[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Proposed Rules]
[Pages 63576-63631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21589]
[[Page 63575]]
Vol. 81
Thursday,
No. 179
September 15, 2016
Part II
Department of Justice
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Drug Enforcement Administration
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21 CFR Parts 1300, 1301, 1302, et al.
Revision of Import and Export Requirements for Controlled Substances,
Listed Chemicals, and Tableting and Encapsulating Machines, Including
Changes To Implement the International Trade Data System; Revision of
Reporting Requirements for Domestic Transactions in Listed Chemicals
and Tableting and Encapsulating Machines; and Technical Amendments;
Proposed Rule
Federal Register / Vol. 81 , No. 179 / Thursday, September 15, 2016 /
Proposed Rules
[[Page 63576]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312,
1313, 1314, 1315, 1316, and 1321
[Docket No. DEA-403]
RIN 1117-AB41
Revision of Import and Export Requirements for Controlled
Substances, Listed Chemicals, and Tableting and Encapsulating Machines,
Including Changes To Implement the International Trade Data System;
Revision of Reporting Requirements for Domestic Transactions in Listed
Chemicals and Tableting and Encapsulating Machines; and Technical
Amendments
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration is proposing to update its
regulations for the import and export of tableting and encapsulating
machines, controlled substances, and listed chemicals, and its
regulations relating to reports required for domestic transactions in
listed chemicals, gamma-hydroxybutyric acid, and tableting and
encapsulating machines. In accordance with Executive Order 13563, the
Drug Enforcement Administration has reviewed its import and export
regulations and reporting requirements for domestic transactions in
listed chemicals (and gamma-hydroxybutyric acid) and tableting and
encapsulating machines, and evaluated them for clarity, consistency,
continued accuracy, and effectiveness. The proposed amendments clarify
certain policies and reflect current procedures and technological
advancements. The amendments also allow for the implementation, as
applicable to tableting and encapsulating machines, controlled
substances, and listed chemicals, of the President's Executive Order
13659 on streamlining the export/import process and requiring the
government-wide utilization of the International Trade Data System.
This proposal additionally contains amendments that would implement
recent changes to the Controlled Substances Import and Export Act
(CSIEA) for reexportation of controlled substances among members of the
European Economic Area made by the Improving Regulatory Transparency
for New Medical Therapies Act. The proposal includes additional
substantive and technical amendments.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before October 17, 2016. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after 11:59 p.m. Eastern Time on the last day of the
comment period.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Management
and Budget (OMB) on or before October 17, 2016.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-403'' on all correspondence, including any
attachments.
The Drug Enforcement Administration encourages that all comments be
submitted through the Federal eRulemaking Portal, which provides the
ability to type short comments directly into the comment field on the
Web page or to attach a file for lengthier comments. Please go to
http://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon completion of your submission you
will receive a Comment Tracking Number for your comment. Please be
aware that submitted comments are not instantaneously available for
public view on Regulations.gov. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment. Paper comments that duplicate an
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Information
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ,
Washington, DC 20503. Please state that your comment refers to RIN
1117-AB41/Docket No. DEA-403.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA or Administration) for public inspection online at
http://www.regulations.gov. Such information includes personal
identifying information (such as your name, address, etc.) voluntarily
submitted by the commenter. The Freedom of Information Act (FOIA)
applies to all comments received. 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 made publicly available, you
must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the
first paragraph of your comment. You must also place the personal
identifying information you do not want made publicly available 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 made publicly available, 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.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) included in the text of your
electronic submission that is not identified as directed above as
confidential.
An electronic copy of this document and supplemental information to
this proposed rule are available at http://www.regulations.gov for easy
reference. The DEA specifically solicits written comments regarding the
DEA's economic analysis of the impact of these proposed changes. The
DEA requests that commenters provide detailed descriptions in their
comments of any expected economic impacts, especially to small
entities. Commenters should
[[Page 63577]]
provide empirical data to illustrate the nature and scope of such
impact.
Outline
I. Background and Purpose
A. Legal Authority
B. Current Import/Export Practices and Regulatory Framework
1. Import and Export Permits for Controlled Substances
2. Import and Export Declarations for Controlled Substances
3. Import and Export Declarations and Notices for Listed
Chemicals
4. Import and Export Reports for Tableting and Encapsulating
Machines; Reports for Domestic Transactions in Listed Chemicals,
Gamma-Hydroxybutyric Acid, and Tableting and Encapsulating Machines
5. Transshipments of Controlled Substances
6. Transshipments of Listed Chemicals
7. Notifications of International Transactions by Brokers or
Traders
C. Purpose of Regulatory Action
II. Discussion of Technical Amendments and Proposed Significant
Regulatory Changes
A. Proposed Amendments Directly Associated With Implementation
of the International Trade Data System
1. Applications, Notices and Other Filings
a. Import and Export Permits for Controlled Substances
b. Import and Export Declarations for Controlled Substances
c. Import and Export Declarations for Listed Chemicals
d. Import and Export Reports for Tableting and Encapsulating
Machines
e. Transshipments of Controlled Substances
f. Transshipments of Listed Chemicals
g. Notifications of International Transactions by Brokers or
Traders
2. Security
3. Miscellaneous
B. Proposed Amendments Indirectly Associated With Implementation
of the International Trade Data System
1. Terminology and Definitions
2. Part 1302: Labeling and Packaging Requirements for Controlled
Substances
3. Part 1304: Records and Reports of Registrants
4. Part 1308: Schedules of Controlled Substances
5. Part 1309: Registration of Manufacturers, Distributors,
Importers and Exporters of List I Chemicals
6. Part 1310: Records and Reports of Listed Chemicals and
Certain Machines
a. Mail Order Reporting for Ephedrine, Pseudoephedrine,
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
b. Listed Chemicals and Tableting and Encapsulating Machines
7. Part 1312: Importation and Exportation of Controlled
Substances
8. Reexportation of Controlled Substances--Including
Implementation of section 4 of the Improving Regulatory Transparency
for New Medical Therapies Act
9. Part 1313: Importation and Exportation of List I and List II
Chemicals
10. Part 1316: Administrative Functions, Practices, and
Procedures
C. DEA Mailing Addresses
III. Regulatory Analyses
I. Background and Purpose
A. Legal Authority
The DEA implements and enforces titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, as
amended. 21 U.S.C. 801-971. Titles II and III are known as the
``Controlled Substances Act'' and the ``Controlled Substances Import
and Export Act,'' respectively, and are collectively referred to as the
``Controlled Substances Act'' or ``CSA'' for the purpose of this
action. The DEA publishes implementing regulations for these statutes
in title 21 of the Code of Federal Regulations (CFR), chapter II. The
CSA and its implementing regulations are designed to prevent, detect,
and eliminate the diversion of controlled substances and listed
chemicals into the illicit market while ensuring an adequate supply is
available for the legitimate medical, scientific, research, and
industrial needs of the United States. Controlled substances have the
potential for abuse and dependence and are controlled to protect the
public health and safety.
Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the substance may cause. 21 U.S.C. 812. The initial
schedules of controlled substances established by Congress are found at
21 U.S.C. 812(c), and pursuant to 21 U.S.C. 812 (a) and (b), the
current list of all scheduled substances is published at 21 CFR part
1308. Controlled substances generally include narcotics, stimulants,
depressants, and hallucinogens that have a potential for abuse and
physical and psychological dependence, as well as anabolic steroids.
Listed chemicals are separately classified based on their use and
importance to the illicit manufacture of controlled substances (list I
or list II chemicals). 21 U.S.C. 802 (33)-(35).
Through the enactment of the CSA and its amendments, Congress has
established a closed system of distribution making it unlawful to
handle any controlled substance (manufacture, distribute, reverse
distribute, dispense, conduct research, engage in narcotic treatment or
maintenance, import, export, collect, conduct chemical analysis,
dispose, or possess) or manufacture, distribute, import, or export any
listed chemical except in a manner authorized by the CSA. See e.g.,
Gonzales v. Raich, 545 U.S. 1, 12-13 (2005) (stating ``The main
objectives of the CSA were to conquer drug abuse and to control the
legitimate and illegitimate traffic in controlled substances. Congress
was particularly concerned with the need to prevent the diversion of
drugs from legitimate to illicit channels. To effectuate these goals,
Congress devised a closed regulatory system making it unlawful to
manufacture, distribute, dispense, or possess any controlled substance
except in a manner authorized by the CSA. 21 U.S.C. Sec. Sec.
841(a)(1), 844(a).''); H.R. Rep. No. 91-1444, pt. 1 at 3 (1970)
(stating: ``Title II: Control and Enforcement.--The bill provides for
control by the Justice Department of problems related to drug abuse
through registration of manufacturers, wholesalers, retailers, and all
others in the legitimate distribution chain, and makes transactions
outside the legitimate distribution chain illegal.'').
In order to maintain this closed system of distribution, the CSA
requires handlers of controlled substances, unless exempt from
registration, to be registered with the DEA at each principal place of
business or professional practice where controlled substances are
manufactured, distributed, or dispensed. 21 U.S.C. 822. The CSA also
requires persons who manufacture or distribute, or who propose to
manufacture or distribute, list I chemicals to be registered at each
principal place of business or professional practice, unless exempt. 21
U.S.C. 822; 21 CFR 1309.22. A separate registration is also required
for each principal place of business where controlled substances or
list I chemicals are imported or exported, unless exempt from
registration. 21 U.S.C. 958. A ``registrant'' is any person who is
registered pursuant to either section 303 or section 1008 of the CSA
(codified at 21 U.S.C. 823 or 958).\1\ 21 CFR 1300.01(b). Registrants
are permitted to possess controlled substances and list I chemicals as
authorized by their registration and must comply with the applicable
requirements associated with their registration. 21 U.S.C. 822 and 958.
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\1\ Unless otherwise noted, all references to registrant(s) in
this preamble include persons exempt from DEA registration and
persons not registered with the DEA as an importer or exporter who
are authorized to perform importing or exporting activities as a
coincident activity of their research or chemical analysis
registration in accordance with 21 CFR 1301.13(e).
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In contrast, a ``regulated person'' means ``a person who
manufactures, distributes, imports, or exports a listed
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chemical, a tableting machine, or an encapsulating machine or who acts
as a broker or trader \2\ for an international transaction \3\
involving a listed chemical, a tableting machine, or an encapsulating
machine.'' 21 U.S.C. 802(38). (Tableting machines and encapsulating
machines are also commonly known as ``pill presses'' and ``capsule
fillers'' respectively.) Regulated persons who engage in ``regulated
transactions,'' defined at 21 U.S.C. 802(39),\4\ are subject to
specific recordkeeping and reporting requirements pursuant to 21 U.S.C.
830, 971; 21 CFR part 1310. In addition, a person located in the United
States who is a broker or trader for an international transaction in a
listed chemical that is a regulated transaction shall, with respect to
that transaction, be subject to all of the notification, reporting,
recordkeeping, and other requirements placed upon exporters of listed
chemicals. 21 U.S.C. 971(e).
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\2\ A ``broker'' and ``trader'' are persons that assist in
arranging an international transaction in a listed chemical by:
negotiating contracts; serving as an agent or intermediary; or
bringing together a buyer and seller, a buyer and transporter, or a
seller and transporter. 21 U.S.C. 802(43).
\3\ An ``international transaction'' is a transaction that
involves ``the shipment of a listed chemical across an international
border (other than a United States border) in which a broker or
trader located in the United States participates.'' 21 U.S.C.
802(42).
\4\ The CSA defines a ``regulated transaction'' as being: (1)
with certain enumerated exceptions, ``a distribution, receipt, sale,
importation, or exportation of, or an international transaction
involving shipment of, a listed chemical, or if the Attorney General
establishes a threshold amount for a specific listed chemical, a
threshold amount, including a cumulative threshold amount for
multiple transactions (as determined by the Attorney General, in
consultation with the chemical industry and taking into
consideration the quantities normally used for lawful purposes), of
a listed chemical;'' and (2) ``a distribution, importation, or
exportation of a tableting machine or encapsulating machine.'' 21
U.S.C. 802(39).
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The CSA grants the Attorney General authority to promulgate rules
and regulations relating to: the registration of controlled substance
and list I chemical handlers; control of the manufacture, distribution,
and dispensing of controlled substances; control of the manufacture and
distribution of listed chemicals; maintenance and submission of records
and reports; and for the efficient execution of her statutory
functions. 21 U.S.C. 821-822, 825, 827-831, 871, 952, 954, 956, 958,
971. The Attorney General is further authorized by the CSA to
promulgate rules and regulations relating to the registration and
control of importers and exporters of controlled substances or listed
chemicals. 21 U.S.C. 958(f). The Attorney General has delegated these
authorities to the Administrator of the DEA, who in turn redelegated
many of these authorities to the Deputy Administrator of the DEA and
the Deputy Assistant Administrator of the DEA Office of Diversion
Control. 28 CFR 0.100 et seq.
Within the DEA, the Office of Diversion Control is the strategic
focus area that carries out the mandates of the CSA to ensure that
adequate supplies of controlled substances and listed chemicals are
available to meet legitimate domestic medical, scientific, industrial,
and export needs. The Office of Diversion Control carries out the
mission of the DEA to prevent, detect, and eliminate the diversion of
these substances into the illicit drug market. Activities in support of
the Office of Diversion Control and its mission include: Determination
of program priorities; field management oversight; coordination of
major investigations; drafting and promulgating regulations; the design
and proposal of national legislation; advice and leadership on State
legislation/regulatory initiatives; oversight of the importation and
exportation of tableting and encapsulating machines, controlled
substances, and listed chemicals; establishment of national drug
production quotas; activities related to drug scheduling and compliance
with international treaty obligations; the design and execution of
diplomatic missions; computerized monitoring and tracking of the
distribution of certain controlled substances; planning and allocation
of program resources; and liaison efforts with industry and their
representative associations as well as to the DEA's regulatory and law
enforcement counterparts at the federal, State, tribal, and local
levels.
B. Current Import/Export Practices and Regulatory Framework
Under the CSA, a controlled substance, listed chemical, or
tableting or encapsulating machine is considered imported if it is
either brought into the customs territory from a place that is outside
the customs territory but within the United States (e.g., a shipment
from an insular possession such as Guam into one of the 50 States) or
brought into the United States from any other place (e.g., a shipment
from India into one of the 50 States or into an insular possession such
as American Samoa). 21 U.S.C. 951, 952; see also 21 U.S.C. 802(39),
830(a). For purposes of the CSA, the ``customs territory of the United
States'' includes only the 50 States, the District of Columbia, and
Puerto Rico. 21 U.S.C. 951(a)(2). In contrast, an export of a
controlled substance, listed chemical, or tableting or encapsulating
machine occurs when that item is taken out of, or removed from, the
United States, which, pursuant to the definition at 21 U.S.C. 802(28),
includes ``all places and waters, continental or insular, subject to
the jurisdiction of the United States.'' See 21 U.S.C. 802 (38) and
(39), 830(a), 953(a).
The DEA regulations are drafted to be consistent with the meaning
of ``import'' and ``export'' under the CSA, which is broader in scope
than the meaning of those terms as used in the U.S. Customs and Border
Protection's (CBP) regulations. The DEA regulations are also drafted to
take into account the authority of customs officials of U.S.
territories to enforce the CSA. The CSA and DEA regulations prohibit
any person from importing or exporting any controlled substance or list
I chemical unless that person is registered with the DEA (or exempt
from registration). 21 U.S.C. 957. In addition, these substances may
only be imported and exported if specific statutory criteria are met.
For instance, schedule II controlled substances may be imported to the
extent that the Attorney General finds such importation is ``necessary
to provide for the medical, scientific, or other legitimate needs of
the United States * * * in any case in which the Attorney General finds
that such controlled substance is in limited quantities exclusively for
scientific, analytical, or research uses,'' 21 U.S.C. 952(a)(2)(C), or
in other limited circumstances. Schedule II narcotic drugs may be
exported if, inter alia, ``substantial evidence is furnished to the
Attorney General by the exporter that (A) the narcotic drug is to be
applied exclusively to medical or scientific uses within the country of
import, and (B) there is an actual need for the narcotic drug for
medical or scientific uses within such country.'' 21 U.S.C. 953(a)(4).
Depending on the circumstances surrounding the proposed import or
export, in most cases the CSA and implementing regulations require
importers and exporters, in advance of the import or export, to obtain
a permit from the DEA, or to report the activity to the DEA by filing a
declaration. 21 U.S.C. 952-953, 971; 21 CFR 1312.11, 1312.21, 1313.12,
1313.21.
1. Import and Export Permits for Controlled Substances
Registrants (and those exempt from registration) \5\ who wish to
import a
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controlled substance listed in schedule I or II; any narcotic drug
listed in schedule III, IV, or V; any non-narcotic drug in schedule III
that has been specifically designated by regulation in 21 CFR 1312.30;
or any non-narcotic substance listed in schedule IV or V that is also
listed in schedule I or II of the Convention on Psychotropic
Substances, 1971, must apply (on DEA Form 357) for and be granted a
permit from the DEA prior to the import. 21 U.S.C. 952; 21 CFR 1312.11,
1312.12, 1312.13. Similarly, registrants who wish to export any
schedule I or II controlled substance; any narcotic drug in schedule
III or IV; any non-narcotic drug in schedule III that has been
specifically designated by regulation in 21 CFR 1312.30; or any non-
narcotic substance listed in schedule IV or V that is also listed in
schedule I or II of the Convention on Psychotropic Substances, 1971,
must apply (on DEA Form 161 or 161R) for and be granted a permit from
the DEA prior to the export. 21 U.S.C. 953; 21 CFR 1312.21, 1312.22,
1312.23. The DEA currently issues permits in sextuplet for imports and
in septuplet for exports, serially numbered, on special paper. 21 CFR
1312.13(e), 1312.23(e). The copies are distributed among the importer,
the foreign exporter, the foreign government authority, CBP, and the
DEA in accordance with Sec. Sec. 1312.14 and 1312.24. Permits expire
on the date specified on the permit, but in no event shall the date be
more than six months after the date the permit is issued. 21 CFR
1312.16(b), 1312.25. Unused permits are required to be returned to the
DEA for cancellation. Id.
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\5\ As discussed in note 1, unless specifically noted otherwise,
discussion of ``registrants'' also includes persons exempt from
registration for purposes of the preamble portion of this notice.
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2. Import and Export Declarations for Controlled Substances
Those non-narcotic controlled substances listed in schedule III,
IV, or V, that are not subject to the requirement of a permit, may be
imported or exported if the registrant files a controlled substances
import/export declaration (on DEA Form 236) with the DEA. 21 U.S.C.
952(b), 953(e); 21 CFR 1312.11(b), 1312.21(b). Likewise, narcotic
controlled substances in schedule V may be exported if the registrant
files a controlled substances export declaration. 21 U.S.C. 953(e); 21
CFR 1312.21(b). Currently, the declaration must be executed in
quintuplicate and Copy 4 shall be filed with the DEA not later than 15
calendar days prior to the proposed date of importation or exportation.
21 CFR 1312.18, 1312.19, 1312.27, 1312.28. The five copies of the
import/export declaration (DEA Form 236) are distributed among the
importer, the foreign shipper, the governmental authority of the
foreign country, CBP, and the DEA in accordance with Sec. 1312.19 or
Sec. 1312.28.
3. Import and Export Declarations and Notices for Listed Chemicals
The CSA and DEA regulations have established a system of
recordkeeping and reporting requirements that provide the DEA with a
mechanism to track international movement of listed chemicals in order
to prevent their being diverted for use in the clandestine manufacture
of controlled substances. The CSA generally requires regulated persons
who import or export a listed chemical to report the transaction to the
DEA, as delegated by the Attorney General, at least 15 days in advance.
21 U.S.C. 971(a). This requirement is modified for regulated persons
engaging in a transaction with a ``regular customer'' and for regulated
persons designated as ``regular importers.'' 21 U.S.C. 802 (36) and
(37), 971(b); 21 CFR 1313.15, 1313.24. The DEA has the obligation to
examine the report in order to determine if the shipment is legitimate
and that the chemical will not be diverted into the illicit manufacture
of controlled substances, pursuant to the authority granted in 21
U.S.C. 971 (c) and (d).
For listed chemicals at or above thresholds set forth in Sec.
1310.04(f) and listed chemicals for which no threshold has been
established as identified in Sec. 1310.04(g), regulated persons may
import or export list I or II chemicals by filing a listed chemical
import declaration (on DEA Form 486/486A) or an export declaration (on
DEA Form 486) with the Administration not later than 15 calendar days
prior to the date of the proposed importation or exportation (unless
DEA has waived such advance reporting through regulation). 21 CFR
1313.12, 1313.13, 1313.21, 1313.22. The United States importer or
exporter must include on their declaration the name and address of each
person to whom the listed chemical(s) will be transferred (i.e., the
transferee, consignee, and intermediate consignees), including the
quantity. 21 U.S.C. 971(d); 21 CFR 1313.13(c), 1313.22(c). For an
importer, the transferee is the person to whom the importer transfers
the listed chemical (i.e., the downstream customer). For an export from
the United States, the transferee/consignee is the foreign importer.
For a broker or trader, the transferee/consignee is the foreign
customer purchasing the listed chemicals. Importers are also required
to list their foreign supplier on their declaration. The DEA Form 486/
486A must be executed in triplicate. 21 CFR 1313.13, 1313.22. The three
copies of the listed chemical import/export declaration are distributed
among the importer/exporter, CBP, and the DEA in accordance with
Sec. Sec. 1313.14 and 1313.23.
If, after submission of the initial DEA Form 486/486A, the
importer, exporter, broker or trader will not be transferring the
listed chemical to the transferee named on the declaration, or if the
quantity of listed chemical to be imported, exported, or transferred is
greater than the quantity originally indicated on the declaration, the
importer, exporter, broker or trader must file an amended DEA Form 486/
486A reporting the change. 21 CFR 1313.16(b), 1313.26(b), 1313.32(d).
Even if an importer or exporter did not have to file an initial
notification--either because he or she is a regular importer selling to
a regular customer, or an exporter selling to a regular customer--if
the newly arranged spot market sale is not to a regular customer, the
importer or exporter must file an advance notice 15 days prior to
transferring the chemical to a new customer. 21 CFR 1313.16, 1313.26.
Within 30 days after an import or export of a listed chemical has
occurred, the importer/exporter must file with the DEA a return
declaration containing the particulars of the transaction, including
the date, quantity, chemical, container, name of transferees, and any
other information as the Administration may specify. 21 U.S.C. 971(g);
21 CFR 1313.17(a), 1313.27(a). An importer may file a single return
declaration including the particulars of both the importation and the
distribution. 21 CFR 1313.17(a). If the importer has not distributed
all chemicals imported by the end of the initial 30-day period, the
importer must file supplemental return declarations every 30 days until
the distribution or other disposition of all chemicals imported under
the declaration or amended declaration have been accounted for. 21 CFR
1313.17(a). If an import/export for which a declaration has been filed
does not in fact take place, the importer/exporter must file an amended
declaration notifying the DEA that the transaction did not in fact
occur. 21 CFR 1313.17(b), 1313.27(b).
4. Import and Export Reports for Tableting and Encapsulating Machines;
Reports for Domestic Transactions in Listed Chemicals, Gamma-
Hydroxybutyric Acid, and Tableting and Encapsulating Machines
Regulated persons who engage in a regulated transaction involving a
listed chemical, a tableting machine, or an
[[Page 63580]]
encapsulating machine must keep records of the transaction and file
reports in accordance with Sec. Sec. 1310.03(a), 1310.04, and 1310.05.
Regulated persons who import or export a tableting machine or
encapsulating machine are not required to obtain prior approval from
the DEA for the transaction, but they are required to file a report
with the DEA of any importation or exportation of a tableting or an
encapsulating machine on or before the date of importation or
exportation. 21 U.S.C. 830(b)(1)(D); 21 CFR 1310.05(c), 1310.06 (e) and
(f).
Regulated persons who engage in an export transaction that involves
ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals
or controlled substance) and use or attempt to use the U.S. Postal
Service or a private or commercial carrier are required to file monthly
reports of these transactions in accordance with Sec. Sec. 1310.03(c),
1310.05(e), 1310.06(i), and 1314.110; see also Sec. 1310.04. The
report must be submitted to the Import/Export Unit of the DEA on
company letterhead, signed by the person authorized to sign the
registration application forms on behalf of the registrant. 21 CFR
1310.05(e). Regulated persons who engage in any domestic regulated
transaction with a tableting machine or an encapsulating machine,
including those following an import of such machines, must orally
report, when possible, and subsequently file written reports with the
Special Agent in Charge of the DEA Divisional Office for the area in
which the regulated person making the report is located. 21 CFR 1310.05
(a)(4) and (b).
Regulated persons are required to report regulated transactions
involving extraordinary quantities of a listed chemical, uncommon
method of payment or delivery, or other circumstances that the
regulated person believes may indicate that the listed chemical will be
used in violation of the CSA and its implementing regulations. 21 CFR
1310.05 (a)(1) and (b). Regulated persons must also report the unusual
or excessive loss or disappearance of a listed chemical under their
control, 21 CFR 1310.05 (a)(3) and (b), and any proposed regulated
transaction with a person whose description or identifying
characteristic the Administration has previously provided. 21 CFR
1310.05(a)(2).
5. Transshipments of Controlled Substances
The transshipment of controlled substances through the United
States is governed by 21 U.S.C. 954. Persons seeking to transship or
transfer for immediate exportation schedule I controlled substances
within the United States must apply for a permit at least 30 days in
advance of the expected transshipment or, in the case of an emergency,
as soon as practicable, and receive a transshipment permit from the DEA
before the transshipment may occur. 21 CFR 1312.31. Controlled
substances listed in schedule II, III, or IV may be so transshipped or
transferred if 15 days advance written notice is provided to the DEA in
accordance with 21 CFR 1312.32. 21 U.S.C. 954(2). A specific DEA Form
is not required for transshipments, however the application for prior
written approval (for schedule I substances) and the advance notice
(for schedule II, III, or IV substances) must conform with very
specific requirements outlined in Sec. 1312.31 (b) and (c). See 21 CFR
1312.32(b).
6. Transshipments of Listed Chemicals
As stated above, the CSA generally requires regulated persons who
import or export a listed chemical to report the transaction to the
DEA, as delegated by the Attorney General, at least 15 days in advance.
21 U.S.C. 971(a). This requirement is modified for regulated persons
engaging in a transaction with a ``regular customer'' and for regulated
persons designated as ``regular importers.'' 21 U.S.C. 802 (36) and
(37), 971(b); 21 CFR 1313.15, 1313.24. No waiver of the 15-day advance
notice is permitted under 21 CFR 1313.31(d) for importations for
transshipment purposes of threshold or greater quantities of listed
chemicals. Regardless of whether the shipment is a direct export or a
transshipment, the DEA has the obligation to examine the report in
order to determine if the shipment is legitimate and that the chemical
will not be diverted into the illicit manufacture of controlled
substances.
Persons seeking to transship or transfer listed chemicals in a
quantity that meets or exceeds the threshold amounts found in Sec.
1310.04(f) must provide advance notification to the DEA not later than
15 days prior to the proposed date that the listed chemical will
transship or transfer through the United States. 21 CFR 1313.31. The
notification must contain the information that is required by the DEA
Form 486, but it is not required to be submitted to DEA using the DEA
Form 486.
7. Notifications of International Transactions by Brokers or Traders
Brokers or traders engaging in international transactions involving
listed chemicals which meet or exceed the threshold amounts found in
Sec. 1310.04 must provide notification to the DEA not later than 15
days in advance of the transaction by filing DEA Form 486. 21 CFR
1313.32.
Within 30 days after an international transaction has occurred, the
broker or trader must send the DEA a return declaration containing the
particulars of the transaction, including the date, quantity, chemical,
container, name of transferees, and any other information as the
Administration may specify. 21 CFR 1313.35(a). If an international
transaction for which a DEA Form 486 has been filed does not in fact
take place, the broker or trader must file an amended DEA Form 486
notifying the DEA that the transaction did not in fact occur. 21 CFR
1313.35(b).
C. Purpose of Regulatory Action
The DEA is proposing to update its regulations regarding the import
and export of tableting and encapsulating machines, controlled
substances, and listed chemicals. In accordance with Executive Order
13563, the DEA has reviewed its import and export regulations and
reporting requirements for domestic transactions involving listed
chemicals (and gamma-hydroxybutyric acid) and tableting and
encapsulating machines, and evaluated them for clarity, consistency,
continued accuracy, and effectiveness. The amendments would codify
current practices and incorporate current procedures and technological
advancements and allow for implementation of the President's Executive
Order on streamlining the export/import process and requiring
Government-wide utilization of the International Trade Data System
(ITDS). Section 3 of the President's Executive Order 13659 of February
19, 2014, ``Streamlining the Export/Import Process for America's
Businesses,'' directs participating agencies to have capabilities,
agreements, and other requirements in place to allow electronic filing
through ITDS and supporting systems of data and other relevant
documents (exclusive of applications for permits, licenses, or
certifications) required for imported and exported goods. Businesses
are able to transmit their import and export data according to the
Electronic Data Interchange (EDI), an electronic communication
framework providing standards for exchanging data via any
[[Page 63581]]
electronic means. Data transmitted through EDI links to the Automated
Commercial Environment (ACE), which serves as the single window for CBP
and participating agencies. For purposes of this notice, the DEA will
describe EDI, ACE, and any successor system to ACE, by the statutory
term for the single window goal, which is ITDS.
As discussed above, current DEA regulations specifically require
applications for permits, and declarations and other required notices
and reports to be filed in paper form, or by electronic means in some
circumstances. The DEA must amend its regulations in order to integrate
DEA procedures related to the importation and exportation of tableting
and encapsulating machines, controlled substances, and listed chemicals
with the ITDS.
Because the ITDS excludes applications for permits, licenses, or
certifications, the ITDS single window will not be used by DEA
registrants, regulated persons, or brokers or traders applying for
permits or filing import/export declarations, notifications or reports
with the DEA. The DEA import/export application and filing processes
will continue to remain separate from (and in advance of) the ITDS
single window. Entities will continue to use the DEA application and
filing processes; however, the processes will be electronic rather than
paper. After DEA's approval or notification of receipt as appropriate,
the DEA will transmit the necessary information electronically to the
ITDS and the registrant or regulated person so that customs officers
can validate importations and exportations subject to DEA regulations.
Because of the requirement that regulated persons submit reports of
regulated transactions in tableting machines and encapsulating machines
to the DEA, the DEA also proposes to require such domestic regulated
transaction reports to be submitted through the DEA Office of Diversion
Control secure network application, in addition to import and export
regulated transactions. Mandatory reporting requirements for domestic
regulated transactions are included as part of this proposal because it
allows for the DEA to create, at one time, an efficient, streamlined
reporting structure of regulated activities applicable to tableting and
encapsulating machines. Additional information related to the proposed
mandatory electronic reporting requirements for tableting and
encapsulating machines is discussed in section II, B, 6, b of this
document.
This proposal additionally contains amendments that would implement
section 4, Re-exportation Among Members of the European Economic Area,
of the Improving Regulatory Transparency for New Medical Therapies Act,
Public Law 114-89, which was signed into law on November 25, 2015.
Section 4 amended section 1003 of the Controlled Substances Import and
Export Act (21 U.S.C. 953) by making changes to paragraph (f) and
adding paragraph (g) that allows for reexportation of controlled
substances among members of the European Economic Area. Additional
information related to the proposed revisions to implement section 4 of
the Improving Regulatory Transparency for New Medical Therapies Act is
discussed in section II, B, 8 of this document.
This proposal also includes technical and stylistic changes to
several regulations to clarify and simplify the language and to further
the goals of the President's memorandum on Transparency and Open
Government. 74 FR 4685, Jan. 26, 2009.
II. Discussion of Technical Amendments and Proposed Significant
Regulatory Changes
A. Proposed Amendments Directly Associated With Implementation of the
International Trade Data System
1. Applications, Notices, and Other Filings
The principal changes necessary to implement the ITDS are also
those that will allow the efficient and standardized electronic
exchange of required information.
To transmit data electronically to the ITDS, the first global
change that the DEA is proposing is to mandate the electronic
submission of all applications and other required filings and reports
(e.g., declarations, notices, returns) associated with the importation
or exportation of tableting and encapsulating machines, controlled
substances, and listed chemicals. 21 U.S.C. 958(f). However, the DEA
will not require electronic submission of transshipment data. (The
electronic application and filing process is not feasible in such
circumstances because foreign IP addresses are blocked by the
Department of Justice's firewall and are prevented from accessing the
DEA Office of Diversion Control secure network application.)
Accordingly, the vast majority of persons subject to the CSA
requirements and DEA regulations pertaining to imports and exports
would be required to make all DEA-required submissions through the DEA
Office of Diversion Control secure network application. The DEA will
provide customs information to validate importations subject to DEA
regulations, and this change will enable the DEA to analyze and
electronically transmit necessary information to the ITDS quickly and
accurately. The DEA Office of Diversion Control secure network
application will be accessed by DEA registrants and regulated persons
through the DEA Office of Diversion Control Web site. Security of the
new electronic system is discussed in section II, A, 2 of this document
under the heading ``Security.'' In addition, importers and exporters
would obtain information regarding approved permits and DEA's receipt
of completed declarations, notices, returns, and reports through the
same DEA Office of Diversion Control secure network application. If
importers and exporters were permitted to continue submitting paper
documents, the DEA would have to manually transcribe the paper
information into an electronic format for transmission to the ITDS.
Such an intermediary step would cause unnecessary delay and is subject
to error. In addition to providing for electronic filing of information
to CBP through ITDS and reducing errors, electronic applications,
approvals, declarations, notices, and reports strengthen the DEA's
ability to monitor and prevent unauthorized imports and exports and
will enhance information sharing between CBP/customs services of
Insular Areas and the DEA.\6\ Electronic processing is expected to help
the DEA identify unauthorized or suspicious shipments prior to import
or export, and diversion of in-transit shipments being exported or
imported, by improving the quality and timeliness of data review and
transaction authorization.
---------------------------------------------------------------------------
\6\ For purposes of this preamble, ``customs services of Insular
Areas'' means the governmental authority/authorities (federal or
insular), charged with enforcement of the customs laws of the United
States/Insular Area.
---------------------------------------------------------------------------
For the foregoing reasons, the DEA is proposing amendments to its
regulations that would authorize electronic submission of data, and
would make the procedure mandatory over paper in most circumstances. 21
U.S.C. 958(f). The use of electronic applications and filings is
consistent not only with the requirements of Executive Order 13659, but
also with the general principles outlined in the Government's Open Data
Policy which requires agencies to collect or create information in a
way that supports downstream information processing and
[[Page 63582]]
dissemination.\7\ The Open Data Policy states that information should
be collected electronically by default. As discussed in greater detail
in the Regulatory Analyses section of this document, the DEA believes
that the regulated community should be able to easily adapt to this new
requirement with minimal effort or cost.
---------------------------------------------------------------------------
\7\ OMB Memorandum M-13-13, Open Data Policy--Managing
Information as an Asset, available at https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf.
---------------------------------------------------------------------------
If an importer/exporter tries to submit an application,
declaration, notice, report, or other required submission through the
DEA Office of Diversion Control secure network application but does not
complete all of the required fields or enters key data that is not
valid or is inaccurate (e.g., unknown port or erroneous drug code) with
the submission, the DEA Office of Diversion Control secure network
application will automatically alert the filer to the fact that
information is missing or does not meet the validation requirements.
Applications, declarations, notices, and reports filed through the
DEA Office of Diversion Control secure network application would
generally not be deemed filed until the DEA assigns a single-use,
randomly-generated, unique identifier. This identifier would be
referenced as the ``transaction identification number,'' except for
permits, where the transaction identification number would continue to
be called the ``permit number'' to correspond with current business
practice. A permit number would be assigned once the DEA has approved
an application for a permit. A transaction identification number would
be assigned once the DEA reviews a declaration, notice, or other filing
for completeness, and it is accepted for filing. Although issuance of a
transaction identification number would signify that the declaration,
notice, or other filing has been reviewed for completeness, the
issuance of the transaction identification number does not mean that
such filing has been ``approved'' by the DEA. The DEA reserves the
right to cancel an import or export permit or declaration for cause and
suspend shipments of listed chemicals in accordance with applicable
regulations. Currently, the DEA assigns a Web Tracking Number to each
filing submitted electronically to the DEA and would continue to do so
under this proposal. However, unlike the proposed transaction
identification number, the Web Tracking Number is assigned
automatically upon submission to the DEA; the transaction
identification number would be assigned only after the DEA has reviewed
the filing for completeness.
Instead of distributing ``copies,'' registrants and other
importers/exporters, once logged into the DEA Office of Diversion
Control secure network application through authenticated access, would
be able to use the assigned permit or transaction identification number
to access the ``official record'' of the filing from the DEA Office of
Diversion Control secure network application. The registrant or other
importer/exporter would then be responsible for forwarding official
record information to their broker or any other of their agents needing
the information contained therein to complete the release process
through customs. Permit numbers and transaction identification numbers
are discussed in more detail later in this document for each
transaction category.
