[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Rules and Regulations]
[Pages 54715-54718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22919]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-415F]
Schedules of Controlled Substances: Removal of
[123I]Ioflupane From Schedule II of the Controlled
Substances Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Administrator of the
Drug Enforcement Administration removes [\123\I]ioflupane from the
schedules of the Controlled Substances Act. This action is pursuant to
the Controlled Substances Act which requires that such actions be made
on the record after an opportunity for a hearing through formal
rulemaking. Prior to the effective date of this rule, [\123\I]ioflupane
was, by definition, a schedule II controlled substance because it is
derived from cocaine via ecgonine, both of which are schedule II
controlled substances. This action removes the regulatory controls and
administrative, civil, and criminal sanctions applicable to controlled
substances, including those specific to schedule II controlled
substances, on persons who handle (manufacture, distribute, reverse
distribute, dispense, conduct research, import, export, or conduct
chemical analysis) or propose to handle [\123\I]ioflupane.
DATES: Effective Date: September 11, 2015.
FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of
Diversion Control, Drug Enforcement Administration; Mailing Address:
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202)
598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purpose of this action. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), chapter II.
[[Page 54716]]
The CSA and its implementing regulations are designed to prevent,
detect, and eliminate the diversion of controlled substances and listed
chemicals into the illicit market while ensuring an adequate supply is
available for the legitimate medical, scientific, research, and
industrial needs of the United States. Controlled substances have the
potential for abuse and dependence and are controlled to protect the
public health and safety.
Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the substance may cause. 21 U.S.C. 812. The initial
schedules of controlled substances established by Congress are found at
21 U.S.C. 812(c), and the current list of scheduled substances is
published at 21 CFR part 1308.
Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule,
``remove any drug or other substance from the schedules if he finds
that the drug or other substance does not meet the requirements for
inclusion in any schedule.'' The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
DEA, 28 CFR 0.100.
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (1) on her own motion, (2) at the
request of the Secretary of the Department of Health and Human Services
(HHS),\1\ or (3) on the petition of any interested party. 21 U.S.C.
811(a). This action was initiated at the request of the Assistant
Secretary for Health of the HHS, and is supported by, inter alia, a
recommendation from the Assistant Secretary of the HHS and an
evaluation of all relevant data by the DEA. This action removes the
regulatory controls and administrative, civil, and criminal sanctions
applicable to controlled substances, including those specific to
schedule II controlled substances, on persons who handle or propose to
handle [\123\I]ioflupane.
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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 the HHS
in carrying out the Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 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
[\123\I]Ioflupane is, by definition, a schedule II controlled
substance because it is derived from cocaine, a schedule II substance,
via ecgonine (a schedule II substance). See 21 U.S.C. 812(c), Schedule
II, (a)(4). [\123\I]Ioflupane is the active pharmaceutical ingredient
(API) in the drug product DaTscan and it is a new molecular entity. The
Food and Drug Administration (FDA) approved the New Drug Application
(NDA) for DaTscan on January 14, 2011, for the indication of
visualizing striatal DATs in the brains of adult patients with
suspected Parkinsonian syndromes (PS).
DEA and HHS Eight Factor Analyses
Pursuant to 21 U.S.C. 811(b), (c), and (f), the HHS recommended to
the DEA on November 2, 2010, that FDA-approved products containing
[\123\I]ioflupane be removed from schedule II of the CSA. The HHS
provided to DEA a scientific and medical evaluation document entitled
``Basis for the Recommendation to Remove FDA Approved Products
Containing [\123\I]Ioflupane from Schedule II of the Controlled
Substances Act (CSA).'' Pursuant to 21 U.S.C. 811(b), this document
contained an eight-factor analysis of FDA-approved products containing
[\123\I]ioflupane, along with the HHS's recommendation to remove FDA-
approved products containing [\123\I]ioflupane from the schedules of
the CSA. The HHS later clarified to DEA that its November 2, 2010,
recommendation also supports the decontrol of the substance
[\123\I]ioflupane.\2\
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\2\ Letter from Karen B. DeSalvo, Acting Assistant Secretary for
Health, HHS to John J. Riley, Acting Deputy Administrator, DEA (Aug.
