[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Rules and Regulations]
[Pages 70814-70850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21735]



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Vol. 88

Thursday,

No. 196

October 12, 2023

Part V





Department of Health and Human Services





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42 CFR Chapter I





Mandatory Guidelines for Federal Workplace Drug Testing Programs; Final 
Rule

  Federal Register / Vol. 88 , No. 196 / Thursday, October 12, 2023 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter I


Mandatory Guidelines for Federal Workplace Drug Testing Programs

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

ACTION: Issuance of mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') has revised the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using Oral Fluid (OFMG) which published 
in the Federal Register of October 25, 2019.

DATES: The mandatory guidelines are effective October 10, 2023.

FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA, 
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by 
telephone (240) 276-1459 or by email at [email protected].

SUPPLEMENTARY INFORMATION: 

Executive Summary

    These revised Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Oral Fluid (OFMG) establish a process whereby 
the Department annually publishes the authorized drug testing panel 
(i.e., drugs, analytes, or cutoffs) to be used for Federal workplace 
drug testing programs; revise the definition of a substituted specimen 
to include specimens with a biomarker concentration inconsistent with 
that established for a human specimen, establish a process whereby the 
Department publishes an authorized biomarker testing panel (i.e., 
biomarker analytes and cutoffs) for Federal workplace drug testing 
programs; update and clarify the oral fluid collection procedures; 
revise the Medical Review Officer (MRO) verification process for 
positive codeine and morphine specimens; and require MROs to submit 
semiannual reports to the Secretary or designated HHS representative on 
Federal agency specimens that were reported as positive for a drug or 
drug metabolite by a laboratory and verified as negative by the MRO. In 
addition, some wording changes have been made for clarity and for 
consistency with the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Urine (UrMG) or to apply to any authorized 
specimen type.
    The Department is publishing a separate Federal Register 
Notification (FRN) elsewhere in this issue of the Federal Register with 
the revised UrMG, which include the same or similar revisions as the 
OFMG, where appropriate.

Background

    Pursuant to its authority under section 503 of Public Law 100-71, 5 
U.S.C. 7301, and Executive Order 12564, HHS 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.
    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS-certified laboratories, the Department estimates that 
275,000 urine specimens are tested annually by Federal agencies. No 
Federal agencies are testing hair or oral fluid specimens at this time.
    HHS originally published the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs (hereinafter referred to as Guidelines 
or Mandatory 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). SAMHSA published the current Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine (UrMG) on January 
23, 2017 (82 FR 7920) and published the current Mandatory Guidelines 
for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on 
October 25, 2019 (84 FR 57554). SAMHSA published proposed Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Hair (HMG) 
on September 10, 2020 (85 FR 56108) and proposed revisions to the UrMG 
(87 FR 20560) and OFMG (87 FR 20522) on April 7, 2022.
    There was a 60-day public comment period following publication of 
the proposed OFMG, during which 53 commenters submitted 204 comments on 
the OFMG. These commenters were comprised of individuals, 
organizations, and private sector companies. The comments are available 
for public view at https://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.
    Some submitted comments were specific to transportation industry 
drug testing which is regulated by the Department of Transportation 
(DOT). The Department has noted these comments below, but responded 
only to comments that are relevant to these Guidelines. DOT issued a 
notice of proposed rulemaking (NPRM) on February 28, 2022 (87 FR 
11156). Subsequently, DOT extended the comment period to April 29, 2022 
(87 FR 16160), and published the final rule on May 2, 2023 (88 FR 
27596).

Authorized Drug Testing Panel

    The Department requested comments on its proposal to publish the 
drug testing panel separately from the OFMG in a Federal Register\[[[[p 
Notification (FRN) each year. Fifteen commenters submitted a total of 
40 comments on this topic for the OFMG.
    Nine commenters disagreed with publishing a revised drug testing 
panel without a public comment period, expressing concerns that 
stakeholders including individuals subject to federally regulated drug 
testing would not be given the opportunity to provide comment and that 
the Department would miss valuable input including information on costs 
and burden. Some of these commenters suggested alternate ways to permit 
public comment while enabling a quicker response to testing panel 
changes (e.g., setting a shorter comment period, publishing the 
Guidelines as an interim final rule or issuing an advance notice of 
proposed rulemaking). The Department has reviewed these comments and 
suggestions and determined that no changes to the proposed Guidelines 
are needed. The Department has developed procedures which will allow 
review and comment before testing panel changes are published, as 
described below.
    Consistent with current procedures, prior to making a change to the 
drug or biomarker testing panel, the Department will conduct a thorough 
review of the scientific and medical literature, and will solicit 
review and input from subject matter experts such as Responsible 
Persons (RPs) of HHS-certified laboratories, Medical Review Officers 
(MROs), research scientists,

[[Page 70815]]

manufacturers of collection devices and/or immunoassay kits, as well as 
Federal partners such as DOT, the Food and Drug Administration (FDA), 
and the Drug Enforcement Administration (DEA). Further, the Department 
plans to provide notice and opportunity for public comment regarding 
any proposed changes to the drug and biomarker testing panels as part 
of Drug Testing Advisory Board (DTAB) meetings and procedures.
    Information regarding any proposed changes to the drug and 
biomarker testing panels and a request for public comment will be 
included in an advance notice of the DTAB meeting published in the 
Federal Register, along with the timeframe and method(s) for comment 
submission. During the meeting, the Department will present the basis 
for adding or removing analytes (i.e., including technical and 
scientific support for the proposed changes), as well as a discussion 
of related costs and benefits. This information will be provided in 
advance to DTAB members. The Department will review all submitted 
public comments and will share information during a DTAB session prior 
to DTAB's review of SAMHSA's recommendation to the Secretary regarding 
each proposed change.
    The Department will make the final decision on any panel changes 
and include the effective date(s) in the annual Notice, to allow time 
for drug testing service providers (e.g., immunoassay kit 
manufacturers, oral fluid collection device manufacturers) to develop 
or revise their products, and for HHS-certified laboratories to develop 
or revise assays, complete validation studies, and revise procedures.
    Three commenters specifically agreed with the need to streamline 
and improve processes for making changes to the testing panels, but 
expressed concern over the process for testing panel review and who 
would be involved. These commenters suggested involving other 
stakeholders (e.g., HHS-certified laboratories, DTAB, FDA). As noted 
above, the Department will use multiple methods and involve subject 
matter experts from various stakeholder groups to determine testing 
panel changes, and will provide opportunity for public review and 
comment before changes are made. FDA, DOT, and other Federal partners 
will have opportunities to review and provide input.
    Four commenters disagreed that HHS is exempt from the 
Administrative Procedure Act (APA) requirements. Two of these 
specifically stated that the Guidelines are subject to APA requirements 
because DOT is required to use the Guidelines for their transportation 
industry drug testing programs. The Department has reviewed these 
comments and determined that no change is needed to the proposed 
Guidelines. The Department explained why the APA does not apply under 
the Regulatory Impact and Notices section of the current OFMG (84 FR 
57554) and has repeated the same information in that section below.
    Two commenters suggested that the Department limit changes to every 
few years (e.g., four to five years). The Department will not set such 
time limits for panel changes. The need for more timely testing panel 
changes was clearly explained in the preamble to the proposed 
Guidelines.
    Eight commenters were concerned that the Department will not allow 
sufficient time for stakeholders to implement changes (e.g., time for 
FDA clearance for new or revised products, information technology [IT] 
changes, process development and/or changes, contractual changes, and 
training). Some of these commenters suggested that the Department set a 
standard time for implementation of all changes (e.g., 90 days, six 
months) or based on the complexity of the change (e.g., between 90 and 
365 days). The Department will establish a reasonable time for 
implementation based on the change, rather than setting a standard time 
period for all changes. As noted above, the Department will solicit 
information from multiple sources to assist in decision making.
    In regard to the use of FDA-cleared collection devices and 
immunoassay initial tests, four commenters suggested that federally 
regulated drug testing could fall under what they referred to as the 
FDA's Employment and Insurance exemption. The Department notes that, 
while some drugs of abuse test systems intended for employment and 
insurance testing are, under certain circumstances, exempt from the 
premarket notification procedures in 21 CFR part 807, subpart E, such 
exemptions do not apply to test systems intended for Federal drug 
testing programs. See 21 CFR part 862, subpart D. Because the 
Department does not address FDA clearance requirements for test systems 
in the Mandatory Guidelines, the reference to FDA clearance for oral 
fluid collection devices has been removed from Section 7.1. Applicant 
and HHS-certified laboratories must verify that oral fluid collection 
devices and test systems subject to FDA regulations are approved or 
otherwise cleared by FDA and, in addition, must validate the oral fluid 
collection devices and test systems prior to use in accordance with 
requirements specified in the National Laboratory Certification Program 
(NLCP) Manual for Oral Fluid Laboratories.
    Two commenters appeared to misinterpret the Department's testing 
panel proposal, objecting to the Department making changes to the 
testing panels each year. The Department plans to issue an annual 
Notice with the current testing panels and required nomenclature, but 
will make changes only when needed to ensure the continued 
effectiveness of Federal workplace drug testing programs, which may not 
be every year.
    See additional comments under Section 3.4 below.

