Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V
| Published date | 31 January 2020 |
| Citation | 85 FR 5557 |
| Record Number | 2020-01957 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 21 (Friday, January 31, 2020)
[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Rules and Regulations]
[Pages 5557-5562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01957]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-558]
Schedules of Controlled Substances: Placement of Lasmiditan in
Schedule V
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Interim final rule with request for comments.
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SUMMARY: On October 11, 2019, the U.S. Food and Drug Administration
approved a new drug application for Reyvow (lasmiditan) tablets for
oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1-
methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the
Department of Health and Human Services provided the Drug Enforcement
Administration (DEA) with a scheduling recommendation to place
lasmiditan in schedule V of the Controlled Substances Act (CSA). In
accordance with the CSA, as revised by the Improving Regulatory
Transparency for New Medical Therapies Act, DEA is hereby issuing an
interim final rule placing lasmiditan, including its salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, in schedule V of the CSA.
DATES: The effective date of this rulemaking is January 31, 2020.
Interested persons may file written comments on this rulemaking in
accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic
comments must be submitted, and written comments must be postmarked, on
or before March 2, 2020. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after 11:59
p.m. Eastern Time on the last day of the comment period.
Interested persons may file a request for hearing or waiver of
hearing in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.44.
Requests for hearing and waivers of an opportunity for a hearing or to
participate in a hearing must be received on or before March 2, 2020.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-558'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration
encourages that all comments be submitted electronically through the
Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular
[[Page 5558]]
or express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DRW, 8701 Morrissette Drive, Springfield, VA
22152.
Hearing requests: All requests for hearing and waivers of
participation must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing and waivers of participation should also be sent
to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement Administration (DEA) for public
inspection online at http://www.regulations.gov. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter. The Freedom of
Information Act (FOIA) applies to all comments received. If you want to
submit personal identifying information (such as your name, address,
etc.) as part of your comment, but do not want it to be made publicly
available, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
place all of the personal identifying information you do not want made
publicly available in the first paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) included in the text of your
electronic submission that is not identified as directed above as
confidential.
An electronic copy of this document and supplemental information,
including the complete Department of Health and Human Services and Drug
Enforcement Administration eight-factor analyses, to this interim final
rule are available at http://www.regulations.gov for easy reference.
Request for Hearing, or Waiver of Participation in Hearing
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. Interested persons may file requests for a hearing, or
notices of intent to participate in a hearing, in conformity with the
requirements of 21 CFR 1308.44(a) or (b), and include a statement of
interest in the proceeding and the objections or issues, if any,
concerning which the person desires to be heard. Any interested person
may file a waiver of an opportunity for a hearing or to participate in
a hearing together with a written statement regarding the interested
person's position on the matters of fact and law involved in any
hearing as set forth in 21 CFR 1308.44(c).
All requests for a hearing and waivers of participation must be
sent to DEA using the address information provided above.
Background and Legal Authority
Under the Improving Regulatory Transparency for New Medical
Therapies Act (Pub. L. 114-89), which was signed into law on November
25, 2015, the DEA is required to commence an expedited scheduling
action with respect to certain new drugs approved by the U.S. Food and
Drug Administration (FDA). As provided in 21 U.S.C. 811(j), this
expedited scheduling is required where both of the following conditions
apply: (1) The Secretary of the Department of Health and Human Services
(Secretary of HHS or the Secretary) has advised DEA that a New Drug
Application (NDA) has been submitted for a drug that has a stimulant,
depressant, or hallucinogenic effect on the central nervous system
(CNS), and that it appears that such drug has an abuse potential; and
(2) the Secretary recommends that DEA control the drug in schedule II,
III, IV, or V, pursuant to 21 U.S.C. 811(a) and (b). In these
circumstances, DEA is required to issue an interim final rule
controlling the drug within 90 days.