19, 2015).
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In response, the DEA reviewed the scientific and medical evaluation
and scheduling recommendation provided by the HHS, and all other
relevant data. The DEA and HHS collaborated further regarding the
available information. In a letter dated February 2, 2015, the HHS
provided detailed responses to specific inquiries from the DEA
(submitted by letter dated September 16, 2014). Upon further review of
all of the available information, the DEA completed its own eight-
factor review document on FDA-approved diagnostic products containing
[\123\I]ioflupane (currently, only DaTscan) pursuant to 21 U.S.C.
811(c).
The FDA-approved diagnostic product, DaTscan, was used as the basis
for the scientific and medical evaluation of FDA-approved products
containing [\123\I]ioflupane for both the HHS and DEA eight-factor
analysis. Both the DEA and HHS analyses and other relevant documents
are available in their entirety in the public docket of this rule
(Docket Number DEA-415F) at http://www.regulations.gov under
``Supporting and Related Material.''
Determination To Decontrol [\123\I]ioflupane
After a review of the available data, including the scientific and
medical evaluation and recommendation, the Administrator of the DEA
published in the Federal Register a notice of proposed rulemaking
(NPRM) entitled ``Schedules of Controlled Substances: Removal of
[\123\I]Ioflupane from Schedule II of the Controlled Substances Act''
which proposed removal of [\123\I]ioflupane from the schedules of the
CSA. 80 FR 31521, June 3, 2015. The proposed rule provided an
opportunity for interested persons to file a request for a hearing in
accordance with DEA regulations by July 6, 2015.
No requests for such a hearing were received by the DEA. The NPRM
also provided an opportunity for interested persons to submit written
comments on the proposal on or before July 6, 2015.
Comments Received
The DEA received nine comments on the proposed rule to decontrol
[\123\I]ioflupane. All commenters supported the decontrol of
[\123\I]ioflupane.
Commenters in support of decontrolling [\123\I]ioflupane included
an international medical society for neurology; an association of
industry members that manufacture radiopharmaceuticals; a professional
organization representing radiologists, radiation oncologists,
interventional radiologists, nuclear medicine physicians, and medical
physicists; an advocacy group for the Parkinson's community; a trade
association representing medical imaging, radiotherapy and
radiopharmaceutical manufacturers; the sponsor of the drug product
containing [\123\I]ioflupane; a physician; a health services company;
and a private citizen, all of whom expressed support for the DEA's
proposal to decontrol [\123\I]ioflupane. Some commenters also stated
that the proposal would improve patient access to an important
diagnostic pharmaceutical and reduce the burden on providers and
nuclear pharmacies.
The DEA appreciates the comments in support of this rulemaking.
Effective Date of the Rule
Generally, DEA scheduling actions are effective 30 days from the
date of
[[Page 54717]]
publication of the final rule in the Federal Register. 21 CFR 1308.45;
see also 5 U.S.C. 553(d). In this instance, and in accordance with 21
CFR 1308.45, the DEA finds that the conditions of public health or
safety necessitate an earlier effective date, i.e., the date of
publication in the Federal Register. An earlier effective date would
allow specialized members of the healthcare community to readily
utilize this substance as a component of an important diagnostic tool,
DaTscan. DaTscan, which contains [\123\I]ioflupane, is used in
differentiating essential tremors from tremors due to PS, (idiopathic
Parkinson's disease, multiple system atrophy, and progressive
supranuclear palsy), and can help healthcare professionals provide more
accurate diagnoses. This earlier effective date will allow patients to
receive, without delay, important diagnostic testing that is critical
to their health and treatment. These findings, coupled with the fact
that this is an action for decontrol, indicate that conditions of
public health necessitate an immediate effective date upon publication
in the Federal Register.
The DEA also notes that its decision to make this rule effective
upon publication aligns with the exceptions to the 30-day effective
date requirement of the Administrative Procedure Act (APA). One of the
APA's exceptions to the 30-day effective date is for a substantive rule
granting or recognizing an exemption or which relieves a restriction. 5
U.S.C. 553(d)(3).
