Rules - 2011
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61563-61564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25596]
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.
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
- 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.
- 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
- 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.
- 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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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