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Federal
Register Notices > Rules -
2007 > Proposed Rule: Combat Methamphetamine Epidemic Act of 2005: Fee for Self- Certification
for Regulated Sellers of Scheduled Listed Chemical Products
FR Doc E7-19215 [Federal Register: October 1, 2007 (Volume 72, Number 189)]
[Proposed Rules] [Page 55712-55717] From the Federal Register Online via GPO
Access [wais.access.gpo.gov] [DOCID:fr01oc07-20]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1314
[Docket No. DEA-298P] RIN 1117-AB13
Combat Methamphetamine Epidemic Act of 2005: Fee for Self- Certification
for Regulated Sellers of Scheduled Listed Chemical Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: As part of its implementation of the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), "regulated sellers'' or persons and entities
selling scheduled listed chemical products at retail locations are required to
self-certify with DEA relative to certain requirements of the CMEA. The
Diversion Control Program is required to recover the full costs of the
certification process, under the Controlled Substances Act; as such the DEA is
proposing to charge regulated sellers, who are not DEA registrants, a fee for
self-certification.
DATES: Written comments must be postmarked, and electronic comments must be
sent, on or before November 30, 2007.
ADDRESSES: To ensure proper handling of comments, please reference "Docket
No. DEA-298'' on all written and electronic correspondence. Written comments
being sent via regular mail should be sent to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537, Attention: DEA Federal Register Representative/ODL.
Written comments sent via express mail should be sent to DEA Headquarters,
Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis
Highway, Alexandria, VA 22301. Comments may be directly sent to DEA
electronically by sending an electronic message to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided on that site. An electronic copy of
this document is also available at the http://www.regulations.gov Web site.
DEA will accept attachments to electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any
file formats other than those specifically listed here.
Posting of Public Comments: Please note that all comments received are
considered part of the public record and made available for public inspection
online at http://www.regulations.gov and in the DEA's public docket. Such
information includes personal identifying information (such as your name,
address, etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be posted online
or made available in the public docket, you must include the phrase "PERSONAL
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must
also place all the personal identifying information you do not want posted
online or made available in the public docket in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of your
comment, but do not want it to be posted online or made available in the
public docket, you must include the phrase "CONFIDENTIAL BUSINESS
INFORMATION'' in the first paragraph of your comment. You must also
prominently identify confidential business information to be redacted within
the comment. If a comment has so much confidential business information that
it cannot be effectively redacted, all or part of that comment may not be
posted online or made available in the public docket.
Personal identifying information and confidential business information
identified and located as set forth above will be redacted and posted online
and placed in the DEA's public docket file. If you wish to inspect the
agency's public docket file in person by appointment, please see the FOR
FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy
Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537; Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
[[Page 55713]]
Background
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.
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). The CMEA amends the CSA to
change the regulations for selling nonprescription products that contain
ephedrine, pseudoephedrine, phenylpropanolamine, their salts, optical isomers,
and salts of optical isomers. DEA implemented the retail provisions of CMEA
through an Interim Rule entitled "Retail Sales of Scheduled Listed Chemical
Products; Self- Certification of Regulated Sellers of Scheduled Listed
Chemical Products'' published in the Federal Register September 26, 2006 (71
FR 56008, corrected at 71 FR 60609, October 13, 2006). In that Interim Rule,
DEA extensively discussed its intent to publish this Notice of Proposed
Rulemaking, including the various costs to be included in the certification
fee and the methodology for calculating fees (see specifically 71 FR
56013-56015, corrected at 71 FR 60609, October 13, 2006).
Section 886a of the Controlled Substances Act (CSA) defines the Diversion
Control Program as "the controlled substance and chemical diversion control
activities of the Drug Enforcement Administration,'' which are further defined
as the "activities related to the registration and control of the
manufacture, distribution and dispensing, importation and exportation of
controlled substances and listed chemicals.'' The CSA also states that
reimbursements from the Diversion Control Fee Account " * * * shall be made
without distinguishing between expenses related to controlled substances
activities and expenses related to chemical activities.'' [Pub. L. 108- 447
Consolidated Appropriations Act of 2005]
In addition, Section 111(b)(3) of the Departments of Commerce, Justice, and
State, the Judiciary, and Related Agencies Appropriations Act of 1993 (Pub. L.
