Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products, 20518-20524 [2011-9016]
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
options that would minimize any
significant impact of a rule on small
entities. Because the final rule allows
the Director of CBER or the Director of
CDER, as appropriate, to approve
exceptions or alternatives to the
regulations for constituent materials,
this action increases the flexibility and
reduces the regulatory burden for
affected entities. Therefore, FDA
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $135
million, using the most current (2009)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
The benefit of this regulatory action is
its reduction, through greater flexibility
in the regulatory requirements, of
burdens on the biological products
industry. These issues are discussed in
greater detail in section I of this
document. Industry cost reductions may
result in consumers being offered lower
prices or wider availability of existing
and new biological products; this would
have a positive effect on patients’
welfare.
Any administrative and paperwork
costs associated with this regulatory
action are expected to be minimal and
widely dispersed among affected
entities. Based on FDA experience, we
estimate that we would receive a total
of approximately three requests
annually for an exception or alternative
under § 610.15. FDA experience with
similar information collection
requirements suggests that
approximately 1 hour would be required
to prepare and submit each such
request.
We received comments expressing
concern that this rule would generate
additional costs in the form of negative
public health effects. FDA has
considered the potential for adverse
consequences, including increased
morbidity and mortality, associated
with allowing deviations from the
constituent materials regulations set
forth in § 610.15(a) through (c), and will
grant exemptions only in cases where
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data indicate that biological products in
their exempted forms will be safe, pure,
and potent for the conditions for which
the applicant is seeking approval. As
experience with the October 1981 rule
has shown, FDA is able to conduct a
constituent materials exemption process
in a manner that is consistent with its
public health mandate. For all these
reasons, we believe the final rule will
impose no overall public health cost.
B. Environmental Impact
The Agency has determined under 21
CFR 25.31(h) that this action is of a type
that does not individually or
cumulatively have a significant adverse
effect on the human environment.
Therefore, neither an environmental
assessment nor an environmental
impact statement is required.
C. Federalism
VI. Paperwork Reduction Act of 1995
Section 610.15(d) of this final rule
contains reporting requirements that
were submitted for review and approval
to the Director of the Office of
Management and Budget (OMB), as
required by section 3507(d) of the
Paperwork Reduction Act of 1995. The
requirements were approved and
assigned OMB control number 0910–
0666.
List of Subjects in 21 CFR Part 610
Biologics, Labeling, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR part 610 is amended
as follows:
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
1. The authority citation for 21 CFR
part 610 continues to read as follows:
■
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2. Amend § 610.15 by adding
paragraph (d) to read as follows:
■
§ 610.15
Constituent materials.
*
*
*
*
*
(d) The Director of the Center for
Biologics Evaluation and Research or
the Director of the Center for Drug
Evaluation and Research may approve
an exception or alternative to any
requirement in this section. Requests for
such exceptions or alternatives must be
in writing.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8885 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the final rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
Agency has concluded that the final rule
does not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
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Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1314
[Docket No. DEA–347I]
RIN 1117–AB30
Self-Certification and Employee
Training of Mail-Order Distributors of
Scheduled Listed Chemical Products
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Interim final rule with request
for comment.
AGENCY:
On October 12, 2010, the
President signed the Combat
Methamphetamine Enhancement Act of
2010 (MEA). It establishes new
requirements for mail-order distributors
of scheduled listed chemical products.
Mail-order distributors must now selfcertify to DEA in order to sell scheduled
listed chemical products at retail. Sales
at retail are those sales intended for
personal use; mail-order distributors
that sell scheduled listed chemical
products not intended for personal use,
e.g., sale to a university, are not affected
by the new law. This self-certification
must include a statement that the mailorder distributor understands each of
the requirements that apply under part
1314 and agrees to comply with these
requirements. Additionally, mail-order
distributors are now required to train
their employees prior to self
certification. DEA is promulgating this
rule to incorporate the statutory
provisions and make its regulations
consistent with the new requirements
SUMMARY:
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
and other existing regulations related to
self-certification.
DATES: Effective Date: This rule is
effective April 13, 2011.
Comment Date: Written comments
must be postmarked and electronic
comments must be submitted on or
before June 13, 2011. Commenters
should be aware that the electronic
Federal Docket Management System
will not accept comments after midnight
Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–347’’ on all written and
electronic correspondence. Comments
may be sent electronically through
https://www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the https://
www.regulations.gov Web site.
Comments may be sent to DEA by
sending an electronic message to
dea.diversion.policy@usdoj.gov. 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.
Please note that DEA is requesting
that electronic comments be submitted
before midnight Eastern Time on the
day the comment period closes because
https://www.regulations.gov terminates
the public’s ability to submit comments
at midnight Eastern Time on the day the
comment period closes. Commenters in
time zones other than Eastern Time may
want to consider this so that their
electronic comments are received.
Written comments sent via regular or
express mail should be sent to the Drug
Enforcement Administration, Attention:
DEA Federal Register Representative/
ODL, 8701 Morrissette Drive,
Springfield, VA 22152.
All comments sent via regular or
express mail will be considered timely
if postmarked on the day the comment
period closes.
FOR FURTHER INFORMATION CONTACT:
Cathy A. Gallagher, Acting Chief,
Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; telephone: (202)
307–7297.
SUPPLEMENTARY INFORMATION:
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 https://
www.regulations.gov and in the Drug
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Enforcement Administration’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 the comment, in
redacted form, will be posted online and
placed in the Drug Enforcement
Administration’s public docket file.
Please note that the Freedom of
Information Act applies to all comments
received. If you wish to inspect the
agency’s public docket file in person by
appointment, please see the FOR
FURTHER INFORMATION CONTACT
paragraph.
DEA’s Legal Authority
DEA implements and enforces 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
1321. 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.
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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,
distribution, importation, and
exportation 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 October 12, 2010, the President
signed the Combat Methamphetamine
Enhancement Act of 2010 (MEA) (Pub.
L. 111–268). Generally, the
Administrative Procedure Act (APA) (5
U.S.C. 553) requires agencies to provide
notice of proposed rulemaking and the
opportunity for public comment in its
regulations implementing an Act of
Congress. However, an agency may find
good cause to exempt a rule from certain
provisions of the APA, 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. DEA is invoking the APA good
cause exception and promulgating this
rule as an interim final rule rather than
a proposed rule because the
requirements of the MEA addressed by
this rulemaking are self-implementing
and changes in this rulemaking provide
conforming amendments to make the
language of the regulations consistent
with that of the law. The MEA also
specifically states that ‘‘[t]he Attorney
General may issue regulations on an
interim basis as necessary to ensure the
implementation of this Act by the
effective date.’’ Public Law 111–268,
Sec. 6(b). DEA is accepting comments
on this rulemaking.
Mail-Order Distributor
DEA regulations do not specifically
define ‘‘mail-order distributor.’’
However, part 1314 of the regulations
defines ‘‘mail-order sale’’ as ‘‘a retail sale
of scheduled listed chemical products
for personal use where a regulated
person uses or attempts to use the U.S.
Postal Service or any private or
commercial carrier to deliver the
product to the customer.’’ 21 CFR
1314.03. Also, mail-order sale ‘‘includes
purchase orders submitted by phone,
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mail, fax, Internet, or any method other
than face-to-face transaction.’’ 21 CFR
1314.03.
