[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7771-7782]
[FR Doc No: 2017-01131]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2016-0189]
RIN 2105-AE58

Procedures for Transportation Workplace Drug and Alcohol Testing
Programs: Addition of Certain Schedule II Drugs to the Department of
Transportation's Drug-Testing Panel and Certain Minor Amendments

AGENCY: Office of the Secretary of Transportation (OST), U.S.
Department of Transportation (DOT).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Transportation is proposing to amend its
drug-testing program regulation to add four opioids (hydrocodone,
hydromorphone, oxymorphone, and oxycodone) to its drug-testing panel;
add methylenedioxyamphetamine (MDA) as an initial test analyte; and
remove methylenedioxyethylamphetamine, (MDEA) as a confirmatory test
analyte. The proposed revision of the drug-testing panel is intended to
harmonize with the revised Mandatory Guidelines established by the U.S.
Department of Health and Human Services for Federal drug-testing
programs for urine testing. This proposal also adds clarification to
certain drug-testing program provisions where necessary, removes
outdated information in the regulations that is no longer needed, and
proposes to remove the requirement for employers and Consortium/Third
Party Administrators to submit blind specimens.

DATES: Comments to the notice of proposed rulemaking should be
submitted by March 24, 2017. Late-filed comments will be considered to
the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions,
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE., West Building Ground Floor
Room W12-140, Washington, DC 20590-0001.
     Hand delivery: West Building Ground Floor, Room W-12-140,
1200 New Jersey Ave. SE., between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The telephone number is<PHONE_NUMBER>.
    Instructions: To ensure proper docketing of your comment, please
include the agency name and docket number DOT-OST-2016-0189 or the
Regulatory Identification Number (RIN), 2105-AE58, for the rulemaking
at the beginning of your comments. All comments received will be posted
without change to http://www.regulations.gov, including any personal
information provided.

FOR FURTHER INFORMATION CONTACT: Patrice M. Kelly, Acting Director,
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey
Avenue SE., Washington, DC 20590; telephone number<PHONE_NUMBER>;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Purpose

    The Department of Transportation (DOT or the Department) is issuing
this notice of proposed rulemaking (NPRM) to revise Part 40 of Title 49
of the Code of Federal Regulations to harmonize with the revised
Department of Health and Human Services (HHS) Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Urine (HHS Mandatory
Guidelines) published on January 23, 2017, effective October 1, 2017.
DOT currently requires urine testing for safety-sensitive
transportation industry employees subject to drug testing under Part
40.
    There are two changes to the HHS Mandatory Guidelines to which this
notice proposes to harmonize Part 40. First, the revised HHS Mandatory
Guidelines, in part, allow Federal agencies with drug-testing
responsibilities to test for four additional Schedule II (of the
Controlled Substances Act) prescription medications: Hydrocodone,
hydromorphone, oxycodone, and oxymorphone. Second, the HHS Mandatory
Guidelines remove methylenedioxyethylamphetamine, (MDEA) as a
confirmatory test analyte from the existing drug-testing panel and add
methylenedioxyamphetamine (MDA) as an initial test analyte.
    In addition to harmonizing with pertinent sections of the HHS
Mandatory Guidelines for urine testing, we also propose in this NPRM to
modify (for clarification) certain existing Part 40 provisions that
cover the handling of urine specimens; to remove provisions that no
longer are necessary (such as obsolete compliance dates); and to add
clarifying language to other provisions (such as updated definitions
and web links where necessary.) The Department also proposes to remove
existing Part 40 requirements related to blind specimen testing.

II. Authority for This Rulemaking

    This rulemaking is promulgated pursuant to the Omnibus
Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143,
tit. V, 105 Stat. 952). OTETA sets forth DOT reliance on the HHS
Mandatory Guidelines for scientific testing issues. Section 503 of the
Supplemental Appropriations Act, 1987 (Pub. L. 100-71, 101 Stat 391,
468), 5 U.S.C. 7301, and Executive Order 12564 establish HHS as the
agency that directs scientific and technical guidelines for Federal
workplace drug-testing programs and standards for certification of
laboratories engaged in such drug testing. While DOT has discretion
concerning many aspects of the regulations governing testing in the
transportation industries' regulated programs, we must follow the HHS
Mandatory Guidelines for the categories of drugs for which we will
require testing.

III. Background

Relevant History of the DOT Drug-Testing Program Regulation

    The Department first published its drug-testing program regulation
(49 CFR part 40) on November 21, 1988 as an interim final rule (53 FR
47002). We based the rule on HHS Mandatory Guidelines for Federal
Workplace Drug Testing Programs (See 53 FR 11970), which, in part,
required cocaine and marijuana to be screened by Federal agencies. HHS
based this requirement on the incidence and prevalence of the abuse of
these two substances in the general population and on the experiences,
at the time, of the Departments of Defense and Transportation in
screening their workforces (53 FR 11973-11974). Agencies also were
authorized under the 1988 HHS Mandatory Guidelines to test for
phencyclidine, amphetamines, and opiates. Among other provisions from
those guidelines, DOT incorporated a 5-panel test to include all of the
drugs HHS authorized and published a final rule on December 1, 1989 (54
FR 49854).
    We made the last comprehensive revisions to Part 40, on August 16,
2010 (See 75 FR 49850). This 2010 revision once again harmonized our
DOT drug-testing program, where necessary, with the HHS Mandatory
Guidelines effective October 1, 2010 (See 73 FR 7185; 75 FR 22809).
Specifically, to harmonize we required initial and confirmatory testing
for methylenedioxymethamphetamine (MDMA); confirmatory testing for MDA
and MDEA; and initial testing for 6-acetylmorphine (6-AM). We also
lowered the initial and confirmatory test cutoff concentrations for
amphetamines and cocaine.
    Just as we have revised Part 40 in the past, we propose to revise
Part 40 now to harmonize, in pertinent part, with the most recently
revised HHS Mandatory Guidelines issued on January 23, 2017. HHS has
set an effective date of October 1, 2017, for compliance with its final
revision.

Relevant Changes to the HHS Mandatory Guidelines

    HHS monitors drug abuse trends and reviews information on new drugs
of abuse from sources such as Federal regulators, researchers, the
drug-testing industry, and public and private sector employers. In its
May 15, 2015 ``Notice of Proposed Revisions'' (See 80 FR 28103), HHS
indicated that, since its original Guidelines were published in 1988, a
number of recommendations have been made for additional drugs to be
included in Federal workplace drug-testing programs. According to HHS,
recommendations for the four added semi-synthetic drugs were based on a
review of scientific information and on input from the Drug Testing
Advisory Board (DTAB) \1\ on the methods necessary to detect the
analytes of drugs and on drug abuse trends. With the DTAB
recommendations, private sector experience findings, and analysis of
current drug abuse trends, HHS concluded that the additional opioids,
oxycodone, oxymorphone, hydrocodone, and hydromorphone, should be added
in the Federal program.
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    \1\ The Drug Testing Advisory Board provides advice to HHS (the
Administrator of SAMHSA) based on an ongoing review of the
direction, scope, balance, and emphasis of the Agency's drug-testing
activities and the drug testing laboratory certification program.
See http://www.samhsa.gov/about-us/advisory-councils/drug-testing-advisory-board-dtab/board-charter.
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    In its ``Final Notice of Revisions'' HHS acknowledged that, while
it had proposed MDA and MDEA as initial test analytes, three commenters
disagreed with the addition of MDA and MDEA as target analytes. HHS
indicated that the commenters stated that this change would require
modification of current immunoassay reagents, laboratory processes, or
both. The commenters noted that this imposes an unnecessary burden for
compounds with such low incidence in workplace testing. HHS agreed and,
based on comment, removed MDEA from its Mandatory Guidelines. HHS
determined that the number of positive MDEA specimens reported by HHS-
certified laboratories does not support testing all specimens for MDEA
in Federal workplace drug testing programs. HHS indicated that it
understands that MDA and some other analytes also have a low incidence,
but believes that continued testing for these analytes is warranted in
a deterrent program. In particular, inclusion of MDA as an initial and
confirmatory test analyte is warranted according to HHS because, in
addition to being a drug of abuse, it is a metabolite of MDEA and MDMA.

Harmonizing Changes to the DOT Drug-Testing Program Regulation

    In keeping with our obligations under OTETA to follow the HHS
Mandatory Guidelines for the drugs for which we test, we propose to add
and remove the drugs adopted in the revised HHS Mandatory Guidelines
for urine. Adding the four semi-synthetic opioids, which are already
tested for in many transportation employers' non-DOT testing programs,
would allow the DOT to detect a broader range of potentially impairing
drugs and thereby enhance the safety of the transportation industry and
the public they serve.

