80 FR 54715 - Schedules of Controlled Substances: Removal of [123
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 176 (September 11, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 176 (September 11, 2015)
| Page Range | 54715-54718 | |
| FR Document | 2015-22919 |
[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)] [Rules and Regulations] [Pages 54715-54718] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22919] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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 [\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\ --------------------------------------------------------------------------- \2\ Letter from Karen B. DeSalvo, Acting Assistant Secretary for Health, HHS to John J. Riley, Acting Deputy Administrator, DEA (Aug. 19, 2015). --------------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Rules and Regulations 54715
not contain adequate or appropriate 1. Electronic Engine Control DEPARTMENT OF JUSTICE
safety standards for this design feature.
Maintaining a structured assessment to a. For electronic engine control Drug Enforcement Administration
determine potential installation issues system installations, it must be
mitigates the concern that the addition established that no single failure or 21 CFR Part 1308
of a full authority engine controller does malfunction or probable combinations
[Docket No. DEA–415F]
not produce a failure condition not of failures of Electronic Engine Control
previously considered. (EEC) system components will have an Schedules of Controlled Substances:
effect on the system, as installed in the Removal of [123I]Ioflupane From
Applicability
airplane, that causes the Loss of Thrust Schedule II of the Controlled
The special conditions are applicable Control (LOTC)/Loss of Power Control Substances Act
to the KC–100. Should Korea Aerospace (LOPC) probability of the system to
exceed those allowed in part 33 AGENCY: Drug Enforcement
Industries, Ltd., apply at a later date for
Administration, Department of Justice.
a change to the type certificate to certification.
include another model incorporating the ACTION: Final rule.
b. EEC system installations must be
same novel or unusual design feature, evaluated for environmental and SUMMARY: With the issuance of this final
the special conditions would also apply atmospheric conditions, including rule, the Administrator of the Drug
to that model as well. lightning. The EEC system lightning and Enforcement Administration removes
Conclusion high intensity radiated frequency effects [123I]ioflupane from the schedules of the
that result during an LOTC/LOPC Controlled Substances Act. This action
This action affects only certain novel should be considered catastrophic. is pursuant to the Controlled Substances
or unusual design features on the KC– Act which requires that such actions be
100. It is not a rule of general c. The components of the installation
made on the record after an opportunity
applicability and affects only the must be constructed, arranged, and
for a hearing through formal
applicant who applied to the FAA for installed so as to ensure their continued
rulemaking. Prior to the effective date of
approval of these features on the safe operation between normal this rule, [123I]ioflupane was, by
airplane. inspections or overhauls. definition, a schedule II controlled
The substance of these special d. Functions incorporated into any substance because it is derived from
conditions has been subjected to the EEC that make it part of any equipment, cocaine via ecgonine, both of which are
notice and comment period in several system or installation having functions schedule II controlled substances. This
prior instances and has been derived beyond that of basic engine control, and action removes the regulatory controls
without substantive change from those may also introduce system failures and and administrative, civil, and criminal
previously issued. It is unlikely that malfunctions, are not exempt from sanctions applicable to controlled
prior public comment would result in a § 23.1309 and must be shown to meet substances, including those specific to
significant change from the substance part 23 levels of safety as derived from schedule II controlled substances, on
contained herein. Therefore, notice and § 23.1309. Part 33 certification data, if persons who handle (manufacture,
opportunity for prior public comment applicable, may be used to show distribute, reverse distribute, dispense,
hereon are unnecessary and the FAA compliance with any part 23 conduct research, import, export, or
finds good cause, in accordance with 5 requirements. If part 33 data is to be conduct chemical analysis) or propose
U.S. Code §§ 553(b)(3)(B) and 553(d)(3), used to substantiate compliance with to handle [123I]ioflupane.
making these special conditions part 23 requirements, then the part 23 DATES: Effective Date: September 11,
effective upon issuance. The FAA is 2015.
applicant must be able to provide this
requesting comments to allow interested
data for their showing of compliance. FOR FURTHER INFORMATION CONTACT: John
persons to submit views that may not
Note: The term ‘‘probable’’ in the context R. Scherbenske, Office of Diversion
have been submitted in response to the
of ‘‘probable combination of failures’’ does Control, Drug Enforcement
prior opportunities for comment
not have the same meaning as in AC Administration; Mailing Address: 8701
described above.