Authorized Biomarker Testing Panel

    The Department requested comments on its proposal to publish the 
biomarker testing panel separately from the OFMG in a Federal Register 
Notification each year. Seven commenters submitted a total of 14 
comments on this topic for the OFMG.
    One commenter disagreed with specimen validity or biomarker testing 
for oral fluid specimens, because all collections are observed and 
collection devices are required to have volume indicators. The 
commenter stated these tests would be unnecessary and increase costs. 
The commenter also noted that the observed collections and required 
inspection of the oral fluid reduced the risk of adulteration or 
substitution. Four commenters suggested that the Department require all 
HHS-certified laboratories to perform standardized specimen validity 
and biomarker tests on all federally regulated specimens, and allow 
laboratories to choose whether to offer additional specialized tests 
upon MRO request on a case-by-case basis. The Department agrees that 
there are no known effective subversion products for oral fluid 
specimens at this time; however, such products may be available in the 
future. The Department has also included examples in the HHS Oral Fluid 
Specimen Handbook (posted on SAMHSA's website, https://www.samhsa.gov/workplace) to assist trained collectors in identifying donor attempts 
to tamper with the collection of their oral fluid specimen. The 
Department is not requiring all certified laboratories to conduct oral 
fluid specimen validity testing or biomarker testing at this time. 
However, if the drug testing industry identifies a need for such tests 
and an HHS-certified laboratory chooses to offer them to their 
regulated clients, the Department will ensure that the tests provide 
scientifically valid and forensically defensible results and will 
revisit the

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need for requiring the tests on all specimens.
    Two commenters disagreed with publishing a biomarker testing panel 
without a public comment period, expressing concerns that stakeholders 
would not be given the opportunity to provide comment and that the 
Department would miss valuable input including information on costs and 
burden. The Department has reviewed these comments and determined that 
no changes to the proposed Guidelines are needed. The Department has 
developed procedures which will allow review and comment before testing 
panel changes are published, as described under Authorized drug testing 
panel above.
    Three commenters specifically agreed with the need to streamline 
and improve processes for making changes to the testing panels. One of 
these commenters noted that since there are no currently agreed-upon 
analytes to assess OF validity and there may be differences in buffered 
collection devices, determining a biomarker panel may be complex. The 
other two commenters suggested involving other stakeholders (e.g., HHS-
certified laboratories, DTAB). A different commenter recommended that 
the Department consult with immunoassay manufacturers and OF testing 
laboratories to understand the scope of making proposed changes, 
availability of materials/reagents, etc. As noted under Authorized drug 
testing panel above, the Department will use multiple methods and 
involve subject matter experts from various stakeholder groups to 
determine testing panel changes, and will provide opportunity for 
public review and comment before changes are made. Federal partners 
will also have opportunities to review and provide input.
    One commenter disagreed that HHS is exempt from the APA 
requirements. The Department has reviewed the comment and determined 
that no change is needed to the proposed Guidelines. The Department 
explained why the APA does not apply under the Regulatory Impact and 
Notices section of the current OFMG (84 FR 57554) and has repeated the 
same information in that section below.

Medical Review Officer (MRO) Verification of Codeine and Morphine Test 
Results

    In Section 13.5, the Department removed the requirement for the MRO 
to report specimens with morphine and/or codeine between the cutoff and 
150 ng/mL as positive based on clinical evidence of illicit drug use 
and, instead, directed the MRO to verify such specimens as negative 
unless the donor admits to illegal opioid use that could have caused 
the positive result. Four commenters agreed with this change.

Medical Review Officer (MRO) Semiannual Reports

    In Section 13.11, the Department added requirements for each MRO 
performing medical review services for Federal agencies to submit 
semiannual reports, in January and July of each year, of Federal agency 
specimens that were reported as positive for a drug or drug metabolite 
by the laboratory and verified as negative by the MRO, along with the 
reason for the negative verification (e.g., a valid prescription for a 
drug). Six commenters submitted eight comments on this topic for the 
OFMG.
    Three commenters disagreed, stating that HHS had not clearly 
described the reason and the process for such reports. One commenter 
noted that the Department had not presented data documenting that MROs 
were incorrectly reporting specimens, and it was unclear how the 
reports could be matched to laboratory report information submitted to 
the National Laboratory Certification Program (NLCP). Another commenter 
stated that it was unclear what actions would be taken if the 
Department disagreed with the MRO report. The third commenter was 
concerned that donors would be identifiable, and that ``a database of 
legal drug use'' would violate donor privacy. One of the commenters 
expressed concern over ``unintended consequences'' for DOT and state 
workplace drug testing programs, without further explanation.
    Two commenters disagreed on the basis of added costs and burden to 
MROs. One claimed that this would result in MROs tracking and reporting 
all results sent by the laboratory, as they are already required to 
report positive results to the Federal Motor Carrier Safety 
Administration (FMCSA) Clearinghouse. The other claimed that this would 
require documentation and report generation for each non-negative 
result, and expressed concern that smaller MRO practices could find the 
process too time-consuming and costly to continue in the program.
    One commenter agreed that such reports could be beneficial, but 
suggested that MROs provide the same information as provided by 
laboratories to the NLCP. The commenter incorrectly stated that 
laboratories do not provide specimen identification numbers to the 
NLCP.
    The Department has reviewed the comments and determined that no 
change is needed to the proposed Guidelines. To clarify, this reporting 
policy is only for Federal agency specimens, not DOT-regulated 
specimens. Further, the reports are not for all positive specimens, 
only for those specimens that were reported as positive by the 
laboratory and verified as negative by the MRO. The requested MRO 
information is sufficient to enable matching to HHS-certified 
laboratory information provided to the NLCP without identifying the 
donor. At this time, there is no system-wide mechanism for identifying 
MRO verification practices for Federal agency specimens that are 
inconsistent with the Guidelines, so data on incorrect reporting is not 
available. The Department is not planning to share MRO-specific 
information, but may share statistical information and deidentified 
examples by various means (e.g., DTAB meeting presentations, revisions 
to the MRO Guidance Manual and/or Case Studies). The Department will 
also provide this information to HHS-approved MRO certification 
organizations to share with their certified MROs and to update training 
materials and examinations as needed.

Marijuana Testing

    The Department did not propose any changes to the OFMG in regard to 
marijuana testing, but received comments from 21 commenters: 20 
disagreed and one agreed with the current requirements. Seventeen 
commenters supported medical use of marijuana. Some of these noted that 
many doctors and medical professionals support the use of medical 
marijuana and that many States have legalized marijuana for medical 
use. Commenters expressed concern that Federal employees using 
marijuana for health reasons could lose their jobs or benefits or that 
Federal employees without access to medical marijuana may use other 
drugs such as opioids. Three commenters supported legalization of 
marijuana in general. One commenter stated that marijuana testing 
should be removed from the Guidelines until research can establish 
reliable levels to distinguish marijuana use from use of a legal hemp 
product (i.e., as defined by the 2018 Farm Bill).
    One commenter agreed with continuing to recognize marijuana as a 
Schedule I drug, with zero tolerance for safety-sensitive positions. 
The commenter stated that the liability and risk are not worth allowing 
employees in safety-sensitive positions to use medical marijuana.
    Current Federal law requires Federal agencies to test for marijuana 
under E.O. 12564 in their workplace drug testing

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programs. The Department also edited Section 13.5(c) to clarify that 
only prescription medications can be offered as a legitimate medical 
explanation for a positive drug test (as described under Section 13.5 
below). No further edits are required at this time.

General Comments

    Five commenters submitted general comments concerning the OFMG. 
Three agreed with the use of oral fluid testing, citing benefits of 
oral fluid as a testing matrix compared to urine (e.g., less invasive 
collection is preferable for body/gender issues and the need to respect 
donor privacy; reduces specimen tampering; eliminates need for same 
gender observers; saves time). Two commenters disagreed with making any 
changes to the previous OFMG (published October 25, 2019).

Discussion of Sections

    The Department has not included a discussion in the preamble of any 
sections for which public comments were not submitted or for minor 
wording changes (e.g., edits for clarity, typographical or grammatical 
corrections).

Subpart A--Applicability

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

    Two commenters agreed and two disagreed with the Department's 
proposed revision to the Substituted Specimen definition in Section 1.5 
to include specimens tested for a biomarker.
    Of the two commenters who disagreed, one stated that there are 
situations in which a legitimate specimen may be reported as outside 
the standards for human specimens, and these should be reported as 
invalid. The other commenter stated that there should be clear notice 
and the opportunity to comment on specific biomarkers and criteria for 
substitution and that HHS should continue to require laboratories to 
report specimens as invalid based on normally occurring endogenous 
substances that appear unusual but do not violate standards for 
identified validity tests. The Department has reviewed the comments and 
determined that no change is needed to the proposed Guidelines. The 
Department will follow the procedures summarized under Authorized drug 
testing panel above to enable public comment and review, and will 
ensure that a biomarker test is scientifically supported and 
forensically sound to identify specimens as substituted before allowing 
its use with federally regulated drug testing. Specimens that do not 
meet established criteria for the biomarker test will not be reported 
as substituted.

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

    In Section 1.7(a), the Department proposed to remove two exceptions 
for reporting a refusal to test for a pre-employment test: a donor who 
fails to appear in a reasonable time and a donor who leaves the 
collection site before the collection process begins. Nine commenters 
submitted a total of 16 comments on this proposal. Many of the 
commenters referenced DOT drug testing requirements and/or 
transportation industry issues that are not relevant to these 
Guidelines.
    Eight commenters disagreed with the changes, noting that an 
applicant may fail to appear because they have taken a different job 
offer. The commenters noted that a refusal to test in the individual's 
record could prevent individuals from taking other job offers and/or 
require them to undergo unnecessary return-to-duty testing. The 
Department has reviewed the comments and determined that no change is 
needed. As stated in this section, the Federal agency determines a 
reasonable time for the donor to take the test, specifies the time 
consistent with agency regulations, and directs the individual 
accordingly. At the time an applicant is scheduled for a pre-employment 
drug test, or before, Federal agencies should provide the applicant 
with instructions on how to notify the agency in the event that they 
decide to withdraw their application or to not accept a job offer. Such 
instructions will allow the agency to cancel the drug test and help 
applicants avoid a refusal to test result.
    Three commenters noted that the Guidelines should state that the 
designated employer representative (DER) makes the determination of a 
refusal to test. A fourth commenter noted that the employer, not the 
collector, should determine whether a failure to appear for a pre-
employment test should be considered a refusal, as the collection site 
may not know that a donor is coming or how much time the employer 
allows the donor to complete a test. The Department has reviewed the 
comments and determined that no change is needed. As stated in this 
section, the Federal agency takes action consistent with applicable 
agency regulations. Corresponding wording in Section 8.3 specifies that 
the collector follows the Federal agency policy or contacts the Federal 
agency representative to obtain guidance on action to be taken before 
reporting a refusal to test because a donor does not arrive at an 
assigned time.
    One commenter suggested that the Department add procedures to 
follow when the collection site cannot collect a specimen (e.g., 
collection site closed early, collection site ran out of supplies). The 
Department disagrees with this suggestion. The applicant and/or the 
collector should contact the Federal agency representative when a 
situation beyond the applicant's control prevents completing a drug 
test within the specified time.

