[Federal Register: September 21, 2007 (Volume 72, Number 183)]
[Proposed Rules]
[Page 53973-53977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se07-21]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-302P]
RIN 1117-AB14
Record Requirements for Chemical Distributors
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Proposed Rulemaking (NPRM).
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SUMMARY: In March 2006, Congress enacted the Combat Methamphetamine
Epidemic Act of 2005, which mandates
[[Page 53974]]
that regulated sellers of scheduled listed chemical products self-
certify with DEA before they are allowed to sell these products at
retail. DEA is proposing to revise its recordkeeping requirements to
include a requirement that manufacturers, distributors, and importers
obtain and maintain the certification number issued by DEA to regulated
sellers in their records of sales. This change will ensure that
registrants verify that the regulated sellers to whom they distribute
have successfully completed the mandatory self-certification process
imposed by the CMEA for sales of scheduled listed chemical products.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before November 20, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-302'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, 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 format 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 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 posted online and placed in the Drug Enforcement Administration'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:
DEA's Legal Authority
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 medical, scientific, and
other legitimate 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, retail sale, import, and export 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). CMEA
amends the CSA by adding new provisions related to the importation,
production, and sale of ephedrine, pseudoephedrine, and
phenylpropanolamine, their salts, optical isomers, and salts of optical
isomers, and products that contain any of the three chemicals. Products
that contain any of the three chemicals and which may be marketed or
distributed lawfully in the United States under the Federal Food, Drug,
and Cosmetic Act as a nonprescription drug (an ``over-the-counter''
drug) are defined as scheduled listed chemical products (21 U.S.C.
802(45)). Ephedrine, pseudoephedrine, and phenylpropanolamine are List
I chemicals because they are used in, and important to, the illegal
manufacture of methamphetamine, a Schedule II controlled substance.
Products containing these List I chemicals also have legitimate medical
uses. Ephedrine is used in some products for treating asthma.
Pseudoephedrine, a decongestant, is a common ingredient in cold and
allergy medications. In November 2000, the Food and Drug Administration
(FDA) issued a public health advisory concerning phenylpropanolamine
and requested that all drug companies discontinue marketing products
containing phenylpropanolamine due to risk of hemorrhagic stroke. In
response, many companies voluntarily reformulated their products to
exclude phenylpropanolamine. Subsequently, on December 22, 2005, FDA
published a Notice of Proposed Rulemaking (70 FR 75988) proposing to
categorize all over-the-counter nasal decongestants and weight control
drug products containing phenylpropanolamine preparations as Category
II, nonmonograph, i.e., not generally recognized as being safe for
human consumption. Most products containing phenylpropanolamine
intended for humans have been
[[Page 53975]]
withdrawn from the market, but phenylpropanolamine is still sold by
prescription for veterinary uses.
CMEA Requirements
CMEA regulates the sale of scheduled listed chemical products at
retail, including the sale of those products by regulated sellers. CMEA
defines regulated seller to mean a retail distributor (including a
pharmacy or a mobile retail vendor) (21 U.S.C. 802(46)). Retail
distributor means a grocery store, general merchandise store, drug
store, or other entity or person whose activities as a distributor
relating to drug products containing pseudoephedrine or
phenylpropanolamine are limited almost exclusively to sales for
personal use, both in number of sales and volume of sales, either
directly to walk-in customers or in face-to-face transactions by direct
sales (21 U.S.C. 802(49)). Mobile retail vendor means a person or
entity that makes sales at retail from a stand that is intended to be
temporary, or is capable of being moved from one location to another,
whether the stand is located within or on the premises of a fixed
facility (such as a kiosk at a shopping center or an airport) or
whether the stand is located on unimproved real estate (such as a lot
or field leased for retail purposes) (21 U.S.C. 802(47)). [Note that
mail order distributors are not regulated sellers.]
As of September 30, 2006, regulated sellers that wish to sell
scheduled listed chemical products at retail must comply with the
requirements in CMEA for product placement and packaging,
recordkeeping, sales limits, and employee training and must self-
certify to DEA that they are in compliance prior to selling the
products. When a regulated seller self-certifies, DEA issues a self-
certification certificate (DEA Form 598) which includes a certification
number. The expiration date of the self-certification is printed on the
self-certification certificate. Self-certifications must be renewed
annually if the regulated seller continues to sell scheduled listed
chemical products. Regulated sellers are not required to register with
DEA although many regulated sellers may be DEA registrants because they
also handle controlled substances. Note that self-certification is
independent of DEA registration; the fact that an entity is a DEA
registrant does not negate the requirement that the entity self-certify
with DEA and receive a self-certification certificate.
Proposed Rule
DEA is proposing to revise 21 CFR 1310.06(a) to require that those
DEA registrants who distribute scheduled listed chemical products to
regulated sellers verify that the regulated seller to whom they are
distributing the products has certified to DEA that the regulated
seller is in compliance with the requirements for retail sales of
scheduled listed chemical products. The registrant who distributes the
products must also maintain the certification number as part of the
sales record. This proposal is consistent with the current rule, which
requires registrants to ensure that their customers are eligible to
purchase listed chemicals and to record their DEA numbers, where
applicable. Collecting DEA and certification numbers assists
registrants to know their customers and to be certain that the
customers are purchasing the products for legitimate purposes.
This requirement will primarily affect distributors, although some
manufacturers and importers may sell directly to regulated sellers.
