[Federal Register Volume 75, Number 108 (Monday, June 7, 2010)]
[Proposed Rules]
[Pages 32140-32142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13521]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1309
[Docket No. DEA-304P]
RIN 1117-AB27
Voluntary Surrender of Certificate of Registration
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to amend
its regulations and to revise applicable implementing forms to clarify
the registration status of a registrant who voluntarily surrenders a
Certificate of Registration for cause. The effect of these proposed
changes would make it clear that a voluntary surrender of a
registration for cause by a registrant has the legal effect of
immediately terminating the registrant's registration without any
further action by DEA.
DATES: Written comments must be postmarked and electronic comments must
be submitted on or before August 6, 2010. 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-304'' on all written and electronic correspondence.
Written
[[Page 32141]]
comments being sent via regular or express mail should be sent to the
Drug Enforcement Administration, Attention: Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
Comments may be sent to DEA by sending an electronic message to
[email protected]. Comments may also be sent
electronically through http://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the http://www.regulations.gov Web site. DEA will
accept attachments to electronic comments in Microsoft word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept
any file format other than those specifically listed here.
Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes because http://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern time on the day the
comment period closes. Commenters in time zones other than Eastern time
may want to consider this so that their electronic comments are
received. All comments sent via regular or express mail will be
considered timely if postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537. Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
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 posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket 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 posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify 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 posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
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. These regulations are silent about
whether the automatic termination provisions apply upon a registrant's
surrender of a DEA registration. Moreover, DEA forms 104 (for
controlled substance registrations) and 104c (for listed chemical
registrations), which are sometimes 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, to terminate a DEA
registration.
DEA regulations, however, do not require any further action by
DEA's Administrator to terminate a DEA registration after the
submission of a voluntary surrender, and in practice, DEA treats the
submission of a voluntary surrender form as an immediate termination of
the DEA registration at issue. The only further action taken by DEA in
such cases is the entry of the surrender into DEA's registration
database. Moreover, DEA regulations do not even 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.
Proposed Action
To ensure that there is no confusion as to actions necessary to
effectuate the voluntary surrender of a DEA registration, DEA intends
to revise 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.
Regulatory Certifications
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), has reviewed this regulation, and by approving
it certifies that this regulation will not have a significant economic
impact upon a substantial number of small entities. This Notice of
Proposed Rulemaking merely clarifies the circumstances under which DEA
registrations may be revoked or surrendered.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this
regulation has been drafted in accordance with the principles of
Executive Order 12866, Section 1(b). It has been determined that this
is a ``significant regulatory action'' under Executive Order 12866, and
accordingly this rule has been reviewed by the Office of Management and
Budget.
Paperwork Reduction Act
This rulemaking would not create any new recordkeeping or reporting
requirements. The forms discussed in this rulemaking are internal to
DEA and are used under specific law enforcement circumstances.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988.
[[Page 32142]]
Executive Order 13132
This 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.
Unfunded Mandates Reform Act of 1995
This rulemaking will not result in the expenditure by State, local,
and tribal governments in the aggregate, or by the private sector, of
$120 million 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 the provisions of the Unfunded
Mandates Reform Act of 1995.
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). 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
proposed to be 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. Section 1301.52(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. 821, 822, 823, 824, 830, 871(b), 875, 877,
886a, 958.
4. Section 1309.62(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: May 26, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-13521 Filed 6-4-10; 8:45 am]
BILLING CODE 4410-09-P