Schedules of Controlled Substances: Placement of Zipeprol in Schedule I
| Published date | 14 May 2020 |
| Citation | 85 FR 28899 |
| Record Number | 2020-09592 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 94 (Thursday, May 14, 2020)
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Proposed Rules]
[Pages 28899-28904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09592]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-477]
Schedules of Controlled Substances: Placement of Zipeprol in
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes placing the
substance zipeprol (Chemical name: 1-methoxy-3-[4-(2-methoxy-2-
phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol), including its
isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers, whenever the existence of such isomers, esters, ethers and
salts is possible, in schedule I of the Controlled Substances Act. This
action is being taken to enable the United States to meet its
obligations under the 1971 Convention on Psychotropic Substances. If
finalized, this action would impose the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess), or
propose to handle zipeprol.
DATES: Comments must be submitted electronically or postmarked on or
before July 13, 2020.
Interested persons may file a request for hearing or waiver of
hearing pursuant to 21 Code of Federal Regulations (CFR) 1308.44 and in
accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests
for hearing and waivers of an opportunity for a hearing or to
participate in a hearing must be received on or before June 15, 2020.
ADDRESSES: Interested persons may file written comments on this
proposal in accordance with 21 CFR 1308.43(g). 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. To ensure proper handling of comments, please reference
``Docket No. DEA-477'' on all electronic and written correspondence,
including any attachments.
Electronic comments: DEA 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 on-line 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 electronic
submissions 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 or express mail to: Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
[[Page 28900]]
Hearing requests: All requests for a 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/DPW, 8701 Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
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 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 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 to
this proposed rule are available at http://www.regulations.gov for easy
reference.
Request for Hearing or Waiver of Participation in Hearing
Pursuant to 21 United States Code (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, 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 hearing and waivers of participation must be sent
to DEA using the address information provided above.
Legal Authority
The United States is a party to the 1971 United Nations Convention
on Psychotropic Substances (1971 Convention), February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting
changes in drug schedules under the 1971 Convention are governed
domestically by 21 U.S.C. 811(d). When the United States receives
notification of a scheduling decision pursuant to Article 2 of the 1971
Convention indicating that a drug or other substance has been added or
transferred to a schedule specified in the notification, the Secretary
of the Department of Health and Human Services (HHS),\1\ after
consultation with the Attorney General, shall first determine whether
existing legal controls under subchapter I of the Controlled Substances
Act (CSA) and the Federal Food, Drug, and Cosmetic Act (FDCA) meet the
requirements of the schedule specified in the notification with respect
to the specific drug or substance. 21 U.S.C. 811(d)(3). If such
requirements are not met by existing controls and the Secretary of the
HHS concurs in the scheduling decision, the Secretary shall recommend
to the Attorney General that he initiate proceedings for scheduling the
drug or substance under the appropriate schedule pursuant to 21 U.S.C.
811(a) and (b). 21 U.S.C. 811(d)(3)(B). Pursuant to 21 U.S.C.
811(a)(1), the Attorney General may, by rule, add to such a schedule or
transfer between such schedules any drug or other substance, if he
finds that such drug or other substance has a potential for abuse, and
makes with respect to such drug or other substance the findings
prescribed by 21 U.S.C. 812(b) for the schedule in which such drug is
to be placed. The Attorney General has delegated this scheduling
authority to the Administrator of the DEA (Administrator). 28 CFR
0.100.
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\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
Controlled Substances Act, with the concurrence of NIDA. 50 FR 9518
(March 8, 1985). The Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the authority to make
domestic drug scheduling recommendations. 58 FR 35460 (July 1,
1993).
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Background
Zipeprol, known chemically as 1-methoxy-3-[4-(2-methoxy-2-
phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol, is pharmacologically
an opioid drug with some hallucinogenic properties that has no approved
medical use in the United States.
In June 1994 and January 1995, the Food and Drug Administration
(FDA), on behalf of the Secretary of the HHS, published notices in the
Federal Register regarding zipeprol to comply with 21 U.S.C. 811(d)(2).
