Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Rules and Regulations 70085 

Abbreviation Commenter 

SCE ................................................. Southern California Edison. 

SDG&E ............................................ San Diego Gas & Electric. 

SIA .................................................. Security Industry Association. 

Southern .......................................... Southern Company Services, Inc. 

TAPS ............................................... Transmission Access Policy Study Group. 

TVA ................................................. Tennessee Valley Authority. 

Trade Associations ......................... American Public Power Association, Large Public Power Council, National Rural Electric Cooperative Association. 

Xcel ................................................. Xcel Energy Services Inc. 

Reply Commenters 

Foundation ...................................... Foundation for Resilient Societies. 

ITC .................................................. International Transmission Company. 

NIPSCO .......................................... Northern Indiana Public Service Company. 

SmartSenseCom ............................. SmartSenseCom, Inc. 

SWTDUG ........................................ Southwest Transmission Dependent Utility Group. 

Tallahassee ..................................... City of Tallahassee. 

[FR Doc. 2014–27908 Filed 11–24–14; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1301 

[Docket No. DEA–394] 

RIN 1117–AB38 

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 DaTscanTM

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Interim final rule with request 

for comment. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is amending its 

regulations to waive the requirement of 

registration for persons who are 

authorized under United States Nuclear 

Regulatory Commission or Agreement 

State medical use licenses or permits 

and administer the drug product 

DaTscanTM. 

DATES: Effective November 25, 2014. 

Interested persons may file written 

comments on this interim final rule 

pursuant to 5 U.S.C. 553. Electronic 

comments must be submitted, and 

written comments must be postmarked, 

on or before January 26, 2015. 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

midnight Eastern Time on the last day 

of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–394’’ on all electronic and 

written correspondence. The DEA 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal which 

provides the ability to type short 

comments directly into the comment 

field on the Web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Paper comments 

that duplicate electronic submissions 

are not necessary. Should you, however, 

wish to submit written comments in 

lieu of electronic comments, they must 

be sent via regular or express mail to: 

Drug Enforcement Administration, 

Attention: DEA Federal Register 

Representative/ODXL, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record and 

will be made available for public 

inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

The Freedom of Information Act 

(FOIA) applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be made publicly available. 

Comments containing personal 

identifying information or confidential 

business information identified as 

directed above will be made publicly 

available in redacted form. 

An electronic copy of this document 

and supplemental information to this 

interim final rule with request for 

comment are available at http://

www.regulations.gov for easy reference. 

If you wish to personally inspect the 

comments and materials received or the 

supporting documentation the DEA 

used in preparing the interim final rule 

with request for comment, these 

materials will be available for public 

inspection by appointment. To arrange 

a viewing, please see the FOR FURTHER

INFORMATION CONTACT paragraph above. 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 


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70086 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Rules and Regulations 

1The DEA continues to review the control status 

of [123I] Ioflupane pursuant to 21 U.S.C. 811. While 

this interim final rule with request for comment is 

separate and apart from the control process, and 

does not resolve the control status of [123I] 

Ioflupane, this waiver of registration is designed to 

encourage use of this drug product as a diagnostic 

tool until the control status of [123I] Ioflupane is 

resolved. 

2An Agreement State is defined as any State with 

which the Nuclear Regulatory Commission or the 

Atomic Energy Commission has entered into an 

effective agreement under subsection 274b of the 

Atomic Energy Act of 1954, as amended (the Act). 

Further, Section 274 of the Act provides a statutory 

basis under which the NRC discontinues its 

regulatory authority to regulate byproduct 

materials; source materials; and small quantities of 

special nuclear materials. The Agreement State 

assumes authority from the NRC with its own 

compatible legislation and regulations, including 

compatible requirements to 10 CFR part 35, once 

the Agreement is signed in accordance with Section 

274b of the Act. Agreement States implement 

regulatory programs to regulate byproduct, source 

and certain special nuclear materials that are 

compatible with NRC requirements and adequate to 

protect public health and safety. 

