Alcohol and Drug Testing: Reporting Positive Results for Tramadol as a Controlled Substance, 38654-38655 [2015-16531]
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Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Rules and Regulations
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OMB Control Number. The OMB
Control Number is 3060–1189.
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the Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–1189.
OMB Approval Date: June 17, 2015.
OMB Expiration Date: June 30, 2018.
Title: Signal Boosters, sections
1.1307(b)(1), 20.3, 20.21(a)(2),
20.21(a)(5), 20.21(e)(2), 20.21(e)(8)(i)(G),
20.21(e)(9)(i)(H), 20.21(f), 20.21(h), 22.9,
24.9, 27.9. 90.203, 90.219(b)(l)(i),
90.219(d)(5), and 90.219(e)(5).
Form Number: N/A.
Respondents: Business or other forprofit entities, Not for profit institutions
and Individuals or household.
Number of Respondents and
Responses: 632,595 respondents and
635,215 responses.
Estimated Time per Response: .5
hours–40 hours.
Frequency of Response:
Recordkeeping requirement, On
occasion reporting requirement and
Third party disclosure requirement.
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obtain or retain benefits. The statutory
authority for this information collection
is contained in 47 U.S.C. 154(I), 303(g),
303(r) and 332.
Total Annual Burden: 324,470 hours.
Total Annual Cost: No cost.
Privacy Impact Assessment: This
information collection affects
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However, the government is not directly
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considered Customer Proprietary
Network Information (CPNI).
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Needs and Uses: On September 19,
2014, the Federal Communications
Commission (Commission or FCC)
adopted an Order on Reconsideration in
WT Docket No. 10–4, FCC No. 14–138,
in which it took the following action,
among others: Required that Consumer
Signal Boosters certified for fixed
operation only be labeled to notify
consumers that such devices may only
be used in fixed, in-building locations.
Therefore, the new labeling requirement
which requires OMB review and
approval is as follows:
The labeling requirement is covered
under 47 CFR 20.21(f)(1)(iv)(A)(2). The
VerDate Sep<11>2014
19:51 Jul 06, 2015
Jkt 235001
new requirement is needed in order to
ensure that consumers are properly
informed about which devices are
suitable for their use and how to comply
with our rules, the Commission required
that all Consumer Signal Boosters
certified for fixed, in-building operation
include a label directing consumers that
the device may only be operated in a
fixed, in-building location. The Verizon
Petitioners state that this additional
labeling requirement is necessary to
inform purchasers of fixed Consumer
Signal Boosters that they may not
lawfully be installed and operated in a
moving vehicle or outdoor location. We
recognize that our labeling requirement
imposes additional costs on entities that
manufacture Consumer Signal Boosters;
however, on balance, we find that such
costs are outweighed by the benefits of
ensuring that consumers purchase
appropriate devices. Accordingly, all
fixed Consumer Signal Boosters, both
Provider-Specific and Wideband,
manufactured or imported on or after
one year from the effective date of the
rule change must include the following
advisory (1) in on-line point-of-sale
marketing materials, (2) in any print or
on-line owner’s manual and installation
instructions, (3) on the outside
packaging of the device, and (4) on a
label affixed to the device: ‘‘This device
may be operated ONLY in a fixed
location for in-building use.’’
Federal Communications Commission.
Gloria J. Miles,
Federal Register Liaison Officer.
[FR Doc. 2015–16536 Filed 7–6–15; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
49 CFR Part 219
[Docket No. FRA–2001–11213, Notice No.
19]
Alcohol and Drug Testing: Reporting
Positive Results for Tramadol as a
Controlled Substance
Federal Railroad
Administration (FRA), DOT.
ACTION: Final rule.
AGENCY:
This document announces
that FRA will begin reporting postaccident toxicological test results for
tramadol to the employee and the
railroad Medical Review Officers. FRA
will also begin including post-accident
toxicological test results for tramadol in
its post-accident toxicology reports.
Because tramadol was not a controlled
SUMMARY:
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
substance when FRA began testing for
it, FRA has kept post-accident
toxicological test results for tramadol
confidential.
