

deficiency) to provide any explanation for its performance and evidence 
that all deficiencies have been corrected.
    (b) A laboratory's HHS certification may be revoked, suspended, or 
no further action taken depending on the seriousness of the 
deficiencies and whether there is evidence that the deficiencies have 
been corrected and that current performance meets the requirements for 
certification.
    (c) An HHS-certified laboratory may be required to undergo a 
special inspection or to test additional PT samples to address 
deficiencies.
    (d) If an HHS-certified laboratory's certification is revoked or 
suspended in accordance with the process described in Subpart P, the 
laboratory is not permitted to test federally regulated specimens until 
the suspension is lifted or the laboratory has successfully completed 
the certification requirements as a new applicant laboratory.

Section 9.13 What factors are considered in determining whether 
revocation of a laboratory's HHS certification is necessary?

    (a) The Secretary shall revoke certification of an HHS-certified 
laboratory in accordance with these Guidelines if the Secretary 
determines that revocation is necessary to ensure fully reliable and 
accurate drug test results and reports.
    (b) The Secretary shall consider the following factors in 
determining whether revocation is necessary:
    (1) Unsatisfactory performance in analyzing and reporting the 
results of drug tests (e.g., an HHS-certified laboratory reporting a 
false positive result for an employee's drug test);
    (2) Unsatisfactory participation in performance testing or 
inspections;
    (3) A material violation of a certification standard, contract 
term, or other condition imposed on the HHS-certified laboratory by a 
federal agency using the laboratory's services;
    (4) Conviction for any criminal offense committed as an incident to 
operation of the HHS-certified laboratory; or
    (5) Any other cause that materially affects the ability of the HHS-
certified laboratory to ensure fully reliable and accurate drug test 
results and reports.
    (c) The period and terms of revocation shall be determined by the 
Secretary and shall depend upon the facts and circumstances of the 
revocation and the need to ensure accurate and reliable drug testing.

Section 9.14 What factors are considered in determining whether to 
suspend a laboratory's HHS certification?

    (a) The Secretary may immediately suspend (either partially or 
fully) a laboratory's HHS certification to conduct drug testing for 
federal agencies if the Secretary has reason to believe that revocation 
may be required and that immediate action is necessary to protect the 
interests of the United States and its employees.
    (b) The Secretary shall determine the period and terms of 
suspension based upon the facts and circumstances of the suspension and 
the need to ensure accurate and reliable drug testing.

Section 9.15 How does the Secretary notify an HHS-certified laboratory 
that action is being taken against the laboratory?

    (a) When a laboratory's HHS certification is suspended or the 
Secretary seeks to revoke HHS certification, the Secretary shall 
immediately serve the HHS-certified laboratory with written notice of 
the suspension or proposed revocation by facsimile, mail, personal 
service, or registered or certified mail, return receipt requested. 
This notice shall state the following:
    (1) The reasons for the suspension or proposed revocation;
    (2) The terms of the suspension or proposed revocation; and
    (3) The period of suspension or proposed revocation.
    (b) The written notice shall state that the laboratory will be 
afforded an opportunity for an informal review of the suspension or 
proposed revocation if it so requests in writing within 30 days of the 
date the laboratory received the notice, or if expedited review is 
requested, within 3 days of the date the laboratory received the 
notice. Subpart P contains detailed procedures to be followed for an 
informal review of the suspension or proposed revocation.
    (c) A suspension must be effective immediately. A proposed 
revocation must be effective 30 days after written notice is given or, 
if review is requested, upon the reviewing official's decision to 
uphold the proposed revocation. If the reviewing official decides not 
to uphold the suspension or proposed revocation, the suspension must 
terminate immediately and any proposed revocation shall not take 
effect.
    (d) The Secretary will publish in the Federal Register the name, 
address, and telephone number of any HHS-certified laboratory that has 
its certification revoked or suspended under Section 9.13 or Section 
9.14, respectively, and the name of any HHS-certified laboratory that 
has its suspension lifted. The Secretary shall provide to any member of 
the public upon request the written notice provided to a laboratory 
that has its HHS certification suspended or revoked, as well as the 
reviewing official's written decision which upholds or denies the 
suspension or proposed revocation under the procedures of Subpart P.

Section 9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?

    Following revocation, a laboratory may apply for recertification. 
Unless otherwise provided by the Secretary in the notice of revocation 
under Section 9.15 or the reviewing official's decision under Section 
16.9(e) or 16.14(a), a laboratory which has had its certification 
revoked may reapply for HHS certification as an applicant laboratory.

Section 9.17 Where is the list of HHS-certified laboratories published?

    (a) The list of HHS-certified laboratories is published monthly in 
the Federal Register. This notice is also available on the internet at 
http://www.samhsa.gov/workplace.
    (b) An applicant laboratory is not included on the list.

Subpart J--Blind Samples Submitted by an Agency

Section 10.1 What are the requirements for federal agencies to submit 
blind samples to HHS-certified laboratories?

    (a) Each federal agency is required to submit blind samples for its 
workplace drug testing program. The collector must send the blind 
samples to the HHS-certified laboratory that the collector sends 
employee specimens.
    (b) Each federal agency must submit at least 3 percent blind 
samples along with its donor specimens based on the projected total 
number of donor specimens collected per year (up to a maximum of 400 
blind samples). Every effort should be made to ensure that blind 
samples are submitted quarterly.
    (c) Approximately 75 percent of the blind samples submitted each 
year by an agency must be negative and 25 percent must be positive for 
one or more drugs.

Section 10.2 What are the requirements for blind samples?

    (a) Drug positive blind samples must be validated by the supplier 
in the selected manufacturer's collection

[[Page 57589]]

device as to their content using appropriate initial and confirmatory 
tests.
    (1) Drug positive blind samples must be fortified with one or more 
of the drugs or metabolites listed in Section 3.4.
    (2) Drug positive blind samples must contain concentrations of 
drugs between 1.5 and 2 times the initial drug test cutoff 
concentration.
    (b) Drug negative blind samples (i.e., certified to contain no 
drugs) must be validated by the supplier in the selected manufacturer's 
collection device as negative using appropriate initial and 
confirmatory tests.
    (c) The supplier must provide information on the blind samples' 
content, validation, expected results, and stability to the collection 
site/collector sending the blind samples to the laboratory, and must 
provide the information upon request to the MRO, the federal agency for 
which the blind sample was submitted, or the Secretary.

Section 10.3 How is a blind sample submitted to an HHS-certified 
laboratory?

    (a) A blind sample must be submitted as a split specimen (specimens 
A and B) with the current Federal CCF that the HHS-certified laboratory 
uses for donor specimens. The collector provides the required 
information to ensure that the Federal CCF has been properly completed 
and provides fictitious initials on the specimen label/seal. The 
collector must indicate that the specimen is a blind sample on the MRO 
copy where a donor would normally provide a signature.
    (b) A collector should attempt to distribute the required number of 
blind samples randomly with donor specimens rather than submitting the 
full complement of blind samples as a single group.

Section 10.4 What happens if an inconsistent result is reported for a 
blind sample?

    If an HHS-certified laboratory reports a result for a blind sample 
that is inconsistent with the expected result (e.g., a laboratory 
reports a negative result for a blind sample that was supposed to be 
positive, a laboratory reports a positive result for a blind sample 
that was supposed to be negative):
    (a) The MRO must contact the laboratory and attempt to determine if 
the laboratory made an error during the testing or reporting of the 
sample;
    (b) The MRO must contact the blind sample supplier and attempt to 
determine if the supplier made an error during the preparation or 
transfer of the sample;
    (c) The MRO must contact the collector and determine if the 
collector made an error when preparing the blind sample for transfer to 
the HHS-certified laboratory;
    (d) If there is no obvious reason for the inconsistent result, the 
MRO must notify both the federal agency for which the blind sample was 
submitted and the Secretary; and
    (e) The Secretary shall investigate the blind sample error. A 
report of the Secretary's investigative findings and the corrective 
action taken in response to identified deficiencies must be sent to the 
federal agency. The Secretary shall ensure notification of the finding 
as appropriate to other federal agencies and coordinate any necessary 
actions to prevent the recurrence of the error.