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. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), parts 1300 to 1321. 

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, every controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, currently accepted medical use, 

and the degree of dependence the drug 

or other substance may cause. 21 U.S.C. 

812. The initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of 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 him.’’ 

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 

by the Attorney General in accordance 

with the rules and regulations 

promulgated by him.’’ 

The Attorney General however may, 

by regulation, waive the requirement for 

registration of certain manufacturers, 

distributors, or dispensers if he 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’’). Section 7 of 

28 CFR part 0, subpart R, App. 

Purpose and Background of the 

Regulatory Action 

On May 10, 1994, the United States 

Patent and Trademark Office issued a 

patent to GE Healthcare, the sole 

manufacturer of the radioactive drug 

DaTscanTM, for 20 years for the 

development of DaTscanTM. On January 

14, 2011, the U.S. Food and Drug 

Administration (FDA) approved 

DaTscanTM as a diagnostic tool 

containing a radioisotopic form of 

ioflupane, [123I]ioflupane. This product 

is approved for medical use and was 

simultaneously granted exclusive 

marketing rights to GE Healthcare for 

five years in accordance with 21 CFR 

314.108. Ioflupane is a schedule II 

controlled substance under the CSA. 

The FDA approved labeling of 

DaTscanTM states that DaTscanTM is a 

radiopharmaceutical indicated for 

striatal dopamine transporter 

visualization using single photon 

emission computed tomography 

(SPECT) brain imaging to assist in the 

evaluation of adult patients with 

suspected Parkinsonian syndromes (PS). 

DaTscanTM is an adjunct to other 

diagnostic evaluations, and it may be 

used to help differentiate essential 

tremors from tremors due to PS, 

(idiopathic Parkinson’s disease (PD), 

multiple system atrophy (MSA), and 

progressive supranuclear palsy (PSP)). 

According to GE Healthcare, DaTscanTM

was not designed to distinguish among 

PD, MSA, and PSP. However, the results 

created by the contrast that occurs after 

the administration of DaTscanTM may 

also be used to help rule out other 

diseases that may have similar 

symptoms, like essential tremor, for 

individuals early in the course of their 

disease. 

Because DaTscanTM contains 

[123I]ioflupane, a schedule II controlled 

substance, it may only be handled by 

entities registered with the DEA to 

handle schedule II controlled 

substances.1 However, due to its I–123 

radioactive component, the handling of 

DaTscanTM in the United States is also 

strictly controlled by Federal and State 

laws limiting distribution to licensed 

radiopharmacies and certain licensed 

medical facilities. It is regulated by the 

United States Nuclear Regulatory 

Commission (NRC) under 10 CFR part 

35 or by an Agreement State 2 under 

equivalent Agreement State 

requirements. NRC also authorizes 

certain Federal Agencies (i.e., Master 

Materials licensees (MML)) to issue 

their medical facilities medical use 

permits that are equivalent to NRC 

medical use licenses. The NRC and 

Agreement States require those medical 

facilities administering radioactive 

medical byproduct material to obtain a 

medical use license or permit and 

comply with specific regulations 

pertaining to security, recordkeeping, 

and reporting. Id. In accordance with 10 

CFR parts 20 and 35 and equivalent 

Agreement State requirements, 

applicants for NRC and Agreement State 

licensure must comply with and 

demonstrate radiation safety 

precautions and instructions, 

methodologies for measurement of 

dosages to be administered, physical 

security of medical byproduct material, 

and recordkeeping requirements. 

As a result of these overlapping 

registration/licensing requirements, 

DaTscanTM is available only by 

authorization from a DEA-registered 

practitioner. Therefore, it may only be 

administered to a patient by physicians 

authorized under an NRC or an 

Agreement State license or NRC MML 

permit to perform imaging and 

localization studies under 10 CFR 

35.200 or equivalent Agreement State 

requirements who are also registered 

with the DEA to administer schedule II 

controlled substances. Accordingly, 

only NRC- or Agreement State-licensed 

or NRC MML permitted radiology 

imaging centers that are also registered 

with the DEA to handle schedule II 

controlled substances, such as hospitals 

and private practice imaging centers, 

may conduct diagnostic analysis using 

DaTscanTM. 

