[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Rules and Regulations]
[Pages 96992-97044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28966]
[[Page 96991]]
Vol. 81
Friday,
No. 251
December 30, 2016
Part IV
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 (ITDS);
Revision of Reporting Requirements for Domestic Transactions in Listed
Chemicals and Tableting and Encapsulating Machines; and Technical
Amendments; Final Rule
Federal Register / Vol. 81 , No. 251 / Friday, December 30, 2016 /
Rules and Regulations
[[Page 96992]]
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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
(ITDS); 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: Final rule.
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SUMMARY: The Drug Enforcement Administration is updating 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 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 (ITDS). This rule additionally
contains amendments that 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 rule also includes additional substantive and technical and
stylistic amendments.
DATES: This rule is effective January 30, 2017. However, compliance
with the revisions to DEA regulations made by this rule is not required
until June 28, 2017.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Outline
I. Background and Purpose
A. Legal Authority
B. Purpose of Regulatory Action
1. Executive Order 13659
2. Pilot Program
3. Notice of Proposed Rulemaking
C. Summary of the Major Provisions of the Regulatory Action
1. Mandatory Electronic Applications and Filings
2. Import and Export Permits for Controlled Substances
3. Import and Export Declarations for Controlled Substances
4. Imports, Exports, and International Transactions for Listed
Chemicals
5. Reexportation of Controlled Substances Among Members of the
European Economic Area
6. Domestic Transaction and Import and Export Reports for
Tableting and Encapsulating Machines
7. Mail Order Reporting for Ephedrine, Pseudoephedrine,
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
8. Transshipments of Controlled Substances
9. Transshipments of Listed Chemicals
D. List of Changes in the Final Rule
II. Discussion of Comments
A. Electronic Applications and Filings, Generally (5 Issues)
B. Import and Export Permits for Controlled Substances (6
Issues)
C. Import and Export Declarations for Controlled Substances (1
Issue)
D. Import and Export Declarations and Notices for Listed
Chemicals (13 Issues)
E. Reexportation of Controlled Substances Among Members of the
European Economic Area (3 Issues)
F. Miscellaneous Comments (2 Issues)
G. Others
III. Section by Section Summary of the Final Rule
A. 21 CFR Part 1300
B. 21 CFR Part 1301
C. 21 CFR Part 1302
D. 21 CFR Part 1303
E. 21 CFR Part 1304
F. 21 CFR Part 1308
G. 21 CFR Part 1309
H. 21 CFR Part 1310
I. 21 CFR Part 1312
J. 21 CFR Part 1313
K. 21 CFR Part 1314
L. 21 CFR Part 1315
M. 21 CFR Part 1316
N. 21 CFR Part 1321
IV. 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 (21 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
[[Page 96993]]
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. 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 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.\5\ 28 CFR 0.100 et seq.
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\5\ Due to an internal reorganization, on September 19, 2016,
the DEA Office of Diversion Control became the Diversion Control
Division. Throughout the document any references referring to the
Office of Diversion Control have been updated to reflect this
change.
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Within the DEA, the Diversion Control Division 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 Diversion Control Division 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 Diversion Control Division 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. Purpose of Regulatory Action
1. Executive Order 13659
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 the International Trade Data System (ITDS) and supporting
systems of data and other relevant documents (exclusive of applications
for permits, licenses, or certifications) required for imported and
exported goods. Participating agencies are ``[a]ll federal agencies
that require
[[Page 96994]]
documentation for clearing or licensing the importation and exportation
of cargo.'' Section 3 of Executive Order 13659 describes the ITDS as
``an electronic information exchange capability, or ``single window,''
through which businesses will transmit data required by participating
agencies for the importation or exportation of cargo.'' Within the
ITDS, businesses are able to transmit their import and export data
using through an Electronic Data Interchange (EDI), an electronic
communication framework providing standards for exchanging data via any
electronic means. CBP has identified the Automated Commercial
Environment (ACE), and any successor system to ACE, to serve as an
authorized EDI for purposes of import and export data required by CBP
and participating agencies.
In light of Executive Order 13659, the DEA is updating its
regulations regarding the import and export of tableting and
encapsulating machines, controlled substances, and listed chemicals.
The amendments codify existing practices, incorporate existing
procedures and technological advancements, and implement the
President's Executive Order on streamlining the export/import process.
Previous DEA regulations specifically required applications for
permits, declarations, and other required notices and reports to be
filed in paper form, or by electronic means in some circumstances. To
comply with Executive Order 13659, the DEA is amending its regulations
to integrate DEA procedures related to the importation and exportation
of tableting and encapsulating machines, controlled substances, and
listed chemicals with the ITDS.
The ITDS excludes applications for permits, licenses, or
certifications. In light of this, DEA registrants and regulated persons
will continue to use the DEA application and filing process for permit
applications that must be completed in advance of importation or
exportation; however, the processes will be electronic rather than
paper. As a result, DEA registrants or regulated persons applying for
permits (DEA Forms 161, 161R, 161R-EEA, and 357) or filing
notifications or reports with the DEA will apply or file directly with
DEA electronically through the Diversion Control Division secure
network application.
The DEA import/export declarations (DEA Forms 236, 486 and 486A),
will also be replaced with an electronic process. Upon receipt of a
complete declaration through the Diversion Control Division secure
network application, DEA will provide the importer or exporter with the
notice of receipt that must then be filed with CBP as part of the CBP
import or export filing through ACE, or any successor system. DEA will
also transmit the declaration information electronically to CBP 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 is requiring such domestic regulated transaction
reports to be submitted through the DEA Diversion Control Division
secure network application, in addition to import and export regulated
transactions. Mandatory reporting requirements for domestic regulated
transactions are included as part of this rule 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.
Additionally, this final rule contains amendments that 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.
This rule 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.
2. Pilot Program
The DEA published a general notice in the Federal Register
announcing, in coordination with U.S. Customs and Border Protection
(CBP), a pilot test of the ITDS involving the electronic submission of
data related to the importation and exportation of controlled
substances and listed chemicals.\6\ The pilot program is testing the
electronic transmission through CBP's ACE system, of data, forms and
documents required by the DEA using the Partner Government Agency (PGA)
Message Set and the Document Image System (DIS). The data, forms, and
documents will be transmitted for review by the DEA. The PGA Message
Set and DIS would enable importers, exporters, and brokers to
electronically transmit data required by the DEA directly through ACE;
this electronic process will replace certain paper-based processes that
are used outside of the pilot program.
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\6\ Electronic Filing of Certain Import/Export Data Relating to
Controlled Substances and Listed Chemicals: Announcement of the
Partner Government Agency Message Set/Document Image System Test and
Request for Participants, July 15, 2016. 81 FR 46058-89. To be
eligible to apply for and participate in the pilot, an applicant had
to be a self-filing importer or broker, with the ability to file ACE
Entry and Entry Summaries certified for cargo release using a
software program that has completed ACE certification testing for
the PGA Message Set and DIS, and, if an exporter, must have the
ability to file electronically in the Automated Export System (AES)
or in ACE AES Direct.
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The test commenced on August 1, 2016, and will continue until
publication of a notice in the Federal Register. Any party seeking to
participate in the test was instructed to contact their CBP client
representative.
The DEA anticipated that this pilot program would help prepare for
a successful transition from the paper-based process to the electronic
entry and transmission of data to ACE. As of October 25, 2016 there
were 35 companies, representing 95 registration numbers, participating
in the pilot program.
DEA and CBP have determined that the pilot program has successfully
tested the functionality for electronic submission of data related to
the importation and exportation of controlled substances and listed
chemicals. As a result, the pilot program will be concluded as of the
effective date of this final rule. At that time, all importers,
exporters, and brokers will be able to use ACE to electronically file
required data and documentation associated with the importation and
exportation of controlled substances and listed chemicals.
3. Notice of Proposed Rulemaking
The DEA published a notice of proposed rulemaking (NPRM) in the
Federal Register incorporating all the above changes on September 15,
2016.\7\ The NPRM provided an opportunity for
[[Page 96995]]
persons to submit written comments on the proposal on or before October
17, 2016. The DEA specifically solicited comments on the economic
impact of the rule, and requested that commenters describe the specific
nature of any impact on small entities and provide empirical data to
illustrate the extent of such impact.
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\7\ 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, September 15, 2016. 81 FR 63575.
The DEA's Economic Impact Analysis (EIA), was made available in its
entirety under ``Supporting Documents'' in the public docket of this
action at http://www.regulations.gov, under FDMS Docket ID: DEA-
2016-0017 (Docket No. DEA-403).
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C. Summary of the Major Provisions of the Regulatory Action
The DEA is finalizing the rule as proposed except where otherwise
stated in the paragraphs below.
Below are summaries of provisions contained in the final rule.
1. Mandatory Electronic Applications and Filings
The DEA is amending its regulations to authorize electronic
submission of data, and 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 dissemination. The Open Data Policy states that
information should be collected electronically by default.
Executive Order 13659 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 through using an EDI,
an electronic communication framework providing standards for
exchanging data via any electronic means. Data is transmitted through
the EDI links to ACE, which serves as the single window for CBP.
Mandatory electronic applications and filings allow for the DEA to
create an efficient, streamlined reporting structure of regulated
activities.
2. Import and Export Permits for Controlled Substances
The DEA is amending its regulations regarding expiration dates
associated with imports and exports of controlled substances. The DEA
is changing 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 standardizes expiration procedures as not all months have the
same number of days.
The DEA is revising Sec. Sec. [thinsp]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
will submit a request to amend or cancel an application for an import
or export permit, amend an issued import or export permit, or request
cancelation of an issued import or export permit to the Administration
through the DEA Diversion Control Division secure network application.
Consistent with current practice, importers and exporters will
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;[thinsp]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.
Consistent with current practice, importers and exporters will
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 will not be allowed to exceed the
total base weight of controlled substance(s) listed on the
corresponding foreign permit. Neither will 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. Under Sec.
[thinsp]1312.15(a), importers will 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 may not amend permits to add or
replace a controlled substance/Administration controlled substance code
number to the item(s) to be imported or exported. Importers and
exporters who desire to import or export a different controlled
substance than that contained on their issued permit or permit
application must submit a request for the permit or permit application
to be canceled and request 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 Diversion Control Division 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 not
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
[[Page 96996]]
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 will 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 are not amendable.
However, also consistent with current practice, as stated above,
the DEA will 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 Diversion Control Division secure
network application.
Importers and exporters will be required to make an official
request through the DEA Diversion Control Division secure network
application for an amendment. Supplementary information submitted by an
importer or exporter through the DEA Diversion Control Division secure
network application will not automatically trigger the amendment
process. An amendment will have no effect on the date of expiration of
the permit; an amended import or export permit will have the same
expiration date as the originally issued permit. Importers and
exporters will be able to request that an issued import or export
permit be canceled provided that no shipment has yet been made.
Under revised Sec. [thinsp]1312.16(a)(5), registrants and
regulated persons will 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.
[thinsp]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 will 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.