The law further states that the 90-day timeframe starts the later
of: (1) The date DEA receives the HHS scientific and medical
evaluation/scheduling recommendation, or (2) the date DEA receives
notice of the NDA approval by HHS. In addition, the law specifies that
the rulemaking shall become immediately effective as an interim final
rule without requiring DEA to demonstrate good cause therefor. Thus,
the purpose of subsection (j) is to speed the process by which DEA
schedules newly approved drugs that are currently either in schedule I
or not controlled (but which have sufficient abuse potential to warrant
control) so that such drugs may be marketed without undue delay
following FDA approval.\1\
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\1\ Given the parameters of subsection (j), in DEA's view, it
would not apply to a reformulation of a drug containing a substance
currently in schedules II through V for which an NDA has recently
been approved.
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Subsection (j) further provides that the interim final rule shall
give interested persons the opportunity to comment and to request a
hearing. After the conclusion of such proceedings, DEA must issue a
final rule in accordance with the scheduling criteria of subsections 21
U.S.C. 811(b), (c), and (d) and 21 U.S.C. 812(b).
Lasmiditan [2,4,6-trifluoro-N-(6-(1-methylpiperidine-4-
carbonyl)pyridine-2-yl-benzamide] is a new molecular entity with
central nervous system (CNS) depressant properties. Lasmiditan is a 5-
hydroxytryptamine (5-HT, serotonin) 1F receptor agonist. One of its
metabolites has low GABAA channel positive allosteric
activity. On October 11, 2018, Eli Lilly and Company (Sponsor)
submitted an NDA to FDA for Reyvow (lasmiditan) 50 and 100 mg oral
tablets. On November 4, 2019, DEA received notification that FDA, on
October 11, 2019, approved the NDA for Reyvow (lasmiditan), under
section 505(c) of the FDCA, for the acute treatment of migraine with or
without aura in adults.\2\
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\2\ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211280Orig1s000ltr.pdf.
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[[Page 5559]]
Determination To Schedule Lasmiditan
On November 4, 2019, DEA received from HHS a scientific and medical
evaluation document (dated October 23, 2019) prepared by the FDA
related to lasmiditan. This document contained an eight-factor analysis
of the abuse potential of lasmiditan, along with HHS' recommendation to
control lasmiditan under schedule V of the CSA.
On December 4, 2019, the DEA requested clarification from HHS
regarding supporting evidence for factors 6 and 7 listed in 21 U.S.C.
811(c), as well as the third finding under 21 U.S.C. 812(b)(5), for
placement of lasmiditan in schedule V. HHS responded to the DEA via a
letter on January 15, 2020, with the necessary clarification.
In response, DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by HHS, along with all other
relevant data, and completed its own eight-factor review document
pursuant to 21 U.S.C. 811(c). DEA concluded that lasmiditan met the 21
U.S.C. 812(b)(5) criteria for placement in schedule V of the CSA.
Pursuant to subsection 811(j), and based on the HHS recommendation,
NDA approval by HHS/FDA, and DEA's determination, DEA is issuing this
interim final rule to schedule lasmiditan as a schedule V controlled
substance under the CSA.
Included below is a brief summary of each factor as analyzed by HHS
and DEA, and as considered by DEA in its scheduling action. Please note
that both the DEA and HHS analyses are available in their entirety
under ``Supporting Documents'' in the public docket for this interim
final rule at http://www.regulations.gov, under Docket Number ``DEA-
558.'' Full analysis of, and citations to, the information referenced
in the summary may also be found in the supporting and related
material.
1. Its Actual or Relative Potential for Abuse: As noted by HHS,
lasmiditan is a new molecular entity that has not been marketed in the
United States or any other country. As a result, information on the
actual abuse of lasmiditan is limited. According to HHS, lasmiditan is
not currently available for medical treatment, lasmiditan has not been
diverted from legitimate sources, and individuals have not taken the
substance in amounts sufficient to create a hazard to public health and
safety. DEA further notes that there are no reports for lasmiditan in
the National Forensic Laboratory Information System (NFLIS),\3\ which
collects drug identification results from drug cases submitted to and
analyzed by State and local forensic laboratories. There were also no
reports in STARLiMS,\4\ DEA's laboratory drug evidence data system of
record.