The 1994 notice requested information to be considered by the World
Health Organization (WHO) in preparing its scientific and medical
evaluation for zipeprol.\2\ The 1995 notice solicited public comment
regarding a recommendation by the WHO to impose international controls
on zipeprol.\3\ In
[[Page 28901]]
March 1995, the United Nations Commission on Narcotic Drugs (CND), on
the advice of the Director-General of the WHO, placed zipeprol in
Schedule II of the 1971 Convention.\4\
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\2\ FDA notice, International Drug Scheduling; Convention on
Psychotropic Substances; Certain Stimulant/Hallucinogenic Drugs and
Certain Nonbarbiturate Sedative Drugs, 59 FR 31639 (June 20, 1994).
\3\ FDA notice, International Drug Scheduling; Convention on
Psychotropic Substances; World Health Organization Scheduling
Recommendations for Seven Drug Substances, 60 FR 4169, 4173 (January
20, 1995).
\4\ United Nations Office on Drugs and Crime, CND. Decision 2
(XXXVIII). Inclusion of zipeprol in Schedule II of the Convention on
Psychotropic Substances of 1971. https://www.unodc.org/pdf/decisions/decision2_38.pdf (last retrieved October 3, 2018).
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As a party to the 1971 Convention, the United States is taking
action to place appropriate controls on zipeprol by scheduling it under
the CSA after determining that no existing legal controls under
subchapter I of the CSA and the FDCA meet the requirements of the
scheduling decision with respect to zipeprol. 21 U.S.C. 811(d)(3).
Specifically, DEA is proposing to place zipeprol in schedule I of the
CSA. Placing zipeprol in schedule I of the CSA would satisfy the United
States' international obligations as set forth in Article 2, paragraph
7(b) of the 1971 Convention, and as implemented by the CSA. 21 U.S.C.
811(d)(3).
Article 2, paragraph 7(b), of the 1971 Convention sets forth the
minimum requirements that the United States must meet when a substance
has been added to Schedule II of the 1971 Convention. Pursuant to the
1971 Convention, the United States must require licenses for the
manufacture, export and import, and distribution of zipeprol. This
license requirement is accomplished by the CSA's registration
requirement as set forth in 21 U.S.C. 822, 823, 957, 958, and in
accordance with 21 CFR parts 1301 and 1312. In addition, the United
States must adhere to specific export and import provisions set forth
in the 1971 Convention. This requirement is accomplished by the CSA's
export and import provisions established in 21 U.S.C. 952, 953, 957,
958, and in accordance with 21 CFR part 1312. Likewise, under Article
13, paragraphs 1 and 2, of the 1971 Convention, a party to the 1971
Convention may notify another party, through the Secretary-General of
the United Nations, that it prohibits the importation of a substance in
Schedule II, III, or IV of the Convention. If such notice is presented
to the United States, the United States shall take measures to ensure
that the named substance is not exported to the notifying country. This
requirement is also accomplished by the CSA's export provisions
mentioned above. Under Article 16, paragraph 4, of the 1971 Convention,
the United States is required to provide annual statistical reports to
the International Narcotics Control Board (INCB). Using INCB Form P,
the United States shall provide the following information: (1) In
regard to each substance in Schedule I and II of the 1971 Convention,
quantities manufactured, exported to and imported from each country or
region as well as stocks held by manufacturers; (2) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in the manufacture of exempt preparations; and (3) in regard to
each substance in Schedule II--IV of the 1971 Convention, quantities
used for the manufacture of non-psychotropic substances or products.
Lastly, under Article 2 of the 1971 Convention, the United States must
adopt measures in accordance with Article 22 to address violations of
any statutes or regulations that are adopted pursuant to its
obligations under the 1971 Convention. The United States complies with
this provision as persons acting outside the legal framework
established by the CSA are subject to administrative, civil, and/or
criminal action.
