[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Proposed Rules]
[Pages 31521-31525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13455]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-415]


Schedules of Controlled Substances: Removal of [\123\I]Ioflupane 
From Schedule II of the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration proposes to remove 
[\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. [\123\I]Ioflupane is, 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 would remove 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: Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Electronic comments must be 
submitted, and written comments must be postmarked, on or before July 
6, 2015. 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, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811)'', may file a request for 
hearing or waiver of participation pursuant to 21 CFR 1308.44 and in 
accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as 
applicable. Requests for hearing, notices of appearance, and waivers of 
an opportunity for a hearing or to participate in a hearing must be 
received on or before July 6, 2015.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-415'' on all correspondence, including any 
attachments.
     Electronic comments: The DEA encourages that all comments 
be submitted through the Federal eRulemaking Portal, which provides the 
ability to type short comments directly into the comment field on the 
Web page or to 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 an 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a comment in lieu of submitting a comment online, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152.
     Hearing requests: All requests for hearing must be sent 
to: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion

[[Page 31522]]

Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

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 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 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 
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 
online 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, Notice of Appearance at 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, and 21 CFR part 
1316 subpart D. In accordance with 21 CFR 1308.44 (a)-(c), requests for 
hearing, notices of appearance, and waivers of an opportunity for a 
hearing or to participate in a hearing may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).'' 21 CFR 1300.01. Such requests or notices must 
conform to the requirements of 21 CFR 1308.44 (a) or (b), and 1316.47 
or 1316.48, as applicable, and include a statement of the interest of 
the person in the proceeding and the objections or issues, if any, 
concerning which the person desires to be heard. Any waiver must 
conform to the requirements of 21 CFR 1308.44(c) and 1316.49, including 
a written statement regarding the interested person's position on the 
matters of fact and law involved in any hearing.

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, but they 
are collectively referred to as the ``Controlled Substances Act'' or 
the ``CSA'' for the purposes of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. 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 drug or other 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 [or she] 
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 his or her own motion, (2) at 
the request of the Secretary of the Department of Health and Human 
Services,\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 an evaluation of 
all relevant data by the HHS and the DEA. This action would remove 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

Background

    DaTscan is a single-dose, injectable diagnostic radiopharmaceutical 
for use in hospital settings with specialized gamma cameras. It was 
developed as a diagnostic tool for visualization of dopamine 
transporters (DAT) by using single photon emission computed tomography 
(SPECT) brain imaging. 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). [\123\I]Ioflupane is the 
active pharmaceutical ingredient (API) in DaTscan and it is a new 
molecular entity. However, [\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).

[[Page 31523]]

Each vial of DaTscan contains 0.325 micrograms ([mu]g) of 
[\123\I]ioflupane per 2.5 milliliters (ml). The average and maximum 
amounts of non-radioactive ioflupane in each DaTscan vial are estimated 
to be between 0.21 [mu]g and 0.31 [mu]g. Although ioflupane, the non-
radiolabeled API of the drug product DaTscan, binds to DAT and elicits 
behavioral effects similar to that of cocaine, based upon the available 
information and DaTscan's unique formulation-specific properties, 
DaTscan itself presents no practical possibility of abuse, misuse, 
diversion or clandestine production.

Proposed Determination To Decontrol [\123\I]Ioflupane

    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. 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.
    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. By 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 
diagnostic products containing [\123\I]ioflupane for both the HHS and 
DEA eight-factor analysis. Included below is a brief summary of each 
factor as analyzed by the HHS and the DEA, and as considered by the DEA 
in this proposed rule to remove [\123\I]ioflupane from the schedules of 
the CSA. Please note that both the DEA and HHS analyses and other 
relevant documents are available in their entirety under ``Supporting 
and Related Material'' of the public docket for this rule at http://www.regulations.gov under docket number DEA-415.