102-395), codified at 21 U.S.C. 886a(3), requires that "fees charged by the
Drug Enforcement Administration under its diversion control program shall be
set at a level that ensures the recovery of the full costs of operating the
various aspects of that program.''
The CMEA of 2005 implements new requirements governing the sale of
scheduled listed chemical products, defined as nonprescription drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine. As part of
these requirements, CMEA requires self-certification for all regulated sellers
of scheduled listed chemical products, defining regulated seller to mean a
retail distributor (including a pharmacy and mobile retail vendors). The CMEA
requires that on and after September 30, 2006, a regulated seller or any of
its employees must not sell scheduled listed chemical products unless it has
self-certified to DEA, through DEA's Web site. The certification requires the
regulated seller to confirm the following:
Its employees who will be engaged in the sale of scheduled listed chemical
products have undergone training regarding provisions of CMEA.
Records of the training are maintained.
Daily sales to individuals do not exceed 3.6 grams of ephedrine,
pseudoephedrine, or phenylpropanolamine. (Mobile retail vendors must also
confirm that sales to an individual in a 30-day period do not exceed 7.5
grams.)
Nonliquid forms are packaged as required.
Scheduled listed chemical products are stored behind the counter or in a
locked cabinet.
A written or electronic logbook containing the required information on
sales of these products is maintained.
The logbook information will be disclosed only to federal, State, or local
law enforcement and only to ensure compliance with Title 21 of the United
States Code or to facilitate a product recall.
The seller must train its employees and certify before either the seller or
individual employees may sell scheduled listed chemical products. The
certification is subject to the provisions of 18 U.S.C. 1001. A regulated
seller who knowingly or willfully certifies to facts that are not true is
subject to fines and imprisonment.
The CMEA also exempts retail distributors from registration requirements
under the CSA; however, in practice, retail distributors have not previously
registered with DEA because they limited their sales to below-threshold
quantities and to products sold in blister packs.
Self-Certification Fee
DEA considers the self-certification requirements of the CMEA to fall
within the legal definition of control as governed by Section 886a of the CSA
(see above). Accordingly, these activities fall under the general operation of
the Diversion Control Program and are subject to the requirements of the
Appropriations Act of 1993 that mandates that fees charged shall be set at a
level that ensures the recovery of the full costs of operating the various
aspects of the Diversion Control Program. The self-certification requirements
of CMEA fall under these "various aspects.'' Therefore, DEA is hereby
proposing to charge a fee for each self-certification to comply with these
statutory requirements to ensure that the full costs of operating the
Diversion Control Program are covered by fees as required by law.
The fee for certification will cover all associated costs, including the
initial one-time costs of setting up the certification program, web site, and
programmatic infrastructure, as well as ongoing costs associated with the
provision of certifications, call center support, maintenance of the
self-certification system, printing costs for certificates that regulated
sellers cannot print, financial management, and other related costs. DEA has
established a training program for its employees to implement new requirements
of the CMEA, and must establish the infrastructure necessary for the self-
[[Page 55714]]
certification program. Required systems include creation of history,
renewal cycles, investigative tools, business validation rules, and
development and maintenance of the self-certification Web site.
Other DEA activities associated with self-certification and compliance with
CMEA include enforcement and judicial proceedings. CMEA gives DEA the
authority to prohibit a regulated seller from selling scheduled listed
chemical products for certain violations of CMEA. If DEA issues an order to a
regulated seller prohibiting that regulated seller from selling scheduled
listed chemical products, the regulated seller is entitled to an
administrative hearing if the seller files a timely request for a hearing. The
costs of these enforcement activities and the subsequent proceedings must be
supported through fees pursuant to the above described statutory requirements.
However, these costs are not reflected in the proposed self-certification fees
contained in this rulemaking, as DEA is uncertain of their utilization. Once
DEA is able to determine the frequency of use of these tools and their
associated costs, these costs will be recovered through fees associated with
self- certification as established in future rulemakings.