Subpart B--Oral Fluid Specimens

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

    In Section 2.2, the Department allows oral fluid to be used for any 
type of testing conducted in Federal agency drug testing programs, and 
had not proposed any changes. Six commenters submitted comments in 
response to DOT's February 28, 2022 NPRM, regarding whether oral fluid 
should be allowed for all or only some testing reasons.

Section 2.5 How is the split oral fluid specimen collected?

    The Department did not propose any changes to the requirements for 
split oral fluid collections in Sections 2.5 and 8.8 (How does the 
collector prepare the oral fluid specimens?). In its February 28, 2022 
NPRM, DOT prohibits serial or simultaneous collections of A and B oral 
fluid specimens using two separate devices, which are allowed under the 
OFMG. Four commenters requested that HHS and DOT harmonize their 
requirements.
    Three of the commenters requested a clear definition of ``single 
device'' and the fourth commenter recommended that both HHS and DOT 
specifically allow a device that collects a specimen that is then split 
or divided into the primary (A) and split (B) specimens. HHS and DOT 
have discussed oral fluid collection requirements. The Department will 
retain the split specimen collection requirements in the current OFMG 
which are based on current devices used in non-regulated drug testing 
and also allow for development of additional device types validated to 
meet program requirements. HHS-certified laboratories must ensure 
compliance with DOT regulations for specimens collected and tested 
under their regulations.

[[Page 70818]]

Subpart C--Oral Fluid Specimen Tests

Section 3.4 What are the drug and biomarker test analytes and cutoffs 
for undiluted (neat) oral fluid?

    The Department revised Section 3.4 to describe the annual 
publication of the drug testing and biomarker testing panels and the 
nomenclature required for laboratory and MRO reports. Seven commenters 
submitted 10 comments on the required nomenclature required for 
laboratory and MRO reports, which are addressed below. Comments on the 
testing panels are addressed under Authorized drug testing panel and 
Authorized biomarker testing panel above.
    In regard to the required nomenclature specified in the annual 
Federal Register Notice, four commenters noted it is difficult and 
requires substantial effort for stakeholders to make such changes to 
their information technology (IT) systems. Three of these commenters 
suggested that HHS convene a working group for review and input on 
nomenclature changes, to include employers, third party administrators, 
providers of electronic Federal Custody and Control Forms (ECCF 
providers), laboratories, and MROs. The other commenter stated that 
``industry consensus'' should determine how analytes are identified. 
This commenter also stated that standardizing nomenclature for urine 
and oral fluid testing is not practical. One commenter agreed with 
publishing the required nomenclature for each change to the testing 
panel, but suggested that nomenclature not be changed after publication 
to avoid increased costs and confusion. Two commenters recommended a 
minimum of one-year implementation period after nomenclature changes 
are published. Another commenter agreed with specifying nomenclature, 
but noted that clear instructions will be needed for training and 
updating databases. The Department will establish required terminology 
based on correct scientific nomenclature for added analytes. As 
described under Authorized drug testing panel above, the Department has 
developed procedures to allow public notice and comment on proposed 
drug analyte changes through DTAB meetings and procedures. The 
Department will publish separate nomenclature lists for urine and oral 
fluid analytes.
    One commenter disagreed with requiring both cocaine and 
benzoylecgonine as confirmatory test analytes, and recommended testing 
oral fluid specimens for benzoylecgonine only. The commentor cited 
their experience in testing for cocaine and metabolites in oral fluid; 
however, the commentor did not provide a scientific literature citation 
for their recommendation. SAMHSA has reviewed the literature and 
disagrees that testing for benzoylecgonine alone yields the same 
results as testing for both analytes. A 2010 dosing study showed that 
testing for both cocaine and benzoylecgonine increases detection rates 
in the periods 0.08-0.25 hours and 24-48 hours post-dosing as compared 
to testing for cocaine or benzoylecgonine alone.\1\
    The annual Federal Register Notification will be posted on the 
SAMHSA website, https://www.samhsa.gov/workplace. The table in Section 
3.4 of these final Guidelines will remain in effect until the effective 
date of the new panels published in the separate FRN.

Section 4.1 Who may collect a specimen?

    One commenter submitted suggested rewording Section 4.1(a) to 
require the collector to be trained on ``each manufacturer's procedures 
for the collection device.'' The Department disagrees with the 
suggested edit, which may be misconstrued as requiring a collector to 
be trained on all devices. The current OFMG wording (i.e., ``the 
manufacturer's procedures for the collection device'') is clear and 
consistent with the Oral Fluid Specimen Collection Handbook.
    Five commenters submitted comments in response to DOT's February 
28, 2022 NPRM, regarding who may collect an oral fluid specimen.

Subpart F--Federal Drug Testing Custody and Control Form

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

    The Department did not propose any changes to this section. One 
commenter submitted a comment in response to DOT's February 28, 2022 
NPRM, regarding maintaining a fax number on the Federal Custody and 
Control Form (CCF).

Section 6.2 What happens if the correct Office of Management and Budget 
(OMB)-approved Federal CCF is not available or is not used?

    One commenter stated that the Department should specify what 
constitutes an incorrect form, how a collector's signed memorandum must 
be submitted to correct submission of an incorrect CCF, and what 
actions an HHS-certified laboratory must take in response to an 
incorrect CCF. The Department has determined that no changes to the 
Guidelines are needed. The Department issues Guidance for Using the 
Federal CCF as part of the OMB-approved package and provides 
information and guidance specific to the current and expired versions 
of the Federal CCF, rather than including them in these Guidelines.

Subpart G--Oral Fluid Specimen Collection Devices

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

    In Section 7.2(b)(2), the Department added a requirement for oral 
fluid specimen tubes to be sufficiently transparent to enable a visual 
assessment of the contents without opening the tube. See also Section 
8.5(a)(3). Two commenters disagreed with the term ``sufficiently 
transparent,'' noting that opaque tubes would enable visual assessment. 
The Department did not intend that all tubes must be entirely clear 
(thus, the term ``sufficiently transparent''). An opaque tube would not 
allow visual assessment of the contents. For clarity, the Department 
has added ``(e.g., translucent)''.
    In Section 7.2(b)(3), the Department added a requirement for the 
collection device manufacturer to include the device lot expiration 
date on each specimen tube, to enable the collector to verify that each 
tube is within its expiration date prior to use. This is consistent 
with the current Federal CCF and associated documents (i.e., 
Instructions for Completing the Federal CCF for Oral Fluid Specimen 
Collection, Guidance for Using the Federal CCF) which require the 
collector to verify the expiration date and mark the checkbox in Step 2 
of the Federal CCF. The collector may, but is not required to, document 
the expiration date on each tube in Step 4 of the CCF. Four commenters 
disagreed with current requirements, stating that it is sufficient for 
the collector and not the laboratory to document the expiration date of 
each device on the Federal CCF. These commenters suggested that failure 
of the collector to record the date could be recovered with a signed 
memorandum for the record (MFR). Three of the four commenters also 
stated that the expiration date would likely be covered by the label/
seal applied by the collector and noted changing to a transparent label 
would incur additional costs, while the fourth noted that even a 
partially transparent label would take time to develop and would not 
eliminate concerns about label/seal placement. The Department has

[[Page 70819]]

reviewed the comments and determined that no change is needed to the 
proposed OFMG. The expiration date is critical information supporting 
the scientific and forensic defensibility of the test result, and the 
laboratory must not test the specimen if it is unable to verify that 
the device was within its expiration date at the time of collection. A 
trained collector should avoid covering this information when placing 
the label on the tube. If the collector records an incorrect expiration 
date on the CCF, the laboratory corrects the information and is not 
required to obtain an MFR from the collector to recover the error.
    One commenter agreed that the manufacturer should include the lot 
number and expiration date on each collection tube. The Department has 
provided additional guidance to laboratories noting that if the 
expiration date is not visible on the tube upon receipt and the device 
lot number is visible, the laboratory may use that information to 
recover the expiration date.
    One of the commenters noted that the expiration date could be a 
required field on an ECCF, preventing the collector from continuing the 
collection without entering an expiration date. The Department agrees 
that ECCF system providers could implement this safeguard, but this 
does not obviate the need for the laboratory to verify the expiration 
date on each tube, just as the laboratory must verify the specimen 
identification number on each tube and the CCF.

