[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.

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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