Declarations, permits, and most other filings with DEA would not be
deemed filed until a transaction identification number (or permit
number) is issued by the DEA. The transaction identification number
would be issued by the DEA after any necessary corrections are
complete. The DEA considered, but ultimately did not choose to propose,
a specific timeframe in which transaction identification numbers (and
permit numbers) will be issued because of concern of instances that
require longer-than-average review and processing times that can result
from any number of circumstances, not all of which are foreseeable.
However, the DEA does not have reason to believe that by not having a
stated timeframe that there will be any significant impact on import
and export activities.
The DEA is proposing to have the option of deeming a submission
filed on the date submitted, if a listed chemical import or export
declaration, or other filing was complete at the time of filing and no
additional follow-up action was required, instead of on the date the
transaction identification number was issued. However, if a chemical
importer or exporter made a submission on the last day that would
comply with the reporting deadline, and DEA review subsequently found
the submission not to be complete, then he or she would be in violation
of the regulation. The requirement to submit applications,
declarations, notices, reports, and other filings includes the duty
that such filings be complete. If an importer or exporter has concerns
that their information may not be complete they would be able to
contact the DEA in advance of the submission to ask questions and/or
submit the filing in advance of the deadline to ensure that if changes
or additional information is required that those changes can be made
before the established 15-day filing deadline.
In association with this change, the DEA is proposing to globally
amend its import and export regulations to provide that expiration
periods, filing deadlines, and other timed action dates are to be
generally calculated as ``calendar days'' (i.e., including weekends and
holidays) unless otherwise noted in a regulation (e.g., in the case of
amendments). This change corresponds with business rule policies that
will be built into the DEA's electronic systems of records for the
impacted applications, notices, and other filings that will be required
to be electronically submitted to the DEA.
(a) Import and Export Permits for Controlled Substances
The DEA proposes to incorporate the mandatory electronic
application requirements for controlled substance imports and exports
into Sec. Sec. 1312.12 and 1312.22. Applicants for a permit to import
or export controlled substances would be required to access, complete,
and submit the DEA application for import, application for export, or
application for reexport, as appropriate, to the DEA through the DEA
Office of Diversion Control secure network application. This
requirement would also be incorporated into a new Sec. 1312.03, which
references applicable forms for part 1312, and would state that such
forms are electronic.
Other than for transshipments, current DEA regulations requiring
import and export permits to be issued in multiples via paper form
would be eliminated in favor of regulations making such information
available via digital means. The DEA would continue to issue original
permits under existing practices, and would still transmit the original
permit to the pertinent foreign competent national authorities (CNAs);
however, the DEA would eliminate issuing the other copies. The DEA
proposes that ``copies'' currently issued by the DEA to registrants
would only be accessible through the DEA Office of Diversion Control
secure network application. The DEA would assign each approved permit a
permit number (a unique identifier). Once the permit has been issued,
registrants would be able to use the assigned permit number to access
the digital copy of the permit, or the ``official record of the
permit.'' Corresponding changes would be made throughout DEA import/
export regulations. These changes will reference the data downloads
from the
[[Page 63583]]
secure network application by the registrant as an ``official record of
the permit'' instead of a ``copy.'' These changes are proposed in
Sec. Sec. 1312.13, 1312.14, 1312.23, and 1312.24.
The DEA proposes to amend its import/export regulations to describe
the procedures relating to amendments following issuance of an import
or export permit. The DEA is proposing to revise Sec. Sec. 1312.16 and
1312.25 to clearly specify how and under what conditions controlled
substance import and export permits may be amended or cancelled after
issuance and when a new permit is required instead of an amendment.
Registrants would submit a request to amend or cancel an application
for an import or export permit, amend an issued import or export
permit, or request for a cancelation of an issued import or export
permit to the Administration through the DEA Office of Diversion
Control secure network application. Return information on imports and
exports may not be amended.
Consistent with current practice, importers and exporters would
continue to be able to request an amendment to a permit for the
following data fields: The National Drug Control number, description of
the packaging, or trade name of the product, so long as the description
is for the same basic class of controlled substance(s) as in the
original permit; the proposed port of entry or export; the proposed
date of import or export; \8\ the method of transport; any registrant
notes; and the justification entered by the importer or exporter for
why an import or export is needed to meet the medical, scientific, or
other legitimate needs of the United States or foreign jurisdiction.
The DEA allows amendments to these fields as these are areas that may
be easily mis-keyed or subject to change as part of the normal import
and export business practice. While the data contained in these fields
is important to determining the risk of diversion and the tracking of
controlled substances through the closed system of distribution, the
DEA believes that the Administration is able to enforce the CSA and
uphold U.S. obligations under international drug control treaties while
potentially limiting burden on industry by allowing these fields to be
amendable.
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\8\ The DEA is proposing to make global changes to DEA
regulations to change usage, where applicable, of ``import'' and
``export'' to reference the date of release by customs officers for
purposes of DEA recordkeeping and reporting requirements.
---------------------------------------------------------------------------
Consistent with current practice, importers and exporters would
continue to generally be allowed to amend the base weight of controlled
substance(s) listed on their permit prior to the start of an import or
export transaction (i.e., prior to shipment). However, also consistent
with current practice, exporters would not be allowed to exceed the
total base weight of controlled substance(s) listed on the
corresponding foreign permit. Also consistent with current practice,
neither would exporters be allowed to exceed the strength of a
controlled substance product if product strength information has been
included on the import permit issued by the foreign competent national
authority. Consistent with current Sec. 1312.15(a), importers would
continue to be allowed to request an amendment to the quantity of
controlled substances specified on an import permit once a shipment has
arrived at the U.S. customs port of entry if the increase in the amount
of controlled substance to be imported is less than 1% of that listed
on the issued import permit. Importers and exporters need not request
an amendment for the sole purpose of decreasing the amount authorized.
Consistent with current practice, importers and exporters would
continue to be able to request that an import or export permit be
amended to remove a controlled substance. However, importers and
exporters would no longer be able to amend permits to add a new
controlled substance, replace the name of a controlled substance with a
different controlled substance, or amend the controlled substance
content of a drug or preparation. Instead, importers and exporters who
needed to make changes to any of these fields would need to cancel the
existing permit and apply for a new permit. The DEA understands that
sometimes the incorrect controlled substance is identified on the
permit application due to clerical error, for example because a similar
item was selected from the drop-down selection in the DEA Office of
Diversion Control secure network application that was located near the
correct item. However, the DEA has closely considered this issue and
ultimately determined that because the listed controlled substance
proposed to be imported or exported is such a critical element of
determining whether or not a permit should be issued and, if issued,
the amount allowed to be imported or exported, this element should not
be amendable. As stated elsewhere in this preamble, the DEA reminds
importers and exporters that the duty to file reports and other
documents with the DEA includes the duty that these filings be complete
and accurate.
Similarly, in a change from current practice, the DEA is proposing
to cease allowing exporters to amend foreign permit information on
permit applications and issued permits. The DEA understands that
sometimes, especially in the case of less experienced exporters, the
incorrect foreign permit number is entered onto the permit application.
This is often the result of numbers being transposed or a different
number on the foreign permit being entered instead of the actual permit
identification number. However, similar to the controlled substance
identified on the permit, the DEA has closely considered this matter
and ultimately determined that, because the authorization from the
foreign competent national authority is such a critical element in
determining whether a permit can be issued and the amount of the
controlled substance to be exported, this element should not be
amendable. As stated above and elsewhere in this document, the DEA
reminds importers and exporters that the duty to file reports and other
documents with the DEA includes the duty that these filings be complete
and accurate.
Consistent with current practice, importers and exporters would not
be able to request an amendment to a permit for changes to the importer
or exporter's name (as it appears on their DEA certificate of
registration) or the name of the foreign importer or exporter. The DEA
considers the name of the foreign importer or exporter to be a key
factor in determining associated risks of the diversion of controlled
substances and subsequently whether or not to issue an import or export
permit. Therefore, these fields would not be amendable.
However, also consistent with current practice, as stated above,
the DEA would continue to allow importers and exporters to amend any
additional associated company names they are DBA (doing business as)
that they wish to have included in the notes section of the permit. The
only change from current practice is that such amendments would be
required to be made through the DEA Office of Diversion Control secure
network application.
Importers and exporters would be required to make an official
request through the DEA Office of Diversion Control secure network
application for an amendment. Supplementary information submitted by an
importer or exporter through the DEA Office of Diversion Control secure
network application would not automatically trigger the amendment
process. An
[[Page 63584]]
amendment would have no effect on the date of expiration of the permit;
an amended import or export permit would have the same expiration date
as the originally issued permit. Return information would not be
allowed to be amended. Importers and exporters would be able to request
that an issued import or export permit be canceled provided that no
shipment has yet been made.
Under proposed Sec. 1312.16(a)(5), registrants would be required
to submit all requests for an amendment that would affect the total
base weight of each controlled substance, other than those submitted in
accordance with Sec. 1312.15(a), at least three business days in
advance of the date of release by a customs officer. Three business
days are the minimum amount of time that the DEA needs to review this
type of requested amendment, approve or deny the request, and transmit
the applicable data to the ITDS. All other requests for amendment would
be required to be submitted to the DEA at least one business day before
the date of release by a customs officer at the port of entry. One
business day is the minimum amount of time that the DEA needs to review
the requested amendment, approve or deny the request, and transmit the
applicable data to the ITDS.
For the reasons discussed above, the DEA is also proposing
mandatory electronic reporting of return information for controlled
substances imported or exported under permit procedures. The
requirement of return information for imports and exports under permit
procedure is discussed in greater detail in section II, B, 1 of this
proposal under the heading ``Terminology and Definitions.''
(b) Import and Export Declarations for Controlled Substances
The DEA proposes to incorporate the mandatory electronic filing of
DEA import declarations and DEA export declarations for controlled
substances with the DEA into Sec. Sec. 1312.18 and 1312.27. This
requirement would also be incorporated into a new Sec. 1312.03 which
would reference a list of applicable forms for part 1312, and will
state that the declaration forms are electronic. This information is
currently listed multiple times in the applicable regulations.
Consolidating this information into one section will make it easier for
registrants to understand and comply.
Consistent with current requirements, controlled substance
declarations would be required to be filed at least 15 calendar days in
advance of the antipcated date of release by a customs officer at the
port of entry or port of export. 21 CFR 1312.18(b), 1312.27(a). Under
proposed revised Sec. Sec. 1312.18(b) and 1312.27(a), controlled
substance declarations would not be deemed filed until the
Administration issues a transaction identification number. The DEA
proposes to allow registrants to proceed with the import or export
transaction as soon as the transaction identification number has been
issued, regardless of whether 15 calendar days have elapsed since its
issuance. The 15-day advance notification period currently required by
DEA regulations is now used to review notifications. Under this
proposal, that review period would occur prior to the issuance of the
transaction identification number. Therefore, the DEA would no longer
need additional processing time after the issuance of the transaction
identification number. Therefore under this proposal, importers of
controlled substances under declaration procedures would more closely
align with import procedures under permit procedures in regard to
timing as to when they may proceed with the transaction. The DEA
proposes to retain the 15-day-advance time period to ensure enough time
for the DEA to review the submission for completeness and conduct any
necessary follow-up prior to the import/export transaction. As
discussed above, transaction identification numbers would be single-use
identifiers, unique to a specific communication or transaction (e.g., a
notice, filing, report, application, etc.), signifying that a
communication has been received, reviewed, and accepted. While current
DEA regulations do not require confirmation of receipt from the DEA
prior to importation or exportation pursuant to a declaration, the
proposal to assign a transaction identification number is consistent
with the DEA's current practice for declarations submitted online.
Currently, the DEA assigns a Web Tracking Number to each declaration
when it is submitted and accepted. However, unlike the proposed
transaction identification number, the Web Tracking Number is assigned
automatically upon submission to the DEA; the transaction
identification number would be assigned only after the DEA has reviewed
the filing for completeness. The proposed regulatory codification of
the issuance of a transaction identification number is designed to
ensure that electronically submitted declarations are indeed received
by the DEA, are completed, and can be appropriately tracked and
monitored; to streamline the declaration filing process; and to
eliminate duplicate filings. Current DEA regulations requiring
declarations to be completed in triplicate would be eliminated.
The DEA proposes to amend its import/export regulations to describe
the procedures relating to amendments following the filing of a
controlled substance import or export declaration with implementation
of the ITDS. The DEA proposes changes to Sec. Sec. 1312.18(f) and
1312.27(e) to clearly specify how and under what conditions controlled
substance import and export declarations may be amended or cancelled
after having been filed and when a new declaration is required instead
of an amendment. Registrants would submit a request to amend or cancel
a filed declaration to the Administration through the DEA Office of
Diversion Control secure network application. Return information may
not be amended.
Consistent with current practice, importers and exporters would
continue to be able to amend a declaration for the following data
fields: The National Drug Control number, description of the packaging,
or trade name of the product, so long as the description is for the
same basic class of controlled substance(s) as in the original
declaration; the proposed port of entry or export; the anticipated date
of release by a customs officer at the port of entry or port of export;
the method of transport; any registrant notes; and the justification
entered by the importer or exporter for why an import or export is
needed to meet the legitimate scientific or medical needs of the United
States or foreign jurisdiction. The DEA allows amendments to these
fields as these are areas that may be easily mis-keyed or subject to
change as part of the normal import and export business practice. While
the data contained in these fields is important to the tracking of
controlled substances through the closed system of distribution, the
DEA believes that the Administration is able to enforce the CSA and
U.S. obligations under international drug control treaties while
potentially limiting burden on industry by allowing these fields to be
amendable.
Consistent with current practice, importers and exporters would
continue to generally be allowed to amend the base weight of controlled
substance(s) listed on their filed declaration prior to the start of an
import or export transaction (i.e., prior to shipment). However, also
consistent with current practice, exporters would not be allowed to
exceed the total base weight of controlled substance(s) listed on the
corresponding authorization for import
[[Page 63585]]
issued by the foreign competent national authority. Also consistent
with current practice, neither would exporters be allowed to exceed the
strength of a controlled substance product if product strength
information has been included on the authorization for import issued by
the foreign competent national authority. Consistent with Sec.
1312.15(a) for imports of controlled substances under permit procedure,
importers under declaration procedure would be allowed to request an
amendment to an import declaration regarding the quantity of controlled
substances once a shipment has arrived at the U.S. customs port of
entry if the increase in the amount of controlled substance to be
imported is less than 1% of that listed on the filed declaration.
Importers and exporters need not request an amendment for the sole
purpose of decreasing the amount authorized.
Consistent with current practice, importers and exporters would
continue to be able to amend a filed import or export declaration to
remove a controlled substance. However, importers and exporters would
no longer be able to amend declarations to add a new controlled
substance or replace a controlled substance with another controlled
substance. Instead, importers and exporters who needed to make changes
to any of these fields would need to cancel the existing declaration
and file a new declaration. The DEA understands that sometimes the
incorrect controlled substance is identified on the declaration due to
clerical error, for example because a similar item was selected from
the drop-down selection in the DEA Office of Diversion Control secure
network application that was located near the correct item. However,
the DEA has closely considered this issue and ultimately determined
that because the identification of the controlled substance proposed to
be imported or exported is such a critical element of the closed system
of distribution, that this element should not be amendable. As stated
elsewhere in this preamble, the DEA reminds importers and exporters
that the duty to file reports and other documents with the DEA includes
the duty that these filings be complete and accurate.
Similarly, in a change from current practice, the DEA is proposing
to cease allowing importers and exporters to amend information related
to the authorization to import or export from the foreign competent
national authority. The DEA understands that sometimes, especially in
the case of less experienced importers and exporters, the incorrect
foreign authorization identifier is entered onto the declaration. This
is often the result of numbers being transposed or a different number
on the foreign permit being entered instead of the actual authorization
identifier. However, similar to the identification of the controlled
substance to be imported or exported, the DEA has closely considered
this matter and ultimately determined that because the authorization
from the foreign competent national authority to import or export a
controlled substance is such a critical element to the Administration's
ability to monitor and ensure the closed system of distribution, this
element should not be amendable. As stated above and elsewhere in this
document, the DEA reminds importers and exporters that the duty to file
reports and other documents with the DEA includes the duty that these
filings be complete and accurate.
Consistent with current practice, importers and exporters would not
be able to request an amendment to a filed import or export declaration
for changes to the importer or exporter's name (as it appears on their
DEA certificate of registration) or the name of the foreign importer or
exporter. The DEA considers the name of the foreign importer or
exporter to be a key factor in determining associated risks of the
diversion of controlled substances. Therefore, these fields would not
be amendable.
However, also consistent with current practice, as stated above,
the DEA would continue to allow importers and exporters to amend any
additional associated company names they are DBA (doing business as)
that they wish to have included in the notes section of the
declaration. The only change from current practice is that such
amendments would be required to be made through the DEA Office of
Diversion Control secure network application.
Importers and exporters would be required to make an official
request through the DEA Office of Diversion Control secure network
application for an amendment. Supplementary information submitted by an
importer or exporter through the DEA Office of Diversion Control secure
network application would not automatically trigger the amendment
process. An amendment would have no effect on the date of expiration of
the declaration; an amended import or export declaration would have the
same expiration date as the originally filed declaration. Return
information would not be allowed to be amended. Importers and exporters
would be able to request that filed import or export declaration be
canceled provided that no shipment has yet been made.
Registrants would be required to submit all requests for an
amendment that would affect the total base weight of each controlled
substance, other than those allowed to be released into the United
States pursuant to Sec. Sec. 1312.18(f) and 1312.16(a)(5), at least
three business days in advance of the date of release by customs. Three
business days are the minimum amount of time that the DEA needs to
review this type of requested amendment and transmit the applicable
data to the ITDS. All other requests for amendment would be required to
be submitted to the DEA at least one business day before the
anticipated date of release by a customs officer at the port of entry
or port of export. One business day is the minimum amount of time that
the DEA needs to review and accept the requested amendment and transmit
the applicable data to the ITDS.
For the reasons stated above, the DEA is also proposing mandatory
electronic filing of return information for controlled substances
imported or exported under declaration procedures; see section II, B, 1
of this proposal under the heading ``Terminology and Definitions'' for
additional discussion of ``return information.''
(c) Import and Export Declarations for Listed Chemicals
The DEA proposes to incorporate the mandatory electronic filing of
import and export declarations for listed chemicals into Sec. Sec.
1313.12 and 1313.21. Similar to the proposed Sec. 1312.03, discussed
above, the DEA is proposing a new Sec. 1313.03, which references a
list of applicable forms for part 1313, and will state that the
declaration is electronic.
Under this proposal, the DEA would issue a transaction
identification number once the DEA reviewed a listed chemical import or
export declaration for completeness, and the 15-day reporting clock
would begin on the date that the importer or exporter files a complete
declaration. An import or export transaction of a listed chemical would
not be allowed to take place until the transaction identification
number has been issued and 15 calendar days have elapsed from the date
a complete declaration was filed. Transaction identification numbers
would be single-use numbers, unique to a specific transaction. While
current DEA regulations do not require confirmation of receipt or
acceptance from the DEA prior to importation or exportation pursuant to
a declaration, the proposed
[[Page 63586]]
change aligns with current practices. In current practice, for
notifications submitted through the DEA Office of Diversion Control
secure network application and those that are not, industry waits until
the transaction identification number has been issued to proceed with
the transaction. The transaction identification number is assigned by
the DEA only after the DEA has reviewed the filing for completeness.
The proposed regulatory codification of current practices regarding the
issuance of a transaction identification number is designed to ensure
that electronically submitted declarations are indeed received by the
DEA, are completed, and can be appropriately tracked and monitored; to
streamline the declaration filing process; and to eliminate duplicate
filings. Current DEA regulations requiring declarations to be completed
in triplicate would be eliminated.
The DEA is also proposing to amend the language relating to waivers
of the 15-day advance reporting requirement for importations by
``regular importers'' and export transactions between regulated persons
and ``regular customers'' in Sec. Sec. 1313.12, 1313.15, and 1313.21.
With the implementation of the ITDS, it would be difficult for customs
officers to clear a shipment of relevant listed chemicals without first
receiving appropriate information from the DEA. The DEA has determined
that three business days is the minimum amount of time that the DEA
needs to review the information regarding the shipment and to transmit
the applicable data accurately to the ITDS. The CSA requires the DEA to
provide by regulation the circumstances in which the 15-day advance
notice requirement required by 21 U.S.C. 971(a) does not apply for
imports of listed chemicals by ``regular importers'' and exports of
listed chemicals between regulated persons and ``regular customers.''
21 U.S.C. 971(b). Pursuant to this authority, in the current
regulations, the DEA has provided that specific circumstances allow for
a waiver of the entire 15-day period of advance notification.\9\
Because a waiver of the entire 15-day period will no longer be feasible
after implementation of the ITDS, the DEA proposes now to describe
circumstances in which importers and exporters will not be subject to
the 15-day advance notification requirement but must provide 3
calendar-days advance notification. The DEA does, however, propose to
allow registrants to proceed with the import or export transaction as
soon as the transaction identification number has been issued,
regardless of whether the 3-calendar-day period has concluded. While
the CSA also requires regulated persons subject to waivers to notify
the DEA of the transaction ``at the time of any importation or
exportation,'' the DEA intends to consider the notification provided to
the DEA by customs officers at the time of release to serve this
statutory purpose.
---------------------------------------------------------------------------
\9\ Importers should be aware that these waivers of advance
notification requirements apply only to the information the trade
files with the DEA; for example, importers remain required to follow
CBP's Importer Security Filing and Additional Carrier Requirements
(commonly known as ``10+2'') rule, which applies to import cargo
arriving to the United States by vessel.
---------------------------------------------------------------------------
The DEA is proposing to revise Sec. Sec. 1313.16, 1313.17,
1313.26, and 1313.27 to clarify the procedure for amending listed
chemical import and export declarations after filing. Importers and
exporters of listed chemicals would submit a request to amend or cancel
a filed declaration to the Administration through the DEA Office of
Diversion Control secure network application. Return information may
not be amended. Requirements regarding updated notices for change in
circumstances in Sec. Sec. 1313.16 and 1313.26 would remain
essentially the same. However, to accommodate implementation of the
ITDS, the DEA would require that amendments be submitted through the
DEA Office of Diversion Control secure network application. Importers
and exporters for whom the 15-day advance reporting requirement has
been partially waived pursuant to 21 U.S.C. 971(b) needing to make
changes in advance of shipment, such as to increase the quantity of a
listed chemical to be imported or exported, would be required to file
their amendment at least three business days in advance of the date of
release by a customs officer at the port of entry or port of export. As
described above, three business days is the minimum amount of time that
the DEA needs to review the amendment and transmit the applicable data
to the ITDS.
For the reasons stated above, the DEA is also proposing mandatory
electronic filing of return information for listed chemicals imported
or exported under declaration procedures; see section II, B, 1 of this
proposal under the heading ``Terminology and Definitions'' for
additional discussion of ``return information.''
(d) Import and Export Reports for Tableting and Encapsulating Machines
The DEA proposes to incorporate mandatory electronic reporting
requirements into Sec. 1310.05 for all regulated transactions
involving tableting machines and encapsulating machines, including
domestic, import, and export transactions. To standardize and
streamline the electronic filing of these reports, the DEA proposes to
implement usage of a new form, DEA Form 452, Reports for Regulated
Machines, which would cover imports, exports, and domestic regulated
transactions of tableting and encapsulating machines, and whose usage
would be referenced in the revised regulations. The new form would be
accessed, completed, and submitted by regulated persons entirely though
the DEA Office of Diversion Control secure network application. Upon
receipt and review, the Administration will assign each completed
report a transaction identification number. The DEA Form 452 would not
be deemed filed until the Administration issues a transaction
identification number. As discussed above, transaction identification
numbers would be single-use identifiers, unique to a specific
communication or transaction (e.g., a notice, filing, report,
application, etc.), signifying that a communication has been received,
reviewed, and accepted. While current DEA regulations do not require
confirmation of receipt from the DEA before the report is deemed filed,
the proposed change is designed to ensure that electronically submitted
reports are indeed received by the DEA, are completed, and can be
appropriately tracked and monitored; to streamline the report filing
process; and to eliminate duplicate filings. The current Sec. Sec.
1310.05 and 1310.06 would be revised to reflect that these reports
relating to tableting and encapsulating machines would now be submitted
on the DEA Form 452.
Currently, regulated persons must provide notification of the
import or export of a tableting machine or encapsulating machine on or
before the date of importation or exportation. 21 CFR 1310.05(c). The
DEA is proposing to require that the DEA Form 452 be submitted to the
DEA 15 calendar days before the anticipated date of arrival at the port
of entry or port of export in order to allow time for the DEA to review
the information and transmit it to the ITDS. In order for these reports
to be effective, they must be communicated by the DEA to CBP prior to
arrival of the shipment at the port. The DEA has received reports that
under current regulatory procedures, which require reporting ``on or
before'' the date of importation, CBP has encountered machines at a hub
or port of entry for which the importer has not provided DEA with
notification, and
[[Page 63587]]
that seizures have resulted.\10\ Under the revised regulations, an
importer may not initiate an import or export transaction involving a
tableting machine or encapsulating machine until the regulated person
has been issued a transaction identification number from the
Administration. The importer or exporter could proceed with the import
or export of the machine(s) as soon as the transaction identification
number has been issued. These changes are proposed in a revised Sec.
1310.05(c). Correspondingly, the DEA is proposing to amend Sec.
1310.05(c) to provide clear direction that regulated persons are to
submit notification of import or export of tableting or encapsulating
machines through the DEA Office of Diversion Control secure network
application.
---------------------------------------------------------------------------
\10\ As discussed in notes 5 and 9, and later in this document,
the DEA is including in this proposal to make global changes to DEA
regulations to change usage, where applicable, of ``import'' and
``export'' to reference the date of release by customs officers for
purposes of DEA recordkeeping and reporting requirements.
---------------------------------------------------------------------------
The DEA is proposing in the revised Sec. 1310.06(e)(1)(v) that
reports of importation of tableting or encapsulating machines include
the reason for the importation. This information would assist the DEA
in understanding the intended medical, commercial, scientific, or other
legitimate use of the machine.
Additionally, the DEA proposes to add a paragraph (c)(2) to Sec.
1310.05 to address what regulated persons are to do in the event that
an import shipment of tableting machines or encapsulating machines has
been denied release by customs. Proposed requirements for denied
shipments of imported tableting machines and encapsulating machines
parallel the requirements for denied shipments of controlled substances
and listed chemicals. Importers would be required to report to the
Administration, through the DEA Office of Diversion Control secure
network application, within 24 hours of denial, that the shipment was
denied release by a customs officer into the United States and the
reason for the denial. Under the proposal, denials of shipments must be
reported whether or not the denial is based on a violation of the CSA
or its implementing regulations. Reports of denied releases by customs
officers at the port entry of tableting and encapsulating machines are
needed to aid the DEA in identifying attempted unreported imports of
tableting and encapsulating machines. The DEA does not believe that
reports of shipments denied release from the United States at the port
of export are required because the DEA should already have knowledge of
those machines through reports of their previous import (if applicable)
and domestic regulated transactions required by the current Sec.
1310.05(a)(4) and (c). A new proposed Sec. 1310.06(g) would detail the
information to be included in such report of denied release into the
United States. If an importer subsequently receives notice from a
customs officer that their shipment will be released into the United
States, the importer would be required to file an amended DEA Form 452
with the DEA before the shipment may be released. In such
circumstances, the regulated person may seek to have the tableting
machines or encapsulating machines released by customs upon receipt of
a transaction identification number for the refiled and amended DEA
Form 452 without regard to the 15-day advance filing requirement.
For the reasons stated above, the DEA is also proposing mandatory
electronic filing of return information for tableting and encapsulating
machines imported or exported; see section II, B, 1 of this proposal
under the heading ``Terminology and Definitions'' for additional
discussion of ``return information.'' Return requirements would be
incorporated into a new paragraph (h) in Sec. 1310.06 and the existing
paragraphs in the section correspondingly relabeled. This proposed
change and other proposed changes to part 1310 not directly associated
with the implementation of ITDS are discussed in more detail in section
II, B, 6, b of this document.
The DEA also is proposing to revise the text that currently is
located in Sec. 1310.06(g) to require reports relating to exports of
machines that are refused, rejected, or otherwise deemed undeliverable
to be made through the DEA Office of Diversion Control secure network
application. This provision, which is proposed to be moved to Sec.
1310.06(i), does not require the use of a DEA Form 452. The DEA also
proposes to require these reports to be submitted ``at the earliest
practicable opportunity'' rather than the current standard of ``within
a reasonable time.'' This proposed change would conform reporting
requirements for declared exports of machines which are refused,
rejected, or otherwise returned to the statutory language of 21 U.S.C.
830(b) which requires reports of regulated transactions in a tableting
machine or encapsulating machine (including reports of importation or
exportation of such machines) to be reported ``at the earliest
practicable opportunity.''
(e) Transshipments of Controlled Substances
Applications for transshipment permits would still be allowed to be
submitted to the DEA via paper in accordance with the existing
procedures under Sec. 1312.31 for schedule I controlled substances.
Information will be posted to the DEA Office of Diversion Control Web
site informing persons seeking to transship schedule I controlled
substances how to submit an application for a transshipment permit.
Advance notification of transshipments for schedule II, III, and IV
controlled substances would also still be allowed to be submitted to
the DEA via paper in accordance with the current Sec. 1312.32. The
electronic application and filing process is not feasible in such
circumstances because foreign IP addresses are blocked by the
Department of Justice's firewall and are prevented from accessing the
DEA Office of Diversion Control secure network application. Although
the transshippers themselves would not have direct access to the
instructions on the DEA Web site due to the firewall protection, it is
the DEA's understanding that most transshippers have someone in the
United States as a domestic presence facilitating the transaction who
will be able to access the instructions. There is no change from the
current operational system. The DEA also proposes to explicitly state
in Sec. Sec. 1312.31 and 1312.32 that a separate filing is required
for each shipment, conforming the requirements of this section with the
requirements for imports and exports of controlled substances in part
1312.
(f) Transshipments of Listed Chemicals
Advance notification would still be allowed to be submitted to the
DEA via paper in accordance with the existing procedures under Sec.
1313.31 for persons seeking to import a listed chemical into the United
States for transshipment. Advance notification would still also be
allowed to be submitted to the DEA via paper in accordance with the
existing procedures under Sec. 1313.31 for persons seeking to
transfer, or transship listed chemicals within the United States for
immediate exportation. The electronic application and filing process is
not feasible in such circumstances because foreign IP addresses are
blocked by the Department of Justice's firewall and are prevented from
accessing the secure network application on the DEA Office of Diversion
Control Web site. While a broker or trader for an international
transaction might be able to electronically submit the required
[[Page 63588]]
information from a domestic IP address, for consistency and fairness
across all transshipment activities, the DEA is proposing to allow
paper applications and notices to continue for all transshipment
transactions. Although the transshippers themselves would not have
direct access to the instructions on the DEA Web site due to the
firewall protection, it is the DEA's understanding that most
transshippers have someone in the United States as a domestic presence
facilitating the transaction who will be able to access the
instructions. There is no change from the current operational system.
(g) Notifications of International Transactions by Brokers or Traders
The DEA proposes to incorporate in Sec. 1313.32 the mandatory
electronic filing of notifications of international transactions
involving listed chemicals which meet or exceed the threshold amount
identified in Sec. 1310.04. While current DEA regulations do not
require confirmation of receipt from the DEA prior to conducting an
international transaction, the DEA is proposing to amend Sec. 1313.32
to require that notifications of international transactions would not
be deemed filed until a transaction identification number has been
issued by the DEA. This change is designed to ensure that
electronically submitted notifications are received by the DEA, are
completed, and can be appropriately tracked and monitored; to
streamline the notification filing process; and eliminate duplicate
filings.
2. Security
The DEA's secure application authentication methods allow only
authorized persons to gain access to the application and ensure that
persons can only gain access in the roles in which they are authorized.
Because the secure network application can only be accessed through
authentication, verifying the legitimacy of the reporter/applicant is
possible without a requirement for a signature. Additional security
protections are based on the requirement that return information is
tied to a specific transaction. The reporter must have knowledge of the
applicable transaction identification number or permit number in order
to file the required return information.
Under this proposed rule, the application, completion, and filing
processes would be electronic; however, the electronic equivalent of
the current, fillable DEA paper applications and other forms for
imports and exports would not be downloadable. Rather, persons would be
able to securely download approved permits and filed declarations,
notices, and reports in digital image format. The DEA would enable
security measures on the downloaded documents to prevent fraud,
forgery, or other misuse or manipulation.
Applicants and registrants must provide effective controls and
procedures to guard against theft and diversion of controlled
substances. 21 CFR 1301.71(a). This includes responsibility for
ensuring effective controls and procedures for which their agents and
employees have access to and responsibility for completing and filing
applications, notices, reports, and other filings required by DEA
regulations, whether those filings be in paper format or electronic.
Registrants must exercise caution in the consideration of employment of
persons who have access to listed chemicals, who have been convicted of
a felony offense relating to controlled substances or listed chemicals,
or who have, at any time, had any application for registration with the
DEA denied, had a DEA registration revoked, or surrendered a DEA
registration for cause. 21 CFR 1309.72.
The DEA also takes this opportunity to remind registrants, those
exempt from registration, and regulated persons that they may not
delegate their liability away to their agents or employees.
Registrants, those exempt from registration, and regulated persons
remain legally liable (jointly or severally) with their agents or
employees for violations of the CSA. It is unlawful for any person to
knowingly or intentionally import or export controlled substances;
knowingly or intentionally bring or possess on board a vessel,
aircraft, or vehicle a controlled substance; or manufacture, possess
with intent to distribute, or distribute a controlled substance in any
means other than those authorized by the CSA. 21 U.S.C. 960(a). Except
as provided in the CSA, it is unlawful for any person to knowingly
import or export a listed chemical with intent to manufacture a
controlled substance; export a listed chemical in violation of the laws
of the country to which the chemical is exported; serve as a broker or
trader for an international transaction involving a listed chemical, if
the transaction is in violation of the laws of the country to which the
chemical is exported; import or export a listed chemical knowing or
having reasonable cause to believe that the chemical will be used to
manufacture a controlled substance; export a listed chemical, or serve
as a broker or trader for an international transaction involving a
listed chemical knowing or having reasonable cause to believe that the
chemical will be used to manufacture a controlled substance in
violation of the laws of the country to which the chemical is exported;
import or export a listed chemical with the intent to evade the
reporting or recordkeeping requirements of 21 U.S.C. 971; import a
listed chemical in violation of 21 U.S.C. 952, import or export such a
chemical in violation of 21 U.S.C. 957 or 971, or transfer such a
chemical in violation of 21 U.S.C. 971(d); or manufacture, possess with
intent to distribute, or distribute a listed chemical in violation of
21 U.S.C. 959. 21 U.S.C. 960(d). It is unlawful for applicants,
registrants, those exempt from registration, regulated persons, or
agents or employees thereof, to knowingly and willfully falsify,
conceal, or cover up by any trick, scheme, or device a material fact.
18 U.S.C. 1001(a)(1). It is unlawful for applicants, registrants, those
exempt from registration, regulated persons, or agents or employees
thereof, to knowingly and willfully make false statements or
representations. 18 U.S.C. 1001(a)(2). It is unlawful for applicants,
registrants, those exempt from registration, regulated persons, or
agents or employees thereof, to knowingly and willfully make or use any
false writing or document knowing it to contain materially false,
fictitious, or fraudulent statement or entry. 18 U.S.C. 1001(a)(3).
It is the position of the DEA that an employee who has knowledge of
diversion of controlled substances or listed chemicals from his
employer by a fellow employee has an obligation to report such
information to his employer. 21 CFR 1301.91, 1309.73.
3. Miscellaneous
To account for approvals by the Administration through the DEA
Office of Diversion Control secure network application, DEA regulations
would be amended to remove the reference to facsimile signatures found
in Sec. 1312.13 for import permits. To account for greater security
and decrease opportunities for diversion, the DEA also proposes to
eliminate the current requirements in Sec. Sec. 1312.13 and 1312.23
that import and export permits be issued sequentially and instead
assign each permit a unique, randomly-generated identifier.
Pursuant to E.O. 13659 (ITDS), the DEA would cease distributing
paper copies of permits and declarations to CBP/customs services of
Insular Areas. Instead, the DEA would electronically transmit pertinent
data fields from the permit, declaration, or other notice to the ITDS.
[[Page 63589]]
To accommodate the change in practices concerning the exchange of
information between the DEA and CBP/customs services of Insular Areas
as part of the implementation of the ITDS, the DEA proposes to
generally, globally remove current DEA regulations that address the
transmission and review of import and export information between the
DEA and CBP. The regulations that would be affected are Sec. Sec.
