[Federal Register Volume 62, Number 98 (Wednesday, May 21, 1997)]
[Rules and Regulations]
[Page 27693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13313]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[DEA-154E]
RIN 1117-AA42
Temporary Exemption From Chemical Registration for Distributors
of Combination Ephedrine Products; Extension of Application Deadline
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim rule.
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SUMMARY: DEA is amending its regulations to extend the temporary
exemption from the chemical registration requirements from May 12, 1997
to July 12, 1997. Certain segments of the industry that distribute
combination ephedrine products did not realize that they would be
subject to the registration requirement due to questions regarding the
application of the registration requirements to their activities.
Persons failing to meet the May 12, 1997 deadline would have been
required to cease all distributions of combination ephedrine products
until they had obtained a registration. In order to avoid interruption
of legitimate distributions of combination ephedrine products, based
upon the request of this industry group, DEA is extending the temporary
exemption from the registration requirement for the additional period
to allow affected persons sufficient time to make application for
registration.
EFFECTIVE DATE: May 21, 1997. The new deadline for submitting an
application for registration is July 12, 1997.
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, D.C.
20537, Telephone (202) 307-4025.
SUPPLEMENTARY INFORMATION: The Comprehensive Methamphetamine Control
Act of 1996 (MCA) removed the exemption from DEA's chemical controls
for combination ephedrine drug products, effective October 3, 1996. As
a result, these products became subject to the chemical registration,
recordkeeping, and reporting requirements set forth in Title 21, Code
of Federal Regulations (CFR), parts 1309, 1310, and 1313.
To allow businesses to continue to distribute combination ephedrine
products pending issuance of a registration to engage in such
activities, DEA amended its regulations by interim rule published in
the Federal Register on February 10, 1997 (62 FR 5914) to provide that
any person who submitted a properly completed application for
registration to DEA on or before May 12, 1997, would be exempt from the
registration requirement until DEA took final action on such
application (21 CFR 1310.09).
Following publication of the interim rule, questions were raised by
a segment of the industry distributing combination ephedrine products
regarding whether the registration requirements applied to their
activities. Following clarification of the chemical registration
requirements, a request was received from Food Distributors
International for an extension of the application deadline to allow
adequate time for the affected distributors to make application for
registration. DEA has no objection to granting the request. Therefore,
21 CFR 1310.09 is being amended to provide that the deadline for
submitting an application is extended to July 12, 1997.
The Acting Deputy Administrator of the Drug Enforcement
Administration hereby certifies that this interim rulemaking will have
no significant impact upon entities whose interests must be considered
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This interim
rulemaking extends a temporary exemption from the registration
requirement for distributors of combination ephedrine products.
This rule is not a significant regulatory action and therefore has
not been reviewed by the Office of Management and Budget pursuant to
Executive Order 12866.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 12612, and it has been determined that the
interim rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
For reasons set out above, Title 21, Code of Federal Regulations,
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 1310.09 is revised to read as follows:
Sec. 1310.09 Temporary exemption from registration.
Each person required by Section 302 of the Act (21 U.S.C. 822) to
obtain a registration to distribute, import, or export a combination
ephedrine product is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before July 12, 1997. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect.
Dated: May 14, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-13313 Filed 5-20-97; 8:45 am]
BILLING CODE 4410-09-M