IV. Discussion of the Proposal

    In this NPRM, in addition to proposing to add and remove drugs on
the DOT drug-testing panel, we are using this opportunity to make some
necessary modifications to Part 40. Specifically, we are proposing to
amend certain provisions related to the testing of urine specimens. For
example, we would add a new section to Part 40 to emphasize that only
urine specimens screened and confirmed at HHS certified laboratories
are currently authorized to be used for drug testing. We also have
determined, based on a focused analysis of historical drug-testing
program data, that the burdens associated with blind specimen testing
may not be cost-beneficial. Therefore, in the interest of reducing
burden on program participants who are affected by blind specimen
testing requirements, we propose to remove this requirement from our
program. We propose other, mainly editorial, revisions to improve the
efficiency of our program, such as removing compliance dates that are
no longer needed and updating program web links to reflect those
currently being used on the DOT Web site.
    Here is a more detailed summary of our specific proposals. We
propose to:
    1. Amend our drug-testing panel and Medical Review Officer (MRO)
test result verification procedures to add hydrocodone, hydromorphone,
oxycodone, and oxymorphone (and their corresponding test cutoff
concentrations), add MDA as an initial test analyte, and remove MDEA.
    2. Remove, modify, and add some definitions to further clarify our
program and also to make certain definitions consistent with the
revised HHS Mandatory Guidelines.
    3. Modify three provisions related to urine specimens. We propose
to: Add a new provision to indicate that only urine specimens are
authorized to be used for drug testing under Part 40; revise an
existing provision to describe the procedure for discarding an original
urine specimen under certain circumstances; and align our regulations
with the revised National Laboratory Certification Program (NLCP)
manual by adding three new ``fatal flaws'' to the existing list of four
``fatal flaws'' currently found in Part 40.
    4. Remove Part 40 provisions that reference blind specimen testing.
    5. Add emphasis to an existing Part 40 provision that prohibits DNA
testing of urine specimens.
    6. Amend Sec.  40.141, which refers to how an MRO obtains
information for the

verification decision. We would amend this section to add a
clarification that a ``prescription'' means a ``valid prescription
under the Controlled Substances Act,'' which is language that already
exists in Part 40 and add a new paragraph that would harmonize this
section with Section 3.5 of the HHS Mandatory Guidelines, which allows
MROs to request additional testing of a specimen in certain
circumstances.
    7. Modify Sec. Sec.  40.137 and 40.139, the sections that address
how the MRO must verify test results, by proposing to make minor
modifications to the section headings and regulatory text to
incorporate the addition of the four new semi-synthetic opioids.
    8. Include a provision that would require collectors, Substance
Abuse Professionals (SAPs), MROs, Screening Test Technicians (STTs),
and Breath Alcohol Technicians (BATs) to subscribe to the DOT Office of
Drug and Alcohol Policy and Compliance (ODAPC) list-serve.
    9. Remove the list of SAP certification organizations from the list
of qualifying SAP credentials in Part 40. Instead, we would maintain
the list of certifying organizations on our Web site.
    10. Provide a provision to prohibit program participants from using
DOT- (or other Federal agency) branded items (such as logos, titles,
emblems, etc.) on their Web sites, publications, etc.
    11. Remove certain compliance dates that are now obsolete because
they are more than 5 years old.
    12. Correct two typos, in Sec. Sec.  40.233(c)(4) and 40.162(c),
that reference incorrect paragraph sections and make an editorial
correction in Sec.  40.67(n) that would delete erroneous wording.
    13. Update the following appendices to Part 40: Appendices B and C,
to add the four new drugs to the drugs listed and remove MDEA; Appendix
D, to update a web link; and Appendix H, to remove the instruction
sheet for the Management Information System Data Collection from our
regulations and move it to our guidance material located on our Web
site.
    14. Update web links referenced in the current rule that have
changed on our DOT Web site.

Detailed Discussion of the Proposals

    1. Modification of the Drug-Testing Panel--We propose to modify the
existing drug-testing panel in Sec.  40.87(a) and the MRO test result
verification procedures in Sec. Sec.  40.137 and 40.139, to include
hydrocodone, hydromorphone, oxycodone, and oxymorphone. We also propose
to remove MDEA from Sec.  40.87(a) and add MDA as an initial test
analyte as discussed previously in this document. As indicated above in
the section of this preamble entitled ``II. Authority for this
Rulemaking,'' OTETA mandates that the DOT drug-testing panel must
correspond to HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs. As such, since the inception of our drug-testing
program, the DOT has never deviated from HHS on the drugs for which we
test, the type of specimens which we test, specimen testing validity
values, or initial and confirmatory cutoff values. This proposal is no
different. We propose to fully adhere to the revised HHS guidelines
regarding the drugs for which we propose to require testing.
    Currently, DOT regulations mandate urine testing under a five-panel
test. We propose to maintain the current five-panel test, but would
rename the existing opiates category in Sec.  40.85 from ``opiates'' to
``opioids'' to include the new HHS-mandated drugs.
    Opiates are derived from opium poppy plant alkaloid compounds, and
include codeine and morphine. Heroin is produced by acetylation of
morphine. Opioids is a broader term but, for purposes of Part 40,
includes only opiate and semi-synthetic compounds (i.e., hydrocodone,
hydromorphone, oxycodone, and oxymorphone). Semi-synthetic opioids
interact with the body's chemical system in the same way as natural
opiates (e.g. codeine, morphine, and heroin) and produce similar
effects. Misuse, abuse, opioid use disorder (addiction), and overdose
are potential dangers related to prescription opioids.
    The following is a representative sampling of information provided
by various organizations who have reported on prescription opioid use
trends over the past few years:
     CDC data from 2012 indicates that 259 million
prescriptions were written for prescription opioids, which is more than
enough to give every American adult their own bottle of pills.\2\
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    \2\ Centers for Disease Control and Prevention (2014). Opioid
Painkiller and Prescribing, Where You Live Makes a Difference.
Available at: http://www.cdc.gov/vitalsigns/opioid-prescribing/.
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     According to the SAMHSA National Survey on Drug Use and
Health 2014 data, almost 2 million Americans misused or were dependent
on prescription opioids.\3\
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    \3\ Substance Abuse and Mental Health Services Administration,
National Survey on Drug Use and Health, 2014. Available at: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf.
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     As posted by the Office of National Drug Control Policy,
according to the National Center for Health Statistics, the number of
overdose deaths involving opioids rose from 28,647 in 2014 to 33,091 in
2015.\4\
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    \4\ https://www.whitehouse.gov/the-press-office/2016/12/08/continued-rise-opioid-overdose-deaths-2015-shows-urgent-need-treatment.
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     National Center for Health Statistics \5\ data indicates
that every year since 2002 more than 40 percent of the total number of
overdose deaths in the United States have been related to prescription
opioids.
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    \5\ https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.
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    In light of this compelling information regarding opioid use (and
the national attention being focused on this issue), we propose to
modify the DOT drug-testing regimen not only to meet our statutory
obligation under OTETA to do so, but also to raise the level of safety
for the transportation industry and the public.
    2. Definitions--We propose to revise Sec.  40.3 to make the
following modifications:
     Blind specimen or blind performance test specimen would be
removed. Because we are proposing to remove the requirement for blind
specimen testing, we no longer would need to define this term in Part
40. In addition, Part 40 provisions do not refer to ``blind performance
test specimen,'' so we propose to remove it as well.
     DOT, the Department, DOT agency would be revised to make a
clarification with respect to the status of the U.S. Coast Guard. The
Coast Guard transferred to the Department of Homeland Security (DHS) in
2003, and as such, is not part of the DOT. The Coast Guard, however,
has continued to use Part 40 for most of its drug and alcohol testing
procedures. This amendment would clarify that, when Part 40 mentions
DOT agencies, the Coast Guard is included under that heading even
though it resides in DHS.
     Drugs would be revised (for reasons discussed in detail
earlier in this preamble) to reflect the addition of hydrocodone,
hydromorphone, oxycodone, and oxymorphone to the existing DOT drug-
testing panel. Specifically, we would expand the reference to
``opiates'' in the existing definition to ``opioids.''
    3. Clarification/modifications related to urine specimens--We
propose the following three amendments relating to the testing of urine
specimens:
     We propose to add a new Sec.  40.210 entitled: ``Are drug
tests other than urine permitted under the regulations?'' to indicate
that only urine specimens are currently authorized for drug testing.
Adding new Sec.  40.210 would establish