Regulated sellers submit a certification online via the DEA self-
certification web site and will pay a fee by credit card at the time of each
self-certification. DEA calculated this fee based on estimated set-up costs in
Fiscal Year 2006 ($96,000) and Fiscal Year 2007 operating costs ($1,341,000)
totaling $1,437,000, as shown in Table 1 below. The initial systems
development and set-up costs will not be repeated in subsequent years. The
operational and maintenance costs for Fiscal year 2008 are estimated to be
$811,000. Thus, the total amount to be recovered for Fiscal Years 2006 through
2008 is $2,248,000. Total annual costs associated with operating the
certification process include staff costs, operational and administrative
costs, web hosting, monitoring and maintenance costs (including hardware and
software maintenance), and annual inflation adjustments.
To calculate the fee, DEA divided the total costs for Fiscal Years 2006
through 2008 by the anticipated population of affected regulated sellers of
73,000. As of April 10, 2007, 72,258 retailers had self- certified that they
were in compliance with the rule.
All costs are shown in the table below for Fiscal Years 2006 through 2008.
The self-certification costs reflect the cost per each self-certification per
each facility as required by CMEA.
To minimize administrative and collection burdens, it is DEA's policy to
round all fees up to the nearest dollar when calculating fees. This is done to
ensure that the full cost of the Diversion Control Program is collected as
mandated by statute. Therefore, the fee for self-certifications will be
$16.00.
Table 1.--Self-certification Costs and Fee Calculation
|
Project detail
|
2006*
|
2007
|
2008
|
Total cost
|
|
Planning
|
$4,000
|
$37,000
|
$38,000
|
$79,000
|
|
Design, Development, Deployment
|
44,000
|
704,000
|
72,000
|
820,000
|
|
Call Center, Finance, Mail Room, Printing
|
36,000
|
426,000
|
433,000
|
895,000
|
|
Maintenance
|
12,000
|
174,000
|
177,000
|
363,000
|
|
Enhancements
|
|
|
91,000
|
91,000
|
|
Total
|
96,000
|
1,341,000
|
811,000
|
2,248,000
|
|
Population
|
|
|
73,000
|
73,000
|
|
Cost per certification
|
|
19.68
|
11.11
|
1540
|
*2006 is only 1 month of operations.
|
PLANNING
|
5 - FTE, 3% OF THEIR TIME, 1 - DI
5% OF THEIR TIME.
|
|
Design, Development, Deployment
|
10% allocation of effort.
|
|
Creation of Registration System*
|
2 months planning; 6 months
development; 2 months testing, Q/A, CM, C&A, deployment.
|
|
Operations
Support Operations include
|
Call Center, finance, distribution &
printing.
|
* Registration system includes creation of history, renewal cycles,
investigative tools, business validation rules.
Table 2.--Calculation of Fee
|
Cost for FY2006-2008
|
Number estimated to
self-certify
|
Self-certification and one renewal
|
|
Fee for self- certification
|
|
$2,248,000
|
/(73,000
|
*2)
|
= $15.40
|
= $16.00
|
Methodology Regarding Establishment of Fee
CMEA specifically states that a separate certification is required for each
separate location at which scheduled listed chemical products are sold. As
such, mobile retail vendors must certify for each location at which sales
transactions occur, e.g., a fairground one week, a convention center the next,
etc. Similarly, large corporate chains such as chain pharmacies must certify
for each individual location at which scheduled listed chemical products are
sold. Each location must self- certify for itself. In its Interim Final Rule
implementing the retail provisions of the CMEA (71 FR 56008, September 26,
2006; corrected at 71 FR 60609, October 13, 2006), DEA requested comments on
who should be authorized to sign the self-certification for the regulated
seller, given that the person must be in a position to confirm all the self-
certification requirements listed above and should be authorized to sign
documents for the regulated seller.
Additionally, CMEA mandates self-certification for all regulated sellers
irrespective of the extent such entities or persons handle scheduled listed
chemical products. Accordingly, DEA may not alter the fee structure to account
for the extent to which self-certifiers handle these products. An example
would include adjusting self-certification fees according to sales volume or
size of establishment.
[[Page 55715]]
Finally, as mentioned elsewhere in this NPRM, CMEA requires that all
persons selling scheduled listed chemical products at retail self- certify to
DEA, regardless of whether those persons are registered with DEA to handle
controlled substances or List I chemicals.