Subpart H--Oral Fluid Specimen Collection Procedure

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

    The Department proposed revisions to Section 8.3 consistent with 
removal of refusal to test exceptions for pre-employment collections 
(see Section 1.7), reordered collection steps (e.g., item d, item h.4), 
and reworded items for clarity (e.g., items g and h). The Department 
also added steps similar to those for urine collections to deter donor 
attempts to adulterate or substitute the specimen. Eight commenters 
submitted comments concerning this section.
    In regard to determining a refusal to test, one commenter suggested 
that the Department establish the beginning of the collection by 
specifying that the collection begins when the collector has checked 
the donor's identification. Another commenter who suggested the 
Department retain exceptions for pre-employment drug test collections 
(see Section 1.7) also suggested that this step be specified as the 
beginning of a pre-employment collection. The Department has determined 
that no revision is needed. The Guidelines clearly describe the 
preliminary collection steps and specify that the collector reports a 
refusal to test when a donor leaves the collection site before the 
collection is complete.
    To deter donor attempts to adulterate or substitute the specimen, 
the Department proposed that the collector inspect the contents of the 
donor's pockets only when the collector does not keep the donor under 
direct observation until the end of the collection, including the 10-
minute wait period described in Section 8.3(h). If the donor refuses to 
display the contents of their pockets, the collector will continue with 
the oral fluid collection, but will keep the donor under their direct 
observation and will not report this as a refusal to test. Five 
commenters disagreed, stating that a donor's refusal to empty their 
pockets should be reported as a refusal to test, for consistency with 
requirements for a urine collection. The Department has considered 
these comments and decided that no change is needed. The proposed 
procedures facilitate the collection process and prevent specimen 
tampering while maintaining donor privacy. There were no comments on 
this topic; however, the Department added a sentence in item e stating 
that a donor is not required to remove any items worn for faith-based 
reasons. This requirement will be specified for all authorized specimen 
types.
    One commenter expressed concern over the requirement in Section 
8.3(h)(4) for the collector to direct the donor to remain at the 
collection site until the end of the collection, stating that the 
refusal to test could be cancelled if the donor claimed that the 
collector did not mention this. The Department has determined that no 
revision is needed. It is incumbent upon the collector to instruct the 
donor throughout the collection process, including the instruction to 
remain through the end of the collection, and to inform the donor of 
the consequences for leaving early.

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

    The Department added steps in Section 8.4 to deter donor attempts 
to tamper with the specimen. Added item a requires the donor to wash 
their hands under the collector's observation and to keep their hands 
within view and avoid touching items or surfaces after handwashing. 
Added Section 8.4(b)(1) specifies that the collector opens the package 
containing the collection device in the presence of the donor. Five 
commenters submitted comments on this section.
    Two commenters stated that requiring the donor to wash their hands 
was unnecessary and could cause a problem when the oral fluid 
collection site has no sink or water. The commenters suggested allowing 
the donor to wear gloves or use hand wipes as an alternative. The 
Department has reviewed these comments and determined that no changes 
are needed to the Guidelines. The instruction does not preclude the use 
of other means of handwashing. The Department has included examples of 
alternate means (e.g., alcohol-free hand wipes, moist towelette, or 
hand sanitizer) in the Oral Fluid Specimen Collection Handbook.
    The same two commenters suggested that the donor be instructed not 
to touch the collection pad. The Department does not agree that this 
added instruction is needed. The OFMG require the collector to be 
present and maintain visual contact with the donor throughout the 
collection, and specifically require the collector to go over the 
manufacturer's instructions for use of the device with the donor, 
observe the donor washing their hands before handling the device, and 
observe the donor positioning the device in their mouth. If the 
collector detects any conduct that clearly indicates an attempt to 
tamper with the specimen, the collector reports a refusal to test.
    One commenter stated that requiring the donor to avoid touching 
items or surfaces was unnecessary and unreasonable. Two others agreed 
that the donor should not touch items that they brought with them after 
washing their hands, but stated that it may be difficult for the donor 
to avoid touching surfaces at the collection site. The Department has 
reviewed the comments and determined that no changes are needed to the 
Guidelines. The instruction to not touch items or surfaces at the 
collection site is a reasonable precaution, and compliance should not 
be difficult for the donor.
    Another commenter specifically agreed with added Section 8.4(a)(1), 
noting this would eliminate errors and attempts to subvert the test.
    In regard to added Section 8.4(b)(1), three commenters disagreed 
with the collector opening the package containing the collection 
device. Two recommended that the donor open the package, because some 
devices that are

[[Page 70820]]

inserted into the donor's mouth may not be separately wrapped. A third 
commenter disagreed, stating that a donor could argue that the 
collector contaminated the device when opening the package. This 
commenter also noted that remote collections would not be possible if 
the collector was required to open the package. The Department has 
reviewed the comments and determined that no change is needed to the 
Guidelines. Collectors must be trained to maintain the integrity of the 
specimen (per Section 4.4), and remotely viewed collections are not 
allowed (i.e., the collector must be present).
    Another commenter suggested adding the instruction for the 
collector to verify and record the device expiration date in Section 
8.4(b)(1). The Department agrees with the commenter in part, and has 
edited Section 8.4(b) to state that each device used must be within the 
manufacturer's expiration date and inserted a new Section 8.4(c) 
requiring the collector to verify that each device is within its 
expiration date prior to use and to document the action on the Federal 
CCF. As discussed under Section 7.2 above, the Department disagrees 
with requiring the collector and not the laboratory to record the 
expiration date.

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

    One commenter suggested that the Department clarify how many 
collection attempts should be allowed when a donor is unable to provide 
a sufficient specimen and recommended that only one additional attempt 
be allowed to limit costs. The Department reviewed the comment and 
determined that no change is needed to the proposed Guidelines. As 
noted in the preamble to the current OFMG, the Department set the time 
limit but 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.

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

    Comments relating to Section 8.8 are addressed under Section 2.5 
above.

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

    One commenter disagreed with the requirement for the collector to 
send all copies of the Federal CCF to the Federal agency's designated 
representative, and stated that the collector should keep the Collector 
Copy and give the Donor Copy to the donor. The Department has reviewed 
the comment and determined that no change is needed. The current 
wording reflects HHS requirements.

Subpart M--Medical Review Officer (MRO)

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

    Two commenters submitted comments on this section. One commenter 
stated that the requirements for additional MRO training in the section 
are unclear and should be revised to clarify requirements (e.g., what 
must training consist of, must the MRO take another certification exam, 
would training be required for annual panel changes). This commenter 
also suggested that MROs register with SAMHSA to get updates/
announcements and acknowledge review of that information. A second 
commenter indicated that new and existing MROs should receive 
additional training for oral fluid testing (e.g., collection procedures 
and documentation; differences in drug detection times for oral fluid 
and urine; urine and oral fluid cutoffs; criteria for substituted, 
adulterated, and refusal to test results; dry mouth scenarios; and 
effect of pre-existing conditions on ability to provide oral fluid).
    The Department has reviewed these comments and edited item b of 
this section to clarify that MROs must be trained on any revisions to 
the drug and biomarker testing panels. In regard to training, SAMHSA 
relies on the approved MRO certification entities to ensure that MROs 
certified by their organizations meet Guidelines requirements. Current 
documents on the SAMHSA website https://www.samhsa.gov/workplace 
include the HHS Medical Review Officer Guidance Manual, MRO Cases 
Studies for Urine, and MRO Case Studies for Oral Fluid which address 
most of the suggested topics. The Department does not maintain an email 
list, but sends a notice through the NLCP to HHS-approved MRO 
certification organizations for dissemination to their certified MROs. 
The Department also sends additional guidance to HHS-certified 
laboratories to share with MROs, clients, and collectors as applicable.

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

    The Department received three comments on its proposed revisions to 
Section 13.5.
    One commenter agreed with the Department's proposed revision to 
item 13.5(b)(2) clarifying that the MRO acts on an invalid result only 
when the MRO has verified the other results for the specimen as 
negative or when the split specimen was reported as a failure to 
reconfirm.
    The Department revised Section 13.5(c)(2) to clarify that passive 
exposure to any drug (not just marijuana smoke) and ingestion of food 
products containing a drug (not just those containing marijuana) are 
not acceptable medical explanations for a positive drug test. The 
Department clarified existing item ii regarding ingestion of food 
products containing a drug and added a new item iii. Although an 
increased number of States have authorized marijuana use for medical 
purposes, marijuana remains a Schedule 1 controlled substance and 
cannot be prescribed under Federal law. For purposes of the Federal 
drug free workplace program, Federal law pertaining to marijuana 
control supersedes State marijuana laws, so a physician's 
recommendation for marijuana use is not a legitimate medical 
explanation for a positive marijuana test. Also see comments under 
Marijuana testing above.
    In addition to the changes described above, the Department 
reordered OFMG Sections 13.8 and 13.9 to reflect the procedural order 
(i.e., requirements for an MRO to report a primary specimen test result 
are now in Section 13.8, and requests for a test of the split specimen 
are addressed in Section 13.9).

Subpart O--Criteria for Rejecting a Specimen for Testing

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

    As noted in Section 7.2(b), an oral fluid collection device must 
have an indicator that demonstrates the adequacy of the volume of oral 
fluid specimen collected. Because the oral fluid specimen volume is 
critical for determining the specimen concentration, the collector must 
document that they observed the volume indicator(s) at the time of 
collection. The Department has revised Section 15.1 (i.e., new 
paragraph (e)) specifying that the laboratory must reject the specimen 
when the collector failed to document observation of the volume 
indicator at the time of collection. This is consistent with current 
program documents (e.g., Oral Fluid Specimen Collection Handbook for 
Federal Agency Workplace Drug

[[Page 70821]]

Testing Programs, Collection Site Manual, and Medical Review Officer 
Guidance Manual) posted on the SAMSHSA website, as well as the NLCP 
Manual for Oral Fluid Laboratories.

Regulatory Impact and Notices

    The potential impact that these Guidelines have on the Department 
of Transportation (DOT) and/or Nuclear Regulatory Commission (NRC) 
regulated industries depend on the extent to which these agencies 
incorporate the OFMG revisions into their regulatory programs. 
Therefore, analysis of the potential impact of these Guidelines on such 
programs falls under the regulatory purview of DOT and NRC.