parity with an existing Part 40 alcohol testing section, Sec.  40.277,
entitled: ``Are alcohol tests other than saliva or breath permitted
under these regulations?'' which indicates (for alcohol testing) that
only saliva and breath are authorized.
     We propose to amend existing Sec.  40.83 and Sec.  40.199
to include revisions made to the ``fatal flaws'' listing found in the
latest revision of the NLCP Manual which became effective September 21,
2016. Existing paragraph (b) of Sec.  40.199 provides for four ``fatal
flaws'' but would be amended to include three additional fatal flaws
included in the revised NLCP Manual for a total of seven fatal flaws
that MROs must consider during the review and verification process.
     We propose to amend paragraph Sec.  40.193(b)(4) to
address what a collector does when the employee provides a
``questionable'' specimen (due to signs of tampering or when the
temperature is out of range), and then the employee does not provide a
second sufficient specimen under direct observation even after being
provided with a wait period of up to three hours.
    Currently, Part 40 requires the collector to package and send the
questionable specimen (i.e., out of temperature range specimen or
specimen with signs of tampering) to the laboratory along with a second
sufficient specimen assuming a second specimen was collected
(Sec. Sec.  40.65(b)(7) & 40.65(c)(2), respectively). Part 40 does not,
however, instruct the collector on what to do with the questionable
specimen when the employee does not provide a sufficient specimen after
a ``shy bladder'' wait period. The instructions in Sec.  40.193(b)(1)
direct the collector not to discard a questionable specimen; however,
these instructions are rooted on the assumption that a second specimen
will be collected. So absent a second sufficient specimen, Sec.  40.193
does not tell the collector what to do with the questionable specimen.
    Furthermore, we found the following inconsistencies in our guidance
documents related to questionable specimens. In the July 2008 Q&A on
Sec.  40.193, the collector is instructed to ``. . . discard any
specimen the employee previously provided . . .'' However, the Urine
Specimen Collection Guidelines state that the collector is to send the
questionable specimen to the laboratory and to immediately initiate
another collection under direct observation.
    If the employee did not provide a second specimen during the shy
bladder period, and the collector sends the questionable specimen to
the laboratory, the MRO must verify the employee's laboratory-reported
questionable sample. The MRO would also conduct an evaluation to
determine if a medical condition has, or with a high degree of
probability could have, precluded the employee from providing a
sufficient amount of urine.
    The intent of the shy bladder evaluation is to provide the employee
with an opportunity to provide an explanation for his/her inability to
provide a sufficient specimen. This rationale becomes clouded when it's
coupled with a verified drug test result from the same collection
event. If an employee provides a questionable specimen, the employee
may have tampered with or substituted his/her specimen. Following this
logic, the employee should be able to provide a sufficient specimen
immediately after providing the questionable specimen. If the employee
cannot provide a sufficient specimen, the employee would have the
opportunity to provide an explanation for his/her shy bladder via an
evaluation (Sec.  40.193(c)). Absent a supported medical condition, an
employee's inability to provide a sufficient specimen indicates that
the employee chose not to provide a specimen in an effort to avoid a
positive drug test result. As such, the MRO would report the result as
a ``refusal to test'' to the employer, further ensuring the safety of
the traveling public.
    Therefore, we are proposing to require the collector to discard any
specimen previously collected, thereby leaving the MRO to report only
the outcome of the required evaluation. The Department seeks comment as
to whether the proposed amendment to Sec.  40.193 (b)(4) is a
reasonable approach or whether there may be an alternate solution to
the proposal.
    4. Removal of blind specimen testing--We are proposing to remove
existing Part 40 provisions (from Sec. Sec.  40.3, 40.29, 40.103,
40.105, 40.123, 40.169, and 40.189) that reference blind specimen
testing. We propose this as a burden-relieving measure for affected
entities (e.g. employers, C/TPAs, etc.).
    Existing Part 40 defines a blind specimen as ``a specimen submitted
to a laboratory for quality control testing purposes, with a fictitious
identifier, so that the laboratory cannot distinguish it from an
employee specimen.'' Blind specimens are intended to test the accuracy
and integrity of the laboratory testing system. As part of an overall
quality control effort, employers have been required, since 1990 (54 FR
49857), to send blind urine specimens for drug testing to the
laboratories they use. These samples are made to look like normal
samples, are packaged in the same manner, and arrive unannounced at the
laboratory. Only the senders know if the results of the blind specimens
are negative, positive, adulterated, or substituted.
    Initially, in 1990 (54 FR 49854), the Department required three
blind test specimens for each 100 employee test specimens. For
employers with 2000 or more covered employees, approximately 80 percent
of the samples were required to be negative, with the remaining samples
positive for one or more of the drugs per sample in a distribution such
that all the drugs to be tested were included in approximately equal
frequencies of challenge. The positive samples were required to contain
only those drugs for which the employer was testing.
    DOT has always been concerned about the burdens associated with
imposing blind specimen procedures in its drug-testing program and has
attempted to reduce such burdens incrementally over time. For example,
in an attempt to simplify the process and reduce burden, in 2001, (65
FR 79462; December 19, 2000), the Department revised Part 40 blind
specimen requirements by reducing the number of quarterly blind
specimens sent to a laboratory from three percent to one percent with a
maximum number of 50 blinds per quarter.
    In light of this rulemaking and the requirement in Executive Order
13563 to conduct retrospective analyses, we have once again reviewed
the impact of blind specimen testing. Upon review, we found that, since
the 2000 final rule, we did not identify any laboratory problems
regarding false positives. Any discrepancies that have been brought to
our attention were problems with the manufacturer of the blinds and not
the laboratory testing procedures.
    It is also important to remember that the laboratories are
rigorously inspected through the HHS National Laboratory Certification
Program (NLCP). After a thorough initial inspection, laboratories are
inspected semi-annually and receive performance test ``PT'' samples
every quarter. If there are any discrepancies, NLCP thoroughly
investigates the matter that requires corrective action as necessary.
    Finally, another important ``check and balance'' already in place
is the employee's split specimen or the ``B'' bottle. If the employee
believes that the primary laboratory erred in reporting his/her result
of the ``A'' bottle, the employee, via the MRO, can request to have
his/her split (``B'') specimen sent to another laboratory.
    Blind specimen testing requirements have been diligently followed
over the