23.13091D. The term ‘‘probable’’ in Morrissette Drive, Springfield, Virginia
List of Subjects in 14 CFR Part 23 ‘‘probable combination of failures’’ means 22152; Telephone: (202) 598–6812.
‘‘foreseeable,’’ or not ‘‘extremely SUPPLEMENTARY INFORMATION:
Aircraft, Aviation safety, Signs and
symbols. improbable,’’ as referenced in AC 23.1309–
Legal Authority
1D.
Citation The Drug Enforcement
Issued in Kansas City, Missouri on August Administration (DEA) implements and
The authority citation for these 28, 2015. enforces titles II and III of the
special conditions is as follows: Earl Lawrence, Comprehensive Drug Abuse Prevention
Authority: 49 U.S.C. 106(g), 40113 and Manager, Small Airplane Directorate, Aircraft and Control Act of 1970, as amended. 21
44701; 14 CFR 21.16 and 21.17; and 14 CFR Certification Service. U.S.C. 801–971. Titles II and III are
11.38 and 11.19. referred to as the ‘‘Controlled
[FR Doc. 2015–22872 Filed 9–10–15; 8:45 am]
The Special Conditions Substances Act’’ and the ‘‘Controlled
BILLING CODE 4910–13–P
Substances Import and Export Act,’’
Accordingly, pursuant to the respectively, and are collectively
rmajette on DSK7SPTVN1PROD with RULES
authority delegated to me by the referred to as the ‘‘Controlled
Administrator, the following special Substances Act’’ or the ‘‘CSA’’ for the
conditions are issued as part of the type purpose of this action. The DEA
certification basis for Korea Aerospace publishes the implementing regulations
Industries, Ltd., Model KC–100 for these statutes in title 21 of the Code
airplanes. of Federal Regulations (CFR), chapter II.
VerDate Sep<11>2014 15:06 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1](https://thefederalregister.org/doc/80_FR_54891/page/1.svg)
![54716 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Rules and Regulations
The CSA and its implementing Background DEA eight-factor analysis. Both the DEA
regulations are designed to prevent, [123I]Ioflupane is, by definition, a and HHS analyses and other relevant
detect, and eliminate the diversion of schedule II controlled substance documents are available in their entirety
controlled substances and listed because it is derived from cocaine, a in the public docket of this rule (Docket
chemicals into the illicit market while schedule II substance, via ecgonine (a Number DEA–415F) at http://
ensuring an adequate supply is available schedule II substance). See 21 U.S.C. www.regulations.gov under ‘‘Supporting
for the legitimate medical, scientific, 812(c), Schedule II, (a)(4). and Related Material.’’
research, and industrial needs of the [123I]Ioflupane is the active Determination To Decontrol
United States. Controlled substances pharmaceutical ingredient (API) in the [123I]ioflupane
have the potential for abuse and drug product DaTscan and it is a new
molecular entity. The Food and Drug After a review of the available data,
dependence and are controlled to
Administration (FDA) approved the including the scientific and medical
protect the public health and safety.
New Drug Application (NDA) for evaluation and recommendation, the
Under the CSA, each controlled Administrator of the DEA published in
DaTscan on January 14, 2011, for the
substance is classified into one of five the Federal Register a notice of
indication of visualizing striatal DATs
schedules based upon its potential for proposed rulemaking (NPRM) entitled
in the brains of adult patients with
abuse, its currently accepted medical ‘‘Schedules of Controlled Substances:
suspected Parkinsonian syndromes (PS).
use in treatment in the United States, Removal of [123I]Ioflupane from
and the degree of dependence the DEA and HHS Eight Factor Analyses Schedule II of the Controlled Substances
substance may cause. 21 U.S.C. 812. The Pursuant to 21 U.S.C. 811(b), (c), and Act’’ which proposed removal of
initial schedules of controlled (f), the HHS recommended to the DEA [123I]ioflupane from the schedules of the
substances established by Congress are on November 2, 2010, that FDA- CSA. 80 FR 31521, June 3, 2015. The
found at 21 U.S.C. 812(c), and the approved products containing proposed rule provided an opportunity
current list of scheduled substances is [123I]ioflupane be removed from for interested persons to file a request
published at 21 CFR part 1308. schedule II of the CSA. The HHS for a hearing in accordance with DEA
Pursuant to 21 U.S.C. 811(a)(2), the provided to DEA a scientific and regulations by July 6, 2015.