Executive Order 14094, 13563 and 12866

    Executive Order 14094 of April 6, 2023 (Modernizing Regulatory 
Review) reaffirms the statement set forth in 13563 of January 18, 2011 
(Improving Regulation and Regulatory Review) that ``Our regulatory 
system must protect public health, welfare, safety, and our environment 
while promoting economic growth, innovation, competitiveness, and job 
creation.'' Consistent with this mandate, Executive Order 13563 
requires agencies to tailor ``regulations to impose the least burden on 
society, consistent with obtaining regulatory objectives.'' Executive 
Order 13563 also requires agencies to ``identify and consider 
regulatory approaches that reduce burdens and maintain flexibility and 
freedom of choice'' while selecting ``those approaches that maximize 
net benefits.'' The regulatory approach in this document will reduce 
burdens to providers and to consumers while continuing to provide 
adequate protections for public health and welfare.
    The Secretary has examined the impact of the Guidelines under 
Executive Order 12866, as amended by Executive Order 14094, 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).
    According to Executive Order 12866, as amended by Executive Order 
14094, a ``significant regulatory action'' is one that is likely to 
result in a rule that may meet any one of a number of specified 
conditions, including: (1) have an annual effect on the economy of $200 
million or more in any one year (adjusted every 3 years by the 
Administrator of the Office of Information and Regulatory Affairs 
(OIRA) for changes in gross domestic product); or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, territorial, or tribal governments or communities; (2) create a 
serious inconsistency or otherwise interfere with an action taken or 
planned by another agency; (3) materially alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise legal or policy issues 
for which centralized review would meaningfully further the President's 
priorities or the principles set forth in the Executive order, as 
specifically authorized in a timely manner by the Administrator of OIRA 
in each case. 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.

Costs and Benefits

    The Department included a Regulatory Impact and Notices section 
with cost and benefits analysis and burden estimates in the April 7, 
2022 Federal Register Notification for the proposed OFMG (87 FR 20522), 
and requested public comment on all estimates and assumptions. Three 
commenters submitted comments concerning the Department's costs and 
benefits analysis.
    One commenter noted that the Department did not consider the 
application of the Guidelines to DOT testing, and recommended 
reanalysis of the costs and burden of the proposed changes with 
consideration of the impact on testing by the transportation industry. 
Please see the first paragraph of the Regulatory Impact and Notices 
section above.
    One commenter stated that the Department did not consider costs to 
MROs for training and education to bring MROs and MRO staff up to date 
on new drug panels and reporting methods. This commenter requested that 
the MRO community be allowed input to testing panel and nomenclature 
changes to enable adequate staffing and preparation. Another commenter 
disagreed with the Department's statement in the preamble to the 
proposed OFMG that ``implementation costs would be lower for 
laboratories that already offer the drug test'' compared to those 
laboratories that do not test for the added drug. The commenter 
indicated that the list of cost impacts for any change should include 
the laboratory's assay validation, materials management, and updates to 
IT systems (e.g., laboratory information management system [LIMS], 
recipient systems, and electronic ordering systems). This commenter 
indicated that these additional costs should be considered, and that 
they will be dependent on the complexity and adaptability of these 
systems. The Department agrees that costs will depend on the change and 
noted that in the preamble to the proposed OFMG. The Department will 
continue to proactively solicit cost information from stakeholders when 
conducting a cost analysis. As described under Authorized drug testing 
panel above, the Department will include a discussion of related costs 
and benefits when presenting a proposed panel change during a DTAB 
meeting.

Information Collection/Record Keeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines, which establish the 
scientific and technical guidelines for Federal workplace drug testing 
programs and establish standards for certification of laboratories 
engaged in oral fluid 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 (Federal CCF) used to 
document the collection and chain of custody of urine and oral fluid 
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.
    In support of the Government Paperwork Reduction Act (PRA), the

[[Page 70822]]

Department revised the Federal CCF to enable its use as an electronic 
form (78 FR 42091, July 15, 2013) and developed requirements and 
oversight procedures to ensure that HHS-certified test facilities and 
other service providers (e.g., collection sites, MROs) using an ECCF 
maintain the accuracy, security, and confidentiality of electronic drug 
test information. Before a Federal ECCF can be used for Federal agency 
specimens, HHS-certified test facilities must submit detailed 
information and proposed standard operating procedures (SOPs) to the 
NLCP for SAMHSA review and approval, and undergo an NLCP inspection 
focused on the proposed ECCF.
    Since 2013, SAMHSA has encouraged the use of Federal ECCFs and 
other electronic processes in HHS-certified test facilities, when 
practicable, for federally regulated testing operations. In accordance 
with section 8108(a) of the SUPPORT for Patients and Communities Act, 
SAMHSA originally set a deadline of August 31, 2023 for all HHS-
certified laboratories to submit a request for approval of a digital 
(paperless) electronic Federal CCF. The Department subsequently 
extended the deadline to August 31, 2026, to enable sufficient time for 
all HHS-certified laboratories to identify and contract with an ECCF 
supplier or to develop an ECCF.
    The title and description of the information collected and 
respondent description 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
    Description: The Mandatory 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 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.
    Description of Respondents: Individuals or households, businesses, 
or other-for-profit and not-for-profit institutions.
    The 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 or IITF                     10               1               3              30
                        required to submit
                        application for
                        certification.
9.10(a)(3)...........  Materials to submit to                 10               1               2              20
                        become an HHS inspector.
11.3.................  Laboratory submits                     10               1               2              20
                        qualifications of
                        responsible person (RP)
                        to HHS.
11.4(c)..............  Laboratory submits                     10               1               2              20
                        information to HHS on
                        new RP or alternate RP.
11.20................  Specifications for                     10               5             0.5              25
                        laboratory semiannual
                        statistical report of
                        test results to each
                        Federal agency.
13.8 and 14.7........  Specifies that MRO must               100              14    0.05 (3 min)              70
                        report all verified
                        primary and split
                        specimen test results to
                        the Federal agency.
13.11................  Specifications for MRO                100               2             0.5             100
                        semiannual report to the
                        Secretary or designated
                        representative for
                        Federal agency specimen
                        results that were
                        laboratory-positive and
                        MRO-verified negative.
16.1(b) & 16.5(a)....  Specifies content of                    1               1               3               3
                        request for informal
                        review of suspension/
                        proposed revocation of
                        certification.
16.4.................  Specifies information                   1               1             0.5             0.5
                        appellant provides in
                        first written submission
                        when laboratory
                        suspension/revocation is
                        proposed.
16.6.................  Requires appellant to                   1               1             0.5             0.5
                        notify reviewing
                        official of resolution
                        status at end of
                        abeyance period.
16.7(a)..............  Specifies contents of                   1               1              50              50
                        appellant submission for
                        review.
16.9(a)..............  Specifies content of                    1               1               3               3
                        appellant request for
                        expedited review of
                        suspension or proposed
                        revocation.
16.9(c)..............  Specifies contents of                   1               1              50              50
                        review file and briefs.
                                                 ---------------------------------------------------------------
    Total............  .........................             256  ..............  ..............             392
----------------------------------------------------------------------------------------------------------------

    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 refusal 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(d)); and Sections 13.6 
and 13.7 describe the actions an MRO takes for the medical evaluation 
of a donor who cannot provide an oral fluid specimen. SAMHSA has not 
calculated a separate reporting burden for these requirements because 
they are included in the burden hours estimated for collectors to 
complete Federal CCFs and for MROs to report results to Federal 
agencies.

[[Page 70823]]



                                      Estimate of Annual Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of      Responses/
         Section                 Purpose          respondents     respondent     Hours/ response    Total hours
----------------------------------------------------------------------------------------------------------------
8.3(a), 8.6(b)(2).......  Collector must                   100               1  0.05 (3 min)....               5
                           contact Federal
                           agency point of
                           contact.
11.21, 11.22............  Information on drug               25              10  3...............             750
                           test that
                           laboratory must
                           provide to Federal
                           agency upon request
                           or to donor through
                           MRO.
13.9(b).................  MRO must inform                  100              14  3...............           4,200
                           donor of right to
                           request split
                           specimen test when
                           a positive,
                           adulterated, or
                           substituted result
                           is reported.
                                               -----------------------------------------------------------------
    Total...............  ....................             225  ..............  ................           4,955
----------------------------------------------------------------------------------------------------------------

    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(h)). SAMHSA 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
----------------------------------------------------------------------------------------------------------------
                                                   Number of      Responses/
         Section                 Purpose          respondents     respondent     Hours/ response    Total hours
----------------------------------------------------------------------------------------------------------------
8.3, 8.4, 8.5, 8.8......  Collector completes              100             380  0.07 (4 min)....           2,660
                           Federal CCF for
                           specimen collected.
8.8(d) & (f)............  Donor initials                38,000               1  0.08 (5 min)....           3,040
                           specimen labels/
                           seals and signs
                           statement on the
                           Federal CCF.
11.8(a) & 11.17.........  Laboratory completes              25           1,520  0.05 (3 min)....           1,900
                           Federal CCF upon
                           receipt of specimen
                           and before
                           reporting result.
13.4(d)(4), 13.8(c),      MRO completes                    100             380  0.05 (3 min)....           1,900
 14.7(c).                  Federal CCF before
                           reporting the
                           primary or split
                           specimen result.
14.1(b).................  MRO documents                    100               2  0.05 (3 min)....              10
                           donor's request to
                           have split specimen
                           tested.
                                               -----------------------------------------------------------------
    Total...............  ....................          38,325  ..............  ................           9,510
----------------------------------------------------------------------------------------------------------------

    The Guidelines contain several 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)). 
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 (Section 
8.4(e)) 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. Subpart K describes 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(a); 11.13(a); 
11.16; 11.19(a), (b), and (c); 11.20; 11.21(a) 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. These practices are integrated in the current 
processes and, therefore, SAMHSA does not consider these standard 
business practices to be an additional burden for disclosure.
    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 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. Scheidweiler K.B., Spargo E.A., Kelly T.L., Cone E.J., Barnes 
A.J., Huestis M.A., 2010. Pharmacokinetics of cocaine and 
metabolites in human oral fluid and correlation with plasma 
concentrations after controlled administration. Ther Drug Monit., 
32(5), 628-37.

    Dated: September 27, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.

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

Subpart A--Applicability

1.1 To whom do these Guidelines apply?

[[Page 70824]]

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?
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 drugs other than those in the drug 
testing panel?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug and biomarker test analytes and cutoffs 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 oral fluid specimen as 
substituted?
3.8 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 that seeks 
to perform oral fluid testing?
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?