The idea of mail-order distributor is
further developed later in part 1314,
which discusses a ‘‘regulated person
who makes a sale at retail of a
scheduled listed chemical product and
is required under § 1310.03(c) of this
chapter to submit a report of the sales
transaction to the Administration
* * *’’ 21 CFR 1314.100(a). The CSA
(21 U.S.C. 830(b)(3)) and its
implementing regulations impose
recordkeeping and reporting
requirements on ‘‘[e]ach regulated
person who engages in a transaction
with a nonregulated person or who
engages in an export transaction that
involves ephedrine, pseudoephedrine,
phenylpropanolamine, or gammahydroxybutyric acid, including drug
products containing these chemicals,
and uses or attempts to use the Postal
Service or any private or commercial
carrier * * *’’ 21 CFR 1310.03(c). Such
persons are obligated to file monthly
reports with DEA. 21 CFR 1310.03(c).
Combat Methamphetamine
Enhancement Act of 2010
The MEA amends the CSA to change
the regulations for selling scheduled
listed chemical products—
nonprescription products that contain
ephedrine, pseudoephedrine, and
phenylpropanolamine, their salts,
optical isomers, and salts of optical
isomers. The law requires that each
regulated person making sales at retail
of a scheduled listed chemical product
who is required under Title 21 of the
United States Code ((21 U.S.C.
830(b)(3)) to submit monthly reports of
sales transactions to the Attorney
General (referred to as mail-order
distributors) may not sell any scheduled
listed chemical product at retail unless
such regulated person has submitted to
the Attorney General a self-certification.
Sales at retail are those sales intended
for personal use; mail-order distributors
that sell scheduled listed chemical
products not intended for personal use,
e.g., sale to a university, are not affected
by the new law. The requirement of selfcertification becomes effective April 10,
2011 (180 days after enactment on
October 10, 2010). Mail-order
distributors must be self-certified before
they can sell scheduled listed chemical
products. Such self-certification must be
consistent with the criteria established
for certifications of regulated sellers—
i.e., retail stores and mobile retail
vendors—of scheduled listed chemical
products.
To that end, and pursuant to the
requirements of 21 U.S.C.
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830(e)(1)(B)(ii)(II), DEA is requiring that
each mail-order distributor must be selfcertified at each place of business at
which they sell these products at retail.
For a mail-order distributor, this would
mean that each location that prepares or
packages product for distribution to
customers, and each location where
employees accept payment for such
sales, must be self-certified.
Pursuant to the requirements of 21
U.S.C. 830(e)(1)(B)(iii)(I) pertaining to
regulated sellers, the self-certification
for mail-order distributors is required to
take place via the Internet on DEA’s
Web site. Self-certification includes a
statement that the mail-order
distributors understand the
requirements and agree to comply with
them. MEA also makes it unlawful to
negligently fail to self-certify as required
under 21 U.S.C. 830, by an amendment
to 21 U.S.C. 842(a)(10). Public Law 111–
268, Sec. 5. This applies to regulated
sellers and mail-order distributors.
The MEA also includes a provision
which states that ‘‘[t]he Attorney
General shall by regulation establish
criteria for certifications of mail-order
distributors that are consistent with the
criteria established for the certifications
of regulated sellers under paragraph
(1)(B).’’ 21 U.S.C. 830(e)(2)(C), as
amended by Public Law 111–268, Sec.
2. This means that mail-order
distributors are now required to train
their employees prior to self
certification.
Provisions of the Combat
Methamphetamine Enhancement Act of
2010
Prior to MEA, mail-order distributors
of scheduled listed chemical products,
which covered any sale where the
product is shipped using the Postal
Service or any private or commercial
carrier, did not have to self-certify. They
did have to file monthly reports of all
sales of scheduled listed chemical
products with DEA, and they were
required to verify the identity of their
customer before shipping scheduled
listed chemical products. 21 U.S.C.
830(b)(3) and 830(e)(2)(A).
Sales of scheduled listed chemical
products by mail-order distributors.
MEA requires that on and after April 10,
2011, a mail-order distributor must not
sell scheduled listed chemical products
at retail unless it has self-certified to
DEA, through DEA’s Web site. The selfcertification requires the mail-order
distributor to confirm the following:
• Its employees who will be engaged
in the sale of scheduled listed chemical
products have undergone training
regarding provisions of the Combat
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Methamphetamine Epidemic Act of
2005 (CMEA).
• Records of the training are
maintained.
• Sales to individuals do not exceed
3.6 grams of ephedrine,
pseudoephedrine, or
phenylpropanolamine per day. For
mail-order distributors, sales to
individuals do not exceed 7.5 grams of
ephedrine, pseudoephedrine, or
phenylpropanolamine per 30-day
period.
• Nonliquid forms are packaged as
required. The mail-order distributor
must train its employees and self-certify
before either the mail-order distributor
or individual employees may sell
scheduled listed chemical products. The
law governing self-certification of mailorder distributors does not explicitly
make such certifications subject to 18
U.S.C. 1001, as is the case for regulated
sellers whose sales are limited almost
exclusively to face-to-face retail
transactions. Compare 21 U.S.C.
830(e)(1)(B) to 830(e)(2)(C). However, a
mail-order distributor who knowingly or
willfully self-certifies to facts that are
not true is subject to fines and
imprisonment by virtue of general
applicability of 18 U.S.C. 1001. Also,
when Congress directed that regulations
of the Attorney General establish criteria
for the certification of mail-order
distributors ‘‘that are consistent with the
criteria established for the certification
of regulated sellers under paragraph
(1)(B),’’ it must have intended that this
Federal false statements statute apply.
Training. DEA has developed training
that it has made available on its Web
site (https://
www.deadiversion.usdoj.gov).
Employers must use the content of this
training in the training of their
employees who sell scheduled listed
chemical products. An employer may
include content in addition to DEA’s
content, but DEA’s content must be
included in the training. For example, a
mail-order distributor may elect to
incorporate DEA’s content into initial
training for new employees.
Training records. On and after April
10, 2011, each employee of a mail-order
distributor who is responsible for
delivering scheduled listed chemical
products to purchasers or who deals
directly with purchasers by obtaining
payment for the scheduled listed
chemical products must undergo
training and must sign an
acknowledgement of training received
prior to selling scheduled listed
chemical products. This record must be
kept in the employee’s personnel file.
Self-certification. MEA adds the
requirement that mail-order distributors
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self-certify with DEA. As noted
previously, MEA also makes it unlawful
for mail-order distributors to negligently
fail to self-certify as required under 21
U.S.C. 830.
On and after April 10, 2011, under the
requirements of MEA, mail-order
distributors who sell at retail must selfcertify to DEA as described above. DEA
has established a Web page that will
allow mail-order distributors of
scheduled listed chemical products to
complete the self-certification online
and submit it to DEA electronically. A
self-certification certificate will
immediately be generated by DEA upon
receipt of the application. The mailorder distributors will print this selfcertification certificate, or if they are
unable to print it, DEA will print and
mail the certificate to the self-certifier.
Time for self-certification. MEA
requires that mail-order distributors
self-certify by April 10, 2011. When a
regulated person files the initial selfcertification, the Administration will
assign the regulated person to one of
twelve groups. The expiration date of
the self-certification for all regulated
persons in any group will be the last day
of the month designated for that group.
In assigning a regulated person to a
group, the Administration may select a
group with an expiration date that is not
less than 12 months or more than 23
months from the date of selfcertification. After the initial
certification period, the regulated
person must update the self-certification
annually. It is the responsibility of the
mail-order distributor to ensure that
they renew the self-certification before it
lapses.
