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[Federal Register: June 7, 2010 (Volume 75, Number 108)]
[Proposed Rules]               
[Page 32140-32142]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn10-11]                         

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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 
dea.diversion.policy@usdoj.gov. 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
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