Currently, GE Healthcare 

manufactures DaTscanTM and provides 

it directly to its DEA-registered 

radiopharmacies, who then transfer it to 

DEA-registered imaging centers for 

administration and scanning 

procedures. This process occurs in a 

closed system of distribution that is 

currently regulated by both the DEA and 

the NRC/Agreement State. 


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3Persons that handle other controlled substances 

in addition to DaTscanTM must be registered with 

the DEA to handle those other controlled 

substances. 

In addition to qualifying for 

registration with the DEA pursuant to 21 

U.S.C. 823(f), practitioners must adhere 

to controls pertaining to physical 

security, reporting, and recordkeeping, 

in order to detect and prevent diversion 

of controlled substances. See, e.g., 21 

CFR 1301.75–1301.76, 1304.21–1304.22. 

For example, DEA-registered 

pharmacies and institutional 

practitioners may disperse controlled 

substances throughout the stock of noncontrolled substances in such a manner 

as to obstruct the theft or diversion of 

the controlled substances; they must 

also report thefts or significant losses of 

controlled substances to the DEA within 

one business day of discovery; 

dispositions of schedule II controlled 

substances must be authorized by a DEA 

Form 222; and they must maintain 

specified records of each transaction 

involving a controlled substance for a 

period of two years. 

The NRC and Agreement States 

require that any person who 

manufactures, produces, acquires, 

receives, possesses, prepares, uses, or 

transfers radioactive byproduct material 

for medical use do so only in 

accordance with a specific medical use 

license issued by the NRC or an 

Agreement State or permit issued by an 

NRC MML. See 10 CFR 35.11–12. 

Radioisotope I–123 meets the definition 

of byproduct material in paragraph 3B 

of Section 11e. of the Atomic Energy Act 

(AEA), as revised in 1978 and in 2005 

by the Energy Policy Act (EPAct) (i.e., 

any material that has been made 

radioactive by use of a particle 

accelerator; and is produced, extracted, 

or converted after extraction, before, on, 

or after August 8, 2005, for use for a 

commercial, medical, or research 

activity). 

The NRC and Agreement States 

regulate licensed materials (i.e., 

byproduct material) which must be 

tracked from initial production to final 

disposal in order to ensure 

accountability; to identify when 

licensed material could be lost, stolen, 

or misplaced; and to ensure that 

possession limits listed on the license 

are not exceeded. 

In accordance with 10 CFR 20.1101, 

licensees are required to implement a 

radiation protection program that 

requires licensees to develop, 

document, and implement procedures 

to ensure the security and safe use of all 

the licensed material from the time it 

arrives at their facilities until it is used, 

transferred, or disposed of. The DEA 

regulations require practitioners to 

‘‘provide effective controls and 

procedures to guard against theft and 

diversion of controlled substances.’’ 21 

CFR 1301.71(a). In addition, in 

accordance with 21 CFR 1301.75(b), 

practitioners must store schedule II 

controlled substances in a securely 

locked, substantially constructed 

cabinet. However, pharmacies and 

institutional practitioners (e.g., 

hospitals) may ‘‘disperse such 

substances throughout the stock of 

noncontrolled substances in such a 

manner as to obstruct the theft or 

diversion of the controlled substances.’’ 

Id. 

The NRC and Agreement States also 

require distributor-licensees to verify 

the licensure status of each recipient 

prior to transferring radioactive 

byproduct material each time it is 

transferred. See 10 CFR 30.41. In 

contrast to the NRC/Agreement State 

regulations and licensure requirements, 

the DEA in accordance with 21 CFR 

1301.74(a) has mandated that ‘‘before 

distributing a controlled substance to 

any person who the registrant does not 

know to be registered to possess the 

controlled substance, the registrant shall 

make a good faith inquiry either with 

the Administration or with the 

appropriate State controlled substances 

registration agency, if any, to determine 

that the person is registered to possess 

the controlled substance.’’ 