Fee for self-certification. To comply
with the requirement of the CSA that
fees be set at a level to ensure the
recovery of the full costs of operating
the various aspects of the Diversion
Control Program, DEA established an
annual self-certification fee for certain
regulated sellers selling scheduled listed
chemical products at retail. The annual
self-certification fee for regulated sellers
who are not DEA pharmacy registrants
is $21. To make regulations regarding
mail-order distributors consistent with
those for regulated sellers, the same selfcertification fee will apply to any mailorder distributor that is not a DEAregistered pharmacy.
Table 1 summarizes the requirements
for mail-order distributors of scheduled
listed chemical products that are now in
place since the passage of the MEA.
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TABLE 1—SUMMARY OF
REQUIREMENTS BY TYPE OF SELLER
Mail-order sellers
Daily sales limit ...............
30-day sales limit ............
Blister packs ....................
Storage ............................
Logbook ...........................
Customer ID ....................
Train employees ..............
Self-Certify .......................
Monthly reports ................
Theft and loss reports .....
3.6 gm/chemical.
7.5 gm.
Yes.
NA.
NA.
Verify ID.
Yes.
Yes.
Yes.
Yes.
Discussion of the Rule
To make the rule easier to follow for
regulated sellers and mail-order
distributors, DEA previously created
part 1314 that includes all requirements
related to the sale of scheduled listed
chemical products to end users. Subpart
A contains requirements that apply to
any retail sale. Subpart B applies to
regulated sellers (retail distributors and
mobile retail vendors). Subpart C
applies to retail sales that are shipped
by mail or private or commercial
carriers, regardless of how those sales
are ordered.
In Subpart C, Section 1314.101 is
being added to address employee
training for mail-order distributors.
Section 1314.102 is added to address
self-certification for mail-order
distributors. Section 1314.103 covers
the self-certification fee and the time of
payment for this fee. As discussed
above, DEA is setting an annual period
for renewal of the certification. DEA has
developed a page on its Web site that
will allow mail-order distributors to
complete and submit the selfcertification form online and print out a
self-certification certificate for their
records. The information required will
include the name and address of the
location, a point of contact, and tax
identification number.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C.
553)
The Administrative Procedure Act
(APA) generally requires that agencies,
prior to issuing a new rule, publish a
Notice of Proposed Rulemaking in the
Federal Register. However, the Combat
Methamphetamine Enhancement Act
specifically states, ‘‘[t]he Attorney
General may issue regulations on an
interim basis as necessary to ensure the
implementation of this Act by the
effective date.’’ Public Law 111–268,
Sec. 6(b). Additionally, the APA
provides that agencies may be excepted
from this requirement when ‘‘the agency
for good cause finds (and incorporates
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the finding and a brief statement of
reasons therefor in the rules issued) that
notice and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest.’’ 5 U.S.C.
553(b)(B).
With publication of this interim final
rule, DEA is invoking this ‘‘good cause’’
exception to the APA’s notice
requirement based on the combination
of several factors. The MEA is effective
180 days after its passage. Mail-order
distributors selling scheduled listed
chemical products at retail must selfcertify with DEA in order to continue to
sell these products. Based on the
effective date and the requirements of
the MEA, it is impracticable for DEA to
comply with the APA’s notice and
comment requirements due to the
limited time involved. Were DEA not to
publish this interim final rule with
Request for Comment, mail-order
distributors selling scheduled listed
chemical products at retail would not be
able to self-certify by the date specified
in the law. As a result, these mail-order
distributors would be forced to stop
selling scheduled listed chemical
products, or violate the law by doing so.
Thus, DEA also finds it is contrary to
the public interest to DEA to comply
with the APA’s notice and comment
requirements due to the potential
disruption of sales of scheduled listed
chemical products by mail-order
distributors.
In light of these factors, DEA finds
that ‘‘good cause’’ exists to issue this
interim rule without engaging in
traditional notice and comment
rulemaking.
Regulatory Flexibility Act
The Deputy Assistant Administrator,
Office of Diversion Control, hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612). The Regulatory Flexibility
Act (RFA) applies to rules that are
subject to notice and comment. DEA has
determined, as explained above, that
public notice and comment are
impracticable and contrary to the public
interest. Consequently, the RFA does
not apply.
Although the RFA does not apply to
this interim final rule, DEA has
reviewed the potential impacts. DEA
does not believe that it will have a
significant economic impact on small
entities. Based on reports filed, DEA
expects that the rule will affect only 9
firms, two of which are not small based
on the Small Business Administration’s
size standards. For the seven small
firms, the only costs are the $21 annual
fee, the time required to complete the
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certification (0.5 hours or about $20 for
a new self-certification application), and
cost of training (0.5 hours or about $10).
The cost of compliance for these firms,
which appear to have between 5 and 25
employees, not all of whom would need
to be trained, is less than $200 and in
most cases, less than $100. The smallest
mail order pharmacies (those with fewer
than five employees) have average
annual sales of $1 million. The cost of
compliance is, therefore, less than 0.1
percent of sales and would not impose
a significant economic burden on any
small entity.
Executive Order 12866
The Deputy Assistant Administrator,
Office of Diversion Control, further
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866
§ 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. As discussed above, this action
is codifying statutory provisions and
involves no agency discretion. However,
DEA has reviewed the potential benefits
and costs following OMB Circular A–4.
The time for a mail-order distributor
to self-certify is estimated at 0.5 hours.
Additionally, the time for a mail-order
distributor to train employees is
estimated at 0.5 hours. The nine affected
firms range in size from 5 employees to
more than 800. DEA assumes that the
smallest firms will train half their
employees and the two large firms will
train 20 percent, based on the
percentage of retail sales persons, order
clerks, and order fillers to total
employment in the retail mail order
sector. The total cost of the rule is
estimated to be less than $2,600. DEA
does not expect that the rule will lead
any of the firms to discontinue sales of
the products because they are already
reporting to DEA on these sales. The
low cost of compliance is unlikely to
discourage firms from selling the
products.
Benefits. Congress passed the MEA to
better track retail sales of scheduled
listed chemical products by requiring
self-certification of mail-order
distributors in addition to regulated
sellers (retailers). The MEA also makes
it more difficult for regulated sellers and
mail-order distributors to obtain
scheduled listed chemical products
from distributors by prohibiting
distributors from selling to them if they
have not self-certified. This leaves less
opportunity for diversion at the retail
level.
Methamphetamine remains the
primary drug produced in illicit
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Jkt 223001
laboratories within the United States.
The vast majority of these laboratories
used pharmaceutical products
containing pseudoephedrine, ephedrine,
and phenylpropanolamine as the source
of precursor material.
Conclusion. MEA’s requirements will
not impose an annual cost on the
economy of $100 million or more, the
standard for an economically significant
rule under Executive Order 12866.
Executive Order 13563
Published on January 18, 2011,
Executive Order 13563 supplements and
reaffirms the principles established in
Executive Order 12866. 76 FR 3821. The
new Executive Order emphasizes the
importance of public participation and
cost-effectiveness within the context of
the regulatory process. DEA has
carefully considered the requirements of
the Executive Order and has concluded
that this rule satisfies the applicable
requirements. Although the MEA
provides authorization to issue rules on
an interim basis in order to implement
the self-certification requirements of
Section 2 of the Act, DEA has requested
public comment in order to ensure that
its regulatory process maintains a
flexible approach and seeks the view of
all persons potentially affected by the
MEA’s requirements. Further, because
this rule contains a 60-day comment
period and utilizes regulations.gov
regarding its rulemaking docket, it
complies with the specific requirements
of Section 2(b) of the Executive Order.