DEA registrants have been able to submit DEA forms electronically
for several years, and are familiar with the DEA Diversion Control
Division secure network application system. If a DEA registrant needs
to change information on an application for a permit that is not
amendable, they must submit a new application for a permit. The
registrant will follow the same process used with the original
submission and submit the forms electronically. The DEA will review the
submission, process the document and issue a Transaction Identification
Number (TIN). The estimated time to complete the online document is
minimal. Requiring the new submission will ensure the integrity of the
information in the DEA system as well as what is transmitted to CBP.
To make an allowable amendment, a DEA registrant will access the
DEA secure network application and provide the Transaction
Identification Number which was assigned with the original submission.
The system will provide access to the registrant's application for a
permit, and the registrant can then make the appropriate changes. The
DEA will review the changes and process the document. To ensure that
there is no delay in CBP releasing a product from being imported or
exported, the DEA provides the amended documents or new submissions to
CBP in its daily feed.
As a result of the ITDS/ACE system relying on the Harmonized Tariff
System (HTS) used by CBP to properly release products for import or
export, the DEA had to identify the proper HTS codes for the substances
under its control. The HTS codes are utilized in ACE and directly
correlate to Administration Controlled Substance Code Number. As a
result, the DEA will not allow a registrant to amend an application by
adding a controlled substance that has a different Administration
Controlled Substance Code Number. This will ensure a more streamlined
process and will allow CBP to efficiently release product in a timely
manner.
Countries that are parties to international drug control treaties
have an established competent national authority (CNA) (identified in
the United Nations Office on Drugs and Crime publication ``Competent
National Authorities Under the International Drug Control Treaties'')
that oversees the handling of controlled substances and listed
chemicals to include the approval of imports and exports. All CNAs make
certain reports to the International Narcotics Control Board (INCB) on
the distribution of the substances being imported and exported. The DEA
communicates directly with CNAs or through the INCB if issues arise
regarding official authorization documents submitted to the DEA by DEA
registrants.
For the reasons discussed above, the DEA is also requiring
electronic reporting of return information for controlled substances
imported or exported under permit procedures.
3. Import and Export Declarations for Controlled Substances
The DEA is also amending Sec. Sec. 1312.18 and 1312.27 to specify
an expiration date for import and export declarations for controlled
substances.
Such declarations did not 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 previous regulation. 21
CFR 1312.16 and 1312.25. Similar to permits, declarations filed with
the DEA are sometimes 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, declarations
expire 180 calendar days after the date the declaration is deemed filed
with the Administration.
The DEA is incorporating 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 is also incorportated into a new Sec. 1312.03 which
references a list of applicable forms for part 1312, and will state the
declaration forms are electronic. This information is listed multiple
in the applicable regulations.
Consistent with current requirements, controlled substance
declarations will be required to be filed at least 15 calendar days in
advance of the anticipated date of release by a customs officer at the
port of entry or port of export. 21 CFR 1312.18(b), 1312.27(a). The DEA
is retaining this 15-day-advance filing 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. Under
revised Sec. Sec. [thinsp]1312.18(b) and 1312.27(a), controlled
substance declarations are not deemed filed until the
[[Page 96997]]
Administration issues a transaction identification number. However, the
DEA is allowing registrants and regulated persons 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. Finally, DEA regulations requiring
declarations to be completed in triplicate would be eliminated.
The DEA is amending 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 is changing Sec. Sec. [thinsp]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 and regulated persons will submit a request to
amend or cancel a filed declaration to the Administration through the
DEA Diversion Control Division secure network application.
Consistent with current practice, importers and exporters will
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.
Importers and exporters will 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, exporters would not be allowed to
exceed the total base weight of controlled substance(s) listed on the
corresponding authorization for import issued by the foreign competent
national authority. 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.
[thinsp]1312.15(a) for imports of controlled substances under permit
procedure, importers under declaration procedures will 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.
Importers and exporters will continue to be able to amend a filed
import or export declaration to remove a controlled substance. However,
importers and exporters will 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 need
to make changes to any of these fields will 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.
The DEA is not 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.
Importers and exporters will 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.
The DEA will 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; such amendments would be required to be made through the
DEA Diversion Control Division secure network application.
Importers and exporters will be required to make an official
request through the DEA Diversion Control Division secure network
application for an amendment. Supplementary information submitted by an
importer or exporter through the DEA Diversion Control Division secure
network application will not automatically trigger the amendment
process. An amendment will have no effect on the date of expiration of
the declaration; an amended import or export declaration will have the
same expiration date as the originally filed declaration.
Importers and exporters will be able to request that filed import
or export declarations be canceled provided that no shipment has yet
been made.
Registrants will be required to submit all requests for an
amendment that will affect the total base weight of each controlled
substance, other than those allowed to be released into the United
States pursuant to Sec. Sec. [thinsp]1312.18(f) and 1312.16(a)(5), at
least three business days in advance of the date of release by CBP.
Three business days are the minimum amount of time that the DEA needs
to review this type of requested amendment and transmit the applicable
[[Page 96998]]
data to the ITDS. All other requests for amendment will be required to
be submitted to the DEA at least one business day before the
anticipated date of release by a customs CBP 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.
DEA registrants have been able to submit DEA forms electronically
for several years, and are familiar with the DEA Diversion Control
Division secure network application system. If a DEA registrant needs
to change information on a declaration that is not amendable, they must
submit a new declaration. 21 CFR 1312.12, 1312.18, 1312.22, and
1312.27. The registrant will follow the same process used with the
original submission and submit the forms electronically. The DEA will
review the submission, process the document and issue a Transaction
Identification Number (TIN). The estimated time to complete the online
document is minimal. Requiring the new submission will ensure the
integrity of the information in the DEA system as well as what is
transmitted to CBP.
To make an allowable amendment, a DEA registrant will access the
DEA Secure Network Application and provide the Transaction
Identification Number which was assigned with the original submission.
The system will provide access to the registrant's declaration, and the
registrant can then make the appropriate changes. The DEA will review
the changes and process the document. To ensure that there is no delay
in CBP releasing a product from being imported or exported, the DEA
provides the amended documents or new submissions to CBP in its daily
feed.
As a result of the ITDS/ACE system relying on the Harmonized Tariff
System (HTS) used by CBP to properly release products for import or
export, the DEA had to identify the proper HTS codes for the substances
under its control. The HTS codes are utilized in ACE and directly
correlate to Administration Controlled Substance Code Number. As a
result, the DEA will not allow a registrant to amend a declaration by
adding a controlled substance that has a different Administration
Controlled Substance Code Number. This will ensure a more streamlined
process and will allow CBP to efficiently release product in a timely
manner.
As stated previously all countries that are parties to
international drug control treaties have an established CNA that
oversees the handling of controlled substances and listed chemicals to
include the approval of imports and exports. All CNAs make certain
reports to the INCB on the distribution of the substances being
imported and exported. The DEA communicates directly with CNAs or
through the INCB if issues arise regarding official authorization
documents submitted to the DEA by DEA registrants.
For the reasons stated above, the DEA is also requiring mandatory
electronic filing of return information for controlled substances
imported or exported under declaration procedures.
4. Imports, Exports, and International Transactions for Listed
Chemicals
The DEA is amending part 1313 to provide that each regulated person
who seeks to import or export a listed chemical that meets or exceeds a
threshold quantity, must notify/provide a declaration to the DEA (by
filing a DEA Form 486/486A through the DEA Diversion Control Division
secure network application) of the intended import or export not later
than 15 calendar days before the date of release by a customs officer
at the port of entry. Regarding imports and exports for those entities
with regular customer and regular importer status, the notification
must be filed at least three business days before the date of release
by a customs officer at the port of entry. All declarations must be
signed and dated by the importer or exporter and must contain the
address of the final destination for the shipment.
The DEA is specifying that all 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.
In Sec. 1313.32 the DEA is incorporating the mandatory electronic
filing of notifications of international transactions involving listed
chemicals which meet or exceed the threshold amount identified in Sec.
1310.04. The broker or trader must notify the DEA (by filing a DEA Form
486 through the DEA Diversion Control Division secure network
application) of the intended international transaction not later than
15 calendar days before the transaction is to take place. The DEA is
amending 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.
5. Reexportation of Controlled Substances Among Members of the European
Economic Area
This final rule implements 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, and
provided that the conditions specified in the 2015 Act are met.
In order to effectuate the changes contained in the 2015 Act, the
final rule implements the following changes:
Allowing unlimited reexports among EEA countries.
Eliminating the 180 day time period to complete reexport
(reexport from first country to the second country (ies)).
No longer requiring bulk substances to undergo further
manufacturing processes within the first EEA country if the substance
is to be reexported within the EEA.
No longer requiring that the exporter must provide product
and consignee information beyond the first country in advance of (prior
to) export from the United States.
Establishing a new Form 161R-EEA for the reporting of
reexports among members of the EEA. (The form is accessed, completed,
and submitted through the DEA Diversion Control Division secure network
application.)
All other requirements that existed prior to the enactment of the
2015 Act (and which were not modified by Congress in 2015 Act) remain.
Additionally, persons who export
[[Page 96999]]
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 reexportation, including
certification that the reexportation has occurred and ``information
concerning the consignee, country, and product.'' 21 U.S.C.
953(f)(6)(B). Finally, 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, for the purpose of
consistency, the DEA is making corresponding changes to its reexport of
controlled substances under declaration procedures found in Sec.
1312.27.
6. Domestic Transaction and Import and Export Reports for Tableting and
Encapsulating Machines
The DEA is mandating electronic reporting requirements in 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 is implementing usage of a new form, DEA Form
452, Reports for Regulated Machines, which covers imports, exports, and
domestic regulated transactions of tableting and encapsulating
machines. The new form will be accessed, completed, and submitted by
regulated persons entirely though the DEA Diversion Control Division
secure network application. Upon receipt and review, the Administration
will assign each completed report a transaction identification number.
The DEA Form 452 will not be deemed filed until the Administration
issues a transaction identification number. This 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 DEA Form 452 is used for both domestic transactions and import/
export transactions of tableting and encapsulating machines, and the
reporting requirements implemented by this final rule differ.
Domestic Transactions: Previously in 21 CFR 1310.05(a)(4) and (b),
regulated persons who engaged 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. The new Sec. 1310.05(b)(2)
in the final rule, makes the oral reporting mandatory and mandates the
electronic filing of the written report. Additionally, the new Sec.
1310.05(b)(2) requires 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) is required
to be filed within 15 calendar days after the order has been shipped by
the seller.
Import/Export Transactions: The DEA is requiring that the DEA Form
452 be submitted to the DEA through the DEA Diversion Control Division
secure network application 15 calendar days before the anticipated date
of arrival at the port of entry or port of export. Under this final
rule, an importer or exporter 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 may proceed
with the import or export of the machine(s) as soon as the transaction
identification number has been issued. These changes are in Sec.
1310.05(c). Additionally, the DEA revised Sec. 1310.06(e)(1)(v) so
that reports of importation of tableting or encapsulating machines
include the reason for the importation, i.e., medical, commercial,
scientific, or other legitimate use of the machine.
The DEA also added paragraph (c)(2) to Sec. 1310.05 to require
import shipments of tableting machines or encapsulating machines that
have been denied release by customs to be reported to the
Administration, through the DEA Diversion Control Division secure
network application, within 5 business days of denial. If an importer
subsequently receives notice from a customs officer that their shipment
will be released into the United States, the importer is 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.