This document is effective July
7, 2015.
FOR FURTHER INFORMATION CONTACT: Jerry
Powers, FRA Drug and Alcohol Program
Manager, W33–310, Federal Railroad
Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590,
telephone 202–493–6313 or
gerald.powers@dot.gov; or Sam Noe,
FRA Drug and Alcohol Program
Specialist, telephone 615–719–2951, or
sam.noe@dot.gov.
SUPPLEMENTARY INFORMATION:
DATES:
FRA’s Post-Accident Toxicological
Testing Program
Since 1985, as part of its accident
investigation program, FRA has
routinely conducted alcohol and drug
tests on railroad employees involved in
serious train accidents that meet certain
criteria specified in FRA’s regulations.
See 49 CFR 219.201.1 This post-accident
testing is used to determine if alcohol
misuse or drug abuse played a role in
the occurrence or severity of an
accident. Since the program’s inception,
FRA has routinely conducted postaccident tests for alcohol and certain
drugs the United States Drug
Enforcement Administration (DEA)
classifies as controlled substances.
Controlled substances are drugs or
chemicals that are prohibited or strictly
regulated because of their potential for
abuse or addiction. See 77 FR 29307,
29307, May 17, 2002. The DEA oversees
the classification of controlled
substances into five schedules. Section
I contains illicit drugs such as marijuana
and heroin, which have no legitimate
medical use under Federal law.
Schedules II–V contain legal drugs that
are available only by prescription. See
generally The Controlled Substances
Act (CSA), Title II of the Comprehensive
Drug Abuse Prevention Substances Act
of 1970 (21 U.S.C. 801 et seq.).
FRA has historically conducted postaccident tests for the following
controlled substances: Marijuana,
cocaine, phencyclidine (PCP), and
selected opioids, amphetamines,
barbiturates, and benzodiazepines.
Under 49 CFR 219.211(b), FRA reports
post-accident test results for these
substances to the employee tested and
the employing railroad’s Medical
Review Officer (MRO). See 49 CFR
219.211(b).
1 All references to sections of the Code of Federal
Regulations (CFR) in this document refer to sections
within title 49 of the CFR.
E:\FR\FM\07JYR1.SGM
07JYR1
Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Rules and Regulations
In 2013, FRA amended its alcohol and
drug testing regulations to establish
post-accident testing for non-controlled
substances.2 See 78 FR 14217, Mar. 5,
2013. In the final rule adopting this
revision, FRA provided notice of the
addition of two non-controlled
substances to its standard post-accident
testing panel: Tramadol and sedating
antihistamines. FRA also made clear
that the agency did not intend to report
the results of post-accident tests for
these non-controlled substances to the
employee involved or relevant MRO and
instead intended to use the results for
research and data purposes only. See id.
at 14217 and 14219.
DEA’s Determination To Schedule
Tramadol as a Controlled Substance
In 2014, after FRA issued its final rule
establishing post-accident testing for
non-controlled substances, the DEA
placed tramadol 3 on the CSA’s
Schedule IV. See 79 FR 37623–37630,
Jul. 2, 2014. The DEA’s determination
stated that it took into account a
scientific and medical evaluation the
Department of Health and Human
Services (HHS) prepared which
recommended including tramadol in
Schedule IV of the CSA. See id. at
37623. The HHS evaluation analyzed
tramadol taking into consideration eight
factors listed in 21 U.S.C. 811(c), as well
as tramadol’s abuse potential, legitimate
medical use, and dependence liability.
See id. at 37623–37624. In response to
public comment, DEA explained that
tramadol is considered an opioid
because it produces pharmacological
effects similar to those produced by
other opioids. Id. at 37626. The DEA
also noted ‘‘tramadol is a widely
prescribed drug, with nearly 40 million
srobinson on DSK5SPTVN1PROD with RULES
2 A non-controlled substance is any substance
that is not currently regulated under 21 U.S.C. 801–
971 or 21 CFR part 1308. See § 219.5. Noncontrolled substances can include prescription
medications, over-the-counter products, dietary
supplements, and herbal preparations. See id.