1. The Drug's Actual or Relative Potential for Abuse

    According to HHS and the DEA, there are no data demonstrating that 
individuals are administering quantities of DaTscan sufficient to 
create a hazard to their health or to the safety of other individuals 
or to the community. In clinical studies, DaTscan, due to its low 
concentrations of [\123\I]ioflupane lacked, central nervous activity 
(CNS) in humans.
    According to HHS review of Sponsor's calculation regarding 
psychoactive doses of DaTscan, approximately 6,000 vials of DaTscan 
would be required to produce a subjective ``high'' in humans from 
exposure to [\123\I]ioflupane in this product. The volume of 6,000 
vials is about 15 liters (L) of fluid, an amount that would be lethal 
if administered intravenously (i.v.). The short half-life of DaTscan 
(due to its radioactive decay) will prevent its extended storage for 
future use at the manufacturing, distributing, or radiopharmacy site; 
thereby limiting the amount available for diversion. It is highly 
unlikely that individuals will administer DaTscan on their own 
initiative since DaTscan has a very dilute and small dose of 
[\123\I]ioflupane, and possesses radioactivity. As a result, DaTscan 
will not have significant capability of creating hazards to the health 
of the user or to the safety of the community.

2. Scientific Evidence of the Drug's Pharmacological Effects, If Known

    DaTscan blocks monoamine transporters, such as DAT and other 
monoamine transporters such as serotonin transporters. Ioflupane, the 
active pharmaceutical ingredient in DaTscan, was demonstrated to have 
an affinity to DAT that was approximately 10- and 100-fold greater than 
cocaine in rodent brain homogenates or in cells transfected with rat 
DAT (Neumeyer et al., 1996; Okada et al., 1998; Scheffel et al., 1997). 
As reported by HHS, non-radiolabeled ioflupane at doses >0.1 mg/kg, 
i.v. was able to substitute for cocaine in cocaine-trained rats (10 mg/
kg, intraperitoneal administration) using a drug discrimination 
protocol which is predictive of subjective behavioral effects in 
humans.
    HHS reviewed data from eight human clinical trials involving 942 
subjects and nine years of post-approval use in Europe and found that 
there was not any clinical evidence of pharmacological effects 
resulting from DaTscan administration. The maximum dose of 
[\123\I]ioflupane in DaTscan that is administered to the patient prior 
to undergoing an imaging procedure is 0.325 [mu]g (0.13 [mu]g/ml). HHS 
extrapolated from the locomotor study and drug discrimination study on 
non-radiolabeled ioflupane and estimated that the lowest active dose of 
DaTscan for a 60 kg (132.2 lb) human to achieve a pharmacologic effect 
would be 288 [mu]g or 886 vials of DaTscan. In addition, the 
recreational dose of DaTscan is estimated as 1921 [micro]g or 5,910 
vials.
    Although [\123\I]ioflupane would be expected to have a 
pharmacological profile nearly identical to its non-radioactive form, 
its unique properties (i.e., manufacturing limits and radioactive 
properties) pose practical barriers to its abuse. Furthermore, 
according to HHS, the amount of [\123\I]ioflupane in DaTscan is 
significantly less than the amounts of ioflupane used to elicit the 
pharmacological response in preclinical studies with this compound.