[[Page 70825]]

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?
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 How does an MRO report a primary (A) specimen test result to an 
agency?
13.9 Who may request a test of a split (B) specimen?
13.10 What types of relationships are prohibited between an MRO and an 
HHS-certified laboratory?
13.11 What reports must an MRO provide to the Secretary for oral fluid 
testing?
13.12 What are a Federal agency's responsibilities for designating an 
MRO?

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 How does an HHS-certified laboratory test a split (B) oral fluid 
specimen when the primary (A) specimen was reported substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B) oral 
fluid specimen result from the second HHS-certified laboratory?
14.7 How does an MRO report a split (B) specimen test result to an 
agency?
14.8 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 
an oral fluid 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;

[[Page 70826]]

    (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.

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) Revisions to these Guidelines will be published in final as a 
notification 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.
    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 a normal constituent (e.g., nitrite in urine).
    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.
    Biomarker Testing Panel. The panel published in the Federal 
Register that includes the biomarkers authorized for testing, with 
analytes and cutoffs for initial and confirmatory biomarker tests, as 
described under Section 3.4.
    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 the specimen 
has been 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 an initial 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, drug metabolite, or 
biomarker concentration) used as the decision point to determine a 
result (e.g., negative, positive, adulterated, invalid, or substituted) 
or the need for further testing.
    Donor. The individual from whom a specimen is collected.
    Drug Testing Panel. The panel published in the Federal Register 
that includes the drugs authorized for testing, with analytes and 
cutoffs for initial and confirmatory drug tests, as described under 
Section 3.4.
    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[hyphen]certified 
laboratory, a Medical Review Officer (MRO), or (for urine) an 
HHS[hyphen]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)

[[Page 70827]]

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(digital), 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 adulterated, invalid, substituted, or (for 
urine) dilute.
    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 3.8 when a 
positive, negative, adulterated, or substituted 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 (LOD). The lowest concentration at which the 
analyte (e.g., drug or drug metabolite) can be identified.
    Limit of Quantification (LOQ). 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 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 confirmatory test cutoff.
    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) 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.
    Substituted Specimen. A specimen that has been submitted in place 
of the donor's specimen, as evidenced by the absence of a biomarker or 
a biomarker concentration inconsistent with that established for a 
human specimen, as indicated in the biomarker testing panel, or (for 
urine) creatinine and specific gravity values that are outside the 
physiologically producible ranges of human urine, in accordance with 
the criteria to report a urine specimen as substituted in the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Urine 
(UrMG), Section 3.7.
    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 through 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 https://www.hhs.gov/hipaa/index.html.

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:

[[Page 70828]]

    (1) Fail to appear for any 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;
    (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;
    (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 or wash hands 
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) A refusal to take a test may result in the initiation of 
disciplinary or adverse action for a Federal employee, up to and 
including removal from Federal employment. An applicant's refusal to 
take a pre-employment test may result in 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, 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, email, or secure facsimile [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 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 
13.9.

Subpart C--Oral Fluid Specimen 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 in the drug testing panel described under Section 
3.4;
    (b) Is authorized to test each specimen for other Schedule I or II 
drugs as provided in the drug testing panel;
    (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 specific adulterant;
    (d) Is authorized to test each specimen for one or more biomarkers 
as provided in the biomarker testing panel; and
    (e) May perform additional testing if a specimen exhibits abnormal 
characteristics (e.g., unusual odor or color, semi-solid 
characteristics), 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.

Section 3.2 May a specimen be tested for drugs other than those in the 
drug testing panel?

    (a) On a case-by-case basis, a specimen may be tested for 
additional

[[Page 70829]]

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 the drug testing panel described under Section 3.4. 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 Section 3.2(a).

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 and biomarker test analytes and cutoffs 
for undiluted (neat) oral fluid?

    The Secretary will publish the drug and biomarker test analytes and 
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing 
panel'') for initial and confirmatory drug and biomarker tests in the 
Federal Register each year. The drug and biomarker testing panels will 
also be available on the internet at https://www.samhsa.gov/workplace.
    This drug testing panel will remain in effect until the effective 
date of a new drug testing panel published in the Federal Register:

----------------------------------------------------------------------------------------------------------------
                                                                   Confirmatory test        Confirmatory test
        Initial test analyte          Initial  test cutoff \1\          analyte                   cutoff
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\.................  4 ng/mL \3\.............  THC....................  2 ng/mL.
Cocaine/Benzoylecgonine.............  15 ng/mL................  Cocaine................  8 ng/mL.
                                                                Benzoylecgonine........  8 ng/mL.
Codeine/Morphine....................  30 ng/mL................  Codeine................  15 ng/mL.
                                                                Morphine...............  15 ng/mL.
Hydrocodone/Hydromorphone...........  30 ng/mL................  Hydrocodone............  15 ng/mL.
                                                                Hydromorphone..........  15 ng/mL.
Oxycodone/Oxymorphone...............  30 ng/mL................  Oxycodone..............  15 ng/mL.
                                                                Oxymorphone............  15 ng/mL.
6-Acetylmorphine....................  4 ng/mL\3\..............  6-Acetylmorphine.......  2 ng/mL.
Phencyclidine.......................  10 ng/mL................  Phencyclidine..........  10 ng/mL.
Amphetamine/Methamphetamine.........  50 ng/mL................  Amphetamine............  25 ng/mL.
                                                                Methamphetamine........  25 ng/mL.
MDMA \4\/MDA \5\....................  50 ng/mL................  MDMA...................  25 ng/mL.
                                                                MDA....................  25 ng/mL.
----------------------------------------------------------------------------------------------------------------
\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).

    (a) The drug testing panel will include drugs authorized for 
testing in Federal workplace drug testing programs, with the required 
test analytes and cutoffs;
    (b) The biomarker testing panel will include biomarkers authorized 
for testing in Federal workplace drug testing programs, with the 
required test analytes and cutoffs; and
    (c) HHS-certified laboratories and Medical Review Officers must use 
the nomenclature (i.e., analyte names and abbreviations) published in 
the Federal Register with the drug and biomarker testing panels to 
report Federal workplace drug test results.

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). 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.

[[Page 70830]]

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

    An HHS-certified laboratory reports a primary (A) 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 oral fluid specimen as 
substituted?

    An HHS-certified laboratory reports a primary (A) specimen as 
substituted when a biomarker is not detected or is present at a 
concentration inconsistent with that established for human oral fluid 
for both the initial (first) test and the confirmatory (second) test on 
two separate aliquots (i.e., using the test analytes and cutoffs listed 
in the biomarker testing panel).

Section 3.8 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 initial drug test results cannot be obtained);
    (b) Interference with the confirmatory drug test 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) A specimen validity test on two separate aliquots of the 
specimen indicates that the specimen is not valid for testing.

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 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 
personal friend of the employee (e.g., fianc[eacute]e).

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 the collection procedure 
described in 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 Section 4.3(a).
    (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.

[[Page 70831]]

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) A restricted access area for the secure storage of records.

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 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 information 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?

    A 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) One or two sealable, non-leaking tubes [depending on the device 
type, as described in Section 8.8(a)] that:
    (1) maintain 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,
    (2) are sufficiently transparent (e.g., translucent) to enable a 
visual assessment of the contents (i.e., oral fluid, buffer/diluent, 
collection pad) for identification of abnormal physical characteristics 
without opening the tube, and
    (3) include the device lot expiration date on each specimen tube 
(i.e., the expiration date of the buffer/diluent or, for devices 
without a buffer/diluent, the earliest expiration date of any device 
component);
    (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.

[[Page 70832]]

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 listed in the drug testing panel.

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 take all reasonable steps to prevent 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 must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (e) The collector asks the donor to remove any unnecessary outer 
garments (e.g., coat, jacket) that might conceal items or substances 
that could be used to adulterate or substitute the oral fluid specimen. 
The collector must ensure that all personal belongings (e.g., purse or 
briefcase) remain with the outer garments. The donor may retain the 
donor's wallet. The donor is not required to remove any items worn for 
faith-based reasons.
    (f) If the donor will remain under the collector's direct 
observation until the end of the collection, including the 10-minute 
wait period described in Section 8.3(h), the collector proceeds to 
Section 8.3(g). If the collector will not keep the donor under direct 
observation from this point until the end of the collection, the 
collector asks the donor to empty the donor's pockets and display the 
contents to ensure no items are present that could be used to 
adulterate or substitute the specimen.
    (1) If no items are present that can be used to adulterate or 
substitute the specimen, the collector instructs the donor to return 
the items to their pockets and continues the collection procedure.
    (2) If an item is present whose purpose is to adulterate or 
substitute the specimen (e.g., a commercial drug culture product or 
other substance for which the donor has no reasonable explanation), 
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.
    (3) If an item that could be used to adulterate or substitute the 
specimen (e.g., common personal care products such as mouthwash, 
lozenges, capsules) appears to have been inadvertently brought to the 
collection site, the collector must secure the item and continue with 
the normal collection procedure.
    (4) If the donor refuses to show the collector the items in their 
pockets, the collector must keep the donor under direct observation 
until the end of the oral fluid collection.
    (g) 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 (e.g., candy, gum, food, tobacco) that could impede or 
interfere with the collection of an oral fluid specimen or items that 
could be used to adulterate, substitute, or dilute the specimen.
    (1) If an item is present that whose purpose is to adulterate or 
substitute the specimen (e.g., a commercial drug culture product or 
other item for which the donor has no reasonable explanation), 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.
    (2) If an item is present that could impede or interfere with the 
collection of an oral fluid specimen (including abnormally colored 
saliva), 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. 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).
    (h) The collector must initiate a 10-minute wait period prior to 
collecting the specimen. During these 10 minutes, the collector must:
    (1) Explain the basic collection procedure to the donor;
    (2) Provide the instructions for completing the Federal CCF for the 
donor's review, and informs the donor that these instructions and the 
collection device-specific instructions are available upon request.
    (3) Answer any reasonable and appropriate questions the donor may 
have regarding the collection procedure; and
    (4) Inform the donor that they must remain at the collection site 
(i.e., in the area designated by the collector) during the wait period, 
and that failure to follow these instructions will be reported as a 
refusal to test.

