[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Rules and Regulations]
[Pages 4982-4983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1967]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

28 CFR Part 0

[Docket No. DEA-315F]


Redelegation of Functions; Delegation of Authority to Drug 
Enforcement Administration Official

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: Under delegated authority, the Administrator of the Drug 
Enforcement Administration (DEA), Department of Justice, is amending 
the appendix to the Justice Department regulations to redelegate 
certain functions and authority which were vested in the Attorney 
General by the Controlled Substances Act and subsequently delegated to 
the Administrator of DEA.

DATES: Effective Dates: This Final Rule is effective February 1, 2010.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: DEA implements the Comprehensive Drug Abuse 
Prevention and Control Act of 1970, often referred to as the Controlled 
Substances Act (CSA) and the Controlled Substances Import and Export 
Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing 
regulations for these statutes in Title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1399. These regulations are designed 
to ensure that there is a sufficient supply of controlled substances 
for legitimate medical, scientific, research, and industrial purposes 
and to deter the diversion of controlled substances to illegal 
purposes. The CSA mandates that DEA establish a closed system of 
control for manufacturing, distributing, and dispensing controlled 
substances. Any person who manufactures, distributes, dispenses, 
imports, exports, or conducts research or chemical analysis with 
controlled substances must register with DEA (unless exempt) and comply 
with the applicable requirements for the activity. The CSA, as amended, 
also requires DEA to regulate the manufacture and distribution of 
chemicals that may be used to manufacture controlled substances 
illegally. Listed chemicals that are classified as List I chemicals are 
important to the manufacture of controlled substances. Those classified 
as List II chemicals may be used to manufacture controlled substances.

Retail Sales Provisions of the Combat Methamphetamine Epidemic Act of 
2005

    On March 9, 2006, the President signed the Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). Among 
other things, the CMEA amended the CSA to change the regulations for 
selling nonprescription products that contain ephedrine, 
pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, 
and salts of optical isomers. CMEA created a new category of products 
called scheduled listed chemical products. A scheduled listed chemical 
product is defined as a product that contains ephedrine, 
pseudoephedrine, or phenylpropanolamine that may be marketed or 
distributed lawfully in the United States under the Federal Food, Drug, 
and Cosmetic Act as a nonprescription drug (21 U.S.C. 802(45)(A), 21 
CFR 1300.02(b)(34)(i))).
    CMEA established provisions regarding the retail sale of these 
scheduled listed chemical products by regulated sellers (i.e., retail 
distributors including mobile retail vendors) and distributors required 
to submit reports under 21 U.S.C. 830(b)(3) (i.e., mail order 
distributors). These requirements, which were promulgated in 21 CFR, 
part 1314, include, but are not limited to:
     Packaging requirements for nonliquid forms of scheduled 
listed chemical products (i.e., blister packs, with each blister 
containing no more than two dosage units or, if blister packs are 
technically infeasible, in unit dose packets or pouches) (21 CFR 
1314.05).
     Daily sales limits (21 CFR 1314.20).
     Product placement (i.e., placing the product so that 
customers do not have direct access before the sale is made, referred 
to as ``behind the counter'' placement, including circumstances in 
which the product is stored in a locked cabinet located in an area of 
the facility where customers do have direct access) (21 CFR 
1314.25(b)).
     Recordkeeping (i.e., logbook provisions) (21 CFR 1314.30).
     Employee training (21 CFR 1314.35).
     Self-certification (21 CFR 1314.40).

Redelegation of Authority

    The Attorney General has delegated his functions under the CSA to 
the Administrator of the Drug Enforcement Administration (21 U.S.C. 
871(a) and 28 CFR 0.100(b)). The Attorney General has also authorized 
the Administrator to redelegate any of his functions under the CSA to 
any subordinates (28 CFR 0.104). To further enhance the administration 
of the CSA and its regulations, the Administrator is redelegating to 
the Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, and the authority to exercise all necessary 
functions with respect to the promulgation and implementation of 
regulations in 21 CFR, part 1314. This redelegation will empower the 
Deputy Assistant Administrator, among other things, to exercise signing 
authority for any rules, regulations, or procedures which he may deem 
necessary for the efficient execution of the retail sales provisions 
contained in part 1314. Final orders in connection with the suspension 
or revocation of a regulated seller's or mail order distributor's right 
to sell scheduled listed chemical products shall continue to be made by 
the Deputy

[[Page 4983]]

Administrator of the Drug Enforcement Administration.
    The redelegation of signature authority for the regulations in part 
1314 is consistent with the signature authority already redelegated to 
the Deputy Assistant Administrator of the Office of Diversion Control 
pertaining to the promulgation of regulations related to the 
registration of manufacturers, distributors, dispensers, importers, and 
exporters of controlled substances and List I chemicals in parts 1301 
and 1309, respectively (28 CFR Appendix to Subpart R, 7(a), 7(h)).

