81 FR 9763 - Removal of Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 38 (February 26, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 38 (February 26, 2016)
| Page Range | 9763-9766 | |
| FR Document | 2016-04224 |
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)] [Rules and Regulations] [Pages 9763-9766] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04224] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA-394F] RIN 1117-AB38 Removal of Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: On November 25, 2014, the Drug Enforcement Administration published the interim final rule titled ``Exemption from Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan.'' The Drug Enforcement Administration is hereby removing this interim final rule as it is no longer needed, as a result of the removal of [\123\I]ioflupane from the schedules of controlled substances effective September 11, 2015. DATES: Effective Date: February 26, 2016. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, 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. 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 providing 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 pursuant to 21 U.S.C. 812 (a) and (b), the current list of all scheduled substances is published at 21 CFR part 1308. Pursuant to 21 U.S.C. 822(a)(1), every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by the Attorney General. Further, pursuant to 21 U.S.C. 822(a)(2), every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by the Attorney General. The Attorney General however may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if the Attorney General finds it consistent with the public health and safety pursuant to 21 U.S.C. 822(d). The Attorney General delegated this authority to the Administrator of the DEA, 28 CFR 0.100(b), who in turn redelegated that authority to the Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant Administrator''). 28 CFR part 0, subpart R, App. section 7. Background On November 25, 2014, the DEA published an interim final rule (IFR) exempting from registration persons authorized under Nuclear Regulatory Commission (NRC) or Agreement State Medical Use Licenses or permits and administering the drug product DaTscan directly to patients for diagnostic purposes. 79 FR 70085. The IFR was intended to alleviate the regulatory burdens on those administering the drug product DaTscan, to allow more patients to receive important diagnostic testing. Additionally, because persons who administer DaTscan are subject to strict NRC/Agreement State requirements, the DEA determined in the IFR that the waiver from registration of persons who administer DaTscan was consistent with the public health and safety. The IFR provided an opportunity for interested persons to submit written comments on the rulemaking on or before January 26, 2015. However, effective September 11, 2015, the DEA removed [\123\I]ioflupane from the schedules of controlled substances. 80 FR 54715. [\123\I]Ioflupane is the active pharmaceutical ingredient in DaTscan. Accordingly, a registration exemption is no longer necessary for persons who administer the drug product DaTscan. As the DEA explained in the final rule removing [\123\I]ioflupane from the schedules of controlled substances, all of the administrative, civil, and criminal sanctions applicable to controlled substances no longer apply to those persons who handle [\123\I]ioflupane, or any drug products that contain [\123\I]ioflupane, on or after September 11, 2015. Because the decontrol of [\123\I]ioflupane supersedes the registration exemption provided in the IFR, the DEA hereby finalizes the rulemaking procedure that was initiated with the November 25, 2014, IFR (79 FR 70085) by publishing this final rule removing that regulation. Below the DEA has provided a discussion of comments received in response to the IFR. 79 FR 70085. [[Page 9764]] Comments Received The DEA received six comments on the IFR. Two comments were from GE Healthcare, the manufacturer of the drug product DaTscan, one comment was from a professor of pharmaceutical sciences, two comments were from nuclear medicine industry groups, and one comment was from a Parkinson's Disease advocacy group. Decontrol of DaTscan: Five commenters requested that the DEA follow the November 2, 2010, recommendation by the U.S. Department of Health and Human Services (HHS) to decontrol the drug product DaTscan. One commenter stated that the DEA is bound by the HHS' recommendation. Additionally, five of these commenters cited the lack of abuse of the drug product DaTscan as a reason why it should be decontrolled. Response: There is no doubt that, as a derivative of cocaine, ioflupane is a schedule II controlled substance. Congress specified that ``cocaine, its salts, optical and geometric isomers, and salts of isomers; ecgonine, its derivatives, their salts, isomers, and salts of isomers; or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph'' are schedule II controlled substances. 21 U.S.C. 812(c), Schedule II, (a)(4) (emphasis added). A radioactive form of ioflupane is contained within the drug product DaTscan; accordingly DaTscan was controlled as a schedule II substance at the time of the IFR. The fact that there is a low likelihood of diversion of the drug product DaTscan at the dispensing level supported the registration exemption provided by the IFR at that time. As stated in the IFR, the DEA was continuing to review the control status of [\123\I]ioflupane pursuant to 21 U.S.C. 811. The IFR was separate and apart from the control process, and did not resolve the control status of [\123\I]ioflupane. The purpose of the IFR was to encourage use and expand access of this drug product as a diagnostic tool until the control status of DaTscan\TM\ was resolved. Subsequently, effective September 11, 2015, the DEA removed [\123\I]ioflupane from the schedules of controlled substances. The factors in support of removing [\123\I]ioflupane from the schedules of controlled substances are summarized in the notice of proposed rulemaking and the final rule, (80 FR 13455 and 80 FR 54715, respectively). The DEA explained in the final rule that as a result of removing [\123\I]ioflupane from the schedules of controlled substances, all of the administrative, civil, and criminal sanctions applicable to controlled substances no longer apply to those persons who handle [\123\I]ioflupane. Expedited Rulemaking under the Administrative Procedure Act: One commenter expressed concern that the DEA did not undertake notice and comment procedures before promulgating the IFR. The same commenter stated that the IFR did not meet the legal requirements for expedited rulemaking nor for the issuance of a rule with an immediate effective date, asserting that the IFR did not meet the requirements of the good cause exception to make a rule immediately effective. Response: A rule is exempt from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if the agency for good cause determines that those procedures are unnecessary, impracticable, or contrary to the public interest. 