4982 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

■ 8. Section 1309.25 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 1309.25 Temporary exemption from 

registration for chemical registration 

applicants. 

* * * * * 

(c) Each person required by sections 

302 or 1007 of the Act (21 U.S.C. 822 

or 957) to obtain a registration to 

manufacture or import prescription drug 

products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine is temporarily 

exempted from the registration 

requirement, provided that the person 

submits a proper application for 

registration on or before March 3, 2010. 

The exemption will remain in effect for 

each person who has made such 

application until the Administration has 

approved or denied the application. 

This exemption applies only to 

registration; all other chemical control 

requirements set forth in this part and 

parts 1310, 1313, and 1315 of this 

chapter remain in full force and effect. 

Dated: January 22, 2010. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2010–1968 Filed 1–29–10; 8:45 am] 

BILLING CODE 4410–09–P 

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. 

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 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 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 § 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. 

■ 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 

■ 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. 

■ 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] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2008–0918; FRL–8438–4] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

section 5(a)(2) of the Toxic Substances 

Control Act (TSCA) for 15 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Three 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action requires 

persons who intend to manufacture, 


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