Subpart K--Laboratory

Section 11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?

    (a) An HHS-certified laboratory must have a standard operating 
procedure (SOP) manual that describes, in detail, all HHS-certified 
laboratory operations. When followed, the SOP manual ensures that all 
specimens are tested using the same procedures.
    (b) The SOP manual must include at a minimum, but is not limited 
to, a detailed description of the following:
    (1) Chain of custody procedures;
    (2) Accessioning;
    (3) Security;
    (4) Quality control/quality assurance programs;
    (5) Analytical methods and procedures;
    (6) Equipment and maintenance programs;
    (7) Personnel training;
    (8) Reporting procedures; and
    (9) Computers, software, and laboratory information management 
systems.
    (c) All procedures in the SOP manual must be compliant with these 
Guidelines and all guidance provided by the Secretary.
    (d) A copy of all procedures that have been replaced or revised and 
the dates on which the procedures were in effect must be maintained for 
at least 2 years.

Section 11.2 What are the responsibilities of the responsible person 
(RP)?

    (a) Manage the day-to-day operations of the HHS-certified 
laboratory even if another individual has overall responsibility for 
alternate areas of a multi-specialty laboratory.
    (b) Ensure that there are sufficient personnel with adequate 
training and experience to supervise and conduct the work of the HHS-
certified laboratory. The RP must ensure the continued competency of 
laboratory staff by documenting their in-service training, reviewing 
their work performance, and verifying their skills.
    (c) Maintain a complete and current SOP manual that is available to 
all personnel of the HHS-certified laboratory and ensure that it is 
followed. The SOP manual must be reviewed, signed, and dated by the 
RP(s) when procedures are first placed into use and when changed or 
when a new individual assumes responsibility for the management of the 
HHS-certified laboratory. The SOP must be reviewed and documented by 
the RP annually.
    (d) Maintain a quality assurance program that ensures the proper 
performance and reporting of all test results; verify and monitor 
acceptable analytical performance for all controls and calibrators; 
monitor quality control testing; and document the validity, 
reliability, accuracy, precision, and performance characteristics of 
each test and test system.
    (e) Initiate and implement all remedial actions necessary to 
maintain satisfactory operation and performance of the HHS-certified 
laboratory in response to the following: Quality control systems not 
within performance specifications; errors in result reporting or in 
analysis of performance testing samples; and inspection deficiencies. 
The RP must ensure that specimen results are not reported until all 
corrective actions have been taken and that the results provided are 
accurate and reliable.

Section 11.3 What scientific qualifications must the RP have?

    The RP must have documented scientific qualifications in analytical 
toxicology.
    Minimum qualifications are:
    (a) Certification or licensure as a laboratory director by the 
state in forensic or clinical laboratory toxicology, a Ph.D. in one of 
the natural sciences, or training and experience comparable to a Ph.D. 
in one of the natural sciences with training and laboratory/research 
experience in biology, chemistry, and pharmacology or toxicology;
    (b) Experience in forensic toxicology with emphasis on the 
collection and analysis of biological specimens for drugs of abuse;
    (c) Experience in forensic applications of analytical toxicology 
(e.g., publications, court testimony,

[[Page 57590]]

conducting research on the pharmacology and toxicology of drugs of 
abuse) or qualify as an expert witness in forensic toxicology;
    (d) Fulfillment of the RP responsibilities and qualifications, as 
demonstrated by the HHS-certified laboratory's performance and verified 
upon interview by HHS-trained inspectors during each on-site 
inspection; and
    (e) Qualify as a certifying scientist.

Section 11.4 What happens when the RP is absent or leaves an HHS-
certified laboratory?

    (a) HHS-certified laboratories must have multiple RPs or one RP and 
an alternate RP. If the RP(s) are concurrently absent, an alternate RP 
must be present and qualified to fulfill the responsibilities of the 
RP.
    (1) If an HHS-certified laboratory is without the RP and alternate 
RP for 14 calendar days or less (e.g., temporary absence due to 
vacation, illness, or business trip), the HHS-certified laboratory may 
continue operations and testing of federal agency specimens under the 
direction of a certifying scientist.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all specimens if the 
laboratory does not have an RP or alternate RP for a period of more 
than 14 calendar days. The suspension will be lifted upon the 
Secretary's approval of a new permanent RP or alternate RP.
    (b) If the RP leaves an HHS-certified laboratory:
    (1) The HHS-certified laboratory may maintain certification and 
continue testing federally regulated specimens under the direction of 
an alternate RP for a period of up to 180 days while seeking to hire 
and receive the Secretary's approval of the RP's replacement.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all federally regulated 
specimens if the laboratory does not have a permanent RP within 180 
days. The suspension will be lifted upon the Secretary's approval of 
the new permanent RP.
    (c) To nominate an individual as an RP or alternate RP, the HHS-
certified laboratory must submit the following documents to the 
Secretary: The candidate's current resume or curriculum vitae, copies 
of diplomas and licensures, a training plan (not to exceed 90 days) to 
transition the candidate into the position, an itemized comparison of 
the candidate's qualifications to the minimum RP qualifications 
described in the Guidelines, and have official academic transcript(s) 
submitted from the candidate's institution(s) of higher learning. The 
candidate must be found qualified during an on-site inspection of the 
HHS-certified laboratory.
    (d) The HHS-certified laboratory must fulfill additional inspection 
and PT criteria as required prior to conducting federally regulated 
testing under a new RP.

Section 11.5 What qualifications must an individual have to certify a 
result reported by an HHS-certified laboratory?

    (a) A certifying scientist must have:
    (1) At least a bachelor's degree in the chemical or biological 
sciences or medical technology, or equivalent;
    (2) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (3) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.
    (b) A certifying technician must have:
    (1) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (2) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.

Section 11.6 What qualifications and training must other personnel of 
an HHS-certified laboratory have?

    (a) All HHS-certified laboratory staff (e.g., technicians, 
administrative staff) must have the appropriate training and skills for 
the tasks they perform.
    (b) Each individual working in an HHS-certified laboratory must be 
properly trained (i.e., receive training in each area of work that the 
individual will be performing, including training in forensic 
procedures related to their job duties) before they are permitted to 
work independently with federally regulated specimens. All training 
must be documented.

Section 11.7 What security measures must an HHS-certified laboratory 
maintain?

    (a) An HHS-certified laboratory must control access to the drug 
testing facility, specimens, aliquots, and records.
    (b) Authorized visitors must be escorted at all times, except for 
individuals conducting inspections (i.e., for the Department, a federal 
agency, a state, or other accrediting agency) or emergency personnel 
(e.g., firefighters and medical rescue teams).
    (c) An HHS-certified laboratory must maintain records documenting 
the identity of the visitor and escort, date, time of entry and exit, 
and purpose for access to the secured area.

Section 11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?

    (a) HHS-certified laboratories must use chain of custody procedures 
(internal and external) to maintain control and accountability of 
specimens from the time of receipt at the laboratory through completion 
of testing, reporting of results, during storage, and continuing until 
final disposition of the specimens.
    (b) HHS-certified laboratories must use chain of custody procedures 
to document the handling and transfer of aliquots throughout the 
testing process until final disposal.
    (c) The chain of custody must be documented using either paper copy 
or electronic procedures.
    (d) Each individual who handles a specimen or aliquot must sign and 
complete the appropriate entries on the chain of custody form when the 
specimen or aliquot is handled or transferred, and every individual in 
the chain must be identified.
    (e) The date and purpose must be recorded on an appropriate chain 
of custody form each time a specimen or aliquot is handled or 
transferred.

Section 11.9 What are the requirements for an initial drug test?