5 U.S.C. 553(b)(3)(B). The IFR was intended to enable more persons to administer DaTscan, thereby helping to increase patient access to its diagnostic benefits. The DEA for good cause found that it was unnecessary and contrary to the public interest to seek public comment prior to promulgating the IFR because, without prompt exemption from registration, some members of the health care community would not have been able to utilize this diagnostic tool. It was reasonable to expect that alleviating the registration burden would stimulate use, thereby expanding access. In addition, this exemption was intended to reduce costs for imaging centers because they would not have had to pay DEA registration fees (unless they also handle other pharmaceutical controlled substances). The IFR alleviated certain registration, security, recordkeeping, reporting, and labeling requirements for persons authorized under the NRC, or Agreement State medical use licenses or permits, who administer the drug product DaTscan to a patient for diagnostic purposes. The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, the APA allows an exception for ``a substantive rule which grants or recognizes an exemption or relieves a restriction.'' 5 U.S.C. 553(d)(1). The DEA found that the IFR met this criterion. Although a notice of proposed rulemaking was not published with regard to the drug product DaTscan, the DEA published an IFR with request for comment on November 25, 2014. The comment period for the IFR closed on January 26, 2015, and in that 60-day time frame, the DEA received six comments on the rulemaking, and has considered those comments herein. Exemption from Registration for Radiopharmacies: One commenter stated that the registration exemption should be expanded to include nuclear pharmacies (also known as radiopharmacies) that distribute DaTscan, because it would increase patient access to DaTscan. Response: At the time of the IFR, radiopharmacies that transferred DaTscan to imaging centers and hospitals were required to be registered as distributors because they transferred the now decontrolled substance to other registrants for subsequent administration pursuant to the authority of a DEA Form 222 or digitally signed electronic order rather than pursuant to the authority of a prescription or other lawful order. The commenter does not state how such an exemption would increase patient access, and the radiopharmacy (i.e., the registered distributor of DaTscan) commented that the barrier to patient access is the registration requirement at the imaging centers, rather than at the distributor or manufacturer levels. Therefore, it was appropriate that the IFR did not include radiopharmacies within the scope of the registration exemption. Inconsistency between Federal and State Law: Three commenters asserted concern that the IFR could not directly exempt anyone from state requirements since most states would not automatically incorporate federal exemptions into their corresponding regulatory systems. The commenters expressed further concern that each state would require an independent rulemaking process to implement the registration exemption. Response: Before promulgation of the IFR, only imaging centers that operated in accordance with NRC or Agreement State regulations and that were DEA registrants were able to administer the drug product DaTscan. The IFR alleviated the requirement to register with the DEA, as well as the associated security, recordkeeping, and reporting requirements for persons authorized under the NRC or Agreement State medical use licenses or permits who administer the drug product DaTscan to a patient for diagnostic purposes. With respect to the relationship between Federal and State law in the area of controlled substances, the IFR did not alter State law. The CSA shall not be ``construed as indicating an [[Page 9765]] intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless that is a positive conflict between that provision . . . and that State law so that the two cannot consistently stand together.'' 21 U.S.C. 903. Accordingly, any applicable State law that is more stringent than Federal law applies. This lack of uniformity between Federal and State law with respect to the treatment of controlled substances is not uncommon, and it is encountered by registrants and non-registrants that lawfully handle controlled substances. For example, some states control substances that are not Federally controlled or control substances more stringently than the Federal controls (e.g., carisoprodol, tramadol, pseudoephedrine products). Still other states prohibit activities that are allowed under the CSA (e.g., collection and disposal of controlled substances by certain entities). These issues with respect to lack of uniformity between Federal and State law may also be present with respect to the recent removal of [\123\I]ioflupane from the schedules of controlled substances. In addition, the exemption provided by the IFR was very similar to the DEA-authorized exemption for certain chemical preparations pursuant to 21 CFR 1308.23. In accordance with 21 CFR 1308.23 and 1308.24, certain preparations or mixtures containing one or more controlled substances can be exempt from regulations pertaining to registration, security, labeling, records, and reports. In 2014, the DEA exempted almost 1,500 preparations from certain regulatory requirements, a number that has increased considerably since 2011 when the DEA exempted 390 chemical preparations. It is the DEA's understanding that there has been no confusion with respect to State laws which apply to these chemical preparations. As the registration exemption in the IFR was similar to the exemptions provided for certain chemical preparations, the DEA believed at the time of the IFR that it was unlikely that the IFR would create complications with State laws. Disposal: Three commenters discussed the issue of disposal of the drug product DaTscan. One commenter expressed concern that hospitals and other practitioners currently registered with the DEA and administering the drug product DaTscan are required to change their existing disposal practices with respect to DaTscan as a result of the IFR. The commenter noted that the IFR language can be read to impose new requirements for those handling the drug product DaTscan. The commenter also stated that it was not practice for the current distributor to take back unused portions of DaTscan from those administering the drug product, and that the current distributor is not licensed as a reverse distributor. The commenter also stated that the DEA did not specify the volume of the drug product DaTscan which would constitute ``unused'' product, and inquired about the use of DEA Forms 41 and 222. Another commenter expressed concern that requiring exempt entities (e.g., imaging centers) to return the unused DaTscan to the distributor will increase costs to exempt entities. Response: Under the IFR, hospitals, imaging centers, and other practitioners that were already registered with the DEA were not required to follow the procedures in the IFR if they chose to handle DaTscan as a DEA registrant. Only those entities that chose to benefit from the exemption had to adhere to the requirements of the IFR. Therefore, those entities already registered with the DEA that did not wish to be exempt from registration when handling DaTscan, were permitted to continue to handle