76 FR 3821, 3822. Finally, DEA believes
its rule to be cost-effective and tailored
to impose the least possible burden.
There are only 9 mail-order distributors
that would be affected by this rule and
the cost of implementation is low.
Paperwork Reduction Act of 1995
To address the new mandates of MEA,
DEA is revising an existing information
collection ‘‘Self-Certification, Training,
and Logbooks for Regulated Sellers and
Mail-Order Distributors of Scheduled
Listed Chemical Products,’’ Information
Collection 1117–0046. MEA requires
mail-order distributors to train any
employee who will be involved in
selling scheduled listed chemical
products and to document the training.
Mail-order distributors must also selfcertify to DEA that all affected
employees have been trained and that
the mail-order distributor is in
compliance with all provisions of the
CMEA.
The Department of Justice, Drug
Enforcement Administration, has
submitted the following information
collection request to the Office of
Management and Budget for review and
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Fmt 4700
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clearance in accordance with review
procedures of the Paperwork Reduction
Act of 1995. The information collection
is published to obtain comments from
the public and affected agencies.
All comments and suggestions, or
questions regarding additional
information, to include obtaining a copy
of the information collection instrument
with instructions, should be directed to
Cathy A. Gallagher, Acting Chief,
Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152. Written
comments and suggestions from the
public and affected agencies concerning
the collection of information are
encouraged. Your comments on the
information collection-related aspects of
this rule should address one or more of
the following four points:
• Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
collection of information, including the
validity of the methodology and
assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of Information Collection
1117–0046
(1) Type of Information Collection:
Revision of an existing collection.
(2) Title of the Form/Collection: Selfcertification, Training and Logbooks for
Regulated Sellers and Mail-Order
Distributors of Scheduled Listed
Chemical Products.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection:
Form Number: DEA Form 597.
Office of Diversion Control, Drug
Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: The Controlled Substances
Act mandates that regulated sellers of
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
scheduled listed chemical products
maintain a written or electronic logbook
of sales. The CSA also requires that
regulated sellers and mail-order
distributors retain a record of employee
training, and complete a selfcertification form verifying the training
and compliance with CMEA provisions
regarding retail sales of scheduled listed
chemical products.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond.
As discussed in the previous section,
DEA estimates the number of mail-order
20523
distributors to be around 9. The average
annual burden hour per respondent is
1.8 hours.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 16 hours.
The following table presents the
burden hour calculations.
TABLE 2—ESTIMATE OF TOTAL BURDEN HOURS
Number of
activities
Total burden
hours
Activity
Unit burden hour
Training record .............................................................
Self-certification (regulated sellers) .............................
Self-certification (mail-order distributors) .....................
Transaction record .......................................................
Customer time ..............................................................
0.05 hour (3 minutes) ..................................................
0.25 hour (15 minutes) ................................................
0.5 hours (30 minutes) ................................................
0.033 hour (2 minutes) ................................................
0.033 hour (2 minutes) ................................................
410,228
64,000
9
25,500,000
25,500,000
20,511.4
16,000
4.5
850,000
850,000
Total ......................................................................
......................................................................................
........................
1,736,515.9
If additional information is required
contact: Lynn Murray, Department
Clearance Officer, Information
Management and Security Staff, Justice
Management Division, Department of
Justice, Two Constitution Square, 145 N
Street, NE., Suite 2E–502, Washington,
DC 20530.
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 impose
enforcement responsibilities on any
State; nor does it diminish the power of
any State to enforce its own laws. These
requirements, however, are mandated
under MEA, and DEA has no authority
to alter them or change the preemption.
Accordingly, this rulemaking does not
have federalism implications warranting
the application of Executive Order
13132.
emcdonald on DSK2BSOYB1PROD with RULES
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 $126,400,000 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.
Congressional Review Act
This rule is not a major rule as
defined by section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
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21:27 Apr 12, 2011
Jkt 223001
$100,000,000 or more. It will not cause
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 foreignbased 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 amended as follows:
PART 1314—RETAIL SALE OF
SCHEDULED LISTED CHEMICAL
PRODUCTS
1. The authority citation for part 1314
continues to read as follows:
■
Authority: 21 U.S.C. 802, 830, 842, 871(b),
875, 877, 886a.
2. Section 1314.101 is added to read
as follows:
■
§ 1314.101
Training of sales personnel.
Each regulated person who makes a
sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03(c) of this chapter to submit a
report of the sales transaction to the
Administration must ensure that its
sales of a scheduled listed chemical
product at retail are made in accordance
with the following:
(a) In the case of individuals who are
responsible for preparing and packaging
scheduled listed chemical products for
delivery to purchasers through the
Postal Service or any private or
commercial carrier or who deal either
directly or indirectly with purchasers by
obtaining payments for the products, the
regulated person has submitted to the
Administration a self-certification that
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Sfmt 4700
all such individuals have, in accordance
with criteria issued by the
Administration, undergone training
provided by the regulated person to
ensure that the individuals understand
the requirements that apply under this
part.
(b) The regulated person maintains a
copy of each self-certification and all
records demonstrating that individuals
referred to in paragraph (a) of this
section have undergone the training.
■ 3. Section 1314.102 is added to read
as follows:
§ 1314.102
Self-certification.
(a) A regulated person who makes a
sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03 of this chapter to submit a
report of the sales transaction to the
Attorney General must submit to the
Administration the self-certification
referred to in § 1314.101(a) in order to
sell any scheduled listed chemical
product. The certification is not
effective for purposes of this section
unless, in addition to provisions
regarding the training of individuals
referred to in § 1314.101(a), the
certification includes a statement that
the regulated person understands each
of the requirements that apply in this
part and agrees to comply with the
requirements.
(b) When a regulated person files the
initial self-certification, the
Administration will assign the regulated
person to one of twelve groups. The
expiration date of the self-certification
for all regulated persons in any group
will be the last day of the month
designated for that group. In assigning a
regulated person to a group, the
Administration may select a group with
an expiration date that is not less than
12 months or more than 23 months from
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
the date of self-certification. After the
initial certification period, the regulated
person must update the self-certification
annually.
(c) The regulated person who makes
a sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03 of this chapter to submit a
report of the sales transaction to the
Attorney General must provide a
separate certification for each place of
business at which the regulated person
sells scheduled listed chemical products
at retail.
■ 4. Section 1314.103 is added to read
as follows:
§ 1314.103 Self-certification fee; time and
method of fee payment.
(a) Each regulated person who makes
a sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03 of this chapter to submit a
report of the sales transaction to the
Administration must pay a fee for each
self-certification. For each initial
application to self-certify, and for the
renewal of each existing selfcertification, a regulated seller shall pay
a fee of $21.
(b) The fee for self-certification shall
be waived for any person holding a
current, DEA registration in good
standing as a pharmacy to dispense
controlled substances.
(c) A regulated person 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.
in the third line, ‘‘See’’ should read
‘‘See’’.
2. On page 11957, in the first column,
in the sixth line from the top, ‘‘See’’
should read ‘‘See’’.
PART 1—[CORRECTED]
3. On page 11958, in the first column,
in the fourth line, in amendatory
instruction 3., ‘‘Paragraph (c)(7(iii)’’
should read ‘‘Paragraph (c)(7)(iii)’’.