    (a) An initial drug test may be:
    (1) An immunoassay or
    (2) An alternate technology (e.g., spectrometry, spectroscopy).
    (b) An HHS-certified laboratory must validate an initial drug test 
before testing specimens.
    (c) Initial drug tests must be accurate and reliable for the 
testing of specimens when identifying drugs or their metabolites.
    (d) An HHS-certified laboratory may conduct a second initial drug 
test using a method with different specificity, to rule out cross-
reacting compounds. This second initial drug test must satisfy the 
batch quality control requirements specified in Section 11.11.

[[Page 57591]]

Section 11.10 What must an HHS-certified laboratory do to validate an 
initial drug test?

    (a) An HHS-certified laboratory must demonstrate and document the 
following for each initial drug test:
    (1) The ability to differentiate negative specimens from those 
requiring further testing;
    (2) The performance of the test around the cutoff concentration, 
using samples at several concentrations between 0 and 150 percent of 
the cutoff concentration;
    (3) The effective concentration range of the test (linearity);
    (4) The potential for carryover;
    (5) The potential for interfering substances; and
    (6) The potential matrix effects if using an alternate technology.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) Each initial drug test using an alternate technology must be 
re-verified periodically or at least annually.

Section 11.11 What are the batch quality control requirements when 
conducting an initial drug test?

    (a) Each batch of specimens must contain the following controls:
    (1) At least one control certified to contain no drug or drug 
metabolite;
    (2) At least one positive control with the drug or drug metabolite 
targeted at a concentration 25 percent above the cutoff;
    (3) At least one control with the drug or drug metabolite targeted 
at a concentration 75 percent of the cutoff; and
    (4) At least one control that appears as a donor specimen to the 
analysts.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.

Section 11.12 What are the requirements for a confirmatory drug test?

    (a) The analytical method must use mass spectrometric 
identification [e.g., gas chromatography/mass spectrometry (GC/MS), 
liquid chromatography/mass spectrometry (LC/MS), GC/MS/MS, LC/MS/MS] or 
equivalent.
    (b) A confirmatory drug test must be validated before it can be 
used to test federally regulated specimens.
    (c) Confirmatory drug tests must be accurate and reliable for the 
testing of an oral fluid specimen when identifying and quantifying 
drugs or their metabolites.

Section 11.13 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?

    (a) An HHS-certified laboratory must demonstrate and document the 
following for each confirmatory drug test:
    (1) The linear range of the analysis;
    (2) The limit of detection;
    (3) The limit of quantification;
    (4) The accuracy and precision at the cutoff concentration;
    (5) The accuracy (bias) and precision at 40 percent of the cutoff 
concentration;
    (6) The potential for interfering substances;
    (7) The potential for carryover; and
    (8) The potential matrix effects if using liquid chromatography 
coupled with mass spectrometry.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) HHS-certified laboratories must re-verify each confirmatory 
drug test method periodically or at least annually.

Section 11.14 What are the batch quality control requirements when 
conducting a confirmatory drug test?

    (a) At a minimum, each batch of specimens must contain the 
following calibrators and controls:
    (1) A calibrator at the cutoff concentration;
    (2) At least one control certified to contain no drug or drug 
metabolite;
    (3) At least one positive control with the drug or drug metabolite 
targeted at 25 percent above the cutoff; and
    (4) At least one control targeted at or less than 40 percent of the 
cutoff.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.

Section 11.15 What are the analytical and quality control requirements 
for conducting specimen validity tests?

    (a) Each invalid or adulterated specimen validity test result must 
be based on an initial specimen validity test on one aliquot and a 
confirmatory specimen validity test on a second aliquot;
    (b) The HHS-certified laboratory must establish acceptance criteria 
and analyze calibrators and controls as appropriate to verify and 
document the validity of the test results; and
    (c) Controls must be analyzed concurrently with specimens.

Section 11.16 What must an HHS-certified laboratory do to validate a 
specimen validity test?

    An HHS-certified laboratory must demonstrate and document for each 
specimen validity test the appropriate performance characteristics of 
the test, and must re-verify the test periodically, or at least 
annually. Each new lot of reagent must be verified prior to being 
placed into service.

Section 11.17 What are the requirements for an HHS-certified laboratory 
to report a test result?

    (a) Laboratories must report a test result to the agency's MRO 
within an average of 5 working days after receipt of the specimen. 
Reports must use the Federal CCF and/or an electronic report. Before 
any test result can be reported, it must be certified by a certifying 
scientist or a certifying technician (as appropriate).
    (b) A primary (A) specimen is reported negative when each initial 
drug test is negative or if the specimen is negative upon confirmatory 
drug testing, and the specimen does not meet invalid criteria as 
described in items (e)(1) through (e)(4) below.
    (c) A primary (A) specimen is reported positive for a specific drug 
or drug metabolite when both the initial drug test is positive and the 
confirmatory drug test is positive in accordance with Section 3.4.
    (d) For a specimen that has an invalid result for one of the 
reasons stated in items (e)(1) through (e)(4) below, the HHS-certified 
laboratory shall contact the MRO and both will decide if testing by 
another HHS-certified laboratory would be useful in being able to 
report a positive or adulterated result. If no further testing is 
necessary, the HHS-certified laboratory then reports the invalid result 
to the MRO.
    (e) A primary (A) oral fluid specimen is reported as an invalid 
result when:
    (1) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (2) Interference with the confirmatory drug test occurs on at least 
two separate aliquots of the specimen and the HHS-certified laboratory 
is unable to identify the interfering substance;
    (3) The physical appearance of the specimen is such that testing 
the specimen may damage the laboratory's instruments;
    (4) The physical appearances of the A and B specimens are clearly 
different (note: A is tested); or
    (5) The concentration of a biomarker (e.g., albumin or IgG) is not 
consistent with that established for human oral fluid.
    (f) An HHS-certified laboratory shall reject a primary (A) specimen 
for testing when a fatal flaw occurs as described in Section 15.1 or 
when a correctable flaw as described in Section 15.2 is not

[[Page 57592]]

recovered. The HHS-certified laboratory will indicate on the Federal 
CCF that the specimen was rejected for testing and provide the reason 
for reporting the rejected for testing result.
    (g) An HHS-certified laboratory must report all positive, 
adulterated, and invalid test results for an oral fluid specimen. For 
example, a specimen can be positive for a specific drug and 
adulterated.
    (h) An HHS-certified laboratory must report the confirmatory 
concentration of each drug or drug metabolite reported for a positive 
result.
    (i) An HHS-certified laboratory must report numerical values of the 
specimen validity test results that support a specimen that is reported 
adulterated or invalid (as appropriate).
    (j) When the concentration of a drug or drug metabolite exceeds the 
validated linear range of the confirmatory test, HHS-certified 
laboratories may report to the MRO that the quantitative value exceeds 
the linear range of the test or that the quantitative value is greater 
than ``insert the actual value for the upper limit of the linear 
range,'' or laboratories may report a quantitative value above the 
upper limit of the linear range that was obtained by diluting an 
aliquot of the specimen to achieve a result within the method's linear 
range and multiplying the result by the appropriate dilution factor.
    (k) HHS-certified laboratories may transmit test results to the MRO 
by various electronic means (e.g., teleprinter, facsimile, or 
computer). Transmissions of the reports must ensure confidentiality and 
the results may not be reported verbally by telephone. Laboratories and 
external service providers must ensure the confidentiality, integrity, 
and availability of the data and limit access to any data transmission, 
storage, and retrieval system.
    (l) HHS-certified laboratories must facsimile, courier, mail, or 
electronically transmit a legible image or copy of the completed 
Federal CCF and/or forward a computer-generated electronic report. The 
computer-generated report must contain sufficient information to ensure 
that the test results can accurately represent the content of the 
custody and control form that the MRO received from the collector.
    (m) For positive, adulterated, invalid, and rejected specimens, 
laboratories must facsimile, courier, mail, or electronically transmit 
a legible image or copy of the completed Federal CCF.