The DEA is requiring electronic filing of return information,
specifying the particulars of the transaction, for tableting and
encapsulating machines imported or exported 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. Return information
requirements are incorporated into a new paragraph (h) in Sec. 1310.06
and requires the filing of the report with the Administration (on DEA
Form 452) utilizing the DEA Diversion Control Division secure network
application.
7. Mail Order Reporting for Ephedrine, Pseudoephedrine,
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
The DEA is incorporating 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 requirements of these monthly
mail-order reports, the DEA is implementing usage of a new form, DEA
Form 453. The new form will be accessed, completed, and submitted by
regulated persons entirely through the DEA Diversion Control Division
secure network application. 21 CFR 1310.03(c) is 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. This 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 previous
Sec. 1310.06(i), redesignated in this final rule as Sec. 1310.06(k),
is revised to reflect that the monthly mail-order information is
required to be submitted to the DEA on Form 453. 21 CFR 1310.03(c) is
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.
This 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
[[Page 97000]]
requirements. 21 CFR 1310.05(e) would correspondingly be amended to
reflect the implementation of the mandatory electronic filing
requirement.
The DEA is also technically amending 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.
8. Transshipments of Controlled Substances
Applications for transshipment permits are still 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 Diversion Control Division Web
site informing persons seeking to transship schedule I controlled
substances on 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 Diversion Control Division 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 is explicitly stating 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.
9. Transshipment of Listed Chemicals
Advance notification is still 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 that meets or
exceeds the threshold reporting requirements into the United States for
transshipment. Advance notification is also still 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 Diversion Control
Division Web site. While a broker or trader for an international
transaction might be able to electronically submit the required
information from a domestic IP address, for consistency and fairness
across all transshipment activities, the DEA is allowing 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.
D. List of Changes in the Final Rule
This section discusses the minor changes implemented by this final
rule that were not discussed in the NPRM. The minor changes include,
among others, correcting minor typographical errors and updating
citation listings and internal organizational changes within the DEA.
The effective date of this final rule remains 30 days from the date
of publication. However, the compliance date was extended to 180 days
after the publication of the final rule for all transactions, not only
for tableting and encapsulating machines.
The DEA has eliminated the definitions of shipment and split
shipment that were proposed in the NPRM. Because of the elimination of
these definitions, the DEA has amended Sec. Sec. 1312.13(e) and
1312.23(e) in a manner that is different than proposed. The language
added to this section emphasizes that a shipment of controlled
substances is 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 as opposed to
multiple conveyances. In addition, the language will coincide with
current policy by prohibiting a load of goods from being divided into
multiple parts to be placed onto more than one conveyance, even if the
goods are on the same loading document. A single permit could not be
used for this situation above.
In Sec. Sec. 1310.05, 1312.12, 1312.18, 1312.22, 1312.27, 1313.17,
and 1313.27, the 24-hour reporting requirement to the DEA for the
denial of imported/exported controlled substances, listed chemicals,
tableting or encapsulating machines, has been changed to five business
days.
In revised Sec. Sec. 1312.22(d)(1), 1312.31(d)(4), and 1312.32(b),
the phrase ``and the attestation has been notarized'' has been deleted.
II. Discussion of Comments
The DEA received 12 comments on the NPRM. Eleven commenters
generally supported this rule while also raising issues of concern and
one commenter expressed opposition to the NPRM. Three comments were not
posted due to the entire comment containing confidential business
information; one comment was not posted because it was unrelated to the
NPRM; thus, only eight comments were posted. All of the relevant
comments are summarized below, along with the DEA's responses.
A. Electronic Applications and Filings, Generally (5 Issues)
[1] Comment: Two commenters asked for clarification regarding the
signature requirement applicable to declarations and applications
submitted via the DEA Diversion Control Division secure network
application.
Response: The user will login to the DEA Diversion Control Division
secure network application using the user name and password. Upon
completion of any of the forms associated with this rule, the user must
submit the form by acknowledging the information on the form is
complete and accurate. The acknowledgement serves as a signature. The
DEA believes the use of electronic forms will eliminate the need for
manual signatures and result in an overall reduction in burden. In
addition, this rule does not alter the signature requirements for other
documents; the definitions of ``digital signature'' and ``electronic
signature'' (as defined in Sec. 1300.03), and the requirements for
signatures associated with electronic orders and electronic
prescriptions (as found in part 1311) remain unchanged.
[2] Comment: Three commenters suggested that the DEA should provide
for the continued availability and use of paper forms and hard copy
reporting for imports and exports. Two commenters stated that other DEA
systems such as CSOS and ARCOS have similar provisions, and in the
event that the DEA's electronic system was unavailable for any reason,
an alternate method of applying for and approving imports and exports
is needed as a
[[Page 97001]]
contingency. However, the commenter stated that the DEA needs to have a
stable electronic declaration system with no programming issues,
because if a glitch in the system occurs, this could result in delayed
shipments and significant cost for industry. The commenter stated that
it was essential for importers and exporters to continue to have the
paper option for more time to correct any information derived from
other databases that may be inaccurate. The commenters also requested
that CBP provide additional guidance on how and by whom the electronic
[CBP] certifications should be submitted, in order to ensure that
companies are able to meet all of the DEA legal requirements.
Response: Upon review of results from the ITDS Pilot Program, the
DEA is extending the compliance date of the final rule to 180 days
after publication for all provisions contained in the rule.\8\ The ITDS
Pilot Program (discussed above and in the General Notice at 81 FR
46058, July 15, 2016) has been underway since August 2016. Although no
system failures or processing errors occurred during the ITDS Pilot
Program, the DEA believes that more electronic transactions will
provide a better test of the secure network application. The DEA
anticipates that, during the extended compliance period, registrants
and regulated persons will utilize both the secure network application
and the current paper-based system. This will allow DEA to continue to
test the integrity of the secure network application and enable DEA to
correct any systemic issues while also ensuring an alternate method to
conduct business is available so that trade is not impeded.
---------------------------------------------------------------------------
\8\ The final rule will be effective 30 days after publication
in the Federal Register so registrants and regulated persons may opt
to either submit forms and report information electronically via the
secure network application in anticipation of the mandatory
compliance date, or registrants and regulated persons may continue
with paper submissions until the mandatory compliance date. This
will not affect DEA's ability to continue to submit data to the
ITDS/ACE.
---------------------------------------------------------------------------
In response to the request that CBP provide additional guidance on
how the electronic certifications should be submitted and by whom, the
DEA recommends reviewing the ITDS implementation guidelines on CBP's
Web site, https://www.cbp.gov/document/guidance/dea-implementation-guide-ace.
[3] Comment: Three commenters stated that currently, the only way
to submit a Declaration/Application for import/export from an
analytical laboratory registrant is by sending a hard copy to the DEA,
and that the DEA Diversion Control Division secure network application
does not support imports/exports from analytical laboratory
registrants. The commenter noted that, since an analytical laboratory
is not required to register drug codes on the registration, the drop
down list on the secure network application would need to be extensive
or a free text box would need to be added. In addition, because there
are many drug impurity reference standards that are imported/exported,
the commenter suggested that the continued use of a paper-based system
for imports/exports from analytical laboratory registrants is necessary
until a free text box is added to the secure network application.
Response: As discussed, the DEA is extending the compliance date of
the final rule to 180 days after publication for all provisions
contained in the rule. The ITDS Pilot Program (as discussed and in the
General Notice at 81 FR 46058, July 15, 2016) has been underway since
August 2016. Although no system failures or processing errors occurred
during the ITDS Pilot Program, the DEA believes an extended compliance
date will enable more electronic transactions to test the integrity of
the secure network application and ensure DEA can address any systemic
issues before mandatory compliance. However, with the implementation of
ITDS, the DEA Diversion Control Division secure network application
will enable analytical laboratory registrants to provide all of the
required information electronically. Any registrant, including
analytical laboratories, unable to complete the necessary import/export
forms for any reason may contact Diversion Control Division's
Regulatory Section at 202-307-7194 or [email protected]. Unforeseen
issues that prevent any registrant from completing the necessary
import/export forms will be resolved on a case-by-case basis.
[4] Comment: Two commenters expressed concern that requiring
registrants to report the date that the product was released by a
customs official as well as the amount released by a customs official
is repetitive since the Automated Commercial Environment (ACE) systems
will include this information. The commenters requested that the DEA
remove this requirement from the proposed rule. In support of their
request, the commenters stated that it would be difficult for the
registrant to obtain this information since these activities are
handled by their brokers, and the registrant does not have access to
the ACE system. The commenters went on to say that traditionally, the
registrant reports when the substances leave their facility as this is
the only date the registrant has direct knowledge of.
Response: The DEA appreciates the commenter's concerns. The DEA
believes the release date is available. Some importers/exporters may
need to obtain this information from their brokers. To remove the
ambiguity created from the ``date of import,'' the DEA chose the date
of release by a customs officer. In addition, the DEA is requiring the
date the shipment arrives (for imports) or leaves (for exports) the
registered location or place of business. These two dates provide the
proper accountability of the amounts of controlled substances or listed
chemicals.
[5] Comment: One commenter expressed concern about the protection
of data submitted electronically. The commenter supported the use of
electronic submissions to streamline customs procedures, and requested
additional information regarding how electronically submitted
confidential business information would be protected, especially in
light of the significant security and competitive business interests at
stake regarding the data contained in such transmissions. The commenter
stated that it was essential that CBP take adequate measures to secure
and protect this data from public access and release, and suggested
that CBP implement training and certification procedures for employees
with access to such information.
Response: The DEA cannot respond to questions regarding CBPs
information system security practices. All questions regarding CBPs
information system security practices should be directed to CBP.
B. Import and Export Permits for Controlled Substances (5 Issues)
[1] Comment: One commenter requested that the DEA eliminate the
proposed requirement that a translation be notarized when a translation
of a foreign government-issued import license or Permit is necessary,
because the wording in the current DEA regulations is sufficient. The
commenter stated that the requirement that any such translation be
notarized is not necessary, because it would place an additional burden
on exporters without a commensurate benefit.
Response: The DEA proposed that translations be notarized in order
to ensure that translations are complete and accurate. However, the DEA
has reviewed this comment and after further consideration has removed
the
[[Page 97002]]
requirement for a notarized translation in Sec. Sec. 1312.22, 1312.31,
and 1312.32. The DEA is retaining the requirement that the translator
certify the translation. For the purposes of this requirement,
certified translation means that the translator has signed the
translation legally attesting to the accuracy of the translation. The
regulatory text in Sec. Sec. 1312.22(d)(1), 1312.31(d)(4), and
1312.32(b) have been modified to reflect this change.
[2] Comment: One commenter asked for clarification about what is
meant by ``serial number'' and how this information would be used to
identify the foreign consignee. The commenter also wanted to know what
to do if no such designation is present on the current packaging.
Finally, the commenter wanted to know what the definition of
``narcotic'' was in this context.