§ 1.1502–13
[Corrected]
4. On the same page, in § 1.502–
13(c)(7)(ii), in Example 16(b), in the
third column, in the 36th line, ‘‘See’’
should read ‘‘See’’.
5. On the same page, in § 1.502–
13(c)(7)(ii), in Example 17(b), in the
third column, in the fourth line from the
bottom, ‘‘See’’ should read ‘‘See’’.
6. On page 11959, in § 1.502–
13(c)(7)(ii), in Example 17(b), in the first
column, in the 16th line from the top,
‘‘See’’ should read ‘‘See’’.
7. On the same page, in § 1.502–
13(c)(7)(iii)(B), in the first column, in
the third line, ‘‘see’’ should read ‘‘see’’.
8. On the same page, in § 1.502–
13(c)(7)(iii)(B), in the first column, in
the seventh line, ‘‘see’’ should read ‘‘see’’.
§ 1.502–13T
[Corrected]
[FR Doc. 2011–9016 Filed 4–12–11; 8:45 am]
9. On the same page, in § 1.502–
13T(a), in the first column, in the
second line, ‘‘see’’ should read ‘‘see’’.
10. On the same page, in § 1.502–
13T(a)(B)(2), in the second column, in
the 14th line, ‘‘see’’ should read ‘‘see’’.
11. On the same page, in § 1.502–13T,
in the second column, in paragraph
(f)(5)(ii)(B)(3) through (f)(5)(ii)(E), in the
second line, ‘‘see’’ should read ‘‘see’’.
12. On the same page, in § 1.502–
13T(a)(F)(2), in the second column, in
the third line, ‘‘see’’ should read ‘‘see’’.
BILLING CODE 4410–09–P
[FR Doc. C1–2011–4846 Filed 4–12–11; 8:45 am]
Dated: April 8, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
BILLING CODE 1505–01–D
DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF HOMELAND
SECURITY
26 CFR Part 1
Coast Guard
[TD 9515]
33 CFR Part 110
RIN 1545–BH20
[Docket No. USCG–2008–1082]
emcdonald on DSK2BSOYB1PROD with RULES
Guidance Under Section 1502;
Amendment of Matching Rule for
Certain Gains on Member Stock
RIN 1625–AA01
Correction
In rule document 2011–4846
appearing on pages 11956–11959 in the
issue of Friday, March 4, 2011, make the
following corrections:
1. On page 11956, in the third
column, under the Background heading,
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21:27 Apr 12, 2011
Jkt 223001
Anchorage Regulations; Port of New
York
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is revising
Anchorage Ground No. 19 located east
of the Weehawken-Edgewater Federal
SUMMARY:
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Fmt 4700
Sfmt 4700
Channel on the Hudson River. The
revision is necessary to facilitate safe
navigation and provide safe and secure
anchorages for vessels operating in the
area. This action is intended to increase
the safety of life and property of both
the anchored vessels and those
operating in the area as well as to
provide for the overall safe and efficient
flow of commerce.
DATES: This rule is effective May 13,
2011.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2008–1082 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2008–1082 in the ‘‘Keyword’’ box, and
then clicking ‘‘Search.’’ This material is
also available for inspection or copying
at the Docket Management Facility (M–
30), U.S. Department of Transportation,
West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
e-mail Mr. Jeff Yunker, Coast Guard
Sector New York, Waterways
Management Division; telephone
718–354–4195, e-mail
Jeff.M.Yunker@uscg.mil. If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
On September 18, 2009, we published
a notice of proposed rulemaking
(NPRM) entitled Anchorage Regulations;
Port of New York in the Federal
Register (74 FR 47906). We received one
comment on the NPRM. No public
meeting was requested and none was
held. On April 28, 2010, we published
a supplemental notice of proposed
rulemaking (SNPRM) entitled
Anchorage Regulations; Port of New
York in the Federal Register (75 FR
22323). We received one comment on
the SNPRM. A public meeting was
requested by the New York City
Department of Parks and Recreation
(NYC Parks) but the Coast Guard
determined a public meeting was not
necessary in this case. Instead, a
meeting with representatives from the
NYC Parks, Sandy Hook Pilots
Association, and U.S. Army Corps of
Engineers New York District was held
on August 31, 2010, to discuss their
comment in relation to commercial
E:\FR\FM\13APR1.SGM
13APR1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20518-20524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9016]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1314
[Docket No. DEA-347I]
RIN 1117-AB30
Self-Certification and Employee Training of Mail-Order
Distributors of Scheduled Listed Chemical Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Interim final rule with request for comment.
-----------------------------------------------------------------------
SUMMARY: On October 12, 2010, the President signed the Combat
Methamphetamine Enhancement Act of 2010 (MEA). It establishes new
requirements for mail-order distributors of scheduled listed chemical
products. Mail-order distributors must now self-certify to DEA in order
to sell scheduled listed chemical products at retail. Sales at retail
are those sales intended for personal use; mail-order distributors that
sell scheduled listed chemical products not intended for personal use,
e.g., sale to a university, are not affected by the new law. This self-
certification must include a statement that the mail-order distributor
understands each of the requirements that apply under part 1314 and
agrees to comply with these requirements. Additionally, mail-order
distributors are now required to train their employees prior to self
certification. DEA is promulgating this rule to incorporate the
statutory provisions and make its regulations consistent with the new
requirements
[[Page 20519]]
and other existing regulations related to self-certification.
DATES: Effective Date: This rule is effective April 13, 2011.
Comment Date: Written comments must be postmarked and electronic
comments must be submitted on or before June 13, 2011. Commenters
should be aware that the electronic Federal Docket Management System
will not accept comments after midnight Eastern Time on the last day of
the comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-347'' on all written and electronic correspondence.
Comments may be sent electronically through https://www.regulations.gov
using the electronic comment form provided on that site. An electronic
copy of this document is also available at the https://www.regulations.gov Web site. Comments may be sent to DEA by sending an
electronic message to dea.diversion.policy@usdoj.gov. 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.
Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern Time on the day the comment period
closes because https://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern Time on the day the
comment period closes. Commenters in time zones other than Eastern Time
may want to consider this so that their electronic comments are
received.
Written comments sent via regular or express mail should be sent to
the Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
All comments sent via regular or express mail will be considered
timely if postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Cathy A. Gallagher, Acting Chief,
Liaison and Policy Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152; telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
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 https://www.regulations.gov and in the Drug Enforcement Administration'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 the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
DEA's Legal Authority
DEA implements and enforces 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 1321. 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,
distribution, importation, and exportation 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 October 12, 2010, the President signed the Combat
Methamphetamine Enhancement Act of 2010 (MEA) (Pub. L. 111-268).
Generally, the Administrative Procedure Act (APA) (5 U.S.C. 553)
requires agencies to provide notice of proposed rulemaking and the
opportunity for public comment in its regulations implementing an Act
of Congress. However, an agency may find good cause to exempt a rule
from certain provisions of the APA, 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.
DEA is invoking the APA good cause exception and promulgating this rule
as an interim final rule rather than a proposed rule because the
requirements of the MEA addressed by this rulemaking are self-
implementing and changes in this rulemaking provide conforming
amendments to make the language of the regulations consistent with that
of the law. The MEA also specifically states that ``[t]he Attorney
General may issue regulations on an interim basis as necessary to
ensure the implementation of this Act by the effective date.'' Public
Law 111-268, Sec. 6(b). DEA is accepting comments on this rulemaking.