Section 11.18 How long must an HHS-certified laboratory retain 
specimens?

    (a) An HHS-certified laboratory must retain specimens that were 
reported as positive, adulterated, or as an invalid result for a 
minimum of 1 year.
    (b) Retained specimens must be kept in secured frozen storage (-20 
[deg]C or less) to ensure their availability for retesting during an 
administrative or judicial proceeding.
    (c) Federal agencies may request that the HHS-certified laboratory 
retain a specimen for an additional specified period of time and must 
make that request within the 1-year period.

Section 11.19 How long must an HHS-certified laboratory retain records?

    (a) An HHS-certified laboratory must retain all records generated 
to support test results for at least 2 years. The laboratory may 
convert hardcopy records to electronic records for storage and then 
discard the hardcopy records after 6 months.
    (b) A federal agency may request the HHS-certified laboratory to 
maintain a documentation package (as described in Section 11.21) that 
supports the chain of custody, testing, and reporting of a donor's 
specimen that is under legal challenge by a donor. The federal agency's 
request to the laboratory must be in writing and must specify the 
period of time to maintain the documentation package.
    (c) An HHS-certified laboratory may retain records other than those 
included in the documentation package beyond the normal 2-year period 
of time.

Section 11.20 statistical summary reports must an HHS-certified 
laboratory provide for oral fluid testing?

    (a) HHS-certified laboratories must provide to each federal agency 
for which they perform testing a semiannual statistical summary report 
that must be submitted by mail, facsimile, or email within 14 working 
days after the end of the semiannual period. The summary report must 
not include any personal identifying information. A copy of the 
semiannual statistical summary report will also be sent to the 
Secretary or designated HHS representative. The semiannual statistical 
report contains the following information:
    (1) Reporting period (inclusive dates);
    (2) HHS-certified laboratory name and address;
    (3) Federal agency name;
    (4) Number of specimen results reported;
    (5) Number of specimens collected by reason for test;
    (6) Number of specimens reported negative;
    (7) Number of specimens rejected for testing because of a fatal 
flaw;
    (8) Number of specimens rejected for testing because of an 
uncorrected flaw;
    (9) Number of specimens tested positive by each initial drug test;
    (10) Number of specimens reported positive;
    (11) Number of specimens reported positive for each drug and drug 
metabolite;
    (12) Number of specimens reported adulterated; and
    (13) Number of specimens reported as invalid result.
    (b) An HHS-certified laboratory must make copies of an agency's 
test results available when requested to do so by the Secretary or by 
the federal agency for which the laboratory is performing drug-testing 
services.
    (c) An HHS-certified laboratory must ensure that a qualified 
individual is available to testify in a proceeding against a federal 
employee when the proceeding is based on a test result reported by the 
laboratory.

Section 11.21 What HHS-certified laboratory information is available to 
a federal agency?

    (a) Following a federal agency's receipt of a positive or 
adulterated drug test report, the federal agency may submit a written 
request for copies of the records relating to the drug test results or 
a documentation package or any relevant certification, review, or 
revocation of certification records.
    (b) Standard documentation packages provided by an HHS-certified 
laboratory must contain the following items:
    (1) A cover sheet providing a brief description of the procedures 
and tests performed on the donor's specimen;
    (2) A table of contents that lists all documents and materials in 
the package by page number;
    (3) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the HHS-certified laboratory, and a copy of the electronic report (if 
any) generated by the HHS-certified laboratory;
    (4) A brief description of the HHS-certified laboratory's initial 
drug (and specimen validity, if applicable) testing procedures, 
instrumentation, and batch quality control requirements;
    (5) Copies of the initial test data for the donor's specimen with 
all calibrators and controls and copies of all internal chain of 
custody documents related to the initial tests;
    (6) A brief description of the HHS-certified laboratory's 
confirmatory drug

[[Page 57593]]

(and specimen validity, if applicable) testing procedures, 
instrumentation, and batch quality control requirements;
    (7) Copies of the confirmatory test data for the donor's specimen 
with all calibrators and controls and copies of all internal chain of 
custody documents related to the confirmatory tests; and
    (8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the 
RP(s) and the certifying technician or certifying scientist of record.

Section 11.22 What HHS-certified laboratory information is available to 
a federal employee?

    A federal employee who is the subject of a workplace drug test may 
submit a written request through the MRO and/or the federal agency 
requesting copies of any records relating to the employee's drug test 
results or a documentation package as described in Section 11.21(b) and 
any relevant certification, review, or revocation of certification 
records. Federal employees, or their designees, are not permitted 
access to their specimens collected pursuant to Executive Order 12564, 
Public Law 100-71, and these Guidelines.

Section 11.23 What types of relationships are prohibited between an 
HHS-certified laboratory and an MRO?

    An HHS-certified laboratory must not enter into any relationship 
with a federal agency's MRO that may be construed as a potential 
conflict of interest or derive any financial benefit by having a 
federal agency use a specific MRO.
    This means an MRO may be an employee of the agency or a contractor 
for the agency; however, an MRO shall not be an employee or agent of or 
have any financial interest in the HHS-certified laboratory for which 
the MRO is reviewing drug testing results. Additionally, an MRO shall 
not derive any financial benefit by having an agency use a specific 
HHS-certified laboratory or have any agreement with an HHS-certified 
laboratory that may be construed as a potential conflict of interest.

Subpart L--Instrumented Initial Test Facility (IITF)

Section 12.1 May an IITF test oral fluid specimens for a federal 
agency's workplace drug testing program?

    No, only HHS-certified laboratories are authorized to test oral 
fluid specimens for federal agency workplace drug testing programs in 
accordance with these Guidelines.

Subpart M--Medical Review Officer (MRO)

Section 13.1 Who may serve as an MRO?

    (a) A currently licensed physician who has:
    (1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) 
degree;
    (2) Knowledge regarding the pharmacology and toxicology of illicit 
drugs;
    (3) The training necessary to serve as an MRO as set out in Section 
13.3;
    (4) Satisfactorily passed an initial examination administered by a 
nationally recognized entity or subspecialty board that has been 
approved by the Secretary to certify MROs; and
    (5) At least every five years from initial certification, completed 
requalification training on the topics in Section 13.3 and 
satisfactorily passed a requalification examination administered by a 
nationally recognized entity or a subspecialty board that has been 
approved by the Secretary to certify MROs.

Section 13.2 How are nationally recognized entities or subspecialty 
boards that certify MROs approved?

    All nationally recognized entities or subspecialty boards which 
seek approval by the Secretary to certify physicians as MROs for 
federal workplace drug testing programs must submit their 
qualifications, a sample examination, and other necessary supporting 
examination materials (e.g., answers, previous examination statistics 
or other background examination information, if requested). Approval 
will be based on an objective review of qualifications that include a 
copy of the MRO applicant application form, documentation that the 
continuing education courses are accredited by a professional 
organization, and the delivery method and content of the examination. 
Each approved MRO certification entity must resubmit their 
qualifications for approval every two years. The Secretary shall 
publish at least every two years a notice in the Federal Register 
listing those entities and subspecialty boards that have been approved. 
This notice is also available on the internet at http://www.samhsa.gov/workplace/drug-testing.

Section 13.3 What training is required before a physician may serve as 
an MRO?

    (a) A physician must receive training that includes a thorough 
review of the following:
    (1) The collection procedures used to collect federal agency 
specimens;
    (2) How to interpret test results reported by HHS-certified IITFs 
and laboratories (e.g., negative, negative/dilute, positive, 
adulterated, substituted, rejected for testing, and invalid);
    (3) Chain of custody, reporting, and recordkeeping requirements for 
federal agency specimens;
    (4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing 
Programs for all authorized specimen types; and
    (5) Procedures for interpretation, review (e.g., donor interview 
for legitimate medical explanations, review of documentation provided 
by the donor to support a legitimate medical explanation), and 
reporting of results specified by any federal agency for which the 
individual may serve as an MRO;
    (b) Certified MROs must complete training on any revisions to these 
Guidelines prior to their effective date, to continue serving as an MRO 
for federal agency specimens.