Proposed Determination To Schedule Zipeprol
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on
zipeprol and on April 3, 2009, submitted it to the Assistant Secretary
for Health of the HHS with a request for a scientific and medical
evaluation of available information and a scheduling recommendation for
zipeprol. On May 20, 2013, HHS provided to DEA a written scientific and
medical evaluation and scheduling recommendation entitled, ``Basis for
the Recommendation for Control of Zipeprol and Its Salts in Schedule I
of the Controlled Substances Act.'' Pursuant to 21 U.S.C. 811(b), this
document contained HHS' eight-factor analysis of zipeprol, along with
its recommendation that zipeprol be placed in schedule I of the CSA.
In response, DEA reviewed the scientific and medical evaluation and
scheduling recommendation provided by the HHS and all other relevant
data, and completed its own eight-factor review document pursuant to 21
U.S.C. 811(c). Since receiving the HHS recommendation, no additional
studies have been published in the scientific literature. Included
below is a brief summary of each factor as analyzed by HHS and DEA in
their respective eight-factor analyses, and as considered by DEA in its
proposed scheduling determination. Please note that both DEA and HHS
analyses are available in their entirety under ``Supporting Documents''
of the public docket for this proposed rule at http://www.regulations.gov under docket number ``DEA-477.''
1. The Drug's Actual or Relative Potential for Abuse: As reported
by HHS, there are numerous reports indicating that abuse of zipeprol
resulted in seizures, comas, amnesia, hallucinations, and death in
countries where zipeprol has been marketed as an antitussive. The
pharmacological effects of zipeprol are similar to opioids in schedule
II of the CSA such as morphine; however, zipeprol is a weak opioid
relative to morphine. Hallucinations, convulsions, and opioid-like
tolerance and dependence are observed in humans following zipeprol
intake. Zipeprol abuse is associated with psychological and physical
dependence. Abuse liability studies suggest that the primary motivation
for zipeprol abuse was reaching the opioid-like, hypnotic sedative
effects and euphoria associated with this drug.
2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: Zipeprol binds with low to moderate affinity to mu and kappa
opioid receptors, has a moderate affinity for sigma 1 receptors, and
has a strong affinity for sigma 2 receptors. Animal testing data in
monkeys, rats and mice show that zipeprol is self-administered. Acute
cardiovascular and respiratory toxicity was observed in animals
continuously infused with zipeprol. Published clinical reports have
indicated that euphoric effects are observed at doses ranging from 3-
to 10- fold higher than the therapeutic daily dose range (75-150 mg/
day). Generalized seizures were reported at relatively low doses (375
mg) but still higher than the therapeutic dose range.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: Zipeprol, also known as 1-methoxy-3-[4-(2-methoxy-2-
phenylethyl) piperazin-1-yl]-1-phenylpropan-2-ol, has a molecular
weight of 322.37 g/mol. Zipeprol is extensively metabolized in humans
into four major metabolites. Zipeprol is not expected to be detected in
urine with a normal pH. When urine pH rises above 6.2, unchanged
zipeprol is reabsorbed whereas under acidic urine conditions (pH Convention on Psychotropic Substances in 1995
(CND Dec. 38/2). Queries of DEA's System to Retrieve Information from
Drug Evidence (STRIDE)/STARLiMS \5\ and the National Forensic
Laboratory Information System (NFLIS) \6\ databases on October 3, 2018,
did not generate any reports of zipeprol, suggesting that it is not
trafficked in the United States.
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\5\ STRIDE is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from DEA,
other federal agencies, and law enforcement agencies. On October 1,
2014, STARLiMS replaced STRIDE as DEA laboratory drug evidence data
system of record.
\6\ NFLIS is a national drug forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by state and local forensic laboratories across
the country. The NFLIS participation rate, defined as the percentage
of the national drug caseload represented by laboratories that have
joined NFLIS, is over 97 percent. NFLIS includes drug chemistry
results from completed analyses only.
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5. The Scope, Duration, and Significance of Abuse: The lack of
abuse and overdose associated with zipeprol is most likely due to its
lack of availability for medical use in the United States.
6. What, if any, Risk There is to the Public Health: Currently in
the United States, zipeprol is not an FDA-approved drug, and there have
been no reports or epidemiological studies submitted to FDA regarding
its abuse. In countries where it was available for medical use,
zipeprol became a significant health problem. Based on the available
clinical data, zipeprol has the same risks to public health as schedule
I or schedule II substances. Such risks include deaths due to voluntary
or accidental acute intoxications and the potential for psychological
and physical dependence.