medical evaluation document entitled No requests for such a hearing were
Attorney General may, by rule, ‘‘remove
‘‘Basis for the Recommendation to received by the DEA. The NPRM also
any drug or other substance from the
Remove FDA Approved Products provided an opportunity for interested
schedules if he finds that the drug or
Containing [123I]Ioflupane from persons to submit written comments on
other substance does not meet the
Schedule II of the Controlled Substances the proposal on or before July 6, 2015.
requirements for inclusion in any
schedule.’’ The Attorney General has Act (CSA).’’ Pursuant to 21 U.S.C. Comments Received
811(b), this document contained an
delegated scheduling authority under 21 The DEA received nine comments on
eight-factor analysis of FDA-approved
U.S.C. 811 to the Administrator of the the proposed rule to decontrol
products containing [123I]ioflupane,
DEA, 28 CFR 0.100. [123I]ioflupane. All commenters
along with the HHS’s recommendation
The CSA provides that proceedings to remove FDA-approved products supported the decontrol of
for the issuance, amendment, or repeal containing [123I]ioflupane from the [123I]ioflupane.
of the scheduling of any drug or other schedules of the CSA. The HHS later Commenters in support of
substance may be initiated by the clarified to DEA that its November 2, decontrolling [123I]ioflupane included
Attorney General (1) on her own 2010, recommendation also supports the an international medical society for
motion, (2) at the request of the decontrol of the substance neurology; an association of industry
Secretary of the Department of Health [123I]ioflupane.2 members that manufacture
and Human Services (HHS),1 or (3) on In response, the DEA reviewed the radiopharmaceuticals; a professional
the petition of any interested party. 21 scientific and medical evaluation and organization representing radiologists,
U.S.C. 811(a). This action was initiated scheduling recommendation provided radiation oncologists, interventional
at the request of the Assistant Secretary by the HHS, and all other relevant data. radiologists, nuclear medicine
for Health of the HHS, and is supported The DEA and HHS collaborated further physicians, and medical physicists; an
regarding the available information. In a advocacy group for the Parkinson’s
by, inter alia, a recommendation from
letter dated February 2, 2015, the HHS community; a trade association
the Assistant Secretary of the HHS and
provided detailed responses to specific representing medical imaging,
an evaluation of all relevant data by the
inquiries from the DEA (submitted by radiotherapy and radiopharmaceutical
DEA. This action removes the regulatory
letter dated September 16, 2014). Upon manufacturers; the sponsor of the drug
controls and administrative, civil, and
further review of all of the available product containing [123I]ioflupane; a
criminal sanctions applicable to physician; a health services company;
controlled substances, including those information, the DEA completed its own
eight-factor review document on FDA- and a private citizen, all of whom
specific to schedule II controlled expressed support for the DEA’s
substances, on persons who handle or approved diagnostic products
containing [123I]ioflupane (currently, proposal to decontrol [123I]ioflupane.
propose to handle [123I]ioflupane. Some commenters also stated that the
only DaTscan) pursuant to 21 U.S.C.
811(c). proposal would improve patient access
1 As discussed in a memorandum of
The FDA-approved diagnostic to an important diagnostic
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on product, DaTscan, was used as the basis pharmaceutical and reduce the burden
rmajette on DSK7SPTVN1PROD with RULES
Drug Abuse (NIDA), the FDA acts as the lead agency for the scientific and medical evaluation on providers and nuclear pharmacies.
within the HHS in carrying out the Secretary’s of FDA-approved products containing The DEA appreciates the comments in
scheduling responsibilities under the CSA, with the support of this rulemaking.