history of our program resulting in no cause for concern regarding
laboratory accuracy. After 25 years, blind specimen testing has served
its purpose and is now redundant in urine testing. Therefore, the
Department seeks comment on any concerns, or unforeseen or unintended
consequences, associated with our proposal to remove blind specimen
requirements.
    5. DNA testing--We propose to amend existing Sec.  40.331 to add
language that would further clarify that Deoxyribonucleic Acid (DNA)
testing is not allowed for DOT-regulated urine specimens. To add
further emphasis to this section, we would amend paragraph (f) to add
the following sentence: DNA testing or other types of identity testing
are not authorized. Identity testing, to include (DNA) testing, is
prohibited in Section 3.3 of the HHS Mandatory Guidelines and in Part
40. The Department's main reason for imposing this prohibition (See 65
FR 79484, 79530) was to provide a safeguard against employees who would
attempt to undermine the collection process by substituting a sample
and, subsequently, request identity testing so that their sample would
not be a match. If an employee believes there has been an error with
his/her sample, the employee can request the Bottle B of the specimen
to be drug tested (but not DNA tested) at a second HHS certified
laboratory.
    As the Court of Appeals recently validated in Swaters v. Department
of Transportation, No. 14-1277 (D.C. Cir. June 24, 2016), the
procedures described in the HHS Mandatory Guidelines and a properly
completed Federal Drug Testing Custody and Control Form ensure that the
specimen provided by the donor is the same specimen tested by a
laboratory. Permitting DNA testing would undermine the integrity of the
urine testing program because it would legitimize a donor's
substitution of urine during an unobserved collection. The Court also
indicated that ``neither the DOT's general rule against releasing urine
samples for DNA testing, nor its refusal to release the sample in this
case, is arbitrary, capricious, or contrary to the Omnibus
Transportation Employee Testing Act of 1991.''
    6. MRO Verification--We propose to amend existing Sec.  40.141 (b)
to add a parenthetical ``i.e.'' that would indicate that
``prescription'' is intended to mean (as currently provided in Sec.
40.135 (e)), ``a legally valid prescription under the Controlled
Substances Act (CSA).''
    We understand that there may be various definitions for
``prescription'' under Federal law (e.g., the Controlled Substances Act
Pub. L. 91-513, tit. II, 84 Stat. 1242 (1970) and the Patient
Protection and Affordable Care Act, Pub. L. 111-148, 124 Stat. 119
(2010)). As such, we propose to amend existing Sec.  40.141 (b) to add
language to indicate that, in the DOT drug-testing program,
prescription means ``a legally valid prescription under the Controlled
Substances Act (CSA).'' Doing so will clarify what prescription an MRO
can accept when verifying an employee's claim that his/her use of a
prescribed medication was the reason for the laboratory-confirmed
positive drug result. This clarification does not create a new standard
because this language is identical to the language used in Sec.
40.135(e).
    We also propose to modify Sec.  40.141(b) to harmonize, in part,
with Section 3.5 of the HHS Mandatory Guidelines. Specifically, we
propose to allow MROs to conduct additional testing (i.e., D, L
stereoisomers and tetrahydrocannabivarin (THC-V)) of a DOT urine
specimen, if the MRO determines such testing is necessary for the
purpose of verifying the drug test result. For example, the MRO could
request a D, L stereoisomer test of a laboratory confirmed
methamphetamine result to help rule out whether the result was possibly
due to the use of an over-the-counter product. Another example would be
for the MRO to request a THC-V test when verifying a positive marijuana
test result after a dronabinol (Marinol) \6\ prescription is provided
by the donor. THC-V testing provides useful information to the MRO when
determining whether the laboratory-reported positive result for
marijuana resulted from the employee's use of marijuana. As proposed,
the MRO would not need to obtain DOT consent prior to requesting the D,
L stereoisomer testing and/or the THC-V testing. Furthermore, the HHS-
certified laboratory could only conduct these additional tests if its
testing meets the appropriate validation and quality control
requirements through the NLCP.
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    \6\ Generically known as dronabinol, Marinol is a Schedule III
drug product formulated in sesame oil in soft gelatin capsules,
containing synthetic delta-9-THC. FDA has approved Marinol for the
treatment of nausea and vomiting associated with cancer chemotherapy
and for anorexia. (For further information see 81 FR 53691.)
---------------------------------------------------------------------------

    7. Revision of certain Part 40 provisions to incorporate references
to the new drugs--We would revise the existing section headings and
some regulatory text in Sec. Sec.  40.137 and 40.139 to incorporate the
proposed addition of the new opioids to the drug-testing panel. We
would revise the section headings, and corresponding regulatory
language where appropriate in these sections, to clarify our intent
regarding how the MRO must verify test results. We would revise the
Sec.  40.137 section heading to add the text ``semi-synthetic opioids''
and the Sec.  40.139 section heading so that it would refer to ``6-
acetylmorphine, codeine, and morphine'' specifically. The Department
also proposes to clarify the example used in Sec.  40.139(c)(3)
regarding an employee's admission of an unauthorized use of a substance
when use of that substance is not confirmed by their drug test.
    8. Subscription to ODAPC list-serve--We would amend Sec. Sec.
40.33, 40.121, 40.213, and 40.281 to require collectors, MROs, STTs and
BATs, and SAPs to subscribe to the ODAPC list-serve, found on our Web
site at https://www.transportation.gov/odapc/get-odapc-email-updates.
The ODAPC list-serve provides an additional means for these individuals
to meet existing requirements in the referenced sections to ``be
knowledgeable about'' and to ``keep current on any changes to''
materials used in our program. In addition to all of the information
(web links) available on the ODAPC Web site, the ODAPC list-serve is
the vehicle that allows us to communicate all program matters of
importance to our constituency in the most timely manner possible and,
by extension, enables us to keep our program responsive. The list-serve
is free of charge to list-serve subscribers.
    9. Nationally Recognized Training Organizations--We propose to
remove the list of approved certification organizations and their
respective certified drug and alcohol counselors found in Sec.  40.281,
paragraph (a)(6) and to display that list on the ODAPC Web site.
Currently, when a certification organization requests to be added to
the list of acceptable credentials for a SAP, that organization needs
to petition the DOT for inclusion. The DOT reviews the petition. If the
DOT approves the petition, we must initiate a rulemaking process to add
the SAP certification organization to Part 40. Each time a new
certification organization is added, the DOT must initiate a separate
rulemaking action. Because this is a time-consuming process, we are
proposing to display the list on the ODAPC Web site and update it when
necessary instead of including all qualified SAP certification
organizations in the rule language. Any SAP certification organization
seeking to be added to the web-based list would still need to petition
the DOT and meet the criteria set forth in Appendix E of Part 40.
Although this process would remove the public comment requirement of
rulemaking, DOT would

fully vet the organization before deciding to add it to the list.
Therefore, as a burden-relieving measure, the Department proposes to
remove Sec.  40.281 (a)(6) entirely and henceforth maintain the listing
of nationally-recognized training or professional organizations in
guidance material at https://www.transportation.gov/odapc/sap. In this
manner, we would be able to maintain a more responsive list of
organizations under which an individual may certify as a SAP and update
it as needed without undertaking rulemaking action.
    10. Prohibition against use of federal branding--We would amend
Sec.  40.365 to permit the public interest exclusion of a service agent
for that agent's use of a DOT, or a DOT Agency's, logo on a Web site,
in printed materials, or in any other manner that represents that the
Department has approved, endorsed, or certified the service agent or
its activities. The use of the DOT or DOT Agency's logo on materials
generated by the DOT or the DOT Agency are permitted as long as the
logo was on the original material being reprinted.
    11. Removal of Outdated Compliance Dates--We would remove existing
compliance dates from several Part 40 sections. Five Part 40 sections
provide for training with compliance dates dating back to the early
2000s: Sec.  40.33--A training schedule for collectors for
qualification training and initial proficiency demonstration; Sec.
40.121--a training schedule for MROs for qualification training; Sec.
40.203--a specific timeframe relating to Federal Drug Testing Custody
and Control Forms that has now expired; Sec.  40.213--a training
schedule for STTs and BATs for qualification training, initial
proficiency training, and refresher training; Sec.  40. 281--a training
schedule for qualification for SAPs. These compliance dates are no
longer applicable, thus we propose to remove them from these sections
where they occur.
    12. Editorial corrections--Section 40.162 entitled ``What must MROs
do with multiple verified results for the same testing event?''
contains an incorrect reference to Sec.  40.159(f) in paragraph (c).
Existing Sec.  40.162(c) refers to how an MRO must handle multiple
verified non-negative test results and is intended to conform to a
Sec.  40.159(g) provision that directs the MRO to act on the verified
non-negative result and not report the invalid result unless the split
specimen fails to reconfirm the results of the primary specimen.
Section 40.162(c), however, inadvertently refers to Sec.  40.159(f)
rather than Sec.  40.159(g) requirements because of a typographical
error. We would like this 40.162(c) provision to reference Sec.
40.159(g) which is the correct reference.
    Section 40.233 entitled ``What are the requirements for proper use
and care of EBTs?'' contains an incorrect reference to Sec.
40.333(a)(2) in paragraph (c)(4). Existing Sec.  40.233(c)(4) refers to
maintaining records of the inspection, maintenance, and calibration of
Evidential Breath Testing devices and is intended to conform to a Sec.
40.333(a)(3) provision related to the specific timeframe for keeping
such records. Section 40.233(c)(4), however, inadvertently refers to
Sec.  40.333(a)(2) rather Sec.  40.333(a)(3) requirements because of a
typographical error. We would like this Sec.  40.233(c)(4) provision to
reference Sec.  40.333(a)(3) which is the correct reference.
    Section 40.67 entitled ``When and how is a directly observed
collection conducted?'' would be revised to remove the words ``As the
collector'' to clarify that any service agent participating in the
testing process (not just the collector) who discovers a direct
observation should have taken place, but did not, would inform the
employer.
    13. Appendix Items--We propose amendments to four appendices. At
Appendices B and C, we propose to add to the listing of the new drugs
to conform with the revised drug testing list in proposed Sec.  40.87
and also remove references to MDEA in those appendices. These revisions
are needed to conform with the newly adopted HHS Guidelines that add
these drugs. At Appendix D, we propose to modify existing web links
from http://www.dot.gov/ost/odapc to https://www.transportation.gov/odapc. We propose to remove Appendix H in its entirety and relocate it
to our Web page. This would remove the instruction sheet entitled
``U.S. Department of Transportation Drug and Alcohol Testing MIS Data
Collection Form Instruction Sheet'' and the actual MIS Data Collection
Form. With this change made, we would be able to keep the instruction
sheet and MIS Data Collection Form updated as necessary without a
rulemaking action.
    14. Web links/electronic submissions--We would update references to
web links that have been revised. Periodically our Departmental
webmaster must update DOT Web sites for any number of reasons. The
ODAPC Web site ``http://www.dot.gov/ost/odapc'' currently referenced in
our regulation is now linked at ``https://www.transportation.gov/odapc.'' Therefore, we propose to update the regulation to replace
http://www.dot.gov/ost/odapc with https://www.transportation.gov/odapc
where the link occurs in the following sections: Sec. Sec.  40.33,
40.45, 40.105, 40.121, 40.213, 40.225, and 40.401.