1312.14, 1312.19, 1312.24, 1312.28, 1313.14, and 1313.23. The removal
of these regulations will allow for increased flexibility to make
adjustments regarding the transmission of information between the DEA
and CBP/customs services of Insular Areas as the process is
implemented. No changes or modifications in the exchange of information
between the DEA and CBP/customs services of Insular Areas should have
any impact on those entities that must utilize the DEA Office of
Diversion Control secure network application to submit applications or
filings. The DEA is not proposing to remove current operational
requirements found in Sec. 1312.15, ``Shipments in greater or less
amount than authorized.''
B. Proposed Amendments Indirectly Associated With Implementation of the
International Trade Data System
1. Terminology and Definitions
For purposes of clarity and transparency, the DEA proposes to
update its regulations for consistency of terminology (within DEA
regulations, between DEA regulations and the CSA, and between DEA
regulations and the regulations of other agencies that regulate imports
and exports), to reflect name changes to referenced entities, and to
add new definitions. These changes involve both technical and
substantive amendments.
The DEA proposes to make technical changes to update references to
certain named entities. One, all references to the ``U.S. Customs
Service'' will be changed to ``U.S. Customs and Border Protection''
(CBP). In 2003, the functions of the Customs Service were transferred
to the Department of Homeland Security (DHS). Its successor agency is
known as U.S. Customs and Border protection (CBP). Two, the DEA is
making a change in Sec. 1310.06 to change ``Federal Food and Drug
Administration'' to the agency's formal name, the ``U.S. Food and Drug
Administration.'' Three, the DEA will amend current Sec. 1312.12(b)
(proposed Sec. 1312.12(c)) to reflect that the cities located in the
Republic of India currently referenced as Calcutta and Bombay are now
recognized by the U.S. State Department as Kolkata and Mumbai. The DEA
will also take this opportunity to remove any remaining incongruous
references to the ``Director'' when referencing the head official of
the DEA and alternatively insert the term ``Administrator'' or
``Administration'' as appropriate.
Additionally, the DEA proposes to make a technical change to more
concisely incorporate U.S. obligations under international treaties of
drug control, as statutorily codified in the CSA. The DEA will amend
its regulations to consistently reference the ``competent national
authority'' when referencing a foreign jurisdiction having authority to
authorize the importation or exportation of controlled substances and
listed chemicals into or out of their jurisdiction. This change is
being accompanied by the addition of a definition in the regulations
for ``competent national authority.'' A competent national authority
(CNA) is an entity that has authority to authorize imports and exports
of narcotic drugs and psychotropic substances and regulate or enforce
national controls over precursor and essential chemicals. Generally,
the only entities recognized as such by the DEA are those entities
identified in the directory of ``Competent National Authorities Under
the International Drug Control Treaties'' published by the United
Nations Office on Drugs and Crime. However, for purposes of exports of
narcotic drugs, such term also includes freely associated states
eligible to receive exports of narcotic drugs from the United States
pursuant to 48 U.S.C. 1972.
The DEA will remove ``jurisdiction of the United States'' as a
defined term in Sec. Sec. 1300.01(b) and 1300.02(b) but will add a
clarification of the definition of the term ``United States'' in those
provisions. Although the term ``United States'' is defined at 21 U.S.C.
802(28), the proposed definitions in the regulations will clarify the
Administration's interpretation and make the reader aware that places
and waters subject to the jurisdiction of the United States, in
addition to the customs territory of the United States, include (but
are not limited to) the U.S. territories or possessions listed in the
new term. The list of territories and possessions is not a catalogue of
Insular Areas where the CSA is in effect. Rather, these listed
territories or possessions (U.S. Virgin Islands, Guam, American Samoa,
and the Northern Mariana Islands) are ones that are permanently
inhabited. Thus, they are ones from which controlled substances, listed
chemicals, and tableting or encapsulating machines might be expected to
be regularly imported into the customs territory of the United States
(or exported to foreign jurisdictions), as well as ones into which such
materials may be imported from foreign jurisdictions, all of which
would require compliance with the Administration's import and export
regulations. No substantive change is intended by this revision.
Removal of the definition of ``jurisdiction of the United States'' and
corresponding changes to remove the term in Sec. Sec. 1301.12,
1301.34, and 1302.07, as well as in the definitions of ``export'' and
``import'' in 21 CFR part 1300, will make DEA regulations consistent
with the CSA. The DEA proposes to remove the phrase ``jurisdiction of
the United States'' from Sec. 1301.12(b)(3) because it is redundant
with the preceding clause referencing registration at another location
in the same State, as ``State'' is broadly defined in 21 U.S.C.
802(26). The addition of the phrase ``in which he practices'' to Sec.
1301.12(b)(3) would conform the regulation to registration requirements
for practitioners as stated in 21 U.S.C. 823(f). No substantive change
is intended by this amendment. Similarly, the clause ``within and
without the jurisdiction of the United States'' would be removed from
Sec. 1301.34(c)(2) as it is superfluous with the first portion of that
regulation. No substantive change is intended by this amendment. In
determining whether it is in the public interest to issue a
registration to import schedule I or II controlled substances, the DEA
considers employment of security procedures to guard against in-transit
losses both domestically and abroad and will continue to do so. The
term ``jurisdiction of the United States'' is also found in the
definition of ``chemical import.'' The DEA proposes to remove that
definition as unnecessary and superfluous, as it is only used once in
subsequent DEA regulations, in Sec. 1313.14 in reference to ``listed
chemical import declarations.''
In association with the above, the DEA also proposes to amend
Sec. Sec. 1301.24, 1301.26, 1309.26, 1312.13, and 1312.15 to denote
the responsibility of customs services of Insular Areas, and not just
CBP, to enforce the import and export requirements of the CSA. When
controlled substances, listed chemicals, and tableting or encapsulating
machines are imported into, or exported from, a U.S. territory (or
possession) or an Insular Area of the United States that is not part of
the customs territory of the United States, these items are cleared by
[[Page 63590]]
the customs service of an Insular Area and not CBP.\11\
---------------------------------------------------------------------------
\11\ Although the U.S. Virgin Islands are outside the customs
territory of the United States, the customs laws of the U.S. Virgin
Islands are enforced by U.S. Customs and Border Protection. 19 CFR
7.2(c).
---------------------------------------------------------------------------
The DEA proposes to make global amendments to its import and export
regulations where appropriate to reference the date of ``release'' by
customs officers of items entering or departing the United States
rather than the date of ``import'' or ``export'' where such terms are
currently used in DEA regulations establishing DEA recordkeeping and
reporting requirements (as compared to determining liability under the
CSA as a result of items entering or leaving places and waters subject
to the jurisdiction of the United States). This change will make clear
that the DEA does not equate the ``date of import'' and ``date of
export'' with the date that a customs officer ``releases'' an item that
has been imported or an item intended or destined for export. As noted
earlier in the document, the meaning of import and export under the CSA
is much broader than how those terms may be used by other agencies
exercising import or export control pursuant to organic statutes other
than the CSA (i.e., the actual date of import or export under the CSA
may, and frequently will, occur at a date different than the date of
release by a customs officer).
The DEA proposes to make a technical amendment to remove references
to telex and facsimile number contact information found in various
sections of 21 CFR part 1313, as telex systems and facsimile machines
are now rarely utilized by registrants, regulated persons, or their
agents. The DEA would add a general reference to ``contact
information.'' This change is intended to account for contact
information systems such as email now in common usage as well as other
forms of communication which may be developed in the future.
The DEA proposes to make a technical amendment to replace all
current references in DEA regulations to ``special controlled
substances invoice(s)'' with ``export declaration(s).'' This change
will conform terminology among the DEA Form 236, DEA regulations, and
current practice.
The DEA is proposing global technical amendments related to plain
language principles. The DEA has tried to balance the redrafting of
regulatory language to better correspond with Federal Plain Language
Guidelines against the knowledge that regulated persons have historical
familiarity with long-standing regulatory text which may have been the
subject of previous interpretation by the Administration and court
decisions. Many of the DEA's current import and export regulations have
not ever been significantly modified since the original requirements
were implemented under predecessor drug control statutes (with
reimplementation under authority of the CSA). The DEA has tried to
balance the historical knowledge of the Administration and presently
regulated individuals against the need for newly regulated persons and
a broader segment of the population to be able to more easily read and
comprehend applicable requirements. These proposed changes include
changing the word ``shall'' to ``must,'' ``desiring'' to ``seeking,''
and ``furnish'' to ``file,'' without intending any change to the
meaning of existing regulations. The DEA is proposing technical
amendments throughout the revised regulations to eliminate use of
passive voice in favor of the active voice. This change will make it
easier for readers to identify what actions must be taken and by whom.
The DEA's proposal would also eliminate unnecessary content and
unnecessary words and phrases from regulations. The proposal also
includes reorganization of several regulations to group reporting
requirements for specific individuals or types of reports. This change
will help to reduce the need to cross-reference between multiple
regulations in order to more easily understand at a glance if you must
report, when you must report, what you must report, and how you must
report.
The DEA also proposes to amend various import and export
regulations related to the maintenance of records to add a cross
reference to 21 CFR part 1304 or 1310, as applicable, which are the
general parts governing recordkeeping and reporting responsibilities
related to controlled substances and listed chemicals, respectively.
In addition to the above noted technical changes, the DEA proposes
to define the terms ``customs officer,'' ``port of entry,'' ``port of
export,'' ``return information,'' and ``shipment'' currently utilized
in DEA regulations. Defining these terms will add clarity and
transparency as to how these terms are utilized for the specific
purposes of DEA regulations related to the import and export of
tableting and encapsulating machines, controlled substances, and listed
chemicals as compared to how these terms may be used by other federal
agencies having additional authorities over import or export. The
proposed DEA definitions are substantially similar to how these terms
are used by other agencies with overlapping authority over import and
export. However, the definitions are not exact duplications because of
the unique obligations and requirements imposed on imports and exports
of controlled substances, listed chemicals, and tableting and
encapsulating machines by the CSA. Most specifically, DEA regulations
must take into account that the CSIEA defines ``import'' in broader
terms than just in relation to the customs territory which is used as
the basis for CBP's definition of ``date of importation'' and related
terms. Similarly, CBP's definition of ``port of entry'' is defined
narrowly to reference only the authority of CBP officials, whereas DEA
regulations also need to take into account the authority of customs
officials of Insular Areas of the United States to enforce the CSA.
The proposed definition of ``customs officer'' makes clear that for
purposes of DEA regulations, the term means any person authorized to
enforce the customs laws of the United States. Consistent with 21
U.S.C. 951-953 and other provisions of the CSA, the term ``customs
officer'' includes customs officers of any commonwealth, territory, or
possession of the United States. Correspondingly, in defining ``port of
entry,'' the DEA's goal is to improve readability and transparency, and
to clarify that applicable regulations regarding the importation of
tableting and encapsulating machines, controlled substances, and listed
chemicals apply to all locations at which these machines and substances
may potentially be imported. See 21 U.S.C. 951(a)(1). The proposed
definition of such locations include, but are not limited to, ports of
entry as defined in title 19 of the United States Code, customs
stations, landing rights airports, and user fee airports. Relatedly,
the DEA is proposing to add a definition for ``port of export'' and
make technical amendments throughout the export regulations to
consistently refer to the ``port of export.'' Current DEA regulations
variously refer to the point at which goods are released by customs
officers for export from the United States as both the ``port of exit''
and the ``port of exportation.'' The proposed definition of ``port of
export'' is based on the definition of the term in the Foreign Trade
Regulations. 15 CFR 30.1. The Foreign Trade Regulations are promulgated
by the U.S. Census Bureau, the Federal agency responsible for
collecting, compiling, and publishing trade statistics for the United
States pursuant to title 13, U.S.C., chapter 9. While the proposed
definition is not an
[[Page 63591]]
exact duplication, due to the different authorities and
responsibilities of the respective agencies, no significant substantive
differences are intended. By basing the DEA's definition of ``port of
export'' on 15 CFR 30.1, consistency of meaning, despite the unique
requirements of the CSA, for the term will be achieved throughout the
import and export process for persons who are subject to regulation by
various Federal agencies.
``Shipment'' is variously defined by the federal entities having
authority over importation and exportation of goods. The addition of a
definition of this term in DEA regulations will aid in readability and
transparency on how this term is understood and utilized by the DEA in
regard to the importation and exportation of tableting and
encapsulating machines, controlled substances, and listed chemicals.
Introduction of the proposed definition emphasizes requirements found
in 21 CFR parts 1310, 1312, and 1313 that a shipment of tableting or
encapsulating machines, controlled substances, or listed chemicals is
not only limited to a single transaction between a single importer or
exporter and a single consignee on a single loading document, but also
that the shipment must occur on a single conveyance (e.g., one plane,
one ship, or one freight train--but not each rail car), as opposed to
multiple conveyances (e.g., two planes, two ships, two freight trains,
or any combination thereof). This definition is not meant to preclude
release of merchandise into the United States that has been
transshipped at a location outside of the United States. This is meant
to clarify that each individual shipment of tableting or encapsulating
machines, controlled substances, or listed chemicals must be associated
with a single filing with the DEA for such activity. Consistent with
long-standing DEA policy and the proposed definition, a load of goods
would be considered a ``split shipment'' if it is divided into multiple
parts to be placed onto more than one conveyance, even if on the same
commercial loading document. Under existing DEA policy and under these
proposed regulations, such ``split shipments'' cannot be included on a
single declaration or permit. Each part of such shipment constitutes a
shipment in its own right and requires a separate permit or declaration
pursuant to these proposed changes. This addition of the definition, as
proposed, would not change the ability of registrants to include
multiple line items on one permit application, declaration, or notice.
Neither is the definition meant to preclude the ability of importers
and exporters to utilize multiple common carriers as intermediaries for
the transportation of an entire shipment. Thus, for example, a shipment
consisting of lots A and B, subject to a single valid export permit or
declaration, can be reloaded together from one conveyance to another
(such as from a freight train to a plane on its way to the port), but
lots A and B cannot be separated from each other onto separate
conveyances (such as onto separate planes or separate ships) at any
time until the shipment has reached its final destination and the
export transaction concluded. (The same being true in reverse for
imports until delivered to the registered location.) Likewise, lot A
cannot be subdivided into lots A1 and A2 unless lots A1 and A2 are
subject to separate valid permits or declarations. In relation to this
change, and for consistency with the existing single-shipment
requirements found in 21 CFR parts 1312 and 1313, the DEA proposes to
amend Sec. 1310.05(c)(1) to specify that each shipment of tableting or
encapsulating machines must be reported separately to the DEA. To
further make clear this prohibition, the DEA proposes to add a
definition of ``split shipment'' to mean an import or export shipment
that is divided between two or more conveyances.
Additionally, the DEA is proposing to amend Sec. Sec. 1304.21(d)
and 1310.06 to clarify record keeping requirements concerning imports
and exports. The current text of Sec. 1304.21(d) states that the date
of importation or exportation is the date on which the controlled
substances are ``actually'' imported or exported. The DEA is proposing
to amend these regulations to instead require that in maintaining
records concerning imports and exports, the registrant needs to record
the date on which the items are released by a customs officer at the
port of entry or port of export. However, it should be understood that
this clarification only applies for purposes of recordkeeping. For all
other purposes under the CSIEA, the date of import or export is the
date such activity actually occurs within the meaning of those terms
under the Act. See 21 U.S.C. 951 through 953. The regulation remains
unchanged with respect to recording dates of receipt and distribution,
i.e., the dates will remain the actual date received at the registered
location and distributed from the registered location.
The DEA is additionally proposing to add a definition of ``return
information'' to Sec. Sec. 1300.01(b) and 1300.02(b) stating that such
information references information that persons are required to report
to the Administration following an import or export transaction. While
this term is already generally understood by the regulated community,
the term is not defined, and may cause initial confusion to the general
public or parties that are newly subject to DEA reporting requirements.
The DEA proposes to harmonize the return information requirements
across parts 1310, 1312, and 1313, to the extent possible. This
document discusses the details of each proposal in the relevant section
below. In general, the DEA is proposing that return information must be
reported within 30 calendar days after release by customs at the port
of entry or exit, or within 10 calendar days of a written request by
the Administration, whichever is sooner. All return information for
applications or other initial filings that are required to be made
electronically through the DEA Office of Diversion Control secure
network application would likewise be required to be filed
electronically through the same system. Because the secure network
application can only be accessed through authenticated access that
ensures the legitimacy of the reporter/filer, and because the user must
know the applicable transaction identification number or permit number
in order to input return information for a specific transaction, the
DEA does not see a need for return information to be signed by a
responsible company official. Therefore, the DEA is proposing to remove
the requirement for signature by a responsible company official that
currently appears in Sec. 1312.22(c)(7).
2. Part 1302: Labeling and Packaging Requirements for Controlled
Substances
Corresponding to the removal of ``jurisdiction of the United
States'' and the revised definitions of ``export'' and ``import,'' the
DEA proposes to make a corresponding technical change to Sec. 1302.07
to reflect those definitional changes. The sealing requirement would be
separately stated for imports and exports. This change allows the
import statement to clearly reflect that the sealing requirement for
imported controlled substances applies regardless of whether the import
occurred inside or outside of the customs territory of the United
States. Separating the import and export requirements also makes clear
that the distinction between the customs territory and the non-customs
territory is only applicable to imports and not exports.
[[Page 63592]]
3. Part 1304: Records and Reports for Registrants
The DEA proposes to make a technical amendment to Sec. 1304.02 to
reflect that definitions found in Sec. 1300.02, ``Definitions relating
to listed chemicals,'' are not applicable to part 1304, that addresses
the records and reports that are required of controlled substance
handlers. (21 CFR part 1310 addresses records and reports of listed
chemicals and certain machines.)
As discussed in section II, B, 1 of this document above, the DEA
will make a technical amendment to amend Sec. 1304.21(d) to separately
state reporting requirements concerning imports and exports of
controlled substances. The recording date for receipt, distribution,
other transfer, or destruction would not change. The regulation would
be amended to state that the recording date for imports or exports of
controlled substances is the date on which the controlled substance was
released by a customs officer at the port of entry or port of export.
4. Part 1308: Schedules of Controlled Substances
The DEA proposes to make two technical updates to part 1308. First,
the DEA would amend Sec. 1308.01 to denote that part 1308 also
includes nonnarcotic substances, chemical preparations, veterinary
anabolic steroid implant products, prescription products, and anabolic
steroid products excluded pursuant to 21 U.S.C. 811. Second, the DEA
would amend Sec. 1308.49 to reflect the current requirements of the
CSA regarding issuance of temporary scheduling orders. 21 U.S.C. 811(h)
was amended by section 1153 of the Food and Drug Administration Safety
and Innovation Act of 2012, Public Law 112-144, July 9, 2012, to make
temporary scheduling orders effective for two years, with an option to
extend for up to one year during the pendency of proceeding under 21
U.S.C. 811(a). The CFR was not updated when the law changed. The DEA
also proposes to realign the subsections of Sec. 1308.49 to properly
separate the discussion of the circumstances in which a temporary
scheduling order will be vacated.
5. Part 1309: Registration of Manufacturers, Distributors, Importers
and Exporters of List I Chemicals
The DEA proposes to amend Sec. 1309.32(d) to add ``manufactured''
to the list of business activities each application can include for
each list I chemical. Adding ``manufactured'' would accurately reflect
an ``activity'' that an applicant could conduct with list I chemicals
if appropriately registered. No change is required to DEA Form 510
because ``manufacturer'' is already listed as an option.
The DEA is proposing to correct and update the cross-reference in
Sec. 1309.46(d) by removing the reference ``Sec. 1309.54'' and
replacing it with the reference ``Sec. 1309.53.'' Section 1309.46(d)
currently instructs an applicant to file a request for a hearing
pursuant to Sec. 1309.54. However, Sec. 1309.54 is entitled ``Burden
of Proof,'' and therefore is an inaccurate cross-reference.
The DEA is proposing to correct and update the cross-reference in
Sec. 1309.51(a) by removing the cross-reference to Sec. 1309.57 and
replacing it with the cross-reference ``1309.55.'' Currently, Sec.
1309.57 is a misleading cross-reference since it does not exist in
Title 21, chapter II of the CFR. The ``Hearings'' section in part 1309
concludes at Sec. 1309.55. The DEA is therefore changing the cross-
reference in Sec. 1309.51(a) from ``1309.57'' to ``1309.55.'' Finally,
the DEA is proposing to correct two minor typographic issues in Sec.
1309.71.
6. Part 1310: Records and Reports of Listed Chemicals and Certain
Machines
a. Mail Order Reporting for Ephedrine, Pseudoephedrine,
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
The DEA proposes to incorporate mandatory electronic reporting
requirements into part 1310 for monthly reports of mail-order
transactions involving ephedrine, pseudoephedrine, phenylpropanolamine,
and gamma-hydroxybutyric acid (including drug products containing these
chemicals or controlled substance) required to be filed in accordance
with Sec. 1310.03(c) pursuant to 21 U.S.C. 830(b)(3). To standardize
and streamline the electronic filing requirement of these monthly mail-
order reports, the DEA proposes to implement usage of a new form, DEA
Form 453, which would be referenced in the revised regulations. The new
form would be accessed, completed, and submitted by regulated persons
entirely through the DEA Office of Diversion Control secure network
application. 21 CFR 1310.03(c) would be further revised to reflect that
reports would not be deemed filed until the Administration issues a
transaction identification number unless they are complete upon
submission. As discussed earlier in this document, transaction
identification numbers would be single-use identifiers, unique to a
specific communication, signifying that a communication has been
received, reviewed, and accepted by the DEA. While current DEA
regulations do not require confirmation of receipt from the DEA before
the report is deemed filed, the proposed change is designed to ensure
that electronically submitted reports are indeed received by the DEA,
are complete, and can be appropriately tracked and monitored; to
streamline the report filing process; and to eliminate potential
duplicate filings. The current Sec. 1310.06(i) would be revised to
reflect that the monthly mail-order information required to be
submitted would now be submitted on the DEA Form 453 and would be
designated as Sec. 1310.06(k). 21 CFR 1310.03(c) would be further
revised by separately listing the requirement for monthly reports to be
submitted by regulated persons who engage in the specified domestic
mail-order transactions and export transactions. The proposed revision
also more plainly lays out the requirement that the regulated person
must be engaged in a transaction with one of the specified chemicals or
controlled substance and use or attempt to use the U.S. Postal Service
or any private or commercial carrier for both activities in order to be
required to file the monthly report. This revision is not intended to
impose any different requirements than the current regulation, but only
to ease understanding of the reporting requirements. 21 CFR 1310.05(e)
would correspondingly be amended to reflect the implementation of the
mandatory electronic filing requirement.
The DEA is also proposing technical amendments to Sec. 1310.05(d)
to revise the mailing information in the second sentence and to replace
the term ``shall'' in three locations without changing the
requirements.
b. Listed Chemicals and Tableting and Encapsulating Machines
The DEA proposes to amend Sec. 1310.05 to require reports of
unusual or excessive loss or disappearance of a listed chemical to be
filed through the DEA Office of Diversion Control secure network
application. When determining whether a loss is unusual or excessive,
the DEA is proposing guidelines that the regulated person should
consider: (1) The actual quantity of a listed chemical; (2) the
specific listed chemical involved; (3) whether the loss or
disappearance of the listed chemical can be associated with access to
those listed chemical by specific individuals, or whether the loss or
disappearance can be attributed to unique activities that may take
place involving the listed chemical; and (4) a pattern of losses or
disappearances over
[[Page 63593]]
a specific time period, whether the losses or disappearances appear to
be random, and the result of efforts taken to resolve the losses. If
known, the regulated person would also need to report whether (1) the
specific listed chemical was a likely candidate for diversion and (2)
local trends and other indicators of the diversion potential of the
listed chemical. This language is similar to the current regulatory
language relating to theft and loss of controlled substances in Sec.
1301.74(c).
In addition, the DEA proposes to clarify in the revised Sec.
1310.05(b)(1) that regulated persons must submit a report of unusual or
excessive loss or disappearance whether or not the listed chemical is
subsequently recovered. The DEA also has proposed changes in the
revised Sec. 1310.05(b)(1) to clarify which party has the
responsibility for reporting during domestic and international
transactions. These changes will streamline the data collection process
and allow the DEA to more efficiently respond to diversion as well as
to respond to reporting requests concerning these items from the United
Nations.
The DEA also proposes to remove the phrase ``whenever possible''
from the oral reporting requirements of the current Sec. 1310.05(b).
The DEA believes that the phrase is redundant with the stated
requirement that such reports be made ``at the earliest practicable
opportunity.'' Removing this phrase would better align the reporting
requirements with the statutory language of 21 U.S.C. 830(b)(1).
In response to the above discussed changes, the DEA proposes to
restructure Sec. 1310.05(a) and (b) to reflect the revised reporting
structure. Paragraph (a) would address those reports made solely to the
local DEA office in accordance with the current and revised Sec.
1310.05(a)(1) and (2). Paragraph (b) would address those reports made
orally to the local DEA office with written reports being submitted
through the DEA Office of Diversion Control secure network application.
The reporting requirements now located in Sec. 1310.05(b) would be
transferred to paragraphs (a)(1) and (2), and (b)(1) and (2), as
applicable. This change consolidates the reporting requirements for
each of the applicable reports into their applicable paragraphs;
readers would no longer be required to look at both paragraphs to
determine when and how they must initially report these transactions.
In addition, the DEA proposes to clarify in Sec. 1310.05(a)(2) that
regulated persons must report orally, not in writing, any proposed
regulated transaction with a person whose description or other
identifying characteristic the Administration has provided to the
regulated person. Regulated persons would be required to orally report
the other types of actions at the earliest practicable opportunity to
the Special Agent in Charge of the DEA Divisional Office for the area
in which the regulated person making the report is located.
21 CFR 1310.06 would be revised to reflect the various changes in
Sec. Sec. 1310.03 through 1310.05. Cross-citations have been amended
to reflect where regulations have been moved and new forms instituted.
The DEA also proposes in Sec. 1310.06(a)(3) to require regulated
persons to include the NDC number of the product containing the listed
chemical, if applicable, in all records required by Sec. 1310.03(a).
If the record contains the NDC number, information about the ``form of
packaging'' would not be necessary. The restructuring of Sec.
1310.05(a) also corrects a long-standing typographical error in the
current Sec. 1310.06(c), which now incorrectly references Sec.
1310.05(a)(4) instead of (a)(3). 21 CFR 1310.06(c) currently states
that a report submitted pursuant to Sec. 1310.05(a)(4), domestic
regulated transactions, must include a description of the circumstances
leading the regulated person to make the report. However, the
corresponding example relates to an unusual loss, which is addressed in
the current Sec. 1310.05(a)(3) (proposed Sec. 1310.05(b)(1)). The DEA
also is proposing to make technical amendments in Sec. 1310.06,
including replacing the term ``shall'' in paragraphs (a) and (b).
The DEA would standardize submissions of domestic and import and
export regulated transaction reports involving tableting and
encapsulating machines through the introduction of a new form, the DEA
Form 452. Under the current regulations, regulated persons who engage
in a domestic regulated transaction in a tableting or encapsulating
machine are required, whenever possible, to make an oral report to the
DEA Divisional Office in advance of the transaction, followed by a
written report. 21 CFR 1310.05 (a)(4) and (b). In the revised Sec.
1310.05(b)(2), the DEA proposes to make the oral reporting mandatory
and to mandate the electronic filing of the written report. The DEA
also proposes to provide specific guidelines on when those reports must
be given. The revised Sec. 1310.05(b)(2) would require regulated
persons to orally report domestic regulated transactions in a tableting
machine or an encapsulating machine when an order is placed rather than
at the earliest practicable opportunity after the regulated person
becomes aware of the circumstances involved. The written report (DEA
Form 452) would be required to be filed within 15 calendar days after
the order has been shipped by the seller. The previous standard was
originally adopted for reporting of domestic regulated transactions for
uniformity with the timeframe reporting standard imposed by 21 U.S.C.
830(b)(1)(A) for transactions involving an extraordinary quantity of a
listed chemical, an uncommon method of payment or delivery, or other
suspicious circumstances. However, the DEA proposes to exercise its
authority under 21 U.S.C. 830(b)(1) to impose a different reporting
timeframe standard for machines. The revised standards are not only
less ambiguous for regulated persons to follow, they also ensure the
DEA receives the information in time to take appropriate action as may
be necessary. The new DEA Form 452, which was discussed above in
section II, A, 1, d, would cover not only import and export regulated
transactions of tableting and encapsulating machines required under the
current Sec. 1310.05(c) but also the domestic regulated transactions
of tableting machines or encapsulating machines required by the current
Sec. 1310.05(a)(4). The requirements for the content of domestic
reports would be moved from Sec. 1310.06(d) to a new Sec. 1310.06(f),
while the requirements for reports of importations and exportations
would all be contained within Sec. 1310.06(e). The DEA also is
proposing to amend the recordkeeping requirements in Sec. 1310.06(a)
and reporting requirements in Sec. 1310.06(e) and (f) to require the
inclusion of information about whether the machine is manual or
electric. Under the proposed language in Sec. Sec. 1310.06(e)(1)(vi)
and 1310.06(f)(3), the DEA would require reports of importations and
domestic transactions to include any proposed changes to the
identifying information of imported machines that will occur after the
importation or other transaction.
The DEA also is proposing to amend Sec. 1310.06 to require
regulated persons who import or export a tableting or encapsulating
machine to report return information to the Administration within 30
calendar days of the release of the shipment by customs at the port of
entry or port of export, or within 10 calendar days after receipt of a
written request by the Administration. The DEA has included the
provision for the requirement to submit return information earlier than
the 30 days for two reasons. First, it conforms to the changes proposed
for controlled
[[Page 63594]]
substances and listed chemicals in parts 1312 and 1313. Uniformity of
requirements should simplify procedures and ease understanding of the
requirements by regulated industry. Second, the option to request
advance return information allows the DEA to receive information that
may be needed for time-sensitive requirements, such as investigations
that may need to result in immediate action to protect the public
health and safety. Return information would be required to be submitted
electronically through the DEA Office of Diversion Control secure
network application on the DEA Form 452. Reports would not be deemed
filed until a transaction identification number has been issued by the
DEA. Pursuant to the proposed Sec. 1310.06(h), importers would be
required to report specifics on their return, including dates of the
transaction, quantities of machines involved, and descriptions of the
machines. Consistent with the current requirements importers also would
be required to report subsequent transfers of the machines under Sec.
1310.05(b)(2). Reports of transfers after import may be submitted with
the return information or separately.
The proposed revisions relating to tableting and encapsulating
machines that would standardize the submission of reports of regulated
transactions, whether domestic or import/export, and require return
information, would enhance the monitoring of these machines and allow
the DEA greater ability to detect and prevent their use for the illicit
manufacture of controlled substances. While tableting machines and
encapsulating machines are commonly used by legitimate companies to
produce pharmaceuticals and nutritional supplements, they are also used
by traffickers to produce single dosage units of illicit synthetic
substances such as methylenedioxymethamphetamine (``MDMA'') aka
``Molly,'' ``ecstasy,'' and other synthetic designer drugs classified
as schedule I controlled substances or analogue substances. These
machines have also been known to be used by marijuana dispensaries,
steroid labs, and counterfeit drug manufacturers.
Manual capsule fillers and small encapsulating machines can produce
anywhere from 15 to 1,000 capsules at a time, and rotary presses can
produce massive amounts of tablets in a very short period of time. The
value of the machines can range anywhere from under $100 to over
$400,000 depending on the type of machine. Importers and exporters are
not required to report the value of the machine or its production
capacity to the DEA. However, sometimes the manifest will contain the
weight of the shipment and will provide some indication of the
machine's capacity.
During 2014, 33 machines at various points of entry were seized by
CBP for mislabeling and nonidentification. Regulatory changes in the
proposed rule would require importers and exporters to report to the
DEA when a shipment has been denied release by a customs officer for
any reason, whether or not the denial was based on a violation of DEA
regulations. Likewise, by unifying the reporting format for regulated
transactions in tableting machines, whether domestic, import, or
export, the DEA will be able to monitor the flow of these machines
through the distribution chain. This will allow the DEA to better
understand and monitor the trade in these machines and to adopt more
efficient means of stopping the diversion of tableting and
encapsulating machines, and prevent their use in the illicit
manufacture of controlled substances.
7. Part 1312: Importation and Exportation of Controlled Substances
The DEA proposes to make a technical change to Sec. Sec. 1312.11
and 1312.22 to insert a cross-reference to part 1301 of chapter II of
title 21 of the Code of Federal Regulations when referencing the
registration requirements for the importation of controlled substances.
The DEA proposes to amend Sec. 1312.14 to account for revised
distribution procedures for import permits. The DEA is retaining the
requirement that an official record of the permit (a ``copy'' under
current DEA regulatory terms) accompany the shipment of controlled
substances. This is an important tool utilized by the DEA for ensuring
compliance with the closed system of distribution by allowing quick
initial visual indication of compliance with requirements with the CSA.
However, because customs officers will be able to electronically
validate the legitimacy of the import permit through ITDS, customs
officers will not need to physically detach the official record of the
permit for validation. An official record of the permit must instead
accompany the shipment until it reaches its final destination. The DEA
also proposes to amend Sec. 1312.14 to omit the discussion of the
circumstances in which customs officers will refuse entry of a
shipment.
The final destination for an import must be the registered location
of the importer. (The import must be received at the registered address
of the importer before being moved to another location of the importer
or delivered to a customer.) The receipt of imported goods is a
principal activity of registered importers. Pursuant to 21 U.S.C.
958(h), a separate registration is required at each principal place of
business where applicants import or export controlled substances.
Accordingly, the final destination of a shipment of imported controlled
substances is the registered location of the registrant. Drop
shipments, i.e., deliveries made by an importer directly to a customer
without passing through the registered location of the importer,\12\
are explicitly prohibited under the proposed revisions to Sec.
1312.19. Similarly, consistent with current requirements, deliveries
may not be made directly to a warehouse exempted from registration
pursuant to Sec. 1301.12(b)(1); they must arrive first at the
registered location.
---------------------------------------------------------------------------
\12\ See definition of ``drop shipment,'' e.g., http://www.businessdictionary.com (accessed 05.24.2015).
---------------------------------------------------------------------------
A technical amendment to paragraph (a) of Sec. 1312.15 is proposed
to cross-reference Sec. 1312.16, concerning shipments that may be in
greater or lesser amount than what is authorized by the import permit.
Associated with the foregoing changes, as discussed earlier in this
document, the DEA is additionally proposing to amend its regulations
regarding expiration dates associated with imports and exports of
controlled substances. The DEA proposes to change the current
expiration period of import and export permits found in Sec. Sec.
1312.16 and 1312.25 from not more than six months to not more than 180
calendar days after the date of issuance. This change will standardize
expiration procedures as not all months have the same number of days.
The DEA also proposes to amend Sec. Sec. 1312.18 and 1312.27 to
specify an expiration date for import and export declarations for
controlled substances. Such declarations do not currently have an
expiration date assigned to them; however, permits to import and export
controlled substances expire not more than six months after approved
under the current regulation. 21 CFR 1312.16 and 1312.25. Similar to
permits, at times declarations filed with the DEA are never actually
utilized. The DEA is concerned that absence of an expiration date for
these declarations may lead to incomplete or inaccurate records in the
ITDS. Therefore, the DEA is proposing that declarations expire 180
calendar days after the date the declaration is deemed filed with the
Administration.
The DEA proposes to modify the condition currently found in Sec.
1312.22(a) that requires an application
[[Page 63595]]
for a permit to export controlled substances to contain an affidavit
that the packages of controlled substances for export are labeled in
conformance with obligations of the United States under international
treaties, conventions, or protocols ``in effect on May 1, 1971.'' The
regulation will be amended to instead require that such affidavit state
that packages of controlled substances for export are labeled in
conformance with obligations of the United States under international
treaties, conventions, or protocols which are in effect at the time of
export or reexport. The DEA does not believe that this change will have
any current effect on the regulated community because it is not a new
requirement. However, the DEA is taking this opportunity in revising
its other import and export regulations to propose this change to
account for any changes in international treaties, conventions, or
protocols which might be made in the future.
As discussed above, this proposal includes changes to harmonize, to
the extent possible, return information requirements for import and
export regulations throughout parts 1310, 1312, and 1313 for tableting
and encapsulating machines, controlled substances, and listed
chemicals. Although these provisions are similarly structured, the
actual content of the return information varies across the regulations
to account for international reporting requirements for machines,
controlled substances, and listed chemicals. Variations in return
reporting requirements also vary among controlled substances, listed
chemicals, and tableting and encapsulating machines to maximize the
detection, investigation, and prevention of diversion. The DEA has
reviewed the return information currently collected for imported and
exported controlled substances and is proposing changes.