The NRC and Agreement States also 

require licensees to comply with 

recordkeeping requirements for three 

years from the date of receipt and to 

provide the NRC with accurate records 

for the receipt, transfer, and disposal of 

the byproduct material in accordance 

with 10 CFR 30.51. This is more 

stringent than the DEA regulations, 

which require registrants to maintain 

records for a period of two years for 

inspection and copying by the DEA. See 

21 CFR 1304.04(a). 

With this interim final rule, the DEA 

is only waiving registration 

requirements specifically for persons 

administering DaTscanTM directly to 

patients for diagnostic purposes.3

Persons administering the specific drug 

product DaTscanTM are exempt from 

requirements pertaining to registration, 

security, recordkeeping, and reporting. 

In addition, the drug product 

DaTscanTM is exempt from the labeling 

and packaging requirements of the CSA. 

Exempt persons must follow the 

applicable NRC or Agreement State 

regulations and requirements when 

handling DaTscanTM. 

Because persons who administer 

DaTscan are subject to strict NRC/

Agreement State requirements, the DEA 

has determined that the waiver from 

registration of persons who administer 

DaTscanTM is consistent with the public 

health and safety. These exempt persons 

must be authorized by a valid NRC or 

Agreement State medical use license or 

NRC MML medical use permit for 

imaging or localization studies under 

35.200 or equivalent Agreement State 

requirements and be subject to security, 

oversight, and monitoring that is as 

stringent as that provided by the CSA 

and its implementing regulations. 

Compliance with NRC or Agreement 

State requirements significantly reduces 

the risk of diversion, thereby ensuring 

that the public health and safety will 

not be compromised by this waiver. 

Finally, in accordance with the AEA 

disposal requirements in 10 CFR 

20.2002 through 20.2005, the licensee is 

required to dispose of the radioactive 

medical waste while complying with 

environmental and health protection 

regulations. Since DaTscanTM has a 

radiologic shelf life of less than 36 

hours, it cannot be stored for any 

significant amount of time between the 

time it is manufactured and the time it 

is administered to a patient, thereby 

minimizing the risk of diversion during 

the transfer process and decreasing the 

time to detect theft or loss. Accordingly, 

those persons waived from registration 

and other requirements by this interim 

final rule (i.e., those persons 

administering DaTscanTM directly to 

patients for diagnostic purposes) will be 

also exempted from the disposal 

requirements of 21 CFR part 1317, and 

the manufacturers and distributors of 

DaTscanTM will be required to comply 

with the DEA disposal regulations (21 

CFR part 1317) in order to ensure that 

any drug product that is not 

administered or that remain after 

administration is not diverted to illicit 

use. 

Under this interim final rule, a DEAregistered practitioner must prepare a 

record containing the practitioner’s 

name and signature, DEA registration 

number, drug product name, date the 

record was signed, and patient name, 

and provide this record to the patient. 

The record must be transferred by the 

patient to the imaging center. The 

imaging center will then request the 

drug product DaTscanTM from the DEAregistered distributor by providing the 

written record as authorization to 

transfer the drug product. The DEAregistered distributor shall maintain this 

document as the record of the 

transaction. The DEA-registered 

distributor will verify that the imaging 

center has a current, valid NRC or 

Agreement State medical use license or 


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NRC MML medical use permit that 