V. Regulatory Analyses and Notices

    Changes to Federal regulations must undergo several analyses.
First, Executive Orders 12866 and 13563 direct that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in
5 U.S.C. 601 et seq., requires agencies to analyze the economic impact
of regulatory changes on small entities. The Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3501 et seq.) requires that DOT consider the
impact of paperwork and other information collection burdens imposed on
the public and, under the provisions of PRA section 3507(d), obtain
approval from OMB for each collection of information it conducts,
sponsors, or requires through regulations. Section (a)(5) of division H
of the Fiscal Year 2005 Omnibus Appropriations Act, Public Law 108-447,
118 Stat. 3268 (Dec. 8, 2004) and section 208 of the E-Government Act
of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 17, 2002) requires
DOT to conduct a Privacy Impact Assessment (PIA) of a regulation that
will affect the privacy of individuals. Finally, the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.)
requires DOT to analyze this action to determine whether it will have
an effect on the quality of the environment. This portion of the
preamble summarizes the DOT's analyses of these impacts with respect to
this notice.

Executive Order 12866 and 13563 and DOT's Regulatory Policies and
Procedures

    This proposal is not a significant regulatory action under
Executive Order 12866 and 13563, as well as the Department's Regulatory
Policies and Procedures (44 FR 11034). It proposes to harmonize
specific Part 40 procedures with recently mandated HHS Guidelines and,
in the interest of improving efficiency, make certain program
modifications. As such, this proposal would not impose any major policy
changes and would not impose any significant new costs or burdens.
Actually, DOT estimates a cost-savings of at least $3.1 million per
year for the proposed elimination of the requirement for employers to
submit blind specimen testing to laboratories.

Costs

    The HHS Mandatory Guidelines addressed the burdens associated with
the addition of new drugs to the drug-testing panel. The cost impact of
drug testing for oxycodone, oxymorphone, hydrocodone, and hydromorphone
would be minimal because HHS has determined that all HHS laboratories
testing specimens from Federal agencies are currently conducting tests
for one or more of these analytes on non-regulated urine specimens. HHS
further indicated in its analysis that laboratory personnel currently
are trained to test for the additional drugs and test methods already
have been implemented. Many HHS-certified laboratories conduct non-
regulated tests for transportation employers who already include the
four proposed drugs in their non-regulated testing programs. For those
employers, therefore, shifting the four drugs from non-regulated tests
to regulated tests would not increase testing costs.
    HHS determined that the costs associated with implementation of
testing for the four additional drugs would be approximately $0.11-
$0.30 per test. Once the testing has been implemented, the cost per
specimen for initial testing for the added analytes would range from
$.06 to $0.20 due to reagent costs. Current costs for each confirmatory
test range from $5.00 to $10.00 for each specimen reported as positive
due to costs of sample preparation and analysis. HHS indicated that
based on information from non-regulated workplace drug testing for
these analytes in 2012 and testing performed on de-identified federally
regulated specimens in 2011, approximately 1% of the submitted
specimens is expected to be confirmed as positive for the added
analytes. Therefore, HHS indicates that the added cost for confirmatory
testing will be $0.05 to $0.10 per submitted specimen.
    Approximately 6.3 million DOT-regulated tests occur per year. DOT
considered the maximum ranges HHS provided in its analysis. Therefore,
with the projected maximum implementation cost per specimen of $0.30,
the maximum cost per specimen of initial testing at $0.20, and the
maximum cost per specimen of confirmation testing at $0.10, the
additional cost per urine test would be an additional $0.60. Under the
new HHS Mandatory Guidelines, and based on an estimated 6.3 million DOT
tests conducted annually, a cost of approximately $3,800,000 would be
realized by employers subject to DOT-regulated testing ($0.60 x
6,300,000 DOT tests annually = $3,780,000).
    HHS indicated that there will be minimal costs associated with
adding MDA as an initial test analyte because the current immunoassays
can be adapted to test for this analyte. According to HHS, before a lab
is allowed to test regulated specimens for MDA, HHS must test three
groups of performance test, or ``PT'' samples. HHS provides the PT
samples at no cost to its certified laboratories but HHS estimates that
the laboratory costs to conduct the PT testing would range from $900 to
$1800 for each certified laboratory. There are approximately 27 HHS-
certified laboratories who process DOT drug tests. With the maximum
cost estimate of $1800 for each certified laboratory, a cost of
approximately $48,600 would be realized for DOT ($1800 x 27
laboratories = $48,600.)
    Testing for additional drugs would result in MRO cost as MROs would
have additional review and verification to conduct. Based on the
positivity rates from non-regulated workplace drug testing and the
additional review of specimens confirmed positive for prescription
medications, HHS estimates that MRO costs would increase by
approximately 3%. The additional costs for testing and MRO review would
be incorporated into the overall cost for the Federal agency submitting
the specimen to the laboratory. HHS bases the estimation of costs
incurred on overall cost to the Federal agency affected because cost is
usually based on all specimens submitted from an agency, rather than
individual specimen testing costs or MRO review of positive specimens.
Based on this analysis, therefore, DOT would project an additional MRO
cost of $189,000 (.03 projected increase x 6,300,000 DOT tests
annually).

Cost-Savings

    DOT estimates a cost-savings of at least $3.1 million per year from
the proposed elimination of the requirement for employers to submit
blind specimen testing to laboratories (estimated at approximately $50
per test). This estimate of cost-savings is based on the regulatory
analysis performed when DOT reduced blind specimen testing in 2000,
[see 65 FR 79462, 79517 (Dec 19, 2000)] adjusted for inflation. Based
on the blind specimen requirements made effective in 2000 for employers
to submit 1% of 6,300,000 DOT tests for blind testing conducted
annually at a cost of approximately $50 per test yields a cost-savings
of $3,150,000 (63,000 x $50).

Net Economic Impact

    The DOT believes the projected cost-savings realized would, for the
most part, offset the projected cost to the DOT of implementing testing
for the additional drugs being added to the drug-testing regimen. The
projected $3,848,600 for the four opioid drugs (and MDA) as well as the
$189,000 projected MRO costs would result in a total projected cost of
$4,037,600. The estimated cost impact of this proposal, therefore,
would be negligible, an estimated $887,600 ($4,037,600-$3,150,000). If
identifying illicit drug use by safety-sensitive transportation
employees subjected to drug testing prevents a single serious accident,
then the benefits of this proposal outweigh its minimal cost. This
proposal would not have a major impact under Executive Order 12866
because it would not have an annual effect on the economy of $100
million or more, nor would it adversely affect any sector of the
economy.

Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, ``RFA''), 5
U.S.C. 601 et seq., establishes ``as a principle of regulatory issuance
that agencies shall endeavor, consistent with the objectives of the
rule and of applicable statutes, to fit regulatory and informational
requirements to the scale of the businesses, organizations, and
governmental jurisdictions subject to regulation. To achieve this
principle, agencies are required to solicit and consider flexible
regulatory proposals and to explain the rationale for their actions to
assure that such proposals are given serious consideration.'' The RFA
covers a wide-range of small entities, including small businesses, not-
for-profit organizations, and small governmental jurisdictions.
    Agencies must perform a review to determine whether a proposed rule
would have a significant economic impact on a substantial number of
small entities. If the agency determines that it would, the agency must
prepare a regulatory flexibility analysis. However, if an agency
determines that it is not expected to have a significant economic
impact on a substantial number of small entities, section 605(b)
provides that the head of the agency may so certify, and a regulatory
flexibility analysis would not be required. The certification must
include a statement providing the factual basis for this determination,
and the reasoning should be clear.
    This rulemaking proposes to conform the existing DOT drug-testing
panel to recently issued HHS Mandatory

Guidelines and, with certain minor amendments (mostly editorial), to
improve the efficiency of the DOT drug-testing program. As noted above,
any costs due to this rule are, for the most part, offset by the cost
savings from the proposed elimination of the requirement for employers
to submit blind specimen testing to laboratories. The net costs of this
rule are negligible overall and would not constitute a significant
burden to any entity, small or otherwise. Consequently, the DOT
certifies, under the RFA, that this proposal would not have a
significant economic impact on a substantial number of small entities.