Section 13.4 What are the responsibilities of an MRO?

    (a) The MRO must review all positive, adulterated, rejected for 
testing, invalid, and (for urine) substituted test results.
    (b) Staff under the direct, personal supervision of the MRO may 
review and report negative and (for urine) negative/dilute test results 
to the agency's designated representative. The MRO must review at least 
5 percent of all negative results reported by the MRO staff to ensure 
that the MRO staff are properly performing the review process.
    (c) The MRO must discuss potential invalid results with the HHS-
certified laboratory, as addressed in Section 11.17(d) to determine 
whether testing at another HHS-certified laboratory may be warranted.
    (d) After receiving a report from an HHS-certified laboratory or 
(for urine) HHS-certified IITF, the MRO must:
    (1) Review the information on the MRO copy of the Federal CCF that 
was received from the collector and the report received from the HHS-
certified laboratory or HHS-certified IITF;
    (2) Interview the donor when required;
    (3) Make a determination regarding the test result; and
    (4) Report the verified result to the federal agency.
    (e) The MRO must maintain records for a minimum of 2 years while 
maintaining the confidentiality of the information. The MRO may convert 
hardcopy records to electronic records

[[Page 57594]]

for storage and discard the hardcopy records after 6 months.
    (f) The MRO must conduct a medical examination or a review of the 
examining physician's findings and make a determination of refusal to 
test or cancelled test when a collector reports that the donor was 
unable to provide a specimen, as addressed in Section 8.6.

Section 13.5 What must an MRO do when reviewing an oral fluid 
specimen's test results?

    (a) When the HHS-certified laboratory reports a negative result for 
the primary (A) specimen, the MRO reports a negative result to the 
agency.
    (b) When the HHS-certified laboratory reports multiple results for 
the primary (A) specimen, as the MRO, you must follow the verification 
procedures described in 13.5(c) through (f) and:
    (1) Report all verified positive and/or refusal to test results to 
the federal agency.
    (2) If an invalid result was reported in conjunction with a 
positive or adulterated result, do not report the verified invalid 
result to the federal agency at this time. The MRO reports the verified 
invalid result(s) for the primary (A) specimen only if the split 
specimen is tested and reported as a failure to reconfirm as described 
in Section 14.5(c).
    (c) When the HHS-certified laboratory reports a positive result for 
the primary (A) specimen, the MRO must contact the donor to determine 
if there is any legitimate medical explanation for the positive result.
    (1) If the donor provides documentation (e.g., a valid 
prescription) to support a legitimate medical explanation for the 
positive result, the MRO reports the test result as negative to the 
agency.
    (i) Passive exposure to a drug (e.g., exposure to secondhand 
marijuana smoke) is not a legitimate medical explanation for a positive 
drug test result.
    (ii) Ingestion of food products containing marijuana is not a 
legitimate medical explanation for a positive drug test result.
    (2) If the donor is unable to provide a legitimate medical 
explanation, the MRO reports a positive result to the agency for all 
drugs except codeine and/or morphine as follows:
    (i) For codeine and/or morphine less than 150 ng/mL and no 
legitimate medical explanation: The MRO must determine if there is 
clinical evidence of illegal use (in addition to the drug test result) 
to report a positive result to the agency. If there is no clinical 
evidence of illegal use, the MRO reports a negative result to the 
agency. However, this requirement does not apply if the laboratory 
confirms the presence of 6-acetylmorphine (i.e., the presence of this 
metabolite is proof of heroin use).
    (ii) For codeine and/or morphine equal to or greater than 150 ng/mL 
and no legitimate medical explanation: The MRO reports a positive 
result to the agency. Consumption of food products must not be 
considered a legitimate medical explanation for the donor having 
morphine or codeine at or above this concentration.
    (d) When the HHS-certified laboratory reports an adulterated result 
for the primary (A) oral fluid specimen, the MRO contacts the donor to 
determine if the donor has a legitimate medical explanation for the 
adulterated result.
    (1) If the donor provides a legitimate medical explanation, the MRO 
reports a negative result to the federal agency.
    (2) If the donor is unable to provide a legitimate medical 
explanation, the MRO reports a refusal to test to the federal agency 
because the oral fluid specimen was adulterated.
    (e) When the HHS-certified laboratory reports an invalid result for 
the primary (A) oral fluid specimen, the MRO must contact the donor to 
determine if there is a legitimate explanation for the invalid result.
    (1) If the donor provides a legitimate explanation (e.g., a 
prescription medication), the MRO reports a test cancelled result with 
the reason for the invalid result and informs the federal agency that a 
recollection is not required because there is a legitimate explanation 
for the invalid result.
    (2) If the donor is unable to provide a legitimate explanation, the 
MRO reports a test cancelled result with the reason for the invalid 
result and directs the agency to collect another specimen from the 
donor.
    (i) If the second specimen collected provides a valid result, the 
MRO follows the procedures in 13.5(a) through (d).
    (ii) If the second specimen collected provides an invalid result, 
the MRO reports this specimen as test cancelled and recommends that the 
agency collect another authorized specimen type (e.g., urine).
    (f) When the HHS-certified laboratory reports a rejected for 
testing result for the primary (A) specimen, the MRO reports a test 
cancelled result to the agency and recommends that the agency collect 
another specimen from the donor.

13.6 What action does the MRO take when the collector reports that the 
donor did not provide a sufficient amount of oral fluid for a drug 
test?

    (a) When another specimen type (e.g., urine) was collected as 
authorized by the federal agency, the MRO reviews and reports the test 
result in accordance with the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using the alternative specimen.
    (b) When the federal agency did not authorize the collection of an 
alternative specimen, the MRO consults with the federal agency. The 
federal agency immediately directs the donor to obtain, within five 
days, an evaluation from a licensed physician, acceptable to the MRO, 
who has expertise in the medical issues raised by the donor's failure 
to provide a specimen. The MRO may perform this evaluation if the MRO 
has appropriate expertise.
    (1) For purposes of this section, a medical condition includes an 
ascertainable physiological condition. Permanent or long-term medical 
conditions are those physiological, anatomic, or psychological 
abnormalities documented as being present prior to the attempted 
collection, and considered not amenable to correction or cure for an 
extended period of time.
    (2) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the donor was required to take a federally regulated drug 
test, but was unable to provide a sufficient amount of oral fluid to 
complete the test;
    (ii) The consequences of the appropriate federal agency regulation 
for refusing to take the required drug test;
    (iii) That, after completing the evaluation, the referral physician 
must agree to provide a written statement to the MRO with a 
recommendation for one of the determinations described in paragraph 
(b)(3) of this section and the basis for the recommendation. The 
statement must not include detailed information on the employee's 
medical condition beyond what is necessary to explain the referral 
physician's conclusion.
    (3) As the MRO, if another physician performed the evaluation, you 
must consider and assess the referral physician's recommendations in 
making your determination. You must make one of the following 
determinations and report it to the federal agency in writing:
    (i) A medical condition as defined in paragraph (b)(1) of this 
section has, or

[[Page 57595]]

with a high degree of probability could have, precluded the employee 
from providing a sufficient amount of oral fluid, but is not a 
permanent or long-term disability. As the MRO, you must report a test 
cancelled result to the federal agency.
    (ii) A permanent or long-term medical condition as defined in 
paragraph (b)(1) of this section has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of oral fluid and is highly likely to prevent the 
employee from providing a sufficient amount of oral fluid for a very 
long or indefinite period of time. As the MRO, you must follow the 
requirements of Section 13.7, as appropriate. If Section 13.7 is not 
applicable, you report a test cancelled result to the federal agency 
and recommend that the agency authorize collection of an alternative 
specimen type (e.g., urine) for any subsequent drug tests for the 
donor.
    (iii) There is not an adequate basis for determining that a medical 
condition has or, with a high degree of probability, could have 
precluded the employee from providing a sufficient amount of oral 
fluid. As the MRO, you must report a refusal to test to the federal 
agency.
    (4) When a federal agency receives a report from the MRO indicating 
that a test is cancelled as provided in paragraph (b)(3)(i) of this 
section, the agency takes no further action with respect to the donor. 
When a test is canceled as provided in paragraph (b)(3)(ii) of this 
section, the agency takes no further action with respect to the donor 
other than designating collection of an alternate specimen type (i.e., 
authorized by the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs) for any subsequent collections, in accordance with 
the federal agency plan. The donor remains in the random testing pool.