In a separate Interim Final Rule (71 FR 56008, September 26, 2006;
corrected at 71 FR 60609, October 13, 2006) implementing the retail provisions
of the CMEA, DEA conducted an extensive Economic Impact Analysis in which it
estimated approximately 89,000 persons would self- certify to sell scheduled
listed chemical products at retail. A brief discussion of this Economic Impact
Analysis is found below in this Notice of Proposed Rulemaking. DEA has used
this Economic Impact Analysis in the establishment of fees, as well as actual
information regarding the number of persons self-certified to sell scheduled
listed chemical products, dividing the total costs of self-certification by
the estimated number of persons who will self-certify.
CMEA required persons wishing to continue to sell scheduled listed chemical
products at retail to self-certify with DEA prior to September 30, 2006. In
its Interim Final Rule establishing self-certification and other requirements,
DEA established that certification must be renewed annually. However, to
spread the population of self-certifiers throughout the year (i.e., to prevent
all persons who are self- certified from continuing to renew in the month of
September every year), DEA in its Interim Final Rule indicated that it will
assign self-certifiers to one of 12 groups. Each group will have an expiration
date that will be the last day of a month from 12 to 23 months after the
initial filing. The expiration date is contained in each person's or entity's
self-certification certificate. After the second certification, regulated
sellers will be required to certify annually. Thus, between September 30,
2006, and the end of Fiscal Year 2008 on September 30, 2008, all
self-certifiers will have initially self- certified and renewed their
certification once, assuming they continue to sell scheduled listed chemical
products at retail.
In implementing the self-certification fee, DEA must comply with the CMEA
as well as the Consolidated Appropriations Act of 1993 that requires that fees
charged shall be set at a level that ensures the recovery of the full costs of
operating the various aspects of the Diversion Control Program. In developing
the self-certification program and fee structure, DEA considered two options.
The first option would be to set an annual fee for certification. However,
this methodology would not allow DEA to recover the full costs of the program
for certification from fees, as persons selling scheduled listed chemical
products will have initially self-certified prior to establishment of the fee.
Therefore, DEA decided to establish a fixed fee for Fiscal Years 2006 through
2008, based on the total estimated operating costs of the self-certification
process for those Fiscal Years and the anticipated population of regulated
sellers that will be required to self-certify. This approach offers a clear
fixed fee for this period to entities required to self-certify.
To relieve administrative burdens for the regulated industry and DEA, and
for simplicity in accounting and auditing, DEA has rounded these fee
calculations up to the nearest dollar. The annual self- certification fee will
be clearly defined on the self-certification web site. However, in setting
this fee DEA notes that it is based on assumptions about the total number of
regulated sellers who will be required to certify. Should the total number of
regulated sellers be significantly more or less than 73,000, DEA may adjust
the certification fee as appropriate through future rulemakings. Also, as
noted above, this fee does not account for certain enforcement and judicial
costs associated with self-certification. These costs are not reflected in the
proposed self-certification fees contained in this rulemaking, as DEA is
uncertain of their utilization. Once DEA is able to determine the frequency of
use of these tools and their associated costs, these costs will be recovered
through fees associated with self- certification as established in future
rulemakings. In any case, DEA will not exceed its operating budget as
authorized by Congress.
In implementing this fee, DEA also notes that many of the affected
regulated sellers are already registered with DEA to dispense controlled
substances and therefore already pay a registration/ reregistration fee to DEA.
The CSA requires that all manufacturers, importers, exporters, distributors
and dispensers (e.g., pharmacies) of controlled substances, and List I
chemicals obtain an annual registration with DEA. This process also is under
the administration of the Diversion Control Program. For example, pharmacies
registered with the DEA to distribute controlled substances pay a three-year
registration fee of $551 (an annual equivalent of $184). This annual (or
three-year) registration fee supports the operations of the Diversion Control
Program, including program priorities and field management oversight;
coordination of major investigations; drafting and promulgating of regulations
relating to the enforcement of the CSA and other legislation; advice and
leadership on state legislation/ regulation; legal control of drugs and
chemicals not previously under federal control; control of imports and exports
of licit controlled substances and chemicals; program resource planning and
allocation, and investigation, inspection, and cooperative efforts with other
law enforcement entities and the regulated industries, among other activities.