the drug product DaTscan, including disposal, in accordance with applicable law. At the time of the IFR, the DEA understood that it was common practice for radiopharmacies to take back unused radioactive material in vials and dosage unit syringes, as well as empty vials and empty dosage unit syringes from the medical use licensee, as long as they were originally provided by the radiopharmacy. Further, the DEA understood that as long as the radiopharmacy is authorized under its NRC or Agreement State license for this return, and does not receive anything that it did not send to the medical use licensee, the radiopharmacy is not considered a waste broker in accordance with NRC or Agreement State regulations. The DEA appreciates the commenter's clarification of the business practices relating to the drug product DaTscan. As discussed, effective September 11, 2015, the DEA removed [\123\I]ioflupane from the schedules of controlled substances. The DEA explained in the final rule removing [\123\I]ioflupane from the schedules of controlled substances, none of the requirements applicable to controlled substances will apply on or after that date to those persons who handle [\123\I]ioflupane, such as the drug product DaTscan, including use of the DEA Form 41 and 222. 80 FR 54715. Compliance with Executive Order 12866: One commenter expressed concern that the DEA determined that the IFR was a non-significant regulatory action and had, therefore, circumvented interagency review. The commenter stated that the IFR represents a drastic and notable departure from established practice in the healthcare industry. The commenter was also concerned that the interaction with existing laws and regulations promulgated by other federal agencies should have resulted in interagency review, and the process undertaken by the DEA for the IFR will have a precedential effect on future DEA rulemakings. Response: To be a significant regulatory action in accordance with Executive Order 12866 (E.O. 12866) the action must meet one of the four factors set forth in E.O. 12866.\1\ The DEA determined that the IFR did not meet any of the four factors. In addition, the Office of Management and Budget concurred with the assessment that the IFR was not significant under E.O. 12866, sec. 6. --------------------------------------------------------------------------- \1\ As provided in Executive Order Section 12866, Regulatory Planning and Review, sec. 3(f): ``Significant regulatory action'' means any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order. --------------------------------------------------------------------------- Labeling Requirements: One commenter stated that the DEA is unable to waive the CSA's requirement (21 U.S.C. 825) that controlled substances be labeled as such, and that the DEA is unable to waive labeling requirements enforced by the Food and Drug Administration (FDA). Response: Initially the DEA included the waiver for labeling so that those exempted by this waiver would not be confused by the ``C- II'' labeling on the DaTscan packaging. The comments, however indicated that not requiring ``C-II'' labeling would cause more confusion than requiring it. However, due to the recent removal of [\123\I]ioflupane from the schedules of controlled substances, the ``C-II'' label is no longer required on DaTscan packaging. [[Page 9766]] Regulatory Analyses Executive Orders 12866 and 13563 This final rule has been drafted and reviewed in accordance with Executive Order 12866, ``Regulatory Planning and Review'' section 1(b), Principles of Regulation, and in accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review'' section 1(b) General Principles of Regulation. The Department of Justice has determined that this rule is not a ``significant regulatory action'' under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget. 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 proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175 This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above and in the interim final rule, the DEA determined that there was good cause to exempt the IFR from notice and comment. Consequently, the RFA does not apply to this final rule. Paperwork Reduction Act of 1995 This rule does not involve a collection of information within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.), the DEA has determined and certifies pursuant to UMRA 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 million or more (adjusted for inflation) in any one year . . . .'' Therefore, neither a Small Government Agency Plan nor any other action is required under the provisions of UMRA of 1995. Congressional Review Act This rule is not a major rule as defined by the Congressional Review Act (CRA) (5 U.S.C. 804). 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, or have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-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. Administrative Procedure Act The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, one exception is ``as otherwise provided by the agency for good cause found and published with the rule.'' Because the DEA removed [\123\I]ioflupane from the schedules of controlled substances as of September 11, 2015, [80 FR 22919], there is no longer any need for a registration exemption for persons administering DaTscan, and the DEA is hereby removing the IFR through this final rule. The broader decontrol action has superseded it. Therefore, it is unnecessary to delay the effective date of this final rule by 30 days, and this rule shall take effect immediately upon publication. List of Subjects in 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Controlled substances, Drug abuse, Reporting and recordkeeping requirements. Accordingly, 21 CFR part 1301 is amended as follows: PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 0 1. The authority citation for 21 CFR part 1301 continues to read as follows: Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958, 965. Sec. 1301.29 [Removed and Reserved] 0 2. Remove and reserve Sec. 1301.29. Dated: February 23, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-04224 Filed 2-25-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 9763
IV. Transcripts and Recorded Video Diversion Control, Drug Enforcement Attorney General finds it consistent
Please be advised that as soon as a Administration; Mailing Address: 8701 with the public health and safety
transcript is available, it will be Morrissette Drive, Springfield, Virginia pursuant to 21 U.S.C. 822(d). The
accessible at 22152, Telephone: (202) 598–6812. Attorney General delegated this
http://www.regulations.gov and at SUPPLEMENTARY INFORMATION: authority to the Administrator of the
FDA’s FSMA Web site at: http:// DEA, 28 CFR 0.100(b), who in turn
Legal Authority
www.fda.gov/FSMA. You may also view redelegated that authority to the Deputy
the transcript at the Division of Dockets The Drug Enforcement Assistant Administrator of the DEA
Management (HFA–305), Food and Drug Administration (DEA) implements and Office of Diversion Control (‘‘Deputy
Administration, 5630 Fishers Lane, Rm. enforces Titles II and III of the Assistant Administrator’’). 28 CFR part
Comprehensive Drug Abuse Prevention 0, subpart R, App. section 7.