13.7 What happens when an individual is unable to provide a sufficient 
amount of oral fluid for a federal agency applicant/pre-employment 
test, a follow-up test, or a return-to-duty test because of a permanent 
or long-term medical condition?

    (a) This section concerns a situation in which the donor has a 
medical condition that precludes the donor from providing a sufficient 
specimen for a federal agency applicant/pre-employment test, a follow-
up test, or a return-to-duty test and the condition involves a 
permanent or long-term disability and the federal agency does not 
authorize collection of an alternative specimen. As the MRO in this 
situation, you must do the following:
    (1) You must determine if there is clinical evidence that the 
individual is an illicit drug user. You must make this determination by 
personally conducting, or causing to be conducted, a medical evaluation 
and through consultation with the donor's physician and/or the 
physician who conducted the evaluation under Section 13.6.
    (2) If you do not personally conduct the medical evaluation, you 
must ensure that one is conducted by a licensed physician acceptable to 
you.
    (b) If the medical evaluation reveals no clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
negative test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state the basis for the determination 
that a permanent or long-term medical condition exists, making 
provision of a sufficient oral fluid specimen impossible, and for the 
determination that no signs and symptoms of drug use exist. The MRO 
recommends that the agency authorize collection of an alternate 
specimen type (e.g., urine) for any subsequent collections.
    (c) If the medical evaluation reveals clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
cancelled test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state that a permanent or long-term 
medical condition [as defined in Section 13.6 (b)(1)] exists, making 
provision of a sufficient oral fluid specimen impossible, and state the 
reason for the determination that signs and symptoms of drug use exist. 
Because this is a cancelled test, it does not serve the purposes of a 
negative test (e.g., the federal agency is not authorized to allow the 
donor to begin or resume performing official functions because a 
negative test is needed for that purpose).

Section 13.8 Who may request a test of a split (B) specimen?

    (a) For a positive or adulterated result reported on a primary (A) 
specimen, a donor may request through the MRO that the split (B) 
specimen be tested by a second HHS-certified laboratory to verify the 
result reported by the first HHS-certified laboratory.
    (b) The donor has 72 hours (from the time the MRO notified the 
donor that the donor's specimen was reported positive, adulterated, or 
(for urine) substituted to request a test of the split (B) specimen. 
The MRO must inform the donor that the donor has the opportunity to 
request a test of the split (B) specimen when the MRO informs the donor 
that a positive, adulterated, or (for urine) substituted result is 
being reported to the federal agency on the primary (A) specimen.

Section 13.9 How does an MRO report a primary (A) specimen test result 
to an agency?

    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, facsimile, or computer). Transmissions of 
the reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all 
positive, adulterated, and (for urine) substituted results.
    (d) The MRO must not disclose numerical values of drug test results 
to the agency.

Section 13.10 at types of relationships are prohibited between an MRO 
and an HHS-certified laboratory?

    An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory for which the MRO is reviewing 
drug test results.
    This means an MRO must not derive any financial benefit by having 
an agency use a specific HHS-certified laboratory or have any agreement 
with the HHS-certified laboratory that may be construed as a potential 
conflict of interest.

Subpart N--Split Specimen Tests

Section 14.1 When may a split (B) specimen be tested?

    (a) The donor may request, verbally or in writing, through the MRO 
that the split (B) specimen be tested at a different (i.e., second) 
HHS-certified oral fluid laboratory when the primary (A) specimen was 
determined by the MRO to be positive, adulterated, or (for urine) 
substituted.
    (b) A donor has 72 hours to initiate the request after being 
informed of the result by the MRO. The MRO must

[[Page 57596]]

document in the MRO's records the verbal request from the donor to have 
the split (B) specimen tested.
    (c) If a split (B) oral fluid specimen cannot be tested by a second 
HHS-certified laboratory (e.g., insufficient specimen, lost in transit, 
split not available, no second HHS-certified laboratory available to 
perform the test), the MRO reports to the federal agency that the test 
must be cancelled and the reason for the cancellation. The MRO directs 
the federal agency to ensure the immediate recollection of another oral 
fluid specimen from the donor, with no notice given to the donor of 
this collection requirement until immediately before the collection.
    (d) If a donor chooses not to have the split (B) specimen tested by 
a second HHS-certified oral fluid laboratory, a federal agency may have 
a split (B) specimen retested as part of a legal or administrative 
proceeding to defend an original positive, adulterated, or (for urine) 
substituted result.

Section 14.2 How does an HHS-certified laboratory test a split (B) 
specimen when the primary (A) specimen was reported positive?

    (a) The testing of a split (B) specimen for a drug or metabolite is 
not subject to the testing cutoff concentrations established.
    (b) The HHS-certified laboratory is only required to confirm the 
presence of the drug or metabolite that was reported positive in the 
primary (A) specimen.

Section 14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported adulterated?

    (a) The HHS-certified laboratory must use its confirmatory specimen 
validity test at an established limit of quantification (LOQ) to 
reconfirm the presence of the adulterant.
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
adulterated result reported by the first HHS-certified laboratory.

Section 14.4 Who receives the split (B) specimen result?

    The second HHS-certified laboratory must report the result to the 
MRO.

Section 14.5 What action(s) does an MRO take after receiving the split 
(B) oral fluid specimen result from the second HHS-certified 
laboratory?

    The MRO takes the following actions when the second HHS-certified 
laboratory reports the result for the split (B) oral fluid specimen as:
    (a) Reconfirmed the drug(s) or adulteration result. The MRO reports 
reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
adulterated. If the donor provides a legitimate medical explanation for 
the adulteration result, the MRO reports a failed to reconfirm [specify 
drug(s)] and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm [specify drug(s)] 
and a refusal to test to the agency and indicates the adulterant that 
is present in the specimen. The MRO gives the donor 72 hours to request 
that Laboratory A retest the primary (A) specimen for the adulterant. 
If Laboratory A reconfirms the adulterant, the MRO reports refusal to 
test and indicates the adulterant present. If Laboratory A fails to 
reconfirm the adulterant, the MRO cancels both tests and directs the 
agency to immediately collect another specimen. The MRO shall notify 
the appropriate regulatory office about the failed to reconfirm and 
cancelled test.
    (c) Failed to reconfirm a single or all drug positive results and 
not adulterated. The MRO reports to the agency a failed to reconfirm 
result [specify drug(s)], cancels both tests, and notifies the HHS 
office responsible for coordination of the drug-free workplace program.
    (d) Failed to reconfirm a single or all drug positive results and 
invalid result. The MRO reports to the agency a failed to reconfirm 
result [specify drug(s) and give the reason for the invalid result], 
cancels both tests, directs the agency to immediately collect another 
specimen and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (e) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and adulterated. The MRO reports to the agency a reconfirmed 
result [specify drug(s)] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and found that the specimen was adulterated. The MRO shall 
notify the HHS office responsible for coordination of the drug-free 
workplace program regarding the test results for the specimen.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and not adulterated. The MRO reports to the agency a reconfirmed 
result [specify drug(s)] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and invalid result. The MRO reports to the agency a reconfirmed 
result [specify drug(s)] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and reported an invalid result. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (h) Failed to reconfirm adulteration. The MRO reports to the agency 
a failed to reconfirm result (specify adulterant) and cancels both 
tests. The MRO shall notify the HHS office responsible for coordination 
of the drug-free workplace program regarding the test results for the 
specimen.
    (i) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterant. The MRO reports to the agency a reconfirmed 
result (specify adulterant) and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed result (adulterated) although Laboratory B failed to 
reconfirm the drug(s) result.
    (j) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterant. The MRO reports to the agency a 
failed to reconfirm result [specify drug(s) and adulterant] and cancels 
both tests. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (k) Failed to reconfirm at least one drug and reconfirmed the 
adulterant. The MRO reports to the agency a reconfirmed result [specify 
drug(s) and adulterant] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) and the reconfirmed adulterant although Laboratory 
B failed to reconfirm one or more drugs.
    (l) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterant. The MRO reports to the agency a reconfirmed result 
[specify drug(s)] and a failed to reconfirm result [specify drug(s) and 
adulterant]. The MRO tells the agency that it may take action based on 
the reconfirmed drug(s) although Laboratory B failed to