authorizes imaging and localization and 

if it does, the distributor will then 

request the drug product DaTscanTM

from the manufacturer. After receipt of 

the drug product DaTscanTM from the 

manufacturer, the distributor will 

transfer the ordered amount of the drug 

product DaTscanTM to the imaging 

center for the test. The DaTscanTM will 

be administered to the patient, and the 

test will be performed. Any DaTscanTM

that is not administered or that remains 

after the administration will then be 

returned to the distributor by the 

licensee and subsequently disposed of 

in accordance with the DEA disposal 

regulations. Both the DEA-registered 

distributor and the DEA-registered 

manufacturer must comply with all DEA 

regulations pertaining to schedule II 

controlled substances including 

security, registration, and 

recordkeeping. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

This interim final rule, which waives 

registration for persons authorized 

under United States Nuclear Regulatory 

Commission or Agreement State 

medical use licenses or NRC MML 

medical use permits, who administer 

the drug product DaTscanTM directly to 

patients for diagnostic purposes, 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. 

Further, both Executive Orders 12866 

and 13563 direct agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The DEA 

assessed the costs and benefits of this 

regulation and believes that the 

regulatory approach selected maximizes 

net benefits. 

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 Deputy Assistant Administrator, 

in accordance with the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601– 

612), has reviewed this regulation and 

by approving it certifies that this 

regulation will not have a significant 

economic impact on a substantial 

number of small entities. The RFA 

applies ‘‘[w]henever an agency is 

required by section 553 of [the APA], or 

any other law, to publish a general 

notice of proposed rulemaking for any 

proposed rule.’’ 5 U.S.C. 603. Here, the 

DEA for good cause finds that notice 

and comment procedures are 

unnecessary and contrary to the public 

interest because without prompt waiver 

of registration, some members of the 

healthcare community may not be able 

to utilize the diagnostic tool. 

Accordingly, these rules are being 

adopted on an interim final basis. 

Additionally, this interim final rule is 

alleviating regulatory restrictions on 

those affected by its implementation. 

Although, the DEA does not have a 

basis to estimate the number of affected 

entities and quantify the economic 

impact of this interim final rule, a 

qualitative analysis indicates that this 

interim final rule is likely to result in 

some cost savings for the healthcare 

industry. The affected entities will 

continue to meet NRC or Agreement 

State requirements for licensure, 

security, recordkeeping, and reporting, 

which in many cases are more stringent 

than the DEA’s requirements. The DEA 

estimates cost savings will be realized 

from the removal of DEA requirements 

for those administering the drug product 

DaTscanTM that are duplicative of NRC 

or Agreement State requirements, such 

as: Registration fees, recordkeeping, and 

periodic reports. While the DEA does 

estimate that this interim final rule will 

provide some cost savings, it does not 

believe the savings will be significant 

since the affected entities are required to 

continue to meet NRC requirements for 

handling DaTscanTM. 

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 United States-based companies to 

compete with foreign-based companies 

in domestic and export markets. 

However, pursuant to the CRA, the DEA 

has submitted a copy of this interim 

final rule with request for comment to 

both Houses of Congress and to the 

Comptroller General. 

Administrative Procedure Act 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act 

(APA), including notice of proposed 

rulemaking and the pre-promulgation 

opportunity for public comment, if it is 

determined to be unnecessary, 


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impracticable, or contrary to the public 

interest (5 U.S.C. 553 (b)(B)). The DEA 

for good cause finds that it is 

unnecessary and contrary to the public 

interest to seek public comment prior to 

promulgating this interim final rule 

because, without prompt waiver of 

registration, some members of the 

healthcare community may not be able 

to utilize this diagnostic tool and 

patients in need may not receive it. 

DaTscanTM is an important tool in 

differentiating essential tremors from 

tremors due to Parkinsonian Syndrome 

(PS) and can help healthcare 

professionals provide more accurate 

diagnoses. These rules are therefore, 

being adopted on an interim final basis. 

Additionally, the DEA is alleviating the 

regulatory burdens on those 

administering the drug product 

DaTscanTM. Furthermore, this 

alleviation will mean that patients have 

a greater chance of receiving important 

diagnostic testing. 

In addition, the APA permits an 

agency to make effective upon date of 

publication ‘‘a substantive rule which 

grants or recognizes an exemption or 

relieves a restriction.’’ 5 U.S.C. 553 

(d)(1). The DEA finds that this interim 

final rule with request for comments 

meets the criterion set forth in 5 U.S.C. 

