Drug Enforcement Administration (DEA), Justice.
Notice of proposed rulemaking.
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.
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.
To ensure proper handling of comments, please reference “Docket No. DEA-304” on all written and electronic correspondence. Written Start Printed Page 32141comments 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@example.com. 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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.
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.
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 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.
This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988.Start Printed Page 32142
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.Start List of Subjects
List of SubjectsEnd List of Subjects
For the reasons set out above, 21 CFR parts 1301 and 1309 are proposed to be amended as follows:Start Part
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1. The authority citation for part 1301 continues to read as follows:
2. Section 1301.52(a) is revised to read as follows:
(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:
4. Section 1309.62(a) is revised to read as follows:
(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