Response: The DEA proposed to modify Sec. 1312.26 because it
required exporters to keep Copy 3 of the export permit along with ``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.'' As discussed in the NPRM, with the implementation
of ITDS, Copy 3 is obsolete and with this final rule, exporters will be
required to keep an ``official record of the export permit,'' rather
than Copy 3, with any such serial numbers. As the NPRM did not propose
or discuss any other modifications to Sec. 1312.26, the comment will
be considered as a basis for potential modifications in the future.
[3] Comment: Two commenters sought further modification of the pre-
NPRM and pre-final rule regulation at Sec. 1312.22(d)(7) (implemented
as Sec. 1312.22(h)(6) by this final rule) which requires that a
controlled substance ``will be exported from the first country to the
second country (or second countries) no later than 180 days after the
controlled substance was exported from the United States.'' As these
commenters noted, this 180-day requirement was established by the DEA
in the 2007 regulation implementing the Controlled Substance Export
Reform Act of 2005 (CSERA), but was not imposed by the CSERA itself.
Noting that the 2015 Act contains a provision (21 U.S.C. 953(g)(1))
that eliminates the 180-day requirement for reexports within the EEA,
some commenters requested that the DEA remove this requirement for all
markets (not just the EEA countries) as they view it as an unnecessary
hindrance. One commenter requested that the DEA increase the 180-day
requirement to 365 days for reexports outside of the EEA.
Response: This category of comments is outside the scope of the
NPRM. As indicated above, the 180-day requirement was implemented in a
rulemaking that concluded in 2007 (72 FR 72921, December 26, 2007), and
this requirement was not issued for public comment in the NPRM. For the
reasons stated above and in the NPRM, consistent with the 2015 Act, the
DEA eliminated the 180-day requirement for reexports within the EEA.
However, the 2015 Act left intact the reexport requirements for
reexports outside of the EEA and, accordingly, the NPRM did not reopen
for public comment the regulatory requirements for reexports outside
the EEA. Rather, with regard to reexports, the NPRM only sought
comments on the new regulations that were necessitated by the 2015
Act.\9\ While the 180-day requirement for reexports outside the EEA is
therefore outside the scope of the NPRM, DEA continues to believe that
the justification for the requirement set forth in the 2006 proposed
rule (71 FR 61436, October 18, 2006) and 2007 final rule remains valid.
---------------------------------------------------------------------------
\9\ For formatting purposes, the NPRM renumbered certain
regulations relating to reexports outside the EEA, and thus the text
of such regulations was included in the proposed rule section of the
NPRM. However, the substance of such regulations was not altered
from that promulgated in the 2007 final rule.
---------------------------------------------------------------------------
[4] Comment: One commenter asked for clarification in reference to
adding a reexport market to the list of countries on the Export
Declaration after the initial U.S. Export.
Response: All countries that are parties to any of the Conventions
referred to in 21 U.S.C. 953(f)(1) will be included in the list of
countries when completing forms 161R and 161R-EEA. Countries that are
not parties to any of the Conventions will not be included as,
consistent with the statute, reexport permits would not be granted for
shipments to those countries.
[5] Comment: One commenter commented on the DEA's proposed
definition of shipment. This commenter stated that the definition of
shipment conflicts with how it is used in the DEA's regulations. First,
the commenter reasoned that because the definition of shipment is
placed in Sec. Sec. 1300.01 and 1300.02 then this definition will
apply to all parts of the DEA's regulations. Second, this commenter
noted that the definition of shipment applies only to goods that are
imported or exported. By defining shipment in this manner, the
commenter reasoned that the term shipment can no longer be used in
reference to domestic transactions involving controlled substances and
listed chemicals. In addition, the commenter stated that shipment as
defined conflicts with the definition of international transaction as
set forth in 21 U.S.C. 802(42). International transaction is defined in
part as, ``a transaction involving the shipment of listed chemicals
across an international border (other than a United States Border) * *
*.'' As such, this commenter noted that the CSA contemplates shipments
that are not imports into the United States or exporters from the
United States.
Response: The DEA appreciates this comment. Based on this comment
the DEA has decided to modify the regulation text in a way that is
different than what was proposed. To remove the possibility of having
the definition of shipment apply to all of DEA's regulations, the DEA
is removing the definition of shipment from the definition sections of
Sec. Sec. 1300.01 and 1300.02. In addition, the DEA is removing the
definition of split shipment from the same sections. The DEA has
modified the text of Sec. Sec. 1312.13(e) and 1312.23(e) relating to
the issuance of import and export permits. The language added in these
sections allows for the same intended effect as the proposed language
while eliminating the possibility of having the definition of shipment
apply to all DEA regulations. Therefore, the introduction of this
language will emphasize that a shipment of controlled substances is
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). In addition, the language will coincide with
current policy by prohibiting a load of goods from being divided into
multiple parts to be placed onto more than one conveyance, even if the
goods are on the same loading document. A single permit could not be
used for this situation above.
C. Import and Export Declarations for Controlled Substances (1 Issue)
[1] Comment: One commenter requested that the DEA clarify whether
an import or export declaration is effective immediately upon
assignment of a Transaction Identification Number by the DEA so that
the importer or exporter does not need to wait the full 15 days. The
commenter also asked for additional clarification to make clear
[[Page 97003]]
that if the DEA has not issued a Transaction Identification Number
within 15 days of submission of the declaration, the import or export
can be shipped, as is currently allowed. The commenter stated that if
this was not the case then importers or exporters could have to wait
much longer than 15 days for DEA to issue the Transaction
Identification Number, which would be a significant change from current
practice.
Response: Controlled substances may be imported or exported as soon
as a Transaction Identification Number (TIN) is issued. The DEA works
expeditiously to confirm the accuracy of the declarations and will
issue a TIN as soon as possible. When the TIN is issued for a
controlled substances declaration in less than 15 days the importers
and exporters may immediately request release by a customs official and
do not need to wait for the expiration of the 15 days. Any delay in
issuing a TIN is generally due to incomplete or inaccurate information
on the declaration form and the submitters delay in providing complete
and correct information. The declaration is deemed submitted when a TIN
is issued; therefore, in the rare instances where 15 days have elapsed
without the issuance of a TIN, the importer or exporter must wait for
the TIN and may not request release by a customs official. As a
practical matter, in the new ITDS/ACE system the customs official will
not release a shipment without DEA's transmission of the TIN (among
other data) to CBP.
D. Import and Export Declarations and Notices for Listed Chemicals (13
Issues)
[1] Comment: One commenter was concerned with the proposal to
require electronic filing of the DEA Form 486 via the Diversion Control
Division secure network application. The commenter was concerned
whether steps have or will be taken to reduce confusion or delays in
releasing an import or export declaration that may be associated with
multiple electronic DEA Form 486s but only a single invoice. In
addition, the commenter wanted clarification on whether the DEA had
consulted with foreign competent national authorities regarding the
impact of requiring the processing of multiple electronic DEA Form 486s
relating to the same order, in light of the fact that foreign competent
authority applications are not limited to a specific number of lines
for a particular order or license application.
Response: The DEA appreciates the commenter's concerns. The
concerns raised by the commenter are beyond the scope of this
rulemaking and will not be addressed. However the DEA does not take
issue with the use of multiple Form 486s.
[2] Comment: One commenter requested clarification on the differing
requirements for an import or export transaction to proceed upon
receipt of the TIN. The commenter wanted to know if the DEA intended
for exporters to request release from customs immediately after
issuance of the TIN as explicitly stated for importers.
Response: The DEA intends to treat importers and exporters the same
in regards to the import or export transaction proceeding upon receipt
of the TIN. However, allowing listed chemicals to ship before the 15-
day notification requirement would be in conflict with 21 U.S.C.
971(a). Referring to import declarations, Sec. 1313.12(b) states that
listed chemicals that meet or exceed threshold quantities identified in
Sec. 1310.04(f), or which do have an established threshold, may not be
imported until a transaction identification number (TIN) has been
issued, and the Administrator shall be notified of the importation of
the listed chemical not later than 15 days before it takes place.
Referring to export declarations, Sec. 1313.21(b) states that
exporters may not request that the listed chemical be released until a
transaction identification number (TIN) has been issued. The
Administrator shall be notified of the importation of the listed
chemical not later than 15 days before it takes place. Therefore prior
to export or import a TIN has to be issued and importers and exporters
have to wait the 15-day period.
[3] Comment: Four commenters recommended that the DEA establish a
regulatory timeframe by which the agency will issue transaction
identification numbers to allow for business certainty. One commenter
recommended an initial deadline of three business days for the DEA to
review a transaction and issue the transaction identification number.
The commenters expressed a concerned about business decisions and
timing. They stated that the lack of a definite deadline to issue the
transaction identification number will cause delayed or canceled
shipments and lost revenues.
Response: The DEA understands the commenters' sensitivity to time
and potential for competitive advantage/disadvantage based on timely
shipment of products. However, the DEA declines to set a specific
timeframe for the issuance of a TIN. The DEA works expeditiously to
confirm the accuracy of the declarations and will issue a TIN as soon
as possible. Any delay in issuing a TIN is generally due to incomplete
or inaccurate information on the declaration form and the submitters'
delay in providing complete and correct information.
[4] Comment: Two commenters requested that the DEA clarify the
discrepancy between whether the timeframe is three calendar days or
three business days advance notification before the date of release by
customs officers at the port of entry. One commenter suggested that
since the time period is so small, the DEA should use its proposed text
to require three business days to allow sufficient time for businesses
to react to the unexpected delays or unexpected promptness of
shipments. The commenter recommends that the DEA add appropriate
language within the text of the rule clarifying its statement in the
preamble that registrants can proceed with the import or export
transaction as soon as the transaction identification number has been
issued regardless of whether the three days have passed.
Response: The DEA appreciates the opportunity to correct any
errors. After reviewing the language in the preamble the DEA, in two
instances, erroneously stated 3 ``calendar'' days, rather than
``business'' days. The DEA has corrected the language in the preamble.
The term three ``business'' days is also discussed repeatedly in the
preamble and clearly stated in the regulatory text. However, importers
and exporters may proceed with the transaction as soon as the TIN is
issued regardless of whether the three days have elapsed. The
regulatory text has been updated to clarify this requirement.
[5] Comment: One commenter requested that the DEA issue waivers/
exemptions with respect to the proposed revisions in Sec. Sec.
1313.12, 1313.14, and 1313.17. These proposed revisions would require
that all imported shipments first go to the registered location before
being subsequently shipped to the final destination (referred to within
the industry as ``drop shipment''). The commenter cited potential
shipping risks and the substantial economic hardships small U.S.
businesses would face in the competitive world market as a result of
the proposed revisions. The commenter also expressed concern about the
fact that the proposed revision to Sec. 1313.14, did not specify
whether it applied to List I or List II chemicals or both.
Response: The DEA appreciates the commenter's concerns. The
proposed revision to Sec. 1313.14 still applies to List I chemicals.
``Drop shipments'' have
[[Page 97004]]
always been permitted for List II chemicals, and this rulemaking will
not change that. However with respect to List I chemicals, page 63598
of the published NPRM stated,
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, are explicitly prohibited under the proposed revisions to
Sec. [thinsp]1313.14.