3 The DEA’s decision to designate tramadol as a
Schedule IV controlled substance applied to the
substance 2-[(dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexanol (tramadol), including
its salts, isomers, and salts of isomers. See id. at
37623.
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19:51 Jul 06, 2015
Jkt 235001
prescriptions written in 2012.’’ Id. at
37627 (citations omitted).
Reporting of Tramadol Positives
Because the DEA now designates
tramadol a controlled substance, FRA’s
alcohol and drug regulations apply to
tramadol use and possession the same
as they apply to use and possession of
any other controlled substance, such as
synthetic opioids and valium. For
example, FRA’s regulations place
certain limitations on a railroad
employee’s use and possession of
controlled substances—those limitations
now apply to the use and possession of
tramadol by railroad employees. The
regulations prohibit a railroad employee
from using or possessing a controlled
substance while assigned by a railroad
to perform covered service,4 except as
provided by § 219.103. See 49 CFR
219.101(a)(1). (Section 219.103 provides
that subject to certain conditions and
limitations, a covered employee may
use and possess Schedule II through IV
controlled substances if a medical
practitioner prescribes or authorizes the
use.) The regulations also prohibit a
railroad employee who performs
covered service from using a controlled
substance at any time, whether on or off
duty, except as § 219.103 permits. See
49 CFR 219.102. A railroad employee
who uses or possesses a controlled
substance, including tramadol, in
violation of one of these prohibitions is
subject to the removal, return-to-service,
and follow-up testing requirements of
§ 219.104.
FRA is issuing this document to (1)
make railroads and railroad employees
aware of the DEA’s classification of
tramadol as a controlled substance and
(2) remind railroads and individuals
subject to FRA’s regulations of the effect
of the DEA’s designation of tramadol as
a controlled substance on FRA’s postaccident testing program. Issuance of
this document does not provide
service is service in the United States
that is subject to the hours of service laws at 49
U.S.C. 21103, 21104, or 21105. See 49 CFR 219.5.
Covered service does not include any period the
employee is relieved of all responsibilities and is
free to come and go. See id.
PO 00000
4 Covered
Frm 00043
Fmt 4700
Sfmt 9990
38655
precedent that FRA will notify the
industry whenever DEA designates
additional drugs as controlled
substances or whenever FRA decides to
conduct post-accident testing for
additional controlled substances. This
document is also not an exhaustive
discussion of all FRA requirements
governing controlled substances.
Because DEA has designated tramadol
as a Schedule IV controlled substance,
on July 7, 2015 FRA will begin reporting
post-accident test results for tramadol
pursuant to § 219.211(b), which
provides that post-accident test results
for controlled substances will be
reported to a railroad’s MRO and the
employee. FRA also intends to include
post-accident test results for tramadol in
toxicology reports as § 219.211(f)(2)
requires.
Railroads and MROs must also treat
post-accident test results for tramadol
consistent with all applicable FRA
requirements for controlled substances.
For example, like post-accident test
results for any controlled substance, an
MRO must review tramadol results with
respect to any claim of use or
administration of tramadol consistent
with § 219.103 that could account for
the laboratory findings, and must report
the results of this review to the
employing railroad and FRA. See
§ 219.211(c). Railroads and MROs must
also treat post-accident test results for
tramadol as confidential under
§ 219.211(b). FRA encourages any
railroad, railroad employee, or MRO
that has questions about post-accident
test results for tramadol to contact
FRA’s Drug and Alcohol Program
Manager for guidance.
Finally, the requirements of
§§ 219.101, 219.102, 219.103, and
219.104 now apply to covered
employees’ use and possession of
tramadol.
Robert C. Lauby,
Associate Administrator for Railroad Safety
Chief Safety Officer.