1061, Rockville, MD 20852. A transcript
and Control Act of 1970, as amended. 21
will also be available in either hardcopy Background
U.S.C. 801–971. Titles II and III are
or on CD–ROM, after submission of a
referred to as the ‘‘Controlled
Freedom of Information request. The On November 25, 2014, the DEA
Substances Act’’ and the ‘‘Controlled
Freedom of Information office address is published an interim final rule (IFR)
Substances Import and Export Act,’’
available on FDA’s Web site at http:// exempting from registration persons
respectively, and are collectively
www.fda.gov. Additionally, we will be authorized under Nuclear Regulatory
referred to as the ‘‘Controlled
video recording the public meeting. Commission (NRC) or Agreement State
Substances Act’’ or the ‘‘CSA’’ for the
Once the recorded video is available, it Medical Use Licenses or permits and
purpose of this action. The DEA
will be accessible at FDA’s FSMA Web publishes the implementing regulations administering the drug product DaTscan
site at http://www.fda.gov/FSMA. for these statutes in title 21 of the Code directly to patients for diagnostic
Dated: February 23, 2016. of Federal Regulations (CFR), chapter II. purposes. 79 FR 70085. The IFR was
Leslie Kux, The CSA and its implementing intended to alleviate the regulatory
Associate Commissioner for Policy. regulations are designed to prevent, burdens on those administering the drug
[FR Doc. 2016–04127 Filed 2–25–16; 8:45 am] detect, and eliminate the diversion of product DaTscan, to allow more patients
BILLING CODE 4164–01–P controlled substances and listed to receive important diagnostic testing.
chemicals into the illicit market while Additionally, because persons who
providing for the legitimate medical, administer DaTscan are subject to strict
scientific, research, and industrial needs NRC/Agreement State requirements, the
DEPARTMENT OF JUSTICE
of the United States. Controlled DEA determined in the IFR that the
Drug Enforcement Administration substances have the potential for abuse waiver from registration of persons who
and dependence and are controlled to administer DaTscan was consistent with
21 CFR Part 1301 protect the public health and safety. the public health and safety. The IFR
Under the CSA, each controlled provided an opportunity for interested
[Docket No. DEA–394F] substance is classified into one of five persons to submit written comments on
RIN 1117–AB38 schedules based upon its potential for the rulemaking on or before January 26,
abuse, its currently accepted medical 2015.
Removal of Exemption From use in treatment in the United States, However, effective September 11,
Registration for Persons Authorized and the degree of dependence the 2015, the DEA removed [123I]ioflupane
Under U.S. Nuclear Regulatory substance may cause. 21 U.S.C. 812. The from the schedules of controlled
Commission or Agreement State initial schedules of controlled substances. 80 FR 54715. [123I]Ioflupane
Medical Use Licenses or Permits and substances established by Congress are is the active pharmaceutical ingredient
Administering the Drug Product found at 21 U.S.C. 812(c), and pursuant in DaTscan. Accordingly, a registration
DaTscan to 21 U.S.C. 812 (a) and (b), the current exemption is no longer necessary for
list of all scheduled substances is persons who administer the drug
AGENCY: Drug Enforcement published at 21 CFR part 1308.