Federalism

    This proposal has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
proposal does not include requirements that (1) have substantial direct
effects on the States, the relationship between the national government
and the States, or the distribution of power and responsibilities among
the various levels of government, (2) impose substantial direct
compliance costs on State and local governments, or (3) preempt State
law. Therefore, the consultation and funding requirements of Executive
Order 13132 do not apply.

Paperwork Reduction Act/Privacy Act

    The Paperwork Reduction Act requires that the DOT consider the
impact of paperwork and other information collection burdens imposed on
the public. Information collections for Part 40 currently are approved
under OMB Control No. 2105-0529. The Privacy Act provides safeguards
against invasion of personal privacy through the misuse of records by
Federal Agencies. It establishes controls over what personal
information is collected, maintained, used and disseminated by agencies
in the executive branch of the Federal government. This proposal would
not create any new paperwork or other information collection burdens
needing approval, nor would it require any further protections under
the Privacy Act.

National Environmental Policy Act

    The Department has analyzed the environmental impacts of this
proposed action pursuant to the National Environmental Policy Act of
1969 (NEPA) (42 U.S.C. 4321 et seq.) and has determined that it is
categorically excluded pursuant to DOT Order 5610.1C, Procedures for
Considering Environmental Impacts (44 FR 56420, Oct. 1, 1979).
Categorical exclusions are actions identified in an agency's NEPA
implementing procedures that do not normally have a significant impact
on the environment and therefore do not require either an environmental
assessment (EA) or environmental impact statement (EIS). See 40 CFR
1508.4. In analyzing the applicability of a categorical exclusion,
Federal agencies also must consider whether extraordinary circumstances
are present that would warrant the preparation of an EA or EIS. This
proposal does not meet any of these criteria. Paragraph 3.c.5 of DOT
Order 5610.1C incorporates by reference the categorical exclusions for
all DOT Operating Administrations. This action is covered by the
categorical exclusion listed in the Federal Highway Administration's
implementing procedures, ``[p]romulgation of rules, regulations, and
directives.'' 23 CFR 771.117(c)(20). The agency does not anticipate any
environmental impacts, and there are no extraordinary circumstances
present in connection with this rulemaking.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) does
not require a written statement for this final rule because the rule
does not include a Federal mandate that may result in the expenditure
in any one year of $155,000,000 or more by State, local, and tribal
governments, or the private sector.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.

The Proposal

    For reasons discussed in the preamble, the Department of
Transportation proposes to amend part 40 of Title 49 Code of Federal
Regulations, as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS

0
1. The authority citation for 49 CFR part 40 continues to read as
follows:

    Authority:  40 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
54101 et seq.

0
2. Amend Sec.  40.3 as follows:
0
a. Remove the definition ``Blind specimen or blind performance test
specimen''; and
0
b. Revise and reorder (in correct alphabetical order) the definitions
``DOT, the Department, DOT Agency'' and ``Drugs'' to read as follows:

Sec.  40.3  What do the terms used in this part mean?

* * * * *
    DOT, The Department, DOT Agency. These terms encompass all DOT
agencies, including, but not limited to the Federal Aviation
Administration (FAA), the Federal Railroad Administration (FRA), the
Federal Motor Carrier Safety Administration (FMCSA), the Federal
Transit Administration (FTA), the National Highway Traffic Safety
Administration (NHTSA), the Pipeline and Hazardous Materials Safety
Administration (PHMSA), and the Office of the Secretary (OST). For
purposes of this part, the United States Coast Guard (USCG), in the
Department of Homeland Security, is considered to be a DOT agency.
These terms include any designee of a DOT agency.
* * * * *
    Drugs. The drugs for which tests are required under this part and
DOT agency regulations are marijuana, cocaine, amphetamines,
phencyclidine (PCP), and opioids.
* * * * *
0
3. Revise Sec.  40.26 to read as follows:

Sec.  40.26  What form must an employer use to report Management
Information System data to a DOT agency?

    As an employer, when you are required to report MIS data to a DOT
agency, you must use the U.S. Department of Transportation Drug and
Alcohol Testing MIS Data Collection Form to report that data. You may
view and download this form and its instructions on the Department's
Web site (https://www.transportation.gov/odapc). You must submit the
MIS report in accordance with rule requirements (e.g., dates for
submission, selection of companies required to submit, and method of
reporting) established by the DOT agency regulating your operation.

Sec.  40.29  [Amended]

0
4. Amend Sec.  40.29 by removing the entry ``Sec. Sec.  40.103-40.105--
Blind specimen requirements.''
0
5. Amend Sec.  40.33 by revising paragraphs (a) and (d) to read as
follows:

Sec.  40.33  What training requirements must a collector meet?

* * * * *
    (a) Basic information. You must be knowledgeable about this part,
the current ``DOT Urine Specimen Collection Procedures Guidelines,''
and DOT agency regulations applicable to the employers for whom you
perform

collections. The DOT Urine Specimen Collection Procedures Guidelines
document is available from ODAPC (Department of Transportation, 1200
New Jersey Avenue SE., Washington, DC 20590,<PHONE_NUMBER>, or on the
ODAPC Web site (https://www.transportation.gov/odapc). DOT agency
regulations are available at each agency's Web site, on the DOT Web
site (http://www.transportation.dot.gov), or at www.ecfr.gov. You must
keep current on any changes to these materials. You must subscribe to
the ODAPC list-serve (https://www.transportation.gov/odapc/get-odapc-email-updates).
* * * * *
    (d) You must meet the requirements of paragraphs (b) and (c) of
this section before you begin to perform collector functions.
* * * * *
0
6. Amend Sec.  40.67 by revising paragraph (n) to read as follows:

Sec.  40.67  When and how is a directly observed collection conducted?

* * * * *
    (n) As a service agent, when you learn that a directly observed
collection should have been collected but was not, you must inform the
employer that it must direct the employee to have an immediate
recollection under observation.
0
7. Amend Sec.  40.83 by revising paragraph (c) to read as follows:

Sec.  40.83  How do laboratories process incoming specimens?

* * * * *
    (c) You must inspect each specimen and CCF for the following
``fatal flaws:''
    (1) There is no CCF;
    (2) There is no specimen submitted with the CCF;
    (3) There is no printed collector's name and no collector's
signature;
    (4) Two separate collections are performed using one CCF;
    (5) The specimen ID numbers on the specimen bottle and the CCF do
not match;
    (6) The specimen bottle seal is broken or shows evidence of
tampering, unless a split specimen can be redesignated (see paragraph
(h) of this section);
    (7) There is an insufficient amount of urine in the primary bottle
for analysis, unless the specimens can be redesignated (see paragraph
(h) of this section).
* * * * *
0
8. Revise Sec.  40.85 to read as follows:

Sec.  40.85  What drugs do laboratories test for?

    As a laboratory, you must test for the following five drugs or
classes of drugs in a DOT drug test. You must not test ``DOT
specimens'' for any other drugs.
    (a) Marijuana metabolites.
    (b) Cocaine metabolites.
    (c) Amphetamines.
    (d) Opioids.
    (e) Phencyclidine (PCP).
0
9. Amend Sec.  40.87 by revising paragraph (a) to read as follows:

Sec.  40.87  What are the cutoff concentrations for drug tests?