[FR Doc. 2015–16531 Filed 7–6–15; 8:45 am]
BILLING CODE 4910–06–P
E:\FR\FM\07JYR1.SGM
07JYR1
Agencies
[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Rules and Regulations]
[Pages 38654-38655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16531]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
49 CFR Part 219
[Docket No. FRA-2001-11213, Notice No. 19]
Alcohol and Drug Testing: Reporting Positive Results for Tramadol
as a Controlled Substance
AGENCY: Federal Railroad Administration (FRA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document announces that FRA will begin reporting post-
accident toxicological test results for tramadol to the employee and
the railroad Medical Review Officers. FRA will also begin including
post-accident toxicological test results for tramadol in its post-
accident toxicology reports. Because tramadol was not a controlled
substance when FRA began testing for it, FRA has kept post-accident
toxicological test results for tramadol confidential.
DATES: This document is effective July 7, 2015.
FOR FURTHER INFORMATION CONTACT: Jerry Powers, FRA Drug and Alcohol
Program Manager, W33-310, Federal Railroad Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590, telephone 202-493-6313 or
gerald.powers@dot.gov; or Sam Noe, FRA Drug and Alcohol Program
Specialist, telephone 615-719-2951, or sam.noe@dot.gov.
SUPPLEMENTARY INFORMATION:
FRA's Post-Accident Toxicological Testing Program
Since 1985, as part of its accident investigation program, FRA has
routinely conducted alcohol and drug tests on railroad employees
involved in serious train accidents that meet certain criteria
specified in FRA's regulations. See 49 CFR 219.201.\1\ This post-
accident testing is used to determine if alcohol misuse or drug abuse
played a role in the occurrence or severity of an accident. Since the
program's inception, FRA has routinely conducted post-accident tests
for alcohol and certain drugs the United States Drug Enforcement
Administration (DEA) classifies as controlled substances.
---------------------------------------------------------------------------
\1\ All references to sections of the Code of Federal
Regulations (CFR) in this document refer to sections within title 49
of the CFR.
---------------------------------------------------------------------------
Controlled substances are drugs or chemicals that are prohibited or
strictly regulated because of their potential for abuse or addiction.
See 77 FR 29307, 29307, May 17, 2002. The DEA oversees the
classification of controlled substances into five schedules. Section I
contains illicit drugs such as marijuana and heroin, which have no
legitimate medical use under Federal law. Schedules II-V contain legal
drugs that are available only by prescription. See generally The
Controlled Substances Act (CSA), Title II of the Comprehensive Drug
Abuse Prevention Substances Act of 1970 (21 U.S.C. 801 et seq.).
FRA has historically conducted post-accident tests for the
following controlled substances: Marijuana, cocaine, phencyclidine
(PCP), and selected opioids, amphetamines, barbiturates, and
benzodiazepines. Under 49 CFR 219.211(b), FRA reports post-accident
test results for these substances to the employee tested and the
employing railroad's Medical Review Officer (MRO). See 49 CFR
219.211(b).
[[Page 38655]]
In 2013, FRA amended its alcohol and drug testing regulations to
establish post-accident testing for non-controlled substances.\2\ See
78 FR 14217, Mar. 5, 2013. In the final rule adopting this revision,
FRA provided notice of the addition of two non-controlled substances to
its standard post-accident testing panel: Tramadol and sedating
antihistamines. FRA also made clear that the agency did not intend to
report the results of post-accident tests for these non-controlled
substances to the employee involved or relevant MRO and instead
intended to use the results for research and data purposes only. See
id. at 14217 and 14219.
---------------------------------------------------------------------------
\2\ A non-controlled substance is any substance that is not
currently regulated under 21 U.S.C. 801-971 or 21 CFR part 1308. See
Sec. 219.5. Non-controlled substances can include prescription
medications, over-the-counter products, dietary supplements, and
herbal preparations. See id.
---------------------------------------------------------------------------
DEA's Determination To Schedule Tramadol as a Controlled Substance
In 2014, after FRA issued its final rule establishing post-accident
testing for non-controlled substances, the DEA placed tramadol \3\ on
the CSA's Schedule IV. See 79 FR 37623-37630, Jul. 2, 2014. The DEA's
determination stated that it took into account a scientific and medical
evaluation the Department of Health and Human Services (HHS) prepared
which recommended including tramadol in Schedule IV of the CSA. See id.
at 37623. The HHS evaluation analyzed tramadol taking into
consideration eight factors listed in 21 U.S.C. 811(c), as well as
tramadol's abuse potential, legitimate medical use, and dependence
liability. See id. at 37623-37624. In response to public comment, DEA
explained that tramadol is considered an opioid because it produces
pharmacological effects similar to those produced by other opioids. Id.
at 37626. The DEA also noted ``tramadol is a widely prescribed drug,
with nearly 40 million prescriptions written in 2012.'' Id. at 37627
(citations omitted).