Administration, Department of Justice. product DaTscan. As the DEA explained
Pursuant to 21 U.S.C. 822(a)(1), every
ACTION: Final rule. in the final rule removing
person who manufactures or distributes
[123I]ioflupane from the schedules of
SUMMARY: On November 25, 2014, the any controlled substance or list I
chemical, or who proposes to engage in controlled substances, all of the
Drug Enforcement Administration administrative, civil, and criminal
the manufacture or distribution of any
published the interim final rule titled sanctions applicable to controlled
controlled substance or list I chemical,
‘‘Exemption from Registration for substances no longer apply to those
shall obtain annually a registration
Persons Authorized Under U.S. Nuclear persons who handle [123I]ioflupane, or
issued by the Attorney General in
Regulatory Commission or Agreement any drug products that contain
accordance with the rules and
State Medical Use Licenses or Permits [123I]ioflupane, on or after September
regulations promulgated by the Attorney
and Administering the Drug Product 11, 2015.
General. Further, pursuant to 21 U.S.C.
DaTscan.’’ The Drug Enforcement Because the decontrol of
822(a)(2), every person who dispenses,
Administration is hereby removing this [123I]ioflupane supersedes the
or who proposes to dispense, any
interim final rule as it is no longer registration exemption provided in the
controlled substance, shall obtain from
needed, as a result of the removal of IFR, the DEA hereby finalizes the
the Attorney General a registration
mstockstill on DSK4VPTVN1PROD with RULES
[123I]ioflupane from the schedules of rulemaking procedure that was initiated
issued in accordance with the rules and
controlled substances effective with the November 25, 2014, IFR (79 FR
regulations promulgated by the Attorney
September 11, 2015. 70085) by publishing this final rule
General.
DATES: Effective Date: February 26, The Attorney General however may, removing that regulation. Below the
2016. by regulation, waive the requirement for DEA has provided a discussion of
FOR FURTHER INFORMATION CONTACT: registration of certain manufacturers, comments received in response to the
Barbara J. Boockholdt, Office of distributors, or dispensers if the IFR. 79 FR 70085.
VerDate Sep<11>2014 17:33 Feb 25, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\26FER1.SGM 26FER1](https://thefederalregister.org/doc/81_FR_9801/page/1.svg)
![9764 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations
Comments Received administrative, civil, and criminal comment on November 25, 2014. The
The DEA received six comments on sanctions applicable to controlled comment period for the IFR closed on
the IFR. Two comments were from GE substances no longer apply to those January 26, 2015, and in that 60-day
Healthcare, the manufacturer of the drug persons who handle [123I]ioflupane. time frame, the DEA received six
Expedited Rulemaking under the comments on the rulemaking, and has
product DaTscan, one comment was
Administrative Procedure Act: considered those comments herein.
from a professor of pharmaceutical One commenter expressed concern Exemption from Registration for
sciences, two comments were from that the DEA did not undertake notice Radiopharmacies:
nuclear medicine industry groups, and and comment procedures before One commenter stated that the
one comment was from a Parkinson’s promulgating the IFR. The same registration exemption should be
Disease advocacy group. commenter stated that the IFR did not expanded to include nuclear
Decontrol of DaTscan: meet the legal requirements for pharmacies (also known as
Five commenters requested that the
expedited rulemaking nor for the radiopharmacies) that distribute
DEA follow the November 2, 2010, DaTscan, because it would increase
issuance of a rule with an immediate
recommendation by the U.S. effective date, asserting that the IFR did patient access to DaTscan.
Department of Health and Human not meet the requirements of the good Response: At the time of the IFR,
Services (HHS) to decontrol the drug cause exception to make a rule radiopharmacies that transferred
product DaTscan. One commenter immediately effective. DaTscan to imaging centers and
stated that the DEA is bound by the Response: A rule is exempt from hospitals were required to be registered
HHS’ recommendation. Additionally, certain provisions of the Administrative as distributors because they transferred
five of these commenters cited the lack Procedure Act (APA), including notice the now decontrolled substance to other
of abuse of the drug product DaTscan as of proposed rulemaking and the pre- registrants for subsequent
a reason why it should be decontrolled. promulgation opportunity for public administration pursuant to the authority
Response: There is no doubt that, as comment, if the agency for good cause of a DEA Form 222 or digitally signed
a derivative of cocaine, ioflupane is a determines that those procedures are electronic order rather than pursuant to
schedule II controlled substance. unnecessary, impracticable, or contrary the authority of a prescription or other
Congress specified that ‘‘cocaine, its to the public interest. 5 U.S.C. lawful order. The commenter does not
salts, optical and geometric isomers, and 553(b)(3)(B). The IFR was intended to state how such an exemption would
salts of isomers; ecgonine, its enable more persons to administer increase patient access, and the
derivatives, their salts, isomers, and DaTscan, thereby helping to increase radiopharmacy (i.e., the registered
salts of isomers; or any compound, patient access to its diagnostic benefits. distributor of DaTscan) commented that
mixture, or preparation which contains The DEA for good cause found that it the barrier to patient access is the
any quantity of any of the substances was unnecessary and contrary to the registration requirement at the imaging
referred to in this paragraph’’ are public interest to seek public comment centers, rather than at the distributor or
schedule II controlled substances. 21 prior to promulgating the IFR because, manufacturer levels. Therefore, it was
U.S.C. 812(c), Schedule II, (a)(4) without prompt exemption from appropriate that the IFR did not include
(emphasis added). A radioactive form of registration, some members of the health radiopharmacies within the scope of the
ioflupane is contained within the drug care community would not have been registration exemption.
product DaTscan; accordingly DaTscan able to utilize this diagnostic tool. It was Inconsistency between Federal and
was controlled as a schedule II reasonable to expect that alleviating the State Law:
substance at the time of the IFR. The registration burden would stimulate use, Three commenters asserted concern
fact that there is a low likelihood of thereby expanding access. In addition, that the IFR could not directly exempt
diversion of the drug product DaTscan this exemption was intended to reduce anyone from state requirements since
at the dispensing level supported the costs for imaging centers because they most states would not automatically
registration exemption provided by the would not have had to pay DEA incorporate federal exemptions into
IFR at that time. registration fees (unless they also handle their corresponding regulatory systems.
As stated in the IFR, the DEA was other pharmaceutical controlled The commenters expressed further
continuing to review the control status substances). concern that each state would require an
of [123I]ioflupane pursuant to 21 U.S.C. The IFR alleviated certain registration, independent rulemaking process to
811. The IFR was separate and apart security, recordkeeping, reporting, and implement the registration exemption.
from the control process, and did not labeling requirements for persons Response: Before promulgation of the
resolve the control status of authorized under the NRC, or IFR, only imaging centers that operated
[123I]ioflupane. The purpose of the IFR Agreement State medical use licenses or in accordance with NRC or Agreement
was to encourage use and expand access permits, who administer the drug State regulations and that were DEA
of this drug product as a diagnostic tool product DaTscan to a patient for registrants were able to administer the
until the control status of DaTscanTM diagnostic purposes. The APA requires drug product DaTscan. The IFR
was resolved. Subsequently, effective the publication of a substantive rule to alleviated the requirement to register
September 11, 2015, the DEA removed be made not less than 30 days before its with the DEA, as well as the associated
[123I]ioflupane from the schedules of effective date. 5 U.S.C. 553(d). However, security, recordkeeping, and reporting
controlled substances. The factors in the APA allows an exception for ‘‘a requirements for persons authorized
support of removing [123I]ioflupane substantive rule which grants or under the NRC or Agreement State
from the schedules of controlled recognizes an exemption or relieves a medical use licenses or permits who
mstockstill on DSK4VPTVN1PROD with RULES
substances are summarized in the notice restriction.’’ 5 U.S.C. 553(d)(1). The administer the drug product DaTscan to
of proposed rulemaking and the final DEA found that the IFR met this a patient for diagnostic purposes.
rule, (80 FR 13455 and 80 FR 54715, criterion. With respect to the relationship
respectively). The DEA explained in the Although a notice of proposed between Federal and State law in the
final rule that as a result of removing rulemaking was not published with area of controlled substances, the IFR
[123I]ioflupane from the schedules of regard to the drug product DaTscan, the did not alter State law. The CSA shall
controlled substances, all of the DEA published an IFR with request for not be ‘‘construed as indicating an
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![Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 9765
intent on the part of the Congress to DaTscan as a result of the IFR. The product DaTscan, including use of the
occupy the field in which that provision commenter noted that the IFR language DEA Form 41 and 222. 80 FR 54715.
operates, including criminal penalties, can be read to impose new requirements Compliance with Executive Order
to the exclusion of any State law on the for those handling the drug product 12866:
same subject matter which would DaTscan. The commenter also stated One commenter expressed concern
otherwise be within the authority of the that it was not practice for the current that the DEA determined that the IFR
State, unless that is a positive conflict distributor to take back unused portions was a non-significant regulatory action
between that provision . . . and that of DaTscan from those administering the and had, therefore, circumvented
State law so that the two cannot drug product, and that the current interagency review. The commenter
consistently stand together.’’ 21 U.S.C. distributor is not licensed as a reverse stated that the IFR represents a drastic
903. Accordingly, any applicable State distributor. The commenter also stated and notable departure from established
law that is more stringent than Federal that the DEA did not specify the volume practice in the healthcare industry. The
law applies. of the drug product DaTscan which commenter was also concerned that the
This lack of uniformity between would constitute ‘‘unused’’ product, interaction with existing laws and
Federal and State law with respect to and inquired about the use of DEA regulations promulgated by other
the treatment of controlled substances is Forms 41 and 222. federal agencies should have resulted in
not uncommon, and it is encountered by Another commenter expressed interagency review, and the process
registrants and non-registrants that concern that requiring exempt entities undertaken by the DEA for the IFR will
lawfully handle controlled substances. (e.g., imaging centers) to return the have a precedential effect on future DEA
For example, some states control unused DaTscan to the distributor will rulemakings.
substances that are not Federally increase costs to exempt entities. Response: To be a significant
controlled or control substances more Response: Under the IFR, hospitals, regulatory action in accordance with
stringently than the Federal controls imaging centers, and other practitioners
(e.g., carisoprodol, tramadol, Executive Order 12866 (E.O. 12866) the
that were already registered with the action must meet one of the four factors
pseudoephedrine products). Still other DEA were not required to follow the
states prohibit activities that are allowed set forth in E.O. 12866.1 The DEA
procedures in the IFR if they chose to determined that the IFR did not meet
under the CSA (e.g., collection and handle DaTscan as a DEA registrant.
disposal of controlled substances by any of the four factors. In addition, the
Only those entities that chose to benefit Office of Management and Budget
certain entities). These issues with from the exemption had to adhere to the
respect to lack of uniformity between concurred with the assessment that the
requirements of the IFR. Therefore, IFR was not significant under E.O.
Federal and State law may also be
those entities already registered with the 12866, sec. 6.
present with respect to the recent
DEA that did not wish to be exempt Labeling Requirements:
removal of [123I]ioflupane from the
from registration when handling One commenter stated that the DEA is
schedules of controlled substances.
In addition, the exemption provided DaTscan, were permitted to continue to unable to waive the CSA’s requirement
by the IFR was very similar to the DEA- handle the drug product DaTscan, (21 U.S.C. 825) that controlled
authorized exemption for certain including disposal, in accordance with substances be labeled as such, and that
chemical preparations pursuant to 21 applicable law. the DEA is unable to waive labeling
CFR 1308.23. In accordance with 21 At the time of the IFR, the DEA requirements enforced by the Food and
CFR 1308.23 and 1308.24, certain understood that it was common practice Drug Administration (FDA).
preparations or mixtures containing one for radiopharmacies to take back unused Response: Initially the DEA included
or more controlled substances can be radioactive material in vials and dosage the waiver for labeling so that those
exempt from regulations pertaining to unit syringes, as well as empty vials and exempted by this waiver would not be
registration, security, labeling, records, empty dosage unit syringes from the confused by the ‘‘C–II’’ labeling on the
and reports. In 2014, the DEA exempted medical use licensee, as long as they DaTscan packaging. The comments,
almost 1,500 preparations from certain were originally provided by the however indicated that not requiring
regulatory requirements, a number that radiopharmacy. Further, the DEA ‘‘C–II’’ labeling would cause more
has increased considerably since 2011 understood that as long as the confusion than requiring it. However,
when the DEA exempted 390 chemical radiopharmacy is authorized under its due to the recent removal of
preparations. It is the DEA’s NRC or Agreement State license for this [123I]ioflupane from the schedules of
understanding that there has been no return, and does not receive anything controlled substances, the ‘‘C–II’’ label
confusion with respect to State laws that it did not send to the medical use is no longer required on DaTscan
which apply to these chemical licensee, the radiopharmacy is not packaging.
preparations. As the registration considered a waste broker in accordance
exemption in the IFR was similar to the with NRC or Agreement State 1 As provided in Executive Order Section 12866,
exemptions provided for certain regulations. The DEA appreciates the Regulatory Planning and Review, sec. 3(f):
chemical preparations, the DEA commenter’s clarification of the ‘‘Significant regulatory action’’ means any
business practices relating to the drug regulatory action that is likely to result in a rule that
believed at the time of the IFR that it may: (1) Have an annual effect on the economy of
was unlikely that the IFR would create product DaTscan. $100 million or more or adversely affect in a
complications with State laws. As discussed, effective September 11, material way the economy, a sector of the economy,
Disposal: 2015, the DEA removed [123I]ioflupane productivity, competition, jobs, the environment,
Three commenters discussed the issue from the schedules of controlled public health or safety, or State, local, or tribal
mstockstill on DSK4VPTVN1PROD with RULES
governments or communities; (2) Create a serious
of disposal of the drug product DaTscan. substances. The DEA explained in the inconsistency or otherwise interfere with an action
One commenter expressed concern that final rule removing [123I]ioflupane from taken or planned by another agency; (3) Materially
hospitals and other practitioners the schedules of controlled substances, alter the budgetary impact of entitlements, grants,
currently registered with the DEA and none of the requirements applicable to user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) Raise novel
administering the drug product DaTscan controlled substances will apply on or legal or policy issues arising out of legal mandates,
are required to change their existing after that date to those persons who the President’s priorities, or the principles set forth
disposal practices with respect to handle [123I]ioflupane, such as the drug in this Executive order.
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![9766 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations
Regulatory Analyses the Paperwork Reduction Act of 1995, PART 1301—REGISTRATION OF
44 U.S.C. 3501–3521. MANUFACTURERS, DISTRIBUTORS,
Executive Orders 12866 and 13563
Unfunded Mandates Reform Act of 1995 AND DISPENSERS OF CONTROLLED
This final rule has been drafted and SUBSTANCES
reviewed in accordance with Executive In accordance with the Unfunded
Order 12866, ‘‘Regulatory Planning and Mandates Reform Act (UMRA) of 1995 ■ 1. The authority citation for 21 CFR
Review’’ section 1(b), Principles of (2 U.S.C. 1501 et seq.), the DEA has part 1301 continues to read as follows:
Regulation, and in accordance with determined and certifies pursuant to Authority: 21 U.S.C. 821, 822, 823, 824,
Executive Order 13563, ‘‘Improving UMRA that this action would not result 831, 871(b), 875, 877, 886a, 951, 952, 953,
Regulation and Regulatory Review’’ in any Federal mandate that may result 956, 957, 958, 965.
section 1(b) General Principles of ‘‘in the expenditure by State, local, and § 1301.29 [Removed and Reserved]
Regulation. tribal governments, in the aggregate, or
The Department of Justice has by the private sector, of $100 million or ■ 2. Remove and reserve § 1301.29.
determined that this rule is not a more (adjusted for inflation) in any one Dated: February 23, 2016.
‘‘significant regulatory action’’ under year . . . .’’ Therefore, neither a Small Louis J. Milione,
Executive Order 12866, section 3(f), Government Agency Plan nor any other Deputy Assistant Administrator.
Regulatory Planning and Review, and action is required under the provisions [FR Doc. 2016–04224 Filed 2–25–16; 8:45 am]
accordingly this rule has not been of UMRA of 1995. BILLING CODE 4410–09–P
reviewed by the Office of Management
Congressional Review Act
and Budget.
Executive Order 12988 This rule is not a major rule as DEPARTMENT OF THE TREASURY
defined by the Congressional Review
This regulation meets the applicable Act (CRA) (5 U.S.C. 804). This rule will Internal Revenue Service
standards set forth in sections 3(a) and not result in an annual effect on the
3(b)(2) of Executive Order 12988 Civil economy of $100,000,000 or more, a 26 CFR Part 301
Justice Reform to eliminate drafting major increase in costs or prices, or have
errors and ambiguity, minimize [TD 9754]
significant adverse effects on
litigation, provide a clear legal standard competition, employment, investment, RIN 1545–BL59
for affected conduct, and promote productivity, innovation, or the ability
simplification and burden reduction. of U.S.-based companies to compete Disclosures of Return Information
with foreign-based companies in Reflected on Returns to Officers and
Executive Order 13132
domestic and export markets. However, Employees of the Department of
This rulemaking does not have pursuant to the CRA, the DEA has Commerce for Certain Statistical
federalism implications warranting the submitted a copy of this final rule to Purposes and Related Activities
application of Executive Order 13132. both Houses of Congress and to the
The proposed rule does not have AGENCY: Internal Revenue Service (IRS),
Comptroller General. Treasury.
substantial direct effects on the States,
on the relationship between the national Administrative Procedure Act ACTION: Final regulations and removal of
government and the States, or the temporary regulations.
The APA requires the publication of
distribution of power and a substantive rule to be made not less SUMMARY: This document contains final
responsibilities among the various than 30 days before its effective date. 5 regulations that authorize the disclosure
levels of government. U.S.C. 553(d). However, one exception of certain items of return information to
Executive Order 13175 is ‘‘as otherwise provided by the agency the Bureau of the Census (Bureau) in
for good cause found and published conformance with section 6103(j)(1) of
This rule does not have tribal with the rule.’’ Because the DEA the Internal Revenue Code (Code).
implications warranting the application removed [123I]ioflupane from the These regulations finalize temporary
of Executive Order 13175. It does not schedules of controlled substances as of regulations that were made pursuant to
have substantial direct effects on one or September 11, 2015, [80 FR 22919], a request from the Secretary of
more Indian tribes, on the relationship there is no longer any need for a Commerce. These regulations require no
between the Federal Government and registration exemption for persons action by taxpayers and have no effect
Indian tribes, or on the distribution of administering DaTscan, and the DEA is on their tax liabilities. Thus, no
power and responsibilities between the hereby removing the IFR through this taxpayers are likely to be affected by the
Federal Government and Indian tribes. final rule. The broader decontrol action disclosures authorized by this guidance.
Regulatory Flexibility Act has superseded it. Therefore, it is DATES: Effective Date: These regulations
unnecessary to delay the effective date are effective on February 26, 2016.
The Regulatory Flexibility Act (RFA) of this final rule by 30 days, and this
(5 U.S.C. 601–612) applies to rules that Applicability Date: For dates of
rule shall take effect immediately upon applicability, see § 301.6103(j)(1)–1(e).
are subject to notice and comment publication.
under section 553(b) of the APA. As FOR FURTHER INFORMATION CONTACT:
explained above and in the interim final List of Subjects in 21 CFR Part 1301 William Rowe, (202) 317–5093 (not a
rule, the DEA determined that there was toll-free number).
mstockstill on DSK4VPTVN1PROD with RULES
Administrative practice and
good cause to exempt the IFR from SUPPLEMENTARY INFORMATION:
procedure, Drug traffic control,
notice and comment. Consequently, the
Controlled substances, Drug abuse, Background and Explanation of
RFA does not apply to this final rule.
Reporting and recordkeeping Provisions
Paperwork Reduction Act of 1995 requirements.
This document contains amendments
This rule does not involve a collection Accordingly, 21 CFR part 1301 is to 26 CFR part 301. Section 6103(j)(1)(A)
of information within the meaning of amended as follows: authorizes the Secretary of Treasury to
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Document Created: 2018-02-02 14:36:58
Document Modified: 2018-02-02 14:36:58
| 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. | |
| Dates | Effective Date: February 26, 2016. | |
| Contact | Barbara J. Boockholdt, Office of | |
| FR Citation | 81 FR 9763 | |
| RIN Number | 1117-AB38 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control; Controlled Substances; Drug Abuse and Reporting and Recordkeeping Requirements |
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