[Federal Register Volume 68, Number 47 (Tuesday, March 11, 2003)]
[Rules and Regulations]
[Pages 11471-11472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5528]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA-242F]
RIN 1117-AA74


Maintenance of Records; Technical Correction

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is hereby correcting 
its regulations to reinstate a paragraph which was inadvertently 
removed by a previous rulemaking. This final rule reinstates that 
paragraph and makes conforming amendments to a related paragraph.

EFFECTIVE DATE: March 11, 2003.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Background

    On October 11, 1994, DEA published a final rule in the Federal 
Register (59 FR 51365) amending 21 CFR 1310.04 by eliminating the 
threshold for the List I chemical ephedrine. DEA did this by adding 
paragraph (g) and subparagraphs (1), (1)(i), (1)(ii), and (2). 
Subsequently, on October 17, 2001, DEA published a final rule in the 
Federal Register making red phosphorus, white phosphorus and 
hypophosphorous acid (and its salts) List I chemicals (66 FR 52670). At 
the same time, DEA did not establish thresholds for these chemicals. 
DEA did this by amending 21 CFR 1310.04(g)(1) by adding new 
subparagraphs (1)(ii), (1)(iii), and (1)(iv). Finally, on March 28, 
2002, DEA further amended 21 CFR 1310.04 by publishing a final rule in 
the Federal Register implementing the provisions of the Comprehensive 
Methamphetamine Control Act of 1996 (MCA) (67 FR 14853). Within this 
rulemaking, DEA failed to note the October 17, 2001, amendments to 
paragraph (g) and, therefore, inadvertently removed paragraph (g) and 
all its subparagraphs. Further, in its March 28, 2002, rulemaking DEA 
placed ephedrine, its salts, optical isomers, and salts of optical 
isomers in paragraph (f)(1)(i).
    To correct the inadvertent removal of 21 CFR 1310.04(g) as amended, 
and to comply with the current language of 21 CFR 1310.04(f) and the 
intended language of 21 CFR 1310.04(g), this final rule removes the 
listing of ``ephedrine, its salts, optical isomers, and salts of 
optical isomers'' from the chart in 21 CFR 1310.04(f)(1)(i) since there 
is no threshold for ephedrine. This final rule then reinstates 
paragraph (g) of 21 CFR 1310.04 as amended, discussing List I chemicals 
for which no thresholds have been established. Finally, this final rule 
amends subparagraph (f)(1)(ii) to reference paragraph (g).

[[Page 11472]]

Regulatory Certifications

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (5 U.S.C. 553), 
including notice of proposed rulemaking and the opportunity for public 
comment, if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. The Drug Enforcement Administration 
finds good cause to exempt this rulemaking from public notice and 
comment as such notice and comment would be unnecessary and 
impracticable. This final rule merely corrects the inadvertent removal 
of 21 CFR 1310.04(g) from the Code of Federal Regulations. Further, DEA 
finds good cause to make this rulemaking effective immediately upon 
publication, as delaying its effective date could cause confusion 
within the regulated industry regarding thresholds for the List I 
chemicals ephedrine, red phosphorus, white phosphorus and 
hypophosphorous acid (and its salts).

Congressional Review Act

    The Drug Enforcement Administration has determined that this action 
is a rule relating to agency procedure and 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.

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by 
approving it certifies that this regulation will not have a significant 
economic impact on a substantial number of small entities. This final 
rule merely corrects the inadvertent removal of a paragraph in title 
21, Code of Federal Regulations, part 1310.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866 section 1(b). DEA has determined that this is not 
a significant regulatory action. 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 
$100,000,000 or more 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.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, List I and II chemicals, Reporting and 
recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1310 is amended as 
follows:

PART 1310--[AMENDED]

    1. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b).


    2. Section 1310.04 is amended by:
    a. Removing paragraph (f)(1)(i)(C), and redesignating existing 
paragraphs (f)(1)(i)(D) through (f)(1)(i)(W) as (f)(1)(i)(C) through 
(f)(1)(i)(V);
    b. Revising paragraph (f)(1)(ii) introductory text; and
    c. Adding paragraph (g).


Sec.  1310.04  Maintenance of records.

* * * * *
    (f) * * *
    (1) * * *
    (ii) Notwithstanding the thresholds established in paragraphs 
(f)(1)(i) and (g) of this section, the following thresholds will apply 
for the following List I chemicals that are contained in drug products 
that are regulated pursuant to Sec.  1300.02(b)(28)(i)(D) of this 
chapter (thresholds for retail distributors and distributors required 
to report under Sec.  1310.03(c) of this part are for a single 
transaction; the cumulative threshold provision does not apply. All 
other distributions are subject to the cumulative threshold 
provision.):
* * * * *
    (g) For listed chemicals for which no thresholds have been 
established, the size of the transaction is not a factor in determining 
whether the transaction meets the definition of a regulated transaction 
as set forth in Sec.  1300.02(b)(28) of this chapter. All such 
transactions, regardless of size, are subject to recordkeeping and 
reporting requirements as set forth in this part and notification 
provisions as set forth in part 1313 of this chapter.
    (1) Listed chemicals for which no thresholds have been established:
    (i) Ephedrine, its salts, optical isomers and salts of optical 
isomers
    (ii) Red phosphorus
    (iii) White phosphorus (Other names: Yellow Phosphorus)
    (iv) Hypophosphorous acid and its salts
    (2) [Reserved]

    Dated: February 26, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-5528 Filed 3-10-03; 8:45 am]
BILLING CODE 4410-09-P