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\3\ NFLIS is a national forensic laboratory reporting system
that systematically collects results from drug chemistry analyses
conducted by State and local forensic laboratories in the United
States. NFLIS data were queried on 11/14/2019.
\4\ STARLiMS is a laboratory information management system that
systematically collects results from drug chemistry analyses
conducted by the DEA laboratories. On October 1, 2014, STARLiMS
replaced STRIDE as the DEA laboratory drug evidence data system of
record. STARLiMS data were queried on 11/18/2019.
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Data from HHS outlined in Factors 2 and 3 demonstrate that
lasmiditan is a 5-hydroxytryyptamine-1F (5-HT1F) receptor
agonist. There are no 5-HT1F receptor agonists currently
controlled in the CSA. Lasmiditan at the highest dose tested did
produce reinforcing effects in a rat self-administration assay. Drug-
liking visual analog scale (VAS) for lasmiditan were significantly
higher than placebo and significantly lower than the schedule IV
benzodiazepine alprazolam in an abuse potential study in humans (see
Factor 3).
2. Scientific Evidence of Its Pharmacological Effects, if Known:
According to HHS, lasmiditan functions as a 5-HT1F receptor
agonist. HHS also further stated that lasmiditan does not bind to
various other receptor targets (opioid, cannabinoid, GABAergic, or
other ion channels) that are typically associated with abuse.
As shown by the studies summarized by HHS, lasmiditan did not
produce abuse-related behaviors in the toxicity studies within mice,
rats, and dogs. HHS stated that the studies demonstrating depressant
effects such as weight loss, sedation, and hypothermia produced by
lasmiditan could be due to its toxic concentrations of lasmiditan. In
addition, results of the drug discrimination assay demonstrated that
lasmiditan did not generalize to the discriminative stimulus effects of
the benzodiazepine lorazepam (schedule IV); however, lasmiditan did
produce reinforcing effects in the self-administration assay.
HHS described results from a Phase 1, randomized, double-blind,
placebo-and active-controlled, crossover clinical trial in adult
subjects who were recreational poly-drug users. The primary objective
of this study was to assess the abuse potential of lasmiditan compared
to alprazolam and placebo using the maximal effect score
(Emax) of the at-the-moment 100-mm bipolar Drug Liking VAS.
Lasmiditan was evaluated by the comparison of Drug Liking
Emax between each dose of lasmiditan and placebo. All doses
of lasmiditan (100 mg, 200 mg, and 400 mg) produced significantly
higher Emax than that of placebo indicating that lasmiditan
has abuse potential. However, these effects of all doses of lasmiditan
were significantly lower than alprazolam on mean Emax of
Drug Liking.
Lasmiditan 200 mg (therapeutic dose), lasmiditan 400 mg
(supratherapeutic dose), and alprazolam 2 mg (43-49 percent) produced
euphoric mood to a similar extent. The lower dose of lasmiditan (100
mg) produced euphoric moods in 25 percent of subjects. Alprazolam
produced a feeling of relaxation in more subjects than that produced by
any dose of lasmiditan. According to HHS, this pattern of adverse
events (AEs) suggests that lasmiditan has a similar or slightly less
potential for abuse than alprazolam.
According to HHS, the Sponsor conducted eighteen Phase 1 studies in
which AEs, including abuse-related AEs, were evaluated. In Phase 1,
single-dose studies with healthy subjects, lasmiditan produced
somnolence, feeling drunk, and euphoric mood. Euphoric mood occurred in
five out of twelve studies for lasmiditan, and one out of seven studies
for a control group. According to HHS, overall, the data from Phase 1
studies indicated that lasmiditan had more abuse-related AEs than
placebo, and alprazolam showed a greater incidence of abuse-related AEs
as compared to lasmiditan in one study.