The DEA is proposing amendments to Sec. Sec. 1312.12, 1312.18,
1312.22, and 1312.27 to require registrants and those exempt from
registration to report return information to the Administration
following imports and exports of controlled substances authorized by
permits and conducted pursuant to filed declarations. The DEA is
proposing to require this information to be submitted within 30
calendar days, or within 10 calendar days after a request from the
Administration, whichever is sooner. This regulatory text change is
consistent with existing business practice, as importers and exporters
generally submit such information to the DEA at the conclusion of
transactions. The submission of such reports will allow the United
States to meet its obligations under article 19 (Estimates of drug
requirements) and article 20 (Statistical returns to be furnished to
the Board) of the Single Convention on Narcotic Drugs, 1961, and
article 16 (Reports to be furnished by the Parties) of the Convention
on Psychotropic Substances, 1971. The DEA will continue to
independently collect such return information outside of the single
window as the ITDS does not capture all elements of the return
information that the DEA needs to submit under those treaty obligations
and otherwise adequately monitor the closed system of distribution of
imports and exports to detect and prevent diversion. 21 U.S.C. 871(b).
Additionally, the timing and frequency of required return information
reporting is outside the scope of the single window. Requirements for
return information to be submitted to the DEA are already specifically
included in Sec. 1312.22(d)(6) for reexported controlled substances
pursuant to 21 U.S.C. 953(f)(6).
For imported and exported controlled substances there are four
principal pieces of information that the DEA is proposing importers and
exporters supply to the DEA in the returns: The date on which the
controlled substances arrived/departed the registered location, the
date on which a customs officer released the shipment, the actual
quantity of controlled substances that arrived/left the registered
location, and the actual quantity of controlled substances that a
customs officer actually released. The current text in 21 CFR 1312.22
relating to controlled substances exported for subsequent reexportation
requires the reporting of the ``date shipped.'' This requirement has
been interpreted differently, sometimes as the date it left the
facility and sometimes as the date the import/export transaction
occurred. Both dates are needed to adequately monitor the closed system
of distribution for import and export transactions. For example, an
analysis of the amount of time it takes a shipment to complete an
import or export transaction could be compared with the rate of theft
and loss and could potentially lead to corresponding changes to DEA
security regulations being proposed. Likewise both the actual amount of
controlled substances that customs released and the actual amount of
controlled substances that arrived or left the registered facility are
needed to adequately monitor the closed system of distribution and
allow precise accountability of all substances within a registrant's
inventory. These figures allow a base level against which to cross-
check reports for in-transit losses for imported and exported
controlled substances.
The DEA proposes to revise Sec. Sec. 1312.12, 1312.18, 1312.22,
and 1312.27 to prohibit the importation/exportation of any shipment of
controlled substances denied release by customs at the port of entry or
port of export for any reason without resubmission of the permit
application or declaration and issuance of a new permit or transaction
identification number by the DEA. For example, if a customs officer
denied release of controlled substances at the port of entry because of
a violation of another agency's regulation (e.g., U.S. Food and Drug
Administration), customs officials would not allow entry until after
the reason for denial was adequately addressed and the DEA has issued a
new permit or transaction identification number. This change is needed
to strengthen the DEA's ability to monitor and detect practices that
may render an importer's or exporter's registration inconsistent with
the public safety, especially in relation to the DEA's statutory
obligation to take into consideration an applicant's compliance with
applicable State and local laws and other relevant factors. 21 U.S.C.
823(a), 958(a).
The DEA proposes to amend Sec. 1312.22 to reflect that the
Administration has discretion whether to issue a permit for reexport
pursuant to 21 U.S.C. 953(f). The proposed revision to Sec.
1312.22(g)(8), like the current regulation, specifies that the exporter
must provide ``a brief summary of the facts that warrant the return''
of an export that has been refused or is otherwise unacceptable or
undeliverable. The DEA Office of Diversion Control secure network
application contains a field appropriate for this information within
the DEA Form 357. Likewise, the ``written request for reexport'' of a
controlled substance subject to declaration requirements, currently
required in Sec. 1312.27(b)(5)(iv), can be submitted in a field of the
DEA Form 236 in the DEA Office of Diversion Control secure network
application. As in the current regulations, a refused or otherwise
unacceptable or undeliverable controlled substance subject to the
declaration requirements could be imported only after the DEA issues
``affirmative authorization in writing.'' A transaction identification
number does not serve as such ``affirmative authorization in writing.''
The DEA proposes to amend Sec. Sec. 1312.22, 1312.31, and 1312.32
to require a certified translation of
[[Page 63596]]
authorizations issued by foreign competent national authorities that
are not issued either entirely in English or bilingual with English. If
the foreign authorization, or the certified copy of such, is not
written in English or bilingual with another language and English, the
registrant must submit with their application or notice a certified
translation of the permit or license. The DEA proposes that for
purposes of this requirement, certified translation will mean that the
translator has signed the translation legally attesting to the accuracy
of the translation and the attestation has been notarized. This change
is meant to ensure that these foreign authorizations are complete and
accurate, and that the information that they contain are accurately
understood and applied to DEA import/export policies and procedures.
8. Reexportation of Controlled Substances--Including Implementation of
Section 4 of the Improving Regulatory Transparency for New Medical
Therapies Act
This proposal contains amendments that would implement section 4,
Re-exportation Among Members of the European Economic Area, of the
Improving Regulatory Transparency for New Medical Therapies Act, Public
Law 114-89 (hereinafter ``the 2015 Act''), which was signed into law on
November 25, 2015. Section 4 of the 2015 Act amended section 1003 of
the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 953)
by making changes to paragraph (f) and adding paragraph (g), changes
that allow for expanded reexportation of certain controlled substances
among members of the European Economic Area (EEA). Prior to passage of
the 2015 Act, the CSIEA (21 U.S.C. 953(f)) provided, with respect to
controlled substances in schedule I or II and narcotic drugs in
schedule III or IV, that such substances could be exported from the
United States for subsequent reexport from the recipient country (the
``first country'') to another country (the ``second country'')--but
with no further reexports from the second country. The 2015 Act removed
this latter limitation provided that every country involved is an EEA
country. As a result, unlimited further reexports may now occur among
EEA countries, provided the conditions specified in the 2015 Act are
met.
Beyond the new allowance for unlimited reexports among EEA
countries, most of the statutory requirements that applied to all
reexports prior to the 2015 Act remain in effect under the 2015 Act
with respect to reexports among EEA countries. For example, it remains
a requirement that first, second, and subsequent countries within the
EEA must be parties to the Single Convention on Narcotic Drugs, 1961,
and the Convention on Psychotropic Substances, 1971. 21 U.S.C.
953(f)(1). Also consistent with pre-enactment statutory requirements,
each such EEA country must have instituted and maintain, in conformity
with such Conventions, a system of controls of imports which the
Attorney General deems adequate, the importer and exporter must be
properly permitted or licensed, and the controlled substance must be
applied exclusively to medical, scientific, or other legitimate uses.
21 U.S.C. 953(f)(2).
However, in contrast to the reexport requirements that apply where
the reexport involves any non-EEA countries, the 2015 Act provides that
reexportation from the first EEA country to a second EEA country may
not be constrained to any specific time period. 21 U.S.C. 953(g)(1).
This notice proposes revisions to DEA regulations to incorporate this
and other changes mandated by the 2015 Act.
In drafting the proposed regulatory changes to implement the
statutory changes made by the 2015 Act, the DEA carefully took into
consideration the new subsection, 21 U.S.C. 953(g)(2), which prohibits
the Attorney General from promulgating or enforcing any regulation,
subregulatory guidance, or enforcement policy which impedes re-
exportation of any controlled substance among European Economic Area
countries, including by promulgating or enforcing any requirement that
information concerning the consignee, country, and product be provided
prior to exportation of the controlled substance from the United States
or prior to each re-exportation among members of the European Economic
Area.
In interpreting the foregoing provision of the 2015 Act, given that
the term ``impedes'' is somewhat vague, the DEA took the following
factors into account. First, the CSIEA itself continues to impose
various requirements that some might characterize as ``impeding''
reexports among EEA countries. Specifically, as described above, the
2015 Act retained, with respect to such reexports, most of the
preexisting requirements in 21 U.S.C. 953(f). Second, for the United
States to continue to meet its reporting and other obligations under
the Single Convention and Psychotropic Convention, the DEA must
continue to obtain certain information from persons involved in
reexport transactions. For these reasons, the DEA does not interpret
the term ``impedes'' in the 2015 Act to prohibit the DEA from imposing
any requirement that goes beyond the explicit requirements of 21 U.S.C.
953(f) and (g). Rather, the DEA interprets the ``impedes'' clause as
follows: (i) The DEA may not promulgate or enforce any regulation of
the specific nature described in paragraphs (1) and (2) of 21 U.S.C.
953(g) and (ii) beyond the type of restrictions referred to in
paragraphs (1) and (2), the DEA must avoid promulgating or enforcing
any unduly burdensome regulations on such reexports.
Consistent with the foregoing interpretation of the 2015 Act, in
the proposed revised regulations, the DEA would no longer require bulk
substances to undergo further manufacturing process within the first
EEA country if the substance is to be reexported within the EEA. Also
consistent with this interpretation of the 2015 Act, the DEA proposes
to remove the requirement that the exporter must provide product and
consignee information beyond the first country in advance of (prior to)
export from the United States. Exporters who submit an application for
reexport among members of the EEA will continue to be required to
supply information of the consignee in the first country, including the
consignee's contact information and business--but (as mandated by the
2015 Act) information concerning the second or subsequent consignee,
country, and product will not be required to be provided prior to
exportation of the controlled substance from the United States or prior
to each reexportation among members of the EEA. The DEA's continued
collection of this information will help ensure that the DEA has
sufficient information to uphold U.S. treaty obligations.
Also consistent with the retained requirements of 21 U.S.C. 953(f),
DEA registered exporters seeking to export controlled substances to the
EEA for such reexport will continue to be required to submit an
affidavit that the consignee in the second country and any country of
subsequent reexport within the EEA is authorized under the laws and
regulations of the recipient country to receive the controlled
substances, that the packages are labeled in conformance with U.S.
treaty obligations that the controlled substances are to be applied
exclusively for medical or scientific uses, that the controlled
substances will not be reexported outside of the EEA, and that there is
an actual need for the controlled substances for medical or scientific
uses within the recipient country. Consistent
[[Page 63597]]
with past practice, this affidavit will constitute ``substantial
evidence'' for purposes of 21 U.S.C. 953(f)(4) for reexports of
controlled substances among members of the European Economic Area. See
71 FR 61436, 61438, Oct. 18, 2006.
Presently, under the current Sec. 1312.22(d)(7), the DEA requires
that controlled substances must be reexported from the first country to
the second country, or countries, within 180 days after the controlled
substances have been exported from the United States. As discussed in
the notice of proposed rulemaking for Reexportation of Controlled
Substances, for which the associated final rule added this provision to
Sec. 1312.22, the justification behind this requirement is to minimize
the likelihood of uncertainties regarding the status of reexport
shipments and thereby minimize the likelihood of diversion. 71 FR
61436, 61437, Oct. 18, 2006. However, as previously stated above, the
2015 Act specifically provides that reexportation among members of the
EEA may not be constrained to any specific time period. 21 U.S.C.
953(g)(1). Therefore, the DEA proposes to eliminate application of this
provision to reexports of controlled substances among members of the
EEA.
While, as just discussed, the DEA is proposing to eliminate certain
requirements for EEA reexports in order to bring DEA regulations into
accordance with the 2015 Act, the DEA continues to believe that those
requirements serve an important purpose in safeguarding against
international diversion and promoting compliance with international
treaty obligations. Therefore, the DEA is not proposing to change or
exclude those requirements as they apply outside of the EEA reexport
context, as Congress did not require the DEA to do so.
Persons who export controlled substances for reexport among members
of the EEA are required by the law to provide return information to the
Attorney General within 30 days after each re-exportation, including
certification that the reexportation has occurred and ``information
concerning the consignee, country, and product.'' 21 U.S.C.
953(f)(6)(B). This return information is in addition to the return
information that the exporter must provide related to the export of the
controlled substance from the United States to the first country.
Because of the constraints imposed by the statutory language in the
2015 Act, the DEA is proposing a straightforward 30-calendar-day
reporting limit for reexports of controlled substances without the
caveat that the Administration may request such information sooner, as
is generally contained in this proposal for other return information.
Although the DEA is without authority to require such information to be
submitted in advance of the 30-day statutory deadline, the DEA
continues to encourage return information on reexports to be submitted
as soon as possible so as to allow the DEA to meet its treaty reporting
deadlines.\13\
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\13\ ``Under the Single Convention, each country that is a party
to the treaty is required to furnish the International Narcotics
Control Board (INCB) with annual estimates of, among other things,
the quantities of narcotic drugs on hand, the anticipated amounts
that will be consumed by the party for legitimate purposes, and the
anticipated production quantities. The Single Convention also
requires parties to furnish the INCB with statistical returns for
the prior year, indicating the amounts of drugs produced, utilized,
consumed, imported, exported, seized, disposed of, and in stock. The
Psychotropic Convention requires the parties to provide the INCB
with statistical reports and assessments containing similar
information with respect to psychotropic substances. Through the
collection of this information, the INCB provides exporting
countries with information on the legitimate requirements of the
importing countries and can take steps to reduce the likelihood of
international diversion.'' 71 FR 61436, 61438, Oct. 18, 2006.
---------------------------------------------------------------------------
To effectuate and efficiently implement the different reexport
requirements between those controlled substances intended for reexport
outside the EEA and those intended for reexport within the EEA, the DEA
is proposing to restructure Sec. 1312.22. The DEA proposes to
restructure Sec. 1312.22 to generally align with the three types of
exports covered by the regulation--export not for reexport, export for
reexport outside of the EEA, and export for reexport within the EEA.
The requirements for export/reexport and return information would be
addressed separately under the corresponding header for each type of
transaction. Of particular note, this reorganization would allow
readers to easily understand the return reporting information for each
type of transaction: Return on an export from the United States (not
for reexport); for reexports outside the EEA--the return on the initial
export from the United States to the first country and a return on the
export from the first country to the second country; and for reexports
among members of the EEA--the return on the initial export from the
United States to the first country and return on the export from the
first country to the second country/subsequent export(s) to other EEA
member countries.
The DEA is proposing to establish a new Form 161R-EEA for the
reporting of reexports among members of the EEA. The DEA Form 161R-EEA
would be accessed, completed, and submitted through the DEA Office of
Diversion Control secure network application. The DEA considered, but
ultimately did not choose to propose, that such applications would be
made electronically on the DEA Form 161R based on the fact that there
are different application requirements for the two types of
transactions required by the CSA. Most important of these distinctions
for tracking purposes are that reexports among members of the European
Economic Area do not have a time period for which such transactions
will ``close'' (i.e., all return information submitted). While under
current Sec. 1312.22(d)(7) (proposed Sec. 1312.22(h)(6)), other
reexports must be completed no later than 180 days after initial export
from the United States, the 2015 Act specifies that controlled
substances may continue to be reexported within the European Economic
Area indefinitely, so long as the statutory conditions are met. Use of
a new form should not impose a burden on registrants, however. Because
the system is electronic the experience for the registrant will be the
same regardless of whether they are entering the required application
information on a new electronic form or being redirected to a different
portion of the electronic DEA Form 161R.
While the new law did not have a direct impact on reexports for
nonnarcotic controlled substances in schedules III and IV or controlled
substances in schedule V, the DEA is proposing to make corresponding
changes to its reexport of controlled substances under declaration
procedures found in Sec. 1312.27. If such conforming amendments were
not made, there would be stricter requirements for controlled
substances exported for reexport within the European Economic Area
under declaration procedures than under permit procedures. See also DEA
final rule, Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances; Registration of Importers and Exporters of
Controlled Substances; Importation and Exportation of Controlled
Substances; updating Requirements, 52 FR 17286, 17287, May 7, 1987
(``One of the stated purposes for the Diversion Control Amendments is
to decrease the disparity of control between narcotic and non-narcotic
controlled substances.'').
[[Page 63598]]
9. Part 1313: Importation and Exportation of List I and List II
Chemicals
The DEA proposes to add a new Sec. 1313.03 that would consolidate
the DEA Form information applicable to part 1313 in a corresponding
change to that proposed for the new Sec. 1312.03. The new Sec.
1313.03 would consist of a table referencing the DEA Form number, form
name, information about where the form may be accessed, and where the
completed form should be submitted.
The DEA proposes to amend Sec. 1313.12(b) to require that all
declarations (DEA Form 486/486A) must be complete and accurate when
submitted. Under Sec. 1304.21, registrants must maintain complete and
accurate records for controlled substances. That requirement applies to
import and export declarations for controlled substances. This proposed
revision would impose the same requirement for import/export
declarations as for listed chemicals.
Declarations (DEA Forms 486/486A) would not be deemed filed until
the transaction identification number has been issued by the DEA. Upon
receipt and review, the DEA would assign each declaration a transaction
identification number (a unique identifier). Once the declaration has
been accepted and assigned a transaction identification number,
registrants would be able to use the assigned transaction
identification number to access the official record of the declaration.
While current DEA regulations do not require confirmation of receipt
from the DEA prior to importation or exportation pursuant to a
declaration, the proposed change is consistent with current practices.
Currently, the DEA assigns a Web Tracking Number to each declaration
when it is submitted and accepted. The proposed regulatory codification
of the issuance of a transaction identification number is designed to
ensure that electronically submitted declarations are indeed received
by the DEA, are completed, and can be appropriately tracked and
monitored; to streamline the declaration filing process; and to
eliminate duplicate filings. The fact that the DEA issues a transaction
identification number after reviewing the filing does not waive the
Administration's right to suspend a shipment under Sec. 1313.41.
The DEA is proposing to make changes in the regulatory text to
reflect that 21 U.S.C. 830 has been changed to require official records
of import declarations involving listed chemicals to be retained for
two years.
As discussed above, return information requirements have been
harmonized across parts 1310, 1312, and 1313, to the extent possible.
The DEA is proposing that return information must be reported within 30
calendar days after release by a customs officer at the port of entry
or export, or reexport. All return information for applications or
other initial filings that are required to be made electronically
through the DEA Office of Diversion Control secure network application
would likewise be required to be filed electronically through the same
system. As with controlled substance return information, the DEA is
proposing to require listed chemical importers and exporters to include
both the date a customs officer releases an imported item or releases
an item for export and the date that the shipment arrived at the
location of the importer or exporter, the actual quantities of product
both when released by a customs officer and at the time of shipment
from the exporter's location or arrival at the importer's location, and
the actual port of entry or export. These revised reporting
requirements will better allow the DEA to track the flow of listed
chemicals, and detect and prevent diversion. For example, by tracking
and comparing diversion of listed chemicals against the actual port of
entry or exit, the DEA will be better able to detect potential weak
spots in the import/export system and direct more resources to that
region. The DEA also is proposing to revise the regulatory text to
clarify that the references to ``chemical'' and ``container'' apply to
the reporting of subsequent transfers.
The final destination for an import of a list I chemical must be
the registered location of the registered importer. The import must be
received at the registered address of the importer before being moved
to another location of the importer or delivered to a customer. The
receipt of imported goods is a principal activity of registered list I
chemical importers. Pursuant to 21 U.S.C. 958(h), a separate
registration is required at each principal place of business where
applicants import or export list I chemicals. Accordingly, the final
destination of a shipment of an imported list I chemical is the
registered location of the registrant. Drop shipments, i.e., deliveries
made by an importer directly to a customer without passing through the
registered location of the importer,\14\ are explicitly prohibited
under the proposed revisions to Sec. 1313.14. Similarly, consistent
with current requirements, deliveries may not be made directly to a
warehouse exempted from registration pursuant to Sec. 1309.23(b)(1);
they must arrive first at the registered location.
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\14\ See definition of ``drop shipment'', e.g., http://www.businessdictionary.com (accessed 05.24.2015).
---------------------------------------------------------------------------
The DEA is proposing to amend Sec. 1313.22(a) to add a cross-
reference to Sec. 1310.04(g) relating to listed chemicals that may be
exported. This change would harmonize Sec. 1313.22(a) with Sec.
1313.21(a).
10. Part 1316: Administrative Functions, Practices, and Procedures
The DEA proposes to amend Sec. 1316.47(a) to align with the DEA's
current practice referenced in all recent Federal Register publications
that requests for a hearing are to be sent directly to the Hearing
Clerk. Specifically, this amendment would remove ``Attention: DEA
Federal Register Representative'' from the template letter. Since the
paragraph before the template letter states that persons requesting a
hearing should refer to Sec. 1321.01 for current mailing addresses,
the DEA is not adding an ``Attention'' field in the template letter.
The DEA is proposing to amend Sec. 1316.48 so that the filing of
notices of appearance corresponds with the DEA's practice that requests
for hearing shall be sent to the Hearing Clerk. Specifically, the DEA
would remove ``Attention: Federal Register Representative'' from the
template letter. Since the paragraph before the template letter states
that persons requesting a hearing should see Sec. 1321.01 for current
mailing addresses, the DEA is not adding an ``Attention'' field in the
template letter.
C. DEA Mailing Addresses
The DEA proposes to amend the Table of DEA Mailing Addresses found
in Sec. 1321.01 to account for changes proposed in this rule as part
of the implementation of ITDS. The DEA is also taking this opportunity
to propose various technical amendments to the Table of DEA Mailing
Addresses.
Pursuant to this proposed action all import and export applications
and filings would be submitted through the DEA Office of Diversion
Control secure network application. The DEA proposes to amend the Table
of DEA Mailing Addresses to retain a reference to the notifications
that, prior to this rule, could be made by mail, but note with an
asterisk that those filings must now be made electronically. The CFR
sections listed under the DEA Import/Export Unit would be merged with
those under the DEA Regulatory Section and placed under the header of
``DEA Regulatory Section.''
[[Page 63599]]
The mailing addresses for Sec. Sec. 1308.21(a), 1308.23(b),
1308.25(a), 1308.31(a), 1308.33(b), and 1310.13(b) will be transferred
from the DEA Office of Diversion Control to the DEA Drug & Chemical
Evaluation Section (ODE), the subject matter experts on excluded and
exempted products. This change will allow these matters to be processed
in a more efficient manner. The reference to Sec. 1307.22, ``Disposal
of Controlled substances by the Administration delivery application,''
will be revised to ``Delivery of surrendered and forfeited controlled
substances'' in conformity with the final rule, Disposal of Controlled
Substances, 79 FR 53520, Sept. 9, 2014. Corresponding to recent
internal DEA reorganization, the mailing addresses for Sec. Sec.
1303.12(b), 1303.12(d), 1303.22, 1304.31(a), 1304.32(a), 1315.22,
1315.32(e) and (g), 1315.34(d), and 1315.36(b), regarding quota
applications and reporting, will be moved from the DEA Drug & Chemical
Evaluation Section to the UN Reporting & Quota Section under a new
corresponding header.
The DEA proposes to amend Sec. 1316.48 to provide that notices of
appearance should be sent to the DEA Hearing Clerk instead of the DEA
Administrator so that notices of appearance will be filed in a more
efficient manner. The DEA also proposes to amend Sec. 1316.47 to
provide that requests for hearing should be sent to the DEA Hearing
Clerk instead of the DEA Federal Register Representative so that such
requests will be filed in a more efficient manner. In the Table of DEA
Mailing Addresses in Sec. 1321.01, DEA proposes to make the
corresponding change, and to add Sec. Sec. 1301.43, 1303.34, 1308.44,
and 1316.47(a), regarding requests for hearing or appearance and/or
waivers, under the DEA Hearing Clerk heading. These items are being
directed to the DEA Hearing Clerk to expedite the hearing process and
will lead to fewer delays. The DEA is additionally revising this
portion of the table to correct the attention line of the mailing
address for the DEA Hearing Clerk. The address will be changed from
``Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701
Morrissette Drive, Springfield, VA 22152'' to ``Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, VA 22152.''
The DEA is adding the following citations to be directed to the DEA
Federal Register Representative: Sec. 1301.34(a)--Filing of written
comments regarding application for importation of Schedule I and II
substances; Sec. 1303.11(c)--Filing of written comments regarding
notice of an aggregate production quota; and Sec. 1303.13(c)--Filing
of written comments regarding adjustments of aggregate production
quotas. These topics have been added so that comments corresponding to
Federal Register publications can be sent directly to the Federal
Register Representative whose responsibility it is to review comments
and make them publicly available, as appropriate. The DEA is
additionally amending this portion of the table to revise the attention
line of the mailing address for the DEA Federal Register
Representative. The address will be changed from ``Drug Enforcement
Administration, Attn: Federal Register Representative/ODL, 8701
Morrissette Drive, Springfield, VA 22152'' to ``Drug Enforcement
Administration, Attn: Federal Register Representative/ODW, 8701
Morrissette Drive, Springfield, VA 22152.'' Additionally, this rule
adds the Web address for the Federal eRulemaking Portal, http://www.regulations.gov, under the heading ``DEA Federal Register
Representative.'' This Web address provides the ability to type short
comments directly into the comment field on the Web page or to attach a
file for lengthier comments. This change conforms to the DEA's current
practice, referenced in the DEA's recent Federal Register publications,
which requires that comments either be submitted through http://www.regulations.gov or be directed to the DEA Federal Register
Representative.
III. Regulatory Analyses
Executive Orders 12866 and 13563
This proposed rule was developed in accordance with the principles
of Executive Orders 12866 and 13563. The DEA has determined that this
proposed rule is a significant regulatory action, and accordingly this
rule has been submitted to the Office of Management and Budget for
review.
By business activity, the DEA estimates this rule will result in a
combined annual savings of $424,640 for controlled substances
importers, exporters, researchers, and analytical labs; a combined
annual cost of $5,011 for listed chemical importers and exporters and
tableting and encapsulating machine importers and exporters; and no
economic impact for brokers, domestic transactions in tableting and
encapsulating machines, and mail order transactions of ephedrine (EPH),
pseudoephedrine (PSE), phenylpropanolamine (PPA), or gamma-
hydroxybutyric acid (GHB). Therefore, the estimated net annual impact
of this rule is a cost savings of $419,629 and the estimated combined
annual economic effect is $429,650. The DEA does not anticipate that
this rulemaking will have an annual effect on the economy of $100
million or more or adversely affect, in a material way, the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities. An economic analysis of the proposed rule
can be found in the rulemaking docket at http://www.regulations.gov.
Executive Order 12988
The proposed regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175
This proposed rule is in accordance with the February 19, 2014,
Executive Order 13659, ``Streamlining the Export/Import Process for
America's Businesses,'' 79 FR 10657, Feb. 25, 2014. It does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving
it certifies that it will not have a significant economic impact on a
substantial number of small entities.
Below is a summary of the threshold analyses conducted by the DEA
to support the certification statement above. The complete threshold
analysis is available at http://www.regulations.gov for easy reference.
The DEA specifically solicits written comments regarding the DEA's
economic threshold analysis of the impact of these proposed changes.
The
[[Page 63600]]
DEA requests that commenters provide detailed descriptions in their
comment of any expected economic impacts, especially to small entities.
Commenters should provide empirical data to illustrate the nature and
scope of such impact.
In accordance with the RFA, the DEA evaluated the impact of this
rule on small entities. This proposed rule affects all entities who
import or export, or seek to import or export, controlled substances,
listed chemicals, tableting and encapsulating machines, or who broker
international transactions (from foreign country to another foreign
country while in the United States). Additionally, this proposed rule
affects all persons who would be required to report unusual or
excessive loss or disappearance of a listed chemical under the control
of the regulated person in accordance with proposed revised Sec.
1310.05(b)(1), all persons who are required to report domestic
regulated transactions in tableting or encapsulating machines in
accordance with proposed revised 21 CFR 1310.05(b)(2), and all persons
who are required to report mail order transactions of ephedrine (EPH),
pseudoephedrine (PSE), phenylpropanolamine (PPA), or gamma-
hydroxybutyric acid (GHB) in accordance with 21 CFR 1310.03(c). The
affected entities include DEA registrants and non-registrants. A DEA
registration is required to import or export any controlled substance
and most list I chemicals. A DEA registration is not required to import
or export some list I chemicals or any list II chemical, to import or
export tableting and encapsulating machines, or to broker international
transactions. Also, a DEA registration is not required to conduct
domestic transactions in tableting and encapsulating machines or mail
order transactions of EPH, PSE, or PPA. (Registration is required for
mail order transactions of GHB as GHB is a schedule I controlled
substance.) The affected entities (DEA registrants and non-registrants)
are grouped into ``business activities,'' based on types of activities
performed by the entities. The business activities described in this
analysis that are required to have DEA registrations are importers/
exporters, researchers, analytical labs, and chemical importers/
exporters that deal in the list I chemicals requiring registration
(referred to as ``DEA-registered listed chemical importers/
exporters''). The business activities described in this analysis that
are not required to have DEA registrations are chemical importers/
exporters that deal in list I chemicals not requiring registration and
list II chemicals (referred to as ``non-registered listed chemical
importers/exporters''), tableting/encapsulating machine importers/
exporters, brokers of international transactions, tableting/
encapsulating machine domestic suppliers, and entities selling EPH,
PSE, and/or PPA by mail order.
The DEA estimates that 7,840 entities are affected by this rule,
which consist of 331 controlled substances importers/exporters; 5,884
researchers; 1,200 analytical labs; 231 DEA-registered listed chemical
importers/exporters; 76 non-registered listed chemical importers/
exporter; 56 tableting/encapsulating machine importers/exporters; 12
brokers of international transactions; 46 tableting/encapsulating
machine domestic suppliers; and 4 entities selling EPH, PSE, PPA, and/
or GHB by mail order. Regulated persons potentially reporting unusual
or excessive loss or disappearance of a listed chemical would be
included in one of the business activities above.
The DEA estimates 7,321 (93.4%) of total 7,840 affected entities
are small entities. Specifically, the DEA examined the impact of the
proposed changes regarding (1) mandatory electronic permit applications
and filings, and (2) 180-calendar-day expiration for all declarations
for the 7,321 small entities affected by the proposed rule, which
consist of 310 controlled substances importers/exporters; 5,474
researchers; 1,134 analytical labs; 218 DEA-registered listed chemical
importers/exporters; 72 non-registered listed chemical importers/
exporters; 54 tableting/encapsulating machine importers/exporters; 11
brokers of international transactions; 44 tableting/encapsulating
machine domestic suppliers; and 4 entities selling EPH, PSE, PPA, and/
or GHB by mail order.
The DEA is proposing to mandate the electronic submission of all
permit applications and other required filings and reports associated
with the importation or exportation of tableting and encapsulating
machines, controlled substances, and listed chemicals. Additionally,
the DEA is proposing to mandate the electronic submission of all
reports associated with the unusual or excessive loss or disappearance
of a listed chemical, domestic regulated transactions in tableting or
encapsulating machines, and mail order transactions of EPH, PSE, PPA,
and GHB. The DEA would cease to accept paper filing of controlled
substances import/export permit applications (other than
transshipments), controlled substances import/export declarations,
listed chemicals import/export declarations, and certain filings and
reports specified as discussed previously in this document. Currently,
some electronic forms associated with these activities are available
online and in use. Usage rates vary for each form and also vary by
business activities. However, as virtually all paper submissions of
permit applications and declarations are currently delivered via
express common carrier with pre-paid return envelope or account
information, savings are anticipated because of this change.
The DEA estimates that each conversion to electronic filing from
paper controlled substances import/export permit application and
controlled substances import/export declaration will result in an
estimated cost savings of $58.75 and $9.75, respectively. Based on
DEA's registration data, the DEA assumes all affected entities have
information systems capable of completing and submitting online forms
and downloading, printing, and transmitting electronic documents at
nominal additional cost. Among the affected establishments that hold
DEA registrations, 92% of previous applications for registration or
renewal of registration were made online. Furthermore, even though the
email address is an optional data field, 99% of the registrations have
an email address on record. Based on these facts and the high rate of
internet penetration in the general U.S. population,\15\ it is
reasonable to assume virtually all regulated establishments,
registrants and non-registrants, have information systems capable of
completing and submitting online forms and downloading, printing, and
transmitting electronic documents at minimal additional cost. No
special software or equipment will be needed to access the DEA Office
of Diversion Control secure network application.
---------------------------------------------------------------------------
\15\ See note 15 of the accompanying Economic Impact Analysis
(``An estimated 78.1 percent of people in U.S. households had a
high-speed Internet connection in 2013. ``Computer and Internet Use
in the United States: 2013,'' U.S. Census Bureau, http://www.census.gov/content/dam/Census/library/publications/2014/acs/acs-28.pdf.'').
---------------------------------------------------------------------------
There are no anticipated cost savings for the conversion to
electronic filing from paper for the listed chemicals import/export
declarations and tableting and encapsulating machine import/export
notifications since virtually all are currently submitted via online,
facsimile, or email, without the use of a common carrier. However, the
DEA anticipates an additional cost associated
[[Page 63601]]
with the new requirement for tableting/encapsulating machine importers/
exporters to submit return information within 30 calendar days after
the release by a customs officer has taken place or within 10 calendar
days after receipt of a written request by the Administration to the
exporter/importer, whichever is sooner.
The DEA estimates there will be no economic impact associated with
the electronic submission of all reports associated with the unusual or
excessive loss or disappearance of a listed chemical, domestic
regulated transactions in tableting or encapsulating machines, and mail
order transactions of EPH, PSE, PPA, and GHB. While the written reports
would be required to be made online, the labor cost of making the
report is expected to be the same, whether on paper or online.
Based on the varying number of annual occurrences estimated for
each of the business activities, the DEA estimates importers/exporters
as a group would save $383,857, researchers as a group would save
$4,316, and analytical labs as a group would save $37,567. The DEA
estimates tableting/encapsulating machine importers/exporters as a
group would have an additional cost of $3,978, for a total net savings
of $421,761 for the electronic submissions requirement. (Figures are
rounded.) Based on the number of affected entities and the cost savings
to the business activities as a group, the DEA estimated the average
annual cost savings for each affected entity. The DEA estimates
importers/exporters, researchers, and analytical labs will save on
average $1,160, $1, and $31 per year, respectively, and tableting/
encapsulating machine importers/exporters would have a cost of $71 per
year.
In addition, the DEA is proposing to specify that all controlled
substance and listed chemical declarations expire in 180 calendar days,
consistent with the controlled substance import/export permits. If
release by a customs officer will occur more than 180 calendar days
after the declaration is deemed filed, the declarant must submit a new
declaration for the transaction. The 180-calendar-day expiration
provision for all controlled substance and listed chemical declarations
is estimated to cause a small increase in the number of re-submissions
of the declarations. The DEA estimates approximately 1% of all
declarations would require re-submissions to replace the expiring
declaration, requiring a total of an additional 85 controlled substance
declarations and 132 listed chemical declarations per year. The
estimated cost of each re-submission of controlled substance
declarations and listed chemical declarations, based on estimated labor
rates and time to complete the forms, is $13.02 and $7.81,
respectively. There is no cost to tableting/encapsulating machine
importers/exporters and brokers of international transactions, as this
provision does not apply to these business activities. Based on the
varying number of annual re-submissions estimated for each of the
business activities, the DEA estimates this provision, if promulgated,
would cost importers/exporters as a group $1,023, researchers as a
group $24, analytical labs as a group $54, chemical importers/exporters
as a group $689, and non-registered chemical importers/exporters as a
group $344, for a total of $2,132. Based on the number of affected
entities and the cost to the business activities as a group, the DEA
estimated the average annual cost for each affected entity. The DEA
estimates importers/exporters, researchers, analytical labs, chemical
importers/exporters, and non-registered chemical importers/exporters
will have an average cost impact of $3; $0; $0; $3; and $5 per year,
respectively. (Figures are rounded.)
In summary, the DEA combined the impact of the two provisions to
estimate the net impact to the affected small entities. The DEA
estimates an average annual net savings of $1,157 for the 310
controlled substance importers/exporters, an average annual net savings
of $1 for the 5,474 researchers, an average annual net savings of $31
for the 1,134 analytical labs, an average annual net cost of $3 for the
218 DEA-registered listed chemical importers/exporters, an average
annual net cost of $5 for the 72 non-registered listed chemicals
importers/exporters, an annual net cost of $71 for the 54 tableting/
encapsulating machine importers/exporters, no economic impact for the
11 brokers of international transactions, no economic impact for the 44
tableting/encapsulating machine domestic suppliers, and no economic
impact for 4 entities selling EPH, PSE, PPA, and GHB by mail order.