[6] Comment: Five commenters suggested that the DEA allow listed
chemicals to be relieved of the 15-day waiting period as allowed for
controlled substances. The commenters stated that the DEA did not
explain the reasoning behind this decision, and that it was
inconsistent with other DEA regulations that treat controlled
substances with stronger regulation than listed chemicals. The
commenters recommended that the DEA modify the proposed rule to state
that listed chemicals can also proceed with the import or export
transaction as soon as the transaction identification number has been
issued, regardless of whether the 15 calendar days have elapsed since
its issuance
Response: After careful consideration, the DEA has decided not to
allow the shipment to proceed when the TIN is issued. As stated above
prior to export or import a TIN has to be issued and importers and
exporters have to wait the 15-day period.
[7] Comment: One commenter stated that the proposed amendments to
Sec. Sec. 1313.12(d) and 1313.21(d) to require an import or export
declaration on DEA Form 486 or 486A at least three business day before
the date of release by a customs officer exceeds the statutory
authority granted to DEA under 21 U.S.C. 971(b). The commenter stated
that the previous versions of Sec. Sec. 1313.12(d) and 1313.21(d) are
consistent with the statutory limit on the timing of the waiver for
transactions involving regular importers and regular customers.
Response: The DEA appreciates this comment. However, the DEA
continues to believe that this modification is within its statutory
authority pursuant to 21 U.S.C. 971. As stated in the NPRM it is
necessary for DEA to provide customs officers with the necessary
information first so that the customs officers can then clear a
shipment of relevant listed chemicals. Because of this, the DEA
determined that three business days is needed to review all pertinent
information relating to the shipment and transmit the data accurately
to the ITDS. As a result, the waiver of the entire 15 day period can no
longer be applied in these specific instances.
As stated in the NPRM accompanying this final rule, 21 U.S.C.
971(b) provides the DEA with authority to waive the 15 day requirement,
by regulation, for imports of listed chemicals by regular importers and
exports of listed chemicals between regulated persons and regular
customers. The DEA is exercising this authority in the final rule. The
DEA does acknowledge that 21 U.S.C. 971(b)(1) requires regulated
persons subject to waivers to notify the DEA of the transaction ``at
the time of any importation or exportation.'' To maintain the effect of
this provision the DEA is allowing registrants to proceed with the
import and export transaction as soon as the transaction identification
number is issued, regardless of whether the three-calendar day period
has concluded. In addition, the DEA considers the notification provided
to the DEA by the customs officers at the time of release to meet the
requirements of 21 U.S.C. 971(b)(1). With these two allowances the DEA
believes that it is meeting the statutory requirements and is setting
forth reasonable requirements.
[8] Comment: One commenter stated that the wording used in revised
Sec. Sec. 1313.12(d) and 1313.21(d) is ambiguous. The commenter noted
that the ``name and description'' of a listed chemical may not appear
on the product label, and that DEA labeling requirements apply to
controlled substances and not listed chemicals. The commenter suggested
that the phrase ``name and description of each listed chemical'' would
be better phrased as ``trade name of the listed chemical or mixture
containing one or more listed chemical.'' The commenter argues that
this wording would be consistent with Sec. 1310.13, which requires an
applicant for exemption from registration to provide the DEA with the
trade name(s) of it chemical mixture(s).
Response: Under the DEA labeling requirements, the ``name and
description'' of a listed chemical does not necessarily mean the trade
name. The DEA is looking to determine what the listed chemical is.
Therefore the trade name is not the only description that can be used.
[9] Comment: One commenter suggested an amendment to the DEA Form
Data. The commenter stated that the current wording could require that
any waiting period in the consignee country be completed before
beginning any waiting period in the United States. The commenter stated
that variations in national requirements may result in situations where
the consignee is not required to have a permit; this would accommodate
situations in which the competent national authority of a consignee may
require documentation of a bona fide intent to import prior to issuing
a permit; finally this would expedite shipments by allowing concurrent
waiting periods in both countries.
Response: The registrant would still be required to abide by the
laws of the country of import.
[10] Comment: Two commenters expressed concern over the proposed
amendment to the language in Sec. Sec. 1313.17 and 1313.27 to require
an importer or exporter to notify the DEA within 24 hours of the denial
of the release of an import or export of listed chemicals. The
commenters asked that the DEA remove the 24-hour period, because the
need for the shortened time frame was not apparent, and cited instances
where it might been unworkable because the consignor and customs agents
are working different schedules, the denial occurs late Friday or over
the weekend, or the business office is closed for 24 or more hours
during which customs may have denied the release.
Response: Thank you for your comment. Two commenters expressed
similar concerns, and the DEA has decided to change the 24-hour
reporting requirement to a 5-business-day reporting requirement. The
DEA believes that this will give registrants enough time to notify the
DEA and work with Customs to secure a release. See regulation text
changes in Sec. Sec. 1310.05, 1312.12, 1312.18, 1312.22, 1312.27,
1313.17, and 1313.27.
[11] Comment: In proposed 21 CFR 1310.05(b)(1), the DEA added
several factors that regulated persons may consider when determining
whether a loss or disappearance of a listed chemical was unusual or
excessive. One commenter stated that they are not certain the added
language provides clarity to persons that handle listed chemicals or
the DEA field staff. Specifically, the commenter suggested that the
determination of whether a loss or disappearance of a listed chemical
is unusual or excessive is fact specific and
[[Page 97005]]
could vary even within a specific entity. Against this backdrop the
commenter suggested that the DEA remove these factors from 21 CFR
1310.05(b)(1). The commenter also suggested that the inclusion of these
factors, while being similar to those factors in 21 CFR 1301.74(c),
might cause DEA field staff to consider these factors mandatory.
In the alternative to removing the factors from the regulatory
text, this same commenter submitted two suggestions. The commenter
suggested that listed chemical handlers should consider these factors
only if the factors help the handler determine whether a loss is
unusual or excessive. In addition, the commenter suggested that the
factors should only be applied as to the specific facts surrounding the
loss or disappearance.
Lastly, this commenter requested that the DEA discuss its reasoning
for using slightly different factors than the agency uses in 21 CFR
1301.74(c) and to discuss the impact to regulated persons based on this
change, including the interpretation.
Response: The DEA appreciates this comment. As noted in the text of
21 CFR 1310.05(b)(1) the consideration of these factors is not
mandatory. The DEA states that regulated persons should consider, among
others, the factors enumerated. The DEA recognizes that each business
entity is unique and has different business practices. As a result, by
enumerating these factors the DEA is providing factors that may assist
the regulated person. The DEA recognizes and recommends that each
regulated person will tailor their system to detect unusual or
excessive loss or disappearance of listed chemicals to meet their
specific business model. As a result, if the regulated person's
business practice allows for the consideration of these factors then
the DEA would expect the regulated person to consider the factors in
determining if the loss or disappearance of a listed chemical is
excessive or unusual. The language used by the DEA in Sec.
1310.05(b)(1) allows for this flexibility. Furthermore, the DEA does
not believe that the inclusion of these factors will cause DEA field
staff to consider these factors mandatory. It should be noted that the
factors used in Sec. 1301.74(c) are not mandatory. Based on the above
reasoning the DEA does not think it is prudent to amend the language in
Sec. 1310.05(b)(1).
[12] Comment: One commenter stated that the DEA's Combat
Methamphetamine Epidemic Act (CMEA) provided that listed chemicals
could only be imported if a valid customer order was in place. The
commenter stated that although they had been abiding by the new
language, it was challenging and presented an economic disadvantage due
to the business nature of the chemicals they were handling.
Response: This comment is outside the scope of this rulemaking, and
the DEA has no authority to modify the requirements of the CMEA.
[13] Comment: One commenter asked for electronic IDs for two
locations--one for the List I Chemical Registered address and one for
the List II Place of Business. The commenter stated that they had been
told that all electronic entries are to be under the List I registered
address electronic ID. The commenter objected to this, stating that the
regulations and accepted addresses are different for List I and List II
chemicals. For this reason, the commenter stated that there should be
two electronic IDs to differentiate List I chemicals from List II
chemicals, and that this should be addressed in the regulations since
the DEA was requiring electronic filing of the DEA 486 Forms.
Response: The DEA allows more than one system account, one for List
I registered location and one for List II place of business. To resolve
any issues regarding system account setup or any other questions
regarding listed chemicals declarations, please contact the Regulatory
Section at 202-307-7194 or [email protected].
E. Reexportation of Controlled Substances Among Members of the European
Economic Area (3 Issues)
[1] Comment: Several commenters expressed the view that DEA should
strike the proposed regulatory text (Sec. 1312.22(g)(2)) that requires
persons who reexport within the EEA to report to DEA, within 30 days
after each reexportion, information concerning the consignee, country,
and product that was reexported. According to these commenters, this
requirement is difficult, if not impossible, for them to comply with
because, according to the commenters, they are unable to track the
controlled substances once they are transferred to another owner. As to
this point, one of the commenters attached a letter from four members
of Congress, written seven months after the bill was enacted, stating
that holding the manufacturer responsible for complying with this
reporting requirement after a product has ``left the manufacturer's
ownership'' would be contrary to the intent of the 2015 Act. In
addition, commenters assert that the requirement is unnecessary from a
diversion control standpoint and that it could cause them to lose sales
to foreign competitors who are not subject to this requirement. As to
the letter point, some of the commenters assert that the purpose of the
reexport provisions of the 2015 Act is to encourage U.S. commerce
abroad and to prevent U.S. drug firms from moving U.S. manufacturing
jobs overseas. Some of the commenters also contended that their request
to strike this requirement is supported by the provision of the 2015
Act (21 U.S.C. 953(g)) that prohibits DEA from issuing any regulation
``which impedes re-exportation of any controlled substance among [EEA]
countries.''
Response: While DEA has considered carefully the concerns of the
commenters regarding their compliance with the 30-day reporting
requirement, the law precludes the interpretation offered by these
commenters that would eliminate this requirement once the controlled
substances are no longer owned by the exporter. As stated in 21 U.S.C.
953(f)(6)(B), ``In the case of re-exportation among members of the
European Economic Area, within 30 days after each re-exportation, the
person who exported the controlled substance from the United States
delivers to the Attorney General documentation certifying that such re-
exportation has occurred and information concerning the consignee,
country, and product.'' (Emphasis added.) The language of this statute
is clear and there is no mention of ownership being a condition
precedent to reporting pursuant to 21 U.S.C. 953(f)(6)(B).
As the United States Supreme Court has repeatedly held, ``If the
intent of Congress is clear, that is the end of the matter; for the
court, as well as the agency, must give effect to the unambiguously
expressed intent of Congress.'' Chevron, U.S.A., Inc. v. Natural
Resources Defense Council, Inc., 467 U.S. 837, 842-843 (1984). Because
21 U.S.C. 953(f)(6)(B) unambiguously requires reporting ``within 30
days after each re-exportation'' within the EEA, and because the
statute makes no exception to this requirement based on lack of
ownership, DEA is obligated to incorporate this requirement in its
regulations.
With regard to the letter from four members of Congress attached by
one of the commenters, because this letter was written after the law
was enacted, it cannot be considered legislative history. But even if
it were part of the legislative history, Chevron indicates that the
agency cannot rely on it if is inconsistent with the plain language of
the statute.