[[Page 70833]]

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

    (a) The collector shall instruct the donor to wash and dry the 
donor's hands under the collector's observation, and to keep their 
hands within view and avoid touching items or surfaces after 
handwashing. If the donor refuses to wash their hands when instructed 
by the collector, this is a refusal to test.
    (b) The collector will provide or the donor may select the specimen 
collection device(s) to be used for the collection. The device(s) must 
be clean, unused, and wrapped/sealed in original packaging and must be 
within the manufacturer's expiration date printed on the specimen tube. 
See Section 8.8(a) for types of specimen collection devices used for 
oral fluid split specimen collections.
    (1) The collector will open the package in view of the donor.
    (2) Both the collector and the donor 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.
    (c) The collector verifies that each device is within the 
manufacturer's expiration date, and documents this action on the 
Federal CCF.
    (d) 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.
    (e) 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 prevent the device from collecting sufficient oral fluid; 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 the collector must complete the collection in 
accordance with the manufacturer instructions for the collection 
device.
    (3) The collector must inspect the specimen to determine if there 
is any sign indicating that the specimen may not be a valid oral fluid 
specimen (e.g., unusual color, presence of foreign objects or 
material), documents any unusual findings on the Federal CCF, and takes 
action (e.g., recollection) to obtain an acceptable specimen.
    (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 Section 8.5(a)(1), refuses to 
provide a split specimen as instructed by the collector, or refuses to 
provide an alternate specimen when directed to do so, 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 may choose not 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 to collect an alternate 
specimen, 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 alternate 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 70834]]

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 required information is 
included on the Federal CCF.
    (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 including the reason 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 of these 
Guidelines.
    (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 14.8;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.21 and 11.22 and subpart P of these 
Guidelines; and
    (4) Follow the HHS suspension and revocation procedures when 
imposed by the Secretary, follow the HHS

[[Page 70835]]

procedures in subpart P of these Guidelines that will be 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 the drug testing panel 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 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 when the PT sample is 
designated as a retest sample; or
    (iii) The concentration of drug or metabolite may differ from 
Section 9.5(a)(1)(i) and (ii) for a special purpose.
    (2) A PT sample may contain an interfering substance, an 
adulterant, or other substances for special purposes, or may satisfy 
the criteria for a substituted specimen or invalid result.
    (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 
that seeks to perform oral fluid testing?

    (a) An applicant laboratory that seeks certification under these 
Guidelines to perform oral fluid testing 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, do 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;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over the three sets of PT samples;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over the three sets of PT 
samples;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over the three 
sets of PT samples that satisfy the specified criteria; and
    (10) Do not report any PT sample as adulterated with a compound 
that is not present in the sample or substituted when the appropriate 
reference or peer group mean for a biomarker is within the acceptable 
range.
    (b) Failure to satisfy these requirements will result in the denial 
of the laboratory's application for HHS certification to perform oral 
fluid testing.

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

    (a) A laboratory certified under these Guidelines to perform oral 
fluid testing 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, do not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group means;
    (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;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over two consecutive PT cycles;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over two consecutive PT cycles;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over two 
consecutive PT cycles that satisfy the specified criteria; and
    (10) Do not report any PT sample as adulterated with a compound 
that is not present in the sample or substituted when the appropriate 
reference or peer group mean for a biomarker is within the acceptable 
range.
    (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 two or more 
inspectors. The number of inspectors is determined according to the 
number of specimens to be 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.

[[Page 70836]]

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 of these 
Guidelines;
    (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 
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 of 
these Guidelines, 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 fax, 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 of these Guidelines 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 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 of 
these Guidelines.

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

[[Page 70837]]

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 
https://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 device as to their content 
using appropriate initial and confirmatory tests.
    (1) Drug positive blind samples must contain one or more of the 
drugs or metabolites listed in the drug testing panel.
    (2) Drug positive blind samples must contain concentrations of 
drugs between 1.5 and 2 times the initial drug test cutoff.
    (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

[[Page 70838]]

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, 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.

[[Page 70839]]

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.

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, using samples at 
several concentrations between 0 and 150 percent of the cutoff;
    (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;
    (5) The accuracy (bias) and precision at 40 percent of the cutoff;
    (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;
    (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?

    An HHS-certified laboratory may perform specimen validity tests in 
accordance with Sections 3.1 and 3.5.
    (a) Each invalid, adulterated, or substituted 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, as 
described in items o and p below.

[[Page 70840]]

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 Section 11.17(g)(1) through (5).
    (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 the cutoffs 
listed in the drug testing panel.
    (d) A primary (A) oral fluid specimen is reported 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.
    (e) A primary (A) oral fluid specimen is reported substituted when 
a biomarker is not present or is present at a concentration 
inconsistent with that established for human oral fluid.
    (f) For a specimen that has an invalid result for one of the 
reasons stated in Section 11/17(g)(1) through (5), 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, adulterated, or substituted result. If no further 
testing is necessary, the HHS-certified laboratory then reports the 
invalid result to the MRO.
    (g) 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) A specimen validity test on two separate aliquots of the 
specimen indicates that the specimen is not valid for testing.
    (h) 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 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.
    (i) An HHS-certified laboratory must report all positive, 
adulterated, substituted, and invalid test results for an oral fluid 
specimen. For example, a specimen can be positive for a drug and 
adulterated.
    (j) An HHS-certified laboratory must report the confirmatory 
concentration of each drug or drug metabolite reported for a positive 
result.
    (k) An HHS-certified laboratory must report numerical values of the 
specimen validity test results that support an adulterated, 
substituted, or invalid result (as appropriate).
    (l) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing 
panels.
    (m) 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.
    (n) HHS-certified laboratories may transmit test results to the MRO 
by various electronic means (e.g., fax, 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.
    (o) HHS-certified laboratories must fax, 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.
    (p) For positive, adulterated, substituted, invalid, and rejected 
specimens, laboratories must fax, 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, substituted, or as an invalid result 
for a minimum of 1 year.
    (b) Retained oral fluid specimens must be kept in secured storage 
in accordance with the collection device manufacturer's specifications 
(i.e., frozen at -20 [deg]C or less, or refrigerated), 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 following the laboratory's 
reporting of the specimen.

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 What 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, fax, or email within 14 working days 
after the end of the semiannual period. The summary report must not 
include any personally identifiable 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;

[[Page 70841]]

    (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;
    (13) Number of specimens reported substituted; and
    (14) 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, 
adulterated, or substituted 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 (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?

    Federal applicants or employees who are subject to a workplace drug 
test may submit a written request through the MRO and/or the Federal 
agency requesting copies of any records relating to their 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 applicants or 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 a 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 notification in the Federal Register 
listing those

[[Page 70842]]

entities and subspecialty boards that have been approved. This 
notification is also available on the internet at https://www.samhsa.gov/workplace.

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 including any changes to the drug and biomarker testing 
panels 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 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(f) 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 two years while 
maintaining the confidentiality of the information. The MRO may convert 
hardcopy records to electronic records for storage and discard the 
hardcopy records after six 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 and an alternate specimen was not 
collected, as addressed in Sections 8.6 and 13.6.

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, the MRO must follow the verification 
procedures described in Section 13.5(c) through (f) and:
    (1) The MRO reports 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, adulterated, or substituted result, the MRO does not report 
the verified invalid result to the Federal agency at this time. The MRO 
takes action for the verified invalid result(s) for the primary (A) 
specimen as described in Section 13.5(e) only when:
    (i) The MRO verifies the positive, adulterated, or substituted 
result as negative based on a legitimate medical explanation as 
described in Section 13.5(c)(2) and (d)(1), or based on codeine and/or 
morphine concentrations less than 150 ng/mL as described in Section 
13.5(c)(3)(i); or
    (ii) The split (B) specimen is tested and reported as a failure to 
reconfirm the positive, adulterated or substituted result reported for 
the primary (A) specimen as described in Section 14.6(m).
    (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 admits unauthorized use of the drug(s) that caused 
the positive result, the MRO reports the test result as positive to the 
agency. The MRO must document the donor's admission of unauthorized 
drug use in the MRO records and in the MRO's report to the Federal 
agency.
    (2) 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 marijuana smoke) 
is not a legitimate medical explanation for a positive drug test 
result.
    (ii) Ingestion of food products containing a drug (e.g., products 
containing marijuana) is not a legitimate medical explanation for a 
positive drug test result. See exceptions for positive codeine and 
morphine results in Section 13.5(c)(3).
    (iii) A physician's authorization or medical recommendation for a 
Schedule 1 controlled substance is not a legitimate medical explanation 
for a positive drug test result.
    (3) If the donor is unable to provide a legitimate medical 
explanation for the positive result, the MRO reports the 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, the MRO must 
report the result as negative to the agency, unless the donor admits 
unauthorized use of the drug(s) that caused the positive result as 
described in Section 13.5(c)(1).
    (ii) For codeine and/or morphine equal to or greater than 150 ng/mL 
and no legitimate medical explanation, the MRO shall report 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 or 
substituted 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 or substituted 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 or substituted.

[[Page 70843]]

    (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 medicine), 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 Federal agency to immediately collect another 
specimen from the donor.
    (i) If the second specimen collected provides a valid result, the 
MRO follows the procedures in Section 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). If the 
Federal agency does not authorize collection of another specimen type, 
the MRO consults with the agency to arrange a clinical evaluation as 
described in Section 13.7, to determine whether there is a legitimate 
medical reason for the invalid result.
    (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 in 
accordance with Section 8.6, the MRO reviews and reports the test 
result in accordance with the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using the alternate specimen.
    (b) When the Federal agency did not authorize the collection of an 
alternate 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 Section 
13.6(b)(3) 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 Section 13.6(b)(1) has, or 
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 
Section 13.6(b)(1) 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 alternate 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 Section 13.6(b)(3)(i), the 
agency takes no further action with respect to the donor. When a test 
is canceled as provided in Section 13.6(b)(3)(ii), 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 alternate 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

[[Page 70844]]

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 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., fax, 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 substituted results.
    (d) The MRO must not disclose numerical values of drug test results 
to the agency.
    (e) The MRO must report drug test results using the HHS-specified 
nomenclature published with the drug and biomarker testing panels.