HHS reviewed data from five Phase 2 and 3 studies and stated that,
at therapeutic doses, lasmiditan displays abuse-related AEs to a
greater extent than placebo. However, these AEs occur at a low
frequency (about one percent).
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: Appearing as a white to off-white solid, lasmiditan is
highly soluble in water and freely soluble in methanol. Per HHS, none
of the steps in the manufacturing process of lasmiditan produces or
utilizes substances that have a known potential for abuse, nor can they
be easily modified to generate a substance with abuse potential. A high
level of expertise in and knowledge of organic chemistry is required to
synthesize lasmiditan.
Rat studies demonstrate that lasmiditan has a half-life of
approximately 31 hours. HHS also described lasmiditan pharmacokinetic
data from another study conducted in beagle dogs in the fasted
(overnight) state versus the fed state. The time measurement for
maximal concentration
[[Page 5560]]
(Tmax) was the only parameter that significantly differed
between the fed (3.5 hours) and the fasted (1.25 hours) state,
indicating that food has a significant slowing effect on the oral
absorption of lasmiditan.
A separate study in male rats was conducted to compare the plasma
and brain pharmacokinetic parameters, in addition to evaluating the
bioavailability of lasmiditan. Results indicate that lasmiditan crosses
the blood brain barrier and collects in the brain, producing exposure
levels 2.5- to 3-fold higher than those in plasma. The Tmax
in both plasma and brain was reached in 30 minutes. However, the
maximum serum concentration was two- and three-fold higher in the brain
as compared to plasma levels following oral and IV administration,
respectively. The oral bioavailability of the drug was 63.3 percent.
As described by HHS, an in-vitro study was conducted to identify
the human cytochrome P450 isozymes responsible for the in-vitro
metabolism of lasmiditan. Results indicated the possible involvement of
CYP1A2 in the production of metabolites M7, M8, and M18; CYP2D6 and
CYP2C9 in the production of M7 and M18; and CYP2C19 and CYP3A4 in the
production of M7 and M18.
4. Its History and Current Pattern of Abuse: Lasmiditan was
approved by FDA on October 11, 2019. According to HHS, as a single
active ingredient in a drug product formulation, lasmiditan has not
been approved for therapeutic use in any other country. There is no
information available relating to the history and current pattern of
abuse of this formulation of lasmiditan or the active ingredient. As
stated in Factor 1, DEA notes that there has been no diversion of
lasmiditan based on NFLIS and STARLiMS data.
5. The Scope, Duration, and Significance of Abuse: As described in
Factor 4, lasmiditan as a single entity has not been approved for
therapeutic use outside of the United States. A search by DEA of the
NFLIS and STARLiMS databases found no evidence of law enforcement
encounters of lasmiditan in the United States. Based on the preclinical
and clinical study data described by HHS (see Factor 2, above), and on
available epidemiological data, the scope, duration, and significance
of lasmiditan abuse would likely be lower than substances in schedule
IV of the CSA and similar to that of a drug controlled in schedule V.
6. What, if Any, Risk There Is to the Public Health: As stated by
HHS, the extent to which a drug has abuse potential is considered an
indication of its public health risk. Based on the preclinical and
clinical study data described by HHS (see Factor 2, above), lasmiditan
has abuse potential and physical or psychological dependence (Factor 7)
that is lower than substances in schedule IV of the CSA and similar to
that of substances controlled in schedule V.
7. Its Psychic or Physiological Dependence Liability: HHS described
an animal study that was conducted to assess the withdrawal effects of
lasmiditan. Based on the data from the animal study, HHS concluded that
lasmiditan does not produce signs consistent with physical dependence.