[[Page 57597]]

reconfirm one or more drugs and failed to reconfirm the adulterant.

Section 14.6 How does an MRO report a split (B) specimen test result to 
an agency?

    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, facsimile, or computer). Transmissions of 
the reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all split 
specimen results.
    (d) The MRO must not disclose the numerical values of the drug test 
results to the agency.

Section 14.7 How long must an HHS-certified laboratory retain a split 
(B) specimen?

    A split (B) specimen is retained for the same period of time that a 
primary (A) specimen is retained and under the same storage conditions. 
This applies even for those cases when the split (B) specimen is tested 
by a second HHS-certified laboratory and the second HHS-certified 
laboratory does not confirm the original result reported by the first 
HHS-certified laboratory for the primary (A) specimen.

Subpart O--Criteria for Rejecting a Specimen for Testing

Section 15.1 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing?

    The following discrepancies are considered to be fatal flaws. The 
HHS-certified laboratory must stop the testing process, reject the 
specimen for testing, and indicate the reason for rejecting the 
specimen on the Federal CCF when:
    (a) The specimen ID number on the primary (A) or split (B) specimen 
label/seal does not match the ID number on the Federal CCF, or the ID 
number is missing either on the Federal CCF or on either specimen 
label/seal;
    (b) The primary (A) specimen label/seal is missing, misapplied, 
broken or shows evidence of tampering and the split (B) specimen cannot 
be re-designated as the primary (A) specimen;
    (c) The collector's printed name and signature are omitted on the 
Federal CCF;
    (d) There is an insufficient amount of specimen for analysis in the 
primary (A) specimen unless the split (B) specimen can be re-designated 
as the primary (A) specimen;
    (e) The accessioner failed to document the primary (A) specimen 
seal condition on the Federal CCF at the time of accessioning, and the 
split (B) specimen cannot be re-designated as the primary (A) specimen;
    (f) The specimen was received at the HHS-certified laboratory 
without a CCF;
    (g) The CCF was received at the HHS-certified laboratory without a 
specimen;
    (h) The collector performed two separate collections using one CCF; 
or
    (i) The HHS-certified laboratory identifies a flaw (other than 
those specified above) that prevents testing or affects the forensic 
defensibility of the drug test and cannot be corrected.

Section 15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?

    The following discrepancies are considered to be correctable:
    (a) If a collector failed to sign the Federal CCF, the HHS-
certified laboratory must attempt to recover the collector's signature 
before reporting the test result. If the collector can provide a 
memorandum for record recovering the signature, the HHS-certified 
laboratory may report the test result for the specimen. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot recover the collector's signature, the laboratory 
must report a rejected for testing result and indicate the reason for 
the rejected for testing result on the Federal CCF.
    (b) If a specimen is submitted using a non-federal form or an 
expired Federal CCF, the HHS-certified laboratory must test the 
specimen and also attempt to obtain a memorandum for record explaining 
why a non-federal form or an expired Federal CCF was used and ensure 
that the form used contains all the required information. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot obtain a memorandum for record from the collector, 
the laboratory must report a rejected for testing result and indicate 
the reason for the rejected for testing result on the report to the 
MRO.

Section 15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject an oral fluid specimen for testing or an 
MRO to cancel a test?

    (a) The following omissions and discrepancies on the Federal CCF 
that are received by the HHS-certified laboratory should not cause an 
HHS-certified laboratory to reject an oral fluid specimen or cause an 
MRO to cancel a test:
    (1) An incorrect laboratory name and address appearing at the top 
of the form;
    (2) Incomplete/incorrect/unreadable employer name or address;
    (3) MRO name is missing;
    (4) Incomplete/incorrect MRO address;
    (5) A transposition of numbers in the donor's Social Security 
Number or employee identification number;
    (6) A telephone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``reason for test'' box is not marked;
    (9) A ``drug tests to be performed'' box is not marked;
    (10) A ``specimen collection'' box is not marked;
    (11) The lot number of the collection device used for the 
collection is missing;
    (12) The collection site address is missing;
    (13) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (14) The time of collection is not indicated;
    (15) The date of collection is not indicated;
    (16) Incorrect name of delivery service;
    (17) The collector has changed or corrected information by crossing 
out the original information on either the Federal CCF or specimen 
label/seal without dating and initialing the change; or
    (18) The donor's name inadvertently appears on the HHS-certified 
laboratory copy of the Federal CCF or on the tamper-evident labels used 
to seal the specimens.
    (b) The following omissions and discrepancies on the Federal CCF 
that are made at the HHS-certified laboratory should not cause an MRO 
to cancel a test:
    (1) The testing laboratory fails to indicate the correct name and 
address in the results section when a different laboratory name and 
address is printed at the top of the Federal CCF;
    (2) The accessioner fails to print their name;

[[Page 57598]]

    (3) The certifying scientist or certifying technician fails to 
print their name;
    (4) The certifying scientist or certifying technician accidentally 
initials the Federal CCF rather than signing for a specimen reported as 
rejected for testing;
    (c) The above omissions and discrepancies should occur no more than 
once a month. The expectation is that each trained collector and HHS-
certified laboratory will make every effort to ensure that the Federal 
CCF is properly completed and that all the information is correct. When 
an error occurs more than once a month, the MRO must direct the 
collector or HHS-certified laboratory (whichever is responsible for the 
error) to immediately take corrective action to prevent the recurrence 
of the error.

Section 15.4 What discrepancies may require an MRO to cancel a test?

    (a) An MRO must attempt to correct the following errors:
    (1) The donor's signature is missing on the MRO copy of the Federal 
CCF and the collector failed to provide a comment that the donor 
refused to sign the form;
    (2) The certifying scientist failed to sign the Federal CCF for a 
specimen being reported drug positive, adulterated, invalid, or (for 
urine) substituted; or
    (3) The electronic report provided by the HHS-certified laboratory 
does not contain all the data elements required for the HHS standard 
laboratory electronic report for a specimen being reported drug 
positive, adulterated, invalid result, or (for urine) substituted.
    (b) If error (a)(1) occurs, the MRO must contact the collector to 
obtain a statement to verify that the donor refused to sign the MRO 
copy. If, after at least 5 business days, the collector cannot provide 
such a statement, the MRO must cancel the test.
    (c) If error (a)(2) occurs, the MRO must obtain a statement from 
the certifying scientist that they inadvertently forgot to sign the 
Federal CCF, but did, in fact, properly conduct the certification 
review. If, after at least 5 business days, the MRO cannot get a 
statement from the certifying scientist, the MRO must cancel the test.
    (d) If error (a)(3) occurs, the MRO must contact the HHS-certified 
laboratory. If, after at least 5 business days, the laboratory does not 
retransmit a corrected electronic report, the MRO must cancel the test.