The DEA evaluated the net economic impact by size category for each
of the business activities. The DEA estimates that the average annual
cost savings of $1,157 for controlled substance importers/exporters is
economically significant, cost savings greater than 1% of annual
revenue, for 32 of 310 small importer/exporter entities. None of the
remaining 7,011 small entities of the remaining business activities are
estimated to be significantly impacted by this proposed rule. If the
proposed rule were finalized, it would have a significant economic
impact, in form of cost savings, on 32 (0.4%) of the 7,321 affected
small entities. It is the DEA's assessment that 0.4% of small entities
does not constitute a substantial number. The DEA's evaluation of
economic impact by size category indicates that the proposed rule will
not have a significant effect on a substantial number of these small
entities.
Unfunded Mandates Reform Act of 1995
The estimated annual impact of this rule is $429,650; thus, the DEA
has determined in accordance with the Unfunded Mandates Reform Act of
1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result
in 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 for inflation) in any one
year. Therefore, neither a Small Government Agency Plan nor any other
action is required under provisions of UMRA.
Paperwork Reduction Act of 1995
Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.), the DEA has identified the following
collections of information related to this proposed rule and has
submitted this collection request to the Office of Management and
Budget (OMB) for review and approval. This proposed rule updates the
DEA regulations for import and export of controlled substances, listed
chemicals, and tableting and encapsulating machines,. The proposal also
clarifies certain policies and reflects current procedures and
technological advancements. It allows for the implementation of the
President's Executive Order on streamlining the export/import process,
requiring the government-wide utilization of the International Trade
Data System (ITDS). The DEA is not authorized to impose a penalty on
persons for violating information collection requirements which do not
display a current OMB control number, if one is required. Copies of
existing information collections approved by OMB may be obtained at
http://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Proposed Rule
The DEA is proposing to revise existing information collections
1117-0004, 1117-0009 and 1117-0013 by establishing mandatory filing of
return information for imports and exports of controlled substances.
[[Page 63602]]
Additionally, the DEA is also proposing to revise existing
information collection 1117-0024 by establishing two new forms for the
reporting of transactions with listed chemicals, tableting machines,
and encapsulating machines. Specifically, the DEA is creating new DEA
Form 452, ``Reports for Regulated Machines.'' The DEA Form 452 will be
used by regulated persons to report both domestic regulated
transactions as well as import and export regulated transactions of
tableting and encapsulating machines. The DEA is also establishing
mandatory filing of return information for the importing and exporting
of tableting and encapsulating machines that would be incorporated into
the DEA Form 452. Additionally, the DEA is proposing to revise existing
information collection 1117-0024 by establishing a new form for the
reporting of unusual or excessive loss or disappearance of a listed
chemical. Regulated persons would report this information on new DEA
Form 107, ``Reports of Loss or Disappearance of Listed Chemicals.''
The DEA is proposing to revise existing information collection
1117-0033 by establishing a new form for reporting mail-order
transactions involving specified listed chemicals. Specifically, the
DEA is creating new DEA Form 453, ``Report of Mail Order
Transactions.'' The DEA Form 453 will be used by regulated persons
required to file monthly reports of transactions with nonregulated
persons with ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals
or controlled substance) and use or attempt to use the U.S. Postal
Service or any private or commercial carrier as well as regulated
persons required to file monthly reports of export transactions with
ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals
or controlled substance) and use or attempt to use the U.S. Postal
Service or any private or commercial carrier.
1. Title: Application for Permit to Export Controlled Substances--DEA
Form 161/Application for Permit to Export Controlled Substances for
Subsequent Reexport--DEA Form 161R/Application for Permit to Export
Controlled Substances for Subsequent Reexport Among Members of the
European Economic Area--DEA Form 161R-EEA
OMB Control Number: 1117-0004.
Form Number: DEA Form 161, 161R, 161R-EEA.
As part of the implementation of the ITDS, the DEA is proposing
mandatory electronic filing of return information for any person who
desires to export or reexport controlled substances listed in schedule
I or II, any narcotic substance listed in schedules III or IV, or any
non-narcotic substance in schedule II which the Administrator has
specifically designated by regulation in Sec. 1312.30, or any non-
narcotic substance in schedule IV or V which is also listed in schedule
I or II of the Convention on Psychotropic Substances, 1971.
The DEA is proposing amendments to Sec. 1312.22 in the ITDS
proposed rule to provide clear instructions on the process of return
information for controlled substances subject to export permit
requirements, which will be submitted electronically as part of the DEA
Form 161. Specifically, the DEA is proposing to require in Sec.
1312.22 that within 30 calendar days after a controlled substance is
released by a customs officer at the port of export from the United
States in accordance with the permitting process, or within 10 calendar
days after receipt of a written request by the Administration to the
exporter, whichever is sooner, the exporter must file a report with the
Administration through the DEA Office of Diversion Control secure
network application (available on the DEA Office of Diversion Control
Web site) that such export has occurred and the specifics of the
transaction.
As part of the implementation of ITDS, the DEA is proposing to
establish a new DEA Form 161R-EEA, discussed in greater detail below,
to be used by registrants who export controlled substances for reexport
among members of the European Economic Area. The existing DEA Form 161R
would remain in use for exports of controlled substances that will be
reexported to countries that are not members of the European Economic
Area. The DEA is proposing amendments to Sec. 1312.22 in the ITDS
proposed rule to provide clear instructions on the process of return
information for controlled substances subject to reexport permit
requirements that will be reexported outside of the European Economic
Area, which will be submitted electronically as part of the DEA Form
161R. Consistent with current requirements, the amended Sec. 1312.22
would require that within 30 calendar days after a controlled substance
is released by a customs officer at the port of export the exporter
must file a report with the Administration through the DEA Office of
Diversion Control secure network application (available on the DEA
Office of Diversion Control Web site) that such export has occurred and
the specifics of the transaction. Also consistent with current
requirements, the amended text would require that the exporter must
additionally electronically file a similar report of return information
within 30 calendar days of the controlled substances being exported
from the first country to the second country. As noted, the DEA Form
161R, and associated return information, would be required to be
accessed, completed, and submitted to the DEA through the DEA Office of
Diversion Control secure network application.
This proposal contains amendments that would implement section 4,
Re-exportation Among Members of the European Economic Area, of the
Improving Regulatory Transparency for New Medical Therapies Act, Public
Law 114-89, which was signed into law on November 25, 2015. Section 4
amended section 1003 of the Controlled Substances Import and Export Act
(21 U.S.C. 953) by making changes to paragraph (f) and adding paragraph
(g) that allows for reexportation of controlled substances among
members of the European Economic Area. While other reexports must be
completed no later than 180 days after initial export from the United
States, controlled substances may continue to be reexported among
members of the European Economic Area indefinitely, so long as the
statutory conditions are met. As part of the implementation, the DEA is
proposing to establish a new DEA Form 161R-EEA, ``Application for
Permit to Export Controlled Substances for Subsequent Reexport Among
Members of the European Economic Area,'' to be used by registrants who
export controlled substances for reexport among members of the European
Economic Area. Specifically, the DEA is proposing to require in Sec.
1312.22 that within 30 calendar days after the controlled substance is
released by a customs offer at the port of export the exporter must
file a report with the Administration through the DEA Office of
Diversion Control secure network application of the particulars of the
transaction. The exporter must additionally file similar return
information within 30 days of the controlled substances being exported
from the first country to the second country and for each subsequent
reexport among members of the European Economic Area. The DEA
considered but ultimately did not choose to propose that such
applications would be made electronically on the DEA Form 161R based on
the fact that there are different
[[Page 63603]]
application requirements for the two types of transactions required by
the CSA. Most important of these distinctions for tracking purposes are
that reexports among members of the European Economic Area do not have
a time period for which such transactions will ``close'' (i.e., all
return information submitted). While under current Sec. 1312.22(d)(7)
(proposed Sec. 1312.22(h)(6)), other reexports must be completed no
later than 180 days after release by a customs officer at the port of
export from the United States, the 2015 Act specifies that controlled
substances may continue to be reexported among members of the European
Economic Area indefinitely, so long as the statutory conditions are
met. As noted, the DEA Form 161R-EEA, and associated return
information, would be required to be accessed, completed, and submitted
to the DEA through the DEA Office of Diversion Control secure network
application.
The DEA estimates that there will be 125 respondents to this
information collection. The DEA estimates that the frequency of
response will vary as DEA Form 161 is required to be completed by each
respondent per each occurrence. The DEA estimates there will be a total
of 5,386 responses. The DEA estimates, based on data from an already
approved collection containing return information, that it will take 5
minutes (online) to provide return information electronically and that
the total annual burden will be 449 hours. The DEA estimates that the
frequency of response will vary as DEA Form 161R and DEA Form 161R-EEA
are required to be completed by each respondent per each occurrence.
The DEA estimates there will be a combined total of 789 responses for
DEA Form 161R and DEA Form 161R-EEA. Since the distinction between DEA
Form 161R and DEA Form 161R-EEA does not currently exist, the DEA does
not have an estimated number of responses for the two forms separately.
Actual responses will be used for future information collection
requests. Since return information is currently required for
reexportations, the proposed rule does not create a new information
collection burden for reexportations.
2. Title: Controlled Substances Import/Export Declaration--DEA Form 236
OMB Control Number: 1117-0009.
Form Number: DEA Form 236.
As part of the implementation of the ITDS, the DEA is proposing
mandatory electronic filing of return information for any person who
desires to import non-narcotic substances in schedules III, IV, and V
or to export non-narcotic substances in schedules III and IV and any
other substance in schedule V.
The DEA is proposing amendments to Sec. 1312.18(e) in the proposed
rule to provide clear instructions on the process of return information
for controlled substances imported under declaration procedures, which
will be submitted electronically as part of the DEA Form 236 (Import
declaration). The amended regulation would state that within 30
calendar days after actual receipt of a controlled substance at the
importer's registered location, or within 10 calendar days after the
receipt of a written request by the Administration to the importer,
whichever is sooner, the importer must report to the Administration
utilizing the secure network application available on the DEA Office of
Diversion Control Web site certifying that such import occurred and the
details of the transaction.
The DEA is proposing to amend Sec. 1312.27(d) in the proposed rule
to provide clear instructions on the process of return information for
controlled substances exported and reexported under declaration
procedures, which will be submitted electronically as part of the DEA
Form 236 (Export declaration). The amended regulation would state that
within 30 calendar days after the controlled substance is released by a
customs officer at the port of export or within 10 calendar days after
receipt of a written request by the Administration to the exporter,
whichever is sooner, the exporter must report to the Administration
through the DEA Office of Diversion Control secure network application
(available on the DEA Office of Diversion Control Web site) certifying
that such export has occurred and the details of the transaction. For
reexports under declaration procedures, the amended regulation states
that within 30 calendar days after the controlled substance is exported
from the first country to the second country, or within 10 calendar
days after the receipt of a written request by the Administration to
the exporter, whichever is sooner, the exporter must report to the
Administration through the DEA Office of Diversion Control secure
network application (available on the DEA Office of Diversion Control
Web site) certifying that such export from the first country has
occurred and the details of the transaction.
The DEA estimates that there will be 341 respondents to this
information collection. The DEA estimates that the frequency of
response will vary as DEA Form 236 is required to be completed by each
respondent per each occurrence. The DEA estimates there will be a total
of 6,026 responses. The DEA estimates, based on data from an already
approved collection containing return information, that it will take 5
minutes (online) to provide return information electronically and that
the total annual burden will be 502 hours.
3. Title: Application for Permit To Import Controlled Substances for
Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952
OMB Control Number: 1117-0013.
Form Number: DEA Form 357.
As part of the implementation of the ITDS, the DEA is proposing
mandatory electronic filing of return information for any person who
desires to import any controlled substance listed in schedule I or II
or any narcotic controlled substance listed in schedule III, IV, or V
or any non-narcotic controlled substance in schedule III which the
Administrator has specifically designed by regulation in 21 CFR 1312.30
or any non-narcotic controlled substance in schedule IV or V which is
also listed in schedule I or II of the Convention on Psychotropic
Substances.
The DEA is proposing amendments to current Sec. 1312.12(c) in the
proposed rule to provide clear instructions on the process of return
information for controlled substances imported under permit procedures,
which will be submitted electronically as part of the DEA Form 357.
Specifically, the DEA is proposing to require in proposed Sec.
1312.12(d) that within 30 calendar days of actual receipt of a
controlled substance at the importer's registered location, or within
10 calendar days after receipt of a written request by the
Administration, whichever is sooner, the importer must report to the
Administration through the DEA Office of Diversion Control secure
network application (available on the DEA Office of Diversion Control
Web site) that such import occurred and the details of the transaction.
The DEA estimates that there will be 148 respondents to this
information collection. The DEA estimates that the frequency of
response will vary as DEA Form 357 is required to be completed by each
respondent per each occurrence. The DEA estimates there will be a total
of 1,024 responses. The DEA estimates, based on data from an already
approved collection containing return information, that it will take 5
minutes (online) to provide return information electronically and that
the total annual burden will be 85 hours.
[[Page 63604]]
4. Title: Reports of Loss or Disappearance of Listed Chemicals--DEA
Form 107, and Regulated Transactions in Tableting/Encapsulating
Machines--DEA Form 452
OMB Control Number: 1117-0024.
Form Number: DEA Form 107 and DEA Form 452.
As part of the implementation of the ITDS, the DEA is proposing to
establish a new DEA Form 452 to be used by regulated persons involved
in regulated transactions in tableting or encapsulating machines. The
DEA would standardize the current report required in the current Sec.
1310.05(a)(4) for domestic regulated transactions in a tableting or
encapsulating machine as well as the report required in the current
Sec. 1310.05(c) for import and export of tableting and encapsulating
machines. DEA Form 452 would be required to be accessed, completed, and
submitted to the DEA through the DEA Office of Diversion Control secure
network application.
Moreover, under both the current and revised regulation, each
regulated person must orally report any domestic regulated transaction
in a tableting machine or an encapsulating machine to the Special Agent
in Charge of the DEA Divisional Office for the area in which the
regulated person making the report is located, although the DEA now
proposes to clarify that the report must be made when the order is
placed with the seller. The regulated person must subsequently file a
written report of the domestic regulated transaction (on DEA Form 452)
with the Administration through the DEA Office of Diversion Control
secure network application within 15 calendar days after the order has
been shipped by the seller. A report (on DEA Form 452) may contain
multiple line entries for more than one transaction.
Additionally, the DEA is proposing mandatory filing of return
information for the import and export of tableting and encapsulating
machines which will be electronically submitted as part of the DEA Form
452. The amended regulation states that within 30 calendar days of the
the shipment being released by a customs officer at the port of entry
or port of export, or within 10 calendar days after the receipt of a
written request by the Administration to the importer/exporter,
whichever is sooner, the importer/exporter must report to the
Administration through the DEA Office of Diversion Control secure
network application (available on the DEA Office of Diversion Control
Web site) certifying that such import/export occurred and the details
of the transaction. Previously, Sec. 1310.05(c) instructed that
regulated persons needed to provide notification of the import or
export of a tableting machine or encapsulating machine on or before the
date of exportation. However, the DEA has amended Sec. 1310.05(c) in
order for DEA Form 452 to be submitted to the DEA at least 15 calendar
days before the date of release by a customs officer at the port of
entry or port of export in order to allow time for the DEA to review
the information and transmit it into the ITDS prior to the actual
import or export. 21 CFR 1310.05(c).
As part of the implementation of the ITDS, the DEA is proposing to
establish a new DEA Form 107 to be used by regulated persons involved
in reporting unusual or excessive loss or disappearance of a listed
chemical. The DEA would standardize the current report required to be
filed in the current Sec. 1310.05(a)(3). Each regulated person must
report to the Special Agent in Charge of the DEA Divisional Office for
the area in which the regulated person making the report is located any
unusual or excessive loss or disappearance of a listed chemical under
the control of the regulated person. The regulated person will orally
report to the Special Agent in Charge of the DEA Divisional Office at
the earliest practicable opportunity after the regulated person becomes
aware of the circumstances involved. The regulated person must also
file a complete and accurate DEA Form 107 with the Administration
through the DEA Office of Diversion Control secure network application
within 15 calendar days after becoming aware of the circumstances
requiring the report. Unusual or excessive losses or disappearances
must be reported whether or not the listed chemical is subsequently
recovered or the responsible parties are identified and action taken
against them. DEA Form 107 would be required to be accessed, completed,
and submitted to the DEA through the DEA Office of Diversion Control
secure network application. While the report would be electronic, the
filing requirements are essentially unchanged. The DEA estimates that
the reporting burden would continue to be 20 minutes for each report.
Specifically, based on publicly available information and
historical data, the DEA estimates that there will be 130 respondents
to this information collection, 60 for domestic transactions and 70 for
imports or exports. The DEA estimates that the frequency of response
will vary as DEA Form 452 is required to be completed by each
respondent per each occurrence. As the DEA does not have a strong basis
to estimate the number of responses for domestic transactions, the DEA
makes an initial estimate (to be refined later) of 52 responses per
week for each of 60 respondents, or a total of 3,120 domestic
transaction related responses. Based on historical data, the DEA
estimates there will be 917 import or export related responses for a
grand total of 4,037 responses for domestic transactions, imports, and
exports. Because of the information required on the DEA Form 452, the
DEA estimates that this form will take 20 minutes to complete,
including the oral report for domestic transactions and return
information for imports and exports, and that the total annual burden
will be 1,346 hours.
5. Title: Report of Mail Order Transactions--DEA Form 453
OMB Control Number: 1117-0033.
Form Number: DEA Form 453.
As part of the implementation of the ITDS, the DEA is proposing to
establish a new DEA Form 453, ``Report of Mail Order Transactions,'' to
be used by regulated persons required to file monthly reports of
transactions with nonregulated persons with ephedrine, pseudoephedrine,
phenylpropanolamine, or gamma-hydroxybutyric acid (including drug
products containing these chemicals or controlled substance) and use or
attempt to use the U.S. Postal Service or a private or commercial
carrier as well as regulated persons required to file monthly reports
of export transactions with ephedrine, pseudoephedrine,
phenylpropanolamine, or gamma-hydroxybutyric acid (including drug
products containing these chemicals or controlled substance) and use or
attempt to use the U.S. Postal Service or a private or commercial
carrier. The DEA would require reports under the current Sec. Sec.
1310.03(c) and 1310.06(i) to be submitted on a new DEA Form 453 which
would be required to be accessed and submitted to the DEA through the
DEA Office of Diversion Control secure network application.
Additionally, the form would require the following information: The
mail order transaction supplier name and registration number; the
purchaser's name and address; the name and address shipped to (if
different from purchaser's name and address); the name of the chemical
contained in the scheduled listed chemical product and total quantity
shipped (e.g., pseudoephedrine, 3 grams); the date of shipment; the
product name; the dosage form (e.g., tablet, liquid, powder); the
dosage strength; the number of dosage unites; the package type; the
number of
[[Page 63605]]
packages; and the lot number. Previously, Sec. 1310.05(e) instructed
that regulated persons submit a written report, containing the
information listed above, on or before the 15th day of each month
following the month in which the distributions took place. However, the
DEA proposes to amend part 1310 in order for DEA Form 453 to be
submitted to the DEA electronically on or before the 15th day of each
month following the month in which the distributions took place.
Specifically, based on historical data, the DEA estimates that
there will be 7 respondents to this information collection. The
respondents will provide 12 responses per year. The DEA estimates there
will be a total of 84 responses per year. The DEA estimates that this
form will take 15 minutes to complete and that the total annual burden
will be 21 hours.
B. Request for Comments Regarding the Proposed Information Collections
Under the PRA, the DEA is required to provide a notice regarding
the proposed collections of information in the Federal Register with
the notice of proposed rulemaking and solicit public comment. Section
3506(c)(2)(A) and (B) of the PRA (44 U.S.C. 3506(c)(2)(A) and (B))
requires that the DEA solicit comment on the following issues:
[ssquf] The need for the information collection and its usefulness
in carrying out the proper functions of the DEA.
[ssquf] The accuracy of the DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
[ssquf] The quality, utility, and clarity of the information to be
collected.
[ssquf] Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Written comments and suggestions from the public and affected
agencies concerning the proposed collections of information are
encouraged. Please send written comments to the Office of Information
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ,
Washington, DC 20503. Please state that your comments refer to RIN
1117-AB41/Docket No. DEA-403.
All comments must be submitted to OMB on or before October 17,
2016. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Security measures.
21 CFR Part 1302
Drug traffic control, Exports, Imports, Labeling, Packaging and
containers.
21 CFR Part 1303
Administrative practice and procedure, Drug traffic control.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control,
Exports, Imports.
21 CFR Part 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
21 CFR Part 1312
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1313
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1314
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1315
Administrative practice and procedure, Chemicals, Drug traffic
control, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1316
Administrative practice and procedure, Authority delegations
(Government agencies), Drug traffic control, Research, Seizures and
forfeitures.
21 CFR Part 1321
Administrative practice and procedure.
For the reasons stated in the preamble, the DEA proposes to amend
21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312,
1313, 1314, 1315, 1316, and 1321 as follows:
PART 1300--DEFINITIONS
0
1. The authority citation for part 1300 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
0
2. In Sec. 1300.01(b):
0
a. Add definitions for ``Competent national authority'' and ``Customs
officer'' in alphabetical order;
0
b. Revise the definitions of ``Export'' and ``Import'';
0
c. Remove the definition of ``Jurisdiction of the United States'';
0
d. Add definitions for ``Port of entry'', ``Port of export'', ``Return
information'', ``Shipment'', ``Split shipment'', and ``United States''
in alphabetical order.
The additions and revisions read as follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
Competent national authority, for purposes of importation and
exportation of controlled substances and listed chemicals, means an
entity lawfully entitled to authorize the import and export of
controlled substances, and to regulate or enforce national controls
over listed chemicals, and included as such in the directory of
``Competent National Authorities Under the International Drug Control
Treaties'' published by the United Nations Office on Drugs and Crime.
For purposes of exports of narcotic drugs, the term also includes
freely associated states authorized to receive such exports pursuant to
48 U.S.C. 1972.
* * * * *
Customs officer means either an Officer of the Customs as defined
in 19 U.S.C. 1401(h), or any individual duly authorized to accept
entries of merchandise, to collect duties, and to enforce the customs
laws of any commonwealth, territory, or possession of the United
States.
* * * * *
Export means, with respect to any article, any taking out or
removal of such article from the United States (whether or not such
taking out or removal constitutes an exportation within the meaning of
the customs laws, export control laws enforced by other agencies, or
related laws of the United States).
* * * * *
Import means, with respect to any article, any bringing in or
introduction of such article into the customs territory of the United
States from any place outside thereof (but within the United States),
or into the United States from any place outside thereof (whether or
[[Page 63606]]
not such bringing in or introduction constitutes an importation within
the meaning of the tariff laws of the United States).
* * * * *
Port of entry means, unless distinguished as being a foreign port
of entry, any place at which a customs officer is duly authorized to
accept entries of merchandise, to collect duties, and to enforce the
various provisions of the customs laws of the United States (whether or
not such place is a port of entry as defined in title 19 of the United
States Code or its associated implementing regulations). Examples of
ports of entry include, but are not limited to, places designated as
ports of entry or customs stations in title 19 of the Code of Federal
Regulations or by the governing customs authority of that area. When
shipments are transported under U.S. Customs and Border Protection
immediate transportation procedures, the port of entry shall be the
port of final destination.
Port of export means, unless distinguished as being a foreign port
of export, any place under the control of a customs officer where goods
are loaded on an aircraft, vessel or other conveyance for export
outside of the United States. For goods loaded aboard an aircraft or
vessel in the United States, that stops at several ports before
departing the United States, the port of export is the first port where
the goods were actually loaded. For goods off-loaded from the original
conveyance to another conveyance (even if the aircraft or vessel
belongs to the same carrier) at any port subsequent to the port where
the first on-loading occurred in the United States, the port where the
goods were loaded onto the last conveyance before departing the United
States is the port of export.
* * * * *
Return information means supplemental information required to be
reported to the Administration following an import or export
transaction containing the particulars of the transaction and any other
information as the Administration may specify.
* * * * *
Shipment means a quantity of goods or merchandise imported or
exported at one place, at one time, for delivery to one consignee, on a
single conveyance, at one place, on one bill of lading, air waybill, or
other commercial loading document.
Split shipment means a single import or export that is divided onto
two or more conveyances.
* * * * *
United States, when used in a geographic sense, means all places
and waters, continental or insular, subject to the jurisdiction of the
United States, which, in addition to the customs territory of the
United States, include but are not limited to the U.S. Virgin Islands,
Guam, American Samoa, and the Northern Mariana Islands.
* * * * *
0
3. In Sec. 1300.02(b):
0
a. Remove the definition of ``Chemical import'';
0
b. Add definitions for ``Competent national authority'', ``Customs
officer'', ``Export'', and ``Import'' in alphabetical order;
0
c. Remove the definition of ``Jurisdiction of the United States''; and
0
d. Add definitions for ``Port of entry'', ``Port of export'', ``Return
information'', ``Shipment'', ``Split shipment'', and ``United States''
in alphabetical order.
The additions and revisions read as follows:
Sec. 1300.02 Definitions relating to listed chemicals.
* * * * *
Competent national authority, for purposes of importation and
exportation of controlled substances and listed chemicals, means an
entity lawfully entitled to authorize the import and export of
controlled substances, and to regulate or enforce national controls
over listed chemicals, and included as such in the directory of
``Competent National Authorities Under the International Drug Control
Treaties'' published by the United Nations Office on Drugs and Crime.
Customs officer means either an Officer of the Customs as defined
in 19 U.S.C. 1401(h), or any individual duly authorized to accept
entries of merchandise, to collect duties, and to enforce the customs
laws of any commonwealth, territory, or possession of the United
States.
* * * * *
Export means, with respect to any article, any taking out or
removal of such article from the United States (whether or not such
taking out or removal constitutes an exportation within the meaning of
the customs laws, export control laws enforced by other agencies, or
related laws of the United States).
* * * * *
Import means, with respect to any article, any bringing in or
introduction of such article into the customs territory of the United
States from any place outside thereof (but within the United States),
or into the United States from any place outside thereof (whether or
not such bringing in or introduction constitutes an importation within
the meaning of the tariff laws of the United States).
* * * * *
Port of entry, unless distinguished as being a foreign port of
entry, means any place at which a customs officer is duly authorized to
accept entries of merchandise, to collect duties, and to enforce the
various provisions of the customs laws of the United States (whether or
not such place is a port of entry as defined in title 19 of the United
States Code or its associated implementing regulations). Examples of
ports of entry include, but are not limited to, places designated as
ports of entry or customs stations in title 19 of the Code of Federal
Regulations or by the governing customs authority of that area. When
shipments are transported under U.S. Customs and Border Protection
immediate transportation procedures, the port of entry shall be the
port of final destination.
Port of export means, unless distinguished as being a foreign port
of export, any place under the control of a customs officer where goods
are loaded on an aircraft, vessel or other conveyance for export
outside of the United States. For goods loaded aboard an aircraft or
vessel in the United States that stops at several ports before
departing the United States, the port of export is the first port where
the goods were loaded. For goods off-loaded from the original
conveyance to another conveyance (even if the aircraft or vessel
belongs to the same carrier) at any port subsequent to the port where
the first on-loading occurred in the United States, the port where the
goods were loaded onto the last conveyance before departing the United
States is the port of export. For reporting purposes, in the case of an
otherwise lawful export occurring by mail, the port of export is the
place of mailing.
* * * * *
Return information means supplemental information required to be
reported to the Administration following an import or export
transaction containing the particulars of the transaction and any other
information as the Administration may specify.
* * * * *
Shipment means a quantity of goods or merchandise imported or
exported at one place, at one time, for delivery to one consignee, on a
single conveyance, at one place, on one bill of lading, air waybill, or
other commercial loading document.
[[Page 63607]]
Split shipment means a single import or export that is divided onto
two or more conveyances.
* * * * *
United States, when used in a geographic sense, means all places
and waters, continental or insular, subject to the jurisdiction of the
United States, which, in addition to the customs territory of the
United States, include but are not limited to the U.S. Virgin Islands,
Guam, American Samoa, and the Northern Mariana Islands.
* * * * *
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
4. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 953, 956, 957, 958, 965.
0
5. Revise Sec. 1301.12(b)(3) to read as follows:
Sec. 1301.12 Separate registrations for separate locations.
* * * * *
(b) * * *
(3) An office used by a practitioner (who is registered at another
location in the same State in which he or she practices) where
controlled substances are prescribed but neither administered nor
otherwise dispensed as a regular part of the professional practice of
the practitioner at such office, and where no supplies of controlled
substances are maintained.
* * * * *
0
6. Revise Sec. 1301.24(a)(1) to read as follows:
Sec. 1301.24 Exemption of law enforcement officials.
(a) * * *
(1) Any officer or employee of the Administration, any customs
officer, any officer or employee of the U.S. Food and Drug
Administration, and any other Federal or Insular officer who is
lawfully engaged in the enforcement of any Federal law relating to
controlled substances, drugs, or customs, and is duly authorized to
possess or to import or export controlled substances in the course of
his/her official duties; and
* * * * *
0
7. Revise Sec. 1301.26(b) introductory text to read as follows:
Sec. 1301.26 Exemption from import or export requirements for
personal medical use.
* * * * *
(b) The individual makes a declaration to an appropriate customs
officer stating:
* * * * *
0
8. Revise Sec. 1301.34(c)(2) to read as follows:
Sec. 1301.34 Application for importation of Schedule I and II
substances.
* * * * *
(c) * * *
(2) Employment of security procedures to guard against in-transit
losses.
* * * * *
0
9. Revise Sec. 1301.74(c) introductory text to read as follows:
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
* * * * *
(c) The registrant must notify the Field Division Office of the
Administration in his or her area, in writing, of any theft or
significant loss of any controlled substances within one business day
of discovery of the theft or loss. Unless the theft or loss occurs
during an import or export transaction, the supplier is responsible for
reporting all in-transit losses of controlled substances by their agent
or the common or contract carrier selected pursuant to paragraph (e) of
this section, within one business day of discovery of such theft or
loss. In an import transaction, once a shipment has been released by
the customs officer at the port of entry, the importer is responsible
for reporting all in-transit losses of controlled substances by their
agent or the common or contract carrier selected pursuant to paragraph
(e) of this section, within one business day of discovery of such theft
or loss. In an export transaction, the exporter is responsible for
reporting all in-transit losses of controlled substances by their agent
or the common or contract carrier selected pursuant to paragraph (e) of
this section within one business day of discovery of such theft or
loss, until the shipment has been released by the customs officer at
the port of export. The registrant must also complete, and submit to
the Field Division Office in his or her area, DEA Form 106 regarding
the theft or loss. Thefts and significant losses must be reported
whether or not the controlled substances are subsequently recovered or
the responsible parties are identified and action taken against them.
When determining whether a loss is significant, a registrant should
consider, among others, the following factors:
* * * * *
PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED
SUBSTANCES
0
10. The authority citation for part 1302 continues to read as follows:
Authority: 21 U.S.C. 821, 825, 871(b), 958(e).
0
11. Revise Sec. 1302.07 to read as follows:
Sec. 1302.07 Labeling and packaging requirements for imported and
exported substances.
(a) The symbol requirements of Sec. Sec. 1302.03 through 1302.05
apply to every commercial container containing, and to all labeling of,
controlled substances imported into the customs territory of the United
States from any place outside thereof (but within the United States),
or imported into the United States from any place outside thereof.
These sealing and labeling requirements are in addition to any sealing
requirements required under applicable customs laws.
(b) The symbol requirements of Sec. Sec. 1302.03 through 1302.05
do not apply to any commercial containers containing, or any labeling
of, a controlled substance intended for export.
(c) The sealing requirements of Sec. 1302.06 apply to every
bottle, multiple dose vial, or other commercial container of any
controlled substance listed in schedule I or II, or any narcotic
controlled substance listed in schedule III or IV imported into the
customs territory of the United States from any place outside thereof
(but within the United States), or imported into the United States from
any place outside thereof. The sealing requirements of Sec. 1302.06
apply to every bottle, multiple dose vial, or other commercial
container of any controlled substance listed in schedule I or II, or
any narcotic controlled substance listed in schedule III or IV,
exported or intended for export from the United States.
PART 1303--QUOTAS
0
12. The authority citation for part 1303 continues to read as follows:
Authority: 21 U.S.C. 821, 826, 871(b).
Sec. 1303.12 [Amended]
0
13. Amend Sec. 1303.12 as follows:
0
a. In paragraph (b) by removing ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' from the last sentence and adding in
its place ``UN Reporting and Quota Section, Office of Diversion
Control''; and
0
b. In paragraph (d) by removing ``Drug & Chemical Evaluation Section,
Drug
[[Page 63608]]
Enforcement Administration'' from the second sentence and adding in its
place ``UN Reporting and Quota Section, Office of Diversion Control''.
Sec. 1303.22 [Amended]
0
14. In the introductory text to 1303.22, remove ``Drug & Chemical
Evaluation Section, Drug Enforcement Administration'' and add in its
place ``UN Reporting and Quota Section, Office of Diversion Control''.
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
15. The authority citation for part 1304 continues to read as follows:
Authority: 21 U.S.C. 821, 827, 831, 871(b), 958 (e)-(g), and
965, unless otherwise noted.
0
16. Revise Sec. 1304.02 to read as follows:
Sec. 1304.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or Sec. 1300.01, Sec.
1300.03, Sec. 1300.04, or Sec. 1300.05 of this chapter.
0
17. Revise Sec. 1304.21(d) to read as follows:
Sec. 1304.21 General requirements for continuing records.
* * * * *
(d) In recording dates of receipt, distribution, other transfers,
or destruction, the date on which the controlled substances are
actually received, distributed, otherwise transferred, or destroyed
will be used as the date of receipt, distribution, transfer, or
destruction (e.g., invoices or packing slips, or DEA Form 41). In
maintaining records concerning imports and exports, the registrant must
record the date on which the controlled substances are released by a
customs officer at the port of entry or port of export.
* * * * *
Sec. 1304.31 [Amended]
0
18. In Sec. 1304.31(a), remove ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' from the second sentence and add in
its place ``UN Reporting and Quota Section, Office of Diversion
Control''.
Sec. 1304.32 [Amended]
0
19. In Sec. 1304.32(a), remove ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' from the second sentence and add in
its place ``UN Reporting and Quota Section, Office of Diversion
Control''.
0
20. Revise Sec. 1304.33(a) and (f)(1) to read as follows:
Sec. 1304.33 Reports to Automation of Reports and Consolidated Orders
System (ARCOS).
(a) Reports generally. All reports required by this section shall
be filed with the Pharmaceutical Investigations Section, Office of
Diversion Control, Drug Enforcement Administration on DEA Form 333, or
on media which contains the data required by DEA Form 333 and which is
acceptable to the Administration. See the Table of DEA Mailing
Addresses in Sec. 1321.01 of this chapter for the current mailing
address.
* * * * *
(f) * * *
(1) A registered institutional practitioner that repackages or
relabels exclusively for distribution or that distributes exclusively
to (for dispensing by) agents, employees, or affiliated institutional
practitioners of the registrant may be exempted from filing reports
under this section by applying to the Pharmaceutical Investigations
Section, Office of Diversion Control, Drug Enforcement Administration.
See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter
for the current mailing address.
* * * * *
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
21. The authority citation for part 1308 is revised to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
22. Revise Sec. 1308.01 to read as follows:
Sec. 1308.01 Scope of part 1308.
Schedules of controlled substances established by section 202 of
the Act (21 U.S.C. 812) and nonnarcotic substances, chemical
preparations, veterinary anabolic steroid implant products,
prescription products, anabolic steroid products, and cannabis plant
material and products made therefrom that contain tetrahydrocannabinols
excluded pursuant to section 201 of the Act (21 U.S.C. 811), as they
are changed, updated, and republished from time to time, are set forth
in this part.
Sec. 1308.21 [Amended]
0
23. In Sec. 1308.21(a), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
Sec. 1308.23 [Amended]
0
24. In Sec. 1308.23(b), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
Sec. 1308.25 [Amended]
0
25. In Sec. 1308.25(a), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
Sec. 1308.31 [Amended]
0
26. In Sec. 1308.31(a), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
Sec. 1308.33 [Amended]
0
27. In Sec. 1308.33(b), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
0
28. Revise Sec. 1308.49 to read as follows:
Sec. 1308.49 Temporary scheduling.
(a) Pursuant to 21 U.S.C. 811(h) and without regard to the
requirements of 21 U.S.C. 811(b) relating to the scientific and medical
evaluation of the Secretary of Health and Human Services, the Drug
Enforcement Administration may place a substance into Schedule I on a
temporary basis, if it determines that such action is necessary to
avoid an imminent hazard to the public safety. An order issued under
this section may not be effective before the expiration of 30 calendar
days from:
(1) The date of publication by the Administration of a notice in
the Federal Register of its intention to issue such order and the
grounds upon which such order is to be issued, and
(2) The date the Administration has transmitted notification to the
Secretary of Health and Human Services of the Administration's
intention to issue such order.