Under current Sec. 1310.06, registrants are required to include the
following in their sales records:
The name, address, and if applicable, the DEA number of
each party to the transaction.
The date of the transaction.
The name, quantity, and form of packaging of the listed
chemical.
The method of transfer.
The type of identification used by the purchaser and any
unique number on that identification.
DEA is proposing to add the certification number of the purchaser to
the list of information that must be maintained in sales records.
Normal business records can be used to meet this requirement if they
include the required information. Because mail order distributors are
not subject to self-certification, DEA is not requiring registrants to
collect any additional information from these firms. Under the existing
rule, if the mail order distributor is a DEA registrant, the DEA number
must be collected as part of the sales record.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612). The Regulatory Flexibility Act
requires agencies to determine whether proposed rules would have a
significant economic impact on a substantial number of small entities.
DEA expects that some of the distributors subject to this rule will be
small entities. The burden associated with the rule, however, is de
minimis. Registrants will simply have to ask their purchasers for their
DEA certification number and keep that number in their records. For
firms that receive orders electronically and maintain electronic
records, as many do, the certification number can simply be added to
the customer's master record that is associated with individual orders.
If the same customer orders multiple times during a year, the
information could be collected only once a year because certifications
will generally be valid for a year; initial certifications may have
longer validity periods. Because the time required to collect the
information and maintain the record is minimal, the Deputy Assistant
Administrator has determined that this action does not require a
regulatory flexibility analysis.
Executive Order 12866
The Deputy Assistant Administrator 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
rulemaking is a significant regulatory action and, therefore, has been
reviewed by the Office of Management and Budget.
Paperwork Reduction Act
The Paperwork Reduction Act requires agencies to estimate the
burden imposed by recordkeeping and reporting. The records required
under this proposed rule are standard business records. While many DEA-
registered distributors may maintain the self-certification number of
regulated sellers which purchase scheduled listed chemical products
from them, some may not. DEA believes that the additional information
that registrants would be required to collect once a year imposes a
minimal burden that can be met by simply adding the item to the order
form. DEA invites comment regarding whether the inclusion in
distributors' records of the self-certification numbers of regulated
sellers purchasing scheduled listed chemical products imposes a burden
which should be quantified.
The Department of Justice, Drug Enforcement Administration, has
submitted the following information collection request to the Office of
Management and Budget (OMB) for review and clearance in accordance with
review procedures of the Paperwork Reduction Act of 1995. The proposed
information collection is published to obtain comments from the public
and affected agencies.
[[Page 53976]]
All comments and suggestions, or questions regarding additional
information, to include obtaining a copy of the proposed information
collection instrument with instructions, should be directed to Mark W.
Caverly, Chief, Liaison and Policy Section, Office of Diversion
Control, Drug Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments regarding the information-collection aspects
of this rule should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) 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 this information collection:
(1) Type of Information Collection: New collection.
(2) Title of the Form/Collection: [Insert title same as above and
on OMB 83-I].
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection:
Form Number: None.
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: Title 21, United States Code, Section 830, and Title 21,
Code of Federal Regulations, part 1314 require that any person who is a
regulated seller of scheduled listed chemical products to self-certify
to DEA that it has trained its staff in the requirements for selling
scheduled listed chemical products and is in compliance with DEA
regulations. To ensure that persons distributing scheduled listed
chemical products sell only to regulated sellers who are eligible to
sell them, DEA is requiring distributors to collect and retain the
certification number DEA issues to regulated sellers when they self-
certify.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond:
DEA estimates that 38,926 persons will respond to this collection
annually, with each response taking an estimated 2 minutes. DEA
estimated the number of responses as follows.
As of August 6, 2007, 75,721 regulated sellers had self-
certified to DEA. Of those, 39,917 certifications were filed by 103
chains. There were, therefore, 36,804 regulated sellers who filed as
individual regulated sellers. For regulated sellers that belonged to
chains that filed certifications for their stores, DEA assumed that
the chain held the master list and would provide the self-
certification numbers of each self-certified location to
distributors from whom the chain orders scheduled listed chemical
products. Thirty of the self-certified chains are also registered as
chemical or controlled substance distributors; these chains,
therefore, do not need to take any additional action to provide
information to the distributor. The number of regulated sellers who
would need to provide the self-certification number to a distributor
is the 36,804 individual regulated sellers plus the 73 chains that
do not serve as their owner distributors. In addition, DEA assumes
that 2,049 controlled substance and chemical distributors would have
to collect the information. This estimate is conservative because
not all of these distributors handle scheduled listed chemical
products.
(6) An estimate of the total public burden (in hours) associated
with the collection: DEA estimates that this collection will take 1,298
hours annually.
If additional information is required contact: Lynn Bryant,
Department Clearance Officer, Information Management and Security
Staff, Justice Management Division, Department of Justice, Patrick
Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sec. Sec. 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 of 1996
(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 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR part 1310 is proposed to be
amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
2. Section 1310.06 is proposed to be amended by revising paragraph
(a) introductory text and by adding (a)(6) to read as follows:
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03 shall include all of the
following:
* * * * *
(6) For distributions of scheduled listed chemical products to
regulated sellers, the regulated seller's (i.e., the purchaser's) DEA
certification number issued in accordance with section 1314.40(b) of
this chapter.
* * * * *
[[Page 53977]]
Dated: September 12, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E7-18530 Filed 9-20-07; 8:45 am]
BILLING CODE 4410-09-P