Scheduling Conclusion
Based on consideration of all comments, the scientific and medical
evaluation and accompanying recommendation and clarification from the
HHS, and based on the DEA's consideration of its own eight-factor
analysis, the Administrator finds that these facts and all relevant
data demonstrate that [\123\I]ioflupane does not meet the requirements
for inclusion in any schedule, and will be removed from control under
the CSA.
Regulatory Analyses
Executive Orders 12866 and 15363
In accordance with 21 U.S.C. 811(a), this scheduling action is
subject to formal rulemaking procedures done ``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 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.
Executive Order 12988
This 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
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 Federal Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175
This rule does not have tribal implications warranting the
application of Executive Order 13175. This rule 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 Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving
it certifies that it will not have a significant economic impact on a
substantial number of small entities. The purpose of this rule is to
remove [\123\I]ioflupane from the list of schedules of the CSA. This
action removes regulatory controls and administrative, civil, and
criminal sanctions applicable to controlled substances for handlers and
proposed handlers of [\123\I]ioflupane. Accordingly, it has the
potential for some economic impact in the form of cost savings.
This rule will affect all persons who handle, or propose to handle,
[\123\I]ioflupane. Due to the wide variety of unidentifiable and
unquantifiable variables that potentially could influence the
distribution and administration rates of radiopharmaceutical
substances, the DEA is unable to determine the number of entities and
small entities which might handle [\123\I]ioflupane. In other instances
where a controlled pharmaceutical drug is removed from the schedules of
the CSA, the DEA is able to quantify the estimated number of affected
entities and small entities because the handling of the drug is
expected to be limited to DEA registrants even after removal from the
schedules. In such instances, the DEA's knowledge of its registrant
population forms the basis for estimating the number of affected
entities and small entities. However, [\123\I]ioflupane is expected to
be handled by persons who hold DEA registrations regardless of whether
this rule is promulgated (e.g., hospital radiopharmacies) and by
persons who are not currently registered with the DEA to handle
controlled substances (e.g., diagnostic clinics and imaging centers
that do not routinely handle controlled substances). The DEA does not
have a reliable basis to estimate the number of non-registrants who
plan to handle [\123\I]ioflupane.
Although the DEA does not have a reliable basis to estimate the
number of affected entities and quantify the economic impact of this
final rule, a qualitative analysis indicates that this rule is likely
to result in some cost savings for the healthcare industry. The
affected entities will continue to meet existing Federal and/or state
requirements applicable to those who handle radiopharmaceutical
substances, including licensure, security, recordkeeping, and reporting
requirements, which in many cases are more stringent than the DEA's
requirements. However, the DEA believes cost savings will be realized
from the removal of the administrative, civil, and criminal sanctions
for those entities handling or proposing to handle [\123\I]ioflupane,
in the form of saved DEA registration fees, and the elimination of
additional physical security, recordkeeping, and reporting
requirements.
Because of these facts, this rule will not result in a significant
economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
The DEA has determined and certifies pursuant to the Unfunded
Mandates Reform Act of 1995 (UMRA), 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 for
inflation) in any one year . . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under
provisions of UMRA.
[[Page 54718]]
Paperwork Reduction Act
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act, 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 section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act (CRA)). 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 United States-based
companies to compete with foreign-based companies in domestic and
export markets. However, pursuant to the CRA, the DEA has submitted a
copy of this 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, 21 CFR part 1308 is 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), unless otherwise noted.
0
2. In Sec. 1308.12, revise paragraph (b)(4) to read as follows:
Sec. 1308.12 Schedule II.
* * * * *
(b) * * *
(4) Coca leaves (9040) and any salt, compound, derivative or
preparation of coca leaves (including cocaine (9041) and ecgonine
(9180) and their salts, isomers, derivatives and salts of isomers and
derivatives), and any salt, compound, derivative, or preparation
thereof which is chemically equivalent or identical with any of these
substances, except that the substances shall not include:
(i) Decocainized coca leaves or extraction of coca leaves, which
extractions do not contain cocaine or ecgonine; or
(ii) [\123\I]ioflupane.
* * * * *
Dated: September 4, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-22919 Filed 9-10-15; 8:45 am]
BILLING CODE 4410-09-P