[[Page 97006]]
The provision of 21 U.S.C. 953(g) prohibiting DEA from promulgating
any regulation that ``impedes'' reexportation within the EEA does not
alter this conclusion. Congress could not have meant by this provision
that DEA cannot enforce a requirement that Congress itself explicitly
enacted. Rather, the logical interpretation of this clause is that DEA
cannot impose any additional requirements (beyond those imposed by
Congress) that would impede reexports within the EEA. As explained in
the NPRM, DEA has adhered to this requirement by, for example, omitting
from the EEA reexport regulations the requirement in the 2007
regulations that bulk substances undergo further manufacturing
processes in the first country before reexporting to the second
country.
[2] Comment: Two commenters requested that the shipping date should
still be acceptable for reexports reported to the DEA, because customs
clearance dates are not readily accessible by exporters in the first
countries. One commenter expressed concern that requiring first country
customs clearance dates would be burdensome and lead to reporting
delays. Another commenter stated that for reexports within the EEA,
subsequent reexports beyond the second country should not be reportable
to the DEA, because this information serves no purpose for the DEA and
would be unduly burdensome for U.S. exporters to collect and report.
Response: As stated earlier, the requirement to report the date of
release by a customs official remains as proposed. Some importers/
exporters may need to obtain this information from their brokers. To
remove the ambiguity created from the ``date of import'' and ``date of
export,'' the DEA chose the date of release by a customs officer. In
addition, the DEA is requiring the date the shipment arrives (for
imports) or leaves (for exports) the registered location or place of
business. These two dates provide the proper accountability of the
amounts of controlled substances or listed chemicals.
[3] Comment: One commenter requested that the European Economic
Area (EEA) should apply to member countries as of November 25, 2015.
For example, this commenter noted that when the 2015 Act was passed on
November 25, 2015, the United Kingdom was still a member of the
European Union. The commenter suggested that it is unclear whether or
not the United Kingdom's EEA membership will be affected after it
separates from the European Union. To provide stability in implementing
the 2015 Act's provisions, the commenter requested that the DEA
consider, for purposes of the 2015 Act, that the EEA countries include
those that were members on November 25, 2015.
Response: The 2015 Act is devoid of any language stating that the
EEA includes those members as of November 25, 2015. Accordingly, the
DEA interprets that for the EEA provisions to apply, the country must
be a member at the time the export leaves the United States.
F. Miscellaneous Comments (2 Issues)
Two comments were received that were not within the scope of this
rulemaking, and will not be addressed. Both addressed drug scheduling
actions that were outside the subject area of this final rule.
III. Section by Section Summary of the Final Rule
A. 21 CFR Part 1300
For purposes of clarity and transparency, the DEA is updating 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. Additionally, the DEA is making a technical change to more
concisely incorporate U.S. obligations under international treaties of
drug control, as statutorily codified in the CSA.
B. 21 CFR Part 1301
The DEA is amending Sec. Sec. 1301.24, 1301.26, 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
the customs service of an Insular Area and not CBP.
The DEA is also 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.
This topic has 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/DRL, 8701 Morrissette Drive,
Springfield, VA 22152'' to ``Drug Enforcement Administration, Attn:
Federal Register Representative/DRW, 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.
C. 21 CFR Part 1302
Corresponding to the removal of ``jurisdiction of the United
States'' and the revised definitions of ``export'' and ``import,'' the
DEA is making 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.
D. 21 CFR Part 1303
Corresponding to recent internal DEA reorganization, the mailing
addresses for Sec. Sec. 1303.12(b) and (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.
[[Page 97007]]
E. 21 CFR Part 1304
The DEA is making 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.)
The DEA is also making a technical amendment to amend Sec.
1304.21(d) to separately state reporting requirements concerning
imports and exports of controlled substances. The record date for
receipt, distribution, other transfer, or destruction will not change.
The regulation will be amended to state that the record date for
imports or exports of controlled substances is the anticipated date of
release by a customs officer for permits and declarations and the date
on which the controlled substance was released by a customs officer at
the port of entry or port of export.
F. 21 CFR Part 1308
The DEA is making two technical updates to part 1308. First, the
DEA is amending 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 is
amending 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 is
also realigning the paragraphs of Sec. 1308.49 to properly separate
the discussion of the circumstances in which a temporary scheduling
order will be vacated.
G. 21 CFR Part 1309
The DEA is amending 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 correcting and updating 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 correcting and updating the cross-reference in Sec.
1309.51(a) by removing the cross-reference to Sec. 1309.57 and
replacing it with the cross-reference ``Sec. 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 ``Sec.
1309.55.'' Finally, the DEA is correcting two minor typographic issues
in Sec. 1309.71: capitalizing the first word of paragraph (b)(5) and
adding an ``and'' at the end of paragraph (b)(7).
H. 21 CFR Part 1310
i. Mail Order Reporting for Ephedrine, Pseudoephedrine,
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
The DEA is incorporating 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 is implementing usage of a new form, DEA Form
453. The new form is accessed, completed, and submitted by regulated
persons entirely through the DEA Diversion Control Division secure
network application. 21 CFR 1310.03(c) is 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. This 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) is revised to reflect that the monthly mail-order
information required to be submitted would now be submitted on the DEA
Form 453 and is designated as Sec. 1310.06(k). 21 CFR 1310.03(c) is
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.
This 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 making a technical amendment 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 substantive
requirements.
ii. Listed Chemicals and Tableting and Encapsulating Machines
The DEA is amending Sec. 1310.05 to require reports of unusual or
excessive loss or disappearance of a listed chemical to be filed
through the DEA Diversion Control Division secure network application.
When determining whether a loss is unusual or excessive, the guidelines
that the regulated person should consider are: (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 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 is clarifying in the revised Sec.
1310.05(b)(1) that regulated persons must submit a report of unusual or
excessive loss or
[[Page 97008]]
disappearance whether or not the listed chemical is subsequently
recovered. The DEA also has 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 is also removing the phrase ``whenever possible'' from the
oral reporting requirements of the current Sec. 1310.05(b). The DEA
believes that the phrase is redundant given 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 is
restructuring Sec. 1310.05(a) and (b) to reflect the revised reporting
structure. Paragraph (a) is addressing 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) is addressing those reports made
orally to the local DEA office with written reports being submitted
through the DEA Diversion Control Division secure network application.
The reporting requirements now located in Sec. 1310.05(b) will 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 is clarifying 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 are 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 is revised to reflect the various changes in
Sec. Sec. 1310.03-1310.05. Cross-citations have been amended to
reflect where regulations have been moved and new forms instituted. In
Sec. 1310.06(a)(3) regulated persons are required 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 previous Sec. 1310.06(c), which
incorrectly referenced Sec. 1310.05(a)(4) instead of Sec.
1310.05(a)(3). 21 CFR 1310.06(c) previously stated 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 previous
Sec. 1310.05(a)(3) (now Sec. 1310.05(b)(1)). The DEA also is making
technical amendments in Sec. 1310.06, including replacing the term
``shall'' in paragraphs (a) and (b).
The DEA is standardizing 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. In the revised Sec. 1310.05(b)(2), the DEA is making the
oral reporting mandatory and mandating the electronic filing of the
written report. The DEA also is providing specific guidelines on when
those reports must be given. The revised Sec. 1310.05(b)(2) requires
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) is 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 reporting
timeframe 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 is exercising 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,
covers 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 previous Sec. 1310.05(a)(4).
The requirements for the content of domestic reports were moved from
Sec. 1310.06(d) to a new Sec. 1310.06(f), while the requirements for
reports of importations and exportations are all contained within Sec.
1310.06(e). The DEA also is amending 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. In Sec. 1310.06(e)(1)(vi) and (f)(3), the DEA is
requiring 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 amending 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 for controlled
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 is required to be submitted
electronically through the DEA Diversion Control Division 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 Sec. 1310.06(h), importers are 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 are 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 revisions relating to tableting and encapsulating machines that
would standardize the submission of reports of
[[Page 97009]]
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'' or ``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.
Regulatory changes in the final rule 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. In response to commenters who
stated that the 24 hour notification requirement related to import or
export denials was unreasonable, the DEA has modified this requirement
from 24 hours to 5 business days. The DEA believes that 5 business days
strikes a balance between investigative needs without unduly burdening
the regulated community. 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.
I. 21 CFR Part 1312
The DEA is making a technical amendment 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 is amending 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
is also amending 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 or regulated
person. Drop shipments, i.e., deliveries made by an importer directly
to a customer without passing through the registered location of the
importer, are explicitly prohibited under the 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.
A technical amendment to paragraph (a) of Sec. 1312.15 is made 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 amending its regulations regarding expiration
dates associated with imports and exports of controlled substances. The
DEA is changing 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 is also amending 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 requiring that
declarations expire 180 calendar days after the date the declaration is
deemed filed with the Administration.
The DEA is modifying the condition previously found in Sec.
1312.22(a) that requires an application 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
is 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 account for any changes in
international treaties, conventions, or protocols which might be made
in the future.
This final rule 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 amending Sec. Sec. 1312.12, 1312.18, 1312.22, and
1312.27 to require
[[Page 97010]]
registrants or regulated persons, 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 requiring 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 requiring 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 of release by customs. Both dates
are needed to adequately monitor the closed system of distribution for
import and export transactions.
The DEA is revising 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. 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 is amending 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 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
Diversion Control Division 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 Diversion Control Division 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 is amending Sec. Sec. 1312.22, 1312.31, and 1312.32 to
require a certified translation of 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.
For the purposes of this requirement, certified translation will mean
that the translator has signed the translation legally attesting to the
accuracy of the translation. 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.
In response to commenters who stated that the 24 hour notification
requirement related to import or export denials was unreasonable, the
DEA has modified this requirement from 24 hours to 5 business days. The
DEA believes that 5 business days strikes a balance between
investigative needs without unduly burdening the regulated community.
As mentioned above, in response to comments the DEA amended
Sec. Sec. 1312.13(e) and 1312.23(e) in a manner that is different than
proposed. The language added to this section will emphasize that a
shipment of controlled substances is 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 as opposed to multiple conveyances. In addition, the
language will coincide with current policy by prohibiting a load of
goods from being divided into multiple parts to be placed onto more
than one conveyance, even if the goods are on the same loading
document. A single permit could not be used for this situation above.
J. 21 CFR Part 1313
The DEA is adding a new Sec. 1313.03 that will consolidate the DEA
Form information applicable to part 1313 in a corresponding change for
the new Sec. 1312.03. The new Sec. 1313.03 will 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 is amending 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 revision
will impose the same requirement for import/export declarations as for
listed chemicals.
Declarations (DEA Forms 486/486A) will not be deemed filed until
the transaction identification number has been issued by the DEA. Upon
receipt and review, the DEA will assign each declaration a transaction
identification number (a unique identifier). Once the declaration is
accepted and assigned a
[[Page 97011]]
transaction identification number, registrants will 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 change is consistent with
current practices. Currently, the DEA assigns a Web Tracking Number to
each declaration when it is submitted and accepted. The 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 wishes to clarify that import or export transactions may
not proceed as soon as the transaction identification number has been
issued, because the 15-calendar-day requirement since the filing of DEA
Form 486/486A has not changed. Import or export transactions for which
the 15-calendar-day notification has been waived, may proceed as soon
as the transaction identification number has been issued, regardless of
whether the 3 business days have elapsed since filing of DEA Form 486/
486A.