    (a) As a laboratory, you must use the cutoff concentrations
displayed in the following table for initial and confirmatory drug
tests. All cutoff concentrations are expressed in nanograms per
milliliter (ng/mL). The table follows:

----------------------------------------------------------------------------------------------------------------
                                                                  Confirmatory test     Confirmatory test cutoff
       Initial test analyte           Initial test cutoff \1\          analyte               concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolites (THCA) \2\..  50 ng/mL \3\..............  THCA.................  15 ng/mL.
Cocaine metabolite                  150 ng/mL \3\.............  Benzoylecgonine......  100 ng/mL.
 (Benzoylecgonine).
Codeine/Morphine..................  2000 ng/mL................  Codeine..............  2000 ng/mL.
                                                                Morphine.............  2000 ng/mL.
Hydrocodone/Hydromorphone.........  300 ng/mL.................  Hydrocodone..........  100 ng/mL.
                                                                Hydromorphone........  100 ng/mL.
Oxycodone/Oxymorphone.............  100 ng/mL.................  Oxycodone............  100 ng/mL.
                                                                Oxymorphone..........  100 ng/mL.
6-Acetylmorphine..................  10 ng/mL..................  6-Acetylmorphine.....  10 ng/mL.
Phencyclidine.....................  25 ng/mL..................  Phencyclidine........  25 ng/mL.
Amphetamine/Methamphetamine.......  500 ng/mL.................  Amphetamine..........  250 ng/mL
                                                                Methamphetamine......  250 ng/mL.
MDMA \4\/MDA \5\..................  500 ng/mL.................  MDMA.................  250 ng/mL.
                                                                MDA..................  250 ng/mL.
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
  cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
  not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending
  on the technology. At least one analyte within the group must have a concentration equal to or greater than
  the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the
  laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol-9-carboxylic acid
  (THCA).
\3\ Alternate technology (THCA and benzoylecgonine): When using alternate technology to test for THCA and
  Benzoylecgonine, the screening and confirmatory test cutoff concentrations must be the same respectively
  (i.e., 15 ng/mL for THCA and 100 ng/mL for Benzoylecgnine).''
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

* * * * *

Sec.  40.103  [Removed]

0
10. Remove Sec.  40.103.
0
11. Remove Sec.  40.105.
0
12. Amend Sec.  40.121 by revising paragraphs (b)(3) and (c)(3), and
the paragraph (d) introductory text to read as follows:

Sec.  40.121  Who is qualified to act as an MRO?

* * * * *
    (b) * * *
    (3) You must be knowledgeable about this part, the DOT MRO
Guidelines, and the DOT agency regulations applicable to the employers
for whom you evaluate drug test results, and you must keep current on
any changes to these materials. You must subscribe to the ODAPC list-
serve at https://www.transportation.gov/odapc/get-odapc-email-updates.
DOT agency regulations, DOT MRO Guidelines, and other materials are
available from ODAPC (Department of Transportation, 1200 New Jersey
Avenue SE.,

Washington, DC 20590,<PHONE_NUMBER>, or on the ODAPC Web site (http://www.transportation.gov/odapc).
    (c) * * *
    (3) You must meet the requirements of paragraphs (a), (b), and (c)
of this section before you begin to perform MRO functions.
    (d) Requalification training. During each five-year period from the
date on which you satisfactorily completed the examination under
paragraph (c) (2) of this section or have successfully completed the
required continuing education requirements, you must complete
requalification training.
* * * * *
0
13. Amend Sec.  40.123 by revising paragraph (e) to read as follows:

Sec.  40.123  What are the MRO's responsibilities in the DOT drug
testing program?

* * * * *
    (e) You must act to investigate and correct problems where possible
and notify appropriate parties (e.g., HHS, DOT, employers, service
agents) where assistance is needed (e.g., cancelled or problematic
tests, incorrect results).
* * * * *
0
14. Amend Sec.  40.137 by revising the section heading and paragraph
(a) to read as follows:

Sec.  40.137  On what basis does the MRO verify test results involving
marijuana, cocaine, amphetamines, semi-synthetic opioids, or PCP?

    (a) As the MRO, you must verify a confirmed positive test result
for marijuana, cocaine, amphetamines, semi-synthetic opioids (i.e.,
hydrocodone, hydromorphone, oxycodone, and oxymorphone), and/or PCP
unless the employee presents a legitimate medical explanation for the
presence of the drug(s)/metabolite(s) in his or her system.
* * * * *
0
15. Amend Sec.  40.139 by revising the section heading and paragraphs
(c) introductory text and (c)(3) to read as follows:

Sec.  40.139  On what basis does the MRO verify test results involving
6-acetylmorphine, codeine, and morphine?

* * * * *
    (c) For all other codeine and morphine positive results, you must
verify a confirmed positive test result only if you determine that
there is clinical evidence, in addition to the urine test, of
unauthorized use of any opium, opiate, or opium derivative (i.e.,
morphine, codeine, or heroin).
    (1) * * *
    (2) * * *
    (3) To be the basis of a verified positive result for codeine or
morphine, the clinical evidence you find must concern a drug that the
laboratory found in the specimen. (For example, if the test confirmed
the presence of codeine, and the employee admits to unauthorized use of
hydrocodone, you must verify the test positive for codeine. The
admission must be for the substance that was found through the actual
drug test).
* * * * *
0
16. Amend Sec.  40.141 by revising paragraph (b) to read as follows:

Sec.  40.141  How does the MRO obtain information for the verification
decision?

* * * * *
    (b) If the employee asserts that the presence of a drug or drug
metabolite in his or her specimen results from taking prescription
medication (i.e., a legally valid prescription under the Controlled
Substances Act), you must review and take all reasonable and necessary
steps to verify the authenticity of all medical records the employee
provides. You may contact the employee's physician or other relevant
medical personnel for further information. You may request an HHS-
certified laboratory with validated protocols (see Sec.  40.81(c)) to
conduct D, Lstereoisomer testing or tetrahydrocannabivarin (THC-V)
testing when verifying lab results, as you determine necessary.
0
17. Amend Sec.  40.162 by revising paragraph (c) to read as follows:

Sec.  40.162  What must MROs do with multiple verified results for the
same testing event?

* * * * *
    (c) As an exception to paragraphs (a) and (b) of this section, as
the MRO, you must follow procedures at Sec.  40.159(g) when any
verified non-negative result is also invalid.

Sec.  40.169  [Amended]

0
18. Amend Sec.  40.169 by removing the entry ``Sec.  40.105--
Notification of discrepancies in blind specimen results.''

Sec.  40.189  [Amended]

0
19. Amend Sec.  40.189 by removing the entry ``Sec.  40.103--Blind
split specimens.''
0
20. Amend Sec.  40.193 by revising paragraph (b)(4) to read as follows:

Sec.  40.193  What happens when an employee does not provide a
sufficient amount of urine for a drug test?

* * * * *
    (b) * * *
    (4) If the employee has not provided a sufficient specimen within
three hours of the first unsuccessful attempt to provide the specimen,
you must discontinue the collection, note the fact on the ``Remarks''
line of the CCF (Step 2), and immediately notify the DER. You must also
discard any specimen the employee previously provided to include any
specimen that is `out of temperature range' or shows signs of
tampering. In the remarks section of the CCF that you will distribute
to the MRO and DER, you must note the fact that the employee provided
an `out of temperature range specimen' or `specimen that shows signs of
tampering' and that it was discarded because the employee did not
provide a second sufficient specimen.
* * * * *
0
21. Amend Sec.  40.199 by revising paragraph (b) to read as follows:

Sec.  40.199  What problems always cause a drug test to be cancelled?

    (a) * * *
    (b) The following are ``fatal flaws'':
    (1) There is no CCF;
    (2) There is no specimen submitted with the CCF;
    (3) There is no printed collector's name and no collector's
signature;
    (4) Two separate collections are performed using one CCF;
    (5) The specimen ID numbers on the specimen bottle and the CCF do
not match;
    (6) The specimen bottle seal is broken or shows evidence of
tampering (and a split specimen cannot be re-designated, see Sec.
40.83(h)); and
    (7) Because of leakage or other causes, there is an insufficient
amount of urine in the primary specimen bottle for analysis and the
specimens cannot be re-designated (see Sec.  40.83(h)).
* * * * *
0
22. Amend Sec.  40.203 by revising paragraph (d)(3) to read as follows:

Sec.  40.203  What problems cause a drug test to be cancelled unless
they are corrected?

* * * * *
    (d) * * *
    (3) The collector uses a non-Federal form or an expired CCF for the
test. This flaw may be corrected through the procedure set forth in
Sec.  40.205(b)(2), provided that the collection testing process has
been conducted in accordance with the procedures in this part in an
HHS-certified laboratory.
0
23. Add Sec.  40.210 in subpart I to read as follows:

Sec.  40.210  Are drug tests other than urine permitted under the
regulations?