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. [123I]ioflupane for both the HHS and
The Secretary of the HHS has delegated to the Effective Date of the Rule
Assistant Secretary for Health of the HHS the 2 Letterfrom Karen B. DeSalvo, Acting Assistant
authority to make domestic drug scheduling Secretary for Health, HHS to John J. Riley, Acting Generally, DEA scheduling actions are
recommendations. 58 FR 35460, July 1, 1993. Deputy Administrator, DEA (Aug. 19, 2015). effective 30 days from the date of
VerDate Sep<11>2014 15:06 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1](https://thefederalregister.org/doc/80_FR_54891/page/2.svg)
![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Rules and Regulations 54717
publication of the final rule in the Executive Order 12866 and the able to quantify the estimated number of
Federal Register. 21 CFR 1308.45; see principles reaffirmed in Executive Order affected entities and small entities
also 5 U.S.C. 553(d). In this instance, 13563. because the handling of the drug is
and in accordance with 21 CFR 1308.45, expected to be limited to DEA
Executive Order 12988
the DEA finds that the conditions of registrants even after removal from the
public health or safety necessitate an This regulation meets the applicable schedules. In such instances, the DEA’s
earlier effective date, i.e., the date of standards set forth in sections 3(a) and knowledge of its registrant population
publication in the Federal Register. An 3(b)(2) of Executive Order 12988 Civil forms the basis for estimating the
earlier effective date would allow Justice Reform to eliminate drafting number of affected entities and small
specialized members of the healthcare errors and ambiguity, minimize entities. However, [123I]ioflupane is
community to readily utilize this litigation, provide a clear legal standard expected to be handled by persons who
substance as a component of an for affected conduct, and promote
hold DEA registrations regardless of
important diagnostic tool, DaTscan. simplification and burden reduction.
whether this rule is promulgated (e.g.,
DaTscan, which contains Executive Order 13132 hospital radiopharmacies) and by
[123I]ioflupane, is used in differentiating persons who are not currently registered
essential tremors from tremors due to This rulemaking does not have
federalism implications warranting the with the DEA to handle controlled
PS, (idiopathic Parkinson’s disease, substances (e.g., diagnostic clinics and
multiple system atrophy, and application of Executive Order 13132.
The rule does not have substantial imaging centers that do not routinely
progressive supranuclear palsy), and handle controlled substances). The DEA
can help healthcare professionals direct effects on the States, on the
relationship between the Federal does not have a reliable basis to estimate
provide more accurate diagnoses. This
Government and the States, or the the number of non-registrants who plan
earlier effective date will allow patients
distribution of power and to handle [123I]ioflupane.
to receive, without delay, important
diagnostic testing that is critical to their responsibilities among the various Although the DEA does not have a
health and treatment. These findings, levels of government. reliable basis to estimate the number of
coupled with the fact that this is an Executive Order 13175 affected entities and quantify the
action for decontrol, indicate that economic impact of this final rule, a
This rule does not have tribal qualitative analysis indicates that this
conditions of public health necessitate
implications warranting the application rule is likely to result in some cost
an immediate effective date upon
of Executive Order 13175. This rule
publication in the Federal Register. savings for the healthcare industry. The
does not have substantial direct effects
The DEA also notes that its decision affected entities will continue to meet
on one or more Indian tribes, on the
to make this rule effective upon existing Federal and/or state
relationship between the Federal
publication aligns with the exceptions requirements applicable to those who
Government and Indian tribes, or on the
to the 30-day effective date requirement handle radiopharmaceutical substances,
distribution of power and
of the Administrative Procedure Act including licensure, security,
responsibilities between the Federal
(APA). One of the APA’s exceptions to recordkeeping, and reporting
Government and Indian tribes.
the 30-day effective date is for a requirements, which in many cases are
substantive rule granting or recognizing Regulatory Flexibility Act more stringent than the DEA’s
an exemption or which relieves a The Administrator, in accordance requirements. However, the DEA
restriction. 5 U.S.C. 553(d)(3). with the Regulatory Flexibility Act (5 believes cost savings will be realized
Scheduling Conclusion U.S.C. 601–612) (RFA), has reviewed from the removal of the administrative,
this rule and by approving it certifies civil, and criminal sanctions for those
Based on consideration of all entities handling or proposing to handle
that it will not have a significant
comments, the scientific and medical [123I]ioflupane, in the form of saved
economic impact on a substantial
evaluation and accompanying DEA registration fees, and the
number of small entities. The purpose of
recommendation and clarification from elimination of additional physical
this rule is to remove [123I]ioflupane
the HHS, and based on the DEA’s security, recordkeeping, and reporting
from the list of schedules of the CSA.