7. Its Psychic or Physiological Dependence Liability: Psychological
and physiological dependence is associated with zipeprol. Several
clinical studies examined and described physical dependence and
withdrawal effects associated with zipeprol abuse. Main signs of
zipeprol withdrawal include sweating, diarrhea, anxiety, insomnia,
dyspnea, yawning, and pain. The euphoric and hallucinogenic effects
associated with zipeprol and other opioid-like drugs serve as
reinforcers and can result in psychological dependence and are
supported by case studies with zipeprol abusers.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: DEA and HHS find that zipeprol is not
an immediate precursor of a substance already controlled under the CSA.
Conclusion: Based on consideration of the scientific and medical
evaluation and accompanying recommendation of HHS, and based on DEA's
consideration of its own eight-factor analysis, DEA finds that these
facts and all relevant data constitute substantial evidence of
potential for abuse of zipeprol. As such, DEA hereby proposes to
schedule zipeprol as a controlled substance under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary for Health of the HHS and
review of all available data, the Acting Administrator of the DEA
(Acting Administrator), pursuant to 21 U.S.C. 812(b)(1), finds that:
(1) Zipeprol has a high potential for abuse. Widespread reports of
zipeprol abuse have occurred in countries that have marketed zipeprol.
Zipeprol is self-administered in animals and clinical studies reported
that zipeprol abuse is related to its opioid, sedative, hallucinogenic,
and euphorigenic effects. Epidemiological reports on zipeprol,
worldwide, have indicated that adverse reactions (primarily seizures)
are caused by zipeprol abuse and dependence.
(2) There are no approved New Drug Applications for zipeprol and no
known therapeutic applications for zipeprol in the United States.\7\
Therefore, zipeprol has no currently accepted medical use in treatment
in the United States.
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\7\ Although there is no evidence suggesting that zipeprol has a
currently accepted medical use in treatment in the United States, it
bears noting that a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by
the FDA, to have a currently accepted medical use in treatment in
the United States, all of the following must be demonstrated:
i. the drug's chemistry must be known and reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled studies proving
efficacy;
iv. the drug must be accepted by qualified experts; and
v. the scientific evidence must be widely available.
57 FR 10499 (1992).
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(3) There is a lack of accepted safety for use of zipeprol under
medical supervision. Zipeprol was first approved and introduced as an
antitussive in France and Italy during the late 1970s. Following
several reports of abuse and overdosing from zipeprol, this drug was
withdrawn in the early to mid-1990s.
Based on these findings, the Acting Administrator concludes that
zipeprol warrants control in schedule I of the CSA. 21 U.S.C.
812(b)(1). More precisely, because of its opioid effects, and producing
opioid-like tolerance and dependence in humans, DEA is proposing to
place zipeprol in 21 CFR 1308.11(b) (the opiates category of schedule
I). As such, the proposed control of zipeprol includes the substance as
well as its isomers, esters, ethers, salts, and salts of isomers,
esters and ethers, whenever the existence of such isomers, esters,
ethers and salts is possible within the specific chemical designation.
Requirements for Handling Zipeprol
If this rule is finalized as proposed, zipeprol would be subject to
the CSA's schedule I regulatory controls and administrative, civil, and
criminal sanctions applicable to the manufacture, distribution, reverse
distribution, import, export, engagement in research, conduct of
instructional activities or chemical analysis with, and possession of
schedule I controlled substances, including the following:
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses)
zipeprol, or who desires to handle zipeprol, would need to be
registered with DEA to conduct such activities pursuant to 21 U.S.C.