    No. Drug tests other than on urine specimens are not authorized for
testing under this part. Only urine specimens screened and confirmed at
HHS

certified laboratories (see Sec.  40.81) are allowed for drug testing
under this part. Point-of-collection urine testing or instant tests are
not authorized.
0
24. Amend Sec.  40.213 by revising paragraphs (a), (d), and (e) to read
as follows:

Sec.  40.213  What training requirements must STTs and BATs meet?

* * * * *
    (a) You must be knowledgeable about the alcohol testing procedures
in this part and the current DOT guidance. Procedures and guidance are
available from ODAPC (Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER>, or on the ODAPC Web
site, https://www.transportation.gov/odapc). You must keep current on
any changes to these materials. You must subscribe to the ODAPC list-
serve at (https://www.transportation.gov/odapc/get-odapc-email-updates).
* * * * *
    (d) You must meet the requirements of paragraphs (b) and (c) of
this section before you begin to perform STT or BAT functions.
    (e) Refresher training. No less frequently than every five years
from the date on which you satisfactorily complete the requirements of
paragraphs (b) and (c) of this section, you must complete refresher
training that meets all the requirements of paragraphs (b) and (c) of
this section.
* * * * *
0
25. Amend Sec.  40.233 by revising paragraph (c)(4) to read as follows:

Sec.  40.233  What are the requirements for proper use and care of
EBTs?

* * * * *
    (c) * * *
    (4) You must maintain records of the inspection, maintenance, and
calibration of EBTs as provided in Sec.  40.333(a)(3).
* * * * *
0
26. Amend Sec.  40.281 by revising paragraphs (a)(6), (b)(3), and
(c)(3) to read as follows:

Sec.  40.281  Who is qualified to act as a SAP?

* * * * *
    (a) * * *
    (6) You are a drug and alcohol counselor certified by an
organization listed at https://www.transportation.gov/odapc/sap.
    (b) * * *
    (3) You must be knowledgeable about this part, the DOT agency
regulations applicable to the employers for whom you evaluate
employees, and the DOT SAP Guidelines. You must keep current on any
changes to these materials. You must subscribe to the ODAPC list-serve
at https://www.transportation.gov/odapc/get-odapc-email-updates. DOT
agency regulations, DOT SAP Guidelines, and other materials are
available from ODAPC (Department of Transportation, 1200 New Jersey
Avenue SE., Washington DC, 20590<PHONE_NUMBER>), or on the ODAPC Web
site (http://www.transportation.gov/odapc).
    (c) * * *
    (3) You must meet the requirements of paragraphs (a), (b), and (c)
of this section before you begin to perform SAP functions.
* * * * *
0
27. Amend Sec.  40.331 by revising paragraph (f) to read as follows:

Sec.  40.331  To what additional parties must employers and service
agents release information?

* * * * *
    (f) Except as otherwise provided in this part, as a laboratory you
must not release or provide a specimen or a part of a specimen to a
requesting party, without first obtaining written consent from ODAPC.
DNA testing and other types of identity testing are not authorized and
ODAPC will not give permission for such testing. If a party seeks a
court order directing you to release a specimen or part of a specimen
contrary to any provision of this part, you must take necessary legal
steps to contest the issuance of the order (e.g., seek to quash a
subpoena, citing the requirements of Sec.  40.13). This part does not
require you to disobey a court order, however.
* * * * *
0
28. Amend Sec.  40.365 by revising paragraph (b)(10) to read as
follows:

Sec.  40.365  What is the Department's policy concerning starting a PIE
proceeding?

* * * * *
    (b) * * *
    (10) For any service agent, representing falsely that the service
agent or its activities is approved or certified by the Department or a
DOT agency (such representation includes, but is not limited to, the
use of a Department or DOT agency logo, title, or emblem).
* * * * *
0
29. Revise appendix B to part 40 to read as follows:

Appendix B to Part 40--DOT Drug-Testing Semi-Annual Laboratory Report
to Employers

    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)

Specimen Results Reported (total number)
By Test Reason
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
    By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Specimens Reported as Positive (total number) By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opioids (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)

0
30. Revise appendix C to part 40 to read as follows:

Appendix C to Part 40--DOT Drug-Testing Semi-Annual Laboratory Report
to DOT

    Mail, fax, or email to:

U.S. Department of Transportation, Office of Drug and Alcohol Policy
and Compliance, W62-300, 1200 New Jersey Avenue SE., Washington, DC
20590, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
    The following items are required on each report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
DOT Specimen Results Reported (total number)
2. Negative Results Reported (total number)
    Negative (number)
    Negative-Dilute (number)
3. Rejected for Testing Results Reported (total number)
    By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Positive Results Reported (total number)
    By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opioids (number)

    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
5. Adulterated Results Reported (total number)
    By Reason (number)
6. Substituted Results Reported (total number)
7. Invalid Results Reported (total number)
    By Reason (number)

0
31. Revise appendix D to part 40 to read as follows:

Appendix D to Part 40--Report Format: Split Specimen Failure To
Reconfirm

    Mail, fax, or submit electronically to: U.S. Department of
Transportation, Office of Drug and Alcohol Policy and Compliance,
W62-300, 1200 New Jersey Avenue SE., Washington, DC 20590, Fax:
(202) 366-3897.

    Submit Electronically: https://www.transportation.gov/content/split-specimen-cancellation-notification-49-cfr-part-40187-appendix-d
    The following items are required on each report:

MRO name, address, phone number, and fax number.
2. Collection site name, address, and phone number.
3. Date of collection.
4. Specimen I.D. number.
5. Laboratory accession number.
6. Primary specimen laboratory name, address, and phone number.
7. Date result reported or certified by primary laboratory.
8. Split specimen laboratory name, address, and phone number.
9. Date split specimen result reported or certified by split
specimen laboratory.
10. Primary specimen results (e.g., name of drug, adulterant) in the
primary specimen.
11. Reason for split specimen failure-to-reconfirm result (e.g.,
drug or adulterant not present, specimen invalid, split not
collected, insufficient volume).
12. Actions taken by the MRO (e.g., notified employer of failure to
reconfirm and requirement for recollection).
13. Additional information explaining the reason for cancellation.
14. Name of individual submitting the report (if not the MRO).

Appendix H to Part 40 [Removed]

0
32. Remove appendix H to part 40.

    Dated: January 12, 2017.
Anthony R. Foxx,
Secretary of Transportation.
[FR Doc. 2017-01131 Filed 1-19-17; 8:45 am]
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[Federal Register Volume 83, Number 6 (Tuesday, January 9, 2018)]
[Notices]
[Pages 1095-1096]
[FR Doc No: 2018-00164]

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 DEPARTMENT OF TRANSPORTATION

[Docket No. NHTSA-2017-0106]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to renew an information collection. Before a Federal
agency can collect certain information from the public, it must receive
approval from the Office of Management and Budget (OMB). Under
procedures established by the Paperwork Reduction Act of 1995, before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatement of previously approved collections.

DATES: Written comments should be submitted by March 12, 2018.

ADDRESSES: You may submit comments using any of the following methods:
     Electronic submissions: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.
     Comments may also be faxed to<PHONE_NUMBER>.
     Instructions: Each submission must include the Agency name
and Docket number for the proposed collection of information.

FOR FURTHER INFORMATION CONTACT: Walter Culbreath, NIO-0300, (202) 366-
1566, Office of the Chief Information Officer, W51-316, U.S Department
of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION:
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
    OMB Control Number: 2127-0682.
    Type of Review: Renewal of a currently approved information
collection.
    Abstract: The proposed information collection activity provides a
means to garner qualitative customer and stakeholder feedback in an
efficient, timely manner, in accordance with the Administration's
commitment to improving service delivery.
    This feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
    The solicitation of feedback will target areas such as: Timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
    The Agency will only submit a collection for approval under this
generic clearance if it meets the following conditions:
     The collections are voluntary;
     The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
     The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
     Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the agency (if
released, the agency must indicate the qualitative nature of the
information);
     Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
     Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
    Feedback collected under this generic clearance provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: The target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
    As a general matter, information collections will not result in any
new system of records containing privacy information and will not ask
questions of a sensitive nature, such as sexual behavior and attitudes,
religious beliefs, and other matters that are commonly considered
private.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Estimated Number of Respondents: 113,582.
    Frequency: Once per request.
    Number of Responses: 113,582.
    Estimated Total Annual Burden: 20,204.

    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information. The agency
will summarize and/or include your comments in the request for OMB's
clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

Kevin Mahoney,
Director, Office of Information Technology Services.
[FR Doc. 2018-00164 Filed 1-8-18; 8:45 am]
 BILLING CODE 4910-59-P