Subpart P--Laboratory Suspension/Revocation Procedures

Section 16.1 When may the HHS certification of a laboratory be 
suspended?

    These procedures apply when:
    (a) The Secretary has notified an HHS-certified laboratory in 
writing that its certification to perform drug testing under these 
Guidelines has been suspended or that the Secretary proposes to revoke 
such certification.
    (b) The HHS-certified laboratory has, within 30 days of the date of 
such notification or within 3 days of the date of such notification 
when seeking an expedited review of a suspension, requested in writing 
an opportunity for an informal review of the suspension or proposed 
revocation.

Section 16.2 What definitions are used for this subpart?

    Appellant. Means the HHS-certified laboratory which has been 
notified of its suspension or proposed revocation of its certification 
to perform testing and has requested an informal review thereof.
    Respondent. Means the person or persons designated by the Secretary 
in implementing these Guidelines.
    Reviewing Official. Means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more of the official's 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.

Section 16.3 Are there any limitations on issues subject to review?

    The scope of review shall be limited to the facts relevant to any 
suspension or proposed revocation, the necessary interpretations of 
those facts, the relevant Mandatory Guidelines for Federal Workplace 
Drug Testing Programs, and other relevant law. The legal validity of 
these Guidelines shall not be subject to review under these procedures.

Section 16.4 Who represents the parties?

    The appellant's request for review shall specify the name, address, 
and telephone number of the appellant's representative. In its first 
written submission to the reviewing official, the respondent shall 
specify the name, address, and telephone number of the respondent's 
representative.

Section 16.5 When must a request for informal review be submitted?

    (a) Within 30 days of the date of the notice of the suspension or 
proposed revocation, the appellant must submit a written request to the 
reviewing official seeking review, unless some other time period is 
agreed to by the parties. A copy must also be sent to the respondent. 
The request for review must include a copy of the notice of suspension 
or proposed revocation, a brief statement of why the decision to 
suspend or propose revocation is wrong, and the appellant's request for 
an oral presentation, if desired.
    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.

Section 16.6 What is an abeyance agreement?

    Upon mutual agreement of the parties to hold these procedures in 
abeyance, the reviewing official will stay these procedures for a 
reasonable time while the laboratory attempts to regain compliance with 
the Guidelines or the parties otherwise attempt to settle the dispute. 
As part of an abeyance agreement, the parties can agree to extend the 
time period for requesting review of the suspension or proposed 
revocation. If abeyance begins after a request for review has been 
filed, the appellant shall notify the reviewing official at the end of 
the abeyance period, advising whether the dispute has been resolved. If 
the dispute has been resolved, the request for review will be 
dismissed. If the dispute has not been resolved, the review procedures 
will begin at the point at which they were interrupted by the abeyance 
agreement with such modifications to the procedures as the reviewing 
official deems appropriate.

Section 16.7 What procedures are used to prepare the review file and 
written argument?

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's Documents and Brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):

[[Page 57599]]

    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is wrong (appellant's brief).
    (b) Respondent's Documents and Brief. Within 15 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification to perform drug 
testing, which is tabbed and organized chronologically, and accompanied 
by an index identifying each document. Only essential documents should 
be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply Briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative Efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive Documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.

Section 16.8 When is there an opportunity for oral presentation?

    (a) Electing Oral Presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding Official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary Conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues, stipulations 
and admissions, limitations on evidence and witnesses that will be 
presented at the hearing, time allotted for each witness and the 
hearing altogether, scheduling the hearing, and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at their discretion, produce a written document 
summarizing the conference or transcribe the conference, either of 
which will be made a part of the record.
    (d) Time and Place of the Oral Presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date the appellant's request for review is received or within 10 days 
of submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the Oral Presentation.
    (1) General. The presiding official is responsible for conducting 
the oral presentation. The presiding official may be assisted by one or 
more of the official's employees or consultants in conducting the oral 
presentation and reviewing the evidence. While the oral presentation 
will be kept as informal as possible, the presiding official may take 
all necessary steps to ensure an orderly proceeding.
    (2) Burden of Proof/Standard of Proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
wrong.
    (3) Admission of Evidence. The Federal Rules of Evidence do not 
apply and the presiding official will generally admit all testimonial 
evidence unless it is clearly irrelevant, immaterial, or unduly 
repetitious. Each party may make an opening and closing statement, may 
present witnesses as agreed upon in the prehearing conference or 
otherwise, and may question the opposing party's witnesses. Since the 
parties have ample opportunity to prepare the review file, a party may 
introduce additional documentation during the oral presentation only 
with the permission of the presiding official. The presiding official 
may question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At their discretion, the presiding 
official may require or permit the parties to submit post-hearing 
briefs or proposed findings and conclusions. Each party may submit 
comments on any major prejudicial errors in the transcript.

Section 16.9 Are there expedited procedures for review of immediate 
suspension?

    (a) Applicability. When the Secretary notifies an HHS-certified 
laboratory in writing that its certification to perform drug testing 
has been immediately suspended, the appellant may request an expedited 
review of the suspension and any proposed revocation. The appellant 
must submit this request in writing to the reviewing official within 3 
days of the date the HHS-certified laboratory received notice of the 
suspension. The request for review must include a copy of the 
suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing Official's Response. As soon as practicable after the 
request for review is received, the reviewing official

[[Page 57600]]

will send an acknowledgment with a copy to the respondent.
    (c) Review File and Briefs. Within 7 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, which is tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral Presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official, the presiding 
official will attempt to schedule the oral presentation within 7-10 
days of the date of appellant's request for review at a time and place 
determined by the presiding official following consultation with the 
parties. The presiding official may hold a prehearing conference in 
accordance with Section 16.8(c) and will conduct the oral presentation 
in accordance with the procedures of Sections 16.8(e), (f), and (g).
    (e) Written Decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7-10 days of the date of the 
oral presentation or within 3 days of the date on which the transcript 
is received or the date of the last submission by either party, 
whichever is later. All other provisions set forth in Section 16.14 
will apply.
    (f) Transmission of Written Communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be by facsimile, secured electronic 
transmissions, or overnight mail.

Section 16.10 Are any types of communications prohibited?

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.

Section 16.11 How are communications transmitted by the reviewing 
official?

    (a) Because of the importance of a timely review, the reviewing 
official should normally transmit written communications to either 
party by facsimile, secured electronic transmissions, or overnight mail 
in which case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) In counting days, include Saturdays, Sundays, and federal 
holidays. However, if a due date falls on a Saturday, Sunday, or 
federal holiday, then the due date is the next federal working day.

Section 16.12 What are the authority and responsibilities of the 
reviewing official?

    In addition to any other authority specified in these procedures, 
the reviewing official and the presiding official, with respect to 
those authorities involving the oral presentation, shall have the 
authority to issue orders; examine witnesses; take all steps necessary 
for the conduct of an orderly hearing; rule on requests and motions; 
grant extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, 
usually with notice to the parties; reconsider a decision of the 
reviewing official where a party promptly alleges a clear error of fact 
or law; and to take any other action necessary to resolve disputes in 
accordance with the objectives of these procedures.

Section 16.13 What administrative records are maintained?

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.

Section 16.14 What are the requirements for a written decision?

    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefore in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
their decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of 
the date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public Notice. If the suspension and proposed revocation are 
upheld, the revocation will become effective immediately and the public 
will be notified by publication of a notice in the Federal Register. If 
the suspension and proposed revocation are denied, the revocation will 
not take effect and the suspension will be lifted immediately. Public 
notice will be given by publication in the Federal Register.

Section 16.15 Is there a review of the final administrative action?

    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal Law. The reviewing official's decision, under 
Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe 
for judicial review as of the date of the decision.

[FR Doc. 2019-22684 Filed 10-24-19; 8:45 am]
 BILLING CODE P