Section 13.9 Who may request a test of a split (B) specimen?

    (a) For a positive, adulterated, or substituted 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 
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 substituted result is being reported to the 
Federal agency on the primary (A) specimen.

Section 13.10 What 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.

Section 13.11 What reports must an MRO provide to the Secretary for 
oral fluid testing?

    (a) An MRO must send to the Secretary or designated HHS 
representative a semiannual report of Federal agency specimens that 
were reported as positive for a drug or drug metabolite by a laboratory 
and verified as negative by the MRO. The report must not include any 
personally identifiable information for the donor and must be submitted 
by mail, fax, or other secure electronic transmission method within 14 
working days after the end of the semiannual period (i.e., in January 
and July). The semiannual report must contain the following 
information:
    (1) Reporting period (inclusive dates);
    (2) MRO name, company name, and address;
    (3) Federal agency name; and
    (4) For each laboratory-reported positive drug test result that was 
verified as negative by the MRO:
    (i) Specimen identification number;
    (ii) Laboratory name and address;
    (iii) Positive drug(s) or drug metabolite(s) verified as negative;
    (iv) MRO reason for verifying the positive drug(s) or drug 
metabolite(s) as negative (e.g., a donor prescription [the MRO must 
specify the prescribed drug]);
    (v) All results reported to the Federal agency by the MRO for the 
specimen; and
    (vi) Date of the MRO report to the Federal agency.
    (b) An MRO must provide copies of the drug test reports that the 
MRO has sent to a Federal agency when requested to do so by the 
Secretary.
    (c) If an MRO did not verify any positive laboratory results as 
negative during the reporting period, the MRO should file a report that 
states that the MRO has no reportable results during the applicable 
reporting period.

Section 13.12 What are a Federal agency's responsibilities for 
designating an MRO?

    (a) Before allowing an individual to serve as an MRO for the 
agency, a Federal agency must verify and document the following:
    (1) that the individual satisfies all requirements in Section 13.1, 
including certification by an MRO certification organization that has 
been approved by the Secretary, as described in Section 13.2; and
    (2) that the individual is not an employee, agent of, or have any 
financial interest in an HHS-certified laboratory that tests the 
agency's specimens, as described in Section 13.10.
    (b) The Federal agency must verify and document that each MRO 
reviewing and reporting results for the agency:
    (1) completes training on any revisions to these Guidelines, 
including any changes to the drug and biomarker testing panels, prior 
to their effective date;
    (2) at least every five years, maintains their certification by 
completing requalification training and passing a requalification 
examination; and
    (3) provides biannual reports to the Secretary or designated HHS 
representative as required in Section 13.11;
    (c) The Federal agency must ensure that each MRO reports drug test 
results to the agency in accordance with Sections 13.8 and 14.7.
    (1) Before allowing an MRO to report results electronically, the 
agency must obtain documentation from the MRO to confirm that the MRO 
and any external service providers ensure the confidentiality, 
integrity, and availability of the data and limit access to any data 
transmission, storage, and retrieval system.

Subpart N--Split Specimen Tests

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

    (a) The donor may request, verbally or in writing, through the MRO 
that the split (B) oral fluid specimen be tested at a different (i.e., 
second) HHS-certified oral fluid laboratory when the primary

[[Page 70845]]

(A) specimen was determined by the MRO to be positive, adulterated, or 
substituted.
    (b) A donor has 72 hours to initiate the request after being 
informed of the result by the MRO. The MRO must 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 to perform the 
test), the MRO reports a cancelled test to the Federal agency and the 
reason for the cancellation. The MRO directs the Federal agency to 
ensure 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 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 cutoffs 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 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 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported substituted?

    The second HHS-certified laboratory may only conduct the 
confirmatory biomarker test(s) needed to reconfirm the substituted 
result reported by the first HHS-certified laboratory.

Section 14.5 Who receives the split (B) specimen result?

    The second HHS-certified laboratory must report the result to the 
MRO using the HHS-specified nomenclature published with the drug and 
biomarker testing panels.

Section 14.6 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), adulteration, and/or substitution 
result. The MRO reports reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
the specimen was adulterated. If the donor provides a legitimate 
medical explanation for the adulteration result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the 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 using a direct observed collection 
procedure. 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 
the specimen was substituted. If the donor provides a legitimate 
medical explanation for the substituted result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and a refusal to 
test (substituted) to the agency. The MRO gives the donor 72 hours to 
request that Laboratory A test the primary (A) specimen using its 
confirmatory test for the biomarker.
    (1) If the primary (A) specimen's test results confirm that the 
specimen was substituted, the MRO reports a refusal to test 
(substituted) to the agency.
    (2) If the primary (A) specimen's results fail to confirm that the 
specimen was substituted, the MRO cancels both tests and directs the 
agency to immediately collect another specimen using a direct observed 
collection procedure. The MRO shall notify the HHS office responsible 
for coordination of the drug-free workplace program about the failed to 
reconfirm and cancelled test.
    (d) Failed to reconfirm a single or all drug positive results and 
the specimen was not adulterated or substituted. The MRO reports to the 
agency a failed to reconfirm result (specifying the drug[s]), cancels 
both tests, and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (e) Failed to reconfirm a single or all drug positive results and 
the specimen had an invalid result. The MRO reports to the agency a 
failed to reconfirm result (specifying the drug[s] and the reason for 
the invalid result), cancels both tests, directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure, and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was adulterated. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the 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.
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was substituted. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the 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 
substituted. 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 one or more drugs, reconfirmed one or more 
drugs, and the specimen was not adulterated or substituted. The MRO 
reports to the agency a reconfirmed result (specifying the drug[s]) and 
a failed to reconfirm result (specifying the drug[s]). The MRO tells 
the agency that it may take action

[[Page 70846]]

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.
    (i) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen had an invalid result. The MRO reports to the 
agency a reconfirmed result (specifying the drug[s]) and a failed to 
reconfirm result (specifying the 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.
    (j) Failed to reconfirm substitution or adulteration. The MRO 
reports to the agency a failed to reconfirm result (not adulterated: 
specifying the adulterant or not substituted) 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 substitution or adulteration and the 
specimen had an invalid result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: specifying the adulterant or not 
substituted, and the reason for the invalid result), cancels both 
tests, directs the agency to immediately collect another specimen using 
a direct observed collection procedure and notifies the HHS office 
responsible for coordination of the drug-free workplace program.
    (l) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterated or substituted result. The MRO reports to 
the agency a reconfirmed result (adulterated or substituted) and a 
failed to reconfirm result (specifying the drug[s]). The MRO tells the 
agency that it may take action based on the reconfirmed result 
(adulterated or substituted) although Laboratory B failed to reconfirm 
the drug(s) result.
    (m) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterated or substituted result. The MRO 
reports to the agency a failed to reconfirm result (specifying the 
drug[s] and not adulterated: specifying the adulterant or not 
substituted) 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.
    (n) Failed to reconfirm at least one drug and reconfirmed the 
adulterated result. The MRO reports to the agency a reconfirmed result 
(specifying the drug[s] and adulterated) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) and the adulterated result 
although Laboratory B failed to reconfirm one or more drugs.
    (o) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterated result. The MRO reports to the agency a reconfirmed 
result (specifying the drug[s]) and a failed to reconfirm result 
(specifying the drug[s] and not adulterated: specifying the 
adulterant). 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 failed to reconfirm the adulterated result.
    (p) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: specifying the adulterant, and 
not substituted) 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.
    (q) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (not adulterated: 
specifying the adulterant). The MRO tells the agency that it may take 
action based on the substituted result although Laboratory B failed to 
reconfirm the adulterated result.
    (r) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.

Section 14.7 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., fax, 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.
    (e) The MRO must report drug test results using the HHS-specified 
nomenclature published with the drug and biomarker testing panels.

Section 14.8 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, 
in accordance with Section 11.18. 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 an oral fluid 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 primary (A) specimen was collected using an expired device 
(i.e., the device expiration date precedes the collection date) and the 
split (B) specimen cannot be re-designated as the primary (A) specimen;
    (d) The collector's printed name and signature are omitted on the 
Federal CCF;

[[Page 70847]]

    (e) The collector failed to document observation of the volume 
indicator(s) at the time of collection for a collection device 
containing a diluent.
    (f) There is an insufficient amount of specimen for analysis in the 
primary (A) specimen and the split (B) specimen cannot be re-designated 
as the primary (A) specimen;
    (g) 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;
    (h) The specimen was received at the HHS-certified laboratory 
without a CCF;
    (i) The CCF was received at the HHS-certified laboratory without a 
specimen;
    (j) The collector performed two separate collections using one CCF; 
or
    (k) 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 hold the specimen and attempt to obtain a 
memorandum for record to recover the collector's signature. 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 report 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) The specimen type box (Oral Fluid) is not marked (i.e., by the 
collector or laboratory);
    (11) A ``collection'' box is not marked;
    (12) The ``each device within expiration date'' box is not marked;
    (13) The collection site address is missing;
    (14) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (15) The time of collection is not indicated;
    (16) The date of collection is not indicated;
    (17) Incorrect name of delivery service;
    (18) 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
    (19) 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;
    (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 
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 substituted.
    (b) If the error in Section 15.4(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 the error in Section 15.4(a)(2) occurs, the MRO must obtain 
a statement from the certifying scientist that they 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 the error in Section 15.4(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

[[Page 70848]]

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):
    (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

[[Page 70849]]

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 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 Section 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 fax, 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 fax, 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

[[Page 70850]]

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. 2023-21735 Filed 10-11-23; 8:45 am]
BILLING CODE 4162-20-P