The DEA is making 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 requiring that return information must be reported within 30
calendar days after release by a customs officer at the port of entry,
export, or reexport. All return information for applications or other
initial filings that are required to be made electronically through the
DEA Diversion Control Division secure network application would
likewise be required to be filed electronically through the same
system. As with controlled substance return information, the DEA is
requiring 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 revising 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, are explicitly prohibited under
the 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.
The DEA is amending Sec. 1313.22(a) to add a cross-reference to
Sec. 1310.04(g) relating to listed chemicals that may be exported.
This change will harmonize Sec. 1313.22(a) with Sec. 1313.21(a).
In response to commenters who stated that the 24 hour notification
requirement related to import or export denials was unreasonable, the
DEA has modified this requirement from 24 hours to 5 business days. The
DEA believes that 5 business days strikes a balance between meeting
investigative needs and not unduly burdening the regulated community.
K. 21 CFR Part 1314
Corresponding to recent internal DEA reorganization, in Sec.
1314.110, in paragraphs (a)(1) and (2), the phrase ``Import/Export
Unit,'' will be removed and in its place ``Regulatory Section,
Diversion Control Division,'' will be added.
L. 21 CFR Part 1315
Corresponding to recent internal DEA reorganization, the mailing
addresses for Sec. Sec. 1303.12(b) and (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.
M. 21 CFR Part 1316
The DEA is amending 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 will 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 amending 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.
The DEA is amending 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 is also amending 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 is making 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
[[Page 97012]]
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/DRL, 8701
Morrissette Drive, Springfield, VA 22152'' to ``Drug Enforcement
Administration, Attn: Federal Register Representative/DRW, 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.
N. 21 CFR Part 1321
The DEA is amending the Table of DEA Mailing Addresses found in
Sec. 1321.01 to account for changes in this rule as part of the
implementation of ITDS. The DEA is also taking this opportunity to
implement various technical amendments to the Table of DEA Mailing
Addresses.
Pursuant to this final action all import and export applications
and filings would be submitted through the DEA Diversion Control
Division secure network application. The DEA will 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 will note with an
asterisk that those filings must now be made electronically. The CFR
sections listed under the DEA Import/Export Unit will be merged with
those under the DEA Regulatory Section and placed under the header of
``DEA Regulatory Section.''
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 Diversion Control Division to the DEA Drug & Chemical
Evaluation Section (DRE), 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) and (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.
IV. Regulatory Analyses
Executive Orders 12866, Regulatory Planning and Review, and 13563,
Improving Regulation and Regulatory Review
This final rule was developed in accordance with the principles of
Executive Orders 12866 and 13563. The DEA has determined that this
final 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 final rule can
be found in the rulemaking docket at http://www.regulations.gov, under
FDMS Docket ID: DEA-2016-0017 (Docket No. DEA-403).
Executive Order 12988, Civil Justice Reform
The 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, Federalism
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, Consultation and Coordination With Indian Tribal
Governments
This final 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
[[Page 97013]]
above. The complete threshold analysis is available at http://www.regulations.gov for easy reference. The DEA specifically solicited
written comments regarding the DEA's economic threshold analysis of the
impact of these proposed changes. The DEA requested that commenters
provide detailed descriptions in their comment of any expected economic
impacts, especially to small entities. Commenters were asked to provide
empirical data to illustrate the nature and scope of such impact. No
comments were received; thus, the analysis that accompanied the NPRM
remains unchanged below.
In accordance with the RFA, the DEA evaluated the impact of this
rule on small entities. This final 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 final 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 EPH, PSE, PPA, or
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 final 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 mandating 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
mandating 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 are 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,\10\ 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
Diversion Control Division secure network application.
---------------------------------------------------------------------------
\10\ 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
[[Page 97014]]
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 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 specifying 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 final rule. This rule
will 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 final 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 final rule and has submitted
this collection request to the Office of Management and Budget (OMB)
for review and approval. This final rule updates the DEA regulations
for import and export of controlled substances, listed chemicals, and
tableting and encapsulating machines. The rule 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 Final Rule
The DEA is revising existing information collections 1117-0004,
1117-0009 and 1117-0013 by
[[Page 97015]]
establishing mandatory filing of return information for imports and
exports of controlled substances.
Additionally, the DEA is also revising 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 revising 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 revising 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 EPH, PSE, PPA, or GHB
(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 EPH, PSE, PPA, or GHB
(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 mandating
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 amending Sec. 1312.22 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, in Sec. 1312.22 the DEA is
requiring 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 Diversion Control Division secure
network application (available on the DEA Diversion Control Division
Web site) that such export has occurred and the specifics of the
transaction.
As part of the implementation of ITDS, the DEA is establishing a
new DEA Form 161R-EEA, discussed in greater detail below, to be used by
registrants or regulated persons 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 amending Sec. 1312.22 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 requires 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 Diversion Control Division secure
network application (available on the DEA Diversion Control Division
Web site) that such export has occurred and the specifics of the
transaction. Also consistent with current requirements, the amended
text requires 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, are required to be accessed, completed, and submitted to
the DEA through the DEA Diversion Control Division secure network
application.
This final rule contains amendments that 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
establishing 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 or regulated
persons who export controlled substances for reexport among members of
the European Economic Area. Specifically, in Sec. 1312.22, the DEA is
requiring that 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 Diversion
Control Division 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 application requirements for the two
types of transactions required by the CSA. Most important of these
[[Page 97016]]
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 previous Sec. 1312.22(d)(7) (now 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 Diversion
Control Division 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 final 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 mandating
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 amending to Sec. 1312.18(e) 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 Diversion
Control Division Web site certifying that such import occurred and the
details of the transaction.
The DEA is amending to Sec. 1312.27(d) in the final 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 Diversion Control Division secure network application
(available on the DEA Diversion Control Division 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 Diversion Control Division secure
network application (available on the DEA Diversion Control Division
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 mandating
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 adding Sec. 1312.12(d) 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, in Sec. 1312.12(d), the DEA is
requiring 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 Diversion Control Division secure
network application (available on the DEA Diversion Control Division
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.
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.
[[Page 97017]]
As part of the implementation of the ITDS, the DEA is establishing
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 previous Sec.
1310.05(a)(4) for domestic regulated transactions in a tableting or
encapsulating machine as well as the report required in the previous
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 Diversion Control Division secure
network application.
Moreover, under both the previous 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. The DEA now clarifies
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 Diversion Control Division 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 mandating 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 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 Diversion Control Division secure network application
(available on the DEA Diversion Control Division 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.
As part of the implementation of the ITDS, the DEA is establishing
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 previous 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 Diversion Control Division 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 Diversion Control Division
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 establishing
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 previous 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 Diversion Control Division 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 units; the package type; the
number of 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 is amending part 1310 in order for DEA Form 453 to be submitted to
the DEA electronically on or before the 15th
[[Page 97018]]
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.
Rule Text
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 amends 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. Revise definitions of ``Export'' and ``Import'';
0
b. Add definitions of ``Competent national authority'', ``Customs
officer'', ``Port of entry'', ``Port of export'', ``Return
information'', and ``United States'', in alphabetical order; and
0
c. Remove the definition of ``Jurisdiction of the United States''.
The revisions and additions read as follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) * * *
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(i) (that is, of the U.S. Customs and Border
Protection), 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 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's
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.
* * * * *
[[Page 97019]]
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.
* * * * *
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. Add definitions of ``Competent national authority'', ``Customs
officer'', ``Export'', ``Import'', ``Port of entry'', ``Port of
export'', ``Return information'', and ``United States'', in
alphabetical order; and
0
b. Remove definitions of ``Chemical import'' and ``Jurisdiction of the
United States''.
The additions read as follows:
Sec. 1300.02 Definitions relating to listed chemicals.
* * * * *
(b) * * *
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(i) (that is, of the U.S. Customs and Border
Protection), 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.
* * * * *
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. In Sec. 1301.12, revise paragraph (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. In Sec. 1301.24, revise paragraph (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. In Sec. 1301.26, revise paragraph (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. In Sec. 1301.34, revise paragraph (c)(2) to read as follows:
[[Page 97020]]
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. In Sec. 1301.74, revise paragraph (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.
(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. These sealing
and labeling requirements are in addition to any sealing requirements
required under applicable customs laws.
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. In Sec. 1303.12:
0
a. In paragraph (b), remove ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' and add in its place ``UN Reporting
and Quota Section, Diversion Control Division''; and
0
b. In paragraph (d), remove ``Drug & Chemical Evaluation Section, Drug
Enforcement Administration'' and add in its place ``UN Reporting and
Quota Section, Diversion Control Division''.
Sec. 1303.22 [Amended]
0
14. In Sec. 1303.22 introductory text, remove ``Drug & Chemical
Evaluation Section, Drug Enforcement Administration'' and add in its
place ``UN Reporting and Quota Section, Diversion Control Division''.
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. In Sec. 1304.21, revise paragraph (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 anticipated date of release by a customs official for permit
applications and declarations and the date on which the controlled
substances are released by a customs officer at the port of entry or
port of export for return information.
* * * * *
Sec. 1304.31 [Amended]
0
18. In Sec. 1304.31(a), remove ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' and add in its place ``UN Reporting
and Quota Section, Diversion Control Division''.
Sec. 1304.32 [Amended]
0
19. In Sec. 1304.32(a), remove ``Drug and Chemical Evaluation Section,
Drug Enforcement Administration'' and add in its place ``UN Reporting
and Quota Section, Diversion Control Division''.
0
20. In Sec. 1304.33, revise paragraphs (a) and (f)(1) to read as
follows:
[[Page 97021]]
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, Diversion
Control Division, 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) Exceptions. (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, Diversion Control Division, 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 this part.
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, Diversion Control Division, 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, Diversion Control Division, 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, Diversion Control Division, 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, Diversion Control Division, 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, Diversion Control Division, 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.
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. In Sec. 1309.26, revise paragraph (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. In Sec. 1309.32, revise paragraph (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. In Sec. 1309.71, revise paragraphs (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
* * * * *
[[Page 97022]]
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. In Sec. 1310.03:
0
a. In paragraph (b), remove ``Section 1310.05'' and add in its place
``Sec. 1310.05''; and
0
b. Revise paragraph (c).
The revision reads as follows:
Sec. 1310.03 Persons required to keep records and file reports.
* * * * *
(c)(1) Each regulated person who engages in a transaction with a
nonregulated person which:
(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or
gamma hydroxybutyric acid (including drug products containing these
chemicals or controlled substance); and
(ii) 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 Diversion Control Division secure network
application.
(2) Each regulated person who engages in an export transaction
which:
(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or
gamma hydroxybutyric acid (including drug products containing these
chemicals or controlled substance); and
(ii) 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
Diversion Control Division secure network application.
