Drug Enforcement Administration (DEA), Department of Justice.
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.
This rule becomes effective November 4, 2011.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone (202) 307-7165.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 61564of 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.
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.
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.
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.
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.Start List of Subjects
List of SubjectsEnd List of Subjects
For the reasons set out above, 21 CFR parts 1301 and 1309 are amended as follows:Start Part
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCESEnd Part Start Amendment Part
1. The authority citation for part 1301 continues to read as follows:End Amendment Part Start Amendment Part
2. In § 1301.52, paragraph (a) is revised to read as follows:End Amendment Part
(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 CHEMICALSEnd Part Start Amendment Part
3. The authority citation for part 1309 continues to read as follows:End Amendment Part Start Amendment Part
4. In § 1309.62, paragraph (a) is revised to read as follows:End Amendment Part
(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