consideration of its own eight-factor
This action removes regulatory controls requirements.
analysis, the Administrator finds that
and administrative, civil, and criminal Because of these facts, this rule will
these facts and all relevant data
sanctions applicable to controlled not result in a significant economic
demonstrate that [123I]ioflupane does
substances for handlers and proposed impact on a substantial number of small
not meet the requirements for inclusion handlers of [123I]ioflupane. Accordingly,
in any schedule, and will be removed entities.
it has the potential for some economic
from control under the CSA. Unfunded Mandates Reform Act of 1995
impact in the form of cost savings.
Regulatory Analyses This rule will affect all persons who
handle, or propose to handle, The DEA has determined and certifies
Executive Orders 12866 and 15363 [123I]ioflupane. Due to the wide variety pursuant to the Unfunded Mandates
In accordance with 21 U.S.C. 811(a), of unidentifiable and unquantifiable Reform Act of 1995 (UMRA), 2 U.S.C.
this scheduling action is subject to variables that potentially could 1501 et seq., that this action would not
formal rulemaking procedures done ‘‘on influence the distribution and result in any federal mandate that may
the record after opportunity for a administration rates of result ‘‘in the expenditure by State,
hearing,’’ which are conducted pursuant radiopharmaceutical substances, the local, and tribal governments, in the
rmajette on DSK7SPTVN1PROD with RULES
to the provisions of 5 U.S.C. 556 and DEA is unable to determine the number aggregate, or by the private sector, of
557. The CSA sets forth the criteria for of entities and small entities which $100,000,000 or more (adjusted for
scheduling a drug or other substance. might handle [123I]ioflupane. In other inflation) in any one year . . . .’’
Such actions are exempt from review by instances where a controlled Therefore, neither a Small Government
the Office of Management and Budget pharmaceutical drug is removed from Agency Plan nor any other action is
(OMB) pursuant to section 3(d)(1) of the schedules of the CSA, the DEA is required under provisions of UMRA.
VerDate Sep<11>2014 15:06 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1](https://thefederalregister.org/doc/80_FR_54891/page/3.svg)
![54718 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Rules and Regulations
Paperwork Reduction Act substances, except that the substances accepted between 9 a.m. and 5 p.m.,
This action does not impose a new shall not include: Monday through Friday, except federal
collection of information requirement (i) Decocainized coca leaves or holidays. The telephone number is 202–
under the Paperwork Reduction Act, 44 extraction of coca leaves, which 366–9329.
U.S.C. 3501–3521. This action would extractions do not contain cocaine or See the ‘‘Public Participation and
not impose recordkeeping or reporting ecgonine; or Request for Comments’’ portion of the
requirements on State or local (ii) [123I]ioflupane. SUPPLEMENTARY INFORMATION section
governments, individuals, businesses, or * * * * * below for instructions on submitting
organizations. An agency may not comments. To avoid duplication, please
Dated: September 4, 2015.
conduct or sponsor, and a person is not use only one of these four methods.
Chuck Rosenberg,
required to respond to, a collection of FOR FURTHER INFORMATION CONTACT: If
Acting Administrator.
information unless it displays a you have questions on this interim rule,
[FR Doc. 2015–22919 Filed 9–10–15; 8:45 am]
currently valid OMB control number. call or email Mr. Rusty Wright, U.S.
BILLING CODE 4410–09–P Coast Guard, District Eight Waterways
Congressional Review Act Management Branch; telephone 504–
This rule is not a major rule as 671–2138, rusty.h.wright@uscg.mil. If
defined by section 804 of the Small DEPARTMENT OF HOMELAND you have questions on viewing or
Business Regulatory Enforcement SECURITY submitting material to the docket, call
Fairness Act of 1996 (Congressional Cheryl F. Collins, Program Manager,
Coast Guard Docket Operations, telephone (202)
Review Act (CRA)). This rule will not
result in: An annual effect on the 366–9826.