DEA considered several options regarding charging fees to registrants and
to the new non-registrants regulated pursuant to the Combat Methamphetamine
Epidemic Act of 2005. DEA invites comment on its proposed decision regarding
the structuring of self-certification fees. DEA considered charging the full
costs of the self-certification aspects of the Diversion Control Program only
to registrants. However, this would mean that registrants would subsidize the
self-certification of non-registrants, and any costs attendant with those
self- certifications. Alternatively, DEA could charge only non-registrants for
the costs of the self-certification aspects of the Diversion Control Program,
as registrants already pay fees to support the Program. However, if DEA were
to charge the $2,248,000 cost of the self-certification aspects of the
Diversion Control Program to the approximately 18,000 non-registrants, this
would result in a renewal fee of $63 per non-registrant self-certifier. As DEA
noted previously, both registrants and non-registrants are required to
self-certify. Therefore, DEA has elected to spread the costs of
self-certification across all registrants, but to waive the self-certification
fee for persons registered with DEA.
Additionally, in the course of developing the proposed fee structure, DEA
considered an alternative of basing the level of the fee on the size of a
business or the volume of the business's sales. Such a fee structure, for
example, would allow small businesses below a certain threshold to
self-certify without being charged the proposed $16 self-certification fee. In
analyzing this option, DEA considered whether the $16 fee would pose a
significant hurdle for small businesses and might potentially reduce access to
these products if small businesses opted to discontinue carrying scheduled
listed
[[Page 55716]]
chemical products due to the annual cost of self-certification. Such a fee
schedule would need to distinguish between small retailers who sell limited
quantities and similarly-sized retailers who, based on their unusual sales
volume, may present an increased concern about drug diversion.
However, after careful consideration of this alternative, DEA was concerned
that, while it may have the statutory authority to waive a fee under certain
circumstances, the agency may not have sufficient statutory authority to
collect the kinds of information needed to administer the type of waiver
discussed above. DEA would first need to determine an equitable threshold for
the size of business or volume of sales below which a waiver would be granted.
As DEA does not have historical information regarding size of business or
volume of sales, and is not aware of a source of such data, such a
determination seems difficult. Further, DEA has concerns about what statute,
if any, would provide statutory authority to collect sales data, or other
similar information, from persons self-certifying to handle scheduled listed
chemical products. If DEA has no statutory authority to collect sales or other
information necessary to enforce the fee waiver, then it cannot verify sales
or other information on which a waiver would potentially be based, and would
have difficulty verifying the veracity of any waiver provisions. For those
reasons, DEA has initially proposed not to waive the fee for
self-certification based on size of business or volume of sales. DEA invites
comment on its interpretation regarding its statutory authority and how to
structure self-certification fees in the final rule. In addition, DEA would
welcome information about what sort of data might be available to enforce a
different fee schedule for small businesses.
That said, DEA notes that while lowering or eliminating the fee depending
on the size of a business would reduce the financial burden on small
businesses, DEA would have to increase the proposed fee charged to the
remaining covered entities to fully fund the self- certification program. In
addition to the cost of the proposed self- certification fee, regulated
sellers are currently required under existing DEA regulations to maintain a
logbook, store covered products behind the counter, and train staff concerning
sales and recordkeeping. Because of the costs associated with these existing
requirements, DEA currently does not anticipate that the proposed $16
self-certification fee will result in a significant incremental increase in
the relative costs of the program for entities carrying covered products, and
thus does not currently believe the fee will pose a barrier to access. DEA
encourages commenters to provide information on this issue.
While existing registrants are required by the CMEA to self-certify with
DEA if selling scheduled listed chemical products, the self- certification fee
will be waived upon submission of an active DEA registration number because
these registrants already pay an annual fee (or annual fee equivalent) to
support the operations of the Diversion Control Program. DEA requests comments
on this aspect of this rulemaking.
Regulatory Certifications
Regulatory Flexibility Act
This rulemaking has been drafted in accordance with the provisions of the
Regulatory Flexibility Act (5 U.S.C. 601-612). The Administrator of DEA hereby
certifies that this regulation will not have a significant economic impact on
a substantial number of small entities.
The proposed rule will affect a substantial number of small entities, but
will not have a significant economic effect. The fee is minimal--$16 a year.