3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance

    The international non-proprietary name of [\123\I]ioflupane is 
methyl(1R, 2S, 3S, 5S)-8-(3-fluoropropyl)-3-(4-[\123\I]iodophenyl)-8-
azabicyclo[3,2,1] octane-2-carboxylate. The molecular formula of 
[\123\I]ioflupane is 
C18H23F[\123\I]NO2 and the molecular 
weight is 427.28 g/mol. [\123\I]Ioflupane is a clear, colorless 
solution and is only present in a solution of ethanol and sodium 
acetate buffer. Non-radioactive ioflupane is a white solid with a 
melting point of 83 [deg]C to 87 [deg]C and soluble in water (less than 
0.1 mg/ml), sodium acetate buffer (pH 7.4; 16 mg/ml), and ethanol (27 
mg/ml).
    HHS states that meaningful extraction of [\123\I]ioflupane from 
DaTscan would be impossible due to its limited production and 
availability and because extraction is technically complex and would 
require advanced equipment not available to the general public. 
Importantly, if extraction of ioflupane from [\123\I]ioflupane is 
accomplished, the ioflupane would be subject to schedule II controls 
under the CSA. According to HHS, the retrosynthesis of DaTscan to 
cocaine and ecgonine would be difficult. Production of DaTscan is 
technically complex as it requires specialized equipment, facilities, 
scientific training and expertise, making clandestine manufacturing 
particularly difficult. HHS indicated that the non-radiolabeled 
precursors needed for the synthesis of [\123\I]ioflupane (and

[[Page 31524]]

DaTscan) are abusable. In addition, the non-radiolabeled precursors 
derived from cocaine or ecgonine are also schedule II controlled 
substances. However, even if an individual obtained the precursors, it 
is impractical and highly unlikely that they would synthesize the 
abusable compound into a radiolabeled formulation with a limited 
storage life that is not desired by drug users.
    On January 14, 2011, FDA approved the NDA for DaTscan with the 
indication of visualizing striatal dopamine transporters in the brains 
of adult patients with suspected Parkinsonian syndromes using SPECT 
imaging. As such, any FDA-approved diagnostic product containing 
[\123\I]ioflupane has a currently accepted medical use in the United 
States.

4. Its History and Current Pattern of Abuse

    According to HHS, there have been no reports of abuse of 
[\123\I]ioflupane. Over 168,000 doses of DaTscan have been administered 
to patients worldwide, and no pharmacological effects have been noted. 
Further, according to HHS, no single user has received more than 10 
vials of DaTscan in a single day.

5. The Scope, Duration, and Significance of Abuse

    There have been no reports of abuse of [\123\I]ioflupane. According 
to the National Forensic Laboratory Information System (NFLIS) \2\ and 
the System to Retrieve Information from Drug Evidence (STRIDE) \3\, 
there have been no reports of [\123\I]ioflupane seizures during the 
time period January 2010 to February 2015.
---------------------------------------------------------------------------

    \2\ NFLIS is a program of the DEA that collects drug 
identification results from drug cases analyzed by other Federal, 
State, and local forensic laboratories. NFLIS was queried on April 
16, 2015.
    \3\ STRIDE collected the results of drug evidence analyzed at 
DEA laboratories and reflects evidence submitted by the DEA, other 
Federal law enforcement agencies, and some local law enforcement 
agencies. STRIDE data was queried by date submitted to Federal 
forensic laboratories. On October 1, 2014, STARLiMS replaced STRIDE 
as the DEA laboratory drug evidence data system of record.
---------------------------------------------------------------------------

6. What, If Any, Risk There Is to the Public Health

    According to the HHS, because of the limited amounts of 
manufactured DaTscan, the low concentration of [\123\I]ioflupane per 
vial, and the existence of stringent regulatory controls (controls 
other than those imposed by the CSA and its implementing regulations, 
including regulation by the United States Nuclear Regulatory Commission 
under 10 CFR part 35 and/or by states) \4\ on the manufacturing and 
handling of DaTscan, abuse of DaTscan is not possible as a practical 
matter. Thus, there is little to no practical risk to public health 
from DaTscan abuse.
---------------------------------------------------------------------------

    \4\ There are Federal and state laws and regulations which limit 
the public's exposure to radioactivity in radiopharmaceuticals, thus 
limiting the potential for toxicity imposed on the public.
---------------------------------------------------------------------------

7. Its Psychic or Physiological Dependence Liability

    As reviewed by HHS, non-radiolabeled ioflupane has cocaine-like 
properties. In a drug discrimination study in cocaine-trained rats, 
non-radiolabeled ioflupane produced cocaine-appropriate responding, 
which suggests that non-radiolabeled ioflupane may produce cocaine-like 
subjective effects in humans (HHS, 2010).
    However, the available evidence suggests that there is no psychic 
or physiological dependence potential of FDA-approved diagnostic 
products containing [\123\I]ioflupane. The psychic or physiological 
dependence potential of FDA-approved diagnostic products is currently 
expected to be very limited due to the low exposure concentration of 
[\123\I]ioflupane, the aforementioned low potential for abuse (see 
Factor 1) and the extremely high and lethal quantities needed to 
achieve a subjective ``high.''