Regulatory Certifications

Congressional Review Act

    The DEA has determined that this action pertains to DEA management 
and is a rule relating to DEA organization, procedure or practice that 
does not substantially affect the rights or obligations of non-agency 
parties, and, accordingly, is not a ``rule'' as that term is used by 
the Congressional Review Act (Subtitle E of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121). 
Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

Administrative Procedure Act

    This rule redelegates signature authority for the promulgation of 
certain regulations related to the retail sale of scheduled listed 
chemical products from the Deputy Administrator of the DEA to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration. Since the rule relates to agency 
organization, procedure, or practice, it is excepted from the general 
notice requirements of the Administrative Procedure Act (5 U.S.C. 
553(b) pursuant to 5 U.S.C. 553(b)(A). The redelegation of signature 
authority for the regulations in part 1314 is consistent with the 
signature authority already redelegated to the Deputy Assistant 
Administrator, Office of Diversion Control, pertaining to the 
promulgation of regulations related to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances and List I chemicals in parts 1301 and 1309, 
respectively (28 CFR Appendix to Subpart R, 7(a), 7(h)).
    Further, the Administrative Procedure Act permits an agency to make 
this rule effective upon the date of publication as provided by the 
agency for good cause found and published with the rule (5 U.S.C. 
553(d)(3)). As this rule merely redelegates signature authority for 
certain regulations and has no impact on regulated entities, DEA finds 
good cause to make this rule effective upon publication.

Regulatory Flexibility Act

    The Acting Administrator hereby certifies that this rulemaking has 
been drafted in accordance with the Regulatory Flexibility Act (5 
U.S.C. 601-612). This rule will not have a significant economic impact 
on a substantial number of small entities because it pertains to 
administrative matters affecting the DEA. Further, a Regulatory 
Flexibility Analysis was not required to be prepared for this final 
rule because DEA was not required to publish a general notice of 
proposed rulemaking for this matter.

Executive Order 12866

    The Acting Administrator certifies that this rulemaking has been 
drafted in accordance with the principles in Executive Order 12866 
Sec.  1(b). This rule is limited to agency organization, management and 
personnel as described by Executive Order 12866 section (3)(d)(3) and, 
therefore, is not a ``regulation'' or ``rule'' as defined by that 
Executive Order. Therefore, this action has not been reviewed by the 
Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform.

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 rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 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 the provisions of the Unfunded 
Mandates Reform Act of 1995.

List of Subjects in 28 CFR Part 0

    Authority delegations (Government agencies), Government employees, 
Organizations and functions (Government agencies), Privacy, Reporting 
and recordkeeping requirements, Whistleblowing.

0
For the reasons set forth above, and pursuant to the authority vested 
in the Administrator of the Drug Enforcement Administration by 28 CFR 
0.100 and 0.104, and 21 U.S.C. 871, 28 CFR, part 0 is amended as 
follows:

PART 0--ORGANIZATION OF THE DEPARTMENT OF JUSTICE

0
1. The authority citation for part 0 continues to read as follows:

    Authority:  5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519.


0
2. Section 7 of the Appendix to subpart R is amended by adding a new 
paragraph (m) to read as follows:

Appendix to Subpart R of Part 0--Redelegation of Functions

* * * * *

Sec. 7. Promulgation of regulations.

* * * * *
    (m) Part 1314, incident to the retail sale of scheduled listed 
chemical products by regulated sellers and distributors required to 
submit reports under section 310(b)(3) of the Act (21 U.S.C. 
830(b)(3)), except that final orders in connection with suspension 
or revocation of the regulated seller's or mail order distributor's 
right to sell scheduled listed chemical products shall be made by 
the Deputy Administrator of the Drug Enforcement Administration.
* * * * *

    Dated: January 21, 2010.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. 2010-1967 Filed 1-29-10; 8:45 am]
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