[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Rules and Regulations]
[Pages 53958-53959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27452]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1309
[DEA Number--169N]
Comprehensive Methamphetamine Control Act of 1996; Registration
Fees
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of fee wavier.
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SUMMARY: DEA is waiving a portion of the registration fee for non-
retail distributors of pseudoephedrine, phenylpropanolamine, and
combination ephedrine drug products. Under the Comprehensive
Methamphetamine Control Act of 1996 (MCA), wholesale distributors of
these drug products are subject to the existing List I chemical
registration and fee requirements. However, because the drug products
are distributed in substantially different channels than other List I
chemicals, the existing pre-registration investigation procedures,
which were established primarily with respect to the handlers of
chemicals, as opposed to drug products, are not necessarily applicable
to the new type of applicant. DEA will be reviewing the pre-
registration investigation procedures to determine what changes will be
necessary to account for the different manner of distribution of the
drug products. Recognizing that changes are likely to be made in the
pre-registration process, thus causing changes to the fees assessed,
DEA is waiving a portion of the fee at this time, rather than requiring
that new applicants pay a fee that would not be consistent with the
resources actually expended in the issuance of the registration.
EFFECTIVE DATE: October 17, 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) 307-7297.
SUPPLEMENTARY INFORMATION: The MCA's removal of the exemption for
pseudoephedrine, phenylpropanolamine, and combination ephedrine drug
products (regulated drug products) opens up to chemical registration
and regulation a new and different segment of industry from that
previously subject to the chemical controls. Prior to the MCA the group
subject to chemical registration consisted primarily of specialty
chemical handlers distributing products of limited consumer end-use to
a largely industrial customer base. By contrast, the principal group
subject to registration under the MCA consists of general merchandisers
distributing a wide variety of consumer products to retail outlets for
sale to the public. Often, one company will operate several
distribution centers to serve wholly owned or independent retail
outlets. In response to applications submitted by this new group, DEA
is re-examining the pre-registration investigation process for issuing
registrations. This process will affect the registration application
fees.
The procedures for issuing a chemical registration and the
associated application fee were developed in 1994 as part of the
implementation of the Domestic Chemical Diversion Control Act of 1993
(DCDCA). (For specific details regarding the procedures and fees, see
DEA's notice of proposed rulemaking (NPRM) regarding Implementation of
the Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103-200)
which was published in the Federal Register on October 13, 1994 (59 FR
51887)). The procedures were developed based on the type of applicants
expected under the DCDCA, e.g., specialty chemical handlers dealing
with products of limited consumer end-use. These applicants dealt
almost exclusively in chemicals and often distributed from contract
operated warehouses/storage depots. Pursuant to the requirements of the
Office of Management and Budget (OMB) Circular A-25, the costs and
resources required to conduct the pre-registration investigation and
issue the registration were assessed to the applicants as the
application fee.
The group subject to registration under the MCA is significantly
different, consisting principally of general merchandisers distributing
hundreds or thousands of different consumer products, often from a
large number of applicant-owned warehouse/distribution centers, to
retail outlets for sale to the public. The volume of regulated drug
products handled is often only a very small portion of the total volume
of products distributed by the location. For these applicants,the pre-
registration procedures developed for chemical handlers are not
entirely suitable. DEA has, therefore, initiated a review of the pre-
registration procedures to determine what changes will be necessary to
make the process consistent with the different activities of this group
of applicants. This review will affect the costs and resources
associated with the issuance of registrations to these applicants and,
thus, the fee to be charged. DEA will publish notice, with opportunity
for comment, in the Federal Register regarding any proposed change to
the procedures and consequent changes to the fees.
The MCA removed the exemption from regulation for combination
ephedrine drug products effective
[[Page 53959]]
October 3, 1996, and will remove the exemption from regulation for
pseudoephedrine and phenylpropanolamine drug products effective October
3, 1997, making persons who distribute the respective products subject
to the registration requirement on those dates. Determination of the
appropriate procedures and amendment of the regulations to set the new
fees will extend well beyond those deadlines for registration.
Therefore, DEA is waiving a portion of the application fee for new
registration. It would be inconsistent with the principles of OMB
Circular A-25 to charge a fee for a specific service, e.g., completing
the processing of the application and the pre-registration
investigation, knowing that the costs and resources to be expended in
providing that service will change. Persons who have already applied
for registration to distribute regulated drug products and paid the
existing fee will be refunded the amount of fee that is being waived.
The Acting Deputy Administrator of DEA is, therefore, waiving that
portion of the fee for registration as a non-retail distributor of
regulated drug products associated with the 12 hours of investigator
time allocated for the on-site visit and travel time, which, at $39.92
per hour, amounts to $479.00 (See 59 FR 51892). The remaining
administrative costs and time allotted for background checks and
reports will continue. Thus the fee for an initial application for
registration as a non-retail distributor of regulated drug products is
$116.00. That fee will remain in effect until the review of the
registration procedures has been completed and a determination has been
made regarding how the processing of such applications and the pre-
registration investigation will be carried out. At that time, a notice
will be published in the Federal Register regarding the procedures to
be followed and fee that will be required for future applications.
This waiver applies only to applicants for registration as non-
retail distributors of regulated drug products. All other applicants
remain subject to the full fees, as set forth in Title 21, Code of
Federal Regulations, Section 1309.11. As noted earlier, persons who
have already submitted an application for registration as a non-retail
distributor of regulated drug products and paid the full fee will be
provided with a $479.00 refund.
Dated: October 8, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-27452 Filed 10-16-97; 8:45 am]
BILLING CODE 4410-09-M