8. Whether the Substance Is an Immediate Precursor of a Substance 
Already Controlled Under the CSA

    [\123\I]Ioflupane 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 the HHS and based on the DEA's 
consideration of its own eight-factor analysis, the DEA finds that the 
facts and all available and relevant data demonstrate that 
[\123\I]ioflupane does not possess abuse or dependence potential. 
Accordingly, the DEA finds that [\123\I]ioflupane does not meet the 
requirements for inclusion in any schedule and should be removed from 
control under the CSA.

Findings for Schedule Placement Pursuant to 21 U.S.C. 812(b)

    The CSA outlines the findings required to place a drug or other 
substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 
812(b). The Assistant Secretary for Health of the HHS recommended 
removal of ``FDA approved products containing [\123\I]ioflupane from 
schedule II of the'' CSA. However, because the DEA finds no basis to 
remove only FDA approved products containing [\123\I]ioflupane from the 
schedules, this action proposes to remove the substance 
[\123\I]ioflupane from the CSA schedules. Historically, when new 
molecular entities are removed from control, the substance itself is 
removed from control rather than the specific FDA-approved drug product 
(e.g., naloxegol, 80 FR 3468; naloxone, 39 FR 44392). As summarized 
above, the data currently support removal of substances that contain 
[\123\I]ioflupane, primarily because [\123\I]ioflupane itself has a 
lethal radioactive barrier, and its manufacturing process is highly 
regulated and technically complex, thus making abuse highly unlikely.
    After consideration of the analyses and recommendation of the 
Assistant Secretary for Health of the HHS and review of all relevant 
and available data, the Administrator of the DEA, pursuant to 21 U.S.C. 
812(b)(5), finds that:
    (1) [\123\I]Ioflupane has no comparable potential for abuse 
relative to substances in Schedule V.
    (2) [\123\I]Ioflupane has a currently accepted medical use in 
treatment in the United States. FDA approved the New Drug Application 
for DaTscan on January 14, 2011, with the indication of visualizing 
striatal dopamine transporters in the brains of adult patients with 
suspected Parkinsonian syndromes using SPECT imaging.
    (3) [\123\I]Ioflupane is not abusable, therefore, its use is not 
likely to lead to physical or psychological dependence.
    Based on these findings, the Administrator of the DEA concludes 
that [\123\I]ioflupane does not warrant control under the CSA.

Effect on Other Rulemakings

    On November 25, 2014, DEA published an interim final rule waiving 
the requirement of DEA registration for certain entities that are 
authorized under other federal or state authorities to administer 
DaTscan. 79 FR 70085. If finalized, this proposal to remove 
[\123\I]ioflupane from the schedules of controlled substances would 
make such waivers unnecessary. Therefore, if this action is finalized, 
DEA intends to withdraw the regulations established through that 
interim final rule.

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

[[Page 31525]]

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 and for removing a drug or substance from the schedules 
of controlled substances. 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 proposed 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 will remove 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.
    If finalized, the proposed rule will affect all persons who would 
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 new 
molecular entities, the DEA is unable to determine the number of 
entities and small entities which might 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 
proposed rule, a qualitative analysis indicates that, if finalized, 
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 estimates 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 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

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, 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.

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.

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), 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: May 6, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-13455 Filed 6-2-15; 8:45 am]
 BILLING CODE 4410-09-P