---------------------------------------------------------------------------
\3\ The DEA's decision to designate tramadol as a Schedule IV
controlled substance applied to the substance 2-
[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol),
including its salts, isomers, and salts of isomers. See id. at
37623.
---------------------------------------------------------------------------
Reporting of Tramadol Positives
Because the DEA now designates tramadol a controlled substance,
FRA's alcohol and drug regulations apply to tramadol use and possession
the same as they apply to use and possession of any other controlled
substance, such as synthetic opioids and valium. For example, FRA's
regulations place certain limitations on a railroad employee's use and
possession of controlled substances--those limitations now apply to the
use and possession of tramadol by railroad employees. The regulations
prohibit a railroad employee from using or possessing a controlled
substance while assigned by a railroad to perform covered service,\4\
except as provided by Sec. 219.103. See 49 CFR 219.101(a)(1). (Section
219.103 provides that subject to certain conditions and limitations, a
covered employee may use and possess Schedule II through IV controlled
substances if a medical practitioner prescribes or authorizes the use.)
The regulations also prohibit a railroad employee who performs covered
service from using a controlled substance at any time, whether on or
off duty, except as Sec. 219.103 permits. See 49 CFR 219.102. A
railroad employee who uses or possesses a controlled substance,
including tramadol, in violation of one of these prohibitions is
subject to the removal, return-to-service, and follow-up testing
requirements of Sec. 219.104.
---------------------------------------------------------------------------
\4\ Covered service is service in the United States that is
subject to the hours of service laws at 49 U.S.C. 21103, 21104, or
21105. See 49 CFR 219.5. Covered service does not include any period
the employee is relieved of all responsibilities and is free to come
and go. See id.
---------------------------------------------------------------------------
FRA is issuing this document to (1) make railroads and railroad
employees aware of the DEA's classification of tramadol as a controlled
substance and (2) remind railroads and individuals subject to FRA's
regulations of the effect of the DEA's designation of tramadol as a
controlled substance on FRA's post-accident testing program. Issuance
of this document does not provide precedent that FRA will notify the
industry whenever DEA designates additional drugs as controlled
substances or whenever FRA decides to conduct post-accident testing for
additional controlled substances. This document is also not an
exhaustive discussion of all FRA requirements governing controlled
substances.
Because DEA has designated tramadol as a Schedule IV controlled
substance, on July 7, 2015 FRA will begin reporting post-accident test
results for tramadol pursuant to Sec. 219.211(b), which provides that
post-accident test results for controlled substances will be reported
to a railroad's MRO and the employee. FRA also intends to include post-
accident test results for tramadol in toxicology reports as Sec.
219.211(f)(2) requires.
Railroads and MROs must also treat post-accident test results for
tramadol consistent with all applicable FRA requirements for controlled
substances. For example, like post-accident test results for any
controlled substance, an MRO must review tramadol results with respect
to any claim of use or administration of tramadol consistent with Sec.
219.103 that could account for the laboratory findings, and must report
the results of this review to the employing railroad and FRA. See Sec.
219.211(c). Railroads and MROs must also treat post-accident test
results for tramadol as confidential under Sec. 219.211(b). FRA
encourages any railroad, railroad employee, or MRO that has questions
about post-accident test results for tramadol to contact FRA's Drug and
Alcohol Program Manager for guidance.
Finally, the requirements of Sec. Sec. 219.101, 219.102, 219.103,
and 219.104 now apply to covered employees' use and possession of
tramadol.
Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2015-16531 Filed 7-6-15; 8:45 am]
BILLING CODE 4910-06-P