0
38. In Sec. 1310.05, revise paragraphs (a), (b), (c), (d) and (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. 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 Diversion Control
Division 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;
and
(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 Diversion Control Division 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
[[Page 97023]]
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 Diversion Control Division 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 5 business
days 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 Diversion Control Division 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, Diversion Control Division, 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 (d) 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 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.
[[Page 97024]]
(c)(1) Each report required by Sec. 1310.05(a) must include the
information as specified by paragraph (a) of this section, 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;
(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; and
(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) 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; and
(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 release; 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 Diversion Control Division 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
[[Page 97025]]
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
Diversion Control Division secure network application specifying the
particulars of the transaction. This report must include the following
information: The date on which 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 Diversion Control
Division 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).
(12) Lot number (if drug product).
(l) Information provided in reports required by Sec. 1310.05(e)
which is exempt from disclosure under section 552(a) of title 5, by
reason of section 552(b)(6) of title 5, 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, Diversion Control Division, 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 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 electronic.
to Export Controlled Substances for
Subsequent Reexport Among Members of the
European Economic Area.
DEA Form 236, Controlled Substances Import/ electronic.
Export Declaration.
[[Page 97026]]
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; 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 Diversion Control Division 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 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; and
(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
Diversion Control Division 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 5 business days 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 Diversion Control
[[Page 97027]]
Division 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. In Sec. 1312.13, revise paragraph (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. A single
import permit shall authorize a quantity of goods to be imported/
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
commercial loading document; a single permit shall not authorize a
quantity of goods to be imported/exported if the goods are divided onto
two or more conveyances. 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
Diversion Control Division 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. In Sec. 1312.15:
0
a. In paragraph (a):
0
i. Remove the phrase ``the U.S. Customs Service'' and add in its place
``U.S. Customs and Border Protection or customs service of an Insular
Area''; and
0
ii. At the end of the first sentence, add the phrase ``in accordance
with Sec. 1312.16(a)''; and
0
b. In paragraph (b):
0
i. Remove the phrase ``the U.S. Customs Service'' and add in its place
``U.S. Customs and Border Protection or customs service of an Insular
Area''; and
0
ii. In the final sentence, remove ``Director of the Administration''
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 Diversion Control Division 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 Diversion Control Division 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 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
[[Page 97028]]
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
Diversion Control Division 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 and paragraphs (b), (c) introductory
text, and (c)(3); and
0
b. 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 Diversion Control Division 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
Diversion Control Division 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 Diversion Control
Division secure network application. Except as provided in Sec. Sec.
1312.16(a)(5) and 1312.15(a), importers must submit all amendments at
least one full business day in advance of the date of release by a
customs officer. Importers must specifically note that an amendment is
being made; supplementary information submitted by an importer through
the DEA Diversion Control Division 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 paragraph (g) of
this section.
(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 Diversion
Control Division 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 5 business days 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 Diversion Control Division secure
network application.
[[Page 97029]]
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 Diversion Control Division 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 Diversion Control Division 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, 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; and
(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), (g), and (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.
[[Page 97030]]
(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), (g), and (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. (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 Diversion Control Division 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) of this section, 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 with the Administration through
the DEA Diversion Control Division 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 Diversion Control Division 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
[[Page 97031]]
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 paragraphs (f)(1) through (4) and (6)
of this section 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) through (4) and (6) of this section and
paragraph (g)(2) are met with respect to each subsequent country from
which the controlled substance is exported pursuant to this paragraph
(g); and
(B) The conditions applicable with respect to the second country
under paragraphs (f)(1) through (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 (g).
(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 Diversion Control Division 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; and
(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 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
[[Page 97032]]
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
Diversion Control Division 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), (g), and (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 5
business days 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 Diversion Control
Division 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. In Sec. 1312.23, revise paragraph (e) 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. A single export permit shall authorize a quantity of
goods to be 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 commercial loading document; a single permit shall not
authorize a quantity of goods to be exported if the goods are divided
onto two or more conveyances. 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 Diversion
Control Division 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 Diversion Control Division secure network
application. Except as provided in paragraph (a)(5) 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
Diversion Control Division 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.
[[Page 97033]]
(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
Diversion Control Division 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 Diversion Control
Division 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 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.
(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.
(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
(B) The substance is being imported for consumption within the
importing country to satisfy medical, scientific or other legitimate
purposes.
(v) The reexport of non-narcotic controlled substances in Schedules
III and IV, and controlled substances in
[[Page 97034]]
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 Diversion Control Division 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--(1) 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 Diversion Control Division 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.
(2) Return information for reexports outside of the European
Economic Area--(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 with the Administration through the DEA
Diversion Control Division 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.
(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
[[Page 97035]]
the first country to the second country the exporter must file a report
with the Administration through the DEA Diversion Control Division
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.
(3) Reexports among members of the European Economic Area--(i)
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)(2)(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
exporter must file a report with the Administration through the DEA
Diversion Control Division 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 Diversion Control
Division 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
Diversion Control Division 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 paragraph
(f) of this section.
(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 5 business days 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 Diversion Control Division 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 Diversion Control Division 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 Diversion
Control Division secure network application after the Administration
issues a transaction identification number) required pursuant to Sec.
1312.27(d) as his or her record of authority for the exportation, in
accordance with part 1304 of this chapter.
0
59. In Sec. 1312.31:
0
a. Revise paragraph (b) introductory text;
0
b. In paragraph (d)(2), remove the word ``and'' at the end of the
paragraph;
0
c. In paragrarph (d)(3), remove the period at the end of the paragraph
and add ``; and'' in its place; and
0
d. Add paragraph (d)(4).
The revision and addition 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, Diversion Control Division, 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:
* * * * *
[[Page 97036]]
(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.
* * * * *
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, Diversion Control Division, 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.
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 and 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) 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 Diversion Control
Division 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 Diversion Control Division 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, Diversion Control Division, 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
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,
[[Page 97037]]
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. For List I chemicals, 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 Diversion Control Division 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
65. 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, three 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 Diversion
Control Division 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 Diversion Control
Division secure network application specifying the particulars of the
transaction. This report must include the following information: The
date on which 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
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 Diversion Control
Division 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 5 business days 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
[[Page 97038]]
Diversion Control Division 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 and 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) 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 Diversion Control
Division 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 Diversion Control Division 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, Diversion Control Division, 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
Diversion Control Division 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 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
[[Page 97039]]
statutory authority other than the Controlled Substances Import and
Export Act. An official record of the declaration (available from the
DEA Diversion Control Division 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 of three 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
Diversion Control Division 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
Diversion Control Division 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 Diversion Control Division
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 5 business days 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 Diversion Control Division 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 Sec. 1313.21(b).
0
74. In Sec. 1313.31, revise paragraphs (b) introductory text and
(b)(7), (8), (14), and (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, Diversion Control Division, 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:
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,
[[Page 97040]]
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 Diversion Control Division 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 Diversion Control Division 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. In Sec. 1313.33, revise the paragraphs (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 Diversion Control
Division 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 Diversion Control Division 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 Diversion Control Division 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:
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,
Diversion Control Division''.
PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE,
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
0
81. The authority citation for part 1315 continues to read as follows:
[[Page 97041]]
Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.
0
82. In part 1315, remove ``Drug & Chemical Evaluation Section, Drug
Enforcement Administration'' and ``Drug & Chemical Evaluation Section''
and add in their place ``UN Reporting & Quota Section, Diversion
Control Division, Drug Enforcement Administration''.
PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
Subpart D--Administrative Hearings
0
83. 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
84. In Sec. 1316.47, revise paragraph (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 Sir:
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
85. 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 Sir:
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
86. The authority citation for part 1321 continues to read:
Authority: 21 U.S.C. 871(b).
0
87. 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.
------------------------------------------------------------------------
DEA Diversion Control Division
------------------------------------------------------------------------
1307.03--Exception request filing. Drug Enforcement
1307.22--Delivery of surrendered and Administration, Attn:
forfeited controlled substances. Diversion Control Division/
1310.21(b)--Sale by Federal departments or DC, 8701 Morrissette Drive,
agencies of chemicals which could be used Springfield, VA 22152.
to manufacture controlled substances
certification request.\2\
[[Page 97042]]
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/DRG,
review for List I chemicals. 8701 Morrissette Drive,
1310.03(c)--Mail-Order reports involving Springfield, VA 22152.
transactions with nonregulated persons or
exports.\1\
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.\1\
1310.05(c)(1)--Reports of imports and
exports of a tableting machine or an
encapsulating machine.\1\
1310.05(c)(2)--Report of declared exports
of machines refused, rejected, or
returned.
1312.12(a)--Application for import permit
(DEA Form 357).\1\
1312.18(b)--Import declaration (DEA Form
236) submission.\1\
1312.22(g)(8)--Request for return of
unacceptable or undeliverable exported
controlled substances.\1\
1312.27(a)--Controlled substances export
declaration (DEA Form 236) filing.\1\
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).\1\
1313.12(e)--Quarterly reports of listed
chemicals importation.
1313.21(b)--Authorization to export listed
chemicals (DEA Form 486).\1\
1313.21(e)--Quarterly reports of listed
chemicals exportation.
1313.22(c)--Notice of declared exports of
listed chemicals refused, rejected or
undeliverable.\1\
1313.31(b)--Advanced notice of importation
for transshipment or transfer of listed
chemicals.
1313.32(b)(1)--International transaction
authorization (DEA Form 486).\1\
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
preparations. Section/DRE, 8701
1308.24(d)--Exempt narcotic chemical Morrissette Drive,
preparations importer/exporter reporting. Springfield, VA 22152.
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/
DRQ, 8701 Morrissette
Drive, Springfield, VA
22152.
[[Page 97043]]
1303.12(d)--Controlled substances quota
adjustment request.
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.
1315.22--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,
and 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/DOPT, 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, 225, Registration Section/DRR
and 363. P.O. Box 2639, Springfield,
1301.14(a)--Controlled substances VA 22152-2639.
registration application submission.
1301.18(c)--Research project controlled
substance increase request.
1301.51--Controlled substances
registration modification request.
1301.52(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:
1303.34--Request for hearing or Hearing Clerk/OALJ, 8701
appearance; waiver. Morrissette Drive,
1308.44--Request for hearing or Springfield, VA 22152.
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 Drug Enforcement
regarding application for bulk Administration, Attn:
manufacture of Schedule I and II Federal Register
substances.\2\ Representative/DRW, 8701
1301.34(a)--Filing of written comments Morrissette Drive,
regarding application for importation of Springfield, VA 22152.
Schedule I and II substances.\2\ http://www.regulations.gov/.
1303.11(c)--Filing of written comments
regarding notice of an aggregate
production quota.\2\
1303.13(c)--Filing of written comments
regarding adjustments of aggregate
production quotas.\2\
1303.13(c)--Filing of written comments
regarding adjustments of aggregate
production quotas.\2\
1308.43(g)--Filing of written comments
regarding initiation of proceedings for
rulemaking.\2\
------------------------------------------------------------------------
\1\ Applications/filings/reports are required to be filed electronically
in accordance with this chapter.
\2\ Applications/filings/reports may be filed electronically in
accordance with this chapter.
[[Page 97044]]
Dated: November 28, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-28966 Filed 12-29-16; 8:45 am]
BILLING CODE 4410-09-P