70814 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

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. 

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 Eugene.Hayes@

samhsa.hhs.gov. 

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 HHScertified laboratories, Medical Review 

Officers (MROs), research scientists, 


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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., HHScertified 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-bycase 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 preemployment 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 preemployment 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. 


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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 


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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 preemployment 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 preemployment drug test collections (see 

Section 1.7) also suggested that this step 

be specified as the beginning of a preemployment 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 


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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 HHSapproved MRO certification 

organizations for dissemination to their 

certified MROs. The Department also 

sends additional guidance to HHScertified 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 


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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 


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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

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

9.2(a)(1) ........ Laboratory or IITF required to submit application for certification.10 1 3 30 

9.10(a)(3) ...... Materials to submit to become an HHS inspector ............... 10 1 2 20 

11.3 ............... Laboratory submits qualifications of responsible person 

(RP) to HHS.

10 1 2 20 

11.4(c) ........... Laboratory submits information to HHS on new RP or alternate RP.10 1 2 20 

11.20 ............. Specifications for laboratory semiannual statistical report of 

test results to each Federal agency.

10 5 0.5 25 

13.8 and 14.7 Specifies that MRO must report all verified primary and 

split specimen test results to the Federal agency.

100 14 0.05 (3 min) 70 

13.11 ............. Specifications for MRO semiannual report to the Secretary 

or designated representative for Federal agency specimen results that were laboratory-positive and MROverified negative.

100 2 0.5 100 

16.1(b) & 

16.5(a).

Specifies content of request for informal review of suspension/proposed revocation of certification.1 1 3 3 

16.4 ............... Specifies information appellant provides in first written submission when laboratory suspension/revocation is proposed.1 1 0.5 0.5 

16.6 ............... Requires appellant to notify reviewing official of resolution 

status at end of abeyance period.

1 1 0.5 0.5 

16.7(a) .......... Specifies contents of appellant submission for review ........ 1 1 50 50 

16.9(a) .......... Specifies content of appellant request for expedited review 

of suspension or proposed revocation.

1 1 3 3 

16.9(c) ........... Specifies contents of review file and briefs .......................... 1 1 50 50 

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. 


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ESTIMATE OF ANNUAL DISCLOSURE BURDEN

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

8.3(a), 8.6(b)(2) ......... Collector must contact Federal agency point of contact ........................ 100 1 0.05 (3 min) ..... 5 

11.21, 11.22 .............. Information on drug test that laboratory must provide to Federal agency upon request or to donor through MRO.25 10 3 ...................... 750 

13.9(b) ....................... MRO must inform donor of right to request split specimen test when a 

positive, adulterated, or substituted result is reported.

100 14 3 ...................... 4,200 

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

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

8.3, 8.4, 8.5, 8.8 ........ Collector completes Federal CCF for specimen collected ..................... 100 380 0.07 (4 min) ..... 2,660 

8.8(d) & (f) ................. Donor initials specimen labels/seals and signs statement on the Federal CCF.38,000 1 0.08 (5 min) ..... 3,040 

11.8(a) & 11.17 ......... Laboratory completes Federal CCF upon receipt of specimen and before reporting result.25 1,520 0.05 (3 min) ..... 1,900 

13.4(d)(4), 13.8(c), 

14.7(c).

MRO completes Federal CCF before reporting the primary or split 

specimen result.

100 380 0.05 (3 min) ..... 1,900 

14.1(b) ....................... MRO documents donor’s request to have split specimen tested ........... 100 2 0.05 (3 min) ..... 10 

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? 


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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 OMBapproved 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? 


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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 HHScertified 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 HHScertified 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/preemployment 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 HHScertified 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; 


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(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 HHScertified 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 HHScertified 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 HHScertified 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-certified laboratory, a Medical 

Review Officer (MRO), or (for urine) an 

HHS-certified Instrumented Initial Test 

Facility (IITF). 

Failed to Reconfirm. The result 

reported for a split (B) specimen when 

a second HHS-certified laboratory is 

unable to corroborate the result reported 

for the primary (A) specimen. 

Federal Drug Testing Custody and 

Control Form (Federal CCF). The Office 

of Management and Budget (OMB) 


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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 HHScertified 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: 


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(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/preemployment 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/Preemployment 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., nonrecovery 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 


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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: 

Initial test analyte Initial 

test cutoff 1 Confirmatory test analyte Confirmatory test cutoff 

Marijuana (THC) 2 ........................................................... 4 ng/mL 3 ...... THC ............................................................................... 2 ng/mL. 

Cocaine/Benzoylecgonine .............................................. 15 ng/mL ...... Cocaine ..........................................................................

Benzoylecgonine ...........................................................

8 ng/mL. 

8 ng/mL. 

Codeine/Morphine .......................................................... 30 ng/mL ...... Codeine .........................................................................

Morphine ........................................................................

15 ng/mL. 

15 ng/mL. 

Hydrocodone/Hydromorphone ........................................ 30 ng/mL ...... Hydrocodone .................................................................

Hydromorphone .............................................................

15 ng/mL. 

15 ng/mL. 

Oxycodone/Oxymorphone .............................................. 30 ng/mL ...... Oxycodone .....................................................................

Oxymorphone ................................................................

15 ng/mL. 

15 ng/mL. 

6-Acetylmorphine ............................................................ 4 ng/mL3 ...... 6-Acetylmorphine ........................................................... 2 ng/mL. 

Phencyclidine ................................................................. 10 ng/mL ...... Phencyclidine ................................................................. 10 ng/mL. 

Amphetamine/Methamphetamine ................................... 50 ng/mL ...... Amphetamine .................................................................

Methamphetamine .........................................................

25 ng/mL. 

25 ng/mL. 

MDMA4/MDA5 ............................................................... 50 ng/mL. ..... MDMA ............................................................................

MDA ...............................................................................

25 ng/mL. 

25 ng/mL. 

1For 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. 2An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol (THC). 3Alternate 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 caseby-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 HHScertified 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. 


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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 HHScertified 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., fiance ́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 selfemployed, 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. 


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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 agencydesignated 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 HHScertified 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 preanalytical 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. 


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70832 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

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 °F/ 

18–25 °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. 


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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 


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70834 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

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 HHScertified 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 HHScertified 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 HHScertified 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 OMBapproved 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 


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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 HHScertified 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 HHScertified laboratory must continue to 

satisfy the minimum requirements as 

stated in these Guidelines. 


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70836 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

Section 9.10 Who can inspect an HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 


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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 HHScertified 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 


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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. 


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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 HHScertified 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 HHScertified 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 reverify 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 HHScertified 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. 


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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 HHScertified 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 HHScertified 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 °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 HHScertified 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; 


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(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 HHScertified 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 HHScertified 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 re ́sume ́ 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 HHScertified 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 


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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. 


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(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/preemployment 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/preemployment 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 


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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 HHScertified 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 


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(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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 


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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 drugfree 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 drugfree 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 HHScertified 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 HHScertified 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 HHScertified 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 redesignated 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; 


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(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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified laboratory in writing that its 

certification to perform drug testing 


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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 


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

(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 


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70850 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

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 


ddrumheller on DSK120RN23PROD with RULES4