(b) An order issued under this section will be vacated upon the
conclusion of a subsequent rulemaking proceeding initiated under
section 201(a) (21 U.S.C. 811(a)) with respect to such substance or at
the end of two years from the effective date of the order scheduling
the substance, except that during the pendency of proceedings under
section 201(a) (21 U.S.C. 811(a)) with respect to the substance, the
Administration may extend the temporary scheduling for up to one year.
[[Page 63609]]
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS
AND EXPORTERS OF LIST I CHEMICALS
0
29. The authority citation for part 1309 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875,
877, 886a, 952, 953, 957, 958.
0
30. Revise Sec. 1309.26(a)(1) to read as follows:
Sec. 1309.26 Exemption of law enforcement officials.
(a) * * *
(1) Any officer or employee of the Administration, any customs
officer, any officer or employee of the U.S. Food and Drug
Administration, and any Federal or Insular officer who is lawfully
engaged in the enforcement of any federal law relating to listed
chemicals, controlled substances, drugs, or customs, and is duly
authorized to possess and distribute List I chemicals in the course of
his/her official duties; and
* * * * *
0
31. Revise Sec. 1309.32(d) to read as follows:
Sec. 1309.32 Application forms; contents; signature.
* * * * *
(d) Each application for registration must include the
Administration Chemical Code Number, as set forth in Sec. 1310.02 of
this chapter, for each List I chemical to be manufactured, distributed,
imported, or exported.
* * * * *
Sec. 1309.46 [Amended]
0
32. In Sec. 1309.46(d), remove ``Sec. 1309.54'' and add in its place
``Sec. 1309.53''.
Sec. 1309.51 [Amended]
0
33. In Sec. 1309.51(a), remove ``1309.57'' and add in its place
``1309.55''.
0
34. Revise Sec. 1309.71(b)(5) and (7) to read as follows:
Sec. 1309.71 General security requirements.
* * * * *
(b) * * *
(5) The extent of unsupervised public access to the facility;
* * * * *
(7) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel in areas where
List I chemicals are processed or stored; and
* * * * *
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
35. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
36. Revise the heading of part 1310 to read as set forth above.
0
37. Amend Sec. 1310.03 as follows:
0
a. In paragraph (b) by removing ``Section 1310.05'' and adding in its
place ``Sec. 1310.05''; and
0
b. Revising paragraph (c) to read as follows:
Sec. 1310.03 Persons required to keep records and file reports.
* * * * *
(c) Each regulated person who engages in a transaction with a
nonregulated person which involves ephedrine, pseudoephedrine,
phenylpropanolamine, or gamma hydroxybutyric acid (including drug
products containing these chemicals or controlled substance), and uses
or attempts to use the U.S. Postal Service or any private or commercial
carrier must, on a monthly basis, report to the Administration each
such transaction conducted during the previous month as specified in
Sec. Sec. 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA
Office of Diversion Control secure network application. Each regulated
person who engages in an export transaction which involves ephedrine,
pseudoephedrine, phenylpropanolamine, or gamma hydroxybutyric acid
(including drug products containing these chemicals or controlled
substance), and uses or attempts to use the U.S. Postal Service or any
private or commercial carrier must, on a monthly basis, report each
such transaction conducted during the previous month as specified in
Sec. Sec. 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA
Office of Diversion Control secure network application.
* * * * *
0
38. Revise Sec. 1310.05(a) through (e) to read as follows:
Sec. 1310.05 Reports.
(a)(1) Each regulated person must report to the Special Agent in
Charge of the DEA Divisional Office for the area in which the regulated
person making the report is located any regulated transaction involving
an extraordinary quantity of a listed chemical, an uncommon method of
payment or delivery, or any other circumstance that the regulated
person believes may indicate that the listed chemical will be used in
violation of this part. The regulated person will orally report to the
Special Agent in Charge of the DEA Divisional Office at the earliest
practicable opportunity after the regulated person becomes aware of the
circumstances involved and as much in advance of the conclusion of the
transaction as possible. The regulated person must file a written
report of the transaction(s) with the Special Agent in Charge of the
DEA Divisional Office as set forth in Sec. 1310.06 within 15 calendar
days after the regulated person becomes aware of the circumstances of
the event.
(2) Each regulated person must report to the Special Agent in
Charge of the DEA Divisional Office for the area in which the regulated
person making the report is located any proposed regulated transaction
with a person whose description or other identifying characteristic the
Administration has previously furnished to the regulated person. The
regulated person will orally report to the Special Agent in Charge of
the DEA Divisional Office at the earliest practicable opportunity after
the regulated person becomes aware of the circumstances involved. A
transaction may not be completed with a person whose description or
identifying characteristic has previously been furnished to the
regulated person by the Administration unless the transaction is
approved by the Administration.
(b)(1) Each regulated person must report to the Special Agent in
Charge of the DEA Divisional Office for the area in which the regulated
person making the report is located any unusual or excessive loss or
disappearance of a listed chemical under the control of the regulated
person. The regulated person will orally report to the Special Agent in
Charge of the DEA Divisional Office at the earliest practicable
opportunity after the regulated person becomes aware of the
circumstances involved. Unless the loss or disappearance occurs during
an import or export transaction, the supplier is responsible for
reporting all in-transit losses of any listed chemical by their agent
or the common or contract carrier. In an import transaction, once a
shipment has been released by the customs officer at the port of entry,
the importer is responsible for reporting all in-transit losses of any
listed chemical by their agent or the common or contract carrier. In an
export transaction, the exporter is responsible for reporting all in-
transit losses of any listed chemical by their agent or the common or
contract carrier until the shipment has been released by the customs
officer at the port of export.
[[Page 63610]]
The regulated person must also file a complete and accurate DEA Form
107, in accordance with Sec. 1310.06(d), with the Administration
through the DEA Office of Diversion Control secure network application
within 15 calendar days after becoming aware of the circumstances
requiring the report. Unusual or excessive losses or disappearances
must be reported whether or not the listed chemical is subsequently
recovered or the responsible parties are identified and action taken
against them. When determining whether a loss or disappearance of a
listed chemical was unusual or excessive, the regulated persons should
consider, among others, the following factors:
(i) The actual quantity of a listed chemical;
(ii) The specific listed chemical involved;
(iii) Whether the loss or disappearance of the listed chemical can
be associated with access to those listed chemicals by specific
individuals, or whether the loss or disappearance can be attributed to
unique activities that may take place involving the listed chemical;
(iv) A pattern of losses or disappearances over a specific time
period, whether the losses or disappearances appear to be random, and
the result of efforts taken to resolve the losses.
(v) If known, the regulated person should also consider whether the
specific listed chemical was a likely candidate for diversion as well
as local trends and other indicators of the diversion potential of the
listed chemical.
(2) Each regulated person must orally report any domestic regulated
transaction in a tableting machine or an encapsulating machine to the
Special Agent in Charge of the DEA Divisional Office for the area in
which the regulated person making the report is located when the order
is placed with the seller. The regulated person also must file a report
of the transaction (on DEA Form 452) with the Administration through
the DEA Office of Diversion Control secure network application within
15 calendar days after the order has been shipped by the seller. A
report (DEA Form 452) may list more than one machine for a single
transaction. Upon receipt and review, the Administration will assign a
completed report a transaction identification number. The report will
not be deemed filed until a transaction identification number has been
issued by the Administration.
(c) Imports and exports of tableting machines and encapsulating
machines. (1) Each regulated person who imports or exports a tableting
machine, or encapsulating machine, must file a report of such
importation or exportation on DEA Form 452 with the Administration
through the DEA Office of Diversion Control secure network application,
at least 15 calendar days before the anticipated arrival at the port of
entry or port of export. In order to facilitate the importation or
exportation of any tableting machine or encapsulating machine and
implement the purpose of the Act, regulated persons may report to the
Administration as far in advance as possible. A separate report (DEA
Form 452) must be filed for each shipment, in accordance with Sec.
1310.06(e). Upon receipt and review, the Administration will assign a
completed report a transaction identification number. The report will
not be deemed filed until a transaction identification number has been
issued by the Administration. The importer or exporter may only proceed
with the transaction once the transaction identification number has
been issued. Any tableting machine or encapsulating machine may be
imported or exported if that machine is needed for medical, commercial,
scientific, or other legitimate uses. However, an importation or
exportation of a tableting machine or encapsulating machine may not be
completed with a person whose description or identifying characteristic
has previously been furnished to the regulated person by the
Administration unless the transaction is approved by the
Administration.
(2) Denied release at the port of entry. In the event that a
shipment of tableting or encapsulating machine(s) has been denied
release by a customs officer at the port of entry for any reason, the
importer who attempted to import the shipment must, within 24 hours of
the denial, report to the Administration that the shipment was denied,
the basis for denial, and such other information as is required by
Sec. 1310.06(g). Such report must be transmitted to the Administration
through the DEA Office of Diversion Control secure network application.
Upon the importer's report of a denied entry, DEA will assign the
report a transaction identification number and the original import
notification will be void and of no effect. No shipment of tableting
machines or encapsulating machines denied entry for any reason will be
allowed entry without a subsequent refiling of an amended DEA Form 452
by the regulated person. In such circumstances, the regulated person
may proceed with the release of the tableting machines or encapsulating
machines upon receipt of a transaction identification number for the
refiled and amended DEA Form 452 without regard to the 15-day advance
filing requirement in paragraph (c)(1) of this section, so long as the
article is otherwise cleared for entry under U.S. customs laws.
(d) Each regulated bulk manufacturer of a listed chemical must
submit manufacturing, inventory and use data on an annual basis as set
forth in Sec. 1310.06(j). This data must be submitted annually to the
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, on or before the 15th day of March of the
year immediately following the calendar year for which submitted. See
the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for
the current mailing address. A business entity which manufactures a
listed chemical may elect to report separately by individual location
or report as an aggregate amount for the entire business entity
provided that they inform the DEA of which method they will use. This
reporting requirement does not apply to drugs or other products that
are exempted under paragraph (1)(iv) or (v) of the definition of
regulated transaction in Sec. 1300.02 of this chapter except as set
forth in Sec. 1310.06(i)(5). Bulk manufacturers that produce a listed
chemical solely for internal consumption are not required to report for
that listed chemical. For purposes of these reporting requirements,
internal consumption consists of any quantity of a listed chemical
otherwise not available for further resale or distribution. Internal
consumption includes (but is not limited to) quantities used for
quality control testing, quantities consumed in-house, or production
losses. Internal consumption does not include the quantities of a
listed chemical consumed in the production of exempted products. If an
existing standard industry report contains the information required in
Sec. 1310.06(j) and such information is separate or readily
retrievable from the report, that report may be submitted in
satisfaction of this requirement. Each report must be submitted to the
DEA under company letterhead and signed by an appropriate, responsible
official. For purposes of this paragraph only, the term regulated bulk
manufacturer of a listed chemical means a person who manufactures a
listed chemical by means of chemical synthesis or by extraction from
other substances. The term bulk manufacturer does not include persons
whose sole activity consists of the repackaging or
[[Page 63611]]
relabeling of listed chemical products or the manufacture of drug
dosage forms of products which contain a listed chemical.
(e) Each regulated person required to report pursuant to Sec.
1310.03(c) must file a report containing the transaction identification
number for each such transaction (if the regulated person is required
to obtain a transaction identification number under part 1313 of this
chapter) and information set forth in Sec. 1310.06(k), on or before
the 15th day of each month following the month in which the
distributions took place.
* * * * *
0
39. Revise Sec. 1310.06 to read as follows:
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03(a) must include the
following:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.), and,
if required, DEA registration number of each party to the regulated
transaction.
(2) The date of the regulated transaction.
(3) The quantity, chemical name, and, if applicable, National Drug
Code (NDC) number. If NDC number is not applicable, the form of
packaging of the listed chemical or a description of the tableting
machine or encapsulating machine (including make, model serial number,
if any, and whether the machine is manual or electric).
(4) The method of transfer (company truck, picked up by customer,
etc.).
(5) The type of identification used by the purchaser and any unique
number on that identification.
(b) For purposes of this section, normal business records will be
considered adequate if they contain the information listed in paragraph
(a) of this section and are readily retrievable from other business
records of the regulated person. For prescription drug products,
prescription and hospital records kept in the normal course of medical
treatment will be considered adequate for satisfying the requirements
of paragraph (a) of this section with respect to dispensing to
patients, and records required to be maintained pursuant to the U.S.
Food and Drug Administration regulations relating to the distribution
of prescription drugs, as set forth in 21 CFR part 205, will be
considered adequate for satisfying the requirements of paragraph (a) of
this section with respect to distributions.
(c)(1) Each report required by Sec. 1310.05(a) must include the
information as specified by Sec. 1310.06(a), the basis for making the
report, and, where obtainable, the registration number of the other
party, if such party is registered. A report of an uncommon method of
payment or delivery submitted in accordance with Sec. 1310.05(a)(1)
must also include a reason why the method of payment or delivery was
uncommon.
(2) A suggested format for the reports in Sec. 1310.05(a)(1) is
provided below:
Supplier:
Registration Number (if registered)------------------------------------
Name-------------------------------------------------------------------
Address----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Contact Information:---------------------------------------------------
Purchaser:
Registration Number (if registered)------------------------------------
Name-------------------------------------------------------------------
Address----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Contact Information----------------------------------------------------
Identification---------------------------------------------------------
Shipping Address (if different than purchaser Address):
Street-----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Date of Shipment-------------------------------------------------------
Description of Listed Chemical:
Chemical Name----------------------------------------------------------
Quantity---------------------------------------------------------------
National Drug Code (NDC) Number(s), or Form(s) of Packaging------------
Other:
The basis (i.e., reason) for making the report:------------------------
Any additional pertinent
information:-----------------------------------------------------------
(d) Each report of an unusual or excessive loss or disappearance of
a listed chemical required by Sec. 1310.05(b)(1) (on DEA Form 107),
must include the following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.), and,
if applicable, DEA registration number of each party to the regulated
transaction.
(2) The date (or estimated date) on which unusual or excessive loss
or disappearance occurred, and the actual date on which the unusual or
excessive loss or disappearance was discovered by the regulated person.
(3) The quantity, chemical name, and National Drug Code (NDC)
number, if applicable or if not the form of packaging of the listed
chemical.
(4) The type of business conducted by the regulated person, (e.g.,
grocery store, pharmacy/drug store, discount department store,
warehouse club or superstore, convenience store, specialty food store,
gas station, mobile retail vendor, mail-order, etc.) if the regulated
person is not a DEA registrant.
(e)(1) Each report of an importation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452)
must include the following information:
(i) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.) of the import broker or forwarding agent, if any;
(ii) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received;
(iii) The anticipated date of arrival at the port of entry, and the
anticipated port of entry; and
(iv) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignor in the foreign country of exportation.
(v) The intended medical, commercial, scientific, or other
legitimate use of the machine.
(vi) Any proposed changes in identifying information of the
imported machines (e.g., name, brand, serial number, if any, etc.) that
will take place after importation.
(2) Each report of an exportation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452)
must include the following information:
(i) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.) of the export broker (if applicable):
(ii) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received;
(iii) The anticipated date of arrival at the port of export, the
foreign port and country of entry; and
(iv) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignee in the country where the shipment is destined; the name(s)/
business name(s)
[[Page 63612]]
and address(es)/business address(es), and contact information (e.g.,
telephone number(s), email address(es), etc.) of the intermediate
consignee(s) (if any).
(f) Each report of a domestic regulated transaction in a tableting
machine or encapsulating machine required by Sec. 1310.05(b)(2) (on
DEA Form 452) must include the following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.) of the purchaser;
(2) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received;
(3) Any changes made by the regulated person in identifying
information of the machines (e.g., name, brand, serial number, etc.).
(g) Each report of a denied release by a customs officer at the
port of entry of a tableting machine or an encapsulating machine
required by Sec. 1310.05(c)(2) must include the following information:
The quantity of machines denied release; a concise description of the
machines denied relese; the date on which release was denied; the port
where the denial of release was issued from; and the basis for the
denial.
(h) Return information. (1) Within 30 calendar days after actual
receipt of a tableting or encapsulating machine, or within 10 calendar
days after receipt of a written request by the Administration to the
importer, whichever is sooner, the importer must file a report with the
Administration (on DEA Form 452) specifying the particulars of the
transaction utilizing the DEA Office of Diversion Control secure
network application. This report must include the following
information: The date on which a customs officer at the port of entry
released the machine(s)); the date on which the machine(s) arrived at
the final destination; the port of entry where the machine(s) were
actually released by a customs officer; the actual quantity of machines
released by a customs officer; the actual quantity of machines that
arrived at the final destination; a description of each tableting or
encapsulating machine imported (including make, model, and serial
number, if any); any changes in identifying information of the imported
machines (e.g., name, brand, serial number, if any, etc.) that will
take place after importation; and any other information as the
Administration may from time to time specify. Upon receipt and review,
the Administration will assign a transaction identification number to a
completed report. The report will not be deemed filed until the
Administration has issued a transaction identification number. A single
return declaration may include the particulars of both the importation
and distribution. For DEA reporting purposes, import responsibilities
are concluded upon the receipt of the machines by the importer. Once
machines are received by the importer, domestic transaction reporting
requirements commence. Distributions of tableting and encapsulating
machines from the importer to their customers must be reported as
domestic regulated transactions in accordance with Sec. 1310.05(b)(2).
(2) Within 30 calendar days after the tableting or encapsulating
machine is released by a customs officer at the port of export, or
within 10 calendar days after receipt of a written request by the
Administration to the exporter, whichever is sooner, the exporter must
file a report with the Administration (on DEA Form 452) through the DEA
Office of Diversion Control secure network application specifying the
particulars of the transaction. This report must include the following
information: The date on which the the machine(s) was(were) released by
a customs officer at the port of export; the actual quantity of
machines released; a description of each tableting or encapsulating
machine released (including make, model, serial number, if any, and
whether the machine is manual or electric); and any other information
as the Administration may from time to time specify.
(i) Declared exports of machines which are refused, rejected, or
otherwise deemed undeliverable may be returned to the U.S. exporter of
record. A brief written report outlining the circumstances must be
filed with the Administration through the DEA Office of Diversion
Control secure network application, following the return at the
earliest practicable opportunity after the regulated person becomes
aware of the circumstances involved. This provision does not apply to
shipments that have cleared foreign customs, been delivered, and
accepted by the foreign consignee. Returns to third parties in the
United States will be regarded as imports.
(j) Each annual report required by Sec. 1310.05(d) must provide
the following information for each listed chemical manufactured:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) and
chemical registration number (if any) of the manufacturer.
(2) The aggregate quantity of each listed chemical that the company
manufactured during the preceding calendar year.
(3) The year-end inventory of each listed chemical as of the close
of business on the 31st day of December of each year. (For each listed
chemical, if the prior period's ending inventory has not previously
been reported to DEA, this report should also detail the beginning
inventory for the period.) For purposes of this requirement, inventory
shall reflect the quantity of listed chemicals, whether in bulk or non-
exempt product form, held in storage for later distribution. Inventory
does not include waste material for destruction, material stored as an
in-process intermediate or other in-process material.
(4) The aggregate quantity of each listed chemical used for
internal consumption during the preceding calendar year, unless the
chemical is produced solely for internal consumption.
(5) The aggregate quantity of each listed chemical manufactured
which becomes a component of a product exempted from paragraph (1)(iv)
or (v) of the definition of regulated transaction in Sec. 1300.02 of
this chapter during the preceding calendar year.
(6) Data shall identify the specific isomer, salt or ester when
applicable but quantitative data shall be reported as anhydrous base or
acid in kilogram units of measure.
(k) Each monthly report required by Sec. Sec. 1310.03(c) and
1310.05(e) (on DEA Form 453) must provide the following information for
each transaction:
(1) Supplier name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.) and registration number.
(2) Purchaser's name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.).
(3) Name/business name, address/business address shipped to (if
different from purchaser's name/address).
(4) Chemical name, National Drug Code (NDC) number, if applicable,
and total amount shipped.
(5) Date of shipment.
(6) Product name (if drug product).
(7) Dosage form (if drug product) (e.g., pill, tablet, liquid).
(8) Dosage strength (if drug product) (e.g., 30mg, 60mg, per dose
etc.).
(9) Number of dosage units (if drug product) (e.g., 100 doses per
package).
(10) Package type (if drug product) (e.g., bottle, blister pack,
etc.).
(11) Number of packages (if drug product) (e.g., 10 bottles).
[[Page 63613]]
(12) Lot number (if drug product).
(l) Information provided in reports required by Sec. 1310.05(e)
which is exempt from disclosure under 5 U.S.C. 552(a), by reason of 5
U.S.C. 552(b)(6), will be provided the same protections from disclosure
as are provided in section 310(c) of the Act (21 U.S.C. 830(c)) for
confidential business information.
Sec. 1310.13 [Amended]
0
40. In Sec. 1310.13(b), remove ``Office of Diversion Control, Drug
Enforcement Administration'' and add in its place ``Drug and Chemical
Evaluation Section, Office of Diversion Control, Drug Enforcement
Administration''.
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
0
41. The authority citation for part 1312 continues to read as follows:
Authority: 21 U.S.C. 952, 953, 954, 957, 958.
0
42. Add Sec. 1312.03 to precede the undesignated center heading
Importation of Controlled Substances to read as follows:
Sec. 1312.03 Forms applicable to this part.
------------------------------------------------------------------------
Form Access/ submission
------------------------------------------------------------------------
DEA Form 35, Permit to Import................ electronic.
DEA Form 36, Permit to Export................ electronic.
DEA Form 161, Application for Permit to electronic.
Export Controlled Substances.
DEA Form 161R, Application for Permit to electronic.
Export Controlled Substances For Subsequent
Reexport.
DEA Form 161R-EEA, Application for Permit to electronic.
Export Controlled Substances for Subsequent
Reexport among members of the European
Economic Area.
DEA Form 236, Controlled Substances Import/ electronic.
Export Declaration.
DEA Form 357, Application for Permit to electronic.
Import Controlled Substances for Domestic
And/Or Scientific Purposes.
------------------------------------------------------------------------
0
43. Revise Sec. 1312.11 to read as follows:
Sec. 1312.11 Requirement of authorization to import.
(a) No person shall import, or cause to be imported, into the
customs territory of the United States from any place outside thereof
(but within the United States), or into the United States from any
place outside thereof, any controlled substances listed in Schedule I
or II, or any narcotic controlled substance listed in Schedule III, IV,
or V, or any non-narcotic controlled substance listed in Schedule III
which the Administrator has specifically designated by regulation in
Sec. 1312.30 or any non-narcotic controlled substance listed in
Schedule IV or V which is also listed in Schedule I or II of the
Convention on Psychotropic Substances, 1971, unless and until such
person is properly registered under the Act (or, in accordance with
part 1301 of this chapter, exempt from registration) and the
Administration has issued him or her a permit to do so in accordance
with Sec. 1312.13.
(b) No person shall import, or cause to be imported, into the
customs territory of the United States from any place outside thereof
(but within the United States), or into the United States from any
place outside thereof, any non-narcotic controlled substance listed in
Schedule III, IV, or V, excluding those described in paragraph (a) of
this section, unless and until such person is properly registered under
the Act (or, in accordance with part 1301 of this chapter, exempt from
registration) and has filed an import declaration to do so in
accordance with Sec. 1312.18.
(c) A separate permit or declaration is required for each shipment
of a controlled substance to be imported.
0
44. Revise Sec. 1312.12 to read as follows:
Sec. 1312.12 Application for import permit; return information.
(a) Registered importers, other registrants authorized to import as
a coincident activity of their registrations, and persons who in
accordance with part 1301 of this chapter are exempt from registration,
seeking to import a controlled substance in schedule I or II; any
narcotic drug in schedule III, IV, or V; any non-narcotic drug in
schedule III that has been specifically designated by regulation in
Sec. 1312.30 of this part; or any non-narcotic substance listed in
schedule IV or V that is also listed in schedule I or II of the
Convention on Psychotropic Substances, 1971, must submit an application
for a permit to import controlled substances on DEA Form 357. All
applications and supporting materials must be submitted to the
Administration through the DEA Office of Diversion Control secure
network application. The application must be signed and dated by the
importer and must contain the importer's registered address to which
the controlled substances will be imported.
(b) The applicant must include on the DEA Form 357 the registration
number of the importer and a detailed description of each controlled
substance to be imported including the drug name, dosage form, National
Drug Code (NDC) number, the Administration Controlled Substance Code
Number as set forth in part 1308 of this chapter, the number and size
of the packages or containers, the name and quantity of the controlled
substance contained in any finished dosage units, and the quantity of
any controlled substance (expressed in anhydrous acid, base or
alkaloid) given in kilograms or parts thereof. The application must
also include the following:
(1) The name/business name, address/business address, contact
information (e.g., telephone number(s), email address(es), etc.), and
business of the consignor, if known at the time the application is
submitted, but if unknown at that time, the fact should be indicated
and the name and address afterwards furnished to the Administration as
soon as ascertained by the importer;
(2) The foreign port and country of initial exportation (i.e., the
place where the article will begin its journey of exportation to the
United States);
(3) The port of entry into the United States;
(4) The latest date said shipment will leave said foreign port or
country;
(5) The stock on hand of the controlled substance desired to be
imported;
(6) The name of the importing carrier or vessel (if known, or if
unknown it should be stated whether the shipment will be made by
express, freight, or otherwise, imports of controlled substances in
Schedules I or II and
[[Page 63614]]
narcotic drugs in Schedules III, IV, or V by mail being prohibited);
(7) The total tentative allotment to the importer of such
controlled substance for the current calendar year;
(8) The total number of kilograms of said allotment for which
permits have previously been issued and the total quantity of
controlled substance actually imported during the current year to date.
(c) If desired, alternative foreign ports of exportation within the
same country may be indicated upon the application (e.g., 1. Kolkata,
2. Mumbai). If a permit is issued pursuant to such application, it will
bear the names of the two ports in the order given in the application
and will authorize shipment from either port. Alternative ports in
different countries will not be authorized in the same permit.
(d) Return information. Within 30 calendar days after actual
receipt of a controlled substance at the importer's registered
location, or within 10 calendar days after receipt of a written request
by the Administration to the importer, whichever is sooner, the
importer must file a report with the Administration through the DEA
Office of Diversion Control secure network application specifying the
particulars of the transaction. This report must include the following
information: The date the controlled substance was released by a
customs officer at the port of entry); the date on which the controlled
substance arrived at the registered location; the actual quantity of
the controlled substance released by a customs officer at the port of
entry; and the actual quantity of the controlled substance that arrived
at the registered location. Upon receipt and review, the Administration
will assign a transaction identification number to a completed report.
The report will not be deemed filed until the Administration has issued
a transaction identification number.
(e) Denied release at the port of entry. In the event that a
shipment of controlled substances has been denied release by a customs
officer at the port of entry for any reason, the importer who attempted
to have the shipment released must, within 24-hours of the denial,
report to the Administration that the shipment was denied and the
reason for denial. Such report must be transmitted to the
Administration through the DEA Office of Diversion Control secure
network application. This report must include the following
information: The quantity of the controlled substance denied release;
the date on which release was denied; and the basis for the denied
release. Upon the importer's report of a denied release at the port of
entry, the DEA will assign the report a transaction identification
number and the import permit will be void and of no effect. No shipment
of controlled substances denied release for any reason will be allowed
to be released into the United States unless the importer submits a new
DEA Form 357 and the Administration issues a new import permit.
0
45. Revise Sec. 1312.13(e) to read as follows:
Sec. 1312.13 Issuance of import permit.
* * * * *
(e) If an importation is approved, the Administrator will issue an
import permit bearing his or her signature or that of his or her
delegate. Each permit will be assigned a unique permit number. A permit
must not be altered or changed by any person after being signed. Any
change or alteration upon the face of any permit after it has been
signed renders it void and of no effect. Permits are not transferable.
The Administrator or his/her delegate will date and certify on each
permit that the importer named therein is thereby permitted as a
registrant under the Act, to import, through the port of entry named,
one shipment of not to exceed the specified quantity of the named
controlled substances, shipment to be made before a specified date.
Only one shipment may be made on a single import permit. Split
shipments are prohibited. The permit must state that the Administration
is satisfied that the consignment proposed to be imported is required
for legitimate purposes.
* * * * *
0
46. Revise Sec. 1312.14 to read as follows:
Sec. 1312.14 Distribution of import permits.
The Administration shall transmit the import permit to the
competent national authority of the exporting country and shall make an
official record of the import permit available to the importer through
secure electronic means. The importer, or their agent, must submit an
official record of the import permit and/or required data concerning
the import transaction to a customs officer at the port of entry in
compliance with all import control requirements of agencies with import
control authorities under the Act or statutory authority other than the
Controlled Substances Import and Export Act. The importer must maintain
an official record of the import permit (available from the DEA Office
of Diversion Control secure network application after issuance) in
accordance with part 1304 of this chapter as the record of authority
for the importation and shall transmit an official record of the permit
to the foreign exporter. If required by the foreign competent national
authority, the importer shall ensure that an official record of the
import permit is provided (e.g., by transmitting an official record of
the permit to the foreign exporter who shall transmit such record to
the competent national authority of the exporting county). The importer
must ensure that an official record of the permit accompanies the
shipment of controlled substances to its final destination, the
registered location of the importer (i.e., drop shipments are
prohibited).
Sec. 1312.15 [Amended].
0
47. Amend Sec. 1312.15 as follows:
0
a. In paragraph (a), remove ``the U.S. Customs Service'' and add in its
place ``the U.S. Customs and Border Protection or customs service of an
Insular Area'', and add ``, in accordance with Sec. 1312.16(a)'' to
the end of the first sentence; and
0
b. In paragraph (b), remove ``the U.S. Customs Service'' and add in its
place ``the U.S. Customs and Border Protection or customs service of an
Insular Area'', and remove ``Director of the Administration'' from the
last sentence and add in its place ``Administrator''.
0
48. Revise Sec. 1312.16 to read as follows:
Sec. 1312.16 Amendment, cancellation, expiration of import permit.
(a) Importers may only request that an import permit or application
for an import permit be amended in accordance with paragraphs (a)(1)
through (7) of this section. Requests for an amendment must be
submitted through the DEA Office of Diversion Control secure network
application. Except as provided in paragraph (a)(5) of this section and
Sec. 1312.15(a), importers must submit all requests for an amendment
at least one full business day in advance of the date of release by a
customs officer. Importers must specifically request that an amendment
be made; supplementary information submitted by an importer through the
DEA Office of Diversion Control secure network application will not
automatically trigger the amendment process. While the request for an
amendment is being reviewed by the Administration, the original permit
will be temporarily stayed and may not be used to authorize entry of a
shipment of controlled substances. If the importer's request for an
amendment to an issued permit is granted by the Administration, the
Administration will immediately
[[Page 63615]]
cancel the original permit and re-issue the permit, as amended, with a
revised permit number. The DEA and importer will distribute the amended
permit in accordance with Sec. 1312.14. If a request for an amendment
is denied by the Administration, the temporary stay will be lifted;
once lifted, the originally issued permit may immediately be used to
authorize entry of a shipment in accordance with the terms of the
permit, subject to the shipment being compliant with all other
applicable laws.
(1) An importer may request that an import permit or application
for a permit be amended to change the National Drug Control number,
description of the packaging, or trade name of the product, so long as
the description is for the same basic class of controlled substance as
in the original permit.
(2) An importer may request that an import permit or application
for a permit be amended to change the proposed port of entry, the date
of release by a customs officer, or the method of transport.
(3) An importer may request that an import permit or application
for a permit be amended to change the justification provided as to why
an import shipment is needed to meet the legitimate scientific or
medical needs of the United States.
(4) An importer may request that an import permit or application
for a permit be amended to change any registrant notes.
(5) Prior to departure of the shipment from its original foreign
location, an importer may request that an import permit or application
for a permit be amended to increase the total base weight of a
controlled substance. At the U.S. port of entry, an importer may
request that an import permit be amended in accordance with Sec.
1312.15(a). Importers are not required to amend an import permit for
the sole purpose of decreasing the total base weight of a controlled
substance authorized to be imported. However, the balance of any
unimported authorized quantity of controlled substances on an import
permit is void upon entry of a shipment on the issued permit or upon
expiration of the unused permit in accordance with paragraph (b) of
this section, whichever is sooner. Other than for an amendment to an
import permit under Sec. 1312.15(a), importers must submit a request
for an amendment to increase the total base weight of a controlled
substance at least three business days in advance of the date of
release by a customs officer.
(6) An importer may request that an import permit be amended to
remove a controlled substance from the permit. However, an importer may
not amend an import permit to add or replace a controlled substance/
Administration controlled substance code number to the item(s) to be
imported. Importers who desire to import a different controlled
substance than that contained on their issued import permit or permit
application must submit a request for the permit or permit application
to be canceled and request a new permit in accordance with Sec.
1312.12.
(7) An importer may not amend the importer's name (as it appears on
their DEA certificate of registration) or the name of the foreign
exporter as provided in the DEA Form 357. Importers who need to make
any changes to any of these fields must submit a request for the permit
or permit application to be canceled and request a new permit in
accordance with Sec. 1312.12.
(b) An import permit will be void and of no effect after the
expiration date specified therein, and in no event will the date be
more than 180 calendar days after the date the permit is issued.
Amended import permits will retain the original expiration date.
(c) An import permit may be canceled after being issued, at the
request of the importer submitted to the Administration through the DEA
Office of Diversion Control secure network application, provided that
no shipment has been made thereunder. Nothing in this part will affect
the right, hereby reserved by the Administration, to cancel a permit at
any time for proper cause.
0
49. In Sec. 1312.18:
0
a. Revise the section heading;
0
b. Revise paragraphs (b), (c) introductory text, and (c)(3); and
0
c. Add paragraphs (e) through (h);
The revisions and additions read as follows:
Sec. 1312.18 Import declaration.
* * * * *
(b) Any person registered or authorized to import and seeking to
import any non-narcotic controlled substance listed in Schedules III,
IV, or V which is not subject to the requirement of an import permit as
described in paragraph (a) of this section, must file a controlled
substances import declaration (DEA Form 236) with the Administration
through the DEA Office of Diversion Control secure network application
not later than 15 calendar days prior to the anticipated date of
release by a customs officer and distribute an official record of the
declaration as hereinafter directed in Sec. 1312.19. The declaration
must be signed and dated by the importer and must specify the address
of the final destination for the shipment, which must be the importer's
registered location. Upon receipt and review, the Administration will
assign a transaction identification number to each completed
declaration. The import declaration is not deemed filed, and therefore
is not valid, until the Administration has issued a transaction
identification number. The importer may only proceed with the import
transaction once the transaction identification number has been issued.
(c) DEA Form 236 must include the following information:
* * * * *
(3) The anticipated date of release by a customs officer at the
port of entry, the foreign port and country of exportation to the
United States, the port of entry, and the name, address, and
registration number of the recipient in the United States; and
* * * * *
(e) Return information. Within 30 calendar days after actual
receipt of a controlled substance at the importer's registered
location, or within 10 calendar days after receipt of a written request
by the Administration to the importer, whichever is sooner, the
importer must file a report with the Administration through the DEA
Office of Diversion Control secure network application specifying the
particulars of the transaction. This report must include the following
information: The date on which the controlled substance was released by
a customs officer at the port of entry; the date on which the
controlled substance arrived at the registered location; the actual
quantity of the controlled substance released by a customs officer at
the port of entry; the actual quantity of the controlled substance that
arrived at the registered location; and the actual port of entry. Upon
receipt and review, the Administration will assign a transaction
identification number to a completed report. The report will not be
deemed filed until the Administration has issued a transaction
identification number.
(f) An importer may amend an import declaration in the same
circumstances in which an importer may request amendment to an import
permit, as set forth in Sec. 1312.16(a)(1) through (7). Amendments to
declarations must be submitted through the DEA Office of Diversion
Control secure network application. Except as provided in Sec.
1312.16(a)(5) and Sec. 1312.15(a), importers must submit all
amendments at least one full business day in advance of the date of
release by a customs
[[Page 63616]]
officer. Importers must specifically note that an amendment is being
made; supplementary information submitted by an importer through the
DEA Office of Diversion Control secure network application will not
automatically be considered an amendment. While the amendment is being
processed by the Administration, the original declaration will be
temporarily stayed and may not be used to authorize release of a
shipment of controlled substances. Upon receipt and review, the
Administration will assign each completed amendment a transaction
identification number. The amendment will not be deemed filed until the
Administration issues a transaction identification number. The DEA and
importer will distribute the amended declaration in accordance with
Sec. 1312.19. A filed amendment will not change the date that the
declaration becomes void and of no effect pursuant to Sec. 1312.18(g).
(g) An import declaration may be canceled after being filed with
the Administration, at the request of the importer by the importer
submitting to the Administration the request through the DEA Office of
Diversion Control secure network application, provided that no shipment
has been made thereunder. Import declarations shall become void and of
no effect 180 calendar days after the date the declaration is deemed
filed with the Administration.