33 CFR Part 147
economy of $100,000,000 or more; a SUPPLEMENTARY INFORMATION:
major increase in costs or prices for [Docket No. USCG–2015–0512]
Table of Acronyms
consumers, individual industries, RIN 1625–AA00
Federal, State, or local government CFR Code of Federal Regulations
agencies, or geographic regions; or Safety Zone; Mad Dog Truss Spar, DHS Department of Homeland Security
significant adverse effects on EEZ Exclusive Economic Zone
Green Canyon 782, Outer Continental FR Federal Register
competition, employment, investment, Shelf on the Gulf of Mexico IMO International Maritime Organization
productivity, innovation, or on the OCS Outer Continental Shelf
ability of United States-based AGENCY:Coast Guard, DHS.
USCG United States Coast Guard
companies to compete with foreign- Interim rule and request for
ACTION:
based companies in domestic and comments. A. Public Participation and Request for
export markets. However, pursuant to Comments
the CRA, the DEA has submitted a copy SUMMARY: The Coast Guard published in
the Federal Register on July 29, 2005, a We encourage you to participate in
of this final rule to both Houses of this rulemaking by submitting
Congress and to the Comptroller final rule establishing a safety zone
around the Mad Dog Truss Spar. The comments and related materials. All
General. comments received will be posted
coordinates for the location of the Mad
List of Subjects in 21 CFR Part 1308 Dog Truss Spar were published without change to http://
incorrectly as 27°11′18″ N., 91°05′12″ www.regulations.gov and will include
Administrative practice and any personal information you have
procedure, Drug traffic control, W. This interim rule corrects the
coordinates to reflect the actual location provided.
Reporting and Recordkeeping
Requirements. of the Mad Dog Truss Spar as 1. Submitting Comments
For the reasons set out above, 21 CFR 27°11′18.124″ N., 90°16′7.363″ W., If you submit a comment, please
part 1308 is amended to read as follows: therefore correctly publishing the area include the docket number for this
covered by the safety zone around the rulemaking, indicate the specific section
PART 1308—SCHEDULES OF Mad Dog Truss Spar system, located in of this document to which each
CONTROLLED SUBSTANCES Green Canyon Block 782 on the Outer comment applies, and provide a reason
Continental Shelf (OCS) in the Gulf of for each suggestion or recommendation.
■ 1. The authority citation for 21 CFR Mexico. You may submit your comments and
part 1308 continues to read as follows: DATES: This interim rule is effective material online at http://
Authority: 21 U.S.C. 811, 812, 871(b), September 11, 2015. Comments and www.regulations.gov, or by fax, mail, or
unless otherwise noted. related material must be received by the hand delivery, but please use only one
Coast Guard on or before October 13, of these means. If you submit a
■ 2. In § 1308.12, revise paragraph (b)(4)
2015. comment online, it will be considered
to read as follows:
ADDRESSES: You may submit comments received by the Coast Guard when you
§ 1308.12 Schedule II. identified by docket number USCG– successfully transmit the comment. If
* * * * * 2015–0512 using any one of the you fax, hand deliver, or mail your
(b) * * * following methods: comment, it will be considered as
(4) Coca leaves (9040) and any salt, (1) Federal eRulemaking Portal: having been received by the Coast
compound, derivative or preparation of http://www.regulations.gov. Guard when it is received at the Docket
Management Facility. We recommend
rmajette on DSK7SPTVN1PROD with RULES
coca leaves (including cocaine (9041) (2) Fax: 202–493–2251.
and ecgonine (9180) and their salts, (3) Mail or Delivery: Docket that you include your name and a
isomers, derivatives and salts of isomers Management Facility (M–30), U.S. mailing address, an email address, or a
and derivatives), and any salt, Department of Transportation, West telephone number in the body of your
compound, derivative, or preparation Building Ground Floor, Room W12–140, document so that we can contact you if
thereof which is chemically equivalent 1200 New Jersey Avenue SE., we have questions regarding your
or identical with any of these Washington, DC 20590–0001. Deliveries submission.
VerDate Sep<11>2014 15:06 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1](https://thefederalregister.org/doc/80_FR_54891/page/4.svg)
Document Created: 2015-12-15 10:00:29
Document Modified: 2015-12-15 10:00:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Contact | John R. Scherbenske, Office of | |
| FR Citation | 80 FR 54715 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR