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, 9763-9766 [2016-04224]

Download as PDF Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations IV. Transcripts and Recorded Video Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov and at FDA’s FSMA Web site at: http:// www.fda.gov/FSMA. You may also view the transcript at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on FDA’s Web site at http:// www.fda.gov. Additionally, we will be video recording the public meeting. Once the recorded video is available, it will be accessible at FDA’s FSMA Web site at http://www.fda.gov/FSMA. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04127 Filed 2–25–16; 8:45 am] BILLING CODE 4164–01–P 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 Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: 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 [123I]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 mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 17:33 Feb 25, 2016 Jkt 238001 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 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 9763 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 [123I]ioflupane from the schedules of controlled substances. 80 FR 54715. [123I]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 [123I]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 [123I]ioflupane, or any drug products that contain [123I]ioflupane, on or after September 11, 2015. Because the decontrol of [123I]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. E:\FR\FM\26FER1.SGM 26FER1 9764 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES 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 [123I]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 [123I]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 DaTscanTM was resolved. Subsequently, effective September 11, 2015, the DEA removed [123I]ioflupane from the schedules of controlled substances. The factors in support of removing [123I]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 [123I]ioflupane from the schedules of controlled substances, all of the VerDate Sep<11>2014 17:33 Feb 25, 2016 Jkt 238001 administrative, civil, and criminal sanctions applicable to controlled substances no longer apply to those persons who handle [123I]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 prepromulgation 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 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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 E:\FR\FM\26FER1.SGM 26FER1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 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 [123I]ioflupane from the schedules of controlled substances. In addition, the exemption provided by the IFR was very similar to the DEAauthorized 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 VerDate Sep<11>2014 17:33 Feb 25, 2016 Jkt 238001 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 [123I]ioflupane from the schedules of controlled substances. The DEA explained in the final rule removing [123I]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 [123I]ioflupane, such as the drug PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 9765 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. 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 [123I]ioflupane from the schedules of controlled substances, the ‘‘C–II’’ label is no longer required on DaTscan packaging. 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. E:\FR\FM\26FER1.SGM 26FER1 9766 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations the Paperwork Reduction Act of 1995, 44 U.S.C. 3501–3521. 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. mstockstill on DSK4VPTVN1PROD with RULES 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. 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. 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 [123I]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 Paperwork Reduction Act of 1995 This rule does not involve a collection of information within the meaning of Accordingly, 21 CFR part 1301 is amended as follows: 17:33 Feb 25, 2016 Jkt 238001 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. § 1301.29 ■ [Removed and Reserved] 2. Remove and reserve § 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 Congressional Review Act Administrative practice and procedure, Drug traffic control, Controlled substances, Drug abuse, Reporting and recordkeeping requirements. VerDate Sep<11>2014 PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9754] RIN 1545–BL59 Disclosures of Return Information Reflected on Returns to Officers and Employees of the Department of Commerce for Certain Statistical Purposes and Related Activities Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. AGENCY: This document contains final regulations that authorize the disclosure of certain items of return information to the Bureau of the Census (Bureau) in conformance with section 6103(j)(1) of the Internal Revenue Code (Code). These regulations finalize temporary regulations that were made pursuant to a request from the Secretary of Commerce. These regulations require no action by taxpayers and have no effect on their tax liabilities. Thus, no taxpayers are likely to be affected by the disclosures authorized by this guidance. DATES: Effective Date: These regulations are effective on February 26, 2016. Applicability Date: For dates of applicability, see § 301.6103(j)(1)–1(e). FOR FURTHER INFORMATION CONTACT: William Rowe, (202) 317–5093 (not a toll-free number). SUPPLEMENTARY INFORMATION: SUMMARY: Background and Explanation of Provisions This document contains amendments to 26 CFR part 301. Section 6103(j)(1)(A) authorizes the Secretary of Treasury to E:\FR\FM\26FER1.SGM 26FER1

Agencies

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9763-9766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04224]


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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