Mail-Order Distributor
DEA regulations do not specifically define ``mail-order
distributor.'' However, part 1314 of the regulations defines ``mail-
order sale'' as ``a retail sale of scheduled listed chemical products
for personal use where a regulated person uses or attempts to use the
U.S. Postal Service or any private or commercial carrier to deliver the
product to the customer.'' 21 CFR 1314.03. Also, mail-order sale
``includes purchase orders submitted by phone,
[[Page 20520]]
mail, fax, Internet, or any method other than face-to-face
transaction.'' 21 CFR 1314.03.
The idea of mail-order distributor is further developed later in
part 1314, which discusses a ``regulated person who makes a sale at
retail of a scheduled listed chemical product and is required under
Sec. 1310.03(c) of this chapter to submit a report of the sales
transaction to the Administration * * *'' 21 CFR 1314.100(a). The CSA
(21 U.S.C. 830(b)(3)) and its implementing regulations impose
recordkeeping and reporting requirements on ``[e]ach regulated person
who engages in a transaction with a nonregulated person or who engages
in an export transaction that involves ephedrine, pseudoephedrine,
phenylpropanolamine, or gamma-hydroxybutyric acid, including drug
products containing these chemicals, and uses or attempts to use the
Postal Service or any private or commercial carrier * * *'' 21 CFR
1310.03(c). Such persons are obligated to file monthly reports with
DEA. 21 CFR 1310.03(c).
Combat Methamphetamine Enhancement Act of 2010
The MEA amends the CSA to change the regulations for selling
scheduled listed chemical products--nonprescription products that
contain ephedrine, pseudoephedrine, and phenylpropanolamine, their
salts, optical isomers, and salts of optical isomers. The law requires
that each regulated person making sales at retail of a scheduled listed
chemical product who is required under Title 21 of the United States
Code ((21 U.S.C. 830(b)(3)) to submit monthly reports of sales
transactions to the Attorney General (referred to as mail-order
distributors) may not sell any scheduled listed chemical product at
retail unless such regulated person has submitted to the Attorney
General a self-certification. Sales at retail are those sales intended
for personal use; mail-order distributors that sell scheduled listed
chemical products not intended for personal use, e.g., sale to a
university, are not affected by the new law. The requirement of self-
certification becomes effective April 10, 2011 (180 days after
enactment on October 10, 2010). Mail-order distributors must be self-
certified before they can sell scheduled listed chemical products. Such
self-certification must be consistent with the criteria established for
certifications of regulated sellers--i.e., retail stores and mobile
retail vendors--of scheduled listed chemical products.
To that end, and pursuant to the requirements of 21 U.S.C.
830(e)(1)(B)(ii)(II), DEA is requiring that each mail-order distributor
must be self-certified at each place of business at which they sell
these products at retail. For a mail-order distributor, this would mean
that each location that prepares or packages product for distribution
to customers, and each location where employees accept payment for such
sales, must be self-certified.
Pursuant to the requirements of 21 U.S.C. 830(e)(1)(B)(iii)(I)
pertaining to regulated sellers, the self-certification for mail-order
distributors is required to take place via the Internet on DEA's Web
site. Self-certification includes a statement that the mail-order
distributors understand the requirements and agree to comply with them.
MEA also makes it unlawful to negligently fail to self-certify as
required under 21 U.S.C. 830, by an amendment to 21 U.S.C. 842(a)(10).
Public Law 111-268, Sec. 5. This applies to regulated sellers and mail-
order distributors.
The MEA also includes a provision which states that ``[t]he
Attorney General shall by regulation establish criteria for
certifications of mail-order distributors that are consistent with the
criteria established for the certifications of regulated sellers under
paragraph (1)(B).'' 21 U.S.C. 830(e)(2)(C), as amended by Public Law
111-268, Sec. 2. This means that mail-order distributors are now
required to train their employees prior to self certification.
Provisions of the Combat Methamphetamine Enhancement Act of 2010
Prior to MEA, mail-order distributors of scheduled listed chemical
products, which covered any sale where the product is shipped using the
Postal Service or any private or commercial carrier, did not have to
self-certify. They did have to file monthly reports of all sales of
scheduled listed chemical products with DEA, and they were required to
verify the identity of their customer before shipping scheduled listed
chemical products. 21 U.S.C. 830(b)(3) and 830(e)(2)(A).
Sales of scheduled listed chemical products by mail-order
distributors. MEA requires that on and after April 10, 2011, a mail-
order distributor must not sell scheduled listed chemical products at
retail unless it has self-certified to DEA, through DEA's Web site. The
self-certification requires the mail-order distributor to confirm the
following:
Its employees who will be engaged in the sale of scheduled
listed chemical products have undergone training regarding provisions
of the Combat Methamphetamine Epidemic Act of 2005 (CMEA).
Records of the training are maintained.
Sales to individuals do not exceed 3.6 grams of ephedrine,
pseudoephedrine, or phenylpropanolamine per day. For mail-order
distributors, sales to individuals do not exceed 7.5 grams of
ephedrine, pseudoephedrine, or phenylpropanolamine per 30-day period.
Nonliquid forms are packaged as required. The mail-order
distributor must train its employees and self-certify before either the
mail-order distributor or individual employees may sell scheduled
listed chemical products. The law governing self-certification of mail-
order distributors does not explicitly make such certifications subject
to 18 U.S.C. 1001, as is the case for regulated sellers whose sales are
limited almost exclusively to face-to-face retail transactions. Compare
21 U.S.C. 830(e)(1)(B) to 830(e)(2)(C). However, a mail-order
distributor who knowingly or willfully self-certifies to facts that are
not true is subject to fines and imprisonment by virtue of general
applicability of 18 U.S.C. 1001. Also, when Congress directed that
regulations of the Attorney General establish criteria for the
certification of mail-order distributors ``that are consistent with the
criteria established for the certification of regulated sellers under
paragraph (1)(B),'' it must have intended that this Federal false
statements statute apply.
Training. DEA has developed training that it has made available on
its Web site (https://www.deadiversion.usdoj.gov). Employers must use
the content of this training in the training of their employees who
sell scheduled listed chemical products. An employer may include
content in addition to DEA's content, but DEA's content must be
included in the training. For example, a mail-order distributor may
elect to incorporate DEA's content into initial training for new
employees.
Training records. On and after April 10, 2011, each employee of a
mail-order distributor who is responsible for delivering scheduled
listed chemical products to purchasers or who deals directly with
purchasers by obtaining payment for the scheduled listed chemical
products must undergo training and must sign an acknowledgement of
training received prior to selling scheduled listed chemical products.
This record must be kept in the employee's personnel file.
Self-certification. MEA adds the requirement that mail-order
distributors
[[Page 20521]]
self-certify with DEA. As noted previously, MEA also makes it unlawful
for mail-order distributors to negligently fail to self-certify as
required under 21 U.S.C. 830.
On and after April 10, 2011, under the requirements of MEA, mail-
order distributors who sell at retail must self-certify to DEA as
described above. DEA has established a Web page that will allow mail-
order distributors of scheduled listed chemical products to complete
the self-certification online and submit it to DEA electronically. A
self-certification certificate will immediately be generated by DEA
upon receipt of the application. The mail-order distributors will print
this self-certification certificate, or if they are unable to print it,
DEA will print and mail the certificate to the self-certifier.
