[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61563-61564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25596]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301 and 1309

[Docket No. DEA-304F]
RIN 1117-AB27


Voluntary Surrender of Certificate of Registration

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: DEA is amending its regulations to clarify the registration 
status of a registrant who voluntarily surrenders a Certificate of 
Registration. These changes clarify that a voluntary surrender of a 
registration signed by a registrant using any format has the legal 
effect of immediately terminating the registrant's registration without 
any further action by DEA.

DATES: This rule becomes effective November 4, 2011.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone (202) 307-7165.

SUPPLEMENTARY INFORMATION: 

Background

    Under current regulations, the DEA registration of any person 
terminates ``if and when such person dies, ceases legal existence, or 
discontinues business or professional practice * * *.'' 21 CFR 
1301.52(a) and 1309.62(a). Under these provisions, no further action by 
DEA is needed to terminate a DEA Certificate of Registration after one 
of the specified events occurs. However, these regulations are silent 
about whether the automatic termination provisions apply upon a 
registrant's voluntary surrender of a DEA registration. Moreover, DEA 
Forms 104 (for controlled substance registrations) and 104c (for listed 
chemical registrations), which may be used by registrants to effectuate 
voluntary surrenders, state that submission of the forms ``shall be 
authority for the Administrator of the Drug Enforcement Administration 
to terminate * * * my registration without an order to show cause, a 
hearing, or any other proceedings * * *.'' Thus, the forms have led 
some registrants to believe that DEA must issue a final order revoking 
the registration after submission of the forms in order to terminate a 
DEA registration.
    DEA regulations, however, do not require further action by DEA's 
Administrator to terminate a DEA registration after submission of a 
voluntary surrender and, in practice, DEA treats the submission of a 
voluntary surrender as an immediate termination of the DEA registration 
at issue. The only additional action taken by DEA in such cases is the 
entry of the surrender into DEA's registration database. Further, DEA 
regulations do not require a registrant to use any particular format to 
submit a voluntary surrender. DEA accepts voluntary surrenders as long 
as the registrant submits a signed statement expressing the desire to 
surrender a registration.
    DEA Forms 104 and 104c are internal DEA documents that are 
available for registrant use. These forms will be revised consistent 
with this final rule to clarify that a signed voluntary surrender of a 
registration has the legal effect of immediately terminating the 
registrant's registration upon delivery of such statement to any DEA 
employee. No further action by DEA is required.

Notice of Proposed Rulemaking and Comments Received

    To address the circumstances described above, DEA published a NPRM 
proposing the amendment of its regulations to clarify that a DEA 
registration terminates when DEA, through any employee, receives notice

[[Page 61564]]

of a voluntary surrender of a DEA registration. 75 FR 32140, June 7, 
2010. DEA did not receive any comments regarding the NPRM and is thus 
finalizing the rule as proposed.

Action Taken by This Rule

    To ensure that there is no confusion as to actions necessary to 
effectuate the voluntary surrender of a DEA registration, DEA is 
revising the relevant regulations to state that a DEA registration 
terminates when DEA, through any employee, receives notice of a 
voluntary surrender of a DEA registration. Any format may be used as 
long as the registrant submits a signed statement expressing the desire 
to surrender a registration.

Regulatory Analyses

Executive Orders 12866 and 13563

    This regulation has been developed in accordance with the 
principles of Executive Orders 12866 and 13563. It has been determined 
that this is not a ``significant regulatory action'' that requires 
review by the Office of Management and Budget.

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
has reviewed this regulation and hereby certifies that it has been 
drafted in accordance with the provisions of the Regulatory Flexibility 
Act (5 U.S.C. 601-612), and by approving it certifies that this 
regulation will not have a significant economic impact upon a 
substantial number of small entities. This rulemaking merely clarifies 
the circumstances under which DEA registrations may be surrendered.

Paperwork Reduction Act

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. The forms 
discussed in this rulemaking are available to be utilized by 
registrants on a voluntary basis under specific law enforcement 
circumstances and are otherwise internal to DEA.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards and reduce burden.

Executive Order 13132

    This proposed rulemaking does not preempt or modify any provision 
of State law; nor does it impose enforcement responsibilities on any 
State; nor does it diminish the power of any State to enforce its own 
laws. Accordingly, this rulemaking does not have federalism 
implications warranting the application of Executive Order 13132.

Executive Order 13175

    This proposed rule will not have tribal implications and will not 
impose substantial direct compliance costs on Indian tribal 
governments.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$136,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under provisions of the Unfunded Mandates 
Reform Act of 1995, 2 U.S.C. 1532.

Congressional Review Act

    This rulemaking is not a major rule as defined by Section 804 of 
the Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act) (5 U.S.C. 801-808). This rule will not 
result in an annual effect on the economy of $100 million or more, a 
major increase in costs or prices, or significant adverse effects on 
competition, employment, investment, productivity, innovation or on the 
ability of U.S.-based companies to compete with foreign-based companies 
in domestic and export markets.

List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

    For the reasons set out above, 21 CFR parts 1301 and 1309 are 
amended as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 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.


0
2. In Sec.  1301.52, paragraph (a) is revised to read as follows:


Sec.  1301.52  Termination of registration; transfer of registration; 
distribution upon discontinuance of business.

    (a) Except as provided in paragraph (b) of this section, the 
registration of any person, and any modifications of that registration, 
shall terminate, without any further action by the Administration, if 
and when such person dies, ceases legal existence, discontinues 
business or professional practice, or surrenders a registration. Any 
registrant who ceases legal existence or discontinues business or 
professional practice shall notify the Administrator promptly of such 
fact. In the case of a surrender, termination shall occur upon receipt 
by any employee of the Administration of a duly executed DEA form 104 
or any signed writing indicating the desire to surrender a 
registration.
* * * * *

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS, 
AND EXPORTERS OF LIST I CHEMICALS

0
3. The authority citation for part 1309 continues to read as follows:

    Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 
877, 886a, 952, 958.
0
4. In Sec.  1309.62, paragraph (a) is revised to read as follows:


Sec.  1309.62  Termination of registration.

    (a) The registration of any person shall terminate, without any 
further action by the Administration, if and when such person dies, 
ceases legal existence, discontinues business or professional practice, 
or surrenders a registration. In the case of a surrender, termination 
shall occur upon receipt by any employee of the Administration of a 
duly executed DEA form 104c or any signed writing indicating the desire 
to surrender a registration. Any registrant who ceases legal existence 
or discontinues business or professional practice or wishes to 
surrender a registration shall notify the Special Agent in Charge of 
the Administration in the area in which the person is located of such 
fact and seek authority and instructions to dispose of any List I 
chemicals obtained under the authority of that registration.
* * * * *

    Dated: September 27, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2011-25596 Filed 10-4-11; 8:45 am]
BILLING CODE 4410-09-P