HHS, in its clarification letter to DEA, stated that animal data,
discussed in Factor 2, suggest that lasmiditan has the potential to
produce psychological dependence less than that of substances in
schedule IV and similar to that of substances in schedule V. HHS
further added that these circumstances of uncertain physical dependence
and limited psychological dependence have likewise been observed in
their analyses of other schedule V drugs.
8. Whether the Substance Is an Immediate Precursor of a Substance
Already Controlled Under the CSA: Lasmiditan is not an immediate
precursor of a substance that is already controlled in the CSA as
defined in 21 U.S.C. 802(23).
Conclusion: After considering the scientific and medical evaluation
conducted by HHS, HHS' recommendation, and DEA's own eight-factor
analysis, DEA has determined that these facts and all relevant data
constitute substantial evidence of a potential for abuse of lasmiditan.
As such, DEA hereby schedules lasmiditan as a controlled substance
under the CSA.
Determination of Appropriate Schedule
21 U.S.C. 812(b) requires the evaluation of a substance's abuse
potential, accepted medical use, and safety for use under medical
supervision for scheduling under the CSA as a controlled substance.
After consideration of the above eight factors determinative of control
of a substance (21 U.S.C. 811(c)), and a review of the scientific and
medical evaluation and scheduling recommendation provided by HHS, DEA
finds that lasmiditan meets the following criteria for placement in
schedule V of the CSA pursuant to 21 U.S.C. 812(b)(5).
(1) Lasmiditan has a low potential for abuse relative to the drugs
or other substances in Schedule IV.
As stated by HHS, lasmiditan, a 5-HT1F receptor agonist,
did not bind to receptors typically associated with abuse (e.g.,
opioid, cannabinoid, GABAergic). In the drug discrimination paradigm,
lasmiditan did not generalize to the discriminative stimulus effects of
the benzodiazepine lorazepam. Lasmiditan did, however, produce
reinforcing effects in the self-administration assay.
As detailed by HHS, in a human abuse-potential study, all doses of
lasmiditan produced drug-liking scores that were significantly higher
than that of placebo, indicating its abuse potential. Subjects
following lasmiditan reported drug-liking scores that were
significantly smaller than that of alprazolam (schedule IV drug),
indicating that its abuse potential is less than that of alprazolam.
Lasmiditan produced abuse-related adverse events to a greater extent
than that of placebo, but with low frequency (about 1 percent).
(2) Lasmiditan has a currently accepted medical use in the United
States.
The FDA recently approved the NDA for lasmiditan oral tablets for
the acute treatment of migraine with or without aura in adults.
Therefore, lasmiditan has a currently accepted medical use in treatment
in the United States.
(3) Abuse of Lasmiditan may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
Schedule IV.
As stated by HHS, based on the totality of the available scientific
data, lasmiditan may lead to physical or psychological dependence that
is low relative to substances in schedule IV and similar to that of
substances in schedule V.
Based on these findings, the Acting Administrator of DEA concludes
that lasmiditan warrants control in schedule V of the CSA. 21 U.S.C.
812(b)(5).
Requirements for Handling Lasmiditan
Lasmiditan is subject to the CSA's schedule V regulatory controls
and administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, dispensing, importing,
exporting, research, and conduct of instructional activities and
chemical analysis with, and possession involving, schedule V
substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, dispenses, imports, exports, engages in research,
or conducts instructional activities or chemical analysis with, or
possesses)
[[Page 5561]]
lasmiditan, or who desires to handle lasmiditan, must be registered
with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823,
957, and 958, and in accordance with 21 CFR parts 1301 and 1312. Any
person who currently handles or intends to handle lasmiditan, and is
not registered with the DEA, must submit an application for
registration and may not continue to handle lasmiditan, unless the DEA
has approved that application for registration, pursuant to 21 U.S.C.
822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and
1312.
2. Disposal of Stocks. Any person who does not desire, or is not
able to obtain, a schedule V registration must surrender all quantities
of currently held lasmiditan, or may transfer all quantities of
currently held lasmiditan to a person registered with the DEA in
accordance with 21 CFR part 1317, in addition to all other applicable
federal, state, local, and tribal laws.