(h) Denied release at the port of entry. In the event that a
shipment of controlled substances has been denied release by a customs
officer at the port of entry for any reason, the importer who attempted
to have the shipment released, within 24-hours of the denial, report to
the Administration that the shipment was denied release and the reason
for denial. Such report must be transmitted to the Administration
through the DEA Office of Diversion Control secure network application.
This report must include the following information: The quantity of the
controlled substance denied release; the date on which release was
denied; and the basis for the denied release. Upon the importer's
report of a denied release, the DEA will assign the report a
transaction identification number and the import declaration will
become void and of no effect. No shipment of controlled substances
denied release for any reason will be allowed to be released into the
United States until the importer has filed a new import declaration and
the Administration has issued a new transaction identification number.
0
50. Revise Sec. 1312.19 to read as follows:
Sec. 1312.19 Distribution of import declaration.
The importer must furnish an official record of the declaration
(available through the DEA Office of Diversion Control secure network
application after the Administration issues a transaction
identification number) to the foreign shipper. The foreign shipper must
submit an official record of the declaration to the competent national
authority of the exporting country, if required as a prerequisite to
export authorization. The importer, or their agent, must submit an
official record of the declaration and/or required data concerning the
import transaction to a customs officer at the port of entry in
compliance with all import control requirements of agencies with import
control authorities under the Act or statutory authority other than the
Controlled Substances Import and Export Act. The importer must ensure
that an official record of the declaration accompanies the shipment to
its final destination, which must only be the registered location of
the importer (i.e., drop shipments are prohibited). The importer must
maintain an official record of the declaration in accordance with part
1304 of this chapter.
0
51. Revise Sec. 1312.21 to read as follows:
Sec. 1312.21 Requirement of authorization to export.
(a) No person shall in any manner export, or cause to be exported,
from the United States any controlled substance listed in Schedule I or
II, or any narcotic controlled substance listed in Schedule III or IV,
or any non-narcotic controlled substance in Schedule III which the
Administrator has specifically designated by regulation in Sec.
1312.30 or any non-narcotic controlled substance in Schedule IV or V
which is also listed in Schedule I or II of the Convention on
Psychotropic Substances, 1971, unless and until such person is properly
registered under the Act (or, in accordance with part 1301 of this
chapter, exempt from registration) and the Administrator has issued him
or her a permit to do so in accordance with Sec. 1312.23.
(b) No person shall in any manner export, or cause to be exported,
from the United States any non-narcotic controlled substance listed in
Schedule III, IV, or V, excluding those described in paragraph (a) of
this section, or any narcotic controlled substance listed in Schedule
V, unless and until such person is properly registered under the Act
(or, in accordance with part 1301 of this chapter, exempt from
registration) and has furnished an export declaration as provided by
section 1003 of the Act (21 U.S.C. 953(e)) to the Administration in
accordance with Sec. 1312.28.
(c) A separate permit or declaration is required for each shipment
of controlled substance to be exported.
0
52. Revise Sec. 1312.22 to read as follows:
Sec. 1312.22 Application for export or reexport permit; return
information.
(a) Registered exporters, and persons who in accordance with part
1301 of this chapter are exempt from registration, seeking to export
controlled substances must submit an application for a permit to export
controlled substances on DEA Form 161. Registered exporters, and
persons who in accordance with part 1301 of this chapter are exempt
from registration, seeking to reexport controlled substances must
submit an application for a permit to reexport controlled substances on
DEA Form 161R or DEA Form 161R-EEA, whichever applies. All applications
and supporting materials must be submitted to the Administration
through the DEA Office of Diversion Control secure network application.
The application must be signed and dated by the exporter and contain
the exporter's registered address from which the controlled substances
will be exported. Controlled substances may not be exported until a
permit number has been issued.
(b) Exports of controlled substances by mail are prohibited.
(c) Applications. (1) Except as provided in paragraph (c)(2) of
this section, each application for a permit to export or reexport must
include the following information:
(i) The exporter's name/business name, address/business address,
and contact information (e.g., telephone number(s), email address(es),
etc.);
(ii) The exporter's registration number, address, and contact
information (e.g., telephone number(s), etc.) from which the controlled
substances will be exported;
(iii) A detailed description of each controlled substance to be
exported including the drug name, dosage form, National Drug Code (NDC)
number, Administration Controlled Substance Code Number as set forth in
part 1308 of this chapter, the number and size of the packages or
containers, the name and quantity of the controlled substance contained
in any finished dosage units, and the quantity of any controlled
substance (expressed in anhydrous acid,
[[Page 63617]]
base, or alkaloid) given in kilograms or parts thereof;
(iv) The name/business name, address/business address, contact
information (e.g., telephone number(s), email address(es), etc.) and
business of the consignee in the first country (the country to which
the controlled substance is exported from the United States), foreign
port and country of entry/first country of entry, the port of export,
the anticipated date of release by a customs officer at the port of
export, the name of the exporting carrier or vessel (if known, or if
unknown it should be stated whether the shipment will be made by
express, freight, or otherwise), the date and number, if any, of the
supporting foreign import license or permit accompanying the
application, and the authority by whom such foreign license or permit
was issued;
(v) An affidavit that the packages or containers are labeled in
conformance with obligations of the United States under international
treaties, conventions, or protocols in effect at the time of the export
or reexport. The affidavit shall further state that to the best of the
affiant's knowledge and belief, the controlled substances therein are
to be applied exclusively to medical or scientific uses within the
country to which exported, will not be reexported therefrom and that
there is an actual need for the controlled substance for medical or
scientific uses within such country, unless the application is
submitted for reexport in accordance with paragraphs (f) through (h) of
this section. In the case of exportation of crude cocaine, the
affidavit may state that to the best of affiant's knowledge and belief,
the controlled substances will be processed within the country to which
exported, either for medical or scientific use within that country or
for reexportation in accordance with the laws of that country to
another for medical or scientific use within that country;
(2) With respect to reexports among members of the European
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C.
953(f)), the requirements of paragraph (c)(1) of this section shall
apply only with respect to the export from the United States to the
first country and not to any subsequent export from that country to
another country of the European Economic Area.
(d)(1) Except as provided in paragraph (d)(2) of this section, the
applicant must also submit with the application any import license or
permit or a certified copy of any such license or permit issued by the
competent national authority in the country of destination, or other
documentary evidence deemed adequate by the Administration, showing:
that the merchandise is consigned to an authorized permittee; that it
is to be applied exclusively to medical or scientific use within the
country of destination; that it will not be reexported from such
country (unless the application is submitted for reexport in accordance
with paragraphs (f) through (h) of this section); and that there is an
actual need for the controlled substance for medical or scientific use
within such country or countries. If the import license or permit, or
the certified copy of such, is not written in English or bilingual with
another language and English, the registrant must also submit with
their application a certified translation of the permit or license. For
purposes of this requirement, certified translation means that the
translator has signed the translation legally attesting the accuracy of
the translation and the attestation has been notarized. (In the case of
exportation of bulk coca leaf alkaloid, the applicant need only include
with the application the material outlined in paragraph (c) of this
section.)
(2) With respect to reexports among members of the European
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C.
953(f)), the requirements of paragraph (d)(1) of this section shall
apply only with respect to the export from the United States to the
first country and not to any subsequent export from that country to
another country of the European Economic Area.
(e) Return information for exports (on a DEA Form 161). Within 30
calendar days after the controlled substance is released by a customs
officer at the port of export, or within 10 calendar days after receipt
of a written request by the Administration to the exporter, whichever
is sooner, the exporter must report to the Administration through the
DEA Office of Diversion Control secure network application the
particulars of the transaction. This report must include the following
information: the date on which the controlled substance left the
registered location; the date on which the controlled substance was
released by a customs officer at the port of export); the actual
quantity of controlled substance that left the registered location; and
the actual quantity of the controlled substance released by a customs
officer at the port of export; the actual port of export, and any other
information as the Administration may from time to time specify. Upon
receipt and review, the Administration will assign a transaction
identification number to a completed report. The report will not be
deemed filed until the Administration has issued a transaction
identification number.
(f) Reexports outside of the European Economic Area. Except as
provided in paragraph (g), the Administration may authorize any
controlled substance listed in Schedule I or II, or any narcotic drug
listed in Schedule III or IV, to be exported from the United States to
a country for subsequent export from that country to another country,
if each of the following conditions is met, in accordance with section
1003(f) of the Act (21 U.S.C. 953(f)):
(1) Both the country to which the controlled substance is exported
from the United States (referred to in this section as the ``first
country'') and the country to which the controlled substance is
exported from the first country (referred to in this section as the
``second country'') are parties to the Single Convention on Narcotic
Drugs, 1961, and the Convention on Psychotropic Substances, 1971;
(2) The first country and the second country have each instituted
and maintain, in conformity with such Conventions, a system of controls
of imports of controlled substances which the Administration deems
adequate;
(3) With respect to the first country, the controlled substance is
consigned to a holder of such permits or licenses as may be required
under the laws of such country, and a permit or license to import the
controlled substance has been issued by the country;
(4) With respect to the second country, substantial evidence is
furnished to the Administration by the applicant for the export permit
that--
(i) The controlled substance is to be consigned to a holder of such
permits or licenses as may be required under the laws of such country,
and a permit or license to import the controlled substance is to be
issued by the country; and
(ii) The controlled substance is to be applied exclusively to
medical, scientific, or other legitimate uses within the country;
(5) The controlled substance will not be exported from the second
country;
(6) The exporter has complied with paragraph (h) of this section
and a permit to export the controlled substance from the United States
has been issued by the Administration; and
(7) Return information for reexports outside of the European
Economic Area (on DEA Form 161R)--(i) Return information for export
from the United States, for reexport. Within 30 calendar days after the
controlled substance is released by a customs officer at the port of
export the exporter must file a report
[[Page 63618]]
with the Administration through the DEA Office of Diversion Control
secure network application specifying the particulars of the
transaction. This report must include the following information: the
date on which the controlled substance left the registered location;
the date on which the controlled substance was released by a customs
officer at the port of export; the actual quantity of controlled
substance released by a customs officer at the port of export; and the
actual port of export. Upon receipt and review, the Administration will
assign a completed report a transaction identification number. The
report will not be deemed filed until the Administration has issued a
transaction identification number. In determining whether the exporter
has complied with the requirement to file within 30 calendar days, the
report shall be deemed filed on the first date on which a complete
report is filed.
(ii) Return information for export from a first country that is or
is not a member of the European Economic Area to a country outside of
the European Economic Area; return information for export from a first
country that is not a member of the European Economic Area to a member
of the European Economic Area. Within 30 calendar days after the
controlled substance is exported from the first country to the second
country the exporter must file a report with the Administration through
the DEA Office of Diversion Control secure network application
specifying the particulars of the export from the first country. If the
permit issued by the Administration authorized the reexport of a
controlled substance from the first country to more than one second
country, a report for each individual reexport is required. These
reports must include the following information: name of second country;
actual quantity of controlled substance shipped; and the date shipped
from the first country, the actual port from which the controlled
substances were shipped from the first country. Upon receipt and
review, the Administration will assign each completed report a
transaction identification number. The report will not be deemed filed
until the Administration has issued a transaction identification
number.
(g) Reexports among members of the European Economic Area (on DEA
Form 161R-EEA). The Administration may authorize any controlled
substance listed in Schedule I or II, or any narcotic drug listed in
Schedule III or IV, to be exported from the United States to a country
of the European Economic Area for subsequent export from that country
to another country of the European Economic Area, if the following
conditions and the conditions of (f)(1), (2), (3) (4), and (6) are met,
in accordance with section 1003(f) of the Act (21 U.S.C. 953(f)):
(1)(i) The controlled substance will not be exported from the
second country, except that the controlled substance may be exported
from a second country that is a member of the European Economic Area to
another country that is a member of the European Economic Area,
provided that the first country is also a member of the European
Economic Area; and
(ii) Subsequent to any reexportation described in paragraph
(g)(1)(i) of this section, a controlled substance may continue to be
exported from any country that is a member of the European Economic
Area to any other such country, if--
(A) The conditions applicable with respect to the first country
under paragraphs (f)(1), (2), (3), (4), and (6) of this section and
paragraph (g)(2) of this section are met with respect to each
subsequent country from which the controlled substance is exported
pursuant to this paragraph; and
(B) The conditions applicable with respect to the second country
under paragraphs (f)(1), (2), (3), (4), and (6) of this section and
paragraph (g)(2) of this section are met with respect to each
subsequent country to which the controlled substance is exported
pursuant to this paragraph.
(2) Return information for reexports among members of the European
Economic Area--(i) Return information for export from the United
States, for reexport among members of the European Economic Area.
Exporters must comply with the return reporting requirements of
paragraph (f)(7)(i) of this section.
(ii) Reexports among members of the European Economic Area. Within
30 calendar days after the controlled substance is exported from the
first country to the second country, and within 30 calendar days of
each subsequent reexport within the European Economic Area, if any, the
U.S. exporter must file a report with the Administration through the
DEA Office of Diversion Control secure network application specifying
the particulars of the export. These reports must include the name of
country to which the controlled substance was reexported, i.e., another
member of the European Economic Area; the actual quantity of controlled
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g.,
telephone number(s), email address(es), etc.) and business of the
consignee; and the name/business name, address/business address,
contact information (e.g., telephone number(s), email address(es),
etc.) and business of the exporter. Upon receipt and review, the
Administration will assign each completed report a transaction
identification number. The report will not be deemed filed until the
Administration has issued a transaction identification number.
(h) Where a person is seeking to export a controlled substance for
reexport outside of the European Economic Area in accordance with
paragraph (f) of this section, the requirements of paragraphs (h)(1)
through (7) of this section shall apply in addition to (and not in lieu
of) the requirements of paragraphs (a) through (d) of this section.
Where a person is seeking to export a controlled substance for reexport
among members of the European Economic Area in accordance with
paragraph (g) of this section, the requirements of paragraph (h)(4) of
this section shall apply in addition to (and not in lieu of) the
requirements of paragraphs (a) through (d) of this section.
(1) Bulk substances will not be reexported in the same form as
exported from the United States, i.e., the material must undergo
further manufacturing process. This further manufactured material may
only be reexported to a second country.
(2) Finished dosage units, if reexported, must be in a commercial
package, properly sealed and labeled for legitimate medical use in the
second country.
(3) Any proposed reexportation must be made known to the
Administration at the time the initial DEA Form 161R is submitted. In
addition, the following information must also be provided where
indicated on the form:
(i) Whether the drug or preparation will be reexported in bulk or
finished dosage units;
(ii) The product name, dosage strength, commercial package size,
and quantity;
(iii) The name of consignee, complete address, and expected
shipment date, as well as the name and address of the ultimate
consignee in the second country.
(4) The application must contain an affidavit that the consignee in
the second country, and any country of subsequent reexport within the
European Economic Area, is authorized under the laws and regulations of
the second and/or subsequent country to receive the controlled
substances. The
[[Page 63619]]
affidavit must also contain the following statements, in addition to
the statements required under paragraph (c) of this section:
(i) That the packages are labeled in conformance with the
obligations of the United States under the Single Convention on
Narcotic Drugs, 1961, the Convention on Psychotropic Substances, 1971,
and any amendments to such treaties in effect;
(ii) That the controlled substances are to be applied exclusively
to medical or scientific uses within the second country, or country of
subsequent reexport within the European Economic Area;
(iii) That the controlled substances will not be further reexported
from the second country except as provided by paragraph (f) of section
1003 of the Act (21 U.S.C. 953(f)); and
(iv) That there is an actual need for the controlled substances for
medical or scientific uses within the second country, or country of
subsequent reexport within the European Economic Area.
(5) If the applicant proposes that the shipment of controlled
substances will be separated into parts after it arrives in the first
country and then reexported to more than one second country, the
applicant must so indicate on the DEA Form 161R and provide all the
information required in this section for each second country.
(6) Except in the case of reexports among countries of the European
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C.
953(f)), the controlled substance will be reexported from the first
country to the second country (or second countries) no later than 180
calendar days after the controlled substance was released by a customs
officer from the United States.
(7) Shipments that have been exported from the United States and
are refused by the consignee in either the first or second country, or
subsequent member of the European Economic Area, or are otherwise
unacceptable or undeliverable, may be returned to the registered
exporter in the United States upon authorization of the Administration.
In these circumstances, the exporter in the United States must submit a
written request for the return of the controlled substances to the
United States with a brief summary of the facts that warrant the
return, along with a completed DEA Form 357 through the DEA Office of
Diversion Control secure network application. The Administration will
evaluate the request after considering all the facts as well as the
exporter's registration status with the Administration. If the exporter
provides sufficient justification, the Administration may issue an
import permit for the return of these drugs, and the exporter may then
obtain an export permit from the country of original importation. The
substance may not be returned to the United States until after a permit
has been issued by the Administration.
(i) In considering whether to grant an application for a permit
under paragraphs (f) through (h) of this section, the Administration
shall consider whether the applicant has previously obtained such a
permit and, if so, whether the applicant complied fully with the
requirements of this section with respect to that previous permit.
(j) Denied release at the port of export. In the event that a
shipment of controlled substances has been denied release by a customs
officer at the port export from the United States for any reason, the
exporter who attempted to have the shipment released must, within 24-
hours of the denial, report to the Administration that the shipment was
denied release and the reason for denial. Such report must be
transmitted to the Administration through the DEA Office of Diversion
Control secure network application. This report must include the
following information: The quantity of the controlled substance denied
release; the date on which release was denied; the basis for the denied
release, the port from which the denial was issued, and any other
information as the Administration may from time to time specify. Upon
the exporter's report of a denied release, DEA will assign the report a
transaction identification number and the export permit will be void
and of no effect. No shipment of controlled substances denied release
for any reason will be allowed to be released from the United States
unless the exporter submits a new DEA Form 161, 161R, or 161R-EEA, as
appropriate, and the Administration issues a new export permit.
0
53. Revise Sec. 1312.23(e) to read as follows:
Sec. 1312.23 Issuance of export permit.
* * * * *
(e) If an exportation is approved, the Administrator shall issue an
export permit bearing his or her signature or that of his or her
delegate. Each permit will be assigned a permit number that is a
unique, randomly generated identifier. A permit shall not be altered or
changed by any person after being signed. Any change or alteration upon
the face of any permit after it has been signed renders it void and of
no effect. Permits are not transferable. The Administrator or his/her
delegate shall date and certify on each permit that the exporter named
therein is thereby permitted as a registrant under the Act, to export,
through the port of export named, one shipment of not to exceed the
specified quantity of the named controlled substances, shipment to be
made before a specified date. Only one shipment may be made on a single
export permit. Split shipments are prohibited. Each export permit shall
be predicated upon, inter alia, an import certificate or other
documentary evidence issued by a foreign competent national authority.
* * * * *
0
54. Revise Sec. 1312.24 to read as follows:
Sec. 1312.24 Distribution of export permit.
The Administration shall transmit the export permit to the
competent national authority of the importing country and shall make
available to the exporter an official record of the export permit
through secure electronic means. The exporter, or their agent, must
submit an official record of the export permit and/or required data
concerning the export transaction to a customs officer at the port of
export in compliance with all export control requirements of agencies
with export control authorities under the Act or statutory authority
other than the Controlled Substances Import and Export Act. The
exporter must maintain an official record of the export permit
(available from the secure network application on the DEA Office of
Diversion Control Web site after the Administration issues a
transaction identification number) in accordance with part 1304 of this
chapter as the record of authority for the exportation and shall
transmit an official record of the export permit to the foreign
importer. The exporter must ensure that an official record of the
permit accompanies the shipment to its final destination. No shipment
of controlled substances denied release for any reason shall be allowed
to be released from the United States without subsequent authorization
from the Administration.
0
55. Revise Sec. 1312.25 to read as follows:
Sec. 1312.25 Amendment, cancellation, expiration of export permit.
(a) Exporters may only request that an export permit or application
for an export permit be amended in accordance with paragraphs (a)(1)
through (7) of this section. Requests for an amendment must be
submitted through the DEA Office of Diversion Control secure network
application. Except as provided in paragraph (a)(5)
[[Page 63620]]
of this section exporters must submit all requests for an amendment at
least one full business day in advance of the date of release from the
port of export. Exporters must specifically request that an amendment
be made; supplementary information submitted by an exporter through the
DEA Office of Diversion Control secure network application will not
automatically trigger the amendment process. While the request for an
amendment is being reviewed by the Administration, the original permit
will be temporarily stayed and may not be used to authorize release of
a shipment of controlled substances. If the exporter's request for an
amendment to an issued permit is granted by the Administration, the
Administration will immediately cancel the original permit and re-issue
the permit, as amended, with a revised permit number. The DEA and
exporter will distribute the amended permit in accordance with Sec.
1312.24. If a request for an amendment is denied by the Administration,
the temporary stay will be lifted; once lifted, the originally issued
permit may immediately be used to authorize release of a shipment in
accordance with the terms of the permit.
(1) An exporter may request that an export permit or application
for a permit be amended to change the National Drug Control number,
description of the packaging, or trade name of the product, so long as
the description is for the same basic class of controlled substance as
in the original permit.
(2) An exporter may request that an export permit or application
for a permit be amended to change the proposed port of export, the
anticipated date of release by a customs officer, or the method of
transport.
(3) An exporter may request that an export permit or application
for a permit be amended to change the justification provided as to why
an export shipment is needed to meet the legitimate scientific or
medical needs of the country of import.
(4) An exporter may request that an export permit or application
for a permit be amended to change any registrant notes.
(5) Prior to departure of the shipment from the exporter's
registered location, an exporter may request that an export permit or
application for a permit be amended to increase the total base weight
of a controlled substance. However, the total base weight or the
strength of the product (if listed) of a controlled substance may not
exceed that permitted for import as indicated on the import permit from
the foreign competent national authority. Exporters are not required to
amend an export permit for the sole purpose of decreasing the total
base weight of a controlled substance authorized to be exported.
However, the balance of any unexported authorized quantity of
controlled substances on an export permit is void upon release of a
shipment on the issued permit or upon expiration of the unused permit
in accordance with paragraph (b) of this section, whichever is sooner.
Exporters must submit a request for an amendment to increase the total
base weight of a controlled substance at least three business days in
advance of the date of release from the port of export.
(6) An exporter may request that an export permit be amended to
remove a controlled substance from the permit. However, an exporter may
not amend an export permit to add or replace a controlled substance to
the item(s) to be exported. Exporters who desire to export a different
controlled substance than that contained on their issued export permit
or permit application must submit a request for the permit or permit
application to be canceled and request a new permit in accordance with
Sec. 1312.22.
(7) An exporter may not amend the exporter's name (as it appears on
their DEA certificate of registration), the name of the foreign
importer(s), or the foreign permit information as provided in the DEA
Form 161, 161R, or 161R-EEA. Exporters who need to make any changes to
any of these fields must submit a request for the permit or permit
application to be canceled and request a new permit in accordance with
Sec. 1312.22.
(b) An export permit will be void and of no effect after the date
specified therein, which date must conform to the expiration date
specified in the supporting import certificate or other documentary
evidence upon which the export permit is founded, but in no event will
the date be more than 180 calendar days after the date the permit is
issued.
(c) An export permit may be canceled after being issued, at the
request of the exporter submitted to the Administration through the DEA
Office of Diversion Control secure network application, provided that
no shipment has been made thereunder. Nothing in this part will affect
the right, hereby reserved by the Administration, to cancel an export
permit at any time for proper cause.
0
56. Revise Sec. 1312.26 to read as follows:
Sec. 1312.26 Records required of exporter.
In addition to any other records required by this chapter, the
exporter must keep a record of any serial numbers that might appear on
packages of narcotic drugs in quantities of one ounce or more in such a
manner as will identify the foreign consignee, along with an official
record of the export permit, in accordance with part 1304 of this
chapter.
0
57. In Sec. 1312.27:
0
a. Revise the section heading and paragraphs (a) and (b); and
0
b. Add paragraphs (d) through (g);
The revisions and additions read as follows:
Sec. 1312.27 Export/reexport declaration.
(a) Any person registered or authorized to export and seeking to
export any non-narcotic controlled substance listed in Schedule III,
IV, or V, which is not subject to the requirement of an export permit
pursuant to Sec. 1312.23(b) or (c), or any person registered or
authorized to export and seeking to export any controlled substance in
Schedule V, must file a controlled substances export declaration (DEA
Form 236) with the Administration through the DEA Office of Diversion
Control secure network application not less than 15 calendar days prior
to the anticipated date of release by a customs officer at the port of
export, and distribute an official record of the declaration as
hereinafter directed in Sec. 1312.28. The declaration must be signed
and dated by the exporter and must contain the address of the
registered location from which the substances will be shipped for
exportation. Upon receipt and review, the Administration will issue a
completed declaration a transaction identification number. The export
declaration is not deemed filed, and therefore not valid, until the
Administration has issued a transaction identification number. The
exporter may only proceed with the export transaction once the
transaction identification number has been issued.
(b)(1) DEA Form 236 must include the following information:
(i) The name/business name, address/business address, contact
information (e.g., telephone number(s), email address(es), etc.), and
registration number, if any, of the exporter; and the name/business
name, address/business address, contact information (e.g., telephone
number(s), email address(es), etc.), and registration number of the
export broker, if any;
(ii) A detailed description of each controlled substance to be
exported including the drug name, dosage form, National Drug Code (NDC)
number, Administration Controlled Substance Code Number as set forth in
part 1308
[[Page 63621]]
of this chapter, the number and size of the packages or containers, the
name and quantity of the controlled substance contained in any finished
dosage units, and the quantity of any controlled substance (expressed
in anhydrous acid, base, or alkaloid) given in kilograms or parts
thereof; and
(iii) The anticipated date of release by a customs officer at the
port of export, the port of export, the foreign port and country of
entry, the carriers and shippers involved, method of shipment, the name
of the vessel if applicable, and the name, address, and registration
number, if any, of any forwarding agent utilized; and
(iv) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignee in the country of destination, and any registration or
license number if the consignee is required to have such numbers either
by the country of destination or under United States law. In addition,
documentation must be provided to show that:
(A) The consignee is authorized under the laws and regulations of
the country of destination to receive the controlled substances, and
that
(B) The substance is being imported for consumption within the
importing country to satisfy medical, scientific or other legitimate
purposes, and that
(v) The reexport of non-narcotic controlled substances in Schedules
III and IV, and controlled substances in Schedule V is not permitted
under the authority of 21 U.S.C. 953(e), except as provided below and
in paragraph (b)(1)(vi) of this section:
(A) Bulk substances will not be reexported in the same form as
exported from the United States, i.e, the material must undergo further
manufacturing process. This further manufactured material may only be
reexported to a country of ultimate consumption.
(B) Finished dosage units, if reexported, will be in a commercial
package, properly sealed and labeled for legitimate medical use in the
country of destination.
(C) Any reexportation be made known to DEA at the time the initial
DEA Form 236, Controlled Substances Import/Export Declaration is
completed, by checking the box marked ``other'' on the certification.
The following information will be furnished in the remarks section:
(1) Indicate ``for reexport''.
(2) Indicate if reexport is bulk or finished dosage units.
(3) Indicate product name, dosage strength, commercial package
size, and quantity.
(4) Indicate name of consignee, complete address, and expected
shipment date, as well as, the name and address of the ultimate
consignee in the country to where the substances will be reexported.
(5) A statement that the consignee in the country of ultimate
destination is authorized under the laws and regulations of the country
of ultimate destination to receive the controlled substances.
(D) Shipments that have been exported from the United States and
are refused by the consignee in either the first or second country, or
subsequent member of the European Economic Area, or are otherwise
unacceptable or undeliverable, may be returned to the registered
exporter in the United States upon authorization of the Administration.
In this circumstance, the exporter in the United States must file a
written request for reexport, along with a completed DEA Form 236, with
the Administration through the DEA Office of Diversion Control secure
network application. A brief summary of the facts that warrant the
return of the substance to the United States along with an
authorization from the country of export must be included with the
request. DEA will evaluate the request after considering all the facts
as well as the exporter's registration status with DEA. The substance
may be returned to the United States only after affirmative
authorization is issued in writing by DEA.
(vi) The reexport of non-narcotic controlled substances in
Schedules III and IV, and controlled substances in Schedule V is
permitted among members of the European Economic Area only as provided
below:
(A) The controlled substance will not be exported from the second
country or a subsequent country, except that the controlled substance
may be exported from a second country or a subsequent country that is a
member of the European Economic Area to another country that is a
member of the European Economic Area, provided that the first country
is also a member of the European Economic Area; each country is a party
to the Convention on Psychotropic Substances, 1971, as amended; and
each country has instituted and maintains, in conformity with such
Convention, a system of controls of imports of controlled substances
which the Attorney General deems adequate.
(B) Each shipment of finished dosage units, if reexported, must be
in a commercial package, properly sealed and labeled for legitimate
medical use in the country of destination.
(C) Any reexportation must be made known to DEA at the time the
initial DEA Form 236, Controlled Substances Import/Export Declaration
is completed, by checking the box marked ``other'' on the
certification. In addition to the requirements of paragraph (b) of this
section, the following information will be furnished in the remarks
section:
(1) Indicate ``for reexport among members of the European Economic
Area''.
(2) Indicate if reexport is bulk or finished dosage units.
(3) Indicate product name, dosage strength, commercial package
size, and quantity.
(4) Indicate the name/business name, address/business address,
contact information (e.g., telephone number(s), email address(es) and
business of the consignee in the first country.
(5) A statement that the consignee in the second country, and any
subsequent consignee within the European Economic Area, is authorized
under the laws and regulations of the second and/or subsequent country
to receive the controlled substances.
(2) With respect to reexports among members of the European
Economic Area, the requirements of paragraph (b)(1) of this section
shall apply only with respect to the export from the United States to
the first country and not to any subsequent export from that country to
another country of the European Economic Area.
* * * * *
(d) Return information--(i) Return information for exports. Within
30 calendar days after the controlled substance is released by a
customs officer at the port of export, or within 10 calendar days after
receipt of a written request by the Administration to the exporter,
whichever is sooner, the exporter must file a report with the
Administration through the DEA Office of Diversion Control secure
network application specifying the particulars of the transaction. This
report must include the following information: The date on which the
controlled substance left the registered location; the date on which
the controlled substance was released by a customs officer; the actual
quantity of the controlled substance that left the registered location;
and the actual quantity of the controlled substance released by a
customs officer at the port of export; the actual port of export. Upon
receipt and review, the Administration will assign a completed report a
transaction identification number. The report will not be deemed filed
until the Administration has issued a transaction identification
number.
[[Page 63622]]
(ii) Return information for reexports outside of the European
Economic Area--(A) Return information for export from the United
States, for reexport. Within 30 calendar days after the controlled
substance is released by a customs officer at the port of export the
exporter must file a report with the Administration through the DEA
Office of Diversion Control secure network application specifying the
particulars of the transaction. This report must include the following
information: The date on which the controlled substance left the
registered location; the date on which the controlled substance was
released by a customs officer at the port of export; the actual
quantity of controlled substance released by a customs officer at the
port of export; and the actual port of export. Upon receipt and review,
the Administration will assign a completed report a transaction
identification number. The report will not be deemed filed until the
Administration has issued a transaction identification number.
(B) Return information for export from a first country that is or
is not a member of the European Economic Area to a country outside of
the European Economic Area; return information for export from a first
country that is not a member of the European Economic Area to a member
of the European Economic Area. Within 30 calendar days after the
controlled substance is exported from the first country to the second
country the exporter must file a report with the Administration through
the DEA Office of Diversion Control secure network application
specifying the particulars of the export from the first country. If the
permit issued by the Administration authorized the reexport of a
controlled substance from the first country to more than one second
country, a report for each individual reexport is required. These
reports must include the following information: Name of second country;
actual quantity of controlled substance shipped; the date shipped from
the first country; and the actual port from which the controlled
substances were shipped from the first country. Upon receipt and
review, the Administration will assign each completed report a
transaction identification number. The report will not be deemed filed
until the Administration has issued a transaction identification
number.
(iii) Reexports among members of the European Economic Area--(A)
Return information for exports from the United States, for reexport
among members of the European Economic Area. Exporters must comply with
the return reporting requirements of paragraph (d)(ii)(A) of this
section.
(B) Reexports among members of the European Economic Area. Within
30 calendar days after the controlled substance is exported from the
first country to the second country, and within 30 calendar days of
each subsequent reexport within the European Economic Area, if any, the
exporter must file a report with the Administration through the DEA
Office of Diversion Control secure network application specifying the
particulars of the export. These reports must include the name of
country to which the controlled substance was reexported to another
member of the European Economic Area; the actual quantity of controlled
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g.,
telephone number(s), email address(es), etc.) and business of the
consignee; and the name/business name, address/business address,
contact information (e.g., telephone number(s), email address(es),
etc.) and business of the exporter. Upon receipt and review, the
Administration will assign each completed report a transaction
identification number. The report will not be deemed filed until the
Administration has issued a transaction identification number.
(e) An exporter may amend an export declaration in the same
circumstances in which an exporter may request amendment to an export
permit, as set forth in Sec. 1312.25(a)(1) through (7). Amendments to
declarations must be submitted through the DEA Office of Diversion
Control secure network application. Except as provided in Sec.
1312.25(a)(5) exporters must submit all amendments at least one full
business day in advance of the date of release by a customs officer.
Exporters must specifically note that an amendment is being made;
supplementary information submitted by an exporter through the DEA
Office of Diversion Control secure network application will not
automatically be considered an amendment. Upon receipt and review, the
Administration will assign each completed amendment a transaction
identification number. The amendment will not be deemed filed until the
Administration issues a transaction identification number. The DEA and
the exporter will distribute the amended declaration in accordance with
Sec. 1312.28. A filed amendment will not change the date that the
declaration becomes void and of no effect in accordance with Sec.
1312.27(f).
(f) An export declaration may be canceled after being filed with
the Administration, at the request of the exporter, provided no
shipment has been made thereunder. Export declarations shall become
void and of no effect 180 calendar days after the date the declaration
is deemed filed with the Administration.
(g) Denied release at the port of export. In the event that a
shipment of controlled substances has been denied release by a customs
officer at the port of export for any reason, the exporter who
attempted to have the shipment released must, within 24-hours of the
denial, report to the Administration that the shipment was denied
release and the reason for denial. Such report must be transmitted to
the Administration through the DEA Office of Diversion Control secure
network application. This report must include the following
information: The quantity of the controlled substance denied release;
the date on which release was denied; and the basis for the denied
release. Upon the exporter's report of a denied release, DEA will
assign the report a transaction identification number and the export
declaration will be void and of no effect. No shipment of controlled
substances denied release for any reason will be allowed to be released
unless the exporter files a new declaration and the Administration
issues a new transaction identification number.
0
58. Revise Sec. 1312.28 to read as follows:
Sec. 1312.28 Distribution of export declaration.
(a) The exporter must ensure that an official record of the export
declaration (available from the DEA Office of Diversion Control secure
network application after the Administration issues a transaction
identification number) accompanies the shipment of controlled
substances to its destination.
(b) The exporter, or their agent, must submit an official record of
the export declaration and/or required data concerning the export
transaction to a customs officer at the port of export in compliance
with all export control requirements of agencies with export control
authorities under the Act or statutory authority other than the
Controlled Substances Import and Export Act.
(c) The exporter must maintain an official record of the export
declaration and return information (both available from the Office of
Diversion Control secure network application after the Administration
issues a transaction identification number) required pursuant to Sec.
1312.27(d) as his or her
[[Page 63623]]
record of authority for the exportation, in accordance with part 1304
of this chapter.
0
59. In Sec. 1312.31, revise introductory text of paragraph (b) and add
paragraph (d)(4) to read as follows:
Sec. 1312.31 Schedule I: Application for prior written approval.
* * * * *
(b) An application for a transshipment permit must be submitted to
the Regulatory Section, Office of Diversion Control, Drug Enforcement
Administration, at least 30 calendar days, or in the case of an
emergency as soon as is practicable, prior to the expected date of
arrival at the first port in the United States. See the Table of DEA
Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address. A separate permit is required for each shipment of
controlled substance to be imported, transferred, or transshipped. Each
application must contain the following:
* * * * *
(d) * * *
(4) If the import license or permit, or the certified copy of such,
is not written in English or bilingual with another language and
English, the application must include a certified translation of the
permit or license. For purposes of this requirement, certified
translation means that the translator has signed the translation
legally attesting the accuracy of the translation and the attestation
has been notarized.
* * * * *
0
60. Revise Sec. 1312.32 to read as follows:
Sec. 1312.32 Schedules II, III, IV: Advance notice.
(a) A controlled substance listed in Schedules II, III, or IV may
be imported into the United States for transshipment, or may be
transferred or transshipped within the United States for immediate
exportation, provided that written notice is submitted to the
Regulatory Section, Office of Diversion Control, Drug Enforcement
Administration, at least 15 calendar days prior to the expected date of
date of arrival at the first port in the United States. See the Table
of DEA mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing addresses.