553 (d)(1) for an exception to the APA 

effective date requirement. 

List of Subjects in 21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, 

Controlled substances, Drug abuse, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1301 is amended as follows: 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

■ 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, unless otherwise noted. 

■ 2. Add a new § 1301.29 to read as 

follows: 

§ 1301.29 Registration waivers; exemption 

from practitioner registration for persons 

authorized by a United States Nuclear 

Regulatory Commission or agreement state 

medical use license or permit and 

administering the drug product DaTscanTM

(a) The requirement of registration is 

waived for persons administering the 

drug product DaTscanTM to a patient for 

diagnostic purposes if the person is 

authorized by a valid medical use 

license or permit issued by the United 

States Nuclear Regulatory Commission 

(NRC) or NRC master materials licensee 

or an agreement state authorizing the 

person to receive, possess, use, or 

transfer byproduct material in 

accordance with NRC or agreement state 

rules and regulations. 

(1) As used in this section, 

‘‘agreement state’’ is any state with 

which the NRC or the Atomic Energy 

Commission has entered into an 

effective agreement under Section 

274(b) of the Atomic Energy Act of 

1954, as amended. As of October 2014, 

those states considered ‘‘non-agreement 

states’’ include: Alaska, Connecticut, 

Delaware, Hawaii, Idaho, Indiana, 

Michigan, Missouri, Montana, South 

Dakota, Vermont, Washington, DC, West 

Virginia, and Wyoming. All other states 

have entered into agreements with the 

NRC. 

(2) This section does not exempt 

persons identified in this paragraph (a) 

from any statutory or regulatory 

requirements pertaining to any 

controlled substance other than the drug 

product DaTscanTM. 

(3) This section does not exempt from 

the requirement of registration persons 

who prescribe, or order the 

administration of, the drug product 

DaTscanTM. 

(b) Persons identified in paragraph (a) 

of this section are exempt from 

application of 21 U.S.C. 822(a)(2), 827, 

and 828 (registration, records, reports, 

and order forms) and sections 1301.71, 

1301.75, and 1301.76 of this chapter 

(practitioner security), to the extent 

described in paragraphs (e) and (f) of 

this section, only with respect to 

administering the drug product 

DaTscanTM. 

(c) The drug product DaTscanTM is 

exempt from application of 21 U.S.C. 

825 and § 1302.03 of this chapter to the 

extent described in paragraph (d) of this 

section. 

(d) Labeling and packaging. In lieu of 

the requirements set forth in part 1302 

of this chapter, the label and the 

packaging of the drug product 

DaTscanTM must be prominently 

marked with its full trade name or other 

description and the name of the 

manufacturer in such a way that the 

product can be readily identified as the 

drug product DaTscanTM. The symbol 

designating the schedule of the drug 

product DaTscanTM is not required on 

either the label or the packaging of the 

drug product DaTscanTM. 

(e) Registration and security. Any 

person who manufactures or distributes 

the drug product DaTscanTM must be 

registered under the Act and comply 

with all relevant security requirements 

regarding the schedule II controlled 

substances being distributed or used in 

the manufacturing process. Any person 

identified in paragraph (a) of this 

section is not required to be registered 

under the Act to handle the drug 

product DaTscanTM, and these persons 

are not required to store the drug 

product DaTscanTM in accordance with 

security requirements regarding 

controlled substances. 

(f) Records and reports. Any person 

who manufactures or distributes the 

drug product DaTscanTM must keep 

complete and accurate records and file 

all reports required under part 1304 of 

this chapter regarding all controlled 

substances distributed or used in the 

manufacturing process for the drug 

product DaTscanTM. In reports required 

by 21 CFR 1304.33 due to transactions 

with persons identified in paragraph (a) 

of this section, the DEA registration 

number of the person identified in 

paragraph (a) is not required to be 

reported. Any person identified in 

paragraph (a) who handles the drug 

product DaTscanTM is not required to 

maintain records or file reports required 

by the Act or its implementing 

regulations. The authorizing practitioner 

shall prepare a record containing the 

practitioner’s name, signature, date of 

authorization, DEA registration number, 

drug product name, and patient name, 

and provide this record to the patient. 