3. Security. Lasmiditan is subject to schedule III-V security
requirements and must be handled and stored in accordance with 21 CFR
1301.71-1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of lasmiditan must comply with 21 U.S.C. 825 and
958(e), and be in accordance with 21 CFR part 1302.
5. Inventory. Every DEA registrant who possesses any quantity of
lasmiditan must take an inventory of lasmiditan on hand, pursuant to 21
U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04,
and 1304.11.
Any person who becomes registered with the DEA to handle lasmiditan
must take an initial inventory of all stocks of controlled substances
(including lasmiditan) on hand on the date the registrant first engages
in the handling of controlled substances, pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including lasmiditan)
on hand every two years, pursuant to 21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports for lasmiditan, or products containing lasmiditan,
pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR
parts 1304, 1312, and 1317.
7. Prescriptions. All prescriptions for lasmiditan, or products
containing lasmiditan, must comply with 21 U.S.C. 829, and be issued in
accordance with 21 CFR parts 1306 and 1311, subpart C.
8. Manufacturing and Distributing. In addition to the general
requirements of the CSA and DEA regulations that are applicable to
manufacturers and distributors of schedule V controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of lasmiditan may
only be for the legitimate purposes consistent with the drug's
labeling, or for research activities authorized by the Federal Food,
Drug, and Cosmetic Act and the CSA.
9. Importation and Exportation. All importation and exportation of
lasmiditan must be in compliance with 21 U.S.C. 952, 953, 957, and 958,
and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving lasmiditan not authorized by,
or in violation of, the CSA or its implementing regulations, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Administrative Procedure Act
Section 553 of the Administrative Procedure Act (APA) (5 U.S.C.)
generally requires notice and comment for rulemakings. However, 21
U.S.C. 811 provides that in cases where a certain new drug is (1)
approved by HHS and (2) HHS recommends control in CSA schedule II-V,
DEA shall issue an interim final rule scheduling the drug within 90
days. Additionally, the law specifies that the rulemaking shall become
immediately effective as an interim final rule without requiring DEA to
demonstrate good cause.
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
In accordance with 21 U.S.C. 811(a) and (j), this scheduling action
is subject to formal rulemaking procedures performed ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures
and criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order 12866 and the principles
reaffirmed in Executive Order 13563.
This final rule is not an Executive Order 13771 regulatory action
pursuant to Executive Order 12866 and OMB guidance.\5\
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\5\ Office of Mgmt. & Budget, Exec. Office of the President,
Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 Titled ``Reducing Regulation and Controlling
Regulatory Costs'' (Feb. 2, 2017).
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Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate
drafting errors and ambiguity, minimize litigation, provide a clear
legal standard for affected conduct, and promote simplification and
burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA. Under 21 U.S.C. 811(j), DEA is not required to publish a
general notice of proposed rulemaking. Consequently, the RFA does not
apply.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action would not
result in any Federal mandate that may result ``in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any 1 year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.
[[Page 5562]]
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. This rule will not result in: An annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices for consumers, individual industries, Federal, State,
or local government agencies, or geographic regions; or significant
adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of U.S.-based companies to compete with
foreign-based companies in domestic and export markets. However,
pursuant to the CRA, DEA has submitted a copy of this interim final
rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Amend Sec. 1308.15 by:
0
a. Redesignating paragraph (e)(4) as (e)(5);
0
b. Adding new paragraph (e)(4).
The addition reads as follows:
Sec. 1308.15 Schedule V.
* * * * *
(e) * * *
(4) Lasmiditan [2,4,6-trifluoro-N-(6-(1-methylpiperidine-4- 2790
carbonyl)pyridine-2-yl-benzamide]............................
* * * * *
Dated: January 28, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-01957 Filed 1-30-20; 8:45 am]
BILLING CODE 4410-09-P