822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312
as of the effective date of a final scheduling action. Any person who
currently handles zipeprol, and is not registered with DEA, would need
to submit an application for registration
[[Page 28903]]
and may not continue to handle zipeprol after the effective date of a
final scheduling action unless DEA has approved that application for
registration pursuant to 21 U.S.C. 822, 823, 957, 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 I registration would be required to surrender
all quantities of currently held zipeprol, or transfer all quantities
of currently held zipeprol to a person registered with DEA before the
effective date of a final scheduling action in accordance with all
applicable federal, state, local, and tribal laws. As of the effective
date of a final scheduling action, zipeprol would be required to be
disposed of in accordance with 21 CFR part 1317, in addition to all
other applicable federal, state, local, and tribal laws.
3. Security. Zipeprol would be subject to schedule I security
requirements and would need to be handled and stored pursuant to 21
U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71-1301.93 as of
the effective date of a final scheduling action.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of zipeprol would need to be in compliance with
21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302 as
of the effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to
manufacture zipeprol in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303 as of the effective
date of a final scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of
zipeprol on the effective date of a final scheduling action would be
required to take an inventory of zipeprol on hand at that time,
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and (d).
Any person who becomes registered with DEA on or after the
effective date of the final scheduling action would be required to take
an initial inventory of all stocks of controlled substances (including
zipeprol) on hand on the date the registrant first engages in the
handling of controlled substances, pursuant to 21 U.S.C. 827 and 958,
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant would be required
to take an inventory of all controlled substances (including zipeprol)
on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant would be required to
maintain records and submit reports pursuant to 21 U.S.C. 827 and 958,
and in accordance with 21 CFR parts 1304, 1312, and 1317 as of the
effective date of a final scheduling action. Manufacturers and
distributors would be required to submit reports regarding zipeprol to
the Automation of Reports and Consolidated Order System pursuant to 21
U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of the
effective date of a final scheduling action.
8. Order Forms. Every DEA registrant who distributes zipeprol would
be required to comply with order form requirements, pursuant to 21
U.S.C. 828, and in accordance with 21 CFR part 1305 as of the effective
date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of
zipeprol would need to be in compliance with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR part 1312 as of the effective
date of a final scheduling action.
10. Liability. Any activity involving zipeprol not authorized by,
or in violation of, the CSA or its implementing regulations, would be
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
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), this proposed 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 rulemaking is not an Executive Order 13771 regulatory action
because this rule is not significant under Executive Order 12866.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform, 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 proposed rulemaking does not have federalism implications
warranting the application of Executive Order 13132. The proposed rule
does not have substantial direct effects on the States, on the
relationship between the national government and the States, or the
distribution of power and responsibilities among the various levels of
government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed 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.
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).
Regulatory Flexibility Act
The Acting Administrator, in accordance with the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed
rule, and by approving it, certifies that it will not have a
significant economic impact on a substantial number of small entities.
DEA proposes placing the substance zipeprol (chemical name: 1-
methoxy-3-[4-(2-methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-
ol), including its isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers, whenever the existence of such isomers,
esters, ethers and salts is possible, in schedule I of the CSA. This
action is being taken to enable the United States to meet its
obligations under the 1971 Convention on Psychotropic Substances. If
finalized, this action would impose the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical
[[Page 28904]]
analysis with, or possess), or propose to handle zipeprol.
According to HHS, zipeprol has a high potential for abuse, has no
currently accepted medical use in treatment in the United States, and
lacks accepted safety for use under medical supervision. DEA's research
confirms that there is no commercial market for zipeprol in the United
States. Additionally, queries of DEA's STRIDE/STARLiMS and the NFLIS
databases on October 3, 2018, did not generate any reports of zipeprol,
suggesting that it is not trafficked in the United States. Therefore,
DEA estimates that no United States entity currently handles zipeprol
and does not expect any United States entity to handle zipeprol in the
foreseeable future. DEA concludes that no United States entity would be
affected by this rule if finalized. As such, the proposed rule will not
have a significant effect on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the ``Regulatory
Flexibility Act'' section above, DEA has determined and certifies
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C.
1501 et seq.), 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 provisions of the UMRA of 1995.
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, 21 CFR part 1308 is proposed to be
amended to read 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), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11, add paragraph (b)(71) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
(71) Zipeprol.................................................. 9873
* * * * *
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-09592 Filed 5-13-20; 8:45 am]
BILLING CODE 4410-09-P