In its Interim Final Rule implementing the retail provisions of the CMEA (71
FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), DEA
estimated that the other implementation costs associated with the retail sale
of scheduled listed chemical products were also low. DEA estimated that the
time required for training sales personnel and filing the self-certification
is less than three hours a year. Many of the smallest firms, which are likely
to be convenience stores, may limit their sales to single packages of
pseudoephedrine where the package contains not more than 60 milligrams. Such
sales are exempt from the recordkeeping requirements of the CMEA, which would
eliminate the need for logbooks and checking of identification. There will be
some cost to move the product behind the counter, but these moves will make
open display areas available for other products; the shelf-space costs will,
therefore, be offset to some degree. For firms that conduct sales transactions
subject to all of the CMEA requirements, most of the cost will derive from the
cost of checking identification and completing the logbook entries. That cost
will depend on the number of sales. DEA has determined that the smallest
stores sold between $20 and $40 a month in these products. This level of sales
is the equivalent of five to ten sales per month of packages covered by the
logbook requirement or, at the upper limit, about an additional $3.50 per
month in transaction costs for the time required to check the identification.
For the smallest firms, the annual cost of the rule, with the fee, is likely
to be less than $100.
The smallest firms potentially covered are general merchandise stores where
the average sales of the smallest firms are $60,000 a year according to the
2002 Retail Trade-Subject Series of the Economic Census. The smallest firms in
the other sectors, except for discount department stores and superstores, have
annual sales of between $120,000 and $150,000. There are no discount
department stores or superstores with annual sales of less than $1 million and
$5 million, respectively. The annual fee, therefore, would represent less than
0.03 percent of sales for the smallest store and generally about 0.01 percent
of sales. The total cost of the rules for retail sales for the smallest firms
is less than 0.2 percent of sales.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866 Section
1(b). It has been determined that this is a significant regulatory action.
Therefore, this action has been reviewed by the Office of Management and
Budget.
Regulated Sellers. As of April 10, 2007, 72,258 retailers had self-
certified with DEA. Table 3 presents the number of retailers by sector and
indicates whether they have indicated that they are DEA registrants.
Table 3.--Sectors Selling Scheduled Listed Chemical Products
|
NAICS
|
Registrants certified
|
Non-registrants certified
|
|
44511 Grocery stores
|
5,628
|
913
|
|
44611 Pharmacy and drug stores
|
42,769
|
1,513
|
|
452112 Discount Department Stores
|
2,854
|
46
|
|
45291 Warehouse Clubs and Superstores
|
2,948
|
3
|
|
Subtotal
|
54,199
|
2,475
|
|
44512 Convenience stores
|
12
|
6,166
|
|
44711 Gas Stations with convenience stores
|
38
|
8,377
|
|
45299 All other general merchandise stores
|
19
|
672
|
|
Other
|
173
|
127
|
|
Total
|
54,441
|
17,817
|
Costs/Benefits. As discussed in the previous sections, DEA has estimated
costs of $2,248,000 for Fiscal Years 2006 through 2008 for DEA to establish
and support the regulated seller self-certification program, which CMEA
mandates. As required by law, this cost would be recovered from regulated
sellers through a self-certification fee. As noted in the previous section,
the proposed fee imposes a minimal burden on regulated sellers. CMEA requires
self-certification as a condition of selling these products. The fee will
allow DEA to operate a program needed to permit regulated sellers to continue
offering scheduled listed chemical products to their customers.
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.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the Small
Business Regulatory Enforcement Fairness Act (Congressional Review Act). 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 1314
Drug traffic control, Reporting and recordkeeping requirements. For the
reasons set out above, 21 CFR part 1314 is proposed to be amended as follows:
PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
- 1. The authority citation for part 1314 is proposed to be revised to read
as follows:
Authority: 21
U.S.C. 802, 830,
842, 871(b),
875, 877,
886a.
- 2. Section 1314.42 is proposed to be added to read as follows:
Sec. 1314.42 Self-certification fee; time and method of fee payment.
(a) A regulated seller shall pay a fee for each self-certification. For
each initial application to self-certify, and for the renewal of each existing
self-certification, a regulated seller shall pay a fee of $16.
(b) The fee for self-certification shall be waived for any person holding a
current, valid DEA registration as a pharmacy to dispense controlled
substances.
(c) A regulated seller shall pay the fee at the time of self-
certification.
(d) Payment shall be made by credit card.
(e) The self-certification fee is not refundable.
Dated: September 19, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-19215 Filed 9-28-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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