This record prepared by the DEA 

registered practitioner shall be used as 

the distributor’s record of the 

distribution. 

(g) Criminal penalties No exemption 

granted pursuant to this section affects 

the criminal liability for illegal 

manufacture, distribution, or possession 

of controlled substances contained in 

the drug product DaTscanTM. Use of the 

drug product DaTscanTM is lawful for 

registrants and nonregistrants only as 

long as such activity is intended for 

administration for diagnostic purposes. 

(h) The persons identified in 

paragraph (a) of this section shall return 

all unused drug product DaTscanTM to 

the DEA-registered distributor from 

whom the person received it, for 

disposal in accordance with 10 CFR 

20.2001–20.2008. 

(i) Once the drug product DaTscanTM

is returned to the appropriate DEAregistered distributor, it shall be 

disposed of in accordance with the 

following procedures: 

(1) The DEA-registered distributor 

shall keep a record of the return; 

(2) After receipt of the drug product 

DaTscanTM, the DEA-registered 

distributor shall hold the drug product 

DaTscanTM until it is no longer 

considered low-level radioactive waste 


wreier-aviles on DSK4TPTVN1PROD with RULES
70090 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Rules and Regulations 

1 Generally, contributions by employees to 

defined benefit plans (whether mandatory or 

voluntary) are not deductible for federal income tax 

purposes. 

2See also ERISA section 204(c)(2)(B). References 

to the Code in this preamble should be read to 

include the parallel provision under ERISA. 

3Plan assets must be allocated to each priority 

category in succession, beginning with priority 

category one (PC1). The benefits assigned to each 

priority category under section 4044 of ERISA in 

general are as follows: 

• PC1: The portion of a participant’s accrued 

benefit derived from the participant’s voluntary 

contributions. 

• PC2: The portion of a participant’s accrued 

benefit derived from the participant’s mandatory 

contributions. 

in accordance with 10 CFR 

20.2001(a)(2); and 

(3) After the drug product DaTscanTM

is no longer considered low-level 

radioactive waste, the DEA-registered 

distributor shall dispose of all unused 

DaTscanTM in accordance with 21 CFR 

part 1317. 

(j) The exemptions specified in this 

section are not applicable to the drug 

product DaTscanTM if there are any 

changes in the quantitative or 

qualitative composition of the 

preparation or mixture after the date of 

this regulation, or change in the trade 

name or other designation of the drug 

product DaTscanTM. 

Dated: November 18, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–27917 Filed 11–24–14; 8:45 am] 

BILLING CODE 4410–09–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4001, 4022, and 4044 

RIN 1212–AB23 

Title IV Treatment of Rollovers From 

Defined Contribution Plans to Defined 

Benefit Plans 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: In April 2014, PBGC proposed 

to amend its regulations to clarify the 

treatment of benefits resulting from a 

rollover distribution from a defined 

contribution plan to a defined benefit 

plan, if the defined benefit plan was 

terminated and trusteed by PBGC. 

Under the proposal, a benefit resulting 

from rollover amounts generally would 

not be subject to PBGC’s maximum 

guaranteeable benefit or phase-in 

limitations and would be in the second 

highest priority category of benefits in 

the allocation of assets. PBGC is now 

finalizing that proposal. Except for 

making minor clarifications suggested 

by commenters, the final regulation is 

the same as the proposed regulation. 

This rulemaking is part of PBGC’s 

efforts to enhance retirement security by 

promoting lifetime income options. 