(b) A separate advance notice is required for each shipment of
controlled substance to be imported, transferred, or transshipped. Each
advance notice must contain those items required by Sec. 1312.31(b)
and (c). If the export license, permit, or other authorization, issued
by a competent national authority of the country of origin, is not
written in English or bilingual with another language and English, the
notice must be accompanied by a certified translation of the export
license, permit, or other authorization. For purposes of this
requirement, certified translation means that the translator has signed
the translation legally attesting the accuracy of the translation and
the attestation has been notarized.
PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II
CHEMICALS
0
61. The authority citation for part 1313 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
0
62. Add Sec. 1313.03 to read as follows:
Sec. 1313.03 Forms applicable to this part.
------------------------------------------------------------------------
Form Access/ submission
------------------------------------------------------------------------
DEA Form 486, Import/Export Declaration electronic.
for List I and List II Chemicals.
DEA Form 486A Import Declaration for electronic.
ephedrine, pseudoephedrine, and
phenylpropanolamine (including drug
products containing these chemicals).
------------------------------------------------------------------------
0
63. In Sec. 1313.12, revise the section heading, paragraphs (a), (b),
(c) introductory text (d), and (e) introductory text to read as
follows:
Sec. 1313.12 Notification prior to import.
(a) Each regulated person who seeks to import a listed chemical
that meets or exceeds the threshold quantities identified in Sec.
1310.04(f) of this chapter or is a listed chemical for which no
threshold has been established as identified in Sec. 1310.04(g) of
this chapter, must notify the Administration of the intended import by
filing an import declaration (on DEA Form 486/486A) not later than 15
calendar days before the date of release by a customs officer at the
port of entry. Regulated persons who seek to import a listed chemical
below the threshold quantities identified in Sec. 1310.04(f) of this
chapter are not required to file an import declaration in advance of
the release by a customs officer.
(b) A complete and accurate declaration (DEA Form 486/486A) must be
filed with the Administration through the DEA Office of Diversion
Control secure network application not later than 15 calendar days
prior to the date of release by a customs officer at the port of entry.
The declaration must be signed and dated by the importer and must
contain the address of the final destination for the shipment, which
for List I chemicals must be a registered location of the importer.
Upon receipt and review, the Administration will assign a transaction
identification number to each completed declaration. The 15 calendar
days shall begin on the date that the regulated person submits a
completed declaration, without regard to the date that the
Administration assigns a transaction identification number. Listed
chemicals meeting or exceeding the threshold quantities identified in
Sec. 1310.04(f) of this chapter or for which no threshold has been
established may not be imported until a transaction identification
number has been issued.
(c) The 15-calendar-day advance notification requirement for listed
chemical imports may be waived, in whole or in part, for the following:
* * * * *
(d) For imports meeting the requirements of paragraph (c)(1) of
this section, the declaration (DEA Form 486/486A) must be filed with
the Administration through the DEA Office of Diversion Control secure
network application at least three business days before the date of
release by a customs officer at the port of entry. The declaration must
be signed and dated by the importer and must contain the address of the
final destination for the shipment, which must be a registered location
of the importer (for List I chemicals). Upon receipt and review, the
Administration will assign a transaction identification number to each
completed declaration. The importer may proceed with the import
transaction only once the transaction identification number has been
issued.
(e) For importations where advance notification is waived pursuant
to paragraph (c)(2) of this section no DEA Form 486 is required;
however, the regulated person must submit quarterly reports to the
Regulatory Section, Office of Diversion Control, Drug Enforcement
Administration, not later than the 15th day of the month following the
end of each quarter. See the Table of DEA Mailing Addresses in Sec.
1321.01 of this chapter for the current mailing address. The report
shall contain the following information regarding each individual
importation:
* * * * *
0
64. Revise Sec. 1313.13 to read as follows:
Sec. 1313.13 Requirements of import declaration.
(a) Any List I or List II chemical listed in Sec. 1310.02 of this
chapter may be imported if that chemical is necessary for medical,
commercial, scientific, or other legitimate uses within the United
[[Page 63624]]
States. Chemical importations into the United States for immediate
transfer/transshipment outside the United States must comply with the
procedures set forth in Sec. 1313.31 and all other applicable laws.
(b) The DEA Form 486/486A must include the following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
chemical importer; the name/business name, address/business address,
and contact information (e.g., telephone number(s), email address(es),
etc.) of the broker or forwarding agent (if any); and
(2) The name and description of each listed chemical as it appears
on the label or container, the name of each chemical as it is
designated in Sec. 1310.02 of this chapter, the size or weight of
container, the number of containers, the net weight of each listed
chemical given in kilograms or parts thereof, and the gross weight of
the shipment given in kilograms or parts thereof; and
(3) The date of release by a customs officer at the port of entry,
the foreign port and country of export, and the port of entry; and
(4) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignor in the foreign country of exportation; and
(5) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
person or persons to whom the importer intends to transfer the listed
chemical and the quantity to be transferred to each transferee.
(c) Any regulated person importing ephedrine, pseudoephedrine, or
phenylpropanolamine must submit, on the import declaration (DEA Form
486A), all information known to the importer on the chain of
distribution of the chemical from the manufacturer to the importer.
Ephedrine, pseudoephedrine, or phenylpropanolamine include each of the
salts, optical isomers, and salts of optical isomers of the chemical.
(d) Import declarations shall become void and of no effect 180
calendar days after the date the declaration is deemed filed with the
Administration.
0
65. Revise Sec. 1313.14 to read as follows:
Sec. 1313.14 Disposition of import declaration.
The importer, or their agent, must submit an official record of the
import declaration and/or required data concerning the import
transaction to a customs officer at the port of entry in compliance
with all import control requirements of agencies with import control
authorities under the Act or statutory authority other than the
Controlled Substances Import and Export Act. The final destination of
the import transaction must only be the registered location of the
importer (i.e., drop shipments are prohibited). A regulated person must
maintain an official record of the declaration (available from the DEA
Office of Diversion Control secure network application after the
Administration issues a transaction identification number) in
accordance with part 1310 of this chapter as the record of the import.
Official records of import declarations involving listed chemicals must
be retained for two years.
0
66. In Sec. 1313.15, revise the section heading and paragraph (b) to
read as follows:
Sec. 1313.15 Qualification of regular importers.
* * * * *
(b) Each regulated person making application under paragraph (a) of
this section shall be considered a ``regular importer'' 30 calendar
days after receipt of the application by the Administration, as
indicated on the return receipt, unless the regulated person is
otherwise notified in writing by the Administration.
* * * * *
0
67. In Sec. 1313.16, revise the section heading and paragraph (b) to
read as follows:
Sec. 1313.16 Updated notice for change in circumstances.
* * * * *
(b) After a notice under Sec. 1313.12(a) or (d) is submitted to
the Administration, if circumstances change and the importer will not
be transferring the listed chemical to the transferee identified in the
notice, or will be transferring a greater quantity of the chemical than
specified in the notice, the importer must update the notice to
identify the most recent prospective transferee or the most recent
quantity or both (as the case may be) and may not transfer the listed
chemical until after the expiration of the 15-calendar-day period
beginning on the date on which the update is filed with the
Administration, or, if the import is being made by a regular importer
or intended for transfer to a regular customer, 3 business days. The
preceding sentence applies with respect to changing circumstances
regarding a transferee or quantity identified in an update to the same
extent and in the same manner as the sentence applies with respect to
changing circumstances regarding a transferee or quantity identified in
the original notice under Sec. 1313.12(a) or (d). Amended declarations
must be submitted to the Administration through the DEA Office of
Diversion Control secure network application. The amendment must be
signed and dated by the importer. Upon receipt and review, the
Administration will assign each completed amendment a transaction
identification number. Such shipment of listed chemicals may not be
imported into the United States until the transaction identification
number has been issued.
* * * * *
0
68. Revise Sec. 1313.17 to read as follows:
Sec. 1313.17 Return declaration for imports.
(a) Return information. Within 30 calendar days after actual
receipt of a listed chemical at the importer's registered location or
place of business if not required to be registered, the importer must
file a report with the Administration through the DEA Office of
Diversion Control secure network application specifying the particulars
of the transaction. This report must include the following information:
The date on which the the listed chemical was released by a customs
officer at the port of entry; the date on which the listed chemical
arrived at the importer's registered location or place of business; the
actual quantity of the listed chemical released; the actual quantity of
the listed chemical that arrived at the importer's location; the date
of any subsequent transfer; a description of the subsequent transfer,
including the actual quantity transferred, chemical, container, and
name of transferees; the actual port of entry; and any other
information as the Administration may specify. A single report may
include the particulars of both the importation and distribution. If
the importer has not distributed all chemicals imported by the end of
the initial 30-calendar-day period, the importer must file supplemental
reports not later than 30 calendar days from the date of any further
distribution, until the distribution or other disposition of all
chemicals imported under the import declaration or any amendment or
other update is accounted for. Upon receipt and review, the
Administration will assign each completed report a transaction
identification number. In determining whether the importer has complied
with the requirement to file within 30 calendar days, the report shall
[[Page 63625]]
be deemed filed on the first date on which a complete report is filed.
(b) If an importation for which a DEA Form 486/486A has been filed
fails to take place, the importer must report to the Administration
that the importation did not occur through the DEA Office of Diversion
Control secure network application.
(c) Denied release at the port of entry. In the event that a
shipment of listed chemicals has been denied release by a customs
officer at the port of entry for any reason, the importer who attempted
to have the shipment released, within 24-hours of the denial, report to
the Administration that the shipment was denied release and the reason
for denial. Such report must be transmitted to the Administration
through the DEA Office of Diversion Control secure network application.
This report must include the following information: the quantity of the
listed chemical denied release; the date on which release was denied;
and the basis for the denied release. Upon the importer's report of a
denied release, the DEA will assign the report a transaction
identification number and the import declaration will be void and of no
effect. No shipment of listed chemicals denied release for any reason
will be allowed entry into the United States without a subsequent
refiling of an import declaration. Following such refiling the importer
may request release of the listed chemicals immediately after receipt
of a transaction identification number without regard to the 15 day
advance filing requirement in Sec. 1313.12(b).
0
69. In Sec. 1313.21, revise the section heading, paragraphs (a), (b),
(c) introductory text, (d), and (e) introductory text, and add
paragraph (h) to read as follows:
Sec. 1313.21 Notification prior to export.
(a) Each regulated person who seeks to export a listed chemical
that meets or exceeds the threshold quantities identified in Sec.
1310.04(f) of this chapter, or is a listed chemical for which no
threshold has been established as identified in Sec. 1310.04(g) of
this chapter, must notify the Administration of the intended export by
filing an export declaration (DEA Form 486) not later than 15 calendar
days before the date of release by a customs officer at the port of
export. Regulated persons who seek to export a listed chemical below
the threshold quantities identified in Sec. 1310.04(f) of this chapter
are not required to file an export declaration in advance of the
export.
(b) A complete and accurate declaration (DEA Form 486) must be
filed with the Administration through the DEA Office of Diversion
Control secure network application not later than 15 calendar days
prior to the date of release by a customs officer at the port of
export. The declaration must be signed and dated by the exporter and
must contain the address from which the listed chemicals will be
shipped for exportation. Upon receipt and review, the Administration
will assign a transaction identification number to each completed
declaration. The 15 calendar days shall begin on the date that the
regulated person files a completed declaration without regard to the
date that the Administration assigns a transaction identification
number. Exporters may not request release of a listed chemical until a
transaction identification number has been issued.
(c) The 15-calendar-day advance notification requirement for listed
chemical exports may be waived, in whole or in part, for:
* * * * *
(d) For exports meeting the requirements of paragraph (c)(1) of
this section, the declaration (DEA Form 486) must be filed with the
Administration through the DEA Office of Diversion Control secure
network application at least three business days before the date of
release by a customs officer. The declaration must be signed and dated
by the exporter and must contain the address from which the listed
chemicals will be shipped for exportation. Upon receipt and review, the
Administration will assign a transaction identification number to each
completed declaration. The exporter may only proceed with the export
transaction once the transaction identification number has been issued.
(e) For exportations where advance notification is waived pursuant
to paragraph (c)(2) of this section no DEA Form 486 is required;
however, the regulated person must submit quarterly reports with the
Regulatory Section, Office of Diversion Control, Drug Enforcement
Administration, not later than the 15th day of the month following the
end of each quarter. See the Table of DEA Mailing Addresses in Sec.
1321.01 of this chapter for the current mailing address. Such report
shall contain the following information regarding each individual
exportation:
* * * * *
(h) Export declarations shall become void and of no effect 180
calendar days after the date the declaration is deemed filed with the
Administration.
0
70. Revise Sec. 1313.22 to read as follows:
Sec. 1313.22 Export declaration.
(a) Any List I or List II chemical listed in Sec. 1310.02 of this
chapter which meets or exceeds the quantitative threshold criteria
established in Sec. 1310.04(f) of this chapter or is a listed chemical
for which no threshold has been established as identified in Sec.
1310.04(g) of this chapter, may be exported if that chemical is needed
for medical, commercial, scientific, or other legitimate uses.
(b) The export declaration (DEA Form 486) must include all the
following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
chemical exporter; the name/business name, address/business address,
and contact information (e.g., telephone number(s), email address(es),
etc.) of the export broker, if any;
(2) The name and description of each listed chemical as it appears
on the label or container, the name of each listed chemical as it is
designated in Sec. 1310.02 of this chapter, the size or weight of
container, the number of containers, the net weight of each listed
chemical given in kilograms or parts thereof, and the gross weight of
the shipment given in kilograms or parts thereof;
(3) The anticipated date of release by a customs officer at the
port of export, the port of export, and the foreign port and country of
entry; and
(4) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignee in the country where the chemical shipment is destined; the
name(s) and address(es) of any intermediate consignee(s); and a copy of
the foreign permit, license or registration issued by the competent
national authority of the consignee and any intermediate consignees.
(c) Declared exports of listed chemicals which are refused,
rejected, or otherwise deemed undeliverable by the foreign competent
national authority may be returned to the U.S. chemical exporter of
record. The regulated person must provide notification through the DEA
Office of Diversion Control secure network application (this does not
require a DEA Form 486) outlining the circumstances within a reasonable
time following the return. Upon receipt and review, the Administration
will assign the completed notice a transaction identification number.
The notice will not be deemed filed until the Administration issues a
transaction identification number. Listed chemicals so returned may not
be reexported until the exporter has filed a new DEA Form 486 and the
Administration has issued a new transaction identification
[[Page 63626]]
number. This provision does not apply to shipments that have cleared
foreign customs, been delivered, and accepted by the foreign consignee.
Returns to third parties in the United States will be regarded as
imports.
0
71. Revise Sec. 1313.23 to read as follows:
Sec. 1313.23 Disposition of export declaration.
The exporter, or their agent, must submit an official record of the
export declaration and/or required data concerning the export
transaction to a customs officer at the port of export in compliance
with all export control requirements of agencies with export control
authorities under the Act or statutory authority other than the
Controlled Substances Import and Export Act. An official record of the
declaration (available from the DEA Office of Diversion Control secure
network application after the Administration issues a transaction
identification number) must be maintained by the chemical exporter as
the official record of the export in accordance with part 1310 of this
chapter. Export declarations involving a listed chemical must be
retained for two years.
0
72. In Sec. 1313.26, revise the section heading and paragraph (b) to
read as follows:
Sec. 1313.26 Updated notice for change in circumstances.
* * * * *
(b) After a notice under Sec. 1313.21(a) is submitted to the
Administration, if circumstances change and the exporter will not be
transferring the listed chemical to the transferee identified in the
notice, or will be transferring a greater quantity of the chemical than
specified in the notice, the exporter must update the notice to
identify the most recent prospective transferee or the most recent
quantity or both (as the case may be). The exporter may not transfer
the listed chemical until after the expiration of the 15-calendar-day
period beginning on the date on which the update is filed with the
Administration. Except, if the listed chemical is intended for transfer
to a regular customer, the exporter may not transfer the listed
chemical until after the expiration ofthree business days. The
preceding sentence applies with respect to changing circumstances
regarding a transferee or quantity identified in an update to the same
extent and in the same manner as the sentence applies with respect to
changing circumstances regarding a transferee or quantity identified in
the original notice under paragraph (a) of this section. Amended
declarations must be submitted to the Administration through the DEA
Office of Diversion Control secure network application. The amendment
must be signed and dated by the exporter. Upon receipt and review, the
Administration will assign each completed amendment a transaction
identification number. The amendment will not be deemed filed until the
Administration issues a transaction identification number.
* * * * *
0
73. Revise Sec. 1313.27 to read as follows:
Sec. 1313.27 Return declaration for exports.
(a) Return information. Within 30 calendar days after a listed
chemical is released by a customs officer at the port of export, the
exporter must file a report with the Administration through the DEA
Office of Diversion Control secure network application specifying the
particulars of the transaction. This report must include the following
information: the date on which the listed chemical left the registered
location or place of business; the date on which the listed chemical
was released by a customs officer at the port of export; the actual
quantity of listed chemical that left the registered location or place
of business; the actual quantity of the listed chemical released by a
customs officer at the port of export; chemical; container; name of
transferees; and any other information as the Administration may
specify. Upon receipt and review, the Administration will assign a
completed report a transaction identification number. The report will
not be deemed filed until the Administration has issued a transaction
identification number. In determining whether the exporter has complied
with the requirement to file within 30 calendar days, the report shall
be deemed filed on the first date on which a complete report is filed.
(b) If an exportation for which a DEA Form 486 has been filed fails
to take place, the exporter must report to the Administration that the
exportation did not occur through the DEA Office of Diversion Control
secure network application.
(c) Denied release at the port of export. In the event that a
shipment of listed chemicals has been denied release by a customs
officer at the port of export for any reason, the exporter who
attempted to have the shipment released must, within 24-hours of the
denial, report to the Administration that the shipment was denied
release and the reason for denial. Such report must be transmitted to
the Administration through the DEA Office of Diversion Control secure
network application. This report must include the following
information: the quantity of the listed chemicals denied release; the
date on which release was denied; and the basis for the denied release.
Upon the exporter's report of a denied release, DEA will assign the
report a transaction identification number and the export declaration
will be void and of no effect. No shipment of listed chemicals denied
release for any reason will be allowed to be released from the United
States without a subsequent refiling of a complete and accurate export
declaration. Following such refiling, the exporter may request the
release of the listed chemicals immediately after receipt of a
transaction identification number without regard to the 15 day advance
filing required by paragraph Sec. 1313.21(b).
0
74. In Sec. 1313.31, revise paragraph (b) introductory text and
paragraphs (b)(7), (b)(8), (b)(14), and (b)(15) to read as follows:
Sec. 1313.31 Advance notice of importation for transshipment or
transfer.
* * * * *
(b) Advance notification must be provided to the Regulatory
Section, Office of Diversion Control, Drug Enforcement Administration,
not later than 15 calendar days prior to the proposed date the listed
chemical will transship or transfer through the United States. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address. A separate notification is required for each
shipment of listed chemicals to be transferred or transshipped. The
written notification (not a DEA Form 486) must contain the following
information:
* * * * *
(7) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) and
type of business of the foreign exporter;
(8) The foreign port and country of export;
* * * * *
(14) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) and
type of business of the consignee at the foreign port or country of
entry;
(15) The shipping route from the U.S. port of export to the foreign
port or country of entry at final destination;
* * * * *
0
75. Revise Sec. 1313.32 to read as follows:
[[Page 63627]]
Sec. 1313.32 Notification of international transactions.
(a) A broker or trader must notify the Administration prior to an
international transaction involving a listed chemical which meets or
exceeds the threshold quantities identified in Sec. 1310.04(f) of this
chapter or is a listed chemical for which no threshold has been
established as identified in Sec. 1310.04(g) of this chapter, in which
the broker or trader participates. Notification must be made not later
than 15 calendar days before the transaction is to take place. In order
to facilitate an international transaction involving listed chemicals
and implement the purpose of the Act, regulated persons may wish to
provide advance notification to the Administration as far in advance of
the 15 calendar days as possible.
(b) A completed DEA Form 486 must be submitted to the
Administration through the DEA Office of Diversion Control secure
network application, not later than 15 calendar days prior to the
international transaction. The DEA Form 486 must be signed and dated by
the broker or trader. Upon receipt and review, the Administration will
assign a transaction identification number to each completed
notification. A notification is not deemed filed, and therefore is not
valid, until the Administration assigns the notification a transaction
identification number. An international transaction may not take place
until after a transaction identification number has been assigned and
the expiration of the 15-calendar-day period beginning on the date on
which the broker or trader submits a complete notification to the
Administration.
(c) No person shall serve as a broker or trader for an
international transaction involving a listed chemical knowing or having
reasonable cause to believe that the transaction is in violation of the
laws of the country to which the chemical is exported or the chemical
will be used to manufacture a controlled substance in violation of the
laws of the country to which the chemical is exported. The
Administration will publish a notice of foreign import restrictions for
listed chemicals of which DEA has knowledge as provided in Sec.
1313.25.
(d) After a notice under paragraph (a) of this section is submitted
to the Administration, if circumstances change and the broker or trader
will not be transferring the listed chemical to the transferee
identified in the notice, or will be transferring a greater quantity of
the chemical than specified in the notice, the broker or trader must
amend the notice through the DEA Office of Diversion Control secure
network application to identify the most recent prospective transferee
or the most recent quantity or both (as applicable) and may not
transfer the listed chemical until after the expiration of the 15-
calendar-day period beginning on the date on which the update is
submitted to the Administration. The preceding sentence applies with
respect to changing circumstances regarding a transferee or quantity
identified in an amendment to the same extent and in the same manner as
the sentence applies with respect to changing circumstances regarding a
transferee or quantity identified in the original notice under
paragraph (a) of this section.
(e) For purposes of this section:
(1) The term transfer, with respect to a listed chemical, includes
the sale of the chemical.
(2) The term transferee means a person to whom an exporter
transfers a listed chemical.
0
76. Revise Sec. 1313.33(b) and (c) to read as follows:
Sec. 1313.33 Contents of an international transaction declaration.
* * * * *
(b) Any broker or trader who desires to arrange an international
transaction, defined in 21 U.S.C. 802(42), involving a listed chemical
which meets the threshold criteria set forth in Sec. 1310.04 of this
chapter must notify the Administration through the procedures outlined
in Sec. 1313.32(b).
(c) The DEA Form 486 must include:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
chemical exporter; the name/business name, address/business address,
and contact information (e.g., telephone number(s), email address(es),
etc.) of the chemical importer;
(2) The name and description of each listed chemical as it appears
on the label or container, the name of each listed chemical as it is
designated in Sec. 1310.02 of this chapter, the size or weight of
container, the number of containers, the net weight of each listed
chemical given in kilograms or parts thereof, and the gross weight of
the shipment given in kilograms or parts thereof;
(3) The anticipated date of release at the foreign port of export,
the anticipated foreign port and country of export, and the foreign
port and country of entry; and
(4) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignee in the country where the chemical shipment is destined; the
name(s) and address(es) of any intermediate consignee(s).
0
77. Revise Sec. 1313.34 to read as follows:
Sec. 1313.34 Disposition of the international transaction
declaration.
The broker or trader must retain an official record of the
declaration (DEA Form 486) (available from the DEA Office of Diversion
Control secure network application after the Administration issues a
transaction identification number) as the official record of the
international transaction. In accordance with part 1310 of this
chapter, declarations involving listed chemicals must be retained for
two years.
0
78. Revise Sec. 1313.35 to read as follows:
Sec. 1313.35 Return declaration or amendment to Form 486 for
international transactions.
(a) Within 30 calendar days after an international transaction is
completed, the broker or trader must file a report with the
Administration through the DEA Office of Diversion Control secure
network application about the particulars of the transaction. This
report must include the following information: the date(s) on which the
listed chemical was released by the foreign customs officer(s) at the
port(s); the actual quantity of listed chemical that left the country
of export; the actual quantity of the listed chemical released by a
customs officer at the port of entry; chemical; container; name of
transferees; and the transaction identification and any other
information as the Administration may specify. Upon receipt and review,
the Administration will assign a completed report a transaction
identification number. The report will not be deemed filed until the
Administration has issued a transaction identification number.
(b) If an international transaction for which a DEA Form 486 has
been filed fails to take place, the broker or trader must report to the
Administration that the international transaction did not occur
utilizing the DEA Office of Diversion Control secure network
application as soon as the broker or trader becomes aware of the
circumstances.
PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
0
79. The authority citation for part 1314 continues to read as follows:
[[Page 63628]]
Authority: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.
Sec. 1314.110 [Amended]
0
80. In Sec. 1314.110, in paragraphs (a)(1) and (2), remove the phrase
``Import/Export Unit,'' and add in its place ``Regulatory Section,
Office of Diversion Control,''.
PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE,
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
0
81. The authority citation for part 1315 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.
Sec. 1315.22 [Amended]
0
82. In Sec. 1315.22, remove ``Drug & Chemical Evaluation Section, Drug
Enforcement Administration'' from the second sentence of the
introductory text and add in its place ``UN Reporting & Quota Section,
Office of Diversion Control, Drug Enforcement Administration''.
Sec. 1315.27 [Amended]
0
83. In Sec. 1315.27, remove ``Drug & Chemical Evaluation Section'' and
add in its place ``UN Reporting & Quota Section, Office of Diversion
Control, Drug Enforcement Administration''.
Sec. 1315.32 [Amended]
0
84. In Sec. 1315.32(e) and (g), remove ``Drug & Chemical Evaluation
Section, Drug Enforcement Administration'' wherever it appears and add
in its place ``UN Reporting & Quota Section, Office of Diversion
Control, Drug Enforcement Administration''.
Sec. 1315.34 [Amended]
0
85. In Sec. 1315.34(d), remove ``Drug & Chemical Evaluation Section''
from the second sentence and add in its place ``UN Reporting & Quota
Section, Office of Diversion Control, Drug Enforcement
Administration''.
Sec. 1315.36 [Amended]
0
86. In Sec. 1315.36(b), remove ``Drug & Chemical Evaluation Section,
Drug Enforcement Administration'' from the second sentence and add in
its place ``UN Reporting & Quota Section, Office of Diversion Control,
Drug Enforcement Administration''.
PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
0
87. The authority citation for part 1316, subpart D continues to read
as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.
0
88. Revise Sec. 1316.47(a) to read as follows:
Sec. 1316.47 Request for hearing.
(a) Any person entitled to a hearing and desiring a hearing shall,
within the period permitted for filing, file a request for a hearing
and/or an answer that complies with the following format (see the Table
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address):
(Date)-----------------------------------------------------------------
Drug Enforcement Administration, Attn: Hearing Clerk/OALJ
(Mailing Address)------------------------------------------------------
Subject: Request for Hearing
Dear Hearing Clerk:
The undersigned___(Name of the Person) hereby requests a hearing in
the matter of:___(Identification of the proceeding).
(A) (State with particularity the interest of the person in the
proceeding.)
(B) (State with particularity the objections or issues, if any,
concerning which the person desires to be heard.)
(C) (State briefly the position of the person with regard to the
particular objections or issues.)
All notices to be sent pursuant to the proceeding should be
addressed to:
(Name)-----------------------------------------------------------------
(Street Address)-------------------------------------------------------
(City and State)-------------------------------------------------------
Respectfully yours,
(Signature of Person)--------------------------------------------------
* * * * *
0
89. Revise Sec. 1316.48 to read as follows:
Sec. 1316.48 Notice of appearance.
Any person entitled to a hearing and desiring to appear in any
hearing, shall, if he or she has not filed a request for hearing, file
within the time specified in the notice of proposed rulemaking, a
written notice of appearance in the following format (see the Table of
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address):
(Date)-----------------------------------------------------------------
Drug Enforcement Administration, Attn: Hearing Clerk/OALJ
(Mailing Address)------------------------------------------------------
Subject: Notice of Appearance
Dear Hearing Clerk:
Please take notice that___(Name of person) will appear in the
matter of:___(Identification of the proceeding).
(A) (State with particularity the interest of the person in the
proceeding.).
(B) (State with particularity the objections or issues, if any,
concerning which the person desires to be heard.).
(C) (State briefly the position of the person with regard to the
particular objections or issues.).
All notices to be sent pursuant to this appearance should be
addressed to:
(Name)-----------------------------------------------------------------
(Street Address)-------------------------------------------------------
(City and State)-------------------------------------------------------
Respectfully yours,
(Signature of Person)--------------------------------------------------
PART 1321--DEA MAILING ADDRESSES
0
90. The authority citation for part 1321 continues to read:
Authority: 21 U.S.C. 871(b).
0
91. Revise Sec. 1321.01 to read as follows:
Sec. 1321.01 DEA mailing addresses.
The following table provides information regarding mailing
addresses to be used when sending specified correspondence to the Drug
Enforcement Administration.
Table of DEA Mailing Addresses
------------------------------------------------------------------------
Code of Federal Regulations Section--
Topic DEA mailing address
------------------------------------------------------------------------
DEA Administrator
------------------------------------------------------------------------
1308.43(b)--Petition to initiate Drug Enforcement
proceedings for rulemaking. Administration, Attn:
1316.23(b)--Petition for grant of Administrator, 8701
confidentiality for research subjects. Morrissette Drive,
1316.24(b)--Petition for exemption from Springfield, VA 22152.
prosecution for researchers..
------------------------------------------------------------------------
[[Page 63629]]
DEA Office of Diversion Control
------------------------------------------------------------------------
1307.03--Exception request filing. Drug Enforcement
1307.22--Delivery of surrendered and Administration, Attn: Office
forfeited controlled substances.. of Diversion Control/OD, 8701
1310.21(b)--Sale by Federal departments Morrissette Drive,
or agencies of chemicals which could Springfield, VA 22152.
be used to manufacture controlled
substances certification request.**.
------------------------------------------------------------------------
DEA Regulatory Section
------------------------------------------------------------------------
1301.71(d)--Security system compliance Drug Enforcement
review for controlled substances. Administration, Attn:
1309.71(c)--Security system compliance Regulatory Section/ODG, 8701
review for List I chemicals. Morrissette Drive,
Springfield, VA 22152.
1310.03(c)--Mail-Order reports
involving transactions with
nonregulated persons or exports.*
1310.05(b)(1)--Unusual or excessive
loss or disappearance of listed
chemicals
1310.05(b)(2)--Reports of domestic
regulated transactions in a tableting
machine or an encapsulating machine.*
1310.05(c)(1)--Reports of imports and
exports of a tableting machine or an
encapsulating machine.*
1310.05(c)(2)--Report of declared
exports of machines refused, rejected,
or returned.
1312.12(a)--Application for import
permit (DEA Form 357).*
1312.18(b)--Import declaration (DEA
Form 236) submission.*
1312.22(g)(8)--Request for return of
unacceptable or undeliverable exported
controlled substances.*
1312.27(a)--Controlled substances
export declaration (DEA Form 236)
filing.*
1312.31(b)--Controlled substances
transshipment permit application.
1312.32(a)--Advanced notice of
importation for transshipment or
transfer of controlled substances.
1313.12(b)--Authorization to import
listed chemicals (DEA Form 486/486A).*
1313.12(e)--Quarterly reports of listed
chemicals importation.
1313.21(b)--Authorization to export
listed chemicals (DEA Form 486).*
1313.21(e)--Quarterly reports of listed
chemicals exportation.
1313.22(c)--Notice of declared exports
of listed chemicals refused, rejected
or undeliverable.*
1313.31(b)--Advanced notice of
importation for transshipment or
transfer of listed chemicals.
1313.32(b)(1)--International
transaction authorization (DEA Form
486).*
1314.110(a)(1)--Reports for mail-order
sales.
1314.110(a)(2)--Request to submit mail-
order sales reports.
------------------------------------------------------------------------
DEA Drug & Chemical Evaluation Section
------------------------------------------------------------------------
1308.21(a)--Exclusion of nonnarcotic Drug Enforcement
substance. Administration, Attn: Drug &
1308.23(b)--Exemption for chemical Chemical Evaluation Section/
preparations.. ODE, 8701 Morrissette Drive,
Springfield, VA 22152.
1308.24(d)--Exempt narcotic chemical
preparations importer/exporter
reporting.
1308.24(i)--Exempted chemical
preparations listing.
1308.25(a)--Exclusion of veterinary
anabolic steroid implant product
application.
1308.26(a)--Excluded veterinary
anabolic steroid implant products
listing.
1308.31(a)--Exemption of a nonnarcotic
prescription product application.
1308.32--Exempted prescription products
listing.
1308.33(b)--Exemption of certain
anabolic steroid products application.
1308.34--Exempted anabolic steroid
products listing.
1310.13(b)--Exemption for chemical
preparations.
1310.05(d)--Bulk manufacturer of listed
chemicals reporting.
------------------------------------------------------------------------
UN Reporting & Quota Section
------------------------------------------------------------------------
1303.12(b)--Application for controlled Drug Enforcement
substances procurement quota (DEA Form Administration, Attn: UN
250) filing and request. Reporting & Quota Section/ODQ,
8701 Morrissette Drive,
Springfield, VA 22152.
1303.12(d)--Controlled substances quota
adjustment request.
[[Page 63630]]
1303.22--Application for individual
manufacturing quota (DEA Form 189)
filing and request for schedule I or
II controlled substances.
1304.31(a)--Manufacturers importing
narcotic raw material report
submission.
1304.32(a)--Manufacturers importing
coca leaves report submission.
315.22--Application for individual
manufacturing quota for ephedrine,
pseudoephedrine, phenylpropanolamine
(DEA Form 189) filing and request.
1315.32(e)--Application for procurement
quota for ephedrine, pseudoephedrine,
phenylpropanolamine (DEA Form 250)
filing and request.
1315.32(g)--Procurement quota
adjustment request for ephedrine,
pseudoephedrine, phenylpropanolamine.
1315.34(d)--Application for import
quota for ephedrine, pseudoephedrine,
phenylpropanolamine (DEA Form 488)
request and filing.
1315.36(b)--Request import quota
increase for ephedrine,
pseudoephedrine, or
phenylpropanolamine
------------------------------------------------------------------------
Pharmaceutical Investigations Section
------------------------------------------------------------------------
1304.04(d)--ARCOS separate central Drug Enforcement
reporting identifier request. Administration, Attn: ARCOS
1304.33(a)--Reports to ARCOS........... Unit/ODPT, P.O. Box 2520,
Springfield, VA 22152-2520 OR
Drug Enforcement
Administration, Attn: ARCOS
Unit, 8701 Morrissette Drive,
Springfield, VA 22152.
------------------------------------------------------------------------
DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request Drug Enforcement
(controlled substances registration). Administration, Attn:
1301.13(e)(2)--Request DEA Forms 224, Registration Section/ODR P.O.
225, and 363.. Box 2639, Springfield, VA
22152-2639.
1301.14(a)--Controlled substances
registration application submission.
1301.18(c)--Research project controlled
substance increase request.
1301.51--Controlled substances
registration modification request.
301.52(b)--Controlled substances
registration transfer request.
1301.52(c)--Controlled substances
registration discontinuance of
business activities notification.
1309.03--List I chemicals registration
procedures information request.
1309.32(c)--Request DEA Form 510.
1309.33(a)--List I chemicals
registration application submission.
1309.61--List I chemicals registration
modification request.
------------------------------------------------------------------------
DEA Hearing Clerk
------------------------------------------------------------------------
1301.43--Request for hearing or Drug Enforcement
appearance; waiver. Administration, Attn: Hearing
1303.34--Request for hearing or Clerk/OALJ, 8701 Morrissette
appearance; waiver.. Drive, Springfield, VA 22152.
1308.44--Request for hearing or
appearance; waiver.
1316.45--Hearings documentation filing.
1316.46(a)--Inspection of record.
1316.47(a)--Request for hearing........
1316.48--Notice of appearance.
------------------------------------------------------------------------
DEA Federal Register Representative
------------------------------------------------------------------------
1301.33(a)--Filing of written comments http://www.regulations.gov/.
regarding application for bulk Drug Enforcement
manufacture of Schedule I and II Administration, Attn: Federal
substances.** Register Representative/ODW,
1301.34(a)--Filing of written comments 8701 Morrissette Drive,
regarding application for importation Springfield, VA 22152.
of Schedule I and II substances.**.
1303.11(c)--Filing of written comments
regarding notice of an aggregate
production quota.**
1303.13(c)--Filing of written comments
regarding adjustments of aggregate
production quotas.**
1303.13(c)--Filing of written comments
regarding adjustments of aggregate
production quotas.**
1308.43(g)--Filing of written comments
regarding initiation of proceedings
for rulemaking.**
------------------------------------------------------------------------
* Applications/filings/reports are required to be filed electronically
in accordance with this chapter.
** Applications/filings/reports may be filed electronically in
accordance with this chapter.
[[Page 63631]]
Dated: September 1, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-21589 Filed 9-14-16; 8:45 am]
BILLING CODE 4410-09-P