Time for self-certification. MEA requires that mail-order
distributors self-certify by April 10, 2011. When a regulated person
files the initial self-certification, the Administration will assign
the regulated person to one of twelve groups. The expiration date of
the self-certification for all regulated persons in any group will be
the last day of the month designated for that group. In assigning a
regulated person to a group, the Administration may select a group with
an expiration date that is not less than 12 months or more than 23
months from the date of self-certification. After the initial
certification period, the regulated person must update the self-
certification annually. It is the responsibility of the mail-order
distributor to ensure that they renew the self-certification before it
lapses.
Fee for self-certification. To comply with the requirement of the
CSA that fees be set at a level to ensure the recovery of the full
costs of operating the various aspects of the Diversion Control
Program, DEA established an annual self-certification fee for certain
regulated sellers selling scheduled listed chemical products at retail.
The annual self-certification fee for regulated sellers who are not DEA
pharmacy registrants is $21. To make regulations regarding mail-order
distributors consistent with those for regulated sellers, the same
self-certification fee will apply to any mail-order distributor that is
not a DEA-registered pharmacy.
Table 1 summarizes the requirements for mail-order distributors of
scheduled listed chemical products that are now in place since the
passage of the MEA.
Table 1--Summary of Requirements by Type of Seller
------------------------------------------------------------------------
Mail-order sellers
------------------------------------------------------------------------
Daily sales limit...................... 3.6 gm/chemical.
30-day sales limit..................... 7.5 gm.
Blister packs.......................... Yes.
Storage................................ NA.
Logbook................................ NA.
Customer ID............................ Verify ID.
Train employees........................ Yes.
Self-Certify........................... Yes.
Monthly reports........................ Yes.
Theft and loss reports................. Yes.
------------------------------------------------------------------------
Discussion of the Rule
To make the rule easier to follow for regulated sellers and mail-
order distributors, DEA previously created part 1314 that includes all
requirements related to the sale of scheduled listed chemical products
to end users. Subpart A contains requirements that apply to any retail
sale. Subpart B applies to regulated sellers (retail distributors and
mobile retail vendors). Subpart C applies to retail sales that are
shipped by mail or private or commercial carriers, regardless of how
those sales are ordered.
In Subpart C, Section 1314.101 is being added to address employee
training for mail-order distributors. Section 1314.102 is added to
address self-certification for mail-order distributors. Section
1314.103 covers the self-certification fee and the time of payment for
this fee. As discussed above, DEA is setting an annual period for
renewal of the certification. DEA has developed a page on its Web site
that will allow mail-order distributors to complete and submit the
self-certification form online and print out a self-certification
certificate for their records. The information required will include
the name and address of the location, a point of contact, and tax
identification number.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
The Administrative Procedure Act (APA) generally requires that
agencies, prior to issuing a new rule, publish a Notice of Proposed
Rulemaking in the Federal Register. However, the Combat Methamphetamine
Enhancement Act specifically states, ``[t]he Attorney General may issue
regulations on an interim basis as necessary to ensure the
implementation of this Act by the effective date.'' Public Law 111-268,
Sec. 6(b). Additionally, the APA provides that agencies may be excepted
from this requirement when ``the agency for good cause finds (and
incorporates the finding and a brief statement of reasons therefor in
the rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.'' 5
U.S.C. 553(b)(B).
With publication of this interim final rule, DEA is invoking this
``good cause'' exception to the APA's notice requirement based on the
combination of several factors. The MEA is effective 180 days after its
passage. Mail-order distributors selling scheduled listed chemical
products at retail must self-certify with DEA in order to continue to
sell these products. Based on the effective date and the requirements
of the MEA, it is impracticable for DEA to comply with the APA's notice
and comment requirements due to the limited time involved. Were DEA not
to publish this interim final rule with Request for Comment, mail-order
distributors selling scheduled listed chemical products at retail would
not be able to self-certify by the date specified in the law. As a
result, these mail-order distributors would be forced to stop selling
scheduled listed chemical products, or violate the law by doing so.
Thus, DEA also finds it is contrary to the public interest to DEA to
comply with the APA's notice and comment requirements due to the
potential disruption of sales of scheduled listed chemical products by
mail-order distributors.
In light of these factors, DEA finds that ``good cause'' exists to
issue this interim rule without engaging in traditional notice and
comment rulemaking.
Regulatory Flexibility Act
The Deputy Assistant Administrator, Office of Diversion Control,
hereby certifies that this rulemaking has been drafted in accordance
with the Regulatory Flexibility Act (5 U.S.C. 601-612). The Regulatory
Flexibility Act (RFA) applies to rules that are subject to notice and
comment. DEA has determined, as explained above, that public notice and
comment are impracticable and contrary to the public interest.
Consequently, the RFA does not apply.
Although the RFA does not apply to this interim final rule, DEA has
reviewed the potential impacts. DEA does not believe that it will have
a significant economic impact on small entities. Based on reports
filed, DEA expects that the rule will affect only 9 firms, two of which
are not small based on the Small Business Administration's size
standards. For the seven small firms, the only costs are the $21 annual
fee, the time required to complete the
[[Page 20522]]
certification (0.5 hours or about $20 for a new self-certification
application), and cost of training (0.5 hours or about $10). The cost
of compliance for these firms, which appear to have between 5 and 25
employees, not all of whom would need to be trained, is less than $200
and in most cases, less than $100. The smallest mail order pharmacies
(those with fewer than five employees) have average annual sales of $1
million. The cost of compliance is, therefore, less than 0.1 percent of
sales and would not impose a significant economic burden on any small
entity.
Executive Order 12866
The Deputy Assistant Administrator, Office of Diversion Control,
further certifies that this rulemaking has been drafted in accordance
with the principles in Executive Order 12866 Sec. 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.
As discussed above, this action is codifying statutory provisions and
involves no agency discretion. However, DEA has reviewed the potential
benefits and costs following OMB Circular A-4.
The time for a mail-order distributor to self-certify is estimated
at 0.5 hours. Additionally, the time for a mail-order distributor to
train employees is estimated at 0.5 hours. The nine affected firms
range in size from 5 employees to more than 800. DEA assumes that the
smallest firms will train half their employees and the two large firms
will train 20 percent, based on the percentage of retail sales persons,
order clerks, and order fillers to total employment in the retail mail
order sector. The total cost of the rule is estimated to be less than
$2,600. DEA does not expect that the rule will lead any of the firms to
discontinue sales of the products because they are already reporting to
DEA on these sales. The low cost of compliance is unlikely to
discourage firms from selling the products.
Benefits. Congress passed the MEA to better track retail sales of
scheduled listed chemical products by requiring self-certification of
mail-order distributors in addition to regulated sellers (retailers).
The MEA also makes it more difficult for regulated sellers and mail-
order distributors to obtain scheduled listed chemical products from
distributors by prohibiting distributors from selling to them if they
have not self-certified. This leaves less opportunity for diversion at
the retail level.
Methamphetamine remains the primary drug produced in illicit
laboratories within the United States. The vast majority of these
laboratories used pharmaceutical products containing pseudoephedrine,
ephedrine, and phenylpropanolamine as the source of precursor material.
Conclusion. MEA's requirements will not impose an annual cost on
the economy of $100 million or more, the standard for an economically
significant rule under Executive Order 12866.
Executive Order 13563
Published on January 18, 2011, Executive Order 13563 supplements
and reaffirms the principles established in Executive Order 12866. 76
FR 3821. The new Executive Order emphasizes the importance of public
participation and cost-effectiveness within the context of the
regulatory process. DEA has carefully considered the requirements of
the Executive Order and has concluded that this rule satisfies the
applicable requirements. Although the MEA provides authorization to
issue rules on an interim basis in order to implement the self-
certification requirements of Section 2 of the Act, DEA has requested
public comment in order to ensure that its regulatory process maintains
a flexible approach and seeks the view of all persons potentially
affected by the MEA's requirements. Further, because this rule contains
a 60-day comment period and utilizes regulations.gov regarding its
rulemaking docket, it complies with the specific requirements of
Section 2(b) of the Executive Order. 76 FR 3821, 3822. Finally, DEA
believes its rule to be cost-effective and tailored to impose the least
possible burden. There are only 9 mail-order distributors that would be
affected by this rule and the cost of implementation is low.
Paperwork Reduction Act of 1995
To address the new mandates of MEA, DEA is revising an existing
information collection ``Self-Certification, Training, and Logbooks for
Regulated Sellers and Mail-Order Distributors of Scheduled Listed
Chemical Products,'' Information Collection 1117-0046. MEA requires
mail-order distributors to train any employee who will be involved in
selling scheduled listed chemical products and to document the
training. Mail-order distributors must also self-certify to DEA that
all affected employees have been trained and that the mail-order
distributor is in compliance with all provisions of the CMEA.
The Department of Justice, Drug Enforcement Administration, has
submitted the following information collection request to the Office of
Management and Budget for review and clearance in accordance with
review procedures of the Paperwork Reduction Act of 1995. The
information collection is published to obtain comments from the public
and affected agencies.
All comments and suggestions, or questions regarding additional
information, to include obtaining a copy of the information collection
instrument with instructions, should be directed to Cathy A. Gallagher,
Acting Chief, Liaison and Policy Section, Office of Diversion Control,
Drug Enforcement Administration, 8701 Morrissette Drive, Springfield,
VA 22152. Written comments and suggestions from the public and affected
agencies concerning the collection of information are encouraged. Your
comments on the information collection-related aspects of this rule
should address one or more of the following four points:
Evaluate whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
Evaluate the accuracy of the agency's estimate of the
burden of the collection of information, including the validity of the
methodology and assumptions used;
Enhance the quality, utility, and clarity of the
information to be collected; and
Minimize the burden of the collection of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses.
Overview of Information Collection 1117-0046
(1) Type of Information Collection: Revision of an existing
collection.
(2) Title of the Form/Collection: Self-certification, Training and
Logbooks for Regulated Sellers and Mail-Order Distributors of Scheduled
Listed Chemical Products.
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection:
Form Number: DEA Form 597.
Office of Diversion Control, Drug Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: The Controlled Substances Act mandates that regulated
sellers of
[[Page 20523]]
scheduled listed chemical products maintain a written or electronic
logbook of sales. The CSA also requires that regulated sellers and
mail-order distributors retain a record of employee training, and
complete a self-certification form verifying the training and
compliance with CMEA provisions regarding retail sales of scheduled
listed chemical products.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond.
As discussed in the previous section, DEA estimates the number of
mail-order distributors to be around 9. The average annual burden hour
per respondent is 1.8 hours.
(6) An estimate of the total public burden (in hours) associated
with the collection: 16 hours.
The following table presents the burden hour calculations.
Table 2--Estimate of Total Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Total burden
Activity Unit burden hour activities hours
----------------------------------------------------------------------------------------------------------------
Training record.............................. 0.05 hour (3 minutes)........... 410,228 20,511.4
Self-certification (regulated sellers)....... 0.25 hour (15 minutes).......... 64,000 16,000
Self-certification (mail-order distributors). 0.5 hours (30 minutes).......... 9 4.5
Transaction record........................... 0.033 hour (2 minutes).......... 25,500,000 850,000
Customer time................................ 0.033 hour (2 minutes).......... 25,500,000 850,000
------------------------------------------------------------------
Total.................................... ................................ .............. 1,736,515.9
----------------------------------------------------------------------------------------------------------------
If additional information is required contact: Lynn Murray,
Department Clearance Officer, Information Management and Security
Staff, Justice Management Division, Department of Justice, Two
Constitution Square, 145 N Street, NE., Suite 2E-502, Washington, DC
20530.
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 impose enforcement responsibilities on any
State; nor does it diminish the power of any State to enforce its own
laws. These requirements, however, are mandated under MEA, and DEA has
no authority to alter them or change the preemption. 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
$126,400,000 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.
Congressional Review Act
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more. It will not cause 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 amended as
follows:
PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
0
1. The authority citation for part 1314 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.
0
2. Section 1314.101 is added to read as follows:
Sec. 1314.101 Training of sales personnel.
Each regulated person who makes a sale at retail of a scheduled
listed chemical product and is required under Sec. 1310.03(c) of this
chapter to submit a report of the sales transaction to the
Administration must ensure that its sales of a scheduled listed
chemical product at retail are made in accordance with the following:
(a) In the case of individuals who are responsible for preparing
and packaging scheduled listed chemical products for delivery to
purchasers through the Postal Service or any private or commercial
carrier or who deal either directly or indirectly with purchasers by
obtaining payments for the products, the regulated person has submitted
to the Administration a self-certification that all such individuals
have, in accordance with criteria issued by the Administration,
undergone training provided by the regulated person to ensure that the
individuals understand the requirements that apply under this part.
(b) The regulated person maintains a copy of each self-
certification and all records demonstrating that individuals referred
to in paragraph (a) of this section have undergone the training.
0
3. Section 1314.102 is added to read as follows:
Sec. 1314.102 Self-certification.
(a) A regulated person who makes a sale at retail of a scheduled
listed chemical product and is required under Sec. 1310.03 of this
chapter to submit a report of the sales transaction to the Attorney
General must submit to the Administration the self-certification
referred to in Sec. 1314.101(a) in order to sell any scheduled listed
chemical product. The certification is not effective for purposes of
this section unless, in addition to provisions regarding the training
of individuals referred to in Sec. 1314.101(a), the certification
includes a statement that the regulated person understands each of the
requirements that apply in this part and agrees to comply with the
requirements.
(b) When a regulated person files the initial self-certification,
the Administration will assign the regulated person to one of twelve
groups. The expiration date of the self-certification for all regulated
persons in any group will be the last day of the month designated for
that group. In assigning a regulated person to a group, the
Administration may select a group with an expiration date that is not
less than 12 months or more than 23 months from
[[Page 20524]]
the date of self-certification. After the initial certification period,
the regulated person must update the self-certification annually.
(c) The regulated person who makes a sale at retail of a scheduled
listed chemical product and is required under Sec. 1310.03 of this
chapter to submit a report of the sales transaction to the Attorney
General must provide a separate certification for each place of
business at which the regulated person sells scheduled listed chemical
products at retail.
0
4. Section 1314.103 is added to read as follows:
Sec. 1314.103 Self-certification fee; time and method of fee payment.
(a) Each regulated person who makes a sale at retail of a scheduled
listed chemical product and is required under Sec. 1310.03 of this
chapter to submit a report of the sales transaction to the
Administration must 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 $21.
(b) The fee for self-certification shall be waived for any person
holding a current, DEA registration in good standing as a pharmacy to
dispense controlled substances.
(c) A regulated person 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: April 8, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2011-9016 Filed 4-12-11; 8:45 am]
BILLING CODE 4410-09-P