DATES: Effective December 26, 2014. See 

Applicability in SUPPLEMENTARY

INFORMATION. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion (klion.catherine@

pbgc.gov), Assistant General Counsel, 

Office of the General Counsel, Pension 

Benefit Guaranty Corporation, 1200 K 

Street NW., Washington, DC 20005– 

4026; 202–326–4024. (TTY and TDD 

users may call the Federal relay service 

toll free at 1–800–877–8339 and ask to 

be connected to 202–326–4024.) 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose of the Regulatory Action 

This regulatory action is needed to 

provide guidance on treatment of 

benefits resulting from a rollover 

distribution from a defined contribution 

plan to a defined benefit plan, where the 

defined benefit plan is terminated and 

trusteed by the Pension Benefit 

Guaranty Corporation (PBGC). 

Legal authority for this action comes 

from section 4002(b)(3) of the Employee 

Retirement Income Security Act of 1974 

(ERISA), which authorizes PBGC to 

issue regulations to carry out the 

purposes of Title IV of ERISA, section 

4022 of ERISA (Single-Employer Plan 

Benefits Guaranteed), and section 4044 

of ERISA (Allocation of Assets). 

Major Provisions of the Regulatory 

Action 

Under the final regulation, a benefit 

resulting from rollover amounts 

generally will be in the second highest 

priority category among various classes 

of benefits in the allocation of assets and 

generally will not be subject to PBGC’s 

maximum guaranteeable benefit or 

phase-in limitations. 

Background 

PBGC administers the singleemployer pension plan termination 

insurance program under Title IV of 

ERISA. The program covers privatesector, single-employer defined benefit 

plans, for which premiums are paid to 

PBGC each year. Covered plans that are 

underfunded may terminate either in a 

distress termination under section 

4041(c) of ERISA or in an involuntary 

termination (one initiated by PBGC) 

under section 4042 of ERISA. When 

such a plan terminates, PBGC typically 

is appointed statutory trustee of the 

plan, and becomes responsible for 

paying benefits in accordance with the 

provisions of Title IV. At times, plans 

trusteed by PBGC include contributions 

made by employees that fund part of the 

benefit under the plan. 

Mandatory Contributions 

A plan may be funded in whole or in 

part by mandatory contributions. Under 

section 4044(b)(6) of ERISA, the term 

‘‘mandatory contributions’’ means 

amounts contributed to the plan by a 

participant that are required as a 

condition of employment, as a condition 

of participation in such plan, or as a 

condition of obtaining benefits under 

the plan attributable to employer 

contributions. 

Typically, mandatory employee 

contributions are required under the 

plan as a percentage of the employee’s 

compensation. They are withheld from 

the salary of the employee by the 

employer and deposited to the 

employee’s credit in the defined benefit 

plan on an after-tax basis.1 Such 

mandatory employee contributions have 

generally been used to fund a portion of 

the participant’s accrued benefit as 

determined under the plan’s benefit 

formula and are required in order to 

receive the portion of the accrued 

benefit derived from employer 

contributions. 

Section 411(c)(2)(B) of the Code 2

provides that, in the case of a defined 

benefit plan, the accrued benefit derived 

from mandatory employee contributions 

is equal to the employee’s contributions 

accumulated to normal retirement age 

using specified rates under section 

411(c)(2)(C), and converted to an 

actuarially equivalent annuity 

commencing at normal retirement age, 

using an interest rate under section 

417(e)(3) of the Code as of the 

determination date. Section 411(c)(1) of 

the Code provides that an employee’s 

accrued benefit derived from employer 

contributions as of any date is the 

excess, if any, of the accrued benefit for 

the employee as of that date over the 

accrued benefit derived from 

contributions made by the employee as 

of that date. 

PBGC Treatment of Mandatory 

Employee Contributions in Terminated 

Plans 

When a plan terminates in a distress 

termination or an involuntary 

termination, each participant’s plan 

benefit is assigned to one or more of six 

‘‘priority categories’’ that are described 

in paragraphs (1) through (6) of section 

4044(a